Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Dr. Lee S. Cohen
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Dr. Lee S. Cohen
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Postpartum depression (PPD) remains the most common complication in modern obstetrics, and a leading cause of postpartum mortality in the first year of life. The last 15 years have brought considerable progress with respect to adoption of systematic screening for PPD across America. Screening for PPD, most often using the Edinburgh Postnatal Depression Scale (EPDS), has become part of routine obstetrical care, and is also widely used in pediatric settings.
That is the good news. But the flip side of the identification of those women whose scores on the EPDS suggest significant depressive symptoms is that the number of these patients who, following identification, receive referrals for adequate treatment that gets them well is unfortunately low. This “perinatal treatment cascade” refers to the majority of women who, on the other side of identification of PPD, fail to receive adequate treatment and continue to have persistent depression (Cox E. et al. J Clin Psychiatry. 2016 Sep;77[9]:1189-1200). This is perhaps the greatest challenge to the field and to clinicians – how do we, on the other side of screening, see that these women get access to care and get well with the available treatments at hand?
Dr. Lee S. Cohen
Recently, a widely read and circulated article was published in The Wall Street Journal about the challenges associated with navigating care resources for women suffering from PPD. In that article, it was made clear, based on clinical vignette after clinical vignette from postpartum women across America, that neither obstetricians, mental health professionals, nor pediatricians are the “clinical home” for women suffering from postpartum mood and anxiety disorders. The article painfully highlights the system-wide failure to coordinate mental health care for women suffering from postpartum psychiatric illness.
Within a day of the publication of The Wall Street Journal article, the Food and Drug Administration approved zuranolone (Zurzuvae; Sage Therapeutics; Cambridge, Mass.) for the treatment of PPD following the review of two studies demonstrating the superiority of the new medicine over placebo. Women who were enrolled met criteria for major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders criteria beginning in no earlier than the third trimester of pregnancy or later than 4 weeks of delivery. The two studies included a combined sample size of approximately 350 patients suffering from severe PPD. In the studies, women received either 50 mg or 40 mg of zuranolone, or placebo for 14 days. Treatment was associated with a significant change in the Hamilton Depression Rating Scale at day 15, and treatment response was maintained at day 42, which was 4 weeks after the last dose of study medication.
Zuranolone is a neuroactive steroid, which is taken orally, unlike brexanolone (Zulresso; Sage Therapeutics; Cambridge, Mass.), which requires intravenous administration. Zuranolone will be commercially available based on estimates around the fourth quarter of 2023. The most common side effects are drowsiness, dizziness, and sedation, and the FDA label will have a boxed warning about zuranolone’s potential to impact a person’s driving ability, and performance of potentially hazardous activities.
It is noteworthy that while this new medication received FDA approval for the PPD indication, it did not receive FDA approval for the treatment of major depressive disorder (MDD), and the agency issued a Complete Response Letter to the manufacturers noting their application did not provide substantial evidence of effectiveness in MDD. The FDA said in the Complete Response Letter that an additional study or studies will be needed; the manufacturers are currently evaluating next steps.
Where zuranolone fits into the treatment algorithm for severe PPD
Many clinicians who support women with PPD will wonder, upon hearing this news, where zuranolone fits into the treatment algorithm for severe postpartum major depression. Some relevant issues that may determine the answer are the following:
Cost. The cost of brexanolone was substantial, at $34,000 per year, and was viewed by some as a limiting factor in terms of its very limited uptake. As of this column’s publication, zuranolone’s manufacturer has not stated how much the medication will cost.
Breastfeeding. Unlike selective serotonin reuptake inhibitors, which have been demonstrated to be effective for the treatment of PPD and safe during pregnancy and lactation, we have sparse data on the safety of zuranolone for women who wish to breastfeed. It is also unclear whether women eligible for zuranolone would, based on the limited data on safety in lactation, choose deferral of breastfeeding for 14 days in exchange for treatment.
Duration of treatment. While zuranolone was studied in the context of 14 days of acute treatment, then out to day 42, we have no published data on what happens on the other side of this brief interval. As a simple example, in a patient with a history of recurrent major depression previously treated with antidepressants, but where antidepressants were perhaps deferred during pregnancy, is PPD to be treated with zuranolone for 14 days? Or, hypothetically, should it be followed by empiric antidepressant treatment at day 14? Alternatively, are patient and clinician supposed to wait until recurrence occurs before pursuing adjunctive antidepressant therapy whether it is pharmacologic, nonpharmacologic, or both?
Treatment in patients with bipolar disorder. It is also unclear whether treatment with zuranolone applies to other populations of postpartum women. Certainly, for women with bipolar depression, which is common in postpartum women given the vulnerability of bipolar women to new onset of depression or postpartum depressive relapse of underlying disorder, we simply have no data regarding where zuranolone might fit in with respect to this group of patients.
The answers to these questions may help to determine whether zuranolone, a new antidepressant with efficacy, quick time to onset, and a novel mechanism of action is a “game changer.” The article in The Wall Street Journal provided me with some optimism, as it gave PPD and the issues surrounding PPD the attention it deserves in a major periodical. As a new treatment, it may help alleviate suffering at a critical time for patients and their families. We are inching closer to mitigation of stigma associated with this common illness.
Thinking back across the last 3 decades of my treating women suffering from PPD, I have reflected on what has gotten these patients well. I concluded that successful treatment of PPD is not a “one-stop shop,” but rather typically includes a combination of pharmacologic and nonpharmacologic interventions, along with family and community-based support groups, as well as a culture that reduces stigma and by so doing lessens the toll of this important and too frequently incompletely-treated illness.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. The Center for Women’s Mental Health at MGH was a non-enrolling site for the pivotal phase 3 SKYLARK trial evaluating zuranolone. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected].
Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
Dr. K. Ashley Brandt
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
Dr. K. Ashley Brandt
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.
“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.
The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.
Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.
To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.
Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.
The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).
Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.
The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.
Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.
The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.
“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”
Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”
On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.
Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr
“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.
Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.
The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
Develop more supportive systems
To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.
“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.
Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.
“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.
While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.
“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.
Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.
“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.
She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.
Dr. K. Ashley Brandt
“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said.
The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”
Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.
“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”
The authors and Dr. Brandt had no disclosures to report.
The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention.
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com.
The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention.
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com.
The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention.
The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.
“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.
Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.
“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.
Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context.
“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”
A version of this article was first published on WebMD.com.
FDA approves first over-the-counter birth control pill
Damian McNamara, MA
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
U.S. mammogram update sparks concern, reignites debates
Kerry Dooley Young
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
Marlene Busko
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
FDA approves first over-the-counter birth control pill
Damian McNamara, MA
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
U.S. mammogram update sparks concern, reignites debates
Kerry Dooley Young
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
Marlene Busko
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
FDA approves first over-the-counter birth control pill
Damian McNamara, MA
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
U.S. mammogram update sparks concern, reignites debates
Kerry Dooley Young
A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.
The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.
The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.
The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.
For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.
However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen-ing mammogram.
A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.
Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.
Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.
Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.
The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.
The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.
The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.
‘Artificial pancreas’ for all type 1 diabetes pregnancies?
