Cardiology News

Workers who had the highest exposure to hydrocarbons during the Deepwater Horizon oil spill disaster had a higher risk of having a hypertension diagnosis in the years following the event, a new study suggests.

Results showed that the highest exposure to total petroleum hydrocarbons during the cleanup operation was associated with a 31% higher risk of new hypertension 1-3 years later.

“What is remarkable is that we still found an increased risk of hypertension a couple of years after the cleanup had been completed. This suggests working in this environment even for a short period could have long-term health consequences,” lead author Richard Kwok, PhD, told this news organization.

The study was published online in JAMA Network Open.

For the study, Dr. Kwok, a scientist at the U.S. National Institute of Environmental Health Sciences, and colleagues estimated the levels of exposure to toxic hydrocarbons in 6,846 adults who had worked on the oil spill cleanup after the Deepwater Horizon disaster in 2010, during which 200 million gallons of oil spilled into the Gulf of Mexico. They then investigated whether there was an association with the development of hypertension 1-3 years later.

“Clean-up efforts started almost immediately and lasted over a year,” Dr. Kwok noted. “In the first few months, oil flowed freely into the Gulf of Mexico which released high levels of volatile organic compounds into the air that the workers could have been exposed to. The exposures change over time because the oil becomes weathered and starts to decompose and harden. This is associated with a lower level of volatile organic compounds but can still cause damage.”

Workers involved in the cleanup may have been there for just a few days or could have spent many months at the site and would have had different exposures depending on what types of jobs they were doing, Dr. Kwok reported.

“The highest levels of exposure to total hydrocarbons would have been to those involved in the early months of the oil spill response and cleanup when the oil was flowing freely, and those who were skimming oil off the water, burning oil, handling dispersants, or involved in the decontamination of the vessels. Others who were involved in the cleanup on land or support functions would have had lower exposures,” he said.

Each worker was interviewed and asked about their activities during the cleanup operation, the location of work, and period of work. Their level of exposure to total petroleum hydrocarbons (THCs) was estimated based on their self-reported activities, and when and where they worked.

Two measures of estimated cumulative THC were calculated: cumulative maximum daily exposure, which summed the maximum daily THC exposure level, and cumulative mean exposure, which summed the mean daily exposure levels. These THC values were categorized into quintiles based on the exposure distribution among workers.

Systolic and diastolic blood pressure measurements were collected for the workers during home exams from 2011 to 2013 using automated oscillometric monitors. Newly detected hypertension was defined as either antihypertensive medication use or elevated blood pressure since the spill.

Results showed a clear dose relationship between the level of THC exposure and the development of hypertension at follow-up.

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

Workers who had the highest exposure to hydrocarbons during the Deepwater Horizon oil spill disaster had a higher risk of having a hypertension diagnosis in the years following the event, a new study suggests.

Results showed that the highest exposure to total petroleum hydrocarbons during the cleanup operation was associated with a 31% higher risk of new hypertension 1-3 years later.

“What is remarkable is that we still found an increased risk of hypertension a couple of years after the cleanup had been completed. This suggests working in this environment even for a short period could have long-term health consequences,” lead author Richard Kwok, PhD, told this news organization.

The study was published online in JAMA Network Open.

For the study, Dr. Kwok, a scientist at the U.S. National Institute of Environmental Health Sciences, and colleagues estimated the levels of exposure to toxic hydrocarbons in 6,846 adults who had worked on the oil spill cleanup after the Deepwater Horizon disaster in 2010, during which 200 million gallons of oil spilled into the Gulf of Mexico. They then investigated whether there was an association with the development of hypertension 1-3 years later.

“Clean-up efforts started almost immediately and lasted over a year,” Dr. Kwok noted. “In the first few months, oil flowed freely into the Gulf of Mexico which released high levels of volatile organic compounds into the air that the workers could have been exposed to. The exposures change over time because the oil becomes weathered and starts to decompose and harden. This is associated with a lower level of volatile organic compounds but can still cause damage.”

Workers involved in the cleanup may have been there for just a few days or could have spent many months at the site and would have had different exposures depending on what types of jobs they were doing, Dr. Kwok reported.

“The highest levels of exposure to total hydrocarbons would have been to those involved in the early months of the oil spill response and cleanup when the oil was flowing freely, and those who were skimming oil off the water, burning oil, handling dispersants, or involved in the decontamination of the vessels. Others who were involved in the cleanup on land or support functions would have had lower exposures,” he said.

