MDedge ObGyn

Women who have taken hormone replacement therapy for menopausal symptoms will be relieved by findings from a large British case-control study reporting no overall increased risk of dementia as long as exposure is not long term.

Publishing results online Sept. 29 in BMJ, ( Yana Vinogradova, PhD, a senior research fellow at the University of Nottingham (England), and colleagues made this observation after conducting nested case-control studies involving more than 700,000 women in two U.K. primary care databases. The investigators undertook the study to clarify disparate findings over the past 2 decades on dementia risk associated with menopausal hormone replacement,

“The findings show that menopausal hormone therapy, or MHT, is generally safe for women who require it,” Dr. Vinogradova said in an interview. “A small risk association was found for future development of Alzheimer’s disease increasing with the length of menopausal hormone treatment.” This finding applied only to combined treatments of estrogen plus progestin and became measurable only after long-term use of 5 years or more. “These risk associations, only for long-term use of MHT, are in line with findings related to breast cancer risk,” she said.

The findings also align with previous biological speculations that estrogen combined with progestin may have a harmful effect on the aging brain, she added, “but we also cannot completely rule out other possible factors from our study. For example, some women who were in fact suffering from early signs of Alzheimer’s disease similar to menopausal symptoms may have continued with their menopausal therapy for longer than other women.”

Concerns about the risk of dementia with MHT date back to 2003 when data from the Women’s Health Initiative Memory Study showed that incidence of all-cause dementia doubled in women age 65 years and older after treatment with conjugated equine estrogens and medroxyprogesterone acetate for an average of 4 years. More recently, Finnish research has yielded conflicting data about risks.

The study

The investigators used two U.K. primary care databases (QResearch and CPRD) to analyze MHT prescriptions for 118,501 women age 55 and older diagnosed with dementia between 1998 and 2020 and 497,416 female controls matched by age and general practice, but with no record of dementia.

The cohort was older: mean age of cases was 83.5 years and mean duration of treatment was 16 years for an average age of 67.7 at first captured prescription, considerably later than when most women begin MHT. Relevant factors such as family history, smoking, alcohol consumption, preexisting conditions, and other prescribed drugs were taken into account.

Overall, 16,291 (14%) dementia cases and 68,726 (14%) controls had been exposed to MHT in the period up to 3 years before diagnosis.

After adjusting for potentially confounding factors, the researchers found no overall associations between hormone therapy and risk of dementia, regardless of hormone type, application, dose, or duration of treatment. Within the subgroup of women younger than 80 years who had been taking estrogen-only therapy for 10 years or more, a slightly decreased risk of dementia emerged: odds ratio, 0.85; 95% confidence interval, 0.76-0.94.

However, an analysis of dementia cases with a diagnosis specifically of Alzheimer’s disease showed a slight increase in risk associated with estrogen-progestin therapy. Increased risks of developing specifically Alzheimer’s disease emerged in those who had used combination therapy for 5-9 years (OR, 1.11; 95% CI, 1.04-1.20) and also for 10 years or more (OR, 1.19; 95% CI, 1.06-1.33). This risk rose gradually with each year of exposure, reaching an average 11% increased risk for use from 5-9 years and an average 19% for use 10 years or more – equivalent to, respectively, five and seven extra cases per 10,000 woman-years.

According to Jill M. Rabin, MD, a professor at the Feinstein Institutes for Medical Research and an ob.gyn. with Northwell Health in Manhasset, N.Y., the findings make sense for two reasons. “First, there are other health issues noted in women taking long-term combination hormonal therapy such as an increased risk of breast cancer,” she said in an interview. “Second, progesterone is recommended for women who have retained their uterus in order to counteract the potential effects of estrogen on the uterine lining causing possible overgrowth. There are systemic effects however of progesterone, as it counteracts estrogen, potentially decreasing its benefit on the neurological system.”

She added that this analysis is synchronous with other biological studies demonstrating possible neuroprotective effects of estrogen on the brain, especially among younger women. “The vascular system in the newly menopausal female is noted to have less endothelial and intimal thickening, better blood flow and oxygenation, and in general less vascular damage. Estrogen in these relatively younger, newly menopausal women may help to stabilize the vasculature as well as the neurologic system. On the other hand, estrogen therapy over the age of 80 may be delivered to a neurovasculature damaged with age and time, may be somewhat less beneficial.” Older women also have fewer estrogen receptors and, in general, other medical comorbidities.

According to the authors, the findings will be helpful to policy-makers, doctors, and patients when making choices about hormone therapy.

In an accompanying editorial, two U.S. researchers called the findings reassuring. Pauline M. Maki, PhD, of the University of Illinois at Chicago, and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital, Harvard Medical School, and Harvard T.H. Chan School of Public Health in Boston, however, pointed out that the current study with its older cohort and older age at MHT initiation could not address the important issue of the “timing hypothesis” – namely, that earlier initiation of hormone therapy might confer greater protection against Alzheimer’s disease, compared with later use.

And while the current observations do not change the recommendation that MHT should not be used to prevent dementia, they are helpful for providers to put dementia findings in context for patients. “The primary indication for hormone therapy continues to be the treatment of vasomotor symptoms, and the current study should provide reassurance for women and their providers when treatment is prescribed for that reason,” they wrote.

This study was funded by the U.K. National Institute for Health Research School for Primary Care Research.

Coauthor Dr. Julia Hippisley-Cox is a director of QResearch, EMIS Health, which supplies the QResearch database used for this work, and is a founder and shareholder of ClinRisk., which produces software to implement clinical risk algorithms.

Women who have taken hormone replacement therapy for menopausal symptoms will be relieved by findings from a large British case-control study reporting no overall increased risk of dementia as long as exposure is not long term.

