White House announces vaccination plans for younger children

Article Type
Changed
Wed, 10/20/2021 - 16:51

The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

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The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

The White House says it has purchased enough of Pfizer’s COVID-19 vaccine to immunize all 28 million children in the United States who are between the ages of 5 and 12.

States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.

“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.

Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.

“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.

“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.

Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.

An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
 

Laying the groundwork

Doctors applauded the advance planning.

“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.

The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.

The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.

The White House says 25,000 doctors have already signed up to give the vaccines.

The vaccination campaign will get underway at a tough moment for pediatricians.

The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.

“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.

Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.

“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”

Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.

“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.

Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.

He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.

“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.

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

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Does eating nuts lead to better breast cancer outcomes?

Article Type
Changed
Wed, 01/04/2023 - 17:17

In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

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In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

In the first study of its kind, women with a breast cancer diagnosis who recalled eating nuts were found to have a significantly better disease-free survival over a 10-year study period, compared with those who said they had not eaten nuts.

PxHere

There was also an improvement in overall survival, but this was not statistically significant.

The finding comes from a study of more than 3,000 patients conducted in China, published online in the International Journal of Cancer. Patients were queried about nut consumption on only one occasion, 5 years after their breast cancer diagnosis. 

The investigators report a dose-response pattern between nut eating and the risk of both breast cancer recurrence and overall mortality, with those consuming the largest amounts having the lowest risks.

“Nuts are important components of healthy diets. Promoting this modifiable lifestyle factor should be emphasized in breast cancer survivor guidelines,” conclude Xiao-Ou Shu, MD, PhD, of Vanderbilt University, Nashville, Tenn., and colleagues in the study.

“The association for disease-free survival is quite strong and robust,” Dr. Shu told this news organization.

However, as with all observational studies, this report shows an association and not causation.

“Based upon this study alone, the evidence is weak,” said Wendy Chen, MD, MPH, a breast oncologist at Dana-Farber Cancer Institute in Boston, who was approached for comment.  

The people who consumed nuts generally had more education, higher income, lower body mass index, earlier-stage cancers, and more physically active lives – all factors associated with better breast cancer survival, she observed. “The authors tried to control for these factors,” Dr. Chen acknowledged. But it’s hard to know whether nut consumption was “truly” the difference maker, she said.

Furthermore, the study population is also “a bit unusual” because people had to survive 5 years after diagnosis to be included in the analysis – and thus is not representative of breast cancer survivors, she noted.

Erin Van Blarigan, PhD, an epidemiologist at the University of California, San Francisco, described the overall evidence of the beneficial relationship between nut eating and breast cancer – including this study – as “limited.” She previously led a study that observed benefits of nut intake for patients with colon cancer.

Dr. Van Blarigan also noted that nut intake in this study was “very low” – with the median intake less than one serving per week.

She also offered some general advice about eating nuts.  

“Nuts are an energy-dense food, so portion sizes should be kept small,” she said, explaining a portion should be about 1 ounce or 1/4 cup of nuts or 1-2 tablespoons of nut butter.

A little may go a long way, she suggested, as research to date “suggests only small amounts may be needed to gain potential benefits.”

The level of nut consumption was low in the Chinese study population (median = 17.3 grams/week) compared with the 42.5 grams/week recommended by the American Heart Association, the study authors acknowledge.

“Nuts, particularly tree nuts, are expensive in China. Traditionally, nut consumption level has been low among Chinese, particularly in the old generation,” commented Dr. Shu.
 

Study authors did an adjusted analysis

The new study was conducted among 3,449 participants of the Shanghai Breast Cancer Survival Study.

Nut consumption (including peanuts and tree nuts such as walnuts) was assessed with a food questionnaire at 5 years post-diagnosis.

An analysis was conducted at 10 years post-diagnosis (and 5 years after the diet questionnaire). At this 10-year mark, there were 252 breast cancer-specific deaths. Among 3,274 survivors without previous recurrence at the dietary assessment, 209 went on to develop breast cancer-specific events – either recurrence, metastasis, or breast cancer mortality.

