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ACP: Average-risk women under 50 can postpone mammogram
(CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.
Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.
The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.
“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.
However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.
The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.
It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.
Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.
“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”
The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.
An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.
The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.
Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”
“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”
Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”
Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”
“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.
The guidance authors reported having no conflicts of interest.
SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.
The ACP guidance statements provide “clarity and simplicity amidst the chaos of diverging guidelines,” Joann G. Elmore, MD, and Christoph I. Lee, MD, wrote in an editorial that accompanied the guideline (Ann Intern Med. 2019. doi: 10.7326/M19-0726).
The four statements included in the guidance represent the convergence of differing recommendations, but they also highlight points for physicians to consider in shared decision making with patients, the editorial authors wrote.
Lacking, however, is advice on how clinicians should go about stopping screening in certain patients, they noted.
“We need reliable ways to determine life expectancy given comorbid conditions, as well as methods to appropriately manage the discussion about stopping screening. ... The cessation of routine screening is a highly uncomfortable situation for which we as clinicians currently have little guidance and few tools. At this crossroads of confusion, we need a clear path toward informed, tailored, risk-based screening for breast cancer,” they wrote adding that future guidance statements should “move beyond emphasizing variation across guidelines and instead provide more advice on how to implement high-value screening and deimplement low-value screening.”
Dr. Elmore is with the University of California, Los Angeles. Dr. Lee is with the University of Washington, Seattle.
The ACP guidance statements provide “clarity and simplicity amidst the chaos of diverging guidelines,” Joann G. Elmore, MD, and Christoph I. Lee, MD, wrote in an editorial that accompanied the guideline (Ann Intern Med. 2019. doi: 10.7326/M19-0726).
The four statements included in the guidance represent the convergence of differing recommendations, but they also highlight points for physicians to consider in shared decision making with patients, the editorial authors wrote.
Lacking, however, is advice on how clinicians should go about stopping screening in certain patients, they noted.
“We need reliable ways to determine life expectancy given comorbid conditions, as well as methods to appropriately manage the discussion about stopping screening. ... The cessation of routine screening is a highly uncomfortable situation for which we as clinicians currently have little guidance and few tools. At this crossroads of confusion, we need a clear path toward informed, tailored, risk-based screening for breast cancer,” they wrote adding that future guidance statements should “move beyond emphasizing variation across guidelines and instead provide more advice on how to implement high-value screening and deimplement low-value screening.”
Dr. Elmore is with the University of California, Los Angeles. Dr. Lee is with the University of Washington, Seattle.
The ACP guidance statements provide “clarity and simplicity amidst the chaos of diverging guidelines,” Joann G. Elmore, MD, and Christoph I. Lee, MD, wrote in an editorial that accompanied the guideline (Ann Intern Med. 2019. doi: 10.7326/M19-0726).
The four statements included in the guidance represent the convergence of differing recommendations, but they also highlight points for physicians to consider in shared decision making with patients, the editorial authors wrote.
Lacking, however, is advice on how clinicians should go about stopping screening in certain patients, they noted.
“We need reliable ways to determine life expectancy given comorbid conditions, as well as methods to appropriately manage the discussion about stopping screening. ... The cessation of routine screening is a highly uncomfortable situation for which we as clinicians currently have little guidance and few tools. At this crossroads of confusion, we need a clear path toward informed, tailored, risk-based screening for breast cancer,” they wrote adding that future guidance statements should “move beyond emphasizing variation across guidelines and instead provide more advice on how to implement high-value screening and deimplement low-value screening.”
Dr. Elmore is with the University of California, Los Angeles. Dr. Lee is with the University of Washington, Seattle.
(CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.
Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.
The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.
“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.
However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.
The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.
It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.
Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.
“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”
The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.
An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.
The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.
Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”
“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”
Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”
Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”
“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.
The guidance authors reported having no conflicts of interest.
SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.
(CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.
Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.
The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.
“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.
However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.
The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.
It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.
Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.
“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”
The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.
An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.
The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.
Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”
“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”
Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”
Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”
“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.
The guidance authors reported having no conflicts of interest.
SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.
