Women's Health

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

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

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

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

(Reuters) – President Joe Biden’s administration is urging a judge to reject a request by abortion opponents for a court order withdrawing federal approval for the drug used in medication abortions – which account for more than half of U.S. abortions – citing potential dangers to women seeking to end their pregnancies.
 

The U.S. Food and Drug Administration’s filing to U.S. District Judge Matthew Kacsmaryk, made available online on Tuesday, came in a lawsuit in Texas by antiabortion groups challenging the agency’s approval of the drug mifepristone in 2000 for medication abortion.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for 22 years,” lawyers for the FDA said in the filing to Mr. Kacsmaryk, who is based in Amarillo.

Mifepristone is available under the brand name Mifeprex and as a generic. Used in conjunction with another drug, it is approved to terminate a pregnancy within the first 10 weeks of a pregnancy. The FDA on Jan. 3 said the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights.

“No abortion is safe, and chemical abortions are particularly dangerous,” said Julie Blake, senior counsel at the conservative legal group Alliance Defending Freedom, which represents the plaintiffs in the lawsuit. “The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk.”

The American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to the Biden administration last June that “robust evidence exists regarding the safety of mifepristone for medication-induced abortion.”

Antiabortion groups including the Alliance for Hippocratic Medicine and the American Association of Pro-Life Obstetricians and Gynecologists sued the FDA in November, saying the agency improperly used an accelerated process to approve mifepristone and failed to study its risks for minors adequately.

In its court filing, the FDA said there was no basis for second-guessing the FDA’s judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion. That would result in longer wait times and would carry risks for some patients including those intolerant to anesthesia, the FDA added.

In support of its position, the agency submitted declarations from abortion providers. For example, nonprofit Maine Family Planning said it would have to eliminate abortion services at 17 of its 18 clinics if mifepristone were no longer available.

Mifeprex maker Danco Laboratories on Friday also asked to intervene in the lawsuit to protect its ability to sell the drug.

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

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum/perinatal depression (PPD) remains the most common complication in modern obstetrics, with a prevalence of 10%-15% based on multiple studies over the last 2 decades. Over those same 2 decades, there has been growing interest and motivation across the country – from small community hospitals to major academic centers – to promote screening. Such screening is integrated into obstetrical practices, typically using the Edinburgh Postnatal Depression Scale (EPDS), the most widely used validated screen for PPD globally.

As mentioned in previous columns, the U.S. Preventive Services Task Force recommended screening for PPD in 2016, which includes screening women at highest risk, and both acutely treating and preventing PPD.

Since then, screening women for a common clinical problem like PPD has been widely adopted by clinicians representing a broad spectrum of interdisciplinary care. Providers who are engaged in the treatment of postpartum women – obstetricians, psychiatrists, doulas, lactation consultants, facilitators of postpartum support groups, and advocacy groups among others – are included.

An open question and one of great concern recently to our group and others has been what happens after screening. It is clear that identification of PPD per se is not necessarily a challenge, and we have multiple effective treatments from antidepressants to mindfulness-based cognitive therapy to cognitive-behavioral interventions. There is also a growing number of digital applications aimed at mitigation of depressive symptoms in women with postpartum major depressive disorder. One unanswered question is how to engage women after identification of PPD and how to facilitate access to care in a way that maximizes the likelihood that women who actually are suffering from PPD get adequate treatment.

The “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression. This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well?

With that backdrop, it is surprising that the Canadian Task Force on Preventive Health Care has recently recommended against screening with systematic questionnaires, noting that benefits were unclear and not a particular advantage relative to standard practice. The recommendation carries an assumption that standard practice involves queries about mental health. While the task force continues to recommend screening for PPD, their recommendation against screening with a standardized questionnaire represents a bold, sweeping, if not myopic view.

While the Canadian Task Force on Preventive Health Care made their recommendation based on a single randomized controlled trial with the assumption that women were getting mental health counseling, and that women liked getting mental health engagement around their depression, that is not a uniform part of practice. Thus, it is puzzling why the task force would make the recommendation based on such sparse data.

The way to optimize access to care and referral systems for women who are suffering from PPD is not to remove a part of the system that’s already working. Well-validated questionnaires such as the EPDS are easy to administer and are routinely integrated into the electronic health systems records of both small and large centers. These questionnaires are an inexpensive way to increase the likelihood that women get identified and referred for a spectrum of potentially helpful interventions.

PPD is also easy to treat with medications and a wide spectrum of nonpharmacologic interventions. Novel interventions are also being explored to maximize access for women with postpartum mood and anxiety disorders such as peer-delivered behavioral activation and cognitive-behavioral therapy, which could be community based and implemented from urban to rural settings across the United States.

What may need the greatest study is the path to accessing effective treatments and resources for these women and this problem has prompted our group to explore these issues in our more recent investigations. Better understanding of those factors that limit access to mental health providers with expertise in perinatal mental health to the logistical issues of navigating the health care system for sleep-deprived new moms and their families demands greater attention and clearer answers.

