CDC releases updated draft guidance on opioid prescribing

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Mon, 02/14/2022 - 10:09

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

  • Helping clinicians determine whether or not to initiate opioid treatment for pain
  • Opioid selection and dosage
  • Duration of use and follow-up
  • Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

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The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

  • Helping clinicians determine whether or not to initiate opioid treatment for pain
  • Opioid selection and dosage
  • Duration of use and follow-up
  • Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

The Centers for Disease Controls and Prevention has released a draft update of its current Clinical Practice Guidelines for Prescribing Opioids for pain management and is asking for public comment before moving forward.

The last guidance on this topic was released in 2016 and, among other things, noted that clinicians should be cautious when considering increasing dosage of opioids to 50 or more morphine milligram equivalents (MME)/day and should avoid increasing to a dose of 90 or more MME/day. It also noted that 3 days or less “will often be sufficient” regarding the quantity of lowest effective dose of immediate-release opioids to be prescribed for acute pain – and that more than 7 days “will rarely be needed.”

In the new report from the CDC’s National Center for Injury Prevention and Control (NCIPC), those dose limits have been replaced with the suggestion that clinicians use their best judgement – albeit still urging conservative use and even the possibility of nonopioid treatments.

The updated recommendations are now open for public comment via the Federal Register’s website through April 11.

“This comment period provides another critical opportunity for diverse audiences to offer their perspective on the draft clinical practice guideline,” Christopher M. Jones, PharmD, DrPH, acting director for the NCIPC, said in a release.

“We want to hear many voices from the public, including people living with pain and health care providers who help their patients manage pain,” Dr. Jones added.

Outpatient recommendations

The CDC noted that the updated guidance provides “evidence-based recommendations” for treatment of adults with acute, subacute, or chronic pain. It does not include guidance for managing pain related to sickle cell disease, cancer, or palliative care.

It is aimed at primary care clinicians and others who manage pain in an outpatient setting, including in dental and postsurgical practices and for those discharging patients from emergency departments. It does not apply to inpatient care.

The draft guidance includes 12 recommendations focused on four key areas:

  • Helping clinicians determine whether or not to initiate opioid treatment for pain
  • Opioid selection and dosage
  • Duration of use and follow-up
  • Assessing risk and addressing potential harms from use

The overall aim “is to ensure people have access to safe, accessible, and effective pain management that improves their function and quality of life while illuminating and reducing risks associated with prescription opioids and ultimately reducing the consequences of prescription opioid misuse and overdose,” the CDC notes.

In addition, the guidance itself “is intended to be a clinical tool to improve communication between providers and patients and empower them to make informed, patient-centered decisions,” the agency said in a press release.

It added that the new recommendations “are not intended to be applied as inflexible standards of care.” Rather, it is intended as a guide to support health care providers in their clinical decisionmaking as they provide individualized patient care.

Patients, caregivers, and providers are invited to submit comments over the next 60 days through the Federal Register docket.

“It is vitally important to CDC that we receive, process, and understand public feedback during the guideline update process,” the agency noted.

“The ultimate goal of this clinical practice guideline is to help people set and achieve personal goals to reduce their pain and improve their function and quality of life. Getting feedback from the public is essential to achieving this goal,” Dr. Jones said.

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

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Omicron death rate higher than during Delta surge

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Changed
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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Ketamine fast, effective for suicidal crises

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Changed
Mon, 02/14/2022 - 10:10

Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

 

 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi disclosed no relevant financial relationships.

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

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Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

 

 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi disclosed no relevant financial relationships.

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

Ketamine is a rapid and effective treatment for suicidal ideation and has a “major” moderating effect based on the primary mental health diagnosis, results of a large randomized controlled trial show.

In addition, a strong effect of ketamine was observed in patients with bipolar disorder, “whereas the effect was moderate and did not quite reach significance in those with other psychiatric disorders and unexpectedly was nonsignificant in those with major depressive disorders,” the researchers wrote.

“We assessed for the first time in the same study the effect of ketamine on three a priori–defined groups of nonpsychotic patients: those with a bipolar disorder, those with a depressive disorder, and those with other diagnoses,” study investigator Fabrice Jollant, MD, PhD, professor of psychiatry, University of Paris, said in an interview.

“This allowed us to find that comorbid disorders are important modulators of the clinical effects of ketamine, and that the effect of ketamine is particularly marked among patients with a bipolar disorder,” Dr. Jollant added.  

The study was published online Feb. 2, 2022, in the BMJ.
 

Swift, full remission

The study included 156 adults admitted voluntarily to seven French teaching hospitals with severe suicidal ideation, including 52 with bipolar disorder, 56 with depressive disorder, and 48 with other psychiatric diagnoses.

They were randomly allocated to two 40-minute intravenous infusions of ketamine (0.5 mg/kg) or placebo (saline) administered at baseline and 24 hours, in addition to usual treatment. 

The primary outcome was the rate of patients in full suicidal remission at day 3, confirmed by a score of 3 or less on a clinician-rated scale for suicidal ideation based on 19 items scored 0-2 (maximum score, 38).

“We investigated the full remission of suicidal ideas and not only the response, which is usually defined as a reduction of 50% of scores on a given scale. If people remain slightly suicidal, the suicidal risk persists. We want all suicidal ideas to disappear,” said Dr. Jollant.

They found that more patients reached full remission of suicidal ideas at day 3 after two ketamine infusions than after placebo infusions (63% vs. 32%; odds ratio, 3.7; 95% confidence interval, 1.9-7.3; P < .001).

This antisuicidal effect of ketamine was rapid, with 44% remission only 2 hours after the first infusion, the authors reported.

