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Proposed insurance policy ignites debate over transgender health care

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Mon, 02/14/2022 - 10:05

A new proposed insurance rule to limit discrimination in health plans has ignited a debate over transgender health care.

The policy, known as the Notice of Benefit and Payment Parameters, is part of the Biden administration’s proposal for 2023 for government health insurance exchanges. The rule would require health plans to ensure their benefit designs and implementation don’t discriminate based on sexual orientation, gender identity, age, sociodemographic factors, or other conditions.

The Obama administration first implemented the standard, but the Trump administration removed “sexual orientation” and “gender identity” from the antidiscrimination language in 2020. The Biden proposal would restore protections for those categories.

“We believe such amendments are warranted in light of the existing trends in health care discrimination and are necessary to better address barriers to health equity for LGBTQI+ individuals,” the Department of Health and Human Services wrote in the proposed rule.

The Biden administration, Democratic lawmakers, and advocacy groups have noted that the rule is vital for LGBTQ consumers to access care. But some private insurance companies have said the policy could drive up costs and that the language about what constitutes discrimination is too vague. Conservative groups have also argued that no clinical evidence supports covering care that affirms gender identity, such as hormone blockers or surgery.

Under the proposed rule, an insurer in the government health exchanges wouldn’t be classified as providing “essential health benefits” under federal law if discrimination was found, Roll Call reported. State regulators would be required to enforce the proposal.

The Department of Health and Human Services and the Centers for Medicare and Medicaid Services listed examples of presumptive discrimination that would be banned, such as limiting gender-affirmative care within a health plan. Several state health plains either don’t address coverage or limit coverage for specific services for transgender people, Roll Call reported.

Health benefit plans wouldn’t have to cover every possible health care service, Katie Keith, a researcher at Georgetown University’s Center on Health Insurance Reforms, wrote in an article for Health Affairs. However, an insurer can’t have a different policy or restricted plans for transgender people over patients whose gender identity and sexual orientation match their birth gender.

The proposed rule has sparked a flurry of reactions in recent weeks. America’s Health Insurance Plans, a trade association for health insurance companies, said the nondiscrimination framework is overly broad and limits insurers’ abilities to design plans with controlled costs.

The rule “could create a slippery slope of eliminating benefit limits that are based on clinical evidence, support value-based care, and ensure affordable premiums,” the group wrote in a response letter.

Some conservative groups have pushed back against the coverage requirements as well. The Family Research Council and the Heritage Foundation have questioned the benefits or validity of gender-affirmative care, according to Roll Call.

On the other hand, the HIV+ Hepatitis Policy Initiative said the new rule could help patients who have long faced coverage issues. For instance, some insurers put HIV drugs on the highest-cost plan tiers, which can lead to major expenses for patients.

“It’s not just HIV. It’s other [chronic disease] patients, too,” Carl Schmid, executive director of the patient advocacy group, told Roll Call.

Other insurers, such as the Alliance of Community Health Plans, have said that the updated rule doesn’t give insurers enough time to implement changes. Under the proposal, insurers would have 60 days from final publication to ensure that plans meet the nondiscrimination framework. The group has suggested an effective date of 2024 or later, rather than 2023.

At the same time, some insurance groups have said they’re ready for the change now. The Association for Community Affiliated Plans, which represents small nonprofit plans, said many of its member health plans have already committed resources to ensure all patients can access services, including gender-affirming services or gender identity support for LGBTQ patients.

“We find that their forward-thinking work is – and should be – increasingly the norm,” Margaret Murray, the association’s CEO, wrote in a response letter.

Comments on the proposed rule were due Jan. 27. Now the proposal will wind through the annual approval process.

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

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A new proposed insurance rule to limit discrimination in health plans has ignited a debate over transgender health care.

The policy, known as the Notice of Benefit and Payment Parameters, is part of the Biden administration’s proposal for 2023 for government health insurance exchanges. The rule would require health plans to ensure their benefit designs and implementation don’t discriminate based on sexual orientation, gender identity, age, sociodemographic factors, or other conditions.

The Obama administration first implemented the standard, but the Trump administration removed “sexual orientation” and “gender identity” from the antidiscrimination language in 2020. The Biden proposal would restore protections for those categories.

“We believe such amendments are warranted in light of the existing trends in health care discrimination and are necessary to better address barriers to health equity for LGBTQI+ individuals,” the Department of Health and Human Services wrote in the proposed rule.

The Biden administration, Democratic lawmakers, and advocacy groups have noted that the rule is vital for LGBTQ consumers to access care. But some private insurance companies have said the policy could drive up costs and that the language about what constitutes discrimination is too vague. Conservative groups have also argued that no clinical evidence supports covering care that affirms gender identity, such as hormone blockers or surgery.

Under the proposed rule, an insurer in the government health exchanges wouldn’t be classified as providing “essential health benefits” under federal law if discrimination was found, Roll Call reported. State regulators would be required to enforce the proposal.

The Department of Health and Human Services and the Centers for Medicare and Medicaid Services listed examples of presumptive discrimination that would be banned, such as limiting gender-affirmative care within a health plan. Several state health plains either don’t address coverage or limit coverage for specific services for transgender people, Roll Call reported.

Health benefit plans wouldn’t have to cover every possible health care service, Katie Keith, a researcher at Georgetown University’s Center on Health Insurance Reforms, wrote in an article for Health Affairs. However, an insurer can’t have a different policy or restricted plans for transgender people over patients whose gender identity and sexual orientation match their birth gender.

The proposed rule has sparked a flurry of reactions in recent weeks. America’s Health Insurance Plans, a trade association for health insurance companies, said the nondiscrimination framework is overly broad and limits insurers’ abilities to design plans with controlled costs.

The rule “could create a slippery slope of eliminating benefit limits that are based on clinical evidence, support value-based care, and ensure affordable premiums,” the group wrote in a response letter.

Some conservative groups have pushed back against the coverage requirements as well. The Family Research Council and the Heritage Foundation have questioned the benefits or validity of gender-affirmative care, according to Roll Call.

On the other hand, the HIV+ Hepatitis Policy Initiative said the new rule could help patients who have long faced coverage issues. For instance, some insurers put HIV drugs on the highest-cost plan tiers, which can lead to major expenses for patients.

“It’s not just HIV. It’s other [chronic disease] patients, too,” Carl Schmid, executive director of the patient advocacy group, told Roll Call.

Other insurers, such as the Alliance of Community Health Plans, have said that the updated rule doesn’t give insurers enough time to implement changes. Under the proposal, insurers would have 60 days from final publication to ensure that plans meet the nondiscrimination framework. The group has suggested an effective date of 2024 or later, rather than 2023.

At the same time, some insurance groups have said they’re ready for the change now. The Association for Community Affiliated Plans, which represents small nonprofit plans, said many of its member health plans have already committed resources to ensure all patients can access services, including gender-affirming services or gender identity support for LGBTQ patients.

“We find that their forward-thinking work is – and should be – increasingly the norm,” Margaret Murray, the association’s CEO, wrote in a response letter.

Comments on the proposed rule were due Jan. 27. Now the proposal will wind through the annual approval process.

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

A new proposed insurance rule to limit discrimination in health plans has ignited a debate over transgender health care.