Each worker was interviewed and asked about their activities during the cleanup operation, the location of work, and period of work. Their level of exposure to total petroleum hydrocarbons (THCs) was estimated based on their self-reported activities, and when and where they worked.

Two measures of estimated cumulative THC were calculated: cumulative maximum daily exposure, which summed the maximum daily THC exposure level, and cumulative mean exposure, which summed the mean daily exposure levels. These THC values were categorized into quintiles based on the exposure distribution among workers.

Systolic and diastolic blood pressure measurements were collected for the workers during home exams from 2011 to 2013 using automated oscillometric monitors. Newly detected hypertension was defined as either antihypertensive medication use or elevated blood pressure since the spill.

Results showed a clear dose relationship between the level of THC exposure and the development of hypertension at follow-up.

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

Workers who had the highest exposure to hydrocarbons during the Deepwater Horizon oil spill disaster had a higher risk of having a hypertension diagnosis in the years following the event, a new study suggests.

Results showed that the highest exposure to total petroleum hydrocarbons during the cleanup operation was associated with a 31% higher risk of new hypertension 1-3 years later.

“What is remarkable is that we still found an increased risk of hypertension a couple of years after the cleanup had been completed. This suggests working in this environment even for a short period could have long-term health consequences,” lead author Richard Kwok, PhD, told this news organization.

The study was published online in JAMA Network Open.

For the study, Dr. Kwok, a scientist at the U.S. National Institute of Environmental Health Sciences, and colleagues estimated the levels of exposure to toxic hydrocarbons in 6,846 adults who had worked on the oil spill cleanup after the Deepwater Horizon disaster in 2010, during which 200 million gallons of oil spilled into the Gulf of Mexico. They then investigated whether there was an association with the development of hypertension 1-3 years later.

“Clean-up efforts started almost immediately and lasted over a year,” Dr. Kwok noted. “In the first few months, oil flowed freely into the Gulf of Mexico which released high levels of volatile organic compounds into the air that the workers could have been exposed to. The exposures change over time because the oil becomes weathered and starts to decompose and harden. This is associated with a lower level of volatile organic compounds but can still cause damage.”

Workers involved in the cleanup may have been there for just a few days or could have spent many months at the site and would have had different exposures depending on what types of jobs they were doing, Dr. Kwok reported.

“The highest levels of exposure to total hydrocarbons would have been to those involved in the early months of the oil spill response and cleanup when the oil was flowing freely, and those who were skimming oil off the water, burning oil, handling dispersants, or involved in the decontamination of the vessels. Others who were involved in the cleanup on land or support functions would have had lower exposures,” he said.

Each worker was interviewed and asked about their activities during the cleanup operation, the location of work, and period of work. Their level of exposure to total petroleum hydrocarbons (THCs) was estimated based on their self-reported activities, and when and where they worked.

Two measures of estimated cumulative THC were calculated: cumulative maximum daily exposure, which summed the maximum daily THC exposure level, and cumulative mean exposure, which summed the mean daily exposure levels. These THC values were categorized into quintiles based on the exposure distribution among workers.

Systolic and diastolic blood pressure measurements were collected for the workers during home exams from 2011 to 2013 using automated oscillometric monitors. Newly detected hypertension was defined as either antihypertensive medication use or elevated blood pressure since the spill.

Results showed a clear dose relationship between the level of THC exposure and the development of hypertension at follow-up.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day — I find myself momentarily resenting the patients on my schedule.

As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.

Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?

Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.

First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)

One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.

In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.

But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.

Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?

I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.

Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.

But is this actually true? Or is this my unrealistic expectation of myself?

Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”

Wow, I thought, Healthcare checks all of these boxes.

• Perceived unfairness of work schedules? Check.
• Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.

But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?

• Do we, as physicians, fail to set boundaries?
• Do we fail to ask for what we need?

Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)

And the last one:

• Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?

My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.

But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.

Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?

And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).

It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.

Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”

As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.

Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”

I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.

Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”

Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?

“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”

Again, the discrepancy between expectations and reality creates the negative emotion.

Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”

Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.

Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.

Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”

I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?

Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.

Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.

Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.

Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.

In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.

Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.

“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.

