Medical management of miscarriage curbs costs and maintains quality of care

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Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

 

 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

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Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

 

 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

 

 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

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Roe v. Wade overturned: A family medicine resident reacts

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My first thought when I heard the Supreme Court’s ruling on Roe v. Wade was of a patient of mine who I had been privileged to meet earlier in my residency. She was a child when she became pregnant after a nonconsensual encounter with a much older man.

I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.

Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.

Dr. Victoria Persampiere

The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.

Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.

When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.

Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.

These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”

My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
 

 

 

Economic and health consequences of restricting access to abortion

The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.

The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.

Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.

In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.

Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.

The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.

In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
 

Patient-physicians interactions are changed

As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.

With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.

Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.

The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.

Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at victoria.persampiere@jefferson.edu or via fpnews@mdedge.com.

References

1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states

2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf

3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8

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My first thought when I heard the Supreme Court’s ruling on Roe v. Wade was of a patient of mine who I had been privileged to meet earlier in my residency. She was a child when she became pregnant after a nonconsensual encounter with a much older man.

I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.

Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.

Dr. Victoria Persampiere

The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.

Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.

When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.

Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.

These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”

My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
 

 

 

Economic and health consequences of restricting access to abortion

The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.

The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.

Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.

In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.

Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.

The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.

In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
 

Patient-physicians interactions are changed

As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.

With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.

Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.

The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.

Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at victoria.persampiere@jefferson.edu or via fpnews@mdedge.com.

References

1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states

2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf

3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8

My first thought when I heard the Supreme Court’s ruling on Roe v. Wade was of a patient of mine who I had been privileged to meet earlier in my residency. She was a child when she became pregnant after a nonconsensual encounter with a much older man.

I remember how small and shy she looked, curled into herself in her too-large hospital gown. I remember thinking that it was autumn, and she should have been at her first homecoming dance, not sitting in the ER staring mutely at the hospital-issued safety socks on her feet. Her mother, puffy-eyed from crying, was sitting on the bed beside her, stroking her hair.

Together, my patients and I talked about the pregnancy. She told me how scared she was, how she didn’t want to “kill her baby”, but that she also wasn’t sure she could take care of a child. She told me that she was terrified of childbirth, that she didn’t want her friends at school to know and to judge her. We talked about how she was a victim; how she was an innocent child, too. I reassured her, and her mom emphatically agreed – her body was still her own.

Dr. Victoria Persampiere

The man who hurt her did not take that from her. She could make any choice she wanted, and it would be the right choice.

Eventually, she was able to make a decision which was best for her. I don’t know what became of her, but I hope she is well now, and I hope she’s thriving and happy. I also hope that she doesn’t see the news about Roe v. Wade and feel stripped of her personhood, as many women did.

When I heard about the Supreme Court decision I thought of her, and how important our conversation was to the trajectory of her life. I wondered if across the country these conversations might be silenced, and patients might be left to navigate this important facet of their health alone.

Some version of the conversation I had with my young patient occurs in exam rooms across the country countless times a day. Sometimes these conversations are cut and dry. Other times, they are accompanied by heartbreak and tears.

These conversations are common – one in four women in the United States have had an abortion. I have had many friends who were faced with deciding what to do after an unexpectedly positive pregnancy test. The reasons were different for each person – one was raped at a party, another’s birth control failed, the boyfriend of a third friend wouldn’t wear a condom – but the underlying sentiments were the same for each woman. They thought: “This is a difficult choice, but it’s a choice I’m ready to make. I’m not ready to have a baby at this point in my life.”

My friends talked to their doctors, who assisted them in making an informed choice. Some of them chose abortion. Others chose to deliver their baby. All were helped along in their decision by a physician who was there to support them and assist them in making a well-considered choice for their individual circumstance.
 

 

 

Economic and health consequences of restricting access to abortion

The facts are clear: Nearly half of all pregnancies in American women in 2011 were unplanned, and about 4 in 10 of them ended in an elective abortion, according to the Guttmacher Institute.1 Restricting access to abortions does not stop abortions from happening; it limits the opportunity for women to seek advice from trusted friends and professionals and it reduces access to safe abortions.

The people who will be most harmed by these restrictions are the most socially and economically vulnerable. Wealthy, mobile women with the ability to travel to other states or countries will always be able to access abortion care; low-income, work-tethered women and women with other children to care for at home will struggle to do so.

Denying women abortion services puts them at increased risk for lifelong, multigenerational economic hardship. Women who sought abortions but were unable to obtain them experienced an increase in household poverty which lasted years relative to women who were able to receive an abortion, according to the authors of The Turnaway Study.2 They were less socially, geographically, and economically mobile, and were less likely to go on to receive a higher education.

In a country where citizens do not have paid maternity leave, affordable and accessible childcare services, or universal health care, raising a child is an enormous financial burden. Women who are denied abortions also are much more likely to end up as a single parent, shouldering that burden alone.

Additionally, low socioeconomic status is associated with increased all-cause mortality. People who live in poverty are disproportionately affected by diabetes and other chronic health conditions, and have lower life expectancies overall.

The reversal of Roe v. Wade is not only going to lead directly to patient death by decreasing access to safe abortion, causing women to pursue unsafe alternatives; it will also indirectly result in more women being driven into and remaining in poverty and suffering the health consequences.

In addition to risking a woman’s life medically, pregnancy also significantly increases that individual’s risk of being a victim of intimate partner violence. The number one cause of death in pregnant women is homicide, most often by their sexual partner, said an article published in Nature in 2021.3 Therefore, restricting a woman’s ability to control if and when she has children could put her at risk for death from serious pregnancy-related complications and unsafe abortion consequences and increase her likelihood of dying by domestic violence.
 

Patient-physicians interactions are changed

As a physician I hope that I am able to convey my intense respect for and support of a woman’s autonomy into every family planning visit I conduct. Unfortunately, this ruling will not only have an immediate impact on the lives of women across the country – it will also alter the way many of us interact with our patients on a day-to-day basis. When patients can report doctors to authorities in some states for offering terminations, and doctors can report patients for seeking them, there will be absolutely no trust in the therapeutic relationship.