Nut consumers had higher overall survival (93.7% vs. 89%; P = .003) and disease-free survival (94.1% vs. 86.2%; P <.001) rates than nonconsumers.

However, the two groups had many differences, as noted by the authors and outside experts.

The consumers had a younger age at diagnosis, lower BMI, higher total energy intake, higher diet quality score, and higher soy food intake. In addition, nut consumers were more likely to have a higher education, personal income, and physical activity level (≥7.5 metabolic equivalent of task-hour/week) as well as to have received immunotherapy.

So the investigators adjusted for many of those variables and found that nut consumption was associated with significantly better disease-free survival (hazard ratio, 0.52; 95% confidence interval, 0.35-0.75), but a nonsignificantly improved overall survival (HR, 0.90; 95% CI, 0.66-1.23), as noted above.

Analyses by amount of nut intake showed a dose-response relationship for both overall survival (P trend = .022) and disease-free survival (P trend = .003).

The authors say that “there has been no strong evidence to support individual food items in favor of breast cancer survival,” citing a 2018 report entitled “Diet, Nutrition, Physical Activity and Breast Cancer Survivors” from the World Cancer Research Fund/American Institute for Cancer Research.

The new study provides evidence that nuts may be such a food, they say, while also calling for studies to confirm their findings.

Study limitations include that fact that the statuses of recurrence and metastasis were self-reported. Misclassification, particularly regarding the event date, is likely, the team says.

The study authors and Dr. Van Blarigan and Dr. Chen have disclosed no relevant financial relationships.

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

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Pediatric organizations declare national emergency in mental health

Article Type
Changed
Wed, 10/20/2021 - 16:36

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

  • Increase federal funding to ensure all families can access mental health services.
  • Improve access to telemedicine.
  • Accelerate integration of mental health care in pediatric primary care.
  • Fully fund community-based systems of care that connect families to evidence-based interventions.
  • Promote and pay for trauma-informed care services.
  • Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

Dr. Jenna Triana

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

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The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

  • Increase federal funding to ensure all families can access mental health services.
  • Improve access to telemedicine.
  • Accelerate integration of mental health care in pediatric primary care.
  • Fully fund community-based systems of care that connect families to evidence-based interventions.
  • Promote and pay for trauma-informed care services.
  • Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

Dr. Jenna Triana

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

The American Academy of Pediatrics (AAP), the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association have declared a national emergency in children’s mental health.

COVID-19 has taken a serious toll, the organizations say, on top of already mounting challenges. Policy changes are urgently needed, they say.

“Today’s declaration is an urgent call to policymakers at all levels of government – we must treat this mental health crisis like the emergency it is,” AAP President Lee Savio Beers, MD, said in a statement.

The Centers for Disease Control and Prevention found that between March and October 2020, emergency department visits for mental health emergencies rose by 24% for children ages 5-11 years and 31% for children ages 12-17 years. ED visits for suspected suicide attempts increased nearly 51% among girls ages 12-17 years of age in early 2021 compared to the same period in 2019.

Recent data in Pediatrics also show a marked increase in loss of a caregiver and sharp disparities by race and ethnicity.

“We found that from April 1, 2020, through June 30, 2021, over 140,000 children in the U.S. experienced the death of a parent or grandparent caregiver. The risk of such loss was 1.1 to 4.5 times higher among children of racial and ethnic minorities, compared to non-Hispanic White children,” researchers wrote.

“We are caring for young people with soaring rates of depression, anxiety, trauma, loneliness, and suicidality that will have lasting impacts on them, their families, their communities, and all of our futures,” said AACAP President Gabrielle A. Carlson, MD.