The effect of ketamine on suicidal remission was greatest in patients with bipolar disorder, with 85% achieving full remission at day 3 (OR, 14.1; 95% CI, 3.0-92.2; P < .001), compared with 42% of patients with depressive disorder (OR, 1.3; 95% CI, 0.3-5.2; P = .6) or 62% of those with other disorders (OR, 3.7; 95% CI, 0.9-17.3; P = .07).

At 6 weeks after treatment, remission in the ketamine group remained high, although nonsignificantly versus placebo (69.5% vs. 56.3%; OR, 0.8; 95% CI, 0.3-2.5; P = .7).

The researchers noted the beneficial effect of ketamine on suicidal ideation could be mediated by an effect on psychological pain.

“Although mental pain does not necessarily lead to suicidal ideas, recent studies suggest that individuals with severe suicidal ideas (notably those with a plan) also have high levels of mental pain. Ketamine might therefore exert its effects through analgesic mechanisms that reduce mental pain,” they wrote.

Ketamine’s side effects were “limited” with no manic or psychotic symptoms seen. The main side effects, including sedation, denationalization/derealization, nausea, and dizziness, were of short duration and occurred in about 10% or fewer patients.

The investigators acknowledged that the nonsignificant effect of ketamine in the patients with major depressive disorders in this study is “challenging to interpret.”

They pointed out the study may have lacked power to detect an effect in these patients. In addition, this group might be particularly heterogeneous, with more patients sensitive to a placebo effect and more patients requiring repeated ketamine infusions.
 

 

 

A new perspective on ketamine

In an accompanying editorial, Riccardo De Giorgi, MD, Wellcome Trust doctoral training fellow, department of psychiatry, University of Oxford (England), said the study challenges current thinking about ketamine.

The “unexpected” outcome (no benefit) in the depressive group “perhaps defies the prevailing notion that patients with major depression would benefit most from ketamine,” Dr. De Giorgi wrote.

“In fact, both usual care and ketamine given with usual care led to low, comparable remission rates of 35.7% and 42.3% for suicidal ideation, respectively, in patients with depressive disorder,” Dr. De Giorgi pointed out.

“While this study therefore confirms that many patients with depressive disorder and suicidal ideation remain poorly served by available treatments, it shows that another important group of patients with acute suicidal ideation, those with bipolar disorder, could benefit from ketamine,” Dr. De Giorgi wrote.

“Once again, here is evidence that careful clinical evaluation must precede any consideration of ketamine use, which must be reserved for specific clinical presentations and not given indiscriminately to anyone presenting with suicidal thoughts,” he concluded.

Funding for the study was provided by Programme Hospitalier de Recherche Clinique National. Dr. Jollant and Dr. De Giorgi 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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‘Encouraging’ new national data on chronic pain management

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Mon, 02/14/2022 - 10:12

 

Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.



Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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

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Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.



Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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

 

Most adults in the United States who have chronic pain favor a combination of nondrug and nonopioid approaches to control their pain, which is “encouraging,” new research shows.

A national survey reveals 55% of adults with chronic pain used pain management techniques that did not involve any opioids at all during the prior 3-month period.

However, few participants took advantage of cognitive-behavioral therapy (CBT), which is effective for easing chronic pain, Cornelius Groenewald, MB ChB, department of anesthesiology and pain medicine, University of Seattle, and colleagues write.

The results were published online in a research letter Feb. 7 in JAMA Network Open.

First time for pain questions

An estimated 50.2 million U.S. adults experience chronic pain, according to the 2019 National Health Interview Survey.

The 2019 version of the survey included questions on pain management techniques for the first time. Adults with chronic pain were asked to report on their use of 11 pain management techniques during the previous 3 months.

Among the 31,916 survey respondents, 64% were women; 69% were non-Hispanic White, 13% were Hispanic, and 11% were non-Hispanic Black; 71% were between 18 and 64 years of age, and 29% were 65 and older.



Among the key findings, an estimated 55% of adults with chronic pain used only nonopioid pain management techniques, 11% used both opioids and nonopioid techniques, and 4% used only opioids for chronic pain management; 30% did not report any pain management techniques during the previous 3 months.

Complementary therapies were the most commonly used nonopioid pain management technique (by 35% of adults with chronic pain), followed by physical, occupational, or rehabilitative therapies (19%).

Only about 4% of adults with chronic pain used CBT.

Other techniques used included self-management programs (5%) and chronic pain peer support groups (2%). In addition, 39% of adults with chronic pain reported using other pain approaches not specifically captured in the data set.

Benchmark data

Participants using complementary and psychological or psychotherapeutic interventions were more likely to be younger women with more education, the investigators report.

Adults using physical, occupational, or rehabilitative therapy were more likely to be highly educated older women with medical insurance.

Prescription opioid use for chronic pain was more common among older adults aged 45-64 years vs. those aged 18-44 years (19% vs. 8%).

It was also more common in women than men (17% vs. 13%), in adults with vs. without health insurance (16% vs. 6%), and in those with a high school education or lower, compared with those had more than a high school education (17% vs. 14%).

Prescription opioid use was less common among adults making $100,000 or more annually than in those making less than $35,000 a year (9% vs. 20%).

“While effective for some, opioids prescribed for chronic pain management remain an important determinant of the national opioid crisis,” the investigators write.

The study “provides baseline information on opioid and nonopioid pain management techniques used for chronic pain and serves as a benchmark for evaluating the outcome of health care policies aimed at reducing prescription opioid use,” they add.

The study had no specific funding. The investigators have disclosed no relevant financial relationships.

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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Strangulation deaths spur FDA alert on pediatric enteral feeding kits

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Thu, 02/10/2022 - 16:30

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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

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Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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

Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.

The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.

Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.


“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.

Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.

Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.

The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.

“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”

Parents and health care providers can report injuries caused by these devices to the FDA.

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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