The whole field has an obligation to postpartum women to figure out the amalgam of practitioners, resources, and platforms that need to be used to engage women so that they get effective treatment – because we have effective treatments. But the solution to improving perinatal mental health outcomes, unlike the approach of our colleagues in Canada, is not to be found in abandoning questionnaire-based screening, but in identifying the best ways to prevent PPD and to maximize access to care.

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

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

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

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

Approximately one-fifth of cervical cancer cases are diagnosed in women aged 65 years or older, and most of the cases are late-stage disease associated with poor survival rates. The new finding calls into question yet again the many national screening guidelines that advise physicians to halt cervical screening at age 65.

The findings emerged from an analysis of the California Cancer Registry for 2009-2018. The authors, from the University of California, Davis, who manage the registry on behalf of the state, found that 17% of women diagnosed with a first primary cancer were aged 65 years or older.

Up to 71% of these older women had late-stage disease vs. 34%-to 59% of women aged 21-64.

The team also found that older patients, even those with early disease, had much poorer survival after they were diagnosed with cervical cancer than their younger counterparts. For example, patients aged between 65 and 69 with stage I cervical cancer had a 5-year relative survival – that is, survival adjusted for noncancer causes of death – of 82%. By contrast, 94% of women aged 20-39 survived for at least 5 years.

The study was published on January 9 in Cancer Epidemiology, Biomarkers & Prevention.

These new data echo similar findings from other recent cervical cancer studies out of California, Massachusetts, Ohio, and nationally. Those studies show that, in comparison with younger patients, rates of late-stage disease are higher and survival is poorer among women aged 65 and older.

Even so, a coauthor of the present study, Frances Maguire, PhD, who is an epidemiologist at the University of California, Davis, said she and her colleagues were surprised by what they found.

“There are a lot of women in this older-age category who are being diagnosed, and they’re being diagnosed later stage and their survival is worse,” Dr. Maguire said. “That was surprising to all of us,” given that the current recommendations are to stop screening once women reach the age of 65, and yet this age group is “doing quite poorly.”

The American Cancer Society, the U.S. Preventive Services Task Force, and the American College of Obstetricians and Gynecologists all recommend that cervical screening stop at aged 65 for patients with “adequate prior screening.”

Adequate screening is defined as having three consecutive normal Pap tests or two consecutive negative human papillomavirus tests or two consecutive negative cotests within the prior 10 years, with the most recent screening within 5 years and having no precancerous lesions in the past 25 years.

However, as many as 23% of women aged 60-64 report that their last Pap test was administered more than 5 years ago, according to a recent study by Alex Francoeur, MD, and colleagues at the University of California, Los Angeles.

When asked to comment on the new article, Dr. Francoeur said, “There is literature that increasing comorbidities and visits to the doctor [with age] decrease the likelihood of getting a Pap test, which is concerning, as these may be the highest-risk women.”

Said study author Dr. Maguire, “It could be that [the guidelines] are perfectly fine if women were properly screened before they hit 65, so that’s one of our big questions. Perhaps this group are not properly screened before age 65, and then they hit 65, they don’t screen, and this is the result we’re seeing.”

The situation is compounded by the lack of continuity in care at this crucial juncture, said Alexander Olawaiye, MD, a professor in the division of gynecologic oncology at the University of Pittsburgh, who was also approached for comment.

At age 65, many women retire, move across the country, or access new health care providers through Medicare, which kicks in at age 65, so the woman’s new physician doesn’t have access to her screening history, he commented.

This means that a physician needs to rely on the patient’s memory.

This is unrealistic, said Dr. Olawaiye: “Let’s forget about the 65-year-old women for now. Let’s talk about young women with sharp minds. Half of these young adults cannot even remember correctly their last monthly period. And these are the people you want to recollect accurately [at age 65] the number of tests they’ve had over 10 years and the results of those tests? Are you kidding me?” said Dr. Olawaiye. “Is that the kind of verification that you rely on?”

Dr. Olawaiye has consistently advocated for scrapping the 65+ screening moratorium in past and current versions of the cervical screening guidelines. He is puzzled by the national unwillingness to do so and rejects the economic argument, pointing out that a handful of extra tests is a lot cheaper than caring for a patient with advanced cervical cancer.

“Most American women will die around 84-85 years of age,” Dr. Olawaiye commented. “So between 65 and 85, you will need five screens, maybe four. What are you saving by not doing that?”

Dr. Maguire, Dr. Francoeur, and Dr. Olawaiye have disclosed no relevant financial relationships.

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

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

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

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

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

Women living in states that expanded Medicaid over the past decade were nearly 20% less likely to be hospitalized within 2 months of giving birth, according to a first-of-its-kind study published in Health Affairs.

Researchers analyzed patient records from eight states – four that expanded Medicaid insurance to include a broader swath of residents following the implementation of the Affordable Care Act, and four states that did not.

Hospitalizations in the 60 days after a woman gave birth fell by 17% in states that expanded Medicaid. The analysis also revealed an 8% drop in hospitalizations between 61 days and 6 months post partum.

“This is a very meaningful decline in hospitalization rates,” said Laura Wherry, PhD, a professor of economics and public service at New York University and a co-author of the study.