With this ruling, the content of private and protected conversations between patients and their physicians will be subject to censure and potentially criminal consequences.

Regardless of where I eventually practice medicine, I should not be in the position of talking to a patient and telling them that they do not have any agency over their body unless they have the money and resources to travel to a state where abortion is legal. I should not have to tell a child that she must carry and birth another child just to appease the often-fickle whims of lawmakers.

The conversation I had with my pediatric patient was important to her health and to her future, and she deserved to have the chance to discuss her feelings with a trusted physician. Every woman has the right to make her own decisions within the sanctity of the exam room, not from the distance of a courtroom.

Dr. Persampiere is a resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at victoria.persampiere@jefferson.edu or via fpnews@mdedge.com.

References

1. Unintended pregnancy in the United States. Guttmacher Institute. 2019 Jan 9. https://www.guttmacher.org/fact-sheet/unintended-pregnancy-united-states

2. Foster D et al. The harms of denying a woman a wanted abortion - ANSIRH. https://www.ansirh.org/sites/default/files/publications/files/the_harms_of_denying_a_woman_a_wanted_abortion_4-16-2020.pdf

3. Subbaraman N. 2021 Nov 12. Homicide is a top cause of maternal death in the United States. Nature News. https://www.nature.com/articles/d41586-021-03392-8

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PCOS ups risk of heart complications during delivery period

Article Type
Changed
Mon, 07/11/2022 - 16:13

Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

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Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

Pregnant women with polycystic ovary syndrome (PCOS) appear to be at significantly increased risk of experiencing cardiac complications while hospitalized during and after delivery.

An estimated 5 million women of childbearing age in the United States have PCOS, a hormone disorder linked to infertility. PCOS is also known to contribute to the development of cardiometabolic abnormalities like high cholesterol and high blood pressure, which are associated with acute cardiovascular complications during delivery.

But a study, published online  in the Journal of the American Heart Association, found that even after accounting for pre-eclampsia, age, comorbidities, and race, PCOS was linked to a 76% increased risk for heart failure, a 79% higher risk of a weakened heart, and an 82% increased risk of having blood clots in the hours and days around giving birth in hospital settings, compared with women without PCOS.

“Perhaps women need a closer follow-up during their pregnancy,” said Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins Medicine, Baltimore, and a co-author of the study. “They’re counseled about the difficulties of getting pregnant, but what about when they get pregnant?”

Hospitalizations of women with PCOS were also associated with longer stays (3 vs. 2 days) and higher costs ($4,901 vs. $3616; P < .01), compared with women without PCOS.

Over the 17-year analysis period, the number of women with PCOS rose from 569 per 100,000 deliveries to 15,349 per 100,000 deliveries. The researchers attributed the increase in part to greater awareness and diagnosis of the disorder. Dr. Michos and her colleagues used the National Inpatient Sample, managed by the Agency for Healthcare Research and Quality, to pull claims data for women who gave birth in hospitals between 2002 and 2019.
 

Solutions?

Dr. Michos said there may be more prevention work from og.gyns. to both educate patients about their heart risks during the delivery process and also to refer them to relevant cardiac specialists.

“These women may seek out a gynecologist because of the symptoms, perhaps irregular menses, but along with that should come counseling of the long-term cardiovascular complication,” Dr. Michos said. “And after a pregnancy there should be a good handoff to a primary care provider, so they get a cardiovascular assessment.”

Lifestyle management before, during, and after pregnancy can help prevent the onset of the long-term consequences of cardiac complications during delivery, according to Valerie Baker, MD, director of the division of reproductive endocrinology and infertility at Hopkins Medicine, and her colleagues in a viewpoint published in the journal Fertility and Sterility.

“Once women with PCOS are identified by screening to be at higher risk for [cardiovascular disease], the foundational approach should be lifestyle management followed by statin therapy,” Dr. Baker’s group wrote. “These interventions should include dietary management and physical activity, especially for those who are prediabetic.”

The current study came on the heels of a June 14 meta-analysis by Dr. Michos’ group that found that women with PCOS may be twice as likely as those without PCOS to have coronary artery calcification, a precursor to atherosclerosis and a sign of the early onset of cardiovascular disease.

“We shouldn’t assume that all women of reproductive age are low risk,” Dr. Michos said. “This is the window of time that we can reshape the trajectory early in life.”

The study was supported by the Amato Fund for Women’s Cardiovascular Health research at Johns Hopkins University and through grant support from the American Heart Association (940166). Dr. Michos reported advisory board participation for AstraZeneca, Amarin, Novartis, Novo Nordisk, Bayer, Boehringer Ingelheim, Esperion, and Pfizer. Study coauthor Michael Honigberg, MD, reported consulting fees from CRISPR Therapeutics, unrelated to the present work. The remaining authors have disclosed no relevant financial relationships.

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

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Water birth may have benefits for healthy women: Meta-analysis suggests

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Changed
Mon, 07/11/2022 - 10:48

Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

 

 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

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Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

 

 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.

“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.

Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.

In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.

The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.

Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.

Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).

Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).

The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.

The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.

“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.

“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”

Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.

A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
 

 

 

Education is essential

Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.

“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.

“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.” 

On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.

“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.

The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.

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Nevada sees increase in out-of-state abortion patients

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Changed
Thu, 07/07/2022 - 11:15

Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.

Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.

Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.

“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.

“I don’t think we’re going to see any decrease anytime in the near future,” she said.

Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.

In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.

Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.

Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.

“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”

After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.

Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.

Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.

As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.

“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”

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

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Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.

Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.

Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.

“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.

“I don’t think we’re going to see any decrease anytime in the near future,” she said.

Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.

In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.

Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.

Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.

“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”

After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.

Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.

Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.

As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.

“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”

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

Nevada is already seeing more out-of-state patients seeking an abortion, which state officials expected after the Supreme Court overturned Roe v. Wade.

Las Vegas has seen a 200% increase in patients traveling from Texas, compared with the same time last year, according to the Las Vegas Review-Journal.