REPORTING FROM THE ANNALS OF INTERNAL MEDICINE
Brexanolone approval ‘marks an important milestone’
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
In March 2019, the Food and Drug Administration approved a novel medication, Zulresso (brexanolone), for the treatment of postpartum depression. Brexanolone is the first FDA-approved medication for the treatment of postpartum depression, a serious illness that affects nearly one in nine women soon after giving birth.1
Mothers with postpartum depression experience feelings of sadness, irritability, and anxiety, as well as isolation from their loved ones (including their new baby) and exhaustion. The feelings of sadness and anxiety can be extreme, and can interfere with a woman’s ability to care for herself or her family. In some cases, these symptoms can be life threatening. Indeed, the most common cause of maternal death after childbirth in the developed world is suicide.2 Because of the severity of the symptoms and their impact on the family, postpartum depression usually requires treatment.
Until now, there have been no drugs specifically approved to treat postpartum depression. Commonly, postpartum depression is treated with medications that previously were approved for the treatment of major depressive disorder, despite limited evidence documenting their efficacy for postpartum depression. Other putative treatment alternatives include psychotherapy, estrogen therapy, and neuromodulation, such as electroconvulsive therapy and repetitive transcranial magnetic stimulation. Each of these treatments can take weeks or longer to take effect, time that is of elevated importance given the rapidly developing mother-infant relationship in the early postpartum period. Brexanolone addresses both the issue of efficacy and speed of onset, representing a major step forward in the care of women suffering from postpartum depression.
Importantly, the approval of brexanolone marks an important milestone for the psychiatric research community in general and the National Institute of Mental Health in particular, as it represents a compelling example of successful bench-to-bedside translation of basic neuroscience findings to benefit patients. As we have noted elsewhere,3 the research underlying the discovery of endogenous neurosteroids and their role in modulating GABA receptors laid the foundation for the development of brexanolone, an intravenous formulation of the neurosteroid allopregnanolone. The recognition that allopregnanolone was a protective factor induced by stress, that it derived from progesterone, and that its peripheral blood levels were dramatically reduced in the early postpartum period led to the hypothesis that it might be useful as a treatment for postpartum depression.
Sage Therapeutics took on the task of testing this hypothesis, designing a program, in consultation with the FDA, to test the efficacy of allopregnanolone in women with postpartum depression in a series of randomized, placebo-controlled studies assessing brexanolone. 4,5 It is a significant accomplishment of Sage Therapeutics to not only successfully complete the therapeutic program of studies (given past experience with difficulties recruiting these women for placebo-controlled treatment trials) but as well to demonstrate a robust therapeutic effect.
Although the FDA’s approval of a new and novel treatment is exciting for many women, there are still limitations to the broader use of brexanolone. It is delivered intravenously, requires an overnight stay in a certified medical center, and is likely to be considerably expensive, according to early reports – potentially limiting the access to the treatment. There also are potentially serious side effects, such as sedation, dizziness, or sudden loss of consciousness. Nonetheless, this is a promising first step and hopefully will spur further efforts to identify and optimize additional strategies to treat postpartum depression. In fact, other formulations of allopregnanolone and novel analogs to treat postpartum depression already are under study, including some that are orally bioavailable.6,7,8
Several important questions remain to be answered about both brexanolone and postpartum depression: What is the underlying mechanism through which allopregnanolone acts in the brain and reduces depressive symptoms? Is the mechanism unique to postpartum women, or might brexanolone also be effective in nonreproductive depressions in women and men? What causes postpartum depression, and what are the risk factors involved for women who develop this serious condition? Future work will focus on these and other important questions to the benefit of women who have suffered with this condition.
The FDA approval of brexanolone represents the second approval in a month of a new antidepressant treatment targeting different molecules in the brain. In early March 2019, the agency approved Spravato (esketamine) nasal spray as a therapy for treatment-resistant depression. Like brexanolone, esketamine is a fast-acting antidepressant that works through a novel mechanism, completely different from other antidepressants. These new treatment approvals are encouraging, as there has been a paucity for many years in approving new effective treatments for mood disorders.
However, treatment development in psychiatry still has a long way to go and the full underlying neurobiology of mood disorders, including postpartum depression, remains poorly understood. Many challenges are ahead of us in our efforts to develop new treatments and increase our understanding of mental illnesses. Nevertheless, the approval of brexanolone is an important milestone, giving hope to the many women who suffer from postpartum depression, and paving the way for the development of additional novel and effective medications to treat this serious and sometimes life-threatening condition.