The policy, known as the Notice of Benefit and Payment Parameters, is part of the Biden administration’s proposal for 2023 for government health insurance exchanges. The rule would require health plans to ensure their benefit designs and implementation don’t discriminate based on sexual orientation, gender identity, age, sociodemographic factors, or other conditions.

The Obama administration first implemented the standard, but the Trump administration removed “sexual orientation” and “gender identity” from the antidiscrimination language in 2020. The Biden proposal would restore protections for those categories.

“We believe such amendments are warranted in light of the existing trends in health care discrimination and are necessary to better address barriers to health equity for LGBTQI+ individuals,” the Department of Health and Human Services wrote in the proposed rule.

The Biden administration, Democratic lawmakers, and advocacy groups have noted that the rule is vital for LGBTQ consumers to access care. But some private insurance companies have said the policy could drive up costs and that the language about what constitutes discrimination is too vague. Conservative groups have also argued that no clinical evidence supports covering care that affirms gender identity, such as hormone blockers or surgery.

Under the proposed rule, an insurer in the government health exchanges wouldn’t be classified as providing “essential health benefits” under federal law if discrimination was found, Roll Call reported. State regulators would be required to enforce the proposal.

The Department of Health and Human Services and the Centers for Medicare and Medicaid Services listed examples of presumptive discrimination that would be banned, such as limiting gender-affirmative care within a health plan. Several state health plains either don’t address coverage or limit coverage for specific services for transgender people, Roll Call reported.

Health benefit plans wouldn’t have to cover every possible health care service, Katie Keith, a researcher at Georgetown University’s Center on Health Insurance Reforms, wrote in an article for Health Affairs. However, an insurer can’t have a different policy or restricted plans for transgender people over patients whose gender identity and sexual orientation match their birth gender.

The proposed rule has sparked a flurry of reactions in recent weeks. America’s Health Insurance Plans, a trade association for health insurance companies, said the nondiscrimination framework is overly broad and limits insurers’ abilities to design plans with controlled costs.

The rule “could create a slippery slope of eliminating benefit limits that are based on clinical evidence, support value-based care, and ensure affordable premiums,” the group wrote in a response letter.

Some conservative groups have pushed back against the coverage requirements as well. The Family Research Council and the Heritage Foundation have questioned the benefits or validity of gender-affirmative care, according to Roll Call.

On the other hand, the HIV+ Hepatitis Policy Initiative said the new rule could help patients who have long faced coverage issues. For instance, some insurers put HIV drugs on the highest-cost plan tiers, which can lead to major expenses for patients.

“It’s not just HIV. It’s other [chronic disease] patients, too,” Carl Schmid, executive director of the patient advocacy group, told Roll Call.

Other insurers, such as the Alliance of Community Health Plans, have said that the updated rule doesn’t give insurers enough time to implement changes. Under the proposal, insurers would have 60 days from final publication to ensure that plans meet the nondiscrimination framework. The group has suggested an effective date of 2024 or later, rather than 2023.

At the same time, some insurance groups have said they’re ready for the change now. The Association for Community Affiliated Plans, which represents small nonprofit plans, said many of its member health plans have already committed resources to ensure all patients can access services, including gender-affirming services or gender identity support for LGBTQ patients.

“We find that their forward-thinking work is – and should be – increasingly the norm,” Margaret Murray, the association’s CEO, wrote in a response letter.

Comments on the proposed rule were due Jan. 27. Now the proposal will wind through the annual approval process.

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

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Omicron death rate higher than during Delta surge

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Fri, 02/11/2022 - 13:07

With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

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With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

With the Omicron variant now accounting for almost 100% of COVID-19 cases in the United States, the 7-day average of daily COVID-related deaths hit 2,600 recently, the highest rate in about a year, the Washington Post reported.

That’s higher than the approximately 2,000 daily deaths in fall 2021 during the Delta surge, but less than the 3,000 daily deaths in January 2021, when COVID vaccines were not widely available, the Post’s data analysis said.

The Omicron variant generally causes less severe disease than other strains of COVID, but because it is so transmissible, Omicron is infecting higher raw numbers of people that previous strains.

“Even if on a per-case basis fewer people develop severe illness and die, when you apply a small percentage to a very large number, you get a substantial number,” Jennifer Nuzzo, DrPH, an epidemiologist at the Johns Hopkins University, Baltimore, told the Post.

The unvaccinated, people over 75, and people with underlying medical conditions are the groups most endangered by Omicron, the Post said. About half of the deaths in January 2022 were among people over 75, compared with about a third in September 2021 during the Delta surge.

The age trend is seen in Florida, said Jason Salemi, PhD, an epidemiologist at the University of South Florida, Tampa. He told the Post that seniors accounted for about 85% of deaths in the winter of 2020-2021, about 60% during the Delta surge, and about 80% now during the Omicron surge.

The uptick in senior deaths may have occurred because seniors who got vaccinated in early 2021 didn’t get boosted ahead of the Omicron surge, he said.

“Omicron may be less severe for younger people, but it will still find vulnerable seniors in our community,” Dr. Salemi said. “That vaccination back in February isn’t as effective now if you aren’t boosted.”

CDC data shows that 95% of people in the United States over 65 have gotten at least one dose of vaccine, 88.5% are fully vaccinated, but only 62.5% have gotten a booster dose.

The COVID death rate is highest in the Midwest. During the last 2 months, Chicago reported more than 1,000 COVID deaths, almost as much as the December 2020 peak, The Post said. Minorities have been hit hard. About third of the city’s population is Black but about half the COVID victims are Black, the Post said.

“It’s been challenging because it goes up against the national narrative that omicron is nothing dangerous,” said Allison Arwady, commissioner of the Chicago Department of Public Health.

In a Feb. 9 news briefing at the White House, CDC Director Rochelle Walensky, MD, provided slightly different statistics on COVID-related deaths. She said that the 7-day average of daily deaths was about 2,400, up 3% from the previous week.

The 7-day daily average of cases is about 247,300 cases per day, down 44% from the previous week, she said. Hospital admissions are about 13,000 daily, down 25% from the previous week.

Dr. Walensky said the Omicron variant now accounts for almost 100% of COVID viruses circulating in the United States.

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

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Testes may ‘serve as viral sanctuary’ for SARS-CoV-2, small study shows

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Fri, 02/11/2022 - 12:15

A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

 

 

The authors say they are the first to show:

  • The longer the severe condition, the lower the number of surviving germ cells.
  • There was fluctuation in several essential testicular genes.
  • The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

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A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

 

 

The authors say they are the first to show:

  • The longer the severe condition, the lower the number of surviving germ cells.
  • There was fluctuation in several essential testicular genes.
  • The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

A small study of deceased nonvaccinated men who died of COVID-19 complications suggests the testes may be a sanctuary for the SARS-CoV-2 virus, raising questions about potential consequences for reproductive health among those infected.

The study, published online Feb. 8 on the preprint server MedRxiv, found that “patients who become critically ill exhibit severe damages and may harbor the active virus in testes,” which can “serve as a viral sanctuary.”

Guilherme M.J. Costa, PhD, a professor at Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, led the study, which has not yet been peer-reviewed.