Patients are also expected from Arizona, Idaho, Oklahoma, and Utah after the ruling. Abortion providers are preparing for a ripple effect as abortion bans begin across the country.

“We haven’t seen the peak yet,” Kristina Tocce, MD, medical director for Planned Parenthood of the Rocky Mountains and an obstetrician-gynecologist in Colorado, told the newspaper.

“I don’t think we’re going to see any decrease anytime in the near future,” she said.

Nevada made the right to abortion part of state law more than 3 decades ago, in 1990, which protects abortions up to 24 weeks. Colorado passed a similar law this year.

In June, before Roe was overturned, Dr. Tocce said the organization expected abortions to rise by 80% – or about 10,000 patients – in the Rocky Mountain region, which includes southern Nevada, Colorado, and New Mexico.

Even before the ruling took place, Planned Parenthood saw higher numbers of patients as abortion bans took effect in Texas and Oklahoma, she said. After the 6-week ban took place in Texas, about 45% of traveling patients went to Oklahoma. Now that a ban is in place in Oklahoma, patients are going elsewhere.

Las Vegas providers have asked patients why they decided to travel to southern Nevada for services rather than Colorado or New Mexico, which are closer to Texas, Dr. Tocce said. Patients cited several reasons, including direct flight paths, cheaper plane tickets, and the presence of family or friends who could support them.

“We’re going to see such a demand on abortion in any state that has secure access,” Dr. Tocce said. “Patients may be forced to travel further away.”

After Roe was overturned, Nevada Gov. Steve Sisolak held an emergency news conference to reaffirm the state’s commitment to protecting abortion rights. He also said he wasn’t sure about Nevada’s capacity to support out-of-state patients but providers were researching and preparing.

Two Planned Parenthood centers in southern Nevada are adding staff and increasing their hours, Dr. Tocce told the newspaper last month, though there weren’t immediate plans to increase the number of locations or add centers near state borders.

Last week, Governor Sisolak signed an executive order that stops Nevada agencies from helping other states investigate patients seeking an abortion in Nevada. The order also protects patients from extradition and health care providers from losing their license for providing abortion services.

As abortion bans continue to roll out across the U.S., patients will likely consider traveling to states that have certain protections and accessible appointments, Dr. Tocce said.

“We’re in such an ambiguous time right now, we just don’t know what each state is going to attempt to enact,” she said. “My head just swims with all of the possibilities. If that’s challenging for me, I can’t even imagine what it’s going to be like for a patient to navigate.”

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

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The toll of the unwanted pregnancy

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Changed
Wed, 07/06/2022 - 14:28

In the wake of the Supreme Court’s June decision to repeal a federal right to abortion, many women will now be faced with the prospect of carrying an unwanted pregnancy to term.

One group of researchers has studied the fate of these women and their families for the last decade. Their findings show that women who were denied an abortion are worse off physically, mentally, and economically than those who underwent the procedure.

“There has been much hypothesizing about harms from abortion without considering what the consequences are when someone wants an abortion and can’t get one,” said Diana Greene Foster, PhD, professor of obstetrics and gynecology at University of California, San Francisco.

Dr. Foster leads the Turnaway Study, one of the first efforts to examine the physical and mental health effects of receiving or being denied abortions. The ongoing research also charts the economic and social outcomes of women and their families in either circumstance.

Dr. Foster and her colleagues have followed women through childbirth, examining their well-being through phone interviews months to years after the initial interviews.

The economic consequences of carrying an unwanted pregnancy are clear. Women who did not receive a wanted abortion were more likely to live under the poverty line and struggle to cover basic living expenses like food, housing, and transportation.

The physical toll is also significant.

A 2019 analysis from the Turnaway Study found that eight out of 1,132 participants died, two after delivery, during the five-year follow up period – a far greater proportion than what would be expected among women of reproductive age. The researchers also found that women who carry unwanted pregnancies have more comorbid conditions before and after delivery than other women.

Lauren J. Ralph, PhD, MPH, an epidemiologist and member of the Turnaway Study team, examined the physical well-being of women after delivering their unwanted pregnancies.

“They reported more chronic pain, more gestational hypertension, and were more likely to rate their health as fair or poor,” Dr. Ralph said. “Somewhat to our surprise, we also found that two women denied abortions died due to pregnancy-related causes. This is my biggest concern with the loss of abortion access, as all scientific evidence indicates we will see a rise in maternal deaths as a result.”

At least one preliminary study, released as a preprint and not yet peer reviewed, estimates that the number of women who will die each year from pregnancy complications will rise by 24%. For Black women, mortality could jump from 18% to 39% in every state, according to the researchers from the University of Colorado, Boulder.
 

State of denial

Regulations set in place at abortion clinics in each state individually determine who is able to obtain an abortion, dictated by a “gestational age limit” – how far along a woman is in her pregnancy from the end of her menstrual cycle. Some of the women from the Turnaway Study were unable to receive an abortion because of how far along they were. Others were granted the abortion because they were just under their state’s limit.

Before the latest Supreme Court ruling, this limit was 20 weeks in most states. Now, the cutoff can be as little as 6 weeks – before many women know they are pregnant – or zero weeks, under the most restrictive laws

Over 70% of women who are denied an abortion carry the pregnancy to term, according to Dr. Foster’s analysis. 

Interviews with nearly 1,000 women – in both the first and second trimester of pregnancy – in the Turnaway Study who sought abortions at 30 abortion clinics around the country revealed the main reasons for seeking the procedure were (a) not being able to afford a child; (b) the pregnancy coming at the wrong time in life; or (c) the partner involved not being suitable.

According to the U.S. Centers for Disease Control and Prevention, 59.7% of women seeking an abortion in the United States are already mothers. Having an unplanned child results in dramatically worse economic circumstances for their other children, who become nearly four times more likely to live below the poverty line than their peers. They also experience slower physical and mental development as a result of the arrival of the new sibling.