Marlene Busko
In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.
The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.
Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.
The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.
CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”
The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
Medical education has changed drastically over the years. As theories and practices continue to change, what was once standard 10 or 20 years ago has been replaced with newer ideologies, processes, or technology. It seems likely, then, that you may disagree with some of the things that you learned as medical school has evolved.
This news organization asked physicians what they learned in med school that they now contest. Many of their answers include newer philosophies and practice methods.
Treat appropriately for pain
Jacqui O’Kane, DO, a 2013 med school graduate, was taught to avoid prescribing controlled medications whenever possible.
“Initially this attitude made sense to me,” says Dr. O’Kane, “but as I became an experienced physician – and patient – I saw the harm that such an attitude could cause. Patients on controlled medication long-term were often viewed as drug-seekers and treated as such, even if their regimen was largely regarded as appropriate. Likewise, those who could benefit from short-term controlled prescriptions were sometimes denied them because of their clinician’s fear.”
Today, Dr. O’Kane believes controlled medications should seldom be the first option for patients suffering pain, anxiety, or insomnia. But, she says, “they should remain on the table and without judgment for those who fail first-line treatment or for whom alternatives are contraindicated.”
Amy Baxter, MD, believes that the amount of time spent on pain education in school needs to change.
“Doctors in the U.S. get only 12 hours of pain education, and most of it is on pharmacology,” says Dr. Baxter, who graduated from med school in 1995. “In addition to incorrect information on home opioids and addiction, I was left with the impression that medication could treat chronic pain. I now have a completely different understanding of pain as a whole-brain warning system. The goal shouldn’t be pain-free, just more comfortable.”
Practice lifestyle and preventive medicine
Dolapo Babalola, MD, went to medical school eager to learn how to care for the human body and her family members’ illnesses, such as the debilitating effects of arthritic pain and other chronic diseases.
“I was taught the pathology behind arthritic pain, symptoms, signs, and treatment – that it has a genetic component and is inevitable to avoid – but nothing about how to prevent it,” says Dr. Babalola, a 2000 graduate.
Twenty years later, she discovered lifestyle medicine when she began to experience knee pain.
“I was introduced to the power of health restoration by discovering the root cause of diseases such as inflammation, hormonal imbalance, and insulin resistance due to poor lifestyle choices such as diet, inactivity, stress, inadequate sleep, and substance abuse,” she says.
Adebisi Alli, DO, who graduated in 2011, remembers being taught to treat type 2 diabetes by delaying progression rather than aiming for remission. But today, “lifestyle-led, team-based approaches are steadily becoming a first prescription across medical training with the goal to put diabetes in remission,” she says.
Patient care is at the core of medicine
Tracey O’Connell, MD, recalls her radiology residency in the early to mid-90s, when radiologists were integral to the health care team.
“We interacted with referrers and followed the course of patients’ diseases,” says Dr. O’Connell. “We knew patient histories, their stories. We were connected to other humans, doctors, nurses, teams, and the patients themselves.”
But with the advent of picture archiving and communication systems, high-speed CT and MRI, digital radiography, and voice recognition, the practice of radiology has changed dramatically.
“There’s no time to review or discuss cases anymore,” she says. “Reports went from eloquent and articulate documents with lists of differential diagnoses to short checklists and templates. The whole field of patient care has become dehumanizing, exactly the opposite of what humans need.”
Mache Seibel, MD, who graduated almost 50 years ago, agrees that patient care has lost its focus, to the detriment of patients.
“What I learned in medical school that is forgotten today is how to listen to patients, take a history, and do an examination using my hands and a stethoscope,” says Dr. Seibel. “Today with technology and time constraints, the focus is too much on the symptom without context, ordering a test, and getting the EMR boxes filled out.”
Physician, heal thyself
Priya Radhakrishnan, MD, remembers learning that a physician’s well-being was their responsibility. “We now know that well-being is the health system’s responsibility and that we need to diagnose ourselves and support each other, especially our trainees,” says Dr. Radhakrishna. She graduated in 1992. “Destigmatizing mental health is essential to well-being.”
Rachel Miller, MD, a 2009 med school graduate was taught that learning about health care systems and policy wasn’t necessary. Dr. Miller says they learned that policy knowledge would come in time. “I currently disagree. It is vital to understand aspects of health care systems and policy. Not knowing these things has partly contributed to the pervasiveness of burnout among physicians and other health care providers.”
Practice with gender at the forefront
Janice L. Werbinski, MD, an ob.gyn., and Elizabeth Anne Comen, MD, a breast cancer oncologist, remember when nearly all medical research was performed on the 140-lb White man. Doctors learned to treat patients through that male lens.
“The majority of the anatomy we saw in medical school was on a male figure,” says Dr. Comen, author of “All in Her Head,” a HarperCollins book slated to be released in February 2024. She graduated from med school in 2004. “The only time we saw anatomy for females was in the female reproductive system. That’s changing for the better.”
Dr. Werbinski chose a residency in obstetrics and gynecology in 1975 because she thought it was the only way she could serve female patients.
“I really thought that was the place for women’s health,” says Dr. Werbinski, cochair of the American Medical Women’s Association Sex & Gender Health Coalition.
“I am happy to say that significant awareness has grown since I graduated from medical school. I hope that when this question is asked of current medical students, they will be able to say that they know to practice with a sex- and gender-focused lens.”
Talk about racial disparities
John McHugh, MD, an ob.gyn., recalls learning little about the social determinants of health when he attended med school more than 30 years ago.
“We saw disparities in outcomes based on race and class but assumed that we would overcome them when we were in practice,” says Dr. McHugh, an AMWA Action Coalition for Equity member. “We didn’t understand the root causes of disparities and had never heard of concepts like epigenetics or weathering. I’m hopeful current research will help our understanding and today’s medical students will serve a safer, healthier, and more equitable world.”
Curtiland Deville, MD, an associate professor of radiation oncology, recalls having few conversations around race; racial disparities; and diversity, equity, and inclusion.
“When I went to medical school, it often felt like you weren’t supposed to talk about the differences in race,” says Dr. Deville, who graduated in 2005. But today, in the post-2020 era between COVID, during which health disparities got highlighted, and calls for racial justice taking center stage, Dr. Deville says many of the things they didn’t talk about have come to the forefront in our medical institutions.
Information at your fingertips
For Paru David, MD, a 1996 graduate, the most significant change is the amount of health and medical information available today. “Before, the information that was taught in medical school was obtained through textbooks or within journal articles,” says Dr. David.
“Now, we have databases of information. The key to success is being able to navigate the information available to us, digest it with a keen eye, and then apply it to patient care in a timely manner.”
A version of this article first appeared on Medscape.com.
A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.
How should this patient be managed?
Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6
Making a diagnosis of ICP
The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.
Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.
Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7
For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7
PHOTO: CHAJAMP/SHUTTERSTOCK
Continue to: Risks associated with ICP...
Risks associated with ICP
For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7
In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11
Management of patients with ICP
Laboratory evaluation
There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11
In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.
Antepartum fetal surveillance
Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.
Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.
Medications
While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18
Timing of delivery
The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.
