Women's Health

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

A large percentage of studies in neurology and psychiatry over the past decade have failed to account for differences between the sexes, according to a team of Canadian researchers.

In a survey of more than 3,000 papers published in six neuroscience and psychiatry journals from 2009 to 2019, researchers found that only 5% analyzed sex as a variable.

“Despite the fact there are papers that are using males and females in the studies, they’re not using the males and females in the way that would optimally find the possibility of sex differences,” lead author Liisa A.M. Galea, PhD, told this news organization. Dr. Galea is a professor and distinguished scholar at the Djavad Mowafaghian Center for Brain Health at the University of British Columbia in Vancouver.

The study was published online in Nature Communications.
 

Optimal design uncommon

Differences in how neurologic and psychiatric diseases affect men and women have been well documented. Women, for example, are more susceptible to severe stroke, and men are more prone to cognitive decline with schizophrenia. With Alzheimer’s disease, women typically have more severe cognitive defects.

The researchers surveyed 3,193 papers that included a multitude of studies. Although most of the papers reported studies that included both sexes, only 19% of surveyed studies used what Dr. Galea called an optimal design for the discovery of sex differences. “What I mean by ‘optimally’ is the design of the experiments and the analysis of sex as a variable,” she said. And in 2019, only 5% of the studies used sex as a variable for determining differences between the sexes, the study found.

In the current research, two authors read the methods and results of each study described in each paper, Dr. Galea said. The readers noted whether the paper reported the study sample size and whether the studies used a balanced design. The surveyed journals include Nature Neuroscience, Neuron, Journal of Neuroscience, Molecular Psychiatry, Biological Psychiatry, and Neuropsychopharmacology.
 

‘Not much is changing’

“I had a suspicion that this was happening,” Dr. Galea said. “I didn’t know that it’s so bad, to be fair.” The “good news story,” she said, is that more papers considered sex as a factor in the later years surveyed. In 2019, more than 95% of papers across both disciplines reported participants’ sex, compared with about 70% in 2009. However, less than 20% of the papers in all study years reported studies that used sex optimally to determine differences between the sexes.

“The other thing that shocked me,” Dr. Galea said, “was that even despite the fact that we saw this increase in the number of papers that were using males and females, we didn’t see the sort of corresponding increase in those that were using ‘optimal design’ or ‘optimal analysis,’ ” Dr. Galea said. In 2009, 14% of papers used optimal design and 2% used optimal analysis for determining sex differences. By 2019, those percentages were 19% and 5%, respectively.

But even the papers that used both sexes had shortcomings, the study found. Just over one-third of these papers (34.5%) didn’t use a balanced design. Just over one-quarter (25.9%) didn’t identify the sample size, a shortcoming that marked 18% of these studies in 2009 and 33% in 2019. Fifteen percent of papers examined included studies that used both sexes inconsistently.

“That matters, because other studies have found that about 20% of papers are doing some kind of analysis with sex, but we had a suspicion that a lot of studies would include sex as a covariate,” Dr. Galea said. “Essentially what that does is, you remove that variable from the data. So, any statistical variation due to sex is then gone.

“The problem with that,” she added, “is you’re not actually looking to see if there’s an influence of sex; you’re removing it.”

Dr. Galea noted that this study points to a need for funding agencies to demand that researchers meet their mandates on sex- and gender-based analysis. “Despite the mandates, not much is really changing as far as the analysis or design of experiments, and we need to figure out how to change that,” she said. “We need to figure out how to get researchers more interested to use the power of studying sex differences.”
 

‘Not surprising, but disappointing’

Vladimir Hachinski, MD, professor of neurology and epidemiology at Western University in London, Ont., and former editor in chief of Stroke, told this news organization that women have almost twice the life risk of developing dementia, are at higher risk of stroke below age 35 years, and have more severe strokes and higher rates of disability at any age.

Commenting on the current study, Dr. Hachinski said, “It’s not surprising, but it’s disappointing, because we’ve known the difference for a long time.” He added, “The paper is very important because we were not aware that it was that bad.”

Dr. Hachinski also stated, “This paper needs a lot of reading. It’s a great resource, and it should be highlighted as one of those things that needs to be addressed, because it matters.”

The study was funded by a Natural Sciences and Engineering Research Council of Canada grant and by the British Columbia Women’s Foundation. Dr. Galea and Hachinski had no relevant disclosures.

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

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – If a medical professional is trying to figure out the best medical treatment for a pregnant woman with headache, it may be helpful to review data from randomized clinical trials (RCTs). Well, make that data from the RCT. There’s just been one, Northwestern Medicine obstetrician-gynecologist Catherine Stika, MD, told colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Only a single efficacy RCT has examined headache in pregnancy, said Dr. Stika. “Overall, we have very limited data in pregnancy to tell us exactly what to do,” she added.

But ob.gyns. aren’t entirely in the dark, according to medical specialists who spoke at the session. Expert opinion and fetal safety data offer insight into the best treatments, as does a new ACOG clinical practice guideline on headaches during pregnancy and post partum that was coauthored by the speakers.

And there’s some good news: Pregnancy itself is often a good treatment for headaches.