Publishing results online Sept. 29 in BMJ, ( Yana Vinogradova, PhD, a senior research fellow at the University of Nottingham (England), and colleagues made this observation after conducting nested case-control studies involving more than 700,000 women in two U.K. primary care databases. The investigators undertook the study to clarify disparate findings over the past 2 decades on dementia risk associated with menopausal hormone replacement,

“The findings show that menopausal hormone therapy, or MHT, is generally safe for women who require it,” Dr. Vinogradova said in an interview. “A small risk association was found for future development of Alzheimer’s disease increasing with the length of menopausal hormone treatment.” This finding applied only to combined treatments of estrogen plus progestin and became measurable only after long-term use of 5 years or more. “These risk associations, only for long-term use of MHT, are in line with findings related to breast cancer risk,” she said.

The findings also align with previous biological speculations that estrogen combined with progestin may have a harmful effect on the aging brain, she added, “but we also cannot completely rule out other possible factors from our study. For example, some women who were in fact suffering from early signs of Alzheimer’s disease similar to menopausal symptoms may have continued with their menopausal therapy for longer than other women.”

Concerns about the risk of dementia with MHT date back to 2003 when data from the Women’s Health Initiative Memory Study showed that incidence of all-cause dementia doubled in women age 65 years and older after treatment with conjugated equine estrogens and medroxyprogesterone acetate for an average of 4 years. More recently, Finnish research has yielded conflicting data about risks.

The study

The investigators used two U.K. primary care databases (QResearch and CPRD) to analyze MHT prescriptions for 118,501 women age 55 and older diagnosed with dementia between 1998 and 2020 and 497,416 female controls matched by age and general practice, but with no record of dementia.

The cohort was older: mean age of cases was 83.5 years and mean duration of treatment was 16 years for an average age of 67.7 at first captured prescription, considerably later than when most women begin MHT. Relevant factors such as family history, smoking, alcohol consumption, preexisting conditions, and other prescribed drugs were taken into account.

Overall, 16,291 (14%) dementia cases and 68,726 (14%) controls had been exposed to MHT in the period up to 3 years before diagnosis.

After adjusting for potentially confounding factors, the researchers found no overall associations between hormone therapy and risk of dementia, regardless of hormone type, application, dose, or duration of treatment. Within the subgroup of women younger than 80 years who had been taking estrogen-only therapy for 10 years or more, a slightly decreased risk of dementia emerged: odds ratio, 0.85; 95% confidence interval, 0.76-0.94.

However, an analysis of dementia cases with a diagnosis specifically of Alzheimer’s disease showed a slight increase in risk associated with estrogen-progestin therapy. Increased risks of developing specifically Alzheimer’s disease emerged in those who had used combination therapy for 5-9 years (OR, 1.11; 95% CI, 1.04-1.20) and also for 10 years or more (OR, 1.19; 95% CI, 1.06-1.33). This risk rose gradually with each year of exposure, reaching an average 11% increased risk for use from 5-9 years and an average 19% for use 10 years or more – equivalent to, respectively, five and seven extra cases per 10,000 woman-years.

According to Jill M. Rabin, MD, a professor at the Feinstein Institutes for Medical Research and an ob.gyn. with Northwell Health in Manhasset, N.Y., the findings make sense for two reasons. “First, there are other health issues noted in women taking long-term combination hormonal therapy such as an increased risk of breast cancer,” she said in an interview. “Second, progesterone is recommended for women who have retained their uterus in order to counteract the potential effects of estrogen on the uterine lining causing possible overgrowth. There are systemic effects however of progesterone, as it counteracts estrogen, potentially decreasing its benefit on the neurological system.”

She added that this analysis is synchronous with other biological studies demonstrating possible neuroprotective effects of estrogen on the brain, especially among younger women. “The vascular system in the newly menopausal female is noted to have less endothelial and intimal thickening, better blood flow and oxygenation, and in general less vascular damage. Estrogen in these relatively younger, newly menopausal women may help to stabilize the vasculature as well as the neurologic system. On the other hand, estrogen therapy over the age of 80 may be delivered to a neurovasculature damaged with age and time, may be somewhat less beneficial.” Older women also have fewer estrogen receptors and, in general, other medical comorbidities.

According to the authors, the findings will be helpful to policy-makers, doctors, and patients when making choices about hormone therapy.

In an accompanying editorial, two U.S. researchers called the findings reassuring. Pauline M. Maki, PhD, of the University of Illinois at Chicago, and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital, Harvard Medical School, and Harvard T.H. Chan School of Public Health in Boston, however, pointed out that the current study with its older cohort and older age at MHT initiation could not address the important issue of the “timing hypothesis” – namely, that earlier initiation of hormone therapy might confer greater protection against Alzheimer’s disease, compared with later use.

And while the current observations do not change the recommendation that MHT should not be used to prevent dementia, they are helpful for providers to put dementia findings in context for patients. “The primary indication for hormone therapy continues to be the treatment of vasomotor symptoms, and the current study should provide reassurance for women and their providers when treatment is prescribed for that reason,” they wrote.

This study was funded by the U.K. National Institute for Health Research School for Primary Care Research.

Coauthor Dr. Julia Hippisley-Cox is a director of QResearch, EMIS Health, which supplies the QResearch database used for this work, and is a founder and shareholder of ClinRisk., which produces software to implement clinical risk algorithms.

Women who have taken hormone replacement therapy for menopausal symptoms will be relieved by findings from a large British case-control study reporting no overall increased risk of dementia as long as exposure is not long term.