For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19
Postpartum follow-up
Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7
CASE Patient follow-up and outcomes
The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●
References
Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.
How should this patient be managed?
Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6
Making a diagnosis of ICP
The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.
Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.
Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7
For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7
PHOTO: CHAJAMP/SHUTTERSTOCK
Continue to: Risks associated with ICP...
Risks associated with ICP
For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7
In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11
Management of patients with ICP
Laboratory evaluation
There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11
In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.
Antepartum fetal surveillance
Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.
Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.
Medications
While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18
Timing of delivery
The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.
For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19
Postpartum follow-up
Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7
CASE Patient follow-up and outcomes
The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●
CASE Pregnant woman with intense itching
A 28-year-old woman (G1P0) is seen for a routine prenatal visit at 32 3/7 weeks’ gestation. She reports having generalized intense itching, including on her palms and soles, that is most intense at night and has been present for approximately 1 week. Her pregnancy is otherwise uncomplicated to date. Physical exam is within normal limits, with no evidence of a skin rash. Cholestasis of pregnancy is suspected, and laboratory tests are ordered, including bile acids and liver transaminases. Test results show that her aspartate transaminase (AST) and alanine transaminase (ALT) levels are mildly elevated at 55 IU/L and 41 IU/L, respectively, and several days later her bile acid level result is 21 µmol/L.
How should this patient be managed?
Intrahepatic cholestasis of pregnancy (ICP) affects 0.5% to 0.7% of pregnant individuals and results in maternal pruritus and elevated serum bile acid levels.1-3 Pruritus in ICP typically is generalized, including occurrence on the palms of the hands and soles of the feet, and it often is reported to be worse at night.4 Up to 25% of pregnant women will develop pruritus during pregnancy but the majority will not have ICP.2,5 Patients with ICP have no associated rash, but clinicians may note excoriations on exam. ICP typically presents in the third trimester of pregnancy but has been reported to occur earlier in gestation.6
Making a diagnosis of ICP
The presence of maternal pruritus in the absence of a skin condition along with elevated levels of serum bile acids are required for the diagnosis of ICP.7 Thus, a thorough history and physical exam is recommended to rule out another skin condition that could potentially explain the patient’s pruritus.
Some controversy exists regarding the bile acid level cutoff that should be used to make a diagnosis of ICP.8 It has been noted that nonfasting serum bile acid levels in pregnancy are considerably higher than those in in the nonpregnant state, and an upper limit of 18 µmol/L has been proposed as a cutoff in pregnancy.9 However, nonfasting total serum bile acids also have been shown to vary considerably by race, with levels 25.8% higher in Black women compared with those in White women and 24.3% higher in Black women compared with those in south Asian women.9 This raises the question of whether we should be using race-specific bile acid values to make a diagnosis of ICP.
Bile acid levels also vary based on whether a patient is in a fasting or postprandial state.10 Despite this variation, most guidelines do not recommend testing fasting bile acid levels as the postprandial state effect overall is small.7,9,11 The Society for Maternal-Fetal Medicine (SMFM) recommends that if a pregnancy-specific bile acid range is available from the laboratory, then the upper limit of normal for pregnancy should be used when making a diagnosis of ICP.7 The SMFM guidelines also acknowledge, however, that pregnancy-specific values rarely are available, and in this case, levels above the upper limit of normal—often 10 µmol/L should be considered diagnostic for ICP until further evidence regarding optimal bile acid cutoff levels in pregnancy becomes available.7
For patients with suspected ICP, liver transaminase levels should be measured in addition to nonfasting serum bile acid levels.7 A thorough history should include assessment for additional symptoms of liver disease, such as changes in weight, appetite, jaundice, excessive fatigue, malaise, and abdominal pain.7 Elevated transaminases levels may be associated with ICP, but they are not necessary for diagnosis. In the absence of additional clinical symptoms that suggest underlying liver disease or severe early onset ICP, additional evaluation beyond nonfasting serum bile acids and liver transaminase levels, such as liver ultrasonography or evaluation for viral or autoimmune hepatitis, is not recommended.7 Obstetric care clinicians should be aware that there is an increased incidence of preeclampsia among patients with ICP, although no specific guidance regarding further recommendations for screening is provided.7
PHOTO: CHAJAMP/SHUTTERSTOCK
Continue to: Risks associated with ICP...
Risks associated with ICP
For both patients and clinicians, the greatest concern among patients with ICP is the increased risk of stillbirth. Stillbirth risk in ICP appears to be related to serum bile acid levels and has been reported to be highest in patients with bile acid levels greater than 100 µmol/L. A systematic review and meta-analysis of ICP studies demonstrated no increased risk of stillbirth among patients with bile acid levels less than 100 µmol/L.12 These results, however, must be interpreted with extreme caution as the majority of studies included patients with ICP who were actively managed with attempts to mitigate the risk of stillbirth.7
In the absence of additional pregnancy risk factors, the risk of stillbirth among patients with ICP and serum bile acid levels between 19 and 39 µmol/L does not appear to be elevated above their baseline risk.11 The same is true for pregnant individuals with ICP and no additional pregnancy risk factors with serum bile acid levels between 40 and 99 µmol/L until approximately 38 weeks’ gestation, when the risk of stillbirth is elevated.11 The risk of stillbirth is elevated in ICP with peak bile acid levels greater than 100 µmol/L, with an absolute risk of 3.44%.11
Management of patients with ICP
Laboratory evaluation
There is no consensus on the need for repeat testing of bile acid levels in patients with ICP. SMFM advises that follow-up testing of bile acid levels may help to guide delivery timing, especially in cases of severe ICP, but the society recommends against serial testing.7 By contrast, the Royal College of Obstetricians and Gynaecologists (RCOG) provides a detailed algorithm regarding time intervals between serum bile acid level testing to guide delivery timing.11 The TABLE lists the strategy for reassessment of serum bile acid levels in ICP as recommended by the RCOG.11
In the United States, bile acid testing traditionally takes several days as the testing is commonly performed at reference laboratories. We therefore suggest that clinicians consider repeating bile acid level testing in situations in which the timing of delivery may be altered if further elevations of bile acid levels were noted. This is particularly relevant for patients diagnosed with ICP early in the third trimester when repeat bile acid levels would still allow for an adjustment in delivery timing.
Antepartum fetal surveillance
Unfortunately, antepartum fetal testing for pregnant patients with ICP does not appear to reliably predict or prevent stillbirth as several studies have reported stillbirths within days of normal fetal testing.13-16 It is therefore important to counsel pregnant patients regarding monitoring of fetal movements and advise them to present for evaluation if concerns arise.
Currently, SMFM recommends that patients with ICP should begin antenatal fetal surveillance at a gestational age when abnormal fetal testing would result in delivery.7 Patients should be counseled, however, regarding the unpredictability of stillbirth with ICP in the setting of a low absolute risk of such.