The latest efforts by states to ban abortion could make the situation much worse, said Liza Fuentes, DrPh, senior research scientist at the Guttmacher Institute. “We will need further research on what it means for women to be denied care in the context of the new restrictions,” Dr. Fuentes told this news organization. 

Researchers cannot yet predict how many women will be unable to obtain an abortion in the coming months. But John Donahue, PhD, JD, an economist and professor of law at Stanford (Calif.) University, estimated that state laws would prevent roughly one-third of the 1 million abortions per year based on 2021 figures.

Dr. Ralph and her colleagues with the Turnaway Study know that restricting access to abortions will not make the need for abortions disappear. Rather, women will be forced to travel, potentially long distances at significant cost, for the procedure or will seek medication abortion by mail through virtual clinics.

But Dr. Ralph said she’s concerned about women who live in areas where telehealth abortions are banned, or who discover their pregnancies late, as medical abortions are only recommended for women who are 10 weeks pregnant or less.

“They may look to self-source the medications online or elsewhere, potentially putting themself at legal risk,” she said. “And, as my research has shown, others may turn to self-managing an abortion with herbs, other drugs or medications, or physical methods like hitting themselves in the abdomen; with this they put themselves at both legal and potentially medical risk.”

Constance Bohon, MD, an ob.gyn. in Washington, D.C., said further research should track what happens to women if they’re forced to leave a job to care for another child.

“Many of these women live paycheck to paycheck and cannot afford the cost of an additional child,” Dr. Bohon said. “They may also need to rely on social service agencies to help them find food and housing.”

Dr. Fuentes said she hopes the Turnaway Study will inspire other researchers to examine laws that outlaw abortion and the corresponding long-term effects on women.

“From a medical and a public health standpoint, these laws are unjust,” Dr. Fuentes said in an interview. “They’re not grounded in evidence, and they incur great costs not just to pregnant people but their families and their communities as well.”

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

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In the wake of the Supreme Court’s June decision to repeal a federal right to abortion, many women will now be faced with the prospect of carrying an unwanted pregnancy to term.

One group of researchers has studied the fate of these women and their families for the last decade. Their findings show that women who were denied an abortion are worse off physically, mentally, and economically than those who underwent the procedure.

“There has been much hypothesizing about harms from abortion without considering what the consequences are when someone wants an abortion and can’t get one,” said Diana Greene Foster, PhD, professor of obstetrics and gynecology at University of California, San Francisco.

Dr. Foster leads the Turnaway Study, one of the first efforts to examine the physical and mental health effects of receiving or being denied abortions. The ongoing research also charts the economic and social outcomes of women and their families in either circumstance.

Dr. Foster and her colleagues have followed women through childbirth, examining their well-being through phone interviews months to years after the initial interviews.

The economic consequences of carrying an unwanted pregnancy are clear. Women who did not receive a wanted abortion were more likely to live under the poverty line and struggle to cover basic living expenses like food, housing, and transportation.

The physical toll is also significant.

A 2019 analysis from the Turnaway Study found that eight out of 1,132 participants died, two after delivery, during the five-year follow up period – a far greater proportion than what would be expected among women of reproductive age. The researchers also found that women who carry unwanted pregnancies have more comorbid conditions before and after delivery than other women.

Lauren J. Ralph, PhD, MPH, an epidemiologist and member of the Turnaway Study team, examined the physical well-being of women after delivering their unwanted pregnancies.

“They reported more chronic pain, more gestational hypertension, and were more likely to rate their health as fair or poor,” Dr. Ralph said. “Somewhat to our surprise, we also found that two women denied abortions died due to pregnancy-related causes. This is my biggest concern with the loss of abortion access, as all scientific evidence indicates we will see a rise in maternal deaths as a result.”

At least one preliminary study, released as a preprint and not yet peer reviewed, estimates that the number of women who will die each year from pregnancy complications will rise by 24%. For Black women, mortality could jump from 18% to 39% in every state, according to the researchers from the University of Colorado, Boulder.
 

State of denial

Regulations set in place at abortion clinics in each state individually determine who is able to obtain an abortion, dictated by a “gestational age limit” – how far along a woman is in her pregnancy from the end of her menstrual cycle. Some of the women from the Turnaway Study were unable to receive an abortion because of how far along they were. Others were granted the abortion because they were just under their state’s limit.

Before the latest Supreme Court ruling, this limit was 20 weeks in most states. Now, the cutoff can be as little as 6 weeks – before many women know they are pregnant – or zero weeks, under the most restrictive laws

Over 70% of women who are denied an abortion carry the pregnancy to term, according to Dr. Foster’s analysis. 

Interviews with nearly 1,000 women – in both the first and second trimester of pregnancy – in the Turnaway Study who sought abortions at 30 abortion clinics around the country revealed the main reasons for seeking the procedure were (a) not being able to afford a child; (b) the pregnancy coming at the wrong time in life; or (c) the partner involved not being suitable.

According to the U.S. Centers for Disease Control and Prevention, 59.7% of women seeking an abortion in the United States are already mothers. Having an unplanned child results in dramatically worse economic circumstances for their other children, who become nearly four times more likely to live below the poverty line than their peers. They also experience slower physical and mental development as a result of the arrival of the new sibling.

The latest efforts by states to ban abortion could make the situation much worse, said Liza Fuentes, DrPh, senior research scientist at the Guttmacher Institute. “We will need further research on what it means for women to be denied care in the context of the new restrictions,” Dr. Fuentes told this news organization. 

Researchers cannot yet predict how many women will be unable to obtain an abortion in the coming months. But John Donahue, PhD, JD, an economist and professor of law at Stanford (Calif.) University, estimated that state laws would prevent roughly one-third of the 1 million abortions per year based on 2021 figures.

Dr. Ralph and her colleagues with the Turnaway Study know that restricting access to abortions will not make the need for abortions disappear. Rather, women will be forced to travel, potentially long distances at significant cost, for the procedure or will seek medication abortion by mail through virtual clinics.