Publishing results online Sept. 29 in BMJ, ( Yana Vinogradova, PhD, a senior research fellow at the University of Nottingham (England), and colleagues made this observation after conducting nested case-control studies involving more than 700,000 women in two U.K. primary care databases. The investigators undertook the study to clarify disparate findings over the past 2 decades on dementia risk associated with menopausal hormone replacement,

“The findings show that menopausal hormone therapy, or MHT, is generally safe for women who require it,” Dr. Vinogradova said in an interview. “A small risk association was found for future development of Alzheimer’s disease increasing with the length of menopausal hormone treatment.” This finding applied only to combined treatments of estrogen plus progestin and became measurable only after long-term use of 5 years or more. “These risk associations, only for long-term use of MHT, are in line with findings related to breast cancer risk,” she said.

The findings also align with previous biological speculations that estrogen combined with progestin may have a harmful effect on the aging brain, she added, “but we also cannot completely rule out other possible factors from our study. For example, some women who were in fact suffering from early signs of Alzheimer’s disease similar to menopausal symptoms may have continued with their menopausal therapy for longer than other women.”

Concerns about the risk of dementia with MHT date back to 2003 when data from the Women’s Health Initiative Memory Study showed that incidence of all-cause dementia doubled in women age 65 years and older after treatment with conjugated equine estrogens and medroxyprogesterone acetate for an average of 4 years. More recently, Finnish research has yielded conflicting data about risks.

The study

The investigators used two U.K. primary care databases (QResearch and CPRD) to analyze MHT prescriptions for 118,501 women age 55 and older diagnosed with dementia between 1998 and 2020 and 497,416 female controls matched by age and general practice, but with no record of dementia.

The cohort was older: mean age of cases was 83.5 years and mean duration of treatment was 16 years for an average age of 67.7 at first captured prescription, considerably later than when most women begin MHT. Relevant factors such as family history, smoking, alcohol consumption, preexisting conditions, and other prescribed drugs were taken into account.

Overall, 16,291 (14%) dementia cases and 68,726 (14%) controls had been exposed to MHT in the period up to 3 years before diagnosis.

After adjusting for potentially confounding factors, the researchers found no overall associations between hormone therapy and risk of dementia, regardless of hormone type, application, dose, or duration of treatment. Within the subgroup of women younger than 80 years who had been taking estrogen-only therapy for 10 years or more, a slightly decreased risk of dementia emerged: odds ratio, 0.85; 95% confidence interval, 0.76-0.94.

However, an analysis of dementia cases with a diagnosis specifically of Alzheimer’s disease showed a slight increase in risk associated with estrogen-progestin therapy. Increased risks of developing specifically Alzheimer’s disease emerged in those who had used combination therapy for 5-9 years (OR, 1.11; 95% CI, 1.04-1.20) and also for 10 years or more (OR, 1.19; 95% CI, 1.06-1.33). This risk rose gradually with each year of exposure, reaching an average 11% increased risk for use from 5-9 years and an average 19% for use 10 years or more – equivalent to, respectively, five and seven extra cases per 10,000 woman-years.

According to Jill M. Rabin, MD, a professor at the Feinstein Institutes for Medical Research and an ob.gyn. with Northwell Health in Manhasset, N.Y., the findings make sense for two reasons. “First, there are other health issues noted in women taking long-term combination hormonal therapy such as an increased risk of breast cancer,” she said in an interview. “Second, progesterone is recommended for women who have retained their uterus in order to counteract the potential effects of estrogen on the uterine lining causing possible overgrowth. There are systemic effects however of progesterone, as it counteracts estrogen, potentially decreasing its benefit on the neurological system.”

She added that this analysis is synchronous with other biological studies demonstrating possible neuroprotective effects of estrogen on the brain, especially among younger women. “The vascular system in the newly menopausal female is noted to have less endothelial and intimal thickening, better blood flow and oxygenation, and in general less vascular damage. Estrogen in these relatively younger, newly menopausal women may help to stabilize the vasculature as well as the neurologic system. On the other hand, estrogen therapy over the age of 80 may be delivered to a neurovasculature damaged with age and time, may be somewhat less beneficial.” Older women also have fewer estrogen receptors and, in general, other medical comorbidities.

According to the authors, the findings will be helpful to policy-makers, doctors, and patients when making choices about hormone therapy.

In an accompanying editorial, two U.S. researchers called the findings reassuring. Pauline M. Maki, PhD, of the University of Illinois at Chicago, and JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital, Harvard Medical School, and Harvard T.H. Chan School of Public Health in Boston, however, pointed out that the current study with its older cohort and older age at MHT initiation could not address the important issue of the “timing hypothesis” – namely, that earlier initiation of hormone therapy might confer greater protection against Alzheimer’s disease, compared with later use.

And while the current observations do not change the recommendation that MHT should not be used to prevent dementia, they are helpful for providers to put dementia findings in context for patients. “The primary indication for hormone therapy continues to be the treatment of vasomotor symptoms, and the current study should provide reassurance for women and their providers when treatment is prescribed for that reason,” they wrote.

This study was funded by the U.K. National Institute for Health Research School for Primary Care Research.

Coauthor Dr. Julia Hippisley-Cox is a director of QResearch, EMIS Health, which supplies the QResearch database used for this work, and is a founder and shareholder of ClinRisk., which produces software to implement clinical risk algorithms.

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

Women with a history of migraine are more likely to experience severe or very severe hot flashes than women without migraines, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society. An estimated one in five women experience migraine, and women tend to have greater migraine symptoms and disability, the authors note in their background information. Since migraines are also linked to a higher risk of cardiovascular disease, the authors sought to learn whether migraines were associated with vasomotor symptoms, another cardiovascular risk factor.

“The question in my mind is, can we do better at predicting cardiovascular risk in women because the risk prediction models that we have really don’t work all that well in women because they were designed for use in men,” Stephanie S. Faubion, MD, MBA, Penny and Bill George Director for Mayo Clinic’s Center for Women’s Health said in an interview. “My ultimate goal is to see if we can somehow use big data, artificial intelligence to figure out how to weight some of these female-specific or female-predominant factors to come up with a better model for cardiovascular risk prediction.”