Medications
While SMFM recommends a starting dose of ursodeoxycholic acid 10 to 15 mg/kg per day divided into 2 or 3 daily doses as first-line therapy for the treatment of maternal symptoms of ICP, it is important to acknowledge that the goal of treatment is to alleviate maternal symptoms as there is no evidence that ursodeoxycholic acid improves either maternal serum bile acid levels or perinatal outcomes.7,17,18 Since publication of the guidelines, ursodeoxycholic acid’s lack of benefit has been further confirmed in a meta-analysis, and thus discontinuation is not unreasonable in the absence of any improvement in maternal symptoms.18
Timing of delivery
The optimal management of ICP remains unknown. SMFM recommends delivery based on peak serum bile acid levels. Delivery is recommended at 36 weeks’ gestation with ICP and total bile acid levels greater than 100 µmol/L as these patients have the greatest risk of stillbirth.7 For patients with ICP and bile acid levels less than 100 µmol/L, delivery is recommended between 36 0/7 and 39 0/7 weeks’ gestation.7 This is a wide gestational age window for clinicians to consider timing of delivery, and certainly the risks of stillbirth should be carefully balanced with the morbidity associated with a preterm or early term delivery.
For patients with ICP who have bile acid levels greater than 40 µmol/L, it is reasonable to consider delivery earlier in the gestational age window, given an evidence of increased risk of stillbirth after 38 weeks.7,12 For patients with ICP who have bile acid levels less than 40 µmol/L, delivery closer to 39 weeks’ gestation is recommended, as the risk of stillbirth does not appear to be increased above the baseline risk.7,12 Clinicians should be aware that the presence of concomitant morbidities, such as preeclampsia and gestational diabetes, are associated with an increased risk of stillbirth and should be considered for delivery planning.19
Postpartum follow-up
Routine laboratory evaluation following delivery is not recommended.7 However, in the presence of persistent pruritus or other signs and symptoms of hepatobiliary disease, liver function tests should be repeated with referral to hepatology if results are persistently abnormal 4 to 6 weeks postpartum.7
CASE Patient follow-up and outcomes
The patient was counseled regarding the diagnosis of ICP. Following shared decision making, the patient opted to undergo twice weekly nonstress tests but was aware to carefully monitor fetal movements due to the unpredictability of stillbirth in ICP. The patient also opted to trial ursodeoxycholic acid for relief of maternal symptoms. Two weeks after her initial diagnosis, repeat total bile acid levels were stable at 22 µmol/L. Therefore, following extensive counseling, the patient opted to undergo induction of labor at 38 weeks’ gestation, with a normal outcome for mother and neonate. ●
References
Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
References
Abedin P, Weaver JB, Egginton E. Intrahepatic cholestasis of pregnancy: prevalence and ethnic distribution. Ethn Health. 1999;4:35-37.
Kenyon AP, Tribe RM, Nelson-Piercy C, et al. Pruritus in pregnancy: a study of anatomical distribution and prevalence in relation to the development of obstetric cholestasis. Obstet Med. 2010;3:25-29.
Wikstrom Shemer E, Marschall HU, Ludvigsson JF, et al. Intrahepatic cholestasis of pregnancy and associated adverse pregnancy and fetal outcomes: a 12-year population-based cohort study. BJOG. 2013;120:717-723.
Ambros-Rudolph CM, Glatz M, Trauner M, et al. The importance of serum bile acid level analysis and treatment with ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a case series from central Europe. Arch Dermatol. 2007;143:757-762.
Szczech J, Wiatrowski A, Hirnle L, et al. Prevalence and relevance of pruritus in pregnancy. Biomed Res Int. 2017;2017:4238139.
Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;15:2049-2066.
Society for Maternal-Fetal Medicine; Lee RH, Greenberg M, Metz TD, et al. Society for Maternal-Fetal Medicine Consult Series #53: intrahepatic cholestasis of pregnancy: replaces Consult #13, April 2011. Am J Obstet Gynecol. 2021;224:B2-B9.
Horgan R, Bitas C, Abuhamad A. Intrahepatic cholestasis of pregnancy: a comparison of Society for Maternal-Fetal Medicine and the Royal College of Obstetricians and Gynaecologists’ guidelines. Am J Obstet Gynecol MFM. 2023;5:100838.
Mitchell AL, Ovadia C, Syngelaki A, et al. Re-evaluating diagnostic thresholds for intrahepatic cholestasis of pregnancy: case-control and cohort study. BJOG. 2021;128:1635-1644.
Adams A, Jacobs K, Vogel RI, et al. Bile acid determination after standardized glucose load in pregnant women. AJP Rep. 2015;5:e168-e171.
Girling J, Knight CL, Chappell L; Royal College of Obstetricians and Gynaecologists. Intrahepatic cholestasis of pregnancy: Green-top guideline no. 43, June 2022. BJOG. 2022;129:e95-e114.
Ovadia C, Seed PT, Sklavounos A, et al. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses. Lancet. 2019;393:899-909.
Alsulyman OM, Ouzounian JG, Ames-Castro M, et al. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175:957-960.
Herrera CA, Manuck TA, Stoddard GJ, et al. Perinatal outcomes associated with intrahepatic cholestasis of pregnancy. J Matern Fetal Neonatal Med. 2018;31:1913-1920.
Lee RH, Incerpi MH, Miller DA, et al. Sudden fetal death in intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2009;113:528-531.
Sentilhes L, Verspyck E, Pia P, et al. Fetal death in a patient with intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2006;107:458-460.
Chappell LC, Bell JL, Smith A, et al; PITCHES Study Group. Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial. Lancet. 2019;394:849-860.
Ovadia C, Sajous J, Seed PT, et al. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis. Lancet Gastroenterol Hepatol. 2021;6:547-558.
Geenes V, Chappell LC, Seed PT, et al. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study. Hepatology. 2014;59:1482-1491.
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
More than 3 years into the COVID-19 era, most Americans have settled back into their prepandemic lifestyles. But a new dominant variant and rising hospitalization numbers may give way to another summer surge.
Since April, a new COVID variant has cropped up. According to recent Centers for Disease Control and Prevention data, EG.5 – from the Omicron family – now makes up 17% of all cases in the United States, up from 7.5% in the first week of July.
A summary from the Center for Infectious Disease Research and Policy at the University of Minnesota says that EG.5, nicknamed “Eris” by health trackers, is nearly the same as its parent strain, XBB.1.9.2, but has one extra spike mutation.
Along with the news of EG.5’s growing prevalence, COVID-related hospitalization rates have increased by 12.5% during the week ending on July 29 – the most significant uptick since December. Still, no connection has been made between the new variant and rising hospital admissions. And so far, experts have found no difference in the severity of illness or symptoms between Eris and the strains that came before it.
Cause for concern?
The COVID virus has a great tendency to mutate, said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University, Nashville, Tenn.
“Fortunately, these are relatively minor mutations.” Even so, SARS-CoV-2, the virus that causes COVID-19, continues to be highly contagious. “There isn’t any doubt that it’s spreading – but it’s not more serious.”
So, Dr. Schaffner doesn’t think it’s time to panic. He prefers calling it an “uptick” in cases instead of a “surge,” because a surge “sounds too big.”
While the numbers are still low, compared with 2022’s summer surge, experts still urge people to stay aware of changes in the virus. “I do not think that there is any cause for alarm,” agreed Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital, New York.