But Dr. Ralph said she’s concerned about women who live in areas where telehealth abortions are banned, or who discover their pregnancies late, as medical abortions are only recommended for women who are 10 weeks pregnant or less.

“They may look to self-source the medications online or elsewhere, potentially putting themself at legal risk,” she said. “And, as my research has shown, others may turn to self-managing an abortion with herbs, other drugs or medications, or physical methods like hitting themselves in the abdomen; with this they put themselves at both legal and potentially medical risk.”

Constance Bohon, MD, an ob.gyn. in Washington, D.C., said further research should track what happens to women if they’re forced to leave a job to care for another child.

“Many of these women live paycheck to paycheck and cannot afford the cost of an additional child,” Dr. Bohon said. “They may also need to rely on social service agencies to help them find food and housing.”

Dr. Fuentes said she hopes the Turnaway Study will inspire other researchers to examine laws that outlaw abortion and the corresponding long-term effects on women.

“From a medical and a public health standpoint, these laws are unjust,” Dr. Fuentes said in an interview. “They’re not grounded in evidence, and they incur great costs not just to pregnant people but their families and their communities as well.”

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

In the wake of the Supreme Court’s June decision to repeal a federal right to abortion, many women will now be faced with the prospect of carrying an unwanted pregnancy to term.

One group of researchers has studied the fate of these women and their families for the last decade. Their findings show that women who were denied an abortion are worse off physically, mentally, and economically than those who underwent the procedure.

“There has been much hypothesizing about harms from abortion without considering what the consequences are when someone wants an abortion and can’t get one,” said Diana Greene Foster, PhD, professor of obstetrics and gynecology at University of California, San Francisco.

Dr. Foster leads the Turnaway Study, one of the first efforts to examine the physical and mental health effects of receiving or being denied abortions. The ongoing research also charts the economic and social outcomes of women and their families in either circumstance.

Dr. Foster and her colleagues have followed women through childbirth, examining their well-being through phone interviews months to years after the initial interviews.

The economic consequences of carrying an unwanted pregnancy are clear. Women who did not receive a wanted abortion were more likely to live under the poverty line and struggle to cover basic living expenses like food, housing, and transportation.

The physical toll is also significant.

A 2019 analysis from the Turnaway Study found that eight out of 1,132 participants died, two after delivery, during the five-year follow up period – a far greater proportion than what would be expected among women of reproductive age. The researchers also found that women who carry unwanted pregnancies have more comorbid conditions before and after delivery than other women.

Lauren J. Ralph, PhD, MPH, an epidemiologist and member of the Turnaway Study team, examined the physical well-being of women after delivering their unwanted pregnancies.

“They reported more chronic pain, more gestational hypertension, and were more likely to rate their health as fair or poor,” Dr. Ralph said. “Somewhat to our surprise, we also found that two women denied abortions died due to pregnancy-related causes. This is my biggest concern with the loss of abortion access, as all scientific evidence indicates we will see a rise in maternal deaths as a result.”

At least one preliminary study, released as a preprint and not yet peer reviewed, estimates that the number of women who will die each year from pregnancy complications will rise by 24%. For Black women, mortality could jump from 18% to 39% in every state, according to the researchers from the University of Colorado, Boulder.
 

State of denial

Regulations set in place at abortion clinics in each state individually determine who is able to obtain an abortion, dictated by a “gestational age limit” – how far along a woman is in her pregnancy from the end of her menstrual cycle. Some of the women from the Turnaway Study were unable to receive an abortion because of how far along they were. Others were granted the abortion because they were just under their state’s limit.

Before the latest Supreme Court ruling, this limit was 20 weeks in most states. Now, the cutoff can be as little as 6 weeks – before many women know they are pregnant – or zero weeks, under the most restrictive laws

Over 70% of women who are denied an abortion carry the pregnancy to term, according to Dr. Foster’s analysis. 

Interviews with nearly 1,000 women – in both the first and second trimester of pregnancy – in the Turnaway Study who sought abortions at 30 abortion clinics around the country revealed the main reasons for seeking the procedure were (a) not being able to afford a child; (b) the pregnancy coming at the wrong time in life; or (c) the partner involved not being suitable.

According to the U.S. Centers for Disease Control and Prevention, 59.7% of women seeking an abortion in the United States are already mothers. Having an unplanned child results in dramatically worse economic circumstances for their other children, who become nearly four times more likely to live below the poverty line than their peers. They also experience slower physical and mental development as a result of the arrival of the new sibling.

The latest efforts by states to ban abortion could make the situation much worse, said Liza Fuentes, DrPh, senior research scientist at the Guttmacher Institute. “We will need further research on what it means for women to be denied care in the context of the new restrictions,” Dr. Fuentes told this news organization. 

Researchers cannot yet predict how many women will be unable to obtain an abortion in the coming months. But John Donahue, PhD, JD, an economist and professor of law at Stanford (Calif.) University, estimated that state laws would prevent roughly one-third of the 1 million abortions per year based on 2021 figures.

Dr. Ralph and her colleagues with the Turnaway Study know that restricting access to abortions will not make the need for abortions disappear. Rather, women will be forced to travel, potentially long distances at significant cost, for the procedure or will seek medication abortion by mail through virtual clinics.

But Dr. Ralph said she’s concerned about women who live in areas where telehealth abortions are banned, or who discover their pregnancies late, as medical abortions are only recommended for women who are 10 weeks pregnant or less.

“They may look to self-source the medications online or elsewhere, potentially putting themself at legal risk,” she said. “And, as my research has shown, others may turn to self-managing an abortion with herbs, other drugs or medications, or physical methods like hitting themselves in the abdomen; with this they put themselves at both legal and potentially medical risk.”

Constance Bohon, MD, an ob.gyn. in Washington, D.C., said further research should track what happens to women if they’re forced to leave a job to care for another child.

“Many of these women live paycheck to paycheck and cannot afford the cost of an additional child,” Dr. Bohon said. “They may also need to rely on social service agencies to help them find food and housing.”