Pregnant women often find relief from one kind of headache – migraine – as their estradiol levels rise, said Laura Mercer, MD, an ob.gyn. at the University of Arizona, Phoenix. “About half of patients will report that migraines are getting better as early as the first trimester, and upwards of 83% will say that their migraines are better by the time they’re in their third trimester,” she said. “What this means for us as obstetricians is that oftentimes we can actually discontinue preventative therapies for patients during pregnancy.”

But simply discontinuing every headache treatment during pregnancy may not be the right approach, Dr. Mercer said. Instead, she said, consider the benefits and risks.

Divalproex sodium (Depakote) and topiramate (Topamax) must be avoided because of fetal risk, she said. “In fact, we will prefer that people stop these medications before they discontinue their contraception if they’re planning on getting pregnant,” she said.

Other medications, such as ACE inhibitors and the herbal remedy feverfew, should not be used at any time during pregnancy, she said.

On the other hand, calcium channel blockers and antihistamines are alright to use in pregnancy, she said. “These two should be considered first-line because there’s no known risks for them.”

Beta-blockers also may be used “with some consideration to the known risks that we’re familiar with when we use them for other indications,” she said.

There are questions about the safety of oral magnesium in pregnancy, although it’s generally considered safe, she added, and “nerve blocks and nerve stimulators seem very promising and have little known risks.”

Dr. Mercer recommended gradually tapering most medications prior to conception. But it’s crucial to stop higher-risk drugs immediately once pregnancy is confirmed, she said.

In regard to acute headache, Dr. Stika urged caution if a patient reports taking a headache medication more than twice a week. “All the medications we use for the treatment of migraine, both in and outside of pregnancy, carry the risk of what’s called medication overuse” that can lead to rebound headaches, she said.

Excedrin Tension Headache may be used for headaches in pregnancy, she said, but not Excedrin Migraine since it includes aspirin. Triptans are not recommended as first-line therapy, she added, and they “should absolutely not be used in any pregnant patient with a history of known cardiac disease or hypertension.”

Dr. Stika added that ACOG advises against the use of drugs that contain butalbital, a barbiturate that’s combined with other agents to treat headache. “Butalbital is the drug that’s most closely associated with getting people into this medication overuse headache,” she said. “It’s even worse than opioids.”

Unlike multiple other countries and the entire European Union, the United States has not banned compounds that contain butalbital, she said.

In some cases, she said, patients may present to triage with vomiting, an inability to keep food down, and persistent headache despite treatment. “This is a really classic presentation.”

The ACOG clinical practice guideline offers a flow chart about what to do, she said. Hydration is key, she said, and various treatment options can help. A referral to neurology may be needed in extreme cases, she said. But “most of the time, you’re able to get rid of her headache.”

Dr. Mercer and Dr. Stika report no disclosures.

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

SAN DIEGO – The end of the legal standards set by Roe v. Wade will likely lead to bans in as many as 26 states and send a flood of abortion seekers to the remaining states that still allow the procedure, an obstetrician-gynecologist warned colleagues at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

“The blue states neighboring those states will likely see an outpouring of patients among those who can travel,” Kristyn Brandi, MD, of New Jersey Medical School, Newark, said in a presentation about legal threats to abortion rights. “These will likely flood the health care systems and delay care for everyone. Make no mistake: Virtually all ob.gyns. across the country have the potential to be impacted.”

Indeed, research suggests that thousands more Texans than usual are heading out of state for abortions each month in the wake of a new, strict antiabortion law there.

Only three sessions at the 3-day ACOG meeting directly addressed abortion. But the topic was clearly on the minds of attendees in the wake of the release of a leaked draft of a Supreme Court ruling that would eliminate federal protection for abortion rights.

The 57,000-member ACOG organization firmly supports abortion rights and declares on its website that “Abortion Is Healthcare.”

In a workshop on challenges to abortion, ACOG chief of staff Dorothea Calvano Lindquist said “we remain your steadfast partner in advocacy and guidance on all levels.”

Ivana S. Thompson, MD, an ob.gyn. at Vanderbilt University, Nashville, Tenn., explained in a presentation that Roe v. Wade established a framework for regulations around abortion; they may not be regulated during the first trimester, but states may impose rules in the second semester that are related to health. “And then in the third trimester, once the fetus reaches viability, the state may regulate abortions or even prohibit them entirely, so long as there are exceptions for medical emergencies,” she said.

The Supreme Court ruling in the 1992 case of Planned Parenthood v. Casey did away with the trimester framework, Dr. Thompson said, and declared that abortion regulations could not place an “undue burden” on women.

This change allowed laws that “are purposely designed to trap providers and clinics and to restrict their ability to provide abortions, not due to health concerns but really just to prevent pregnant people from accessing care,” she said.

In 2018, Mississippi passed a law – which never went into effect and is now challenged before the Supreme Court – that makes most abortions illegal after 15 weeks. And in September 2021, a Texas law went into effect that outlaws abortions after a fetal heartbeat is detected.

What happens if Roe is overturned and laws that ban or severely limit abortion go into effect in states across the country? In Nashville, Dr. Thompson said, patients will have to travel to Illinois – more than 300 miles away – to reach the nearest abortion clinic.