“A critical point of this article is that the virus was active in the patient’s testis after a long period of infection, indicating that the testis is able to maintain the viable virus for extended periods. It happens for many kinds of viruses in this genital organ,” Dr. Costa said in an interview.

Brian Keith McNeil, MD, vice-chair, department of urology at SUNY Downstate Health Sciences University in New York, told this news organization that the topic of COVID-19 and fertility has been discussed but data are sparse on the subject.

“The question this raises is whether or not COVID can live in the testes, and based on this it seems it can,” he said, adding that it also raises the question of whether COVID-19 could be transmitted through semen. “It leads one to wonder whether this could have a long-term impact on fertility in men and women.”

The authors wrote that deep testicular evaluation of patients who have been infected with COVID-19 is critical because the testes have one of the highest expressions of angiotensin converting enzyme 2 (ACE2) receptors, which play a large role in entrance of the virus into cells.

“A direct influence of SARS-CoV-2 in testicular cells might deregulate ACE2, elevating the levels of angiotensin II, a potent pro-inflammatory and angiogenic peptide,” the authors wrote.
 

Sperm-producing cells infected

In 2021, the researchers enrolled 11 male patients deceased from COVID-19 complications; none had received a vaccine. Infection was confirmed by SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) performed during their hospital stay. All 11 patients were admitted to the intensive care unit with severe pulmonary symptoms.

All but one of the patients had children and none had scrotal symptoms or complaints during their time in the hospital. Their clinical histories revealed no testicular disorders.

Dr. Costa said they found that detecting SARS-CoV-2 mRNA in testes is difficult in a conventional RT-PCR test.

Therefore, “We modified the protocol of the RT-PCR and used nanosensors. We observed that SARS-CoV-2 has a huge tropism for the testes in this context,” he said.

He said the team performed stainings and “discovered that macrophages and germ cells are highly infected.”

That’s important, he said, because an immune cell, which is supposed to fight the virus, is infected in the tissue. Also, the germ cell, responsible for sperm production, is infected.

“This reopens the worries about the presence of SARS-CoV-2 in semen, as other authors mentioned,” he said.
 

New findings

The team also found that the testes are a good place for viral replication.

 

 

The authors say they are the first to show:

  • The longer the severe condition, the lower the number of surviving germ cells.
  • There was fluctuation in several essential testicular genes.
  • The intratesticular testosterone levels are 30 times reduced in the testes of COVID-19 patients.

The control group was composed of six patients who had undergone testicle removal after prostate cancer was suspected. Collection of both testicles from the test group was performed within 3 hours of death after a family member signed an informed consent document.

Recent research on semen demonstrates that patients who recovered from COVID-19 reestablish their sperm quality after 3 months of infection.

That study, in Fertility and Sterility, found that sperm quality was initially reduced for months in some men after recovery from COVID-19.

The team studied semen samples from 120 Belgian men (mean age, 35 years) at an average 52 days after their last COVID-19 symptoms. The semen was not found to be infectious.

But among 35 men who provided samples within a month after infection, reductions in sperm motility were evident in 60% and sperm counts were reduced in 37%, according to the report.
 

Testicular damage

The results [of the Costa et al. paper] emphasize the importance of testicular damage in severe COVID-19,” Rafael Kroon Campos, PhD, a postdoctoral fellow in the department of microbiology & immunology at the University of Texas Medical Branch at Galveston, said in an interview.

He noted that other viruses have also been shown to infect or otherwise cause testicular damage or orchitis, such as Zika, Ebola, and the closely related SARS-CoV-1. Sexual transmission has been documented for Zika and Ebola viruses.

Dr. Campos said with SARS-CoV-2, it is unclear whether sexual transmission plays a role.

“Some reports found evidence of viral RNA in semen, but these were rare occurrences. The study by Costa and colleagues used a combination of sensitive techniques and they were able to detect a small amount of viral RNA and viral protein in the testicular tissue of the deceased patients, as well as show viral factories indicating replication of the virus by electron microscopy,” he said.

Dr. Campos said the findings are particularly important and concerning because of the large number of severe cases of COVID-19.

“It is critical to continue to investigate the impact of the disease in testes, including the impact of different variants of concern on testicular damage,” he said.

Dr. McNeil and Dr. Campos have disclosed no relevant financial relationships.

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

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Perinatal deaths from COVID show ‘extensive’ placental damage

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Thu, 12/15/2022 - 14:33

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

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Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

Recent evidence has shown that women who contract COVID-19 during pregnancy are at increased risk for pregnancy loss and neonatal death. Now, an analysis of pathology data from dozens of perinatal deaths shows how.

Unlike numerous pathogens that kill the fetus by infecting it directly, SARS-CoV-2 causes “widespread and severe” destruction of the placenta that deprives the fetus of oxygen, a team of 44 researchers in 12 countries concluded after examining 64 stillbirths and four neonatal deaths in which the placentas were infected with the virus. They noted that such damage occurs in a small percentage of pregnant women with COVID and that all the women in the study had not been vaccinated against the disease.

The findings were published online Feb. 10 in the Archives of Pathology & Laboratory Medicine.

Nearly all placentas had each of three features that pathologists have dubbed SARS-CoV-2 placentitis: large deposits of fibrin, a clotting protein that obstructs the flow of blood, death of cells in the trophoblast, and an unusual form of inflammation called chronic histiocytic intervillositis. Some had other abnormalities that could have exacerbated the condition.

The researchers called the extent of damage “striking,” affecting 77.7% of the placenta on average. The virus did not appear to harm fetal tissue, but placental damage “was extensive and highly destructive,” they write. Notably, none of the women in the analysis were known to have severe COVID.
 

Virus seen ‘chewing up the placenta’

David Schwartz, MD, a pathologist in Atlanta, and the lead author of the study, said COVID appears to be unique in destroying the placenta.

“I don’t know of any infection that does that to this degree or with this uniformity,” Dr. Schwartz told this news organization. “The simple message is that this infection is chewing up the placenta and destroying its capability to oxygenate the fetus.”

In November, the Centers for Disease Control and Prevention reported that maternal COVID increases the risk of losing a pregnancy. From March 2020 to September 2021, 8,154 stillbirths were reported, affecting 0.65% of births by women without COVID and 1.26% of births by women with COVID, for a relative risk of 1.90 (95% confidence interval, 1.69-2.15).

Delta, the variant that dominated in mid-2021, appears to have been particularly harmful. The CDC reported that the relative risk for stillbirth for mothers with COVID-19 during that period increased to 4.04 (95% CI, 3.28-4.97). Many cases in the new analysis coincided with Delta.

Dr. Schwartz and his colleagues said immunization, along with antiviral therapy, might reduce the chance of SARS-CoV-2 infecting the placenta. None of the mothers in the analysis was vaccinated, and Dr. Schwartz said he is not aware of a single case in a vaccinated woman.

The analysis comes on the heels of a study from the National Institutes of Health linking severe to moderate COVID infection to greater risk of other pregnancy complications: cesarean and preterm delivery, death during childbirth, postpartum hemorrhaging, and non-COVID infections.

Diana Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said those findings underscore the need for pregnant women to be vaccinated. (The shots have been shown to be safe for pregnant women.)