The researchers analyzed cross-sectional data from 3,308 women who participated in the Data Registry on the Experiences of Aging, Menopause and Sexuality (DREAMS) study through Mayo Clinic sites in Rochester, Minn.; Scottsdale, Ariz.; and Jacksonville, Fla.. The women ranged in age from 45 to 60 years old, with an average age of 53, and the vast majority of them were white (95%) and had at least some college (93%). Most were also in a long-term relationship (85%), and a majority were employed (69%) and postmenopausal (67%).

The data, collected between May 2015 and December 2019, included a self-reported history of migraine and questionnaires that included the Menopause Rating Scale of menopause-related symptoms.

The researchers adjusted their findings to account for body mass index (BMI), menopause status, smoking status, depression, anxiety, current use of hormone therapy, and presence of low back pain within the past year. ”The diagnosis of low back pain, another pain disorder, was used to test the specificity of the association of migraine and vasomotor symptoms,” the authors write.

Just over a quarter of the women (27%) reported a history of migraine, and these women’s Menopause Rating Scale scores were an average 1.36 points greater than women without a history of migraines (P < .001). Women with self-reported migraine were also 40% more likely than women without migraines to report severe or very severe flashes versus reporting no hot flashes at all (odds ratio, 1.4; P = .02).

“The odds of reporting more severe hot flashes increased monotonically in women with a history of migraine,” the authors report. “In addition, women with low back pain had higher Menopause Rating Scale scores, but were no more likely to have severe/very severe hot flashes than those without back pain, confirming the specificity of the link between vasomotor symptoms and migraine.”

It’s not clear if migraine or hot flashes are risk factors that add to a woman’s existing cardiovascular risk profile or whether they are simply biomarkers of a shared pathway, Dr Faubion said in an interview. She speculates that the common link between migraine and vasomotor symptoms could be neurovascular dysregulation.

Rachael B. Smith, DO, of the department of ob.gyn. at the University of Arizona, Phoenix, was not involved in the research but found that hypothesis plausible as well.

“Our neurologic and vascular systems are coordinated physiologic processes working together for basic brain and body function,” Dr. Smith said in an interview. Some of the symptoms of migraines and menopause are similar and both are often explained by the dysfunction of these systems. The association between history of migraines and severity of vasomotor symptoms is very likely to be explained by this dysregulation between the neurologic and vascular systems.”

Dr. Smith also pointed out, however, that the largely homogeneous study population, all from the same national clinic system, makes it difficult to know how generalizable these findings are.

The primary clinical implications of these findings are that women’s providers need to be sure they’re asking their patients about migraine history and symptoms.

“The counseling we provide on menopausal symptoms should be better tailored to our patients’ medical history, specifically inquiring about history of migraines and how this may impact their symptoms,” Dr. Smith said.

The research was funded by the National Institutes of Health. Dr. Faubion and Dr. Smith had no disclosures.

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.

Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.

The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.

The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
 

Summary of salient studies

• In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
• A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
• An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
• A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.

Consensus statements

• The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
• The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
• The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
• The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
• The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”

Conclusion

The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.

So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.

Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].

The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.

Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.

The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.

The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
 

Summary of salient studies

• In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
• A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
• An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
• A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.

Consensus statements

• The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
• The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
• The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
• The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
• The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”

Conclusion

The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.

So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.

Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].

The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.

Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.

The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.

The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
 

Summary of salient studies

• In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
• A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
• An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
• A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.

Consensus statements

• The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
• The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
• The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
• The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
• The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”

Conclusion

The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.

So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.

Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].

The U.S. Preventive Services Task Force continues to recommend that pregnant women at risk of developing preeclampsia take low-dose aspirin daily, and has expanded the criteria for those at risk.

“I think that this issue has been one that people have talked about and thought about for a long time, but it hasn’t kind of leapt into the front for all practitioners,” Aaron B. Caughey, MD, MPH, PhD, a USPSTF member, said in an interview. “We think it’s really important that all providers and all pregnant persons are aware that folks at an increased risk for preeclampsia can receive a reduction in the risk of preeclampsia from receiving baby aspirin starting after 12 weeks of gestation.”

The task force concluded with moderate certainty that a daily dose of 81 milligrams of aspirin after 12 weeks of pregnancy could reduce the risk for preeclampsia, preterm birth, and stillbirths in pregnant persons at high risk for preeclampsia. The recommendations, which were published in JAMA, are identical to the panel’s 2014 recommendations.

However, the new draft includes a suggestion that expands the list of pregnant patients at risk of developing preeclampsia. In 2014, the USPSTF recommended that clinicians prescribe low-dose daily aspirin to those who had at least two moderate-risk factors related to disparity – first pregnancy, obesity, family history of preeclampsia, lower income, age of 35 years or older, of African descent, and previous adverse pregnancy outcomes. The recent update suggests clinicians consider prescribing low-dose aspirin to patients with just one of the moderate risk factors. The task force also added “in vitro fertilization” as a moderate risk factor.

Dr. Caughey said the motivation for this addition was out of concern for disparities in outcomes for people who have less access to care and to help curb the racial disparity in the prevalence of preeclampsia in Black women and other disadvantaged groups. “[In an effort] to prevent the development of preeclampsia in such individuals that have historically had worse health outcomes, we wanted to emphasize that should at least be considered by clinicians,” Dr. Caughey said.

This change is a “major one,” according to Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy.

“That’s probably three-quarters of my patients. The majority of my patients will now be candidates [to receive a low-dose aspirin prescription to prevent preeclampsia],” Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, Manhasset, N.Y., said in an interview. “[This] may increase the amount of people who will be getting the aspirin and therefore decrease the chance of preeclampsia or developing preeclampsia.”