“When I think about my own clinical practice over the last year, [if the law were in place] I would not have been able to offer an abortion to a developmentally delayed, nonverbal patient who was raped by her brother,” she said. “I would not have been able to offer an abortion to the service person who was sexually assaulted by a coworker in the field. I would not have been able to offer an abortion to a person with a pregnancy complicated by a hypoplastic left heart, congenital diaphragmatic hernias with the stomach in the thorax, an unformed lumbar spine, and other anomalies.”

Bhavik Kumar, MD, a family medicine physician and medical director for primary and trans care at Planned Parenthood Gulf Coast in Houston, said the effects of the new law in Texas are already apparent. As he told ABC News last fall, he used to perform 20-30 abortions per day, but the number dwindled immediately the day the law went into effect.

At the ACOG presentation, Dr. Kumar highlighted a March 2022 research brief that reported that abortions in Texas fell by half in the month after the law was implemented compared with the previous year. And the average number of abortions performed on Texans who left the state grew by more than 10-fold from the period of September-December 2019 (514) to September-December 2021 (5,574).

Once the law went into effect, Dr. Kumar said, “we began to see longer waiting times at clinics in nearby states, wait times that started out as short as a day go to an average of 2-3 weeks to get an initial appointment. And some of these states also have mandatory delays of up to 72 hours.”

Dr. Kumar added that he’s “heard from emergency-room physicians and nurses who call and ask me what they can and cannot say when providing care for pregnant people in Texas and how they should be counseling their patients who may need emergency or urgent care after returning to Texas.”

Dr. Brandi cautioned colleagues that even ob.gyns. who don’t perform abortions will still be affected by the overturning of Roe. In some states, they’ll have to understand the rules about treating women with early ruptured membranes when cardiac motion is detected or with atopic pregnancies with cardiac activity at risk of potential tubal rupture.

The speakers urged colleagues to take action at the ballot box and their own clinics to protect patients. “While the recent leak is a truly scary moment for our country and for our practices, I’m hopeful that it will help galvanize our communities,” Dr. Brandi said. Regardless of where you live, regardless of where you practice, this ruling impacts all ob.gyns., everyone in this room. Each of us needs to go home after this conference and figure out what you are going to do to make sure that our patients can still get the care that they need.”

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.

A new study of hospitals in New York City suggests ways to reduce severe maternal morbidity (SMM). The researchers interviewed health care professionals in four institutions with low performance and four with high performance, and identified various themes associated with good performance.

“Our results raise the hypothesis that hospital learning collaboratives focused on optimizing organizational practices and policies, increasing clinician and staff awareness and education on maternal health disparities, and addressing structural racism may be important tools for improving equity in maternal outcomes,” the authors wrote in the study, published in Obstetrics & Gynecology.

The researchers conducted 50 semistructured interviews with health care professionals at lower-performing and higher-performing New York City hospitals, which were selected based on risk-adjusted morbidity metrics. The interviews explored various topics, including structural characteristics like staffing, organizational characteristics like culture and communication, labor and delivery practices such as teamwork and use of evidence-based practices, and racial and ethnic disparities.

The analysis revealed six broad areas that were stronger in high-performing hospitals: day-to-day involvement of leadership in quality activities, an emphasis on standards and standardized care, good communication and teamwork between nurses and physicians, good staffing and supervision among physicians and nurses, sharing of performance data with health care workers, and acknowledgment of the existence of racial and ethnic disparities and that bias can cause treatment differences.

“I think this qualitative approach is an important lens to pair with the quantitative approach. With such variability in severe maternal morbidity between hospitals in New York, it is not enough to just look at the quantitative data. To understand how to improve you must examine structures and processes. The structures, which are the physical and organizational characteristics in health care, and the process, which is how health care is delivered,” Veronica Gillispie-Bell, MD, wrote in a comment. Dr. Gillispie-Bell is medical director at Louisiana Perinatal Quality Collaborative and the Pregnancy-Associated Mortality Review for the Louisiana Department of Health.

“We know that high reliability organizations are those who are preoccupied with quality and safety. That means accountability from leadership (structure) and stability in standardization of care (processes). However, none of this matters if you do not have a culture that promotes safety. Based on the key findings of the high-performing hospitals, there was a culture that promoted safety and quality evidenced in the nurse-physician communication and the transparency around data through a lens of equity,” wrote Dr. Gillispie-Bell.

She noted that the study should encourage low-performing hospitals, since it illustrates avenues for improvement. Her personal experience reflects that, though she said that hospitals need help. The Louisiana Perinatal Quality Collaborative addressed severe maternal morbidity at birthing centers by implementing evidence-based best practices for management of hypertension and hemorrhage along with health equity measures. The team conducted coaching calls, in-person learning sessions, and in-person visits through a “Listening Tour.”

The result was a 35% reduction in hemorrhage overall and a reduction of 49% in hemorrhage in Black women, as well as hypertension by 12% overall between August 2018 and May 2020. Not all the news was good, as Black women still had an increase in severe maternal morbidity, possibly because of the COVID epidemic, since it is a risk factor for hypertension during pregnancy and infection rates are higher among Black individuals. “We need support for state based perinatal quality collaboratives to do this work and we need accountability as we are now seeing from metrics being implemented by [the Centers for Medicare & Medicaid Services]. Hospitals need to stratify their data by race and ethnicity to see where there are disparities in their outcomes,” said Dr. Gillispie-Bell.