Among the actions the groups are calling for are the following:

  • Increase federal funding to ensure all families can access mental health services.
  • Improve access to telemedicine.
  • Accelerate integration of mental health care in pediatric primary care.
  • Fully fund community-based systems of care that connect families to evidence-based interventions.
  • Promote and pay for trauma-informed care services.
  • Address workforce challenges so that children can access mental health services wherever they live.

The organizations represent more than 77,000 physician members and more than 200 children’s hospitals.

Jenna Triana, MD, a child and adolescent psychiatrist at the University of Minnesota, Minneapolis, said in an interview that while specific institutions such as the University of Colorado have declared emergencies in pediatric mental health, declaring a national emergency is important.

Dr. Jenna Triana

She said the timing is important because fall is typically a heavy time for pediatric psychiatry with children and adolescents returning to school, and it is especially pronounced with the pandemic.

The usual diagnoses providers are seeing “are all worse,” she said.

“The bar for getting admission to the hospital has been raised because we’re such a limited resource. We’ve had to be so thoughtful about who truly, truly needs admission and who can come up with some kind of safe plan for outside of the hospital,” Dr. Triana said.

“The patients I’m seeing in the hospital – the level of illness I’m seeing is much higher than it was a couple of years ago,” she said.

Now, Dr. Triana said, patients who are depressed and suicidal are seeking help outside the hospital in day-treatment programs or intensive outpatient therapy.

At the hospital, she said, “our wait list is usually around 20 kids sitting in the ER waiting for a patient bed. Kids wait either in the ER or a medical bed sometimes a week or more waiting for inpatient psychiatry.”

She said while she thinks all of the proposed recommendations are good, “I think what’s difficult is the speed at which any of this can happen."

“We’re in crisis now and we’ve been in crisis for months,” she added.

She said the key will be using what’s already in place – telehealth options to ease the burdens and training more primary care providers in mental health triage.

Joanna Quigley, MD, a child and adolescent psychiatrist at the University of Michigan in Ann Arbor, said in an interview, “It’s very powerful that these three groups came together and made a joint effort and statement to really highlight how serious this problem is across the country.”

She said she sees all of the challenges the leaders of the organizations describe.

At Michigan, she said, as elsewhere, specialists are seeing a large increase in the number of children presenting to the children’s psychiatric ED and the children’s ED and increased demand for outpatient services.

Children in need are waiting “several months” to see either therapists or psychiatrists, she said.

Dr. Quigley said primary care offices are seeing more children and children with higher levels of anxiety and depression as well as self-harm and suicidal thoughts in the pandemic.

She noted that it’s challenging to find providers who are accepting new patients and hard to find providers who take certain kinds of insurance, particularly Medicaid, she said.

Change will take strengthening all the areas of support the organizations’ leaders are calling for, she said.

“School-based interventions are so vital, especially for these children who have been away from an in-person setting and were without services for the time that schools were shut down,” she said.

Dr. Quigley and Dr. Triana report no relevant financial relationships.

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Uterine fibroid: Prior myomectomy linked to higher risk for preterm birth

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Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

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Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

Key clinical point: The risk for preterm birth (PTB) was higher among women who underwent preconception myomectomy to treat uterine fibroids vs women with fibroids who did not undergo prior myomectomy.

Major finding: Women who underwent prior myomectomy vs those who did not were more likely to experience PTB at less than 37 weeks’ gestation (35% vs 21%; P = .02) and deliver a mean 1.4 weeks earlier (36.3±3.6 vs 37.7±3.7 weeks’ gestation; P = .02).

Study details: Findings are from a retrospective cohort study including 290 women with a viable intrauterine pregnancy, of which 70 had a prior myomectomy and the remaining 220 who did not undergo myomectomy and had at least 1 fibroid of size 5 cm or more detected at less than 21 weeks’ gestation.

Disclosures: This study was funded by the National Institute of Child Health and Human Development. The authors reported no conflict of interests.

Source: Mahalingam M et al. J Matern Fetal Neonatal Med. 2021 Oct 6. doi: 10.1080/14767058.2021.1984424.