Women in states that chose not to expand Medicaid experienced a 7% increase in postpartum hospitalizations during that same time frame, the researchers report.

Many states raised income eligibility thresholds to 138% of the federal poverty level in 2014 with the implementation of the Affordable Care Act, which resulted in more coverage for low-income expectant mothers. To date, a dozen states have not implemented Medicaid expansion.

Dr. Wherry and her colleague wanted to take a closer look at outcomes for pregnant women during the postpartum period, both before and after states chose to expand Medicaid.

“A lot of prior work looking at the Medicaid program examined huge expansions to cover pregnant women during pregnancy, but often other periods of a woman’s life have been overlooked,” Dr. Wherry said. “What we were interested in is how that changed with the Affordable Care Act. You no longer needed to be pregnant to qualify.”

The researchers analyzed hospital discharge data between 2010 and 2017 before and after expansion in Iowa, Maryland, New Mexico, and Washington, which expanded coverage under Medicaid, and Florida, Georgia, Mississippi, and Utah, which did not do so.

Prior to 2014, fewer than 2% of births resulted in a postpartum hospitalization during the 60-day period in Medicaid expansion states. But in states that expanded Medicaid, hospitalizations decreased by 0.289 percentage points (P = .052), or 17% during the 60-day post-birth period.

Approximately 75% of the decline was attributed to diagnoses related to complications in pregnancy, childbirth, and the postpartum period.

Dr. Wherry said a variety of factors possibly drove down hospitalizations for new mothers who were able to obtain Medicaid coverage, including access to robust prenatal care, preconception counseling, and improved management of postpartum conditions outside the hospital.

The study provides a strategy for tackling the rising rate of maternal mortality in the United States, an increase largely attributed to postpartum deaths, said Lindsay Admon, MD, an ob.gyn. at the University of Michigan Medical School in Ann Arbor.

“This is one of the first studies showing or suggesting that Medicaid expansion not only led to improvements in Medicaid insurance but health outcomes as well,” said Dr. Admon, who is also researching maternal health and expanded Medicaid coverage.

Federal law has long required states to provide coverage for pregnant women up to 60 days post partum.

The 2021 American Rescue Act allowed states to extend coverage for pregnant women beyond the federal requirement to a year. More than half of states have chosen to do so. Since the study indicates that Medicaid expansion improves outcomes for these enrollees, Dr. Wherry and Dr. Admon said they hope state officials will consider the new findings during discussions to utilize the Rescue Act Coverage for pregnant women.

Dr. Wherry received support for the study from the Robert Wood Johnson Foundation Policies for Action Program and grant funding from the National Institute on Aging and the National Institute of Child Health and Human Development. Another author received grants from the Agency for Healthcare Research and Quality and the National Institute of Child Health and Human Development.

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

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

Mothers with intellectual or developmental disabilities are less likely to initiate breastfeeding and to receive in-hospital breastfeeding support than are those without a disability, new data suggest.

In a population-based cohort study of more than 600,000 mothers, patients with an intellectual or developmental disability were about 18% less likely to have a chance to initiate breastfeeding during their hospital stay.

“Overall, we did see lower rates of breastfeeding practices and supports in people with intellectual and developmental disabilities, as well as those with multiple disabilities, compared to people without disabilities,” study author Hilary K. Brown, PhD, assistant professor of health and society at University of Toronto Scarborough in Ontario, told this news organization.

The study was published in The Lancet Public Health.
 

Disparities in breastfeeding

“There hasn’t been a lot of research on breastfeeding outcomes in people with disabilities,” said Dr. Brown, who noted that the study outcomes were based on the WHO-UNICEF Baby Friendly Hospital Initiative guidelines. “There have been a number of qualitative studies that have suggested that they do experience barriers accessing care related to breastfeeding and different challenges related to breastfeeding. But as far as quantitative outcomes, there has only been a handful of studies.”

To examine these outcomes, the investigators analyzed health administrative data from Ontario. They included in their analysis all birthing parents aged 15-49 years who had a single live birth between April 1, 2012, and March 31, 2018. Patients with a physical disability, sensory disability, intellectual or developmental disability, or two or more disabilities were identified via diagnostic algorithms and were compared with individuals without disabilities with respect to the opportunity to initiate breastfeeding, to engage in in-hospital breastfeeding, to engage in exclusive breastfeeding at hospital discharge, to have skin-to-skin contact, and to be provided with breastfeeding assistance.

The investigators considered a physical disability to encompass conditions such as congenital anomalies, musculoskeletal disorders, neurologic disorders, or permanent injuries. They defined sensory disability as hearing loss or vision loss. Intellectual or developmental disability was defined as having autism spectrum disorder, chromosomal anomaly, fetal alcohol spectrum disorder, or other intellectual disability. Patients with multiple disabilities had two or more of these conditions.

The study population included 634,111 birthing parents, of whom 54,476 (8.6%) had a physical disability, 19,227 (3.0%) had a sensory disability, 1,048 (0.2%) had an intellectual or developmental disability, 4,050 (0.6%) had multiple disabilities, and 555,310 (87.6%) had no disability.