Dr. Gordon is the director of the National Institute of Mental Health (NIMH), the lead federal agency for research on mental disorders. He oversees an extensive research portfolio of basic and clinical research that seeks to transform the understanding and treatment of mental illnesses, paving the way for prevention, recovery, and cure. Dr. Hillefors works at the NIMH and oversees the Translational Therapeutics Program in the division of translational research, focusing on the development of novel treatments and biomarkers and early phase clinical trials. She received her MD and PhD in neuroscience at the Karolinska Institute, Sweden. Dr. Schmidt joined the NIMH in 1986 after completing his psychiatric residency at the University of Toronto. He is the chief of the Section on Behavioral Endocrinology, within the Intramural Research Program at the NIMH, where his laboratory studies the relationship between hormones, stress, and mood – particularly in the areas of postpartum depression, severe premenstrual dysphoria, and perimenopausal depression.
References
1. J Psychiatric Res. 2018 Sep;104:235-48.
2. Br J Psychiatry. 2003 Oct;183:279-81.
3. NIMH Director’s Messages. 2019 Mar 20.
4. Lancet. 2017 Jul 29;390(10093):480-9.
5. Lancet. 2018 Sep 22; 392(10152):1058-70.
6. Sage Therapeutics News. 2019 Jan 7.
7. Marinus Pharmaceuticals. 2017 Jun 27.
8. ClinicalTrials.gov Identifier: NCT03460756. 2019 Mar.
Powerful breast-implant testimony constrained by limited evidence
What’s the role of anecdotal medical histories in the era of evidence-based medicine?
But the anecdotal histories fell short of producing a clear committee consensus on dramatic, immediate changes in FDA policy, such as joining a renewed ban on certain types of breast implants linked with a rare lymphoma, a step recently taken by 38 other countries, including 33 European countries acting in concert through the European Union.
The disconnect between gripping testimony and limited panel recommendations was most stark for a complication that’s been named Breast Implant Illness (BII) by patients on the Internet. Many breast implant recipients have reported life-changing symptoms that appeared after implant placement, most often fatigue, joint and muscle pain, brain fog, neurologic symptoms, immune dysfunction, skin manifestations, and autoimmune disease or symptoms. By my count, 22 people spoke about their harrowing experiences with BII symptoms out of the 77 who stepped to the panel’s public-comment mic during 4 hours of public testimony over 2-days of hearings, often saying that they had experienced dramatic improvements after their implants came out. The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee also heard presentations from two experts who ran some of the first reported studies on BII, or a BII-like syndrome called Autoimmune Syndrome Induced by Adjuvants (ASIA) described by Jan W.C. Tervaert, MD, professor of medicine and director of rheumatology at the University of Alberta in Edmonton. Dr. Tervaert and his associates published their findings about ASIA in the rheumatology literature last year (Clin Rheumatol. 2018 Feb;37[2]:483-93), and during his talk before the FDA panel, he said that silicone breast implants and the surgical mesh often used with them could be ASIA triggers.
Panel members seemed to mostly believe that the evidence they heard about BII did no more than hint at a possible association between breast implants and BII symptoms that required additional study. Many agreed on the need to include mention of the most common BII-linked patient complaints in informed consent material, but some were reluctant about even taking that step.
“I do not mention BII to patients. It’s not a disease; it’s a constellation of symptoms,” said panel member and plastic surgeon Pierre M. Chevray, MD, from Houston Methodist Hospital. The evidence for BII “is extremely anecdotal,” he said in an interview at the end of the 2-day session. Descriptions of BII “have been mainly published on social media. One reason why I don’t tell patients [about BII as part of informed consent] is because right now the evidence of a link is weak. We don’t yet even have a definition of this as an illness. A first step is to define it,” said Dr. Chevray, who has a very active implant practice. Other plastic surgeons were more accepting of BII as a real complication, although they agreed it needs much more study. During the testimony period, St. Louis plastic surgeon Patricia A. McGuire, MD, highlighted the challenge of teasing apart whether real symptoms are truly related to implants or are simply common ailments that accumulate during middle-age in many women. Dr. McGuire and some of her associates published an assessment of the challenges and possible solutions to studying BII that appeared shortly before the hearing (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S),
Consensus recommendations from the panel to the FDA to address BII included having a single registry that would include all U.S. patients who receive breast implants (recently launched as the National Breast Implant Registry), inclusion of a control group, and collection of data at baseline and after regular follow-up intervals that includes a variety of measures relevant to autoimmune and rheumatologic disorders. Several panel members cited inadequate postmarketing safety surveillance by manufacturers in the years since breast implants returned to the U.S. market, and earlier in March, the FDA issued warning letters to two of the four companies that market U.S. breast implants over their inadequate long-term safety follow-up.