Denise Jamieson, MD, MPH, chair of the department of gynecology and obstetrics at Emory University, Atlanta, who was not involved in the new analysis, said the findings may have important clinical implications. In addition to ensuring that pregnant patients are fully vaccinated, she said “there may be opportunities to more closely monitor the placenta during pregnancy using imaging modalities such as ultrasound.”

Even in the presence of severe abnormalities, a fetus that has reached a viable gestational age could potentially be delivered prior to stillbirth, Dr. Jamieson said. The 64 stillbirths in the analysis ranged from 15 to 39.2 weeks of gestation, with an average of 30 weeks. Eight were delivered at full term.

However, additional studies are needed to support monitoring of placental changes, she said: “It is not ready for prime time now.”

Christopher Zahn, MD, vice president of practice activities the American College of Obstetricians and Gynecologists, cautioned that data on COVID and pregnancy complications remain limited.

The findings in this analysis “do not prove the association between COVID-19 infection and neonatal outcomes,” Dr. Zahn said. “While stillbirth could potentially be another adverse outcome for pregnant people who contract COVID-19, currently we don’t have enough data to confirm that a COVID-19 infection at any point in pregnancy indicates increased risk of stillbirth.”

He added that ACOG continues to strongly recommend vaccination against COVID for women who are pregnant, recently pregnant, or planning to be pregnant.

Dr. Schwartz and Dr. Jamieson have disclosed no relevant financial relationships. One author reported receiving financial support from the Slovak Research and Development Agency. Another reported funding from the Belgian Fund for Scientific Research and the Fetus for Life charity.

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

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Breast cancer now leading cause of cancer death in Black women

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Thu, 12/15/2022 - 17:23

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

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Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

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Universal hepatitis B screening, vaccination deemed cost effective for pregnant women

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Tue, 02/15/2022 - 10:22

Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

Dr. Malavika Prabhu

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

 

 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

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Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

Dr. Malavika Prabhu

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

 

 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

Screening for hepatitis B antibodies and vaccinating pregnant women without immunity appears to be a cost-effective health measure, according to a recent analysis published in Obstetrics & Gynecology.

Malavika Prabhu, MD, of the division of maternal-fetal medicine and department of obstetrics and gynecology at Weill Cornell Medicine in New York, said in an interview that the impetus to conduct the study came from the idea that hepatitis B is a concern throughout a woman’s life, but not necessarily during pregnancy. While vaccination is not routine during pregnancy, guidelines from the American College of Obstetricians and Gynecologists state that at-risk women should be screened and vaccinated for hepatitis B during pregnancy.

Dr. Malavika Prabhu

“What we thought made more sense just from thinking about other principles of prenatal care was that it would make sense for us to screen, see who’s susceptible, counsel them on the risk of hepatitis B, and then vaccinate them in the course of the pregnancy,” Dr. Prabhu said.

After writing a commentary arguing in favor of universal screening and vaccination, she and her colleagues noted it was still unclear whether that approach was cost effective, she said. “Health care costs in this country are so expensive at baseline that, as we continue to add more things to health care, we have to make sure that it’s value added.”

Dr. Prabhu and her colleagues evaluated a theoretical cohort of 3.6 million pregnant women in the United States and created a decision-analytic model to determine how universal hepatitis B surface antibody screening and vaccination for hepatitis B affected factors such as cost, cost-effectiveness, and outcomes. They included hepatitis B virus cases as well as long-term problems associated with hepatitis B infection such as hepatocellular carcinoma, decompensated cirrhosis, liver transplant, and death. Assumptions of the model were that 84% of the women would undergo the screening, 61% would receive the vaccine, and 90% would seroconvert after the vaccine series, and were based on probabilities from other studies.

The cost-effectiveness ratio was calculated as the total cost and quality-adjusted life-years (QALYs) relative to the lifetime of the woman after the index pregnancy, with $50,000 per QALY set as the willingness-to-pay threshold. The researchers also performed an additional analysis and simulations to estimate which variables had the most effect, and an additional model was created to estimate the effect of universal screening and vaccination if at-risk patients were removed.

Dr. Prabhu and colleagues found the universal screening and vaccination program was cost effective, with 1,702 fewer cases of hepatitis B, 11 fewer deaths, 7 fewer decompensated cirrhosis cases, and 4 fewer liver transplants in their model. The incremental cost-effectiveness ratio was $1,890 per QALY, and the total increased lifetime cohort cost was $13,841,889. The researchers said the model held up in scenarios where there was a high level of hepatitis B immunity, and when at-risk women were removed from the model.

“While it does increase some costs to the health care system to screen everyone and vaccinate those susceptible; overall, it would cost more to not do that because we’re avoiding all of those long-term devastating health outcomes by vaccinating in pregnancy,” Dr. Prabhu said in an interview.
 

 

 

Hepatitis B screening and vaccination for all pregnant women?

Is universal hepatitis B screening and vaccination for pregnant women an upcoming change in prenatal care? In a related editorial, Martina L. Badell, MD, of the division of maternal-fetal medicine and department of gynecology and obstetrics at Emory University School of Medicine in Atlanta, emphasized the hepatitis B vaccine’s safety and effectiveness during pregnancy based on prior studies and compared a universal hepatitis B screening and vaccination program for pregnant women to how clinicians screen universally for rubella as standard of care in this group.

“Owing to the success of rubella vaccination campaigns, today there are fewer than 10 cases of rubella in the United States annually, and, since 2012, all of these cases have been in persons infected when living in or traveling to other countries,” she wrote. “Approximately 850,000 people are living with hepatitis B infection in the United States, and approximately 21,900 acute hepatitis B infections occurred in 2015. Despite the very different prevalence in these infections, we currently screen pregnant and nonpregnant patients for rubella immunity but not hepatitis B.”

If real-world studies bear out that a hepatitis B universal screening and vaccination program is cost effective, guidelines on who should be screened and vaccinated might need to be reconsidered, Dr. Prabhu said. Although following women for decades to see whether hepatitis B screening and vaccination is cost effective is impractical, “a lot of medicine has been predicated on risk-based strategies and risk stratifying, and there is a lot of value to approaching patients like that,” she explained.

How an ob.gyn. determines whether a patient is high risk and qualifies for hepatitis B vaccination under current guidelines is made more complicated by the large amount of information covered in a prenatal visit. There is a “laundry list” of risk factors to consider, and “patients are just meeting you for the first time, and so they may not feel comfortable completely sharing what their risk factors may or may not be,” Dr. Prabhu said. In addition, they may not know the risk factors of their partners.

Under guidelines where all pregnant women are screened and vaccinated for hepatitis B regardless of risk, “it doesn’t harm a woman to check one extra blood test when she’s already having this bevy of blood tests at the first prenatal visit,” she said.

Clinicians may be more aware of the need to add hepatitis B screening to prenatal care given that routine hepatitis C screening for pregnant women was recently released by ACOG as a practice advisory. “I think hepatitis is a little bit more on the forefront of the obstetrician or prenatal care provider’s mind as a result of that recent shift,” she said.

“A lot of women only really access care and access consistent care during their pregnancy, either due to insurance reasons or work reasons. People do things for their developing fetus that they might not do for themselves,” Dr. Prabhu said. “It’s a unique opportunity to have the time to build a relationship, build some trust in the health care system and also educate women about their health and what they can do to keep themselves in good health.