So why the higher number of cases? “There has been an increase in COVID cases this summer, probably related to travel, socializing, and dwindling masking,” said Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford (Calif.) University. Even so, “because of an existing level of immunity from vaccination and prior infections, it has been limited and case severity has been lower than in prior surges.”
What the official numbers say
The CDC no longer updates its COVID Data Tracker Weekly Review. They stopped in May 2023 when the federal public health emergency ended.
But the agency continues to track COVID-19 cases, hospitalizations, ED visits, and deaths in different ways. The key takeaways include 9,056 new hospitalizations reported for the week ending July 29, 2023. That is relatively low, compared with July 30, 2022, when the weekly new hospitalization numbers topped 44,000.
“Last year, we saw a summer wave with cases peaking around mid-July. In that sense, our summer wave is coming a bit later than last year,” said Pavitra Roychoudhury, PhD, an assistant professor and researcher in the vaccine and infectious disease division at the University of Washington, Seattle.
“It’s unclear how high the peak will be during this current wave. Levels of SARS-CoV-2 in wastewater, as well as the number of hospitalizations, are currently lower than this time last year.”
For part of the pandemic, the CDC recommended people monitor COVID numbers in their own communities. But the agency’s local guidance on COVID is tied to hospital admission levels, which are currently low for more than 99% of the country, even if they are increasing.
So, while it’s good news that hospitalization numbers are smaller, it means the agency’s ability to identify local outbreaks or hot spots of SARS-CoV-2 is now more limited.
It’s not just an uptick in hospitalizations nationwide, as other COVID-19 indicators, including ED visits, positive tests, and wastewater levels, are increasing across the United States.
In terms of other metrics:
On June 19, 0.47% of ED visits resulted in a positive COVID diagnosis. On Aug. 4, that rate had more than doubled to 1.1%.
On July 29, 8.9% of people who took a COVID test reported a positive result. The positivity rate has been increasing since June 10, when 4.1% of tests came back positive. This figure only includes test results reported to the CDC. Results of home testing remain largely unknown.
The weekly percentage of deaths related to COVID-19 was 1% as of July 29. That’s low, compared with previous rates. For example, for the week ending July 30, 2022, it was 5.8%.
What about new COVID vaccines?
As long as the general public continue to make informed decisions and get the new Omicron vaccine or booster once it’s available, experts predict lower hospitalization rates this winter.
“Everyone should get the Omicron booster when it becomes available,” recommended Dean Winslow, MD, a professor of medicine at Stanford University.
In the meantime, “it is important to emphasize that COVID-19 is going to be with us for the foreseeable future,” he said. Since the symptoms linked to these newer Omicron subvariants are generally milder than with earlier variants, “if one has even mild cold symptoms, it is a good idea to test yourself for COVID-19 and start treatment early if one is elderly or otherwise at high risk for severe disease.”
Dr. Schaffner remains optimistic for now. “We anticipate that the vaccines we currently have available, and certainly the vaccine that is being developed for this fall, will continue to prevent severe disease associated with this virus.”
Although it’s difficult to predict an exact time line, Dr. Schaffner said they could be available by the end of September.
His predictions assume “that we don’t have a new nasty variant that crops up somewhere in the world,” he said. “[If] things continue to move the way they have been, we anticipate that this vaccine ... will be really effective and help us keep out of the hospital during this winter, when we expect more of an increase of COVID once again.”
Asked for his outlook on vaccine recommendations, Dr. Camins was less certain. “It is too soon to tell.” Guidance on COVID shots will be based on results of ongoing studies. “It would be prudent, however, for everyone to plan on getting the flu shot in September.”
Stay alert and stay realistic
Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far and the uptick in new cases and hospitalizations are relatively small, compared with past scenarios, “it makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Dr. Liu said.
“It’s just advisable for everyone – especially those who are at higher risk for hospitalization or death – to be aware,” Dr. Camins said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
While respiratory virus work best at keeping people with the flu, COVID, or RSV out of the hospital, they’re not as good at preventing milder infections. Dr. Schaffner said: “If we don’t expect perfection, we won’t be so disappointed.”
A version of this article first appeared on WebMD.com.
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.
EXPERT COMMENTARY
Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.1
PHOTO: KLAVDIYAV/SHUTTERSTOCK
Details of the study
The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.1 This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.
Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.2
The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.3
The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.
The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.
Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.
Results.At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.
The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.
The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.
Study strengths and limitations
A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.
A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.
Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●
Acknowledgement
The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
In this well-designed, randomized controlled trial by Yeung and colleagues, multivitamin/mineral supplementation improved performance on a test of immediate episodic memory at 1, 2, and 3 years compared with placebo. Given the simplicity and safety of this intervention, even with a small effect size, it makes sense to advise older patients that daily multivitamin use provides micronutrients and vitamins that may be absent in the diet or poorly absorbed by older adults. Whether this highly specific improvement in a test of hippocampal function translates into overall cognitive performance with aging remains a question.
BARBARA LEVY, MD
References
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273282. doi:10.1016/j.ajcnut.2023.05.011.
Baker LD, Manson JE, Rapp SR, et al. Effects of cocoa extract and a multivitamin on cognitive function: a randomized clinical trial. Alzheimers Dement. 2023;19:1308-1319. doi:10.1002/alz.12767.
Brickman AM, Yeung LK, Alshuler DM, et al. Dietary flavanols restore hippocampal-dependent memory in older adults with lower diet quality and lower habitual flavanol consumption. Proc Natl Acad Sci USA. 2023:120:e2216932120. doi:10.1073/ pnas.2216932120.
Barbara Levy, MD, is Clinical Professor of Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences, Washington, DC, and Voluntary Clinical Professor of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego School of Medicine. She serves on the OBG Management Board of Editors.
The author reports no financial relationships relevant to this article.
Barbara Levy, MD, is Clinical Professor of Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences, Washington, DC, and Voluntary Clinical Professor of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego School of Medicine. She serves on the OBG Management Board of Editors.
The author reports no financial relationships relevant to this article.
Author and Disclosure Information
Barbara Levy, MD, is Clinical Professor of Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences, Washington, DC, and Voluntary Clinical Professor of Obstetrics, Gynecology and Reproductive Sciences, UC San Diego School of Medicine. She serves on the OBG Management Board of Editors.
The author reports no financial relationships relevant to this article.
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.
EXPERT COMMENTARY
Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.1
PHOTO: KLAVDIYAV/SHUTTERSTOCK
Details of the study
The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.1 This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.
Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.2
The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.3
The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.
The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.
Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.
Results.At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.
The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.
The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.
Study strengths and limitations
A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.
A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.
Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●
Acknowledgement
The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
In this well-designed, randomized controlled trial by Yeung and colleagues, multivitamin/mineral supplementation improved performance on a test of immediate episodic memory at 1, 2, and 3 years compared with placebo. Given the simplicity and safety of this intervention, even with a small effect size, it makes sense to advise older patients that daily multivitamin use provides micronutrients and vitamins that may be absent in the diet or poorly absorbed by older adults. Whether this highly specific improvement in a test of hippocampal function translates into overall cognitive performance with aging remains a question.