Dr. Fuentes said she hopes the Turnaway Study will inspire other researchers to examine laws that outlaw abortion and the corresponding long-term effects on women.

“From a medical and a public health standpoint, these laws are unjust,” Dr. Fuentes said in an interview. “They’re not grounded in evidence, and they incur great costs not just to pregnant people but their families and their communities as well.”

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

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PTSD may accelerate cognitive decline over time

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Tue, 08/02/2022 - 14:57

Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

 

 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Howard Fillit

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

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

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Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

 

 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Howard Fillit

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

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

Posttraumatic stress disorder (PTSD) is associated with accelerated cognitive decline over time, new research suggests.

In an analysis of more than 12,000 middle-aged women who had experienced at least one trauma in their lives, those with PTSD symptoms showed an approximately twofold faster decline in cognition during follow-up compared with those who did not have PTSD symptoms.

These associations were not fully explained by other known cognition-related factors such as depression, the researchers noted.

“PTSD may increase the risk of dementia by accelerating cognitive decline at midlife,” coinvestigator Jiaxuan Liu, a doctoral candidate at Harvard TH Chan School of Public Health, Boston, said in an interview.

“Our findings may suggest the value of earlier cognitive screening among individuals with PTSD and the importance of PTSD prevention and treatment across the lifespan,” she added.

The results were published online in JAMA Network Open.

Vital public health issue

“Cognitive decline at midlife and older is of vital public health interest,” Ms. Liu said. “It is a risk factor for a variety of poor health outcomes and strongly predicts Alzheimer’s disease and other dementias.

Although PTSD has been linked to lower cognitive function and dementia incidence, it has not been known whether it is associated with decline in cognitive function, she added.

“In addition, both PTSD and dementia are more common in women than men, so it’s important to understand a possible link,” Ms. Liu said.

Because no large-scale study had examined whether PTSD is associated with cognitive decline in women, the current researchers examined PTSD symptoms and their association with repeated measures of cognitive function among a large civilian trauma-exposed cohort of women aged 50-70 years at study baseline.

Participants were drawn from the Nurses’ Health Study II, a longitudinal study of a cohort of 116,429 U.S. female nurses who were between 25 and 42 years old at enrollment in 1989. Participants completed biennial questionnaires, with follow-up on an ongoing basis.

The current analysis included 12,270 trauma-exposed women (mean age at baseline, 61.1 years) who completed assessments every 1 or 12 months for up to 24 months after baseline. The mean follow-up time was 0.9 years.

In the study population, 95.9% were non-Hispanic White, 1.3% were Hispanic, 1% were Asian, 0.6% were Black, and 1.2% were classified as “other.”
 

Higher depression scores

Lifetime trauma exposure and PTSD symptoms were assessed from March 1, 2008, to Feb. 28, 2010, using the Short Screening Scale for DSM-IV PTSD.

In total, 67% of the participants reported experiencing PTSD symptoms. The women were divided into four groups, on the basis of symptom number: no PTSD symptoms (n = 4,052), one to three PTSD symptoms (n = 5,058), four to five PTSD symptoms (n = 2,018), and six to seven PTSD symptoms (n = 1,052).

The Cogstate Brief Battery, a validated and self-administered online cognitive assessment, was completed by participants between Oct. 3, 2014, and July 30, 2019. The researchers measured cognitive function with two composite scores: psychomotor speed and attention, and learning and working memory.

Covariates potentially associated with cognitive decline included demographic, educational, and behavior-related health factors such as body mass index, physical activity, cigarette smoking, diet quality, and alcohol consumption.

The researchers conducted secondary analyses that adjusted for symptoms and history of depression as well as the consequences of potential practice effects of taking the test multiple times.

Behavior-related health factors “did not substantially differ by PTSD symptom level,” the investigators noted. However, compared with women who did not have PTSD symptoms, those who had such symptoms had higher depressive symptom scores and higher rates of clinician-diagnosed depression.

Both cognitive composite scores improved through the follow-up period, “likely because of practice effects,” the researchers wrote. But after adjusting for practice effects, they found a decline over time in both composite scores.
 

 

 

Dose-related trajectories

Results showed that having more PTSD symptoms was associated with dose-related poorer cognitive trajectories.

After adjustment for demographic characteristics, women with the highest symptom level (six to seven symptoms) had a significantly worse rate of change in both composite domains of learning and working memory (beta = −0.08 SD/y; 95% confidence interval [CI], −0.11 to −0.04 SD/y; P < .001) and of psychomotor speed and attention (beta = −0.05 SD/y; 95% CI, −0.09 to −0.01 SD/y; P  = .02) compared with women with no PTSD symptoms.

Women with four to five PTSD symptoms showed a worse rate of change in learning and working memory compared with those who had no symptoms, but not in psychomotor speed and attention. Women with one to three PTSD symptoms had cognitive scores similar to those of women without PTSD symptoms.

Notably, the associations of PTSD with cognitive change remained evident after additional adjustment for behavioral factors and health conditions – and were only “partially attenuated but still evident” after further adjustment for practice effects and comorbid depression, the investigators wrote.

“We thought PTSD might be associated with worse cognitive decline through health behaviors like smoking and alcohol drinking and higher risk of other health conditions like hypertension and depression,” Ms. Liu said.

However, those factors did not account for the current study’s findings, she noted.

“We could not determine why women with PTSD had faster cognitive decline than those without PTSD,” she said.

Ms. Liu suggested that PTSD “may have effects on the brain, such as altering brain structures and affecting brain immune function.” However, more research is needed “to investigate these mechanisms that might underlie the association we found between PTSD and cognitive decline,” she said.
 

Neurotoxic effect

In a comment, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said, “It is well known that stress is neurotoxic, and PTSD is a particularly serious form of stress.”

Dr. Howard Fillit

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

“We tend to think of PTSD in postacute settings, such as soldiers returning from war,” he said. “This study contributes to our understanding of the long-term effects of PTSD on cognitive decline, measured objectively over time”

Dr. Fillit noted that an important implication is that, by increasing the risk for cognitive decline, PTSD also increases risk for Alzheimer’s disease. This leads to the “main take-home, which is that PTSD is a risk factor not only for cognitive decline but also for Alzheimer’s and related dementias,” he said.