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TET1 and lncRNA may help predict postoperative recurrence of UF

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Key clinical point: Long noncoding ribonucleic acid (lncRNA) H19 and 10-11 translocation enzyme 1 (TET1) messenger RNA expression levels showed high diagnostic and predictive values for determining postoperative recurrence of uterine fibroids (UFs).

Major finding: lncRNA H19 (P = .010) and TET1 (P = .014) levels independently predicted UF recurrence. The area under the curve values of lncRNA H19 and TET1 for predicting UF recurrence were 0.814 (sensitivity, 81.13%; specificity, 77.27%) and 0.765 (sensitivity, 69.81%; specificity, 77.27%), respectively.

Study details: This study enrolled 75 patients with UFs who underwent surgical treatment and 60 healthy controls. Patients with UF were followed up for 2 years to evaluate postoperative recurrence of UFs.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Zhan X et al. Clinics. 2021 Sep 28. doi: 10.6061/clinics/2021/e2671.

 

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Key clinical point: Long noncoding ribonucleic acid (lncRNA) H19 and 10-11 translocation enzyme 1 (TET1) messenger RNA expression levels showed high diagnostic and predictive values for determining postoperative recurrence of uterine fibroids (UFs).

Major finding: lncRNA H19 (P = .010) and TET1 (P = .014) levels independently predicted UF recurrence. The area under the curve values of lncRNA H19 and TET1 for predicting UF recurrence were 0.814 (sensitivity, 81.13%; specificity, 77.27%) and 0.765 (sensitivity, 69.81%; specificity, 77.27%), respectively.

Study details: This study enrolled 75 patients with UFs who underwent surgical treatment and 60 healthy controls. Patients with UF were followed up for 2 years to evaluate postoperative recurrence of UFs.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Zhan X et al. Clinics. 2021 Sep 28. doi: 10.6061/clinics/2021/e2671.

 

Key clinical point: Long noncoding ribonucleic acid (lncRNA) H19 and 10-11 translocation enzyme 1 (TET1) messenger RNA expression levels showed high diagnostic and predictive values for determining postoperative recurrence of uterine fibroids (UFs).

Major finding: lncRNA H19 (P = .010) and TET1 (P = .014) levels independently predicted UF recurrence. The area under the curve values of lncRNA H19 and TET1 for predicting UF recurrence were 0.814 (sensitivity, 81.13%; specificity, 77.27%) and 0.765 (sensitivity, 69.81%; specificity, 77.27%), respectively.

Study details: This study enrolled 75 patients with UFs who underwent surgical treatment and 60 healthy controls. Patients with UF were followed up for 2 years to evaluate postoperative recurrence of UFs.

Disclosures: No information on funding was available. The authors declared no conflict of interests.

Source: Zhan X et al. Clinics. 2021 Sep 28. doi: 10.6061/clinics/2021/e2671.

 

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MRI helpful for predicting uterine fibroids shrinkage after GnRH-agonist treatment

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Key clinical point: Signal intensity of the predominant uterine fibroid (UF) on T2-weighted images could predict volume reduction rate (VRR) after gonadotropin-releasing hormone (GnRH)-agonist treatment before uterine artery embolization.

Major finding: The ratio between the mean signal intensity of UF and mean signal intensity of the rectus abdominis (F/R) at an optimal cutoff value of 2.58 and 1.69 could predict VRR 50% or more and less than 30% with an area under the curve of 0.81 (95% confidence interval [CI], 0.62-0.96; sensitivity and specificity, 80%) and 0.84 (95% CI, 0.63-1.00; sensitivity, 100%; specificity, 70%), respectively.

Study details: This was a retrospective analysis of 30 women with a large UF who underwent magnetic resonance imaging (MRI) both before and after GnRH-agonist administration.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee WJ et al. Acta Radiol. 2021 Sep 25. doi: 10.1177/02841851211038802.