BARBARA LEVY, MD
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273-282. doi:10.1016/j.ajcnut.2023.05.011.
EXPERT COMMENTARY
Preservation of function, both physical and cognitive, is key to long-term health and well-being. Age-related loss of function drives millions of people to spend an enormous amount of money each year on unregulated therapies—vitamins, supplements, infusions, hormones, and “natural” products—all toward the promise of improvement or preservation of physical strength, sexual function, and maintenance of lean body mass and cognitive abilities. Yeung and colleagues set out to determine whether the daily use of a multivitamin/mineral supplement (Centrum Silver) would impact memory in older adults.1
PHOTO: KLAVDIYAV/SHUTTERSTOCK
Details of the study
The COSMOS-Web study was designed to test the authors’ primary hypothesis that daily dietary flavanols would improve memory over 1 year.1 This study was embedded within the larger COSMOS (COcoa Supplement and Multivitamin Outcomes Study) trial, in which 21,442 people were recruited to assess the impact of flavanols and multivitamin supplements on cardiovascular and cancer outcomes.
Results of another ancillary study, the COSMOS-Mind trial (n = 2,262, average age 73, 60% female), reported no improvement with flavanols compared with placebo on a battery of tests of cognitive function administered by phone. In COSMOS-Mind, however, it was concluded that a daily multivitamin/mineral supplement improved the composite score of cognitive tests compared with placebo, particularly in participants with a history of cardiovascular disease.2
The COSMOS-Web trial recruited an additional cohort within the larger COSMOS trial from 2016–2017 (n = 3,562, average age 71, 67% female) to participate in this study specifically geared to assess memory, using the web-based ModRey test (a test of memory validated for use in a nonimpaired population). To qualify for enrollment, participants had to have access to an internet-connected computer. They were randomly assigned in a 2 x 2 study design to receive a daily multivitamin supplement or placebo; each of these cohorts was further divided into a flavanol supplementation or a placebo group. Analysis of the data showed no association between flavanol use and performance on any of the measures of memory or cognitive function.3
The COSMOS-Web trial assessed episodic recall, a function of hippocampus-mediated cognition that is particularly vulnerable to the effects of aging as demonstrated previously by neuroimaging and neuropsychological studies. The authors deployed a battery of 3 tests via a web platform for patients to complete online and independently.
The prespecified primary outcome was performance on episodic recall as measured by the ModRey test after 1 year of supplementation with multivitamins versus placebo. The ModRey test presents a series of 20 words at 3-second intervals to participants. At the conclusion of the last word, participants were asked to recall as many words as they could; after completing the 2 additional tasks, participants were asked again to recall the words. A secondary outcome of this test is the ratio of delayed to immediate recall.
Two additional tests were administered to assess cognitive performance related to different brain regions, the ModBent test (assessing novel object recognition) and the Flanker task (a measure of executive function). There was a placebo run-in phase during which participants’ adherence to daily supplement intake was ascertained. Participants were excluded if they demonstrated less than 75% adherence to study pills during the run-in placebo phase. The cognitive tasks were presented at study initiation and at yearly intervals for 3 years. The authors chose to use the results at 1 year as their primary outcome to assess the impact of supplementation during the period when adherence would be highest.
Results.At baseline, the placebo cohort recalled 7.2 words of 20 compared with 7.1 in the supplement group. In both groups there was a practice effect, with improvement in scores in the placebo group to 7.65 words and in the multivitamin group to 7.81 words. The improvement from baseline was statistically significantly better (0.71 words) in the multivitamin cohort than in the placebo group (0.45 words). There was no improvement in either group in the ModRey memory retention test (ability to recall the words after 15 minutes) or in the ModBent or Flanker tests. At 3 years of treatment, the placebo group improved by 0.92 words (SD, 3.22) whereas the multivitamin group improved by 1.13 words (SD, 3.39). These changes remained statistically significant.
The group with cardiovascular disease had lower baseline performance on the ModRey test. With supplementation, however, the improvement in this cohort was significantly greater than in those without cardiovascular disease at 1 year. The authors acknowledged that the changes were small and may not have been noticeable to the individuals, but they argued that even small changes as demonstrated in this study can have large health benefits at a population level.
The results of the COSMOS-Web trial corroborate the findings of the COSMOS-Mind study with respect to the benefits of multivitamin/mineral supplementation on cognitive test performance, particularly in a population with preexisting cardiovascular disease. The tests used across the 2 studies were different, which lends greater reliability to the findings.
Study strengths and limitations
A major strength of this study is its careful, rigorous design as a double-blind, placebo-controlled trial in a large patient population. Great care was devoted to ensuring study medication adherence. Another strength is that the cognitive tests chosen for the COSMOS-Web trial have been validated in cognitively normal populations, not those already impaired.
A limitation, however, is in the demographics of the study. The patient population was overwhelmingly White (93%), 67% were female, and they were well educated (94.8% having completed some college or beyond). Their baseline health was good; only 4.7% had a history of cardiovascular disease. Although generalizability of the study results from this population may be concerning,relative benefits of supplementation in this healthy, generally well-nourished and educated group may be lower than might be expected in a more nutritionally and educationally challenged population.
Finally, the difference between the placebo and active supplementation groups was small. Whether this less-than-1-word difference in immediate memory recall is noticeable by a patient is questionable. Both groups improved in their test performance over time—a consequence of serial cognitive tests of any kind. Although the authors calculated that the difference in recall translates to a 3-year reduction in age-related memory decline, it is hard to reconcile that with the fact that both groups actually improved over the 3 years of the study. ●
Acknowledgement
The author would like to thank JoAnn Manson, MD, DrPH, NCMP, for her assistance in evaluating the study.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
In this well-designed, randomized controlled trial by Yeung and colleagues, multivitamin/mineral supplementation improved performance on a test of immediate episodic memory at 1, 2, and 3 years compared with placebo. Given the simplicity and safety of this intervention, even with a small effect size, it makes sense to advise older patients that daily multivitamin use provides micronutrients and vitamins that may be absent in the diet or poorly absorbed by older adults. Whether this highly specific improvement in a test of hippocampal function translates into overall cognitive performance with aging remains a question.
BARBARA LEVY, MD
References
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273282. doi:10.1016/j.ajcnut.2023.05.011.
Baker LD, Manson JE, Rapp SR, et al. Effects of cocoa extract and a multivitamin on cognitive function: a randomized clinical trial. Alzheimers Dement. 2023;19:1308-1319. doi:10.1002/alz.12767.
Brickman AM, Yeung LK, Alshuler DM, et al. Dietary flavanols restore hippocampal-dependent memory in older adults with lower diet quality and lower habitual flavanol consumption. Proc Natl Acad Sci USA. 2023:120:e2216932120. doi:10.1073/ pnas.2216932120.
References
Yeung LK, Alschuler DM, Wall M, et al. Multivitamin supplementation improves memory in older adults: a randomized clinical trial. Am J Clin Nutrition. 2023;118:273282. doi:10.1016/j.ajcnut.2023.05.011.