However, this opens a potential therapeutic approach, Dr. Fillit added.

Because cortisol and other stress hormones drive the stress response, finding ways to block the neurotoxic effects of these hormones “might be a target to prevent cognitive decline and decrease Alzheimer’s disease risk,” he said.

The study was supported by grants from the National Institute of Mental Health and the National Institutes of Health. Ms. Liu and Dr. Fillit report no relevant financial relationships.

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

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Can bone density scans help predict dementia risk?

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Bone densitometry scans may be a novel, noninvasive, and scalable way to identify older women at risk of developing dementia, new research suggests.

In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.

This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.

“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.

“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.

The findings were published online in The Lancet Regional Health – Western Pacific. 
 

AAC and cognition

Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.

Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.

This provided the rationale for the current study, Dr. Sim noted.

The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.

AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.

Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
 

Improved risk prediction

Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).

After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.

Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.

“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.

“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.

Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.

“This provides an opportunity to identify AAC in large numbers of people,” he said.

He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
 

 

 

‘Not surprising’

Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.

Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.  

“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.

Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.

“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.

The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.

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

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Bone densitometry scans may be a novel, noninvasive, and scalable way to identify older women at risk of developing dementia, new research suggests.

In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.

This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.

“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.

“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.

The findings were published online in The Lancet Regional Health – Western Pacific. 
 

AAC and cognition

Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.

Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.

This provided the rationale for the current study, Dr. Sim noted.

The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.

AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.

Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
 

Improved risk prediction

Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).

After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.

Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.

“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.

“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.

Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.

“This provides an opportunity to identify AAC in large numbers of people,” he said.

He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
 

 

 

‘Not surprising’

Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.

Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.  

“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.

Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.

“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.

The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.

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

Bone densitometry scans may be a novel, noninvasive, and scalable way to identify older women at risk of developing dementia, new research suggests.

In an analysis of more than 900 study participants, women in their 70s with more advanced abdominal aortic calcification (AAC) seen on lateral spine images during dual-energy x-ray absorptiometry (DXA) had a two- to fourfold higher risk for late-life dementia than those with low AAC.

This finding was independent of cardiovascular risk factors and apolipoprotein E (APOE ) genotype.

“While these results are exciting, we now need to undertake further large screening studies in older men and women using this approach to show that the findings are generalizable to older men and can identify people with greater cognitive decline,” coinvestigator Marc Sim, PhD, Edith Cowan University, Joondalup, Australia, said in an interview.

“This will hopefully open the door to studies of early disease-modifying interventions,” Sim said.

The findings were published online in The Lancet Regional Health – Western Pacific. 
 

AAC and cognition

Late-life dementia occurring after age 80 is increasingly common because of both vascular and nonvascular risk factors.

Two recent studies in middle-aged and older men and women showed that AAC identified on bone densitometry was associated with poorer cognition, suggesting it may be related to cognitive decline and increased dementia risk.

This provided the rationale for the current study, Dr. Sim noted.

The researchers assessed AAC using DXA lateral spine images captured in the late 1990s in a prospective cohort of 958 older women who were participating in an osteoporosis study.

AAC was classified into established low, moderate, and extensive categories. At baseline, all women were aged 70 and older, and 45% had low AAC, 36% had moderate AAC, and 19% had extensive AAC.

Over 14.5 years, 150 women (15.7%) had a late-life hospitalization and/or died.
 

Improved risk prediction

Results showed that, compared with women who had low AAC, women with moderate and extensive AAC were more likely to experience late-life dementia hospitalization (9.3% low, 15.5% moderate, and 18.3% extensive) and death (2.8%, 8.3%, and 9.4%, respectively).

After multivariable adjustment, women with moderate AAC had a two- and threefold increased relative risk for late-life dementia hospitalization or death, compared with their peers who had low AAC.

Women with extensive AAC had a two- and fourfold increase in the adjusted relative risk for late-life dementia hospitalization or death.

“To our knowledge this is the first time it has been shown that AAC from these scans is related to late-life dementia,” Dr. Sim said.

“We demonstrated that AAC improved risk prediction in addition to cardiovascular risk factors and APOE genotype, a genetic risk factor for Alzheimer’s disease, the major form of dementia,” he added.

Dr. Sim noted “these additional lateral spine images” can be taken at the same time that hip and spine bone density tests are done.

“This provides an opportunity to identify AAC in large numbers of people,” he said.

He cautioned, however, that further studies with detailed dementia-related phenotypes, brain imaging, and measures of cognition are needed to confirm whether AAC will add value to dementia risk prediction.
 

 

 

‘Not surprising’

Commenting on the findings for this article, Claire Sexton, DPhil, senior director of scientific programs and outreach at the Alzheimer’s Association, Chicago, noted that AAC is a marker of atherosclerosis and is associated with vascular health outcomes.

Therefore, it is “not surprising it would be associated with dementia too. There’s been previous research linking atherosclerosis and Alzheimer’s disease,” Dr. Sexton said.  

“What’s novel about this research is that it’s looking at AAC specifically, which can be identified through a relatively simple test that is already in widespread use,” she added.

Dr. Sexton noted that “much more research” is now needed in larger, more diverse populations in order to better understand the link between AAC and dementia – and whether bone density testing may be an appropriate dementia-screening tool.

“The good news is vascular conditions like atherosclerosis can be managed through lifestyle changes like eating a healthy diet and getting regular exercise. And research tells us what’s good for the heart is good for the brain,” Dr. Sexton said.

The study was funded by Kidney Health Australia, Healthway Health Promotion Foundation of Western Australia, Sir Charles Gairdner Hospital Research Advisory Committee Grant, and the National Health and Medical Research Council of Australia. Dr. Sim and Dr. Sexton have reported no relevant financial relationships.