The investigators found that patients with intellectual or developmental disabilities were less likely than were those without a disability to have an opportunity to initiate breastfeeding (adjusted relative risk [aRR], 0.82), to engage in any in-hospital breastfeeding (aRR, 0.85), to be breastfeeding exclusively at hospital discharge (aRR, 0.73), to have skin-to-skin contact (aRR, 0.90), and to receive breastfeeding assistance (aRR, 0.85) compared with patients without a disability.

They also found that individuals with multiple disabilities were less likely to have an opportunity to initiate breastfeeding (aRR, 0.93), to engage in any in-hospital breastfeeding (aRR, 0.93), to be exclusively breastfeeding at hospital discharge (aRR, 0.90), to have skin-to-skin contact (aRR, 0.93), and to receive breastfeeding assistance (aRR, 0.95) compared with patients without a disability.
 

An understudied population

Commenting on the study, Lori Feldman-Winter, MD, MPH, professor of pediatrics at Rowan University in Camden, N.J., said that one of its strengths is that it included patients who may be excluded from studies of breastfeeding practices. The finding of few differences in breastfeeding practices and supports for people with physical and sensory disabilities, compared with those without disabilities, was positive, she added.

“This is an understudied population, and it is important to call out that there may be practices related to breastfeeding care that suffer, due to implicit bias regarding persons with intellectual and multiple disabilities,” said Dr. Feldman-Winter. “The good news is that other disabilities did not show the same disparities. This study also shows how important it is to measure potential gaps in care across multiple sociodemographic and other variables, such as disabilities, to ensure equitable and inclusive care.”

Health care professionals need to be aware of disparities in breastfeeding care, she added. They need to be open to exploring potential biases when it comes to providing equitable care.

R. Douglas Wilson, MD, president of the Society of Obstetricians and Gynaecologists of Canada and professor emeritus of obstetrics and gynecology at the University of Calgary in Alberta, noted that the size of the cohort represents a strength of the study and that the findings suggest the possible need for closer follow-up of a new mother who is breastfeeding and who has an intellectual disability or multiple disabilities.

“You might keep that patient in hospital for an extra day, and then the home care nurse may look in on them more frequently than they would for someone who does not need that extra oversight,” said Dr. Wilson. When their patients are pregnant, obstetricians and gynecologists can find out whether their patients intend to breastfeed and put them in touch with nurses or lactation consultants to assist them, he added.

The study was funded by the National Institutes of Health and the Canada Research Chairs Program. Dr. Brown, Dr. Feldman-Winter, and Dr. Wilson reported no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

Hormone replacement therapy (HRT) introduced early during the menopausal transition may protect against Alzheimer’s dementia in women carrying the APOE4 gene, new research suggests.

Results from a cohort study of almost 1,200 women showed that use of HRT was associated with higher delayed memory scores and larger entorhinal and hippocampal brain volumes – areas that are affected early by Alzheimer’s disease (AD) pathology.

HRT was also found to be most effective, as seen by larger hippocampal volume, when introduced during early perimenopause.

“Clinicians are very much aware of the susceptibility of women to cognitive disturbances during menopause,” lead author Rasha Saleh, MD, senior research associate, University of East Anglia (England), said in an interview.

“Identifying the at-risk APOE4 women and early HRT introduction can be of benefit. Confirming our findings in a clinical trial would be the next step forward,” Dr. Saleh said.

The findings were published online in Alzheimer’s Research and Therapy.
 

Personalized approaches

Dr. Saleh noted that estrogen receptors are localized in various areas of the brain, including cognition-related areas. Estrogen regulates such things as neuroinflammatory status, glucose utilization, and lipid metabolism.

“The decline of estrogen during menopause can lead to disturbance in these functions, which can accelerate AD-related pathology,” she said.

HRT during the menopausal transition and afterward is “being considered as a strategy to mitigate cognitive decline,” the investigators wrote. Early observational studies have suggested that oral estrogen “may be protective against dementia,” but results of clinical trials have been inconsistent, and some have even shown “harmful effects.”

The current researchers were “interested in the personalized approaches in the prevention of AD,” Dr. Saleh said. Preclinical and pilot data from her group have shown that women with APOE4 have “better cognitive test scores with nutritional and hormonal interventions.”

This led Dr. Saleh to hypothesize that HRT would be of more cognitive benefit for those with versus without APOE4, particularly when introduced early during the menopausal transition.

To investigate this hypothesis, the researchers analyzed baseline data from participants in the European Prevention of Alzheimer’s Dementia (EPAD) cohort. This project was initiated in 2015 with the aim of developing longitudinal models over the entire course of AD prior to dementia clinical diagnosis.

Participants were recruited from 10 European countries. All were required to be at least 50 years old, to have not been diagnosed with dementia at baseline, and to have no medical or psychiatric illness that could potentially exclude them from further research.

The current study included 1,178 women (mean age, 65.1 years), who were divided by genotype into non-APOE4 and APOE4 groups. HRT treatment for current or previous users included estrogen alone or estrogen plus progestogens via oral or transdermal administration routes, and at different doses.

The four tests used to assess cognition were the Mini-Mental State Examination dot counting to evaluate verbal working memory, the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score, the Four Mountain Test, and the supermarket trolley virtual reality test.