 

 

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Key clinical point: Signal intensity of the predominant uterine fibroid (UF) on T2-weighted images could predict volume reduction rate (VRR) after gonadotropin-releasing hormone (GnRH)-agonist treatment before uterine artery embolization.

Major finding: The ratio between the mean signal intensity of UF and mean signal intensity of the rectus abdominis (F/R) at an optimal cutoff value of 2.58 and 1.69 could predict VRR 50% or more and less than 30% with an area under the curve of 0.81 (95% confidence interval [CI], 0.62-0.96; sensitivity and specificity, 80%) and 0.84 (95% CI, 0.63-1.00; sensitivity, 100%; specificity, 70%), respectively.

Study details: This was a retrospective analysis of 30 women with a large UF who underwent magnetic resonance imaging (MRI) both before and after GnRH-agonist administration.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee WJ et al. Acta Radiol. 2021 Sep 25. doi: 10.1177/02841851211038802.

 

 

Key clinical point: Signal intensity of the predominant uterine fibroid (UF) on T2-weighted images could predict volume reduction rate (VRR) after gonadotropin-releasing hormone (GnRH)-agonist treatment before uterine artery embolization.

Major finding: The ratio between the mean signal intensity of UF and mean signal intensity of the rectus abdominis (F/R) at an optimal cutoff value of 2.58 and 1.69 could predict VRR 50% or more and less than 30% with an area under the curve of 0.81 (95% confidence interval [CI], 0.62-0.96; sensitivity and specificity, 80%) and 0.84 (95% CI, 0.63-1.00; sensitivity, 100%; specificity, 70%), respectively.

Study details: This was a retrospective analysis of 30 women with a large UF who underwent magnetic resonance imaging (MRI) both before and after GnRH-agonist administration.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Lee WJ et al. Acta Radiol. 2021 Sep 25. doi: 10.1177/02841851211038802.

 

 

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Uterine fibroids: Nonresponders to elagolix+add-back therapy may still have a clinically meaningful response

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Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.

 

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Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.

 

Key clinical point: Nearly half the patients with uterine fibroids (UF) considered nonresponders to elagolix plus add-back therapy in the 2 phase 3 trials showed a clinically meaningful reduction in menstrual blood loss (MBL).

Major finding: Overall, 24% of patients treated with elagolix+add-back therapy were considered nonresponders as they did not meet 1 or more criteria among MBL less than 80 mL, 50% or more reduction in MBL, and/or premature treatment discontinuation. Of these, 19% met both the bleeding criterion but discontinued treatment and 26% met 1 bleeding criterion. At month 1, the least mean percent change in MBL in nonresponders who met both bleeding criteria was 80.3%.

Study details: Findings are from a pooled post hoc analysis of phase 3 Elaris UF-1 and UF-2 trials, including 549 premenopausal women with UF and heavy menstrual bleeding who received elagolix+add-back therapy or placebo.

Disclosures: This study was funded by AbbVie. Some investigators reported ties with various sources including Abbvie. Three authors declared being current/former employees and/or shareholders of AbbVie.

Source: Stewart EA et al. J Womens Health. 2021 Sep 28. doi: 10.1089/jwh.2021.0152.

 

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Single-layer sutured laparoscopic myomectomy appears safe for subsequent pregnancies

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Key clinical point: Preliminary data showed a low risk for uterine rupture with single-layer closure of the myometrium after laparoscopic myomectomy (LM) and therefore can be considered a safe option for subsequent pregnancies.

Major finding: Overall, 24 pregnant women underwent single-layer closure of the myometrium after LM. The mean duration between the operation and the first pregnancy was 10.2 months. Overall, 24 patients needed a cesarean section (C-section) delivery, 6 had a miscarriage, and 2 had an intrauterine pregnancy. Of these, 8 patients were pregnant again and underwent a C-section delivery. No cases of uterine rupture were observed.