Preeclampsia is a condition characterized by high blood pressure and signs of problems with the kidneys, liver, and other organs during pregnancy, according to the Centers for Disease Control and Prevention. The condition occurs in about 1 in 25 pregnancies in the United States and can cause serious and fatal complications for both the mother and child.

Although the update reaffirms that aspirin is safe and effective in preventing preeclampsia, Dr. Klein believes the dosage they are recommending is too low, as he has had patients develop preeclampsia while taking 81 mg of aspirin daily. Dr. Klein says he prescribes two daily doses of 81 mg aspirin to some of his patients.

“The majority of us in the field of high-risk pregnancies feel that 81 milligrams is not enough,” Dr. Klein said. “So I am disappointed that [they] didn’t talk about consideration for higher doses. I have patients taking two baby aspirins who developed preeclampsia.”

However, the systematic review that the USPSTF’s recommendation was based on did not “really find evidence to suggest that a higher dose was necessarily better than the lower dose,” Dr. Caughey said. However, this may be something they look at again in the near future.

“I know of clinicians that are asking if we should be using a higher dose,” Dr. Caughey explained. “If more evidence accumulates then absolutely we will look at that issue again.”

In their draft, the task force said there’s limited evidence on the side effects of low-dose aspirin on long-term child developmental outcomes and said the evidence report found no physical or developmental differences in infants at age 12 and 18 months.

USPSTF said comparative effectiveness trials are needed to identify “specific aspirin protocols” and evaluate which dosage, timing, and time of day will have the greatest benefit. The task force also said more research is needed to improve identification of those at an increased risk of developing preeclampsia.

Dr. Caughey and Dr. Klein disclosed no conflicts of interest.

The U.S. Preventive Services Task Force continues to recommend that pregnant women at risk of developing preeclampsia take low-dose aspirin daily, and has expanded the criteria for those at risk.

“I think that this issue has been one that people have talked about and thought about for a long time, but it hasn’t kind of leapt into the front for all practitioners,” Aaron B. Caughey, MD, MPH, PhD, a USPSTF member, said in an interview. “We think it’s really important that all providers and all pregnant persons are aware that folks at an increased risk for preeclampsia can receive a reduction in the risk of preeclampsia from receiving baby aspirin starting after 12 weeks of gestation.”

The task force concluded with moderate certainty that a daily dose of 81 milligrams of aspirin after 12 weeks of pregnancy could reduce the risk for preeclampsia, preterm birth, and stillbirths in pregnant persons at high risk for preeclampsia. The recommendations, which were published in JAMA, are identical to the panel’s 2014 recommendations.

However, the new draft includes a suggestion that expands the list of pregnant patients at risk of developing preeclampsia. In 2014, the USPSTF recommended that clinicians prescribe low-dose daily aspirin to those who had at least two moderate-risk factors related to disparity – first pregnancy, obesity, family history of preeclampsia, lower income, age of 35 years or older, of African descent, and previous adverse pregnancy outcomes. The recent update suggests clinicians consider prescribing low-dose aspirin to patients with just one of the moderate risk factors. The task force also added “in vitro fertilization” as a moderate risk factor.

Dr. Caughey said the motivation for this addition was out of concern for disparities in outcomes for people who have less access to care and to help curb the racial disparity in the prevalence of preeclampsia in Black women and other disadvantaged groups. “[In an effort] to prevent the development of preeclampsia in such individuals that have historically had worse health outcomes, we wanted to emphasize that should at least be considered by clinicians,” Dr. Caughey said.

This change is a “major one,” according to Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy.

“That’s probably three-quarters of my patients. The majority of my patients will now be candidates [to receive a low-dose aspirin prescription to prevent preeclampsia],” Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, Manhasset, N.Y., said in an interview. “[This] may increase the amount of people who will be getting the aspirin and therefore decrease the chance of preeclampsia or developing preeclampsia.”

Preeclampsia is a condition characterized by high blood pressure and signs of problems with the kidneys, liver, and other organs during pregnancy, according to the Centers for Disease Control and Prevention. The condition occurs in about 1 in 25 pregnancies in the United States and can cause serious and fatal complications for both the mother and child.

Although the update reaffirms that aspirin is safe and effective in preventing preeclampsia, Dr. Klein believes the dosage they are recommending is too low, as he has had patients develop preeclampsia while taking 81 mg of aspirin daily. Dr. Klein says he prescribes two daily doses of 81 mg aspirin to some of his patients.

“The majority of us in the field of high-risk pregnancies feel that 81 milligrams is not enough,” Dr. Klein said. “So I am disappointed that [they] didn’t talk about consideration for higher doses. I have patients taking two baby aspirins who developed preeclampsia.”

However, the systematic review that the USPSTF’s recommendation was based on did not “really find evidence to suggest that a higher dose was necessarily better than the lower dose,” Dr. Caughey said. However, this may be something they look at again in the near future.

“I know of clinicians that are asking if we should be using a higher dose,” Dr. Caughey explained. “If more evidence accumulates then absolutely we will look at that issue again.”

In their draft, the task force said there’s limited evidence on the side effects of low-dose aspirin on long-term child developmental outcomes and said the evidence report found no physical or developmental differences in infants at age 12 and 18 months.

USPSTF said comparative effectiveness trials are needed to identify “specific aspirin protocols” and evaluate which dosage, timing, and time of day will have the greatest benefit. The task force also said more research is needed to improve identification of those at an increased risk of developing preeclampsia.

Dr. Caughey and Dr. Klein disclosed no conflicts of interest.

The U.S. Preventive Services Task Force continues to recommend that pregnant women at risk of developing preeclampsia take low-dose aspirin daily, and has expanded the criteria for those at risk.