The improvements are needed, given that the United States has the highest rates of maternal mortality and morbidity among developed countries, “most of which is preventable, and we have significant inequities by race and ethnicity,” said Laurie Zephyrin, MD, vice president for advancing health equity at the Commonwealth Fund. The question becomes how to effect change, and “there’s a lot happening in the policy space. Some of this policy change is directed at expanding insurance coverage, including more opportunities, including funding for community health workers and doulas, and thinking about how to incorporate midwives. There’s also work around how do we actually improve the care delivered by our health system.” Dr. Zephyrin added that the Department of Health & Human Services has contracted with the health improvement company Premier to use data and best-practices to improve maternal health.

The new work has the potential to be complementary to such approaches. “It provides some structure around how to approach some of the solutions, none of which I think is rocket science. It’s just something that needs to be focused on more intentionally,” said Dr. Zephyrin.

For example, the report found that high-performing hospitals had leaders who collaborated with frontline clinicians to share performance data, and this occurred in person, at departmental quality meetings, and during grand rounds. In contrast, staff in low-performing hospitals did not mention data feedback and some said that their institution made little effort to communicate performance metrics to frontline staff.

“One of the key lessons from the pandemic is that we need to have better data, and we need to have data around race and ethnicity to be able to understand the impact on marginalized communities. This study highlights that there’s more to be done around data to ensure that we can truly move the needle on advancing health equity,” said Dr. Zephyrin.

The researchers also found that clinicians in low-performing institutions did not acknowledge the presence of structural racism or differences in care associated with race or ethnicity. When they acknowledge differences in care, they attributed them to factors outside of the hospital’s control, such as patients not seeking out health care or not maintaining a healthy weight. Clinicians at high-performing hospitals were more likely to explicitly mention racism and bias and acknowledged that these factors could contribute to differences in care.

Dr. Gillispie-Bell and Dr. Zephyrin have no relevant financial disclosures.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

The percentage of low-income pregnant mothers who received influenza and Tdap vaccinations fell sharply during the COVID-19 pandemic, especially in Black and Hispanic patients, a new study finds.

The percentage of patients who received the influenza vaccines at two Medicaid clinics in Houston dropped from 78% before the pandemic to 61% during it (adjusted odds ratio, 0.38; 95% CI, 0.26-0.53; P < .01), researchers reported at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The percentage receiving the Tdap vaccine dipped from 85% to 76% (aOR, 0.56; 95% CI, 0.40-0.79; P < .01).

New York–Presbyterian/Weill Cornell Medical Center pediatrician Sallie Permar, MD, PhD, who’s familiar with the study findings, called them “alarming” and said in an interview that they should be “a call to action for providers.”

“Continuing the status quo in our routine preventative health care and clinic operations means that we are losing ground in reduction and elimination of vaccine-preventable diseases,” Dr. Permar said in an interview.

According to corresponding author Bani Ratan, MD, an ob.gyn. with the Baylor College of Medicine, Houston, there’s been little if any previous research into routine, non-COVID vaccination in pregnant women during the pandemic.

For the study, researchers retrospectively analyzed the records of 939 pregnant women who entered prenatal care before 20 weeks (462 from May–November 2019, and 477 from May–November 2020) and delivered at full term.

Among ethnic groups, non-Hispanic Blacks saw the largest decline in influenza vaccines. Among them, the percentage who got them fell from 64% (73/114) to 35% (35/101; aOR, 0.30; 95% CI, 0.17-0.52; P < .01). Only Hispanics had a statistically significant decline in Tdap vaccination (OR, 0.52, 95% CI, 0.34-0.80; P < .01, percentages not provided).

Another study presented at ACOG examined vaccination rates during the pandemic and found that Tdap vaccination rates dipped among pregnant women in a Philadelphia-area health care system.

Possible causes for the decline in routine vaccination include hesitancy linked to the COVID-19 vaccines and fewer office visits because of telemedicine, said Dr. Batan in an interview.

Dr. Permar blamed the role of vaccine misinformation during the pandemic and the mistrust caused by the exclusion of pregnant women from early vaccine trials. She added that “challenges in health care staffing and issues of health care provider burnout that worsened during the pandemic likely contributed to a fraying of the focus on preventive health maintenance simply due to bandwidth of health professionals.”

In a separate study presented at ACOG, researchers at the State University of New York, Syracuse, reported on a survey of 157 pregnant women of whom just 38.2% were vaccinated against COVID-19. Among the unvaccinated, who were more likely to have less education, 66% reported that lack of data about vaccination was their primary concern.

No funding or disclosures are reported by study authors. Dr. Permar reported consulting for Merck, Moderna, GlaxoSmithKline, Pfizer, Dynavax, and Hookipa on cytomegalovirus vaccine programs.

*This story was updated on 5/11/2022.