The panel’s decisions about the other major implant-associated health risk it considered, breast implant associated anaplastic large cell lymphoma (BIA-ALCL), faced a different sort of challenge. First described as linked to breast implants in 2011, today there is little doubt that BIA-ALCL is a consequence of breast implants, what several patients derisively called a “man-made cancer.” The key issue the committee grappled with was whether the calculated incidence of BIA-ALCL was at a frequency that warranted a ban on at least selected breast implant types. Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, told the panel that he calculated the Allergan Biocell group of implants, which have textured surfaces that allows for easier and more stable placement in patients, linked with an incidence of BIA-ALCL that was sevenfold to eightfold higher than that with smooth implants. That’s against a background of an overall incidence of about one case for every 20,000 U.S. implant recipients, Dr. Clemens said.
Many testifying patients, including several of the eight who described a personal history of BIA-ALCL, called for a ban on the sale of at least some breast implants because of their role in causing lymphoma. That sentiment was shared by Dr. Chevray, who endorsed a ban on “salt-loss” implants (the method that makes Biocell implants) during his closing comments to his fellow panel members. But earlier during panel discussions, others on the committee pushed back against implant bans, leaving the FDA’s eventual decision on this issue unclear. Evidence presented during the hearings suggests that implants cause ALCL by triggering a local “inflammatory milieu” and that different types of implants can have varying levels of potency for producing this milieu.
Perhaps the closest congruence between what patients called for and what the committee recommended was on informed consent. “No doubt, patients feel that informed consent failed them,” concluded panel member Karen E. Burke, MD, a New York dermatologist who was one of two panel discussants for the topic.
In addition to many suggestions on how to improve informed consent and public awareness lobbed at FDA staffers during the session by panel members, the final public comment of the 2 days came from Laurie A. Casas, MD, a Chicago plastic surgeon affiliated with the University of Chicago and a member of the board of directors of the American Society of Aesthetic Plastic Surgery (also know as the Aesthetic Society). During her testimony, Dr. Casas said “Over the past 2 days, we heard that patients need a structured educational checklist for informed consent. The Aesthetic Society hears you,” and promised that the website of the Society’s publication, the Aesthetic Surgery Journal, will soon feature a safety checklist for people receiving breast implants that will get updated as new information becomes available. She also highlighted the need for a comprehensive registry and long-term follow-up of implant recipients by the plastic surgeons who treated them.
In addition to better informed consent, patients who came to the hearing clearly also hoped to raise awareness in the general American public about the potential dangers from breast implants and the need to follow patients who receive implants. The 2 days of hearing accomplished that in part just by taking place. The New York Times and The Washington Post ran at least a couple of articles apiece on implant safety just before or during the hearings, while a more regional paper, the Philadelphia Inquirer, ran one article, as presumably did many other newspapers, broadcast outlets, and websites across America. Much of the coverage focused on compelling and moving personal stories from patients.
Women who have been having adverse effects from breast implants “have felt dismissed,” noted panel member Natalie C. Portis, PhD, a clinical psychologist from Oakland, Calif., and the patient representative on the advisory committee. “We need to listen to women that something real is happening.”
Dr. Tervaert, Dr. Chevray, Dr. McGuire, Dr. Clemens, Dr. Burke, Dr. Casas, and Dr. Portis had no relevant commercial disclosures.
What’s the role of anecdotal medical histories in the era of evidence-based medicine?
But the anecdotal histories fell short of producing a clear committee consensus on dramatic, immediate changes in FDA policy, such as joining a renewed ban on certain types of breast implants linked with a rare lymphoma, a step recently taken by 38 other countries, including 33 European countries acting in concert through the European Union.