“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”

The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
 

Cardiometabolic health factors

Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.

Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.

Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.

In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).

State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.

They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.

Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”

Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
 

Socioeconomic intervention

Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”

The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.

Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.

The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”

This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.

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

Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.

In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.

Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.

“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.

“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”

The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
 

Cardiometabolic health factors

Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.

Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.

Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.

In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).

State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.

They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.

Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”

Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
 

Socioeconomic intervention

Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”

The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.

Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.

The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”

This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.

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

Less than half of women in the United States enter pregnancy in favorable cardiovascular health, new research suggests.

In 2019, among women aged 20 to 44 years with live births in the United States, only 40.2% were in favorable cardiovascular health prior to pregnancy, defined as normal weight, no diabetes, and no hypertension.

Although all regions and states showed a decline in prepregnancy favorable cardiometabolic health, there were significant differences among geographic regions in the country, the authors report. “These data reveal critical deficiencies and geographic disparities in prepregnancy cardiometabolic health,” they conclude.

“One of the things that we know in the U.S. is that the maternal mortality rate has been increasing, and there are significant differences at the state level in both adverse maternal outcomes, such as maternal mortality, as well as adverse pregnancy outcomes,” corresponding author Sadiya S. Khan, MD, MS, FACC, Northwestern University Feinberg School of Medicine, Chicago, told this news organization.

“These outcomes are often related to health factors that predate pregnancy,” Dr. Khan explained, “and the processes that begin at the very, very beginning of conception are informed by health factors prior to pregnancy, in particular cardiometabolic factors like body mass index or obesity, high blood pressure, and diabetes.”

The results were published online on Feb. 14 in a special “Go Red for Women” spotlight issue of Circulation.
 

Cardiometabolic health factors

Using maternal birth records from live births in the Centers for Disease Control and Prevention Natality Database between 2016 and 2019, the authors analyzed data on 14,174,625 women with live births aged 20 to 44 years. The majority (81.4%) were 20 to 34 years of age, 22.7% were Hispanic or Latina, and 52.7% were non-Hispanic White.

Favorable cardiometabolic health was defined as a BMI of 18 to 24.9 kg/m2, absence of diabetes, and absence of hypertension.

Although all regions and states experienced a decline in favorable cardiometabolic health during the study period of 2016 to 2019, with a drop overall of 3.2% – from 43.5 to 40.2 per 100 live births – it was especially true of the South and Midwest regions.

In 2019, favorable prepregnancy cardiometabolic health was lowest in the South (38.1%) and Midwest (38.8%) and highest in the West (42.2%) and Northeast (43.6%).

State by state, the lowest prevalence of favorable cardiometabolic health was found in Mississippi, at 31.2%, and highest in Utah, at 47.2%.

They also found a correlation between favorable cardiometabolic health and state-level percentages of high-school education or less and enrollment in Medicaid in 2019.

Similar to what has been seen with cardiovascular disease, “we observe that the states with the lowest prevalence of favorable cardiometabolic health were in the Southeast United States,” said Dr. Khan, “and similar geographic variation was observed with some more patterns in education and Medicaid coverage for birth, and these were used as proxies for socioeconomic status in those areas.”

Although Dr. Khan notes that the relationships cannot be determined to be causal from this analysis, she said that “it does suggest that upstream social determinants of health are important determinants of cardiometabolic health.”
 

Socioeconomic intervention

Dr. Khan noted that policies at the federal and state level can identify ways to “ensure that individuals who are thinking about pregnancy have access to health care and have access to resources, too, from a broad range of health determinants, including housing stability, food security, as well as access to health care be optimized prior to pregnancy.”

The authors note that this analysis may actually overestimate the prevalence of favorable cardiometabolic health, and data on cholesterol, diet, a distinction between type 1 and type 2 diabetes, and physical activity were not available.

Only individuals with live births were included, which could result in the elimination of a potentially high-risk group; however, late pregnancy losses represent less than 0.3% of all pregnancies, they say.

The authors conclude that “future research is needed to equitably improve health prior to pregnancy and quantify the potential benefits in cardiovascular disease outcomes for birthing individuals and their offspring.”

This work was supported by grants from the National Heart, Lung, and Blood Institute and American Heart Association Transformational Project Award awarded to Sadiya S. Khan.