“It’s more than just about the next 9 months and keeping you and your baby safe, so I think there’s a real opportunity for us to think about the public health and the long-term health of a woman.”

One author reported receiving funding from UpToDate; the other authors reported no relevant financial disclosures. Dr. Badell reported no relevant financial disclosures.

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Researchers identify growing racial disparity in endometrial cancer mortality

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Thu, 02/10/2022 - 16:04

Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

Rebecca Siegel

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Dr. Alex Francoeur

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

Dr. Ritu Salani

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

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Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

Rebecca Siegel

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Dr. Alex Francoeur

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

Dr. Ritu Salani

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

Women in the United States are less likely to die of ovarian cancer, but more likely to die of endometrial cancer than they were 3 decades ago, according to a recent research letter published in Obstetrics & Gynecology.

“This convergence is because of a steady reduction in the death rate for ovarian cancer, partly because of advances in treatment, alongside a steep increase in the death rate for endometrial cancer,” Rebecca L. Siegel, MPH, corresponding author and senior scientific director of surveillance research at the American Cancer Society, said in an interview. “Endometrial cancer has not had any major treatment advances in 40 years.”

Rebecca Siegel

However, Ms. Siegel and colleagues also found Black women had a twofold higher endometrial cancer–related mortality rate over the same time frame, compared with White women. The disparity in endometrial cancer mortality rates for Black women compared with White women is alarming, the authors said, and might be an underestimate because of a higher rate of hysterectomy among Black women.

The researchers analyzed endometrial and ovarian cancer mortality rates from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) with the SEER*Stat software, stratifying the data by whether the person belonged to mutually exclusive racial and ethnic categories of White, Asian or Pacific Islander, Black, or Hispanic. They identified 232,957 women who died from endometrial cancer and 419,085 people who died from ovarian cancer between 1990 and 2019.

Ms. Siegel and colleagues found there was a decrease in ovarian cancer mortality rates between 1990 (9.3 per 100,000 women) and 2019 (6.0 per 100,000 women) (average annual percent change, 22.7%; 95% confidence interval, 23.5%-22.0%). While endometrial cancer mortality decreased between 1990 (4.3 per 100,000 women) and 1997 (4.0 per 100,000 women), it increased between 1997 and 2019 (5.1 per 100,000 women) (average annual percent change, 1.7%; 95% CI, 1.3%-2.1%). When measuring ovarian cancer mortality to endometrial cancer mortality from 1990 (9.3 vs. 4.3 per 100,000), compared with 2019 (6.0 vs. 5.1 per 100,000), there is a significant decline in excess deaths from ovarian cancer.

“Three decades ago, women in the United States were almost twice as likely to die from ovarian cancer as they were to die from endometrial cancer,” Ms. Siegel said in an interview. “Today the difference is only 15% higher, or an excess of less than 1 death per of 100,000 women.”
 

Growing racial disparity in endometrial cancer mortality

While these results persisted for some racial and ethnic subgroups, it did not persist for Black women, who saw an increase in endometrial cancer mortality rate from 7.2 per 100,000 women between 1990 and 1994 to 9.1 per 100,000 women between 2015 and 2019. Compared with White women, there was a significant increase in the mortality rate ratio for uterine cancer for Black women, from 1.83 between 1990 and 1994 (95% CI, 1.77-1.89) to 1.98 between 2015 and 2019 (95% CI, 1.93-2.02) (P < .001).

“Endometrial cancer has one of the largest racial disparities of any cancer. The 5-year relative survival rate for Black women is 63% compared to 84% for White women – a 21% gap in absolute terms. This is largely due to less access to high-quality health care, which is reflected in both later-stage diagnosis and lower survival for every stage of disease,” Ms. Siegel said in an interview. Other factors that contribute include lack of guideline-concordant surgical treatment, and increased risk of aggressive tumor subtypes.

Dr. Alex Francoeur

Alex A. Francoeur, MD; and Ritu Salani, MD, MBA, of the department of obstetrics and gynecology at the University of California, Los Angeles, who were not involved in the study, said the research by Ms. Siegel and colleagues “highlights growing disparities in uterine cancer between non-Hispanic Black and non-Hispanic White women.”

“Understanding race as a social, not biological construct, and as a proxy for socioeconomic status, is key to understanding this disparity,” said Dr. Francoeur, a third-year ob.gyn. resident at UCLA Health, and Dr. Salani, an Ob.Gyn. News editorial board member. “For example, many studies cite a more advanced stage at diagnosis as an explanation for racial disparities in endometrial cancer; however, this is a substitute for differences in health care access as well as other socioeconomic factors such as income and education.”

Dr. Francoeur and Dr. Salani also acknowledged other disparities in risk factors may play a role in the differences in endometrial mortality rates such as obesity, which “in non-Hispanic Black women is over 60% greater than non-Hispanic White women.”

Dr. Ritu Salani

In terms of limitations, they noted that SEER’s database is less representative of the population, compared with the United States Cancer Statistics database (36.7% vs. 99%), and that factors such as greater prevalence of hysterectomy may contribute to larger racial disparities.

“Future studies need to examine inequities in treatment by race as well as the importance of health care systems in the stage of diagnosis,” they said.

Ms. Siegel said her team plans to follow the patterns outlined in this analysis and examine factors like cancer subtype, socioeconomic status, and place of residence in the future. “However, health inequalities are rooted in systemic racism, so documentation is necessary but insufficient to effect change, which must occur at the institutional level. A more concerted effort is needed to ensure that every woman receives appropriate treatment, regardless of the color of her skin, and education of providers to reduce racial bias and help increase trust in the health care system should be required.”

The authors reported no relevant financial disclosures. Dr. Francoeur and Dr. Salani reported no relevant financial disclosures.

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‘Substantial’ CVD risks, burden up to a year after COVID-19

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Tue, 05/24/2022 - 16:20

People who have had COVID-19 have an increased risk for, and 12-month burden of, cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, said in an interview. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, and males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Although cardiovascular outcomes increased with the severity of the acute infection, the excess risks and burdens were also evident in those who never required hospitalization, a group that represents the majority of people with COVID-19, observed Dr. Al-Aly, who directs the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System.



“This study is very important because it underscores not just the acute cardiovascular risk associated with COVID but the increased risk of chronic cardiovascular outcomes as well,” cardiologist C. Michael Gibson, MD, professor of medicine, Harvard Medical School, Boston, said in an interview. “Given the number of patients in the U.S. who have been infected with COVID, this could represent a significant chronic burden on the health care system, particularly as health care professionals leave the profession.”

For the study, the investigators used national VA databases to build a cohort of 153,760 veterans who were alive 30 days after testing positive for COVID-19 between March 1, 2020, and January 2021. They were compared with a contemporary cohort of 5.6 million veterans with no evidence of SARS-CoV-2 infection and a historical cohort of 5.8 million veterans using the system in 2017 prior to the pandemic. Median follow-up was 347, 348, and 347 days, respectively.

As reported in Nature Medicine, the risk for a major adverse cardiovascular event, a composite of myocardial infarction, stroke, and all-cause mortality, was 4% higher in people who had been infected with COVID-19 than in those who had not.