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

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Hormone therapy and breast cancer: An overview

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Mon, 07/11/2022 - 08:39

It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

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It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

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Menstrual phase impacts exercise effects in type 1 diabetes

Article Type
Changed
Tue, 07/05/2022 - 13:28

Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.



Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

 

 

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

Dr. Helena W. Rodbard

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

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Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.



Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

 

 

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

Dr. Helena W. Rodbard

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

Women with type 1 diabetes may need additional glucose after exercise during the luteal phase of the menstrual cycle, compared with other times, according to a study in nine women.

“We know that exercise is very beneficial for people with type 1 diabetes; we also know that fear of hypoglycemia is a major barrier to exercise in this population,” said Jane E. Yardley, PhD, in a presentation at the annual scientific sessions of the American Diabetes Association, New Orleans. Women with type 1 diabetes (T1D) perceive more barriers, compared with men, she added.

The menstrual cycle could be an additional barrier to exercise for women with T1D because it increases glucose fluctuations that have not been well documented in the literature to date, said Dr. Yardley, of the University of Alberta, Augustana.

The follicular phase of the menstrual cycle lasts from menses to the midcycle, about 14 days later. This is followed by the luteal phase, which lasts until approximately day 28, Dr. Yardley explained. Data on insulin sensitivity have shown that the late luteal phase is associated with “a little less insulin sensitivity” in women with T1D, she noted.

To assess the relationship between menstrual cycle, glucose control, and exercise, Dr. Yardley and colleagues compared the effects of a moderate aerobic exercise on glycemic responses between the early follicular and late luteal phases of the menstrual cycle in nine female participants with T1D.

The exercise involved 45 minutes of aerobic cycling at 50% of predetermined peak oxygen uptake (VO2peak) for 45 min. The mean age of the participants was 30.2 years, the mean hemoglobin A1C was 7.4%, and the mean VO2peak was 32.5 mL/kg per min. The women reported regular menstrual cycles, and none were using oral contraceptives.

Blood samples were collected before and immediately after exercise and after an hour of recovery. Participants wore continuous glucose monitors for at least 1 hour before and after exercise.

Menstrual cycle was confirmed via estrogen, estradiol, and progesterone.



Insulin levels varied greatly among the study participants, but the differences were not significant, Dr. Yardley said. Glucose levels consistently decreased during exercise and increased after exercise, she noted.

No significant difference in glucose was observed between the follicular and luteal phases.

However, “this needs to be interpreted in the context of the safety profiles that are in place in our lab,” which include carbohydrate supplements for individuals whose blood glucose levels drop below 4.5 mmol/L, she said.

In the current study, 6 of 9 participants required additional carbohydrates during the luteal phase, but only 1 participant needed additional carbohydrates during the follicular phase, she noted. For this reason, no differences were noted. “We actually prevented changes,” she said.

No significant differences were noted in mean glucose levels or number of hypoglycemic episodes at any of the time points between the two phases.

“One place where we did see a difference was in hyperglycemia 24 hours after exercise,” Dr. Yardley said. Level 1 hyperglycemia 24 hours after exercise was significantly more frequent in the follicular phase, compared with the luteal phase (P = .028).

The study findings were limited by the small sample size and homogenous population, and more research is needed to interpret the data, said Dr. Yardley.

However, the need for more glucose supplementation to prevent hypoglycemia during the luteal phase suggests a higher hypoglycemic risk associated with aerobic exercise during this time, she said.

In addition, the results suggest that the menstrual cycle should be taken into consideration when female participants are involved in exercise studies, she noted.

 

 

Study supports personalized exercise plans

“It is important to evaluate effects of exercise in people with type 1 diabetes and evaluate whether there is a difference those effects in men and women,” said Helena W. Rodbard, MD, an endocrinologist in private practice in Rockville, Md., in an interview. “There is also a need to evaluate to what extent the changes in blood glucose patterns in women in response to exercise differ depending on the phase of the ovarian cycle,” said Dr. Rodbard, who was not involved in the study.

Dr. Helena W. Rodbard

In the current study, “the researchers observed a decline in glucose during a 45-minute period of moderate aerobic exercise, cycling at 50% VO2peak followed by an increase during a 60-minute recovery period. There was a suggestive finding, in the nine subjects, that more carbohydrate supplementation was needed during the late luteal phase of the menstrual cycle than during the follicular phase,” Dr. Rodbard noted. “In contrast, the authors reported a significantly increased degree of hyperglycemia during the recovery phase for subjects during the follicular phase. These findings are consistent with and extend several recent studies from Dr. Yardley and coworkers, who have been focused on this area of research,” she said.

“This study provides provocative evidence that glucose responses to aerobic exercise in women may depend on the timing in relationship to their ovarian cycle,” said Dr. Rodbard. “These findings are based on a small group of subjects and were present in some but not all subjects. Clinicians should encourage women to evaluate and record their experiences during and after exercise in terms of need for carbohydrate supplementation for documented or symptomatic hypoglycemia and in terms of glucose changes as recorded using continuous glucose monitoring (CGM), both in relation to type of exercise and in relation to time in the menstrual cycle,” she said.

The findings also highlight the importance of individualized therapy that is “based on subjective inputs combined with analysis of CGM data during and following exercise,” said Dr. Rodbard. “It is likely that use of Automated Insulin Delivery (AID) will be helpful in achieving this level of individualization in view of the wide range of types, intensity, and duration of physical activity and exercise in which people with T1D engage and the myriad factors that can influence the glycemic response,” she said.

Looking ahead, “the authors and others should expand the present series of subjects using aerobic exercise and examine other types of exercise as well,” Dr. Rodbard noted. “It will be important to evaluate the consistency of these changes in glucose patterns within individuals on multiple occasions, and it would be helpful to repeat the studies in women using oral contraceptives.”

Dr. Yardley disclosed research support from Abbott, Dexcom, and LifeScan and disclosed serving on the speaker’s bureau for Abbott Diabetes. Dr. Rodbard had no financial conflicts to disclose. She serves on the Editorial Advisory Board of Clinical Endocrinology News.

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