Brain MRI data were collected. The researchers focused on the medial temporal lobe as the “main brain region regulating cognition and memory processing.” This lobe includes the hippocampus, the parahippocampus, the entorhinal cortex, and the amygdala.
 

‘Critical window’

The researchers found a “trend” toward an APOE-HRT interaction (P-interaction = .097) for the total RBANS score. In particular, it was significant for the RBANS delayed memory index, where scores were consistently higher for women with APOE4 who had received HRT, compared with all other groups (P-interaction = .009).

Within-genotype group comparisons showed that HRT users had a higher RBANS total scale score and delayed memory index (P = .045 and P = .002, respectively), but only among APOE4 carriers. Effect size analyses showed a large effect of HRT use on the Four Mountain Test score and the supermarket trolley virtual reality test score (Cohen’s d = 0.988 and 1.2, respectively).

“This large effect was found only in APOE4 carriers,” the investigators noted.

Similarly, a moderate to large effect of HRT on the left entorhinal volume was observed in APOE4 carriers (Cohen’s d = 0.63).

In members of the APOE4 group who received HRT, the left entorhinal and left and right amygdala volumes were larger, compared with both no-APOE4 and non-HRT users (P-interaction = .002, .003, and .005, respectively). Similar trends were observed for the right entorhinal volume (P = .074).

In addition, among HRT users, the left entorhinal volume was larger (P = .03); the right and left anterior cingulate gyrus volumes were smaller (P = .003 and .062, respectively); and the left superior frontal gyrus volume was larger (P = .009) in comparison with women who did not receive HRT, independently of their APOE genotype.

Early use of HRT among APOE4 carriers was associated with larger right and left hippocampal volume (P = .035 and P = .028, respectively) – an association not found in non-APOE4 carriers. The association was also not significant when participants were not stratified by APOE genotype.

“The key important point here is the timing, or the ‘critical window,’ when HRT can be of most benefit,” Dr. Saleh said. “This is most beneficial when introduced early, before the neuropathology becomes irreversible.”

Study limitations include its cross-sectional design, which precludes the establishment of a causal relationship, and the fact that information regarding the type and dose of estrogen was not available for all participants.

HRT is not without risk, Dr. Saleh noted. She recommended that clinicians “carry out various screening tests to make sure that a woman is eligible for HRT and not at risk of hypercoagulability, for instance.”
 

Risk-benefit ratio

In a comment, Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, called the study “exactly the kind of work that needs to be done.”

Dr. Fillit, who was not involved with the current research, is a clinical professor of geriatric medicine, palliative care medicine, and neuroscience at Mount Sinai Hospital, New York.

He compared the process with that of osteoporosis. “We know that if women are treated [with HRT] at the time of the menopause, you can prevent the rapid bone loss that occurs with rapid estrogen loss. But if you wait 5, 10 years out, once the bone loss has occurred, the HRT doesn’t really have any impact on osteoporosis risk because the horse is already out of the barn,” he said.

Although HRT carries risks, “they can clearly be managed; and if it’s proven that estrogen or hormone replacement around the time of the menopause can be protective [against AD], the risk-benefit ratio of HRT could be in favor of treatment,” Dr. Fillit added.

The study was conducted as part of the Medical Research Council NuBrain Consortium. The investigators and Dr. Fillit reported no relevant financial relationships.

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

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

The largest combined analysis of birth outcome data for women with systemic lupus erythematosus (SLE) who took belimumab (Benlysta) during pregnancy appears to indicate that the biologic is “unlikely to cause very frequent birth defects,” but the full extent of possible risk remains unknown. The drug’s effect on B cells, immune function, and infections in exposed offspring were not captured in the data, but a separate case report published after the belimumab pregnancy data report indicates that the drug does cross the placenta and builds up in the blood of the newborn, reducing B cells at birth.

Children of women with SLE have increased birth defect risks, and standard SLE therapeutic agents (for example, cyclophosphamide, methotrexate, mycophenolate mofetil) have been implicated in birth defects and pregnancy loss, but birth defect data for biologic drugs such as belimumab are limited. While belimumab animal data revealed no evidence of fetal harm or pregnancy loss rates, there was evidence of immature and mature B-cell count reductions.

Belimumab is approved by the Food and Drug Administration for use in patients aged 5 years and older with active, autoantibody-positive SLE who are taking standard therapy, and also for those with lupus nephritis.

Michelle Petri, MD, of Johns Hopkins University, Baltimore, and coauthors reported in Annals of the Rheumatic Diseases on data they compiled through March 8, 2020, from belimumab clinical trials, the Belimumab Pregnancy Registry (BPR), and postmarketing/spontaneous reports that encompassed 319 pregnancies with known outcomes.