“People say 4% is small, but actually it’s really, really big if you think about it in the context of the huge number of people who have had COVID-19 in the United States, and also globally,” Dr. Al-Aly said.

Compared with the contemporary control group, people who had COVID-19 had an increased risk (hazard ratio [HR]) and burden per 1,000 people at 1 year for the following cardiovascular outcomes:

  • Stroke: HR, 1.52; burden, 4.03
  • Transient ischemic attack: HR, 1.49; burden, 1.84
  • Dysrhythmias: HR, 1.69; burden, 19.86
  • Ischemic heart disease: HR, 1.66; burden, 7.28
  • Heart failure: HR, 1.72; burden, 11.61
  • Nonischemic cardiomyopathy: HR, 1.62; burden 3.56
  • Pulmonary embolism: HR, 2.93; burden, 5.47
  • Deep vein thrombosis: HR, 2.09; burden, 4.18
  • Pericarditis: HR, 1.85, burden, 0.98
  • Myocarditis: HR, 5.38; burden, 0.31
 

 

Recent reports have raised concerns about an association between COVID-19 vaccines and myocarditis and pericarditis, particularly in young males. Although very few of the participants were vaccinated prior to becoming infected, as vaccines were not yet widely available, the researchers performed two analyses censoring participants at the time of the first dose of any COVID-19 vaccine and adjusting for vaccination as a time-varying covariate.

The absolute numbers of myocarditis and pericarditis were still higher than the contemporary and historical cohorts. These numbers are much larger than those reported for myocarditis after vaccines, which are generally around 40 cases per 1 million people, observed Dr. Al-Aly.

The overall results were also consistent when compared with the historical control subjects.

“What we’re seeing in our report and others is that SARS-CoV-2 can leave a sort of scar or imprint on people, and some of these conditions are likely chronic conditions,” Dr. Al-Aly said. “So you’re going to have a generation of people who will bear the scar of COVID for their lifetime and I think that requires recognition and attention, so we’re aware of the magnitude of the problem and prepared to deal with it.”

With more than 76 million COVID-19 cases in the United States, that effort will likely have to be at the federal level, similar to President Joe Biden’s recent relaunch of the “Cancer Moonshot,” he added. “We need a greater and broader recognition at the federal level to try and recognize that when you have an earthquake, you don’t just deal with the earthquake when the earth is shaking, but you also need to deal with the aftermath.”

Dr. Gibson pointed out that this was a study of predominantly males and, thus, it’s unclear if the results can be extended to females. Nevertheless, he added, “long COVID may include outcomes beyond the central nervous system and we should educate patients about the risk of late cardiovascular outcomes.”

The authors noted the largely White, male cohort may limit generalizability of the findings. Other limitations include the possibility that some people may have had COVID-19 but were not tested, the datasets lacked information on cause of death, and possible residual confounding not accounted for in the adjusted analyses.

The research was funded by the U.S. Department of Veterans Affairs and two American Society of Nephrology and Kidney Cure fellowship awards. The authors declared no competing interests. Dr. Gibson reports having no relevant conflicts of interest.

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

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People who have had COVID-19 have an increased risk for, and 12-month burden of, cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, said in an interview. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, and males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Although cardiovascular outcomes increased with the severity of the acute infection, the excess risks and burdens were also evident in those who never required hospitalization, a group that represents the majority of people with COVID-19, observed Dr. Al-Aly, who directs the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System.



“This study is very important because it underscores not just the acute cardiovascular risk associated with COVID but the increased risk of chronic cardiovascular outcomes as well,” cardiologist C. Michael Gibson, MD, professor of medicine, Harvard Medical School, Boston, said in an interview. “Given the number of patients in the U.S. who have been infected with COVID, this could represent a significant chronic burden on the health care system, particularly as health care professionals leave the profession.”

For the study, the investigators used national VA databases to build a cohort of 153,760 veterans who were alive 30 days after testing positive for COVID-19 between March 1, 2020, and January 2021. They were compared with a contemporary cohort of 5.6 million veterans with no evidence of SARS-CoV-2 infection and a historical cohort of 5.8 million veterans using the system in 2017 prior to the pandemic. Median follow-up was 347, 348, and 347 days, respectively.

As reported in Nature Medicine, the risk for a major adverse cardiovascular event, a composite of myocardial infarction, stroke, and all-cause mortality, was 4% higher in people who had been infected with COVID-19 than in those who had not.

“People say 4% is small, but actually it’s really, really big if you think about it in the context of the huge number of people who have had COVID-19 in the United States, and also globally,” Dr. Al-Aly said.

Compared with the contemporary control group, people who had COVID-19 had an increased risk (hazard ratio [HR]) and burden per 1,000 people at 1 year for the following cardiovascular outcomes:

  • Stroke: HR, 1.52; burden, 4.03
  • Transient ischemic attack: HR, 1.49; burden, 1.84
  • Dysrhythmias: HR, 1.69; burden, 19.86
  • Ischemic heart disease: HR, 1.66; burden, 7.28
  • Heart failure: HR, 1.72; burden, 11.61
  • Nonischemic cardiomyopathy: HR, 1.62; burden 3.56
  • Pulmonary embolism: HR, 2.93; burden, 5.47
  • Deep vein thrombosis: HR, 2.09; burden, 4.18
  • Pericarditis: HR, 1.85, burden, 0.98
  • Myocarditis: HR, 5.38; burden, 0.31
 

 

Recent reports have raised concerns about an association between COVID-19 vaccines and myocarditis and pericarditis, particularly in young males. Although very few of the participants were vaccinated prior to becoming infected, as vaccines were not yet widely available, the researchers performed two analyses censoring participants at the time of the first dose of any COVID-19 vaccine and adjusting for vaccination as a time-varying covariate.

The absolute numbers of myocarditis and pericarditis were still higher than the contemporary and historical cohorts. These numbers are much larger than those reported for myocarditis after vaccines, which are generally around 40 cases per 1 million people, observed Dr. Al-Aly.

The overall results were also consistent when compared with the historical control subjects.

“What we’re seeing in our report and others is that SARS-CoV-2 can leave a sort of scar or imprint on people, and some of these conditions are likely chronic conditions,” Dr. Al-Aly said. “So you’re going to have a generation of people who will bear the scar of COVID for their lifetime and I think that requires recognition and attention, so we’re aware of the magnitude of the problem and prepared to deal with it.”

With more than 76 million COVID-19 cases in the United States, that effort will likely have to be at the federal level, similar to President Joe Biden’s recent relaunch of the “Cancer Moonshot,” he added. “We need a greater and broader recognition at the federal level to try and recognize that when you have an earthquake, you don’t just deal with the earthquake when the earth is shaking, but you also need to deal with the aftermath.”

Dr. Gibson pointed out that this was a study of predominantly males and, thus, it’s unclear if the results can be extended to females. Nevertheless, he added, “long COVID may include outcomes beyond the central nervous system and we should educate patients about the risk of late cardiovascular outcomes.”

The authors noted the largely White, male cohort may limit generalizability of the findings. Other limitations include the possibility that some people may have had COVID-19 but were not tested, the datasets lacked information on cause of death, and possible residual confounding not accounted for in the adjusted analyses.