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

In 2021, the US Preventive Services Task Force (USPSTF) considered 13 topics and made a total of 23 recommendations. They reviewed only 1 new topic. The other 12 were updates of topics previously addressed; no changes were made in 9 of them. In 3, the recommended age of screening or the criteria for screening were expanded. This Practice Alert will review the recommendations made and highlight new recommendations and any changes to previous ones. All complete recommendation statements, rationales, clinical considerations, and evidence reports can be found on the USPSTF website at https://uspreventiveservicestaskforce.org/uspstf/home.¹

Dental caries in children

Dental caries affect about 23% of children between the ages of 2 and 5 years and are associated with multiple adverse social outcomes and medical conditions.² The best way to prevent tooth decay, other than regular brushing with fluoride toothpaste, is to drink water with recommended amounts of fluoride (≥ 0.6 parts fluoride per million parts water).² The USPSTF reaffirmed its recommendation from 2014 that stated when a local water supply lacks sufficient fluoride, primary care clinicians should prescribe oral supplementation for infants and children in the form of fluoride drops starting at age 6 months. The dosage of fluoride depends on patient age and fluoride concentration in the local water (TABLE 1³). The USPSTF also recommends applying topical fluoride as 5% sodium fluoride varnish, every 6 months, starting when the primary teeth erupt.²

BREAKING NEWS At press time, the USPSTF issued its final recommendation on the use of aspirin for primary prevention of cardiovascular disease; see https:// bit.ly/3vklQEe for details.

In addition to fluoride supplements and topical varnish, should clinicians perform screening examinations looking for dental caries? The USPSTF feels there is not enough evidence to assess this practice and gives it an “I” rating (insufficient evidence).

Preventive interventions in pregnancy 

In 2021, the USPSTF assessed 3 topics related to pregnancy and prenatal care.

Screening for gestational diabetes. The USPSTF gave a “B” recommendation for screening at 24 weeks of pregnancy or after, but an “I” statement for screening prior to 24 weeks.⁴ Screening can involve a 1-step or 2-step protocol.

The 2-step protocol is most commonly used in the United States. It involves first measuring serum glucose after a nonfasting 50-g oral glucose challenge; if the resulting level is high, the second step is a 75- or 100-g oral glucose tolerance test lasting 3 hours. The 1-step protocol involves measuring a fasting glucose level, followed by a 75-g oral glucose challenge with glucose levels measured at 1 and 2 hours.

Healthy weight gain in pregnancy. This was the only new topic the USPSTF assessed last year. The resulting recommendation is to offer pregnant women behavioral counseling to promote healthy weight gain and to prevent excessive weight gain in pregnancy. The recommended weight gain depends on the mother’s prepregnancy weight status: 28 to 40 lbs if the mother is underweight; 25 to 35 lbs if she is not under- or overweight; 15 to 25 lbs if she is overweight; and 11 to 20 lbs if she is obese.⁵ Healthy weight gain contributes to preventing gestational diabetes, emergency cesarean sections, and infant macrosomia.

Continue to: Low-dose aspirin

Low-dose aspirin. Reaffirming a recommendation from 2014, the USPSTF advises low-dose aspirin (81 mg/d) starting after 12 weeks’ gestation for all pregnant women who are at high risk for preeclampsia. TABLE 2⁶ lists high- and moderate-risk conditions for preeclampsia and the recommendation for the use of low-dose aspirin.

Sexually transmitted infections

Screening for both chlamydia and gonorrhea in sexually active females through age 24 years was given a “B” recommendation, reaffirming the 2014 recommendation.⁷ Screening for these 2 sexually transmitted infections (STIs) is also recommended for women 25 years and older who are at increased risk of STIs. Risk is defined as having a new sex partner, more than 1 sex partner, a sex partner who has other sex partners, or a sex partner who has an STI; not using condoms consistently; having a previous STI; exchanging sex for money or drugs; or having a history of incarceration.

Screen for both infections simultaneously using a nucleic acid amplification test, testing all sites of sexual exposure. Urine testing can replace cervical, vaginal, and urethral testing. Those found to be positive for either STI should be treated according to the most recent treatment guidelines from the Centers for Disease Control and Prevention (CDC). And sexual partners should be advised to undergo testing.^8,9

The USPSTF could not find evidence for the benefits and harms of screening for STIs in men. Remember that screening applies to those who are asymptomatic. Male sex partners of those found to be infected should be tested, as should those who show any signs or symptoms of an STI. A recent Practice Alert described the most current CDC guidance for diagnosing and treating STIs.⁹

Type 2 diabetes and prediabetes

Screening for type 2 diabetes (T2D) and prediabetes is now recommended for adults ages 35 to 70 years who are overweight or obese.¹⁰ The age to start screening has been lowered to 35 years from the previous recommendation in 2015, which recommended starting at age 40. In addition, the recommendation states that patients with prediabetes should be referred for preventive interventions. It is important that referral is included in the statement because the Affordable Care Act mandates that USPSTF “A” and “B” recommendations must be covered by commercial health insurance with no copay or deductible.

Continue to: Screening can be conducted...

Screening can be conducted using a fasting plasma glucose or A1C level, or with an oral glucose tolerance test. Interventions that can prevent or delay the onset of T2D in those with prediabetes include lifestyle interventions that focus on diet and physical activity, and the use of metformin (although metformin has not been approved for this by the US Food and Drug Administration).

Changes to cancer screening recommendations

In 2021, the USPSTF reviewed and modified its recommendations on screening for 2 types of cancer: colorectal and lung.