Study details: Findings are from a retrospective study including 102 women who underwent single-layer sutured LM to remove uterine fibroids larger than 5 cm and associated with the myometrium.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Aksin S et al. Int J Clin Pract. 2021 Sep 15. doi: 10.1111/ijcp.14870.

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Key clinical point: Preliminary data showed a low risk for uterine rupture with single-layer closure of the myometrium after laparoscopic myomectomy (LM) and therefore can be considered a safe option for subsequent pregnancies.

Major finding: Overall, 24 pregnant women underwent single-layer closure of the myometrium after LM. The mean duration between the operation and the first pregnancy was 10.2 months. Overall, 24 patients needed a cesarean section (C-section) delivery, 6 had a miscarriage, and 2 had an intrauterine pregnancy. Of these, 8 patients were pregnant again and underwent a C-section delivery. No cases of uterine rupture were observed.

Study details: Findings are from a retrospective study including 102 women who underwent single-layer sutured LM to remove uterine fibroids larger than 5 cm and associated with the myometrium.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Aksin S et al. Int J Clin Pract. 2021 Sep 15. doi: 10.1111/ijcp.14870.

Key clinical point: Preliminary data showed a low risk for uterine rupture with single-layer closure of the myometrium after laparoscopic myomectomy (LM) and therefore can be considered a safe option for subsequent pregnancies.

Major finding: Overall, 24 pregnant women underwent single-layer closure of the myometrium after LM. The mean duration between the operation and the first pregnancy was 10.2 months. Overall, 24 patients needed a cesarean section (C-section) delivery, 6 had a miscarriage, and 2 had an intrauterine pregnancy. Of these, 8 patients were pregnant again and underwent a C-section delivery. No cases of uterine rupture were observed.

Study details: Findings are from a retrospective study including 102 women who underwent single-layer sutured LM to remove uterine fibroids larger than 5 cm and associated with the myometrium.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Aksin S et al. Int J Clin Pract. 2021 Sep 15. doi: 10.1111/ijcp.14870.

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Aging may impair restoration of endometrial blood flow after laparoscopic myomectomy

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Key clinical point: The uterine radial artery resistance index (RA-RI) was impaired after laparoscopic myomectomy (LM) and took almost 3 months to return to postoperative levels. However, restoration correlated negatively with the age of the patient.

Major finding: The median impedance of RA-RI was significantly higher 1 week after LM (0.87) vs before (0.73) and 3 months after (0.76) surgery (P < .001). There was a moderately significant correlation between the patient’s age and the rate of recovery at 3 months after LM (Pearson’s correlation coefficient, 0.54; P = .002).

Study details: Findings are from a retrospective study including 19 infertile women with uterine fibroid who underwent LM.

Disclosures: This work was funded by a grant from the Japanese Foundation for Research and Promotion of Endoscopy. The authors declared no conflict of interests.

Source: Ota K et al. J Obstet Gynaecol. 2021 Sep 23. doi: 10.1080/01443615.2021.1945011.

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Key clinical point: The uterine radial artery resistance index (RA-RI) was impaired after laparoscopic myomectomy (LM) and took almost 3 months to return to postoperative levels. However, restoration correlated negatively with the age of the patient.

Major finding: The median impedance of RA-RI was significantly higher 1 week after LM (0.87) vs before (0.73) and 3 months after (0.76) surgery (P < .001). There was a moderately significant correlation between the patient’s age and the rate of recovery at 3 months after LM (Pearson’s correlation coefficient, 0.54; P = .002).

Study details: Findings are from a retrospective study including 19 infertile women with uterine fibroid who underwent LM.

Disclosures: This work was funded by a grant from the Japanese Foundation for Research and Promotion of Endoscopy. The authors declared no conflict of interests.

Source: Ota K et al. J Obstet Gynaecol. 2021 Sep 23. doi: 10.1080/01443615.2021.1945011.