Across 18 clinical trials with 223 live births, birth defects occurred in 4 of 72 (5.6%) belimumab-exposed pregnancies and in 0 of 9 in placebo-exposed pregnancies. Pregnancy loss (excluding elective terminations) occurred in 31.8% (35 of 110) of belimumab-exposed women and 43.8% (7 of 16) of placebo-exposed women in clinical trials. In the BPR retrospective cohort, 4.2% had pregnancy loss. Postmarketing and spontaneous reports had a pregnancy loss rate of 31.4% (43 of 137). Concomitant medications, confounding factors, and/or missing data were noted in all belimumab-exposed women in clinical trials and the BPR cohort. Dr. Petri and colleagues reported no consistent pattern of birth defects across datasets but stated: “Low numbers of exposed pregnancies, presence of confounding factors/other biases, and incomplete information preclude informed recommendations regarding risk of birth defects and pregnancy loss with belimumab use.”

In an interview, coauthor Megan E. B. Clowse, MD, MPH, associate professor of medicine and director of the division of rheumatology and immunology at Duke University, Durham, N.C., said that “the Annals of the Rheumatic Diseases article provides some reassurance that belimumab is unlikely to cause very frequent birth defects. It is clearly not in the risk-range for thalidomide or mycophenolate. However, due to the complexity of collecting these data, this manuscript can’t explore the full extent of possible risks. It also did not provide information about B cells, immune function, or infection risks in exposed offspring.”

A separate case report by Helle Bitter of the department of rheumatology at Sorlandet Hospital Kristiansand (Norway) in Annals of the Rheumatic Diseases is the first to show transplacental passage of belimumab in humans. Other prior reports have shown such transplacental passage for monoclonal IgG antibodies (tumor necrosis factor inhibitors and rituximab). Even though the last infusion was given late in the second trimester, belimumab was present in cord serum at birth, suggesting much higher concentrations before treatment was stopped. While B-cell numbers were reduced at birth, they returned to normal ranges by 4 months post partum when they were undetectable. In the mother, B-cell numbers remained low throughout the study period extending to 7 months after delivery. The authors stated that the child had a normal vaccination response, and except for the reduced B-cell levels at birth, had no adverse effects of prenatal exposure to maternal medication through age 6 years.

“The belimumab transfer in the case report is the level that we would anticipate based on similar studies in infant/mother pairs on other IgG1 antibody biologics like adalimumab – about 60% higher than the maternal level at birth,” Dr. Clowse said. “That the baby has very low B cells at birth is worrisome to me, demonstrating the lasting effect of maternal belimumab on the infant’s immune system, even when the drug was stopped 14 weeks prior to delivery. While this single infant did not have problems with infections, with more widespread use it seems possible that infants would be found to have higher rates of infections after in utero belimumab exposure.”

The field of lupus research greatly needs controlled studies of newer biologics in pregnancy, Dr. Clowse said. “Women with active lupus in pregnancy – particularly with active lupus nephritis – continue to suffer tragic outcomes at an alarming rate. Newer treatments for lupus nephritis provide some hope that we might be able to control lupus nephritis in pregnancy more effectively. The available data suggests the risks of these medications are not so large as to make studies unreasonable. Our current data doesn’t allow us to sufficiently balance the potential risks and benefits in a way that provides clinically useful guidance. Trials of these medications, however, would enable us to identify improved treatment strategies that could result in healthier women, pregnancies, and babies.”

GlaxoSmithKline funded the study. Dr. Clowse reported receiving consulting fees and grants from UCB and GlaxoSmithKline that relate to pregnancy in women with lupus.

A statewide quality initiative can improve severe maternal morbidity (SMM) and reduce the incidence of maternal morbidity and mortality from postpartum hemorrhage (PPH), a modeling analysis found. Such measures could potentially provide savings to birthing hospitals, according to the California cost-effectiveness study, published in Obstetrics & Gynecology.

A team led by Eric C. Wiesehan, MHA, MBA, a PhD candidate in health policy at Stanford (Calif.) University, examined the effects of the safety initiative of the California Maternal Quality Care Collaborative (CMQCC) in a theoretical cohort of 480,000 births across a mix of hospital settings and sizes. The CMQCC developed a PPH toolkit and quality-improvement protocol to increase recognition, measurement, and timely response to PPH.

Drawing retrospectively on a large 2017 California implementation study, the simulation estimated that collaborative implementation of the CMQCC added 182 quality-adjusted life-years (0.000379 per birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78 per birth) owing to avoided SMM costs.

According to the Centers for Disease Control and Prevention, pregnancy-related maternal deaths in the United States have increased from 7.2 per 100,000 live births to 16.9 per 100,000 live births over the past 20 years, making it the only country in the Organization for Economic Cooperation and Development with rising rates of maternal mortality. PPH accounts for 11% of maternal deaths.

As to the study’s broader applicability, Dr. Wiesehan said in an interview, “findings of effectiveness in terms of reducing PPH-related SMM are well known outside of California. In terms of costs, however, it is more of an unknown how much is generalizable. It would go a long way if another state quality care collaborative implementing such a project recorded costs prospectively. Prospective costing, particularly microcosting, would be optimal to precisely place where the most, or least, value of this quality improvement project is achieved.”

Studies of PPH safety programs in other U.S. jurisdictions showing reductions in blood transfusions and maternal morbidities suggest the current findings are relevant to a range of hospital settings and regions. “With state perinatal collaboratives already in 47 states, examination of implementation of the PPH-SMM reduction initiative within additional collaboratives would add further robustness to our findings,” the authors wrote.