For colorectal cancer, the age at which to start screening was lowered from 50 years to 45 years.¹¹ Screening at this earlier age is a “B” recommendation, because, while there is benefit from screening, it is less than for older age groups. Screening individuals ages 50 to 75 years remains an “A” recommendation, and for those ages 76 to 85 years it remains a “C” recommendation. A “C” recommendation means that the overall benefits are small but some individuals might benefit based on their overall health and prior screening results. In its clinical considerations, the USPSTF recommends against screening in those ages 85 and older but, curiously, does not list it as a “D” recommendation. The screening methods and recommended screening intervals for each appear in TABLE 3.¹¹

For lung cancer, annual screening using low-dose computed tomography (CT) was first recommended by the USPSTF in 2013 for adults ages 55 to 80 years with a 30-pack-year smoking history. Screening could stop once 15 years had passed since smoking cessation. In 2021, the USPSTF lowered the age to initiate screening to 50 years, and the smoking history threshold to 20 pack-years.¹² If these recommendations are followed, a current smoker who does not quit smoking could possibly receive 30 annual CT scans. The recommendation does state that screening should stop once a person develops a health condition that significantly affects life expectancy or ability to have lung surgery.

For primary prevention of lung cancer and other chronic diseases through smoking cessation, the USPSTF also reassessed its 2015 recommendations. It reaffirmed the “A” recommendation to ask adults about tobacco use and, for tobacco users, to recommend cessation and provide behavioral therapy and approved pharmacotherapy.¹³ The recommendation differed for pregnant adults in that the USPSTF is unsure about the potential harms of pharmacotherapy in pregnancy and gives that an “I” statement.¹³ An additional “I” statement was made about the use of electronic cigarettes for smoking cessation; the USPSTF recommends using behavioral and pharmacotherapy interventions with proven effectiveness and safety instead.

Continue to: 4 additional recommendation updates with no changes

4 additional recommendation updates with no changes

Screening for high blood pressure in adults ages 18 years and older continues to receive an “A” recommendation.¹⁴ Importantly, the recommendation states that confirmation of high blood pressure should be made in an out-of-­office setting before initiating treatment. Screening for vitamin D deficiency in adults and hearing loss in older adults both continue with “I” statements,^15,16 and screening for asymptomatic carotid artery stenosis continues to receive a “D” recommendation.¹⁷ The implications of the vitamin D “I” statement were discussed in a previous Practice Alert.¹⁸

Continuing value of the USPSTF

The USPSTF continues to set the gold standard for assessment of preventive interventions, and its decisions affect first-dollar coverage by commercial health insurance. The reaffirmation of past recommendations demonstrates the value of adhering to rigorous evidence-based methods (if they are done correctly, they rarely must be markedly changed). And the updating of screening criteria shows the need to constantly review the evolving evidence for current recommendations. Once again, however, funding and staffing limitations allowed the USPSTF to assess only 1 new topic. A listing of all the 2021 recommendations is in TABLE 4.¹

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Nearly three-quarters of clinicians reported screening patients for hypertensive disorders of pregnancy, but only one-quarter comprehensively identified cardiovascular risk, based on survey data from approximately 1,500 clinicians in the United States.

Rates of hypertensive disorders of pregnancy have been on the rise in the United States for the past decade, and women with a history of these disorders require cardiovascular risk monitoring during the postpartum period and beyond, wrote Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Specifically, the American College of Obstetricians and Gynecologists recommends cardiovascular risk evaluation and lifestyle modification for these individuals, the researchers said.

The most effective management of women with a history of hypertensive disorders of pregnancy will likely involve a team effort by primary care, ob.gyns., and cardiologists, but data on clinician screening and referrals are limited, they added.

In a study published in Obstetrics & Gynecology, the researchers reviewed data from a cross-sectional, web-based survey of clinicians practicing in the United States (Fall DocStyles 2020). The study population of 1,502 respondents with complete surveys included 1,000 primary care physicians, 251 ob.gyns., and 251 nurse practitioners or physician assistants. Approximately 60% of the respondents were male, and approximately 65% had been in practice for at least 10 years.

Overall, 73.6% of clinicians reported screening patients for a history of hypertensive disorders of pregnancy. The screening rates were highest among ob.gyns. (94.8%).

However, although 93.9% of clinicians overall correctly identified at least one potential risk associated with hypertensive disorders of pregnancy, only 24.8% correctly identified all cardiovascular risks associated with hypertensive disorders of pregnancy listed in the survey, the researchers noted.

Screening rates ranged from 49% to 91% for pregnant women, 34%-75% for postpartum women, 26%-61% for nonpregnant reproductive-age women, 20%-45% for perimenopausal or menopausal women, and 1%-4% for others outside of these categories.

The most often–cited barriers to referral were lack of patient follow-through (51.5%) and patient refusal (33.6%). To improve and facilitate referrals, respondents’ most frequent resource request was for more referral options (42.9%), followed by patient education materials (36.2%), and professional guidelines (34.1%).

In a multivariate analysis, primary care physicians were more than five times as likely to report not screening patients for hypertensive disorders of pregnancy (adjusted prevalence ratio, 5.54); nurse practitioners and physician assistants were more than seven times as likely (adjusted prevalence ratio, 7.42).