Key clinical point: The uterine radial artery resistance index (RA-RI) was impaired after laparoscopic myomectomy (LM) and took almost 3 months to return to postoperative levels. However, restoration correlated negatively with the age of the patient.

Major finding: The median impedance of RA-RI was significantly higher 1 week after LM (0.87) vs before (0.73) and 3 months after (0.76) surgery (P < .001). There was a moderately significant correlation between the patient’s age and the rate of recovery at 3 months after LM (Pearson’s correlation coefficient, 0.54; P = .002).

Study details: Findings are from a retrospective study including 19 infertile women with uterine fibroid who underwent LM.

Disclosures: This work was funded by a grant from the Japanese Foundation for Research and Promotion of Endoscopy. The authors declared no conflict of interests.

Source: Ota K et al. J Obstet Gynaecol. 2021 Sep 23. doi: 10.1080/01443615.2021.1945011.

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Clinical Edge Journal Scan: Uterine Fibroids November 2021
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Single-port laparoscopy myomectomy feasible for treatment of uterine fibroids

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Mon, 11/01/2021 - 17:24

Key clinical point: Single-port laparoscopic myomectomy (LM) for treatment of uterine fibroids (UF) showed characteristics of lesser trauma, faster recovery, and higher patient satisfaction than the traditional 3-port LM.

Major finding: The specimen removal time, postoperative ambulation time, first exhaust time after surgery, and postoperative hospital stay were lower for single-port vs traditional 3-port LM (all P < .05). After 30 days of operation, the abdominal scar satisfaction score was higher in the single-port vs 3-port LM group (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05).

Study details: Findings are from a retrospective review of 120 patients with UFs who underwent LM. Overall, 60 patients underwent single-port LM, and the remaining 60 were treated with traditional 3-port LM.

Disclosures: This study was funded by the Liaoning Provincial Department of Science and Technology. The authors declared no conflict of interests.

Source: Jiang L et al. Front Oncol. 2021 Sep 24. doi: 10.3389/fonc.2021.722084.

 

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Key clinical point: Single-port laparoscopic myomectomy (LM) for treatment of uterine fibroids (UF) showed characteristics of lesser trauma, faster recovery, and higher patient satisfaction than the traditional 3-port LM.

Major finding: The specimen removal time, postoperative ambulation time, first exhaust time after surgery, and postoperative hospital stay were lower for single-port vs traditional 3-port LM (all P < .05). After 30 days of operation, the abdominal scar satisfaction score was higher in the single-port vs 3-port LM group (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05).

Study details: Findings are from a retrospective review of 120 patients with UFs who underwent LM. Overall, 60 patients underwent single-port LM, and the remaining 60 were treated with traditional 3-port LM.

Disclosures: This study was funded by the Liaoning Provincial Department of Science and Technology. The authors declared no conflict of interests.

Source: Jiang L et al. Front Oncol. 2021 Sep 24. doi: 10.3389/fonc.2021.722084.

 

Key clinical point: Single-port laparoscopic myomectomy (LM) for treatment of uterine fibroids (UF) showed characteristics of lesser trauma, faster recovery, and higher patient satisfaction than the traditional 3-port LM.

Major finding: The specimen removal time, postoperative ambulation time, first exhaust time after surgery, and postoperative hospital stay were lower for single-port vs traditional 3-port LM (all P < .05). After 30 days of operation, the abdominal scar satisfaction score was higher in the single-port vs 3-port LM group (4.17 vs 3.47; P = .00). Intraoperative blood loss was similar in both groups (P > .05).

Study details: Findings are from a retrospective review of 120 patients with UFs who underwent LM. Overall, 60 patients underwent single-port LM, and the remaining 60 were treated with traditional 3-port LM.

Disclosures: This study was funded by the Liaoning Provincial Department of Science and Technology. The authors declared no conflict of interests.

Source: Jiang L et al. Front Oncol. 2021 Sep 24. doi: 10.3389/fonc.2021.722084.

 

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