“I think that this issue has been one that people have talked about and thought about for a long time, but it hasn’t kind of leapt into the front for all practitioners,” Aaron B. Caughey, MD, MPH, PhD, a USPSTF member, said in an interview. “We think it’s really important that all providers and all pregnant persons are aware that folks at an increased risk for preeclampsia can receive a reduction in the risk of preeclampsia from receiving baby aspirin starting after 12 weeks of gestation.”

The task force concluded with moderate certainty that a daily dose of 81 milligrams of aspirin after 12 weeks of pregnancy could reduce the risk for preeclampsia, preterm birth, and stillbirths in pregnant persons at high risk for preeclampsia. The recommendations, which were published in JAMA, are identical to the panel’s 2014 recommendations.

However, the new draft includes a suggestion that expands the list of pregnant patients at risk of developing preeclampsia. In 2014, the USPSTF recommended that clinicians prescribe low-dose daily aspirin to those who had at least two moderate-risk factors related to disparity – first pregnancy, obesity, family history of preeclampsia, lower income, age of 35 years or older, of African descent, and previous adverse pregnancy outcomes. The recent update suggests clinicians consider prescribing low-dose aspirin to patients with just one of the moderate risk factors. The task force also added “in vitro fertilization” as a moderate risk factor.

Dr. Caughey said the motivation for this addition was out of concern for disparities in outcomes for people who have less access to care and to help curb the racial disparity in the prevalence of preeclampsia in Black women and other disadvantaged groups. “[In an effort] to prevent the development of preeclampsia in such individuals that have historically had worse health outcomes, we wanted to emphasize that should at least be considered by clinicians,” Dr. Caughey said.

This change is a “major one,” according to Victor Klein, MD, MBA, CPHRM, a specialist in high-risk pregnancy.

“That’s probably three-quarters of my patients. The majority of my patients will now be candidates [to receive a low-dose aspirin prescription to prevent preeclampsia],” Dr. Klein, vice chairman of obstetrics and gynecology at North Shore University Hospital, Manhasset, N.Y., said in an interview. “[This] may increase the amount of people who will be getting the aspirin and therefore decrease the chance of preeclampsia or developing preeclampsia.”

Preeclampsia is a condition characterized by high blood pressure and signs of problems with the kidneys, liver, and other organs during pregnancy, according to the Centers for Disease Control and Prevention. The condition occurs in about 1 in 25 pregnancies in the United States and can cause serious and fatal complications for both the mother and child.

Although the update reaffirms that aspirin is safe and effective in preventing preeclampsia, Dr. Klein believes the dosage they are recommending is too low, as he has had patients develop preeclampsia while taking 81 mg of aspirin daily. Dr. Klein says he prescribes two daily doses of 81 mg aspirin to some of his patients.

“The majority of us in the field of high-risk pregnancies feel that 81 milligrams is not enough,” Dr. Klein said. “So I am disappointed that [they] didn’t talk about consideration for higher doses. I have patients taking two baby aspirins who developed preeclampsia.”

However, the systematic review that the USPSTF’s recommendation was based on did not “really find evidence to suggest that a higher dose was necessarily better than the lower dose,” Dr. Caughey said. However, this may be something they look at again in the near future.

“I know of clinicians that are asking if we should be using a higher dose,” Dr. Caughey explained. “If more evidence accumulates then absolutely we will look at that issue again.”

In their draft, the task force said there’s limited evidence on the side effects of low-dose aspirin on long-term child developmental outcomes and said the evidence report found no physical or developmental differences in infants at age 12 and 18 months.

USPSTF said comparative effectiveness trials are needed to identify “specific aspirin protocols” and evaluate which dosage, timing, and time of day will have the greatest benefit. The task force also said more research is needed to improve identification of those at an increased risk of developing preeclampsia.

Dr. Caughey and Dr. Klein disclosed no conflicts of interest.

Contraception prescription patterns vary by specialty and geography

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

Contraception prescription patterns vary by specialty and geography

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

Contraception prescription patterns vary by specialty and geography

Access to contraceptive services is dependent on both the local availability of healthcare providers as well as the types of contraception services offered by those providers. Little is known about the national US contraception workforce, which includes any type of provider that offers contraceptive care. In this observational study, three national data sources were combined to construct a comprehensive database of the contraception provider workforce to evaluate Medicaid participation and variation in the supply, distribution, and types of contraceptive services offered. The study found that 73.1% of obstetric and gynecologic medical physicians (OBGYN), 72.6% of nurse-midwives, 51.4% of family medicine physicians, 32.4% of pediatricians, 25.2% of advanced practice nurses, 19.8% of internal medicine physicians, and 19.4% of physician assistants prescribed the contraceptive pill, patch, or ring. Approximately half of OBGYNs and family medicine physicians (50.2% and 52.2%, respectively) provided injectable contraception, compared to 34.7% of internal medicine physicians and 34.1% of pediatricians. Intrauterine devices (IUD) were provided by 92.8% of OBGYNs compared with 16.4% of family physicians, 2.6% of internal medicine physicians, and 0.6% of pediatricians. Contraceptive implants were provided by 56.2% of OBGYNs, compared with 13.7% of family medicine physicians, 1.8% of internal medicine physicians, and 4.0% of pediatricians. The contraception workforce also varied by geography, both in the density and types of providers that different communities depend upon. States ranged from provider-to-population ratios of 27.9 to 74.2 providers per 10,000 women of reproductive age. The availability of different specialties and professions also varied between counties, with 675 of the 1,411 counties lacking either OBGYNs or nurse-midwives prescribing contraception. This study also found variation across states and provider types in the proportion of contraceptive providers who accept Medicaid, with rates of Medicaid acceptance highest amongst OBGYNs and lowest amongst internal medicine physicians. This report highlights that the distribution of the contraception workforce and Medicaid acceptance varies widely by location and specialty and documents large gaps in the provision of highly effective contraceptive services including IUDs and implants. Increasing the number and types of providers that can provide family planning is central to providing comprehensive reproductive healthcare and reducing unintended pregnancies.