The researchers also found that clinicians who saw fewer than 80 patients per week were almost twice as likely not to screen for hypertensive disorders of pregnancy than those who saw 110 or more patients per week (adjusted prevalence ratio, 1.81).

“Beyond the immediate postpartum period, there is a lack of clear guidance on CVD [cardiovascular disease] evaluation and ongoing monitoring in women with history of hypertensive disorders of pregnancy,” the researchers wrote in their discussion. “Recognizing hypertensive disorders of pregnancy as a risk factor for CVD may allow clinicians to identify women requiring early evaluation and intervention,” they said.

The study findings were limited by several factors including potentially biased estimates of screening practices, and the potential for selection bias because of the convenience sample used to recruit survey participants, the researchers noted.

However, the results were strengthened by the inclusion of data from several clinician types and the relatively large sample size, and are consistent with those of previous studies, they said. Based on the findings, addressing barriers at both the patient and clinician level and increasing both patient and clinician education about the long-term risks of hypertensive disorders of pregnancy might increase cardiovascular screening and subsequent referrals, they concluded.
 

More education, improved screening tools needed

“Unfortunately, most CVD risk stratification scores such as the Framingham score do not include pregnancy complications, despite excellent evidence that pregnancy complications increase risk of CVD,” said Catherine M. Albright, MD, MS, of the University of Washington, Seattle, in an interview. “This is likely because these scores were developed primarily to screen for CVD risk in men. Given the rising incidence of hypertensive disorders of pregnancy and the clear evidence that this is a risk factor for future CVD, more studies like this one are needed in order to help guide patient and provider education,” said Dr. Albright, who was not involved in the study.

“It is generally well reported within the ob.gyn. literature about the increased lifetime CVD risk related to hypertensive disorders of pregnancy and we, as ob.gyns., always ask about pregnancy history because of our specialty, which gives us the opportunity to counsel about future risks,” she said.

“Women’s health [including during pregnancy] has been undervalued and underresearched for a long time,” with limited focus on pregnancy-related issues until recently, Dr. Albright noted. “This is clear in the attitudes and education of the primary care providers in this study,” she said.

A major barrier to screening in clinical practice has been that the standard screening guidelines for CVD (for example, those published by the United States Preventive Services Taskforce) have not included pregnancy history, said Dr. Albright. “Subsequently, these questions are not asked during routine annual visits,” she said. Ideally, “we should be able to leverage the electronic medical record to prompt providers to view a previously recorded pregnancy history or to ask about pregnancy history as a routine part of CVD risk assessment, and, of course, additional education outside of ob.gyn. and cardiology is needed,” she said.

The clinical takeaway from the current study is that “every annual visit with a person who has been pregnant is an opportunity to ask about and document pregnancy history,” Dr. Albright said. “After the completion of childbearing, many patients no longer see an ob.gyn., so other providers need to feel comfortable asking about and counseling about risks related to pregnancy complications,” she added.

“It is clear that adverse pregnancy outcomes pose lifetime health risks,” said Dr. Albright. “We will continue to look into the mechanisms of this through research. However, right now the additional research that is needed is to determine the optimal screening and follow-up for patients with a history of hypertensive disorders of pregnancy, as well as to examine how existing CVD-screening algorithms can be modified to include adverse pregnancy outcomes,” she emphasized.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

A fertility procedure that mixes genetic material from three people to prevent couples from having children with certain debilitating and potentially fatal inherited disorders is now legal in two countries: the United Kingdom and Australia.

Australia’s senate passed a bill on March 30 amending pre-existing laws to allow the procedure in certain circumstances.

The goal of this procedure is to prevent genetic disorders caused by defective mitochondria, the power plants inside our cells that provide energy for normal growth and development. When mitochondria don’t produce any energy at all, the resulting genetic disorders are quickly fatal. When mitochondria make only a little energy, children can have severe illnesses and disabilities.

“The outcomes from this problem are really severe, and it’s highly likely that the baby will be very sick or die,” says Arthur Caplan, PhD, head of the division of medical ethics at the New York University Grossman School of Medicine.

Mitochondria have a little bit of DNA, and children inherit them from their mother. To avoid children inheriting this damaged genetic material, mitochondrial donation, also known as three-parent in vitro fertilization (IVF), takes the nucleus, which contains most of the DNA that makes us who we are, from an egg of the mother and puts it into a donated egg from a woman with healthy mitochondria.

The egg is then fertilized with sperm through IVF, and the resulting embryo has genetic material from two women and one man.

One ethical conundrum about mitochondrial donation is that any child conceived this way would inherit modified DNA and pass that along to their own children.

“I think it’s likely that we are going to go down this road to repair disease,” Dr. Caplan says. “I don’t think all genetic engineering of embryos is wrong, but we have to draw the line between enhancement versus treating disease.”

For couples who want a child that shares at least some of their own DNA, there are other ways to have a child without damaged mitochondria. One option would be genetic screening of their embryos to find healthy embryos without this defect, which would work for some women who have relatively few mitochondrial mutations. Another alternative is using a donor egg from a woman with healthy mitochondria.