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

Regular use of acetaminophen, also known as paracetamol, in effervescent or soluble formulations that contain sodium increases the risk of cardiovascular disease (CVD) and death in people with or without hypertension, a large observational study of more than 300,000 adults suggests.

“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.

The study was published online Feb. 24 in the European Heart Journal.
 

‘Compelling results’

Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.

Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).

“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.

Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).

After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).

A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.

The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).

There was also evidence of a dose-response relationship.

In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.

Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).

“The results are compelling,” write the authors of an editorial published with the study.

“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.

“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.

The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.

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

Regular use of acetaminophen, also known as paracetamol, in effervescent or soluble formulations that contain sodium increases the risk of cardiovascular disease (CVD) and death in people with or without hypertension, a large observational study of more than 300,000 adults suggests.

“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.

The study was published online Feb. 24 in the European Heart Journal.
 

‘Compelling results’

Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.

Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).

“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.

Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).

After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).

A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.

The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).

There was also evidence of a dose-response relationship.

In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.

Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).

“The results are compelling,” write the authors of an editorial published with the study.

“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.

“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.

The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.

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

Regular use of acetaminophen, also known as paracetamol, in effervescent or soluble formulations that contain sodium increases the risk of cardiovascular disease (CVD) and death in people with or without hypertension, a large observational study of more than 300,000 adults suggests.

“Numerous studies have reported that high sodium intake is associated with increased risks of cardiovascular disease,” Yuqing Zhang, DSc, with Massachusetts General Hospital and Harvard Medical School, Boston, told this news organization. “Given that the pain relief effect of non–sodium-containing acetaminophen is similar to that of sodium-containing acetaminophen, clinicians may prescribe non–sodium-containing acetaminophen to their patients to minimize the risk of CVD and mortality,” Dr. Zhang said.

The study was published online Feb. 24 in the European Heart Journal.
 

‘Compelling results’

Dr. Zhang and colleagues note that the effervescent and soluble formulations of 0.5 g acetaminophen contain 0.44 and 0.39 g of sodium, respectively.

Therefore, the intake of maximum daily dose (4 g/day) of sodium-containing acetaminophen corresponds to the ingestion of more than 3 g of sodium, a dose that alone exceeds the recommended total daily sodium intake allowance of the World Health Organization (2 g/day).

“This hidden extra sodium intake is often overlooked,” Dr. Zhang told this news organization.

Using data from the Health Improvement Network, a U.K. primary care database, the researchers examined 4,532 patients with hypertension taking sodium-containing acetaminophen and compared them with 146,866 patients with hypertension taking non–sodium-containing acetaminophen (tablet, capsule, or oral suspension formulations).

After 1 year, the risk of incident CVD (myocardial infarction, stroke, and heart failure) was 5.6% in those taking sodium-containing acetaminophen, compared with 4.6% in those taking non–sodium-containing acetaminophen (average weighted hazard ratio, 1.59; 95% confidence interval, 1.32-1.92).

A separate analysis of normotensive patients taking sodium-containing acetaminophen (n = 5,351) or non–sodium-containing acetaminophen (n = 141,948) gave similar results.

The 1-year risk of incident CVD was 4.4% in those taking sodium-containing acetaminophen vs. 3.7% among those taking non–sodium-containing acetaminophen (average weighted HR, 1.45; 95% CI, 1.18-1.79).

There was also evidence of a dose-response relationship.

In those with hypertension, CVD risk increased by roughly one-quarter (odds ratio, 1.26) for those with one prescription of sodium-containing acetaminophen and by nearly one half (OR, 1.45) for those with five or more prescriptions of sodium-containing acetaminophen. Similar findings were observed among adults without hypertension.

Mortality at 1 year was also higher in those taking sodium-containing acetaminophen than non–sodium-containing acetaminophen, in patients with hypertension (7.6% vs. 6.1%) and without hypertension (7.3% vs. 5.9%).

“The results are compelling,” write the authors of an editorial published with the study.

“The direct message from this study is clear – there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” say Aletta Schutte, PhD, and Bruce Neal, MBChB, PhD, of the George Institute for Global Health, Sydney.

“The weight of the evidence makes ongoing inaction on sodium-containing medications untenable. The widespread use of effervescent medication in the general population, and the enormous doses of sodium that can be consumed inadvertently by unsuspecting consumers requires urgent action,” Dr. Schutte and Dr. Neal say.