US Healthcare provider practices related to Emergency Contraception

Emergency contraception (EC) can prevent pregnancy after sexual encounters in which contraception was not used or used incorrectly. The US Selected Practice Recommendations for Contraceptive Use (US SPR) was initially released in 2013 and includes recommendations for healthcare providers on the initiation of EC, increasing access to EC through advance provision of EC pills, and initiation of regular contraception in conjunction with provision of EC pills. The objective of this study was to assess the percentage of healthcare providers reporting frequent provision of select EC practices around the time of and after the release of the US SPR. Two cross-sectional mailed surveys were conducted using different nationwide samples of office-based physicians and public-sector providers around the time of (2013-2014) and after (2019) the initial US SPR release. Providers were asked to indicate how often in the past year they had: 1) provided an advance prescription of EC pills to a woman not specifically seeking EC; 2) provided an advanced supply of EC pills to a woman not specifically seeking EC; 3) provided or prescribed a contraceptive at the same time as EC pills were provided; and 4) provided a copper IUD as EC. Data was pooled from both surveys, resulting in an overall sample size of 3,480 providers (n = 2,060 for the 2013-2014 survey and n = 1,420 for the 2019 survey). In the 2019 nationwide sample, 16% of respondents frequently provided an advance prescription of EC pills, 7% provided an advanced supply of EC pills, 8% provided the copper IUD as EC, and 41% cfrequently provided regular contraception at the time of EC pills. Overall, there were no significant changes in prevalence of frequently providing or prescribing an advance supply of EC pills between 2013-2014 and 2019, which may reflect changes in provider practices based on availability of over-the-counter levonogestrel EC pills in 2013. An increase in the proportion of providers who frequently provided regular contraception at the same time as EC pills and who provided a copper IUD for EC between 2013-2014 and 2019 was observed. In 2019, providers who reported using the US SPR were more likely to provide contraception at the same time as EC pills and provide the copper IUD for EC compared with those who did not use the US SPR. Wider implementation of the US SPR recommendations and an improved understanding of the barriers faced by providers in implementing these practices may improve access to EC. A recent report found that the levonorgestrel 52 IUD provides EC with efficacy similar to that of the copper IUD and may lead to more widespread placement of IUDs for EC (Turok).  


Progestogen-only pill shows promise as a potential non-prescription contraception option for both breastfeeding and non-breastfeeding women

An initiative is currently underway to apply for US Food and Drug Administration (FDA) approval for over-the-counter sales of a progestogen-only contraceptive pill (POP) containing 75 mg/day norgestrel. Although 75 mg/day norgestrel is approved by the FDA for prescription use, this formulation is not currently available in the US as marketing of this product was discontinued in 2005 for reasons not related to safety or effectiveness. The failure rate of the POP is presently reported to be the same as that of combined oral contraceptive pills (COC): 9% typical use and 0.3% perfect use unintended pregnancy rate. The objective of this review is to summarize and present the published data regarding the contraceptive effectiveness of 75 mg/day norgestrel amongst breastfeeding and non-breastfeeding women. A literature search was conducted in 2019 and identified 13 articles that specifically assessed the contraceptive efficacy of 75 mg/day norgestrel. Seven of the 13 studies included a total of 5,258 women who were breastfeeding and six of the 13 studies included a total 3,144 non-breastfeeding women. Taken together, the six studies of 3,144 non-breastfeeding women provide data on 35,319 months of use with a range of overall 12-month failure rates from 0-2.4/hundred woman-years from 75 mg/day norgestrel during typical use with a calculated aggregate Pearl Index of 2.2. Among breastfeeding women, the 12-month life table cumulative pregnancy rates for 75 mg/day norgestrel ranged from 0-3.4. This review concluded that the data support that 75 mg/day norgestrel is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for FDA approval of over-the-counter use of 75 mg/day norgestrel. Most contraindications to use of combination estrogen-progestin contraceptives relate to the estrogen component. Over the counter availability of the norgestrel POP could enhance women’s access to hormonal contraception.  

Millions of women view YouTube videos on self-removal of long-acting contraception

This study reviewed 58 YouTube videos related to self-removal of long-acting reversible contraception (LARC)– namely intrauterine devices (IUD) and contraceptive implants. Video content was analyzed to explore demographic characteristics, method and duration of LARC use, and motivations and experiences of self-removal. There were 48 videos (83%) that featured individuals who self-removed an IUD and 10 videos (17%) that featured individuals who self-removed an implant. All videos were uploaded between 2012-2020 and had over 4 million collective views, with the median number of views being 10,473 per video. Although a much smaller proportion of videos featured the self-removal of an implant, these videos had a higher average number of views (median 23,097 vs, 9533) and comments (median 44 vs. 14) compared to videos of IUD self-removals. The video creators of 53% were identified as White, 31% as Black, and 14% as Latina. The top comments for each video were analyzed and three primary themes emerged: positive affirmations; the viewer’s consideration of or attempt at self-removal; and complaints about LARC. There were 25 videos (n = 25/58) that included a comment from a viewer who stated they had either removed their own LARC device after watching the video or intended to do so soon. Three main motivations for self-removal were identified. Roughly half the sample (n = 30/58) described a desire to remove their method at home out of personal preference or convenience (n = 28/48 IUD users and n = 2/10 implant users). Others noted the inconvenience of an in-clinic removal. A large proportion of LARC users described barriers to clinic-based removal, including cost, lack of insurance, and long waiting times for an appointment. Most individuals in the sample (n = 56/58) successfully removed their device and described their experience in positive terms related to the ease of removal. Roughly a third of all video creators encountered challenges, including difficulty grasping the strings of their IUD or challenges removing the implant (n = 17/48 IUD users and n = 3/10 implant users). Positive experiences of self-removal and high levels of viewer engagement with online videos suggest a need for provider counseling on LARC removal at the time of insertion. Providers should clearly describe any procedural or financial requirements of removal prior to LARC placement. Providers may also wish to proactively discuss the risks and best practices for safe self-removal of LARC, including a conversation about the desired length of the IUD strings, risks associated with self-removal, and available resources when the patient encounters barriers to clinic-based removal. This study provides important data about the characteristics, motivations, and experiences of a group of people that are often invisible to researchers and healthcare providers.