Mitochondrial donation may appeal to couples who want their children to have a genetic connection to both parents, Dr. Caplan says. But prospective parents also need to be aware that this procedure is relatively new and, unlike egg donation, doesn’t have a long track record of success.

“It looks promising, but we don’t have the full safety picture yet, and we’re not going to start to get it for another decade or so,” Dr. Caplan cautions. “I do think it’s worth offering as one option, but you also have to get people to think about how important it is to have a biological child together and make sure that they understand that even if we try this technique, we don’t know the long-term outcomes for children yet.”

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

A fertility procedure that mixes genetic material from three people to prevent couples from having children with certain debilitating and potentially fatal inherited disorders is now legal in two countries: the United Kingdom and Australia.

Australia’s senate passed a bill on March 30 amending pre-existing laws to allow the procedure in certain circumstances.

The goal of this procedure is to prevent genetic disorders caused by defective mitochondria, the power plants inside our cells that provide energy for normal growth and development. When mitochondria don’t produce any energy at all, the resulting genetic disorders are quickly fatal. When mitochondria make only a little energy, children can have severe illnesses and disabilities.

“The outcomes from this problem are really severe, and it’s highly likely that the baby will be very sick or die,” says Arthur Caplan, PhD, head of the division of medical ethics at the New York University Grossman School of Medicine.

Mitochondria have a little bit of DNA, and children inherit them from their mother. To avoid children inheriting this damaged genetic material, mitochondrial donation, also known as three-parent in vitro fertilization (IVF), takes the nucleus, which contains most of the DNA that makes us who we are, from an egg of the mother and puts it into a donated egg from a woman with healthy mitochondria.

The egg is then fertilized with sperm through IVF, and the resulting embryo has genetic material from two women and one man.

One ethical conundrum about mitochondrial donation is that any child conceived this way would inherit modified DNA and pass that along to their own children.

“I think it’s likely that we are going to go down this road to repair disease,” Dr. Caplan says. “I don’t think all genetic engineering of embryos is wrong, but we have to draw the line between enhancement versus treating disease.”

For couples who want a child that shares at least some of their own DNA, there are other ways to have a child without damaged mitochondria. One option would be genetic screening of their embryos to find healthy embryos without this defect, which would work for some women who have relatively few mitochondrial mutations. Another alternative is using a donor egg from a woman with healthy mitochondria.

Mitochondrial donation may appeal to couples who want their children to have a genetic connection to both parents, Dr. Caplan says. But prospective parents also need to be aware that this procedure is relatively new and, unlike egg donation, doesn’t have a long track record of success.

“It looks promising, but we don’t have the full safety picture yet, and we’re not going to start to get it for another decade or so,” Dr. Caplan cautions. “I do think it’s worth offering as one option, but you also have to get people to think about how important it is to have a biological child together and make sure that they understand that even if we try this technique, we don’t know the long-term outcomes for children yet.”

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

A fertility procedure that mixes genetic material from three people to prevent couples from having children with certain debilitating and potentially fatal inherited disorders is now legal in two countries: the United Kingdom and Australia.

Australia’s senate passed a bill on March 30 amending pre-existing laws to allow the procedure in certain circumstances.

The goal of this procedure is to prevent genetic disorders caused by defective mitochondria, the power plants inside our cells that provide energy for normal growth and development. When mitochondria don’t produce any energy at all, the resulting genetic disorders are quickly fatal. When mitochondria make only a little energy, children can have severe illnesses and disabilities.

“The outcomes from this problem are really severe, and it’s highly likely that the baby will be very sick or die,” says Arthur Caplan, PhD, head of the division of medical ethics at the New York University Grossman School of Medicine.

Mitochondria have a little bit of DNA, and children inherit them from their mother. To avoid children inheriting this damaged genetic material, mitochondrial donation, also known as three-parent in vitro fertilization (IVF), takes the nucleus, which contains most of the DNA that makes us who we are, from an egg of the mother and puts it into a donated egg from a woman with healthy mitochondria.

The egg is then fertilized with sperm through IVF, and the resulting embryo has genetic material from two women and one man.

One ethical conundrum about mitochondrial donation is that any child conceived this way would inherit modified DNA and pass that along to their own children.

“I think it’s likely that we are going to go down this road to repair disease,” Dr. Caplan says. “I don’t think all genetic engineering of embryos is wrong, but we have to draw the line between enhancement versus treating disease.”

For couples who want a child that shares at least some of their own DNA, there are other ways to have a child without damaged mitochondria. One option would be genetic screening of their embryos to find healthy embryos without this defect, which would work for some women who have relatively few mitochondrial mutations. Another alternative is using a donor egg from a woman with healthy mitochondria.

Mitochondrial donation may appeal to couples who want their children to have a genetic connection to both parents, Dr. Caplan says. But prospective parents also need to be aware that this procedure is relatively new and, unlike egg donation, doesn’t have a long track record of success.

“It looks promising, but we don’t have the full safety picture yet, and we’re not going to start to get it for another decade or so,” Dr. Caplan cautions. “I do think it’s worth offering as one option, but you also have to get people to think about how important it is to have a biological child together and make sure that they understand that even if we try this technique, we don’t know the long-term outcomes for children yet.”

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

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.