In 2022, a New York City hospital study reported that learning collaboratives that optimize practice and raise staff awareness could be important tools for improving maternal outcomes.

Still to be answered, said Dr. Wiesehan, are questions about the long-term effectiveness and sustainability of the quality initiative project beyond the early pre/post periods. 

The authors indicated no specific funding for the study and had no conflicts of interest to disclose.

A statewide quality initiative can improve severe maternal morbidity (SMM) and reduce the incidence of maternal morbidity and mortality from postpartum hemorrhage (PPH), a modeling analysis found. Such measures could potentially provide savings to birthing hospitals, according to the California cost-effectiveness study, published in Obstetrics & Gynecology.

A team led by Eric C. Wiesehan, MHA, MBA, a PhD candidate in health policy at Stanford (Calif.) University, examined the effects of the safety initiative of the California Maternal Quality Care Collaborative (CMQCC) in a theoretical cohort of 480,000 births across a mix of hospital settings and sizes. The CMQCC developed a PPH toolkit and quality-improvement protocol to increase recognition, measurement, and timely response to PPH.

Drawing retrospectively on a large 2017 California implementation study, the simulation estimated that collaborative implementation of the CMQCC added 182 quality-adjusted life-years (0.000379 per birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78 per birth) owing to avoided SMM costs.

According to the Centers for Disease Control and Prevention, pregnancy-related maternal deaths in the United States have increased from 7.2 per 100,000 live births to 16.9 per 100,000 live births over the past 20 years, making it the only country in the Organization for Economic Cooperation and Development with rising rates of maternal mortality. PPH accounts for 11% of maternal deaths.

As to the study’s broader applicability, Dr. Wiesehan said in an interview, “findings of effectiveness in terms of reducing PPH-related SMM are well known outside of California. In terms of costs, however, it is more of an unknown how much is generalizable. It would go a long way if another state quality care collaborative implementing such a project recorded costs prospectively. Prospective costing, particularly microcosting, would be optimal to precisely place where the most, or least, value of this quality improvement project is achieved.”

Studies of PPH safety programs in other U.S. jurisdictions showing reductions in blood transfusions and maternal morbidities suggest the current findings are relevant to a range of hospital settings and regions. “With state perinatal collaboratives already in 47 states, examination of implementation of the PPH-SMM reduction initiative within additional collaboratives would add further robustness to our findings,” the authors wrote.

In 2022, a New York City hospital study reported that learning collaboratives that optimize practice and raise staff awareness could be important tools for improving maternal outcomes.

Still to be answered, said Dr. Wiesehan, are questions about the long-term effectiveness and sustainability of the quality initiative project beyond the early pre/post periods. 

The authors indicated no specific funding for the study and had no conflicts of interest to disclose.

A statewide quality initiative can improve severe maternal morbidity (SMM) and reduce the incidence of maternal morbidity and mortality from postpartum hemorrhage (PPH), a modeling analysis found. Such measures could potentially provide savings to birthing hospitals, according to the California cost-effectiveness study, published in Obstetrics & Gynecology.

A team led by Eric C. Wiesehan, MHA, MBA, a PhD candidate in health policy at Stanford (Calif.) University, examined the effects of the safety initiative of the California Maternal Quality Care Collaborative (CMQCC) in a theoretical cohort of 480,000 births across a mix of hospital settings and sizes. The CMQCC developed a PPH toolkit and quality-improvement protocol to increase recognition, measurement, and timely response to PPH.

Drawing retrospectively on a large 2017 California implementation study, the simulation estimated that collaborative implementation of the CMQCC added 182 quality-adjusted life-years (0.000379 per birth) by averting 913 cases of SMM, 28 emergency hysterectomies, and one maternal mortality. Additionally, it saved $9 million ($17.78 per birth) owing to avoided SMM costs.

According to the Centers for Disease Control and Prevention, pregnancy-related maternal deaths in the United States have increased from 7.2 per 100,000 live births to 16.9 per 100,000 live births over the past 20 years, making it the only country in the Organization for Economic Cooperation and Development with rising rates of maternal mortality. PPH accounts for 11% of maternal deaths.

As to the study’s broader applicability, Dr. Wiesehan said in an interview, “findings of effectiveness in terms of reducing PPH-related SMM are well known outside of California. In terms of costs, however, it is more of an unknown how much is generalizable. It would go a long way if another state quality care collaborative implementing such a project recorded costs prospectively. Prospective costing, particularly microcosting, would be optimal to precisely place where the most, or least, value of this quality improvement project is achieved.”

Studies of PPH safety programs in other U.S. jurisdictions showing reductions in blood transfusions and maternal morbidities suggest the current findings are relevant to a range of hospital settings and regions. “With state perinatal collaboratives already in 47 states, examination of implementation of the PPH-SMM reduction initiative within additional collaboratives would add further robustness to our findings,” the authors wrote.

In 2022, a New York City hospital study reported that learning collaboratives that optimize practice and raise staff awareness could be important tools for improving maternal outcomes.