Baker LD, Manson JE, Rapp SR, et al. Effects of cocoa extract and a multivitamin on cognitive function: a randomized clinical trial. Alzheimers Dement. 2023;19:1308-1319. doi:10.1002/alz.12767.
Brickman AM, Yeung LK, Alshuler DM, et al. Dietary flavanols restore hippocampal-dependent memory in older adults with lower diet quality and lower habitual flavanol consumption. Proc Natl Acad Sci USA. 2023:120:e2216932120. doi:10.1073/ pnas.2216932120.
Higher daily step counts were associated with reduced risk of all-cause mortality and cardiovascular (CV) mortality, with benefit beginning with any amount over about 4,000 and 2,300 steps, respectively, in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
Leonardo Patrizi/E+/Getty Images
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
Higher daily step counts were associated with reduced risk of all-cause mortality and cardiovascular (CV) mortality, with benefit beginning with any amount over about 4,000 and 2,300 steps, respectively, in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
Leonardo Patrizi/E+/Getty Images
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
Higher daily step counts were associated with reduced risk of all-cause mortality and cardiovascular (CV) mortality, with benefit beginning with any amount over about 4,000 and 2,300 steps, respectively, in a new meta-analysis.
More steps were better – additional benefit was seen with increasing increments of 500 or 1,000 steps.
Leonardo Patrizi/E+/Getty Images
“One of our main aims was to overcome all the inconsistencies in previous studies, where the optimal number of daily steps for health benefits was usually between 6,000 and 10,000,” Maciej Banach, MD, PhD, of the Medical University of Lodz (Poland), said in an interview.
“As a preventive cardiologist, I saw that many of my patients were discouraged and said it’s impossible when I told them that making lifestyle changes included taking at least 7,000 daily steps,” he said.
“But our study in relatively healthy individuals, not patients, showed even a lower number – for example, around 4,000 – may be associated with a significant reduction of mortality.
“I tell people to start early, be regular, and don’t worry about the initial baseline number, because it’s important to start and it’s important to improve,” he said. “Our study showed that if we increase the number of steps per day, every 500- to 1,000-step increase might still be associated with an additional mortality reduction of 7%-15%.”
The study was published online in the European Journal of Preventive Cardiology.
Every move counts
The investigators searched the literature through June 2022 and selected 17 cohort studies with 226,889 participants and a median follow-up of 7.1 years for inclusion in the analysis: 10 studies reported all-cause mortality, 4 reported CV mortality, and 3 reported both outcomes.
The mean age of the participants was 64.4 years, and half were women. Daily step counts in the included studies were objectively measured for at least 7 consecutive days.
As noted, a 1,000-step increment was associated with a 15% decrease in risk of all-cause mortality (hazard ratio, 0.85); a 500-step increment was associated with a 7% decrease in CV mortality (HR, 0.93).
Compared with the reference quartile (median steps/day, 3,967), quartile 1 (median steps, 5,537) was associated with a 48% lower risk of all-cause mortality; quartile 2 (median steps, 7,370), with a 55% lower risk; and quartile 3 (median steps, 11,529), with a 67% risk reduction.
Similarly, compared with the lowest quartile of steps per day used as reference (median steps, 2,337), higher quartiles of steps per day (Q1, 3,982; Q2, 6,661; and Q3, 10,413) were linearly associated with a reduced risk of CV mortality (16%, 49%, and 77%, respectively).
In a restricted cubic splines model, a nonlinear dose-response association was observed between step count and all-cause and CV mortality, with a progressively lower risk of mortality with an increase in step count.
Dose-response curves were similar for men and women. However, there was a difference by age: Among people aged 60 years or older, the size of the risk reduction was smaller. Among the older adults, there was a 42% risk reduction for those who walked between 6000 and 10,000 steps daily, compared with a 49% reduction in risk among younger adults who walked between 7,000 and 13,000 steps a day.
For both groups, daily step counts higher than 5,000 resulted in a “dramatically” lower risk of all-cause mortality.
An analysis that compared the impact of climate regions on the associations showed no significant effect on all-cause mortality. People in all climate zones benefited when the daily step count exceeded approximately 5,500.
Even given the encouraging study results, “we know very well that every kind of exercise is critically important,” Dr. Banach said. It is easier to focus on step counts because the counts can be monitored and calculated with smartwatches, pedometers, and other tools. That also makes it easier to check associations and outcomes for large groups of patients.
“But in fact, we should not be focusing on one type of exercise, such as walking or running,” he said. “We can dance, ride bicycles, and do many other different exercises that mobilize our hearts.
“We also know that in all these activities, including steps, people have different capabilities – for example, some can walk more slowly, others faster and with more intensity.”
Dr. Banach recommended following the European and U.S. physical activity guidelines that advise, in addition to muscle-strengthening activities, 150 minutes of moderate-intensity aerobic training weekly, or 75 minutes of vigorous-intensity aerobic activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity.
From the results he sees in patients, he believes the combination approach is probably best for the heart.
Furthermore, it’s important to exercise regularly, something that’s easier if individuals enjoy what they’re doing. “The type of training or whether you are completely inactive or very active at the start doesn’t matter, because any improvement, any addition to the to the baseline values will have health benefits,” he concluded.
Higher goals helpful
Three experts commented on the study; all noted that the results are in line with previous studies, that the observational nature of the study is a limitation, and that additional randomized, controlled trials are needed to confirm the findings.
Evan Brittain, MD, an associate professor of medicine at Vanderbilt University Medical Center, Nashville, Tenn., expressed some additional concerns.
Dr. Brittain was principal investigator of a recent study that found that the relationship between steps per day and incident disease was inverse and linear for obesity, sleep apnea, gastroesophageal reflux disease, and major depressive disorder. Daily step counts above 8,200 were associated with protection from incident disease.
He noted that, in the current study, “the authors chose to make the least active quartile (25%) the reference group (only 3,967 steps/day for all-cause mortality and only 2,337 steps/day for CV mortality analysis), which somewhat lowers the bar for finding a significant benefit at higher step counts.
“Moreover, in the spline analyses, zero steps per day is used as the comparison, which is not a practical, real-world comparison,” he said. “As a result, those data are very hard to interpret, and I think are overstated.”
Like Dr. Banach, Dr. Brittain said he would continue to advise following guideline recommendations to get 150 minutes per week of moderate-intensity activity. However, he added that although it is reasonable to advise patients that benefits do accrue with daily step counts of less than 10,000, “I would not want patients to misconstrue from this study that getting more than only 2,330 steps per day is a beneficial goal.”
Martin Halle, MD, a professor in the department of prevention and sports medicine at the Technical University of Munich (Germany), said: “From a clinical, medical, and health perspective, the general population should aim for 5,000 steps, which is about 3-4 kilometers [about 2 miles] of walking, and intensity counts – the faster you walk, the better.
“I recommend doing 100 steps fast and 100 steps slow and then 100 steps fast and 100 steps slow,” said Dr. Halle, who is past president of the European Association of Preventive Cardiology. This approach not only motivates people, “but they improve their exercise capacity substantially and very quickly, just within weeks.”
European Society of Cardiology vice president and European Journal of Preventive Cardiology editor-in-chief Massimo Piepoli, MD, PhD, agreed that “little is better than nothing and more is even better. This applies to healthy subjects, as well as patients with chronic diseases.