The research was funded by the U.S. Department of Veterans Affairs and two American Society of Nephrology and Kidney Cure fellowship awards. The authors declared no competing interests. Dr. Gibson reports having no relevant conflicts of interest.

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

People who have had COVID-19 have an increased risk for, and 12-month burden of, cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, said in an interview. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, and males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Although cardiovascular outcomes increased with the severity of the acute infection, the excess risks and burdens were also evident in those who never required hospitalization, a group that represents the majority of people with COVID-19, observed Dr. Al-Aly, who directs the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System.



“This study is very important because it underscores not just the acute cardiovascular risk associated with COVID but the increased risk of chronic cardiovascular outcomes as well,” cardiologist C. Michael Gibson, MD, professor of medicine, Harvard Medical School, Boston, said in an interview. “Given the number of patients in the U.S. who have been infected with COVID, this could represent a significant chronic burden on the health care system, particularly as health care professionals leave the profession.”

For the study, the investigators used national VA databases to build a cohort of 153,760 veterans who were alive 30 days after testing positive for COVID-19 between March 1, 2020, and January 2021. They were compared with a contemporary cohort of 5.6 million veterans with no evidence of SARS-CoV-2 infection and a historical cohort of 5.8 million veterans using the system in 2017 prior to the pandemic. Median follow-up was 347, 348, and 347 days, respectively.

As reported in Nature Medicine, the risk for a major adverse cardiovascular event, a composite of myocardial infarction, stroke, and all-cause mortality, was 4% higher in people who had been infected with COVID-19 than in those who had not.

“People say 4% is small, but actually it’s really, really big if you think about it in the context of the huge number of people who have had COVID-19 in the United States, and also globally,” Dr. Al-Aly said.

Compared with the contemporary control group, people who had COVID-19 had an increased risk (hazard ratio [HR]) and burden per 1,000 people at 1 year for the following cardiovascular outcomes:

  • Stroke: HR, 1.52; burden, 4.03
  • Transient ischemic attack: HR, 1.49; burden, 1.84
  • Dysrhythmias: HR, 1.69; burden, 19.86
  • Ischemic heart disease: HR, 1.66; burden, 7.28
  • Heart failure: HR, 1.72; burden, 11.61
  • Nonischemic cardiomyopathy: HR, 1.62; burden 3.56
  • Pulmonary embolism: HR, 2.93; burden, 5.47
  • Deep vein thrombosis: HR, 2.09; burden, 4.18
  • Pericarditis: HR, 1.85, burden, 0.98
  • Myocarditis: HR, 5.38; burden, 0.31
 

 

Recent reports have raised concerns about an association between COVID-19 vaccines and myocarditis and pericarditis, particularly in young males. Although very few of the participants were vaccinated prior to becoming infected, as vaccines were not yet widely available, the researchers performed two analyses censoring participants at the time of the first dose of any COVID-19 vaccine and adjusting for vaccination as a time-varying covariate.

The absolute numbers of myocarditis and pericarditis were still higher than the contemporary and historical cohorts. These numbers are much larger than those reported for myocarditis after vaccines, which are generally around 40 cases per 1 million people, observed Dr. Al-Aly.

The overall results were also consistent when compared with the historical control subjects.

“What we’re seeing in our report and others is that SARS-CoV-2 can leave a sort of scar or imprint on people, and some of these conditions are likely chronic conditions,” Dr. Al-Aly said. “So you’re going to have a generation of people who will bear the scar of COVID for their lifetime and I think that requires recognition and attention, so we’re aware of the magnitude of the problem and prepared to deal with it.”

With more than 76 million COVID-19 cases in the United States, that effort will likely have to be at the federal level, similar to President Joe Biden’s recent relaunch of the “Cancer Moonshot,” he added. “We need a greater and broader recognition at the federal level to try and recognize that when you have an earthquake, you don’t just deal with the earthquake when the earth is shaking, but you also need to deal with the aftermath.”

Dr. Gibson pointed out that this was a study of predominantly males and, thus, it’s unclear if the results can be extended to females. Nevertheless, he added, “long COVID may include outcomes beyond the central nervous system and we should educate patients about the risk of late cardiovascular outcomes.”

The authors noted the largely White, male cohort may limit generalizability of the findings. Other limitations include the possibility that some people may have had COVID-19 but were not tested, the datasets lacked information on cause of death, and possible residual confounding not accounted for in the adjusted analyses.

The research was funded by the U.S. Department of Veterans Affairs and two American Society of Nephrology and Kidney Cure fellowship awards. The authors declared no competing interests. Dr. Gibson reports having no relevant conflicts of interest.

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

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Scientists see hope in new therapy for COVID-19 brain fog patients

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Tue, 05/24/2022 - 16:20

People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.

For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.

A type of rehabilitation program that allows the brain to rewire itself has been successful in improving the lives of people with brain fog. The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.

“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”

One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.

People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.

Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.

According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.

“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”

Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.

One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.

So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.

When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.

Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.

“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”

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

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People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.

For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.

A type of rehabilitation program that allows the brain to rewire itself has been successful in improving the lives of people with brain fog. The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.

“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”

One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.

People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.

Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.

According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.

“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”

Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.

One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.

So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.

When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.

Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.

“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”

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

People with long-COVID “brain fog” may be able to recover mental abilities that were dulled or stolen from them by the virus through an approach that has improved the effects of stroke, traumatic brain injury, and other post-viral disorders, doctors and scientists say.

For a lucky portion of the population, COVID-19 lasts a handful of days with minor symptoms. But for an estimated 37% who contract the virus, symptoms can linger for weeks, months, or even years. One of the most common symptoms of long COVID is brain fog: a life-altering condition characterized by slow thinking, confusion, difficulty remembering things, and poor concentration.

A type of rehabilitation program that allows the brain to rewire itself has been successful in improving the lives of people with brain fog. The approaches are based on the concept of neuroplasticity: The ability of neural networks in the brain to change, adapt, and strengthen, much like a muscle in the body that has been trained and exercised.

“The brain’s ability to bounce back from injury is what neuroplasticity is, and I’ve worked with people in our rehab clinic who have had brain tumors or suffer the effects of surgery or radiation on the brain, and people who have had West Nile virus, HIV, and meningitis,” said Tom Bergquist, PhD, clinical neuropsychologist at Mayo Clinic in Rochester, Minn. “There’s not a week that goes by that I don’t see someone recovering from COVID-19.”

One of the approaches used in the clinic is errorless learning, or having a patient with memory problems repeat information a certain number of times without error. The repetition helps rebuild those memory skills that were weakened during infection, Dr. Bergquist says.

People who have experienced brain fog after other viral infections have seen improvements with these approaches. Ben Ahrens, co-founder and CEO of re-origin – a company that offers neuroplasticity therapy – says he had long-term cognitive issues after a Lyme disease infection. Posttreatment Lyme disease syndrome, or chronic Lyme disease, occurs in about 1 in 10 people who are infected.

Mr. Ahrens says he was struck with Lyme 10 years ago and had brain fog, joint pain, and brain lesions detectable on scans for several years after infection.