Still to be answered, said Dr. Wiesehan, are questions about the long-term effectiveness and sustainability of the quality initiative project beyond the early pre/post periods. 

The authors indicated no specific funding for the study and had no conflicts of interest to disclose.

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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

Emergency department (ED) encounters for sexual assault increased before the COVID-19 pandemic, decreased immediately after lockdowns were implemented, and fluctuated as the pandemic continued, an analysis of more than 10,000 such visits in Canada’s most populous province shows.

“In 2020, we hoped that the COVID pandemic would only last a few months. However, as it continued, we became increasingly concerned about limited health care access for survivors of sexual assault throughout the ongoing crisis,” study author Katherine A. Muldoon, PhD, MPH, a senior clinical research associate at the Ottawa Hospital Research Institute in Ontario, told this news organization.

“Unexpectedly, we found a 20%-25% increase in the number of survivors of sexual assault presenting for emergency care before the lockdown protocols were enacted,” she added. “After lockdown, the numbers dropped by 50%-60% and fluctuated throughout ... the pandemic.”

As they develop new lockdown protocols, public health officials and governments should incorporate warnings of the risks of violence and state that survivors should still present for urgent care when needed, said Dr. Muldoon. “COVID-19 lockdown protocols have limited access to health care for survivors worldwide, and barriers are likely greater in low-resource settings and those heavily affected by COVID-19.” 

The study was published in JAMA Network Open.
 

Both sexes affected

The researchers analyzed linked health administrative data from 197 EDs in Ontario from January 2019 to September 2021. They used 10 bimonthly time periods to compare differences in the frequency and rates of ED visits for sexual assault in 2020-2021 (during the pandemic), compared with baseline prepandemic rates in 2019.

Sexual assault was defined by 27 ICD-10 procedure and diagnoses codes.

More than 14 million ED presentations occurred during the study period, including 10,523 for sexual assault. The median age was 23 years for female patients and 15 years for males. Most encounters (88.4%) were among females.

During the 2 months before the pandemic (Jan. 11 to Mar. 10, 2020), the rates of ED encounters for sexual assault among females were significantly higher than prepandemic levels (8.4 vs. 6.9 cases per 100,000; age-adjusted rate ratio [aRR], 1.22), whereas during the first 2 months of the pandemic (Mar. 11 to May 10, 2020), rates were significantly lower (4.2 vs. 8.3 cases per 100,000; aRR, 0.51).

Among males, rates were higher during the 2 months before the pandemic, but not significantly different, compared with prepandemic levels (1.2 vs. 1.0 cases per 100,000; aRR, 1.19). However, the rates decreased significantly during the first 2 months of the pandemic (0.5 vs. 1.2 cases per 100,000; aRR, 0.39).

For the 12 months starting July 11, 2020, rates were the same as in 2019. In the final time period (July 11 to Sept. 10, 2021), however, the rates were significantly higher than during prepandemic levels (1.5 vs. 1.1 cases per 100,000; aRR, 1.40).

Further analyses showed a similar pattern for all age groups, community sizes, and income quintiles. Rates were predominantly above prepandemic levels for the 2 months leading up to the pandemic and below expected levels from the beginning of the pandemic onward. However, from July 11 to Sept. 10, 2020 (during a trough in the summer, when sexual assaults are generally higher), and from May 11 to Sept. 10, 2021 (also during a trough and the summer), the rates returned to prepandemic levels.

“The COVID-19 pandemic has caused many changes to society and health care delivery and access,” the authors wrote. “We recommend that the decision-making regarding the management of the COVID-19 pandemic include antiviolence considerations to evaluate how policies and protocols affect the risk of violence and ensure that those who need health care can access services without concern.”

“Specialized and trauma-informed clinics are the best solution for encouraging survivors to come for urgent care following a sexual assault,” said Dr. Muldoon. “Clinicians should be prepared and trained to provide the best possible care for survivors of violence and ensure that getting care is not retraumatizing. Fostering conversations about the common experience of violence and destigmatizing those exposed to violence remain the most important ways to create safer spaces and societies.”
 

Dedicated care pathways

Commenting on the study, Samuel A. McLean, MD, MPH, director of the Institute for Trauma Recovery and professor of emergency medicine, psychiatry, and anesthesiology at the University of North Carolina at Chapel Hill, said, “This important work documents a reduction in visits by sexual assault survivors for emergency care and forensic evidence collection during times of pandemic surge. It’s impossible to know for certain if this reduction in visits is entirely due to a reduction in sexual assaults, but a number of lines of circumstantial evidence make this unlikely.”

The results highlight the importance of ensuring that sexual assault care is maintained during surges in emergency care volume, added Dr. McLean, who was not involved with the current study. “This can be done via methods such as dedicated care pathways that avoid prolonged survivor wait times for care, and public health messaging that informs the public of the continued ready access to care during surges. Evidence, including data cited by the authors, suggests that these same care-seeking reductions are occurring in the United States and elsewhere.”

The study was supported by the Ontario Ministry of Health and Long-term Care Applied Health Research Question Fund. Dr. Muldoon, study coauthors, and Dr. McLean report no relevant financial relationships.

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