References:
Broussard K, Becker A. Self-removal of long-acting reversible contraception: A content analysis of YouTube videos. Contraception. 2021 Aug 13: S0010-7824(21)00346-2 (in press).

Chen C, Strasser J, Banawa R, Luo Q, Bodas M, Castruccio-Prince C, Das K, Pittman P. Who is providing contraception care in the United States? An observational study of the contraception workforce. Am J Obstet Gynecol. 2021 Aug 18:  S0002-9378(21)00883-8 (in press).

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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

Avanos medical to pay $22 million to resolve criminal charge for fraudulent misbranding of PPE

A U.S.-based multinational medical device corporation will pay more than $22 million to resolve a criminal charge regarding fraudulent misbranding of their surgical gowns.

Avanos Medical Inc, which as its U.S. headquarters in Alpharetta, Georgia, is charged with one count of introducing misbranded surgical gowns into interstate commerce with the intent to defraud and mislead.

According to the Department of Justice, the company knowingly falsely labeled its MicroCool surgical gowns as providing AAMI Level 4 protection (the highest level) against fluid and virus penetration. Under the standards set by the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI), the highest protection level for surgical gowns is reserved for gowns intended to be used in surgeries and other high-risk medical procedures on patients suspected of having infectious diseases.

Avanos admitted to selling hundreds of thousands of MicroCool gowns that were falsely labeled as AAMI Level 4 between late 2014 and early 2015, as well as directly lying to customers about the gowns’ protective capacities. In total, Avanos sold almost $9 million of misbranded MicroCool gowns.

“The last thing health care workers should have to worry about is whether their personal protective equipment lives up to manufacturers’ claims,” said Acting U.S. Attorney Prerak Shah for the Northern District of Texas. “Misbranded PPE can pose serious risks to medical professionals and patients alike.”
 

Company pays $38.75 million to settle allegations of knowingly selling defective devices 

Medical device manufacturers Alere and Alere San Diego (collectively, Alere) have agreed to pay almost $39 million to resolve allegations that they violated the False Claims Act by billing, and causing others to bill, the Medicare program for defective rapid point-of-care testing devices. 

From 2008 to 2016, the Department of Justice alleges, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries who were taking anticoagulants. The software algorithms in the monitors contained a material defect, which Alere had found in their research, to cause inaccurate readings. Blood coagulation monitoring is essential for the safety of these patients, enabling them to maintain a safe dosage of their medications. Taking too much of an anticoagulant can cause major bleeding, while taking too little can cause blood clots that lead to strokes. 

While Alere was aware that these devices were linked to over a dozen deaths and hundreds of injuries, the company continued to conceal the defect and billed Medicare for the devices.

In 2016, the product was taken off the market at the request of the FDA.
 

Mass. doctor, wife charged in international money laundering, fraud scheme

Massachusetts psychiatrist Rahim Shafa, MD, and his wife and office manager, Nahid Tormosi Shafa, are charged in connection to an international money laundering scheme involving importing illegal and misbranded drugs. 

Through Shafa’s company, Novel Psychopharmacology, the two allegedly filed false and fraudulent Medicare reimbursement claims from 2016-2019, then deposited the money in their bank accounts, according to federal officials. From 2008-2018, the couple also engaged in an international money laundering scheme to purchase naltrexone pellet implants, disulfiram pellet implants, and injections from Hong Kong that were not approved by the FDA. According to officials, they falsified shipping documents, disguising the naltrexone pellet implants as “plastic beads in plastic tubes” to receive the drugs. They then offered to sell these drugs to patients of Novel Psychopharmacology. 

Rahim Shafa was indicted on conspiracies of international money laundering, health care fraud, and defrauding the United States, as well as illegally importing merchandise and purposely delivering misbranded drugs. His wife was indicted on one count each of health care fraud conspiracy and international money laundering conspiracy.
 

Jury convicts medical equipment company owners of $27 million fraud

A federal jury in Texas convicted the owners of two durable medical equipment (DME) companies linked to a scheme to defraud Medicare.

Leah Hagen, 49, and Michael Hagen, 54, were convicted of one count of conspiracy to defraud the United States and to pay and receive health care kickbacks and one count of conspiracy to commit money laundering. The defendants owned and operated Metro DME Supply and Ortho Pain Solutions. 

Ms. Hagen and Mr. Hagen paid a fixed rate per DME item in exchange for prescriptions and paperwork completed by telemedicine doctors that were used to submit false claims to Medicare, which totaled about $59 million. They were paid $27 million, and wired millions to their personal bank accounts. The defendants paid illegal bribes and kickbacks and wired money to their co-conspirator’s call center in the Philippines that provided signed doctor’s orders for orthotic braces. 

At trial, evidence showed emails between Leah and Michael Hagen and their co-conspirators outlining a per-product pricing structure for orthotic braces, but not disclosing their agreement as one for marketing and other services.

At sentencing, the Hagens each face a maximum sentence of 25 years in prison.

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

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.