“Five hundred steps is a very short distance (such as walking two blocks or walking the dog for about 10-15 minutes every day),” he said. Yet, increasing step counts in increments of 500 “is associated with a significant reduction in cardiovascular mortality both in men and women, particularly in older individuals.
“We do not need to depend on expensive gym facilities,” he added. “But at the same time, we need to live in and to promote the building of neighborhoods where it is possible to walk in a safe and healthy environment.”
The research received no external funding. Dr. Banach has reported financial relationships with Amgen, Daiichi Sankyo, Esperion, Freia Pharmaceuticals, Kogen, KRKA, Polpharma, NewAmsterdam, Novartis, Novo Nordisk, Polfarmex, Sanofi Aventis, Teva, Valeant, Viatris, and Zentiva, and is chief marketing and development officer at Longevity Group and chief marketing officer at Nomi Biotech.
A version of this article first appeared on Medscape.com.
Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
Use current health and desire for pregnancy to guide contraception discussions in primary care, according to authors of an updated report.
In an installment of the American College of Physicians’ In the Clinic series, Rachel Cannon, MD, Kelly Treder, MD, and Elisabeth J. Woodhams, MD, all of Boston Medical Center, presented an article on the complex topic of contraception for patients with chronic illness.
“Many patients with chronic illness or complex medical issues interact with a primary care provider on a frequent basis, which provides a great access point for contraceptive counseling with a provider they trust and know,” said Dr. Cannon and Dr. Treder in a joint interview. “We wanted to create a ‘go to’ resource for primary care physicians to review contraceptive options and counseling best practices for all of their patients. Contraceptive care is part of overall health care and should be included in the primary care encounter.”
The authors discussed the types of contraception, as well as risks and benefits, and offered guidance for choosing a contraceptive method for medically complex patients.
“In recent years, there has been a shift in contraceptive counseling toward shared decision-making, a counseling strategy that honors the patient as the expert in their body and their life experiences and emphasizes their autonomy and values,” the authors said. “For providers, this translates to understanding that contraceptive efficacy is not the only important characteristic to patients, and that many other important factors contribute to an individual’s decision to use a particular method or not use birth control at all,” they said.
Start the conversation
Start by assessing a patient’s interest in and readiness for pregnancy, if applicable, the authors said. One example of a screen, the PATH questionnaire (Parent/Pregnancy Attitudes, Timing, and How important), is designed for patients in any demographic, and includes questions about the timing and desire for pregnancy and feelings about birth control, as well as options for patients to express uncertainty or ambivalence about pregnancy and contraception.
Some patients may derive benefits from hormonal contraceptives beyond pregnancy prevention, the authors wrote. Combined hormonal contraceptives (CHCs) may improve menorrhagia, and data suggest that CHC use also may reduce risk for some cancer types, including endometrial and ovarian cancers, they said.
Overall, contraceptive counseling should include discussions of safety, efficacy, and the patient’s lived experience.
Clinical considerations and contraindications
Medically complex patients who desire contraception may consider hormonal or nonhormonal methods based on their preferences and medical conditions, but clinicians need to consider comorbidities and contraindications, the authors wrote.
When a woman of childbearing age with any complex medical issue starts a new medication or receives a new diagnosis, contraception and pregnancy planning should be part of the discussion, the authors said. Safe and successful pregnancies are possible for women with complex medical issues when underlying health concerns are identified and addressed in advance, they added. Alternatively, for patients seeking to avoid pregnancy permanently, options for sterilization can be part of an informed discussion.
The Centers for Disease Control and Prevention’s Medical Eligibility Criteria for Contraceptive Use offers clinicians detailed information about the risks of both contraceptives and pregnancy for patients with various medical conditions, according to the authors.
The CDC document lists medical conditions associated with an increased risk for adverse health events if the individual becomes pregnant. These conditions include breast cancer, complicated valvular heart disease, cystic fibrosis, diabetes, endometrial or ovarian cancer, epilepsy, hypertension, bariatric surgery within 2 years of the pregnancy, HIV, ischemic heart disease, severe cirrhosis, stroke, lupus, solid organ transplant within 2 years of the pregnancy, and tuberculosis. Women with these and other conditions associated with increased risk of adverse events if pregnancy occurs should be advised of the high failure rate of barrier and behavior-based contraceptive methods, and informed about options for long-acting contraceptives, according to the CDC.
Risks, benefits, and balance
“It is important to remember that the alternative to contraception for many patients is pregnancy – for many patients with complex medical conditions, pregnancy is far more dangerous than any contraceptive method,” Dr. Cannon and Dr. Treder said in an interview. “This is important to consider when thinking about relative contraindications to a certain method or when thinking about ‘less effective’ contraception methods. The most effective method is a method the patient will actually continue to use,” they said.
The recent approval of the over-the-counter minipill is “a huge win for reproductive health care,” said Dr. Cannon and Dr. Treder. The minipill has very few contraindications, and it is the most effective over-the-counter contraceptive now available, they said.
“An over-the-counter contraceptive pill can increase access to contraception without having to see a physician in the clinic, freeing patients from many of the challenges of navigating the health care system,” the authors added.
As for additional research, the establishment of a long-term safety record may help support other OTC contraceptive methods in the future, the authors said.
Contraceptive counseling is everyone’s specialty
In an accompanying editorial, Amy A. Sarma, MD, a cardiologist at Massachusetts General Hospital, Boston, shared an example of the importance of contraceptive discussions with medically complex patients outside of an ob.gyn. setting. A young woman with a family history of myocardial infarction had neglected her own primary care until an MI of her own sent her to the hospital. While hospitalized, the patient was diagnosed with diabetes, hypertension, and hyperlipidemia.
“Her cardiology care team made every effort to optimize her cardiac care, but no one considered that she was also a woman of childbearing potential despite the teratogenic potential of several of her prescribed medications,” Dr. Sarma wrote. When the patient visited Dr. Sarma to discuss prevention of future MIs, Dr. Sarma took the opportunity to discuss the cardiovascular risks of pregnancy and the risks for this patient not only because of her recent MI, but also because of her chronic health conditions.
As it happened, the woman did not want a high-risk pregnancy and was interested in contraceptive methods. Dr. Sarma pointed out that, had the woman been engaged in routine primary care, these issues would have arisen in that setting, but like many younger women with cardiovascular disease, she did not make her own primary care a priority, and had missed out on other opportunities to discuss contraception. “Her MI opened a window of opportunity to help prevent an unintended and high-risk pregnancy,” Dr. Sarma noted.
Dr. Sarma’s patient anecdote illustrated the point of the In the Clinic review: that any clinician can discuss pregnancy and contraception with patients of childbearing age who have medical comorbidities that could affect a pregnancy. “All clinicians who care for patients of reproductive potential should become comfortable discussing pregnancy intent, preconception risk assessment, and contraceptive counseling,” Dr. Sarma said.
The research for this article was funded by the American College of Physicians. The review authors had no financial conflicts to disclose. Dr. Sarma had no financial conflicts to disclose.