The study was supported by the National Natural Science Foundation of China, the National Key Research and Development Project, the Project Program of National Clinical Research Center for Geriatric Disorders, the Key Research and Development Program of Hunan Province, and the Science and Technology Program of Hunan Province. Dr. Zhang, Dr. Schutte, and Dr. Neal have disclosed no relevant financial relationships.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

Have you experienced malpractice?

No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.

It seems to me that physicians may be especially prone to receiving substandard care. If true, there could be several explanations. The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.

Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.

Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.

Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.

Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.

No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?

I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.

Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.

I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)

He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.

As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.

Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.

At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”

Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)

If you have been the victim of physician malpractice, how did you respond?

Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?

Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.

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

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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

Low-value health care services that provide little or no benefit to patients are “common, potentially harmful, and costly,” and there is a critical need to reduce this kind of care, the American Heart Association said in a newly released scientific statement.

Each year, nearly half of patients in the United States will receive at least one low-value test or procedure, with the attendant risk of avoidable complications from cascades of care and excess costs to individuals and society, the authors noted. Reducing low-value care is particularly important in cardiology, given the high prevalence and costs of cardiovascular disease in the United States.

The statement was published online Feb. 22, 2022, in Circulation: Cardiovascular Quality and Outcomes.
 

High burden with uncertain benefit

“Cardiovascular disease is common and can present suddenly, such as a heart attack or abnormal heart rhythm,” Vinay Kini, MD, chair of the statement writing group and assistant professor of medicine at Weill Cornell Medicine, New York, said in a news release.

“Our desire to be vigilant about treating and preventing cardiovascular disease may sometimes lead to use of tests and procedures where the benefits to patients may be uncertain,” Dr. Kini said. “This may impose burdens on patients, in the form of increased risk of physical harm from the low-value procedure or potential complications, as well as follow-up care and out-of-pocket financial costs.”

For example, studies have shown that up to one in five echocardiograms and up to half of all stress tests performed in the United States may be rated as rarely appropriate, based on established guidelines for their use.

In addition, up to 15% of percutaneous coronary interventions (PCIs) are classified as rarely appropriate, the writing group said.

Annually, among Medicare fee-for-service beneficiaries, low-value stress testing in patients with stable coronary artery disease is estimated to cost between $212 million and $2.1 billion, while costs of PCI for stable CAD range from $212 million to $2.8 billion, the writing group noted.

“At best, spending on low-value care potentially diverts resources from higher-value services that would benefit patients more effectively at the same or reduced cost. At worst, low-value care results in physical harm in the form of preventable morbidity and mortality,” they said.

“Thus, reducing low-value care is one of the few patient-centered solutions that directly address both the need to control health care spending and the societal imperative to devote its limited resources to beneficial health care services that improve health,” they added.

The group outlines several ways to reduce low-value cardiovascular care targeting patients, providers, and payers/policymakers.

For patients, education and shared decision-making may help reduce low-value care and dispel misconceptions about the intended purpose of test or treatment, they suggested.

For clinicians, a “layered” approach to reducing low-value care may be most effective, such as through education, audit and feedback, and behavioral science tools (“nudges”) to shift behaviors and practices, they said.

For payers and policy leaders, interventions to reduce low-value care include national insurance coverage determinations; prior authorization; alternative payment models that reward lower costs and higher-quality health care; value-based insurance designs that financially penalize low-value care; and medical liability reform to reduce defensive medical practices.

Low-value cardiovascular care is a complex problem, the writing group acknowledged, and achieving meaningful reductions in low-value cardiovascular care will require a multidisciplinary approach that includes continuous research, implementation, evaluation, and adjustment while ensuring equitable access to care.

“Each approach has benefits and drawbacks,” Dr. Kini said. “For example, prior authorization imposes a large burden on health care professionals to obtain insurance approval for tests and treatments. Prior authorization and some value-based payment models may unintentionally worsen existing racial and ethnic health care disparities.

“A one-size-fits-all approach to reducing low-value care is unlikely to succeed; rather, acting through multiple perspectives and frequently measuring impacts and potential unintended consequences is critical,” he concluded.

The scientific statement was prepared by the volunteer writing group on behalf of the AHA’s Council on Quality of Care and Outcomes Research.

The research had no commercial funding. Dr. Kini disclosed no relevant financial relationships.

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