According to Mr. Ahrens, neuroplasticity-based therapies help combat what researchers have found may be a lingering memory of past infections that lead to a heightened immune response, causing lingering symptoms.

“Essentially, what we believe is happening here, is the brain has learned that these symptoms are life-threatening – because, in fact, they can be,” Mr. Ahrens said. “The brain’s one job is to protect the body, and once it’s learned to associate these symptoms with that potentially very dangerous pathogen, even after it’s gone, things like a normal headache can trigger an immune cascade.”

Studies are underway at the University of Alabama at Birmingham to examine whether constraint-induced therapy – an approach rooted in neuroplasticity and historically used for loss of limb and speech function – is also effective for cognitive impairments like brain fog.

One technique they use is called shaping, which requires a person to repeatedly carry out their personal best function of impaired use – for example, remembering household tasks they have previously forgotten. That is done multiple times over several weeks in the clinic, and patients are given ways to transfer those skills to real-life use.

So far, the results are promising, said Edward Taub, PhD, researcher and professor of psychology at the University of Alabama at Birmingham.

When used in the past for physical impairments, researchers have noted not just clinical improvements, but structural changes. It led to an increase in the brain’s gray matter – which allows individuals to control movement, memory, and emotions – and improved white matter, which helps communication between gray matter areas.

Though results of the cognitive studies have not been published, Dr. Taub said patients with brain fog have shown improvement after just 35 hours of therapy and are nearly 100% improved after 6 months.

“The idea behind this is that the brain is responsive to use,” Dr. Taub said. “The amount of brain territory that’s dedicated to supporting or mediating a given behavioral function depends on the demands placed on the brain.”

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

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Limited benefits of early gestational diabetes screening

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Tue, 05/03/2022 - 15:02

Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

Dr. Jennifer Thompson

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m2. Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.

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Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

Dr. Jennifer Thompson

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m2. Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.

Screening pregnant women with obesity for gestational diabetes before 20 weeks of pregnancy did not lead to any improved maternal or neonatal outcomes compared with doing routine screening between 24 and 28 weeks, according to research presented Feb. 4 at the Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.

“There is increasing evidence that early screening does not reduce the risk of adverse perinatal outcomes,” Jennifer Thompson, MD, associate professor of ob.gyn. at Vanderbilt University, Nashville, Tenn., said in an interview. “The increasing number of studies that have demonstrated no benefit in reducing adverse perinatal outcomes leads to consideration to revise recommendations for early screening.”

Dr. Jennifer Thompson

However, she did note that early screening may be helpful in identifying patients with undiagnosed preexisting diabetes.

Michael Richley, MD, a maternal-fetal medicine fellow at the University of California, Los Angeles, said catching those previously undiagnosed cases is one of the goals of earlier screening with the expectation that earlier management will lead to better outcomes.

“If a patient then obtains the diagnosis of type 2 diabetes, introducing nutritional counseling and possible medical management early can lead to better outcomes,” said Dr. Richley, who attended the presentation but was not involved in the research. ”While catching undiagnosed type 2 diabetes is not common, it is becoming increasingly common lately.”

Obesity is a known risk factor for impaired glucose metabolism and for gestational diabetes, explained presenter Christopher A. Enakpene, MD, an ob.gyn. from Midland, Tex., who completed the study while completing his maternal-fetal medicine fellowship at the University of Illinois in Chicago. Dr. Enakpene reminded attendees that the American College of Obstetricians and Gynecologists (ACOG) currently recommends early screening for gestational diabetes in patients with certain risk factors, including obesity, a history of first-degree relatives with diabetes, or a history of gestational diabetes, impaired glucose tolerance, poor pregnancy outcomes, fetal demise, congenital abnormalities, or birth of an infant large for gestational age.

The researchers screened 7,126 patients for enrollment in the study from March 2017 through February 2019 and identified 600 who met the criteria: An adult with a singleton pregnancy and body mass index (BMI) of at least 30 kg/m2. Patients were excluded if they had preexisting diabetes, elevated blood glucose or impaired glucose tolerance, a history of gestational diabetes, any chromosomal anomalies or abnormalities in the pregnancy, or were past 20 weeks of pregnancy.

The prospective randomized controlled trial was open label and included 296 patients who were randomly assigned to early screening with a 1-hour glucose challenge test (GCT) and hemoglobin A1c before 20 weeks, followed by a 3-hour oral glucose tolerance test if the GCT result was between 140 and 200 mg/dL with an HbA1c of less than 6.5%. The other 304 patients were screened with a 1-hour GCT between 24 and 28 weeks but also had an HbA1c test before 20 weeks.

The primary outcome was macrosomia, defined as a birth weight at least 4,000 g, with various maternal and neonatal secondary outcomes. The only significant difference between the groups at baseline was a higher proportion of Hispanic participants in the early screening group (22.4%) compared to the routine screening group (13.7%).

The groups had no significant differences in birth weight or macrosomia, which occurred in 2.8% of the early screening group and 3.4% of the routine screening group (P = .7). There were no significant differences in gestational age at delivery, preeclampsia, polyhydramnios, shoulder dystocia, cesarean delivery, or NICU admission. However, the rate of gestational diabetes was significantly higher in the early screening group (22.5%) than in the routine screening group (15.7%; P < .05). In addition, more participants with gestational diabetes in the early screening group used insulin (34.4%) compared with those in the routine screening group (15.6%; P < .05).

Dr. Enakpene noted several reasons that the perinatal outcomes may have been similar between the groups, such as the increased rate of gestational diabetes requiring treatment in the early screening group or a higher proportion of participants using insulin in the early screening group.

“Hence, the similarity in adverse perinatal outcomes between the groups despite a higher proportion of gestational diabetes in the early group might be due to more utilization of insulin,” Dr. Enakpene said.

Dr. Richley was not surprised by the findings and hypothesized that the reason for not seeing a difference in outcomes might relate to using a 20-week cutoff for testing when type 2 diabetes would be evident at any stage of pregnancy.

“It would be interesting to have a study look at diabetes testing exclusively in the first trimester for high-risk patients that looks at neonatal outcomes and see if that would show a difference between the two groups,” Dr. Richley said.

Dr. Thompson was similarly interested in whether 20 weeks was an early enough time for early screening.

”I would also like to know the differences in management between the two groups and if the knowledge of early diagnosis impacted their management, such as timing of medication start, amount of medication required, and how that differed from the standard group,” Dr. Thompson said. ”Since patients with a hemoglobin A1c > 6.5% or glucose tolerance test > 200 [mg/dL] were excluded, I’m interested in the number of patients that were excluded since they likely have undiagnosed preexisting diabetes, which are the patients that may benefit most from early screening.”

Dr. Richley pointed out that the potential clinical implications of the study are limited right now.

“While their secondary outcomes of neonatal hypoglycemia, method of delivery, and other common obstetrical measures were not different, we cannot draw conclusions from this as the study was not powered to evaluate these findings,” Dr. Richley said. “I do still see a role in early screening for patients with risk factors but favor doing so at the first prenatal visit, whenever that is, as opposed to as late as mid-second trimester, though this is often when a patient’s first interaction with a health care system will be within their pregnancy.”

Dr. Enakpene, Dr. Thompson, and Dr. Richley reported no disclosures. External funding for the study was not noted.

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