The disconnect between gripping testimony and limited panel recommendations was most stark for a complication that’s been named Breast Implant Illness (BII) by patients on the Internet. Many breast implant recipients have reported life-changing symptoms that appeared after implant placement, most often fatigue, joint and muscle pain, brain fog, neurologic symptoms, immune dysfunction, skin manifestations, and autoimmune disease or symptoms. By my count, 22 people spoke about their harrowing experiences with BII symptoms out of the 77 who stepped to the panel’s public-comment mic during 4 hours of public testimony over 2-days of hearings, often saying that they had experienced dramatic improvements after their implants came out. The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee also heard presentations from two experts who ran some of the first reported studies on BII, or a BII-like syndrome called Autoimmune Syndrome Induced by Adjuvants (ASIA) described by Jan W.C. Tervaert, MD, professor of medicine and director of rheumatology at the University of Alberta in Edmonton. Dr. Tervaert and his associates published their findings about ASIA in the rheumatology literature last year (Clin Rheumatol. 2018 Feb;37[2]:483-93), and during his talk before the FDA panel, he said that silicone breast implants and the surgical mesh often used with them could be ASIA triggers.
Panel members seemed to mostly believe that the evidence they heard about BII did no more than hint at a possible association between breast implants and BII symptoms that required additional study. Many agreed on the need to include mention of the most common BII-linked patient complaints in informed consent material, but some were reluctant about even taking that step.
“I do not mention BII to patients. It’s not a disease; it’s a constellation of symptoms,” said panel member and plastic surgeon Pierre M. Chevray, MD, from Houston Methodist Hospital. The evidence for BII “is extremely anecdotal,” he said in an interview at the end of the 2-day session. Descriptions of BII “have been mainly published on social media. One reason why I don’t tell patients [about BII as part of informed consent] is because right now the evidence of a link is weak. We don’t yet even have a definition of this as an illness. A first step is to define it,” said Dr. Chevray, who has a very active implant practice. Other plastic surgeons were more accepting of BII as a real complication, although they agreed it needs much more study. During the testimony period, St. Louis plastic surgeon Patricia A. McGuire, MD, highlighted the challenge of teasing apart whether real symptoms are truly related to implants or are simply common ailments that accumulate during middle-age in many women. Dr. McGuire and some of her associates published an assessment of the challenges and possible solutions to studying BII that appeared shortly before the hearing (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S),
Consensus recommendations from the panel to the FDA to address BII included having a single registry that would include all U.S. patients who receive breast implants (recently launched as the National Breast Implant Registry), inclusion of a control group, and collection of data at baseline and after regular follow-up intervals that includes a variety of measures relevant to autoimmune and rheumatologic disorders. Several panel members cited inadequate postmarketing safety surveillance by manufacturers in the years since breast implants returned to the U.S. market, and earlier in March, the FDA issued warning letters to two of the four companies that market U.S. breast implants over their inadequate long-term safety follow-up.
The panel’s decisions about the other major implant-associated health risk it considered, breast implant associated anaplastic large cell lymphoma (BIA-ALCL), faced a different sort of challenge. First described as linked to breast implants in 2011, today there is little doubt that BIA-ALCL is a consequence of breast implants, what several patients derisively called a “man-made cancer.” The key issue the committee grappled with was whether the calculated incidence of BIA-ALCL was at a frequency that warranted a ban on at least selected breast implant types. Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, told the panel that he calculated the Allergan Biocell group of implants, which have textured surfaces that allows for easier and more stable placement in patients, linked with an incidence of BIA-ALCL that was sevenfold to eightfold higher than that with smooth implants. That’s against a background of an overall incidence of about one case for every 20,000 U.S. implant recipients, Dr. Clemens said.
Many testifying patients, including several of the eight who described a personal history of BIA-ALCL, called for a ban on the sale of at least some breast implants because of their role in causing lymphoma. That sentiment was shared by Dr. Chevray, who endorsed a ban on “salt-loss” implants (the method that makes Biocell implants) during his closing comments to his fellow panel members. But earlier during panel discussions, others on the committee pushed back against implant bans, leaving the FDA’s eventual decision on this issue unclear. Evidence presented during the hearings suggests that implants cause ALCL by triggering a local “inflammatory milieu” and that different types of implants can have varying levels of potency for producing this milieu.
Perhaps the closest congruence between what patients called for and what the committee recommended was on informed consent. “No doubt, patients feel that informed consent failed them,” concluded panel member Karen E. Burke, MD, a New York dermatologist who was one of two panel discussants for the topic.
In addition to many suggestions on how to improve informed consent and public awareness lobbed at FDA staffers during the session by panel members, the final public comment of the 2 days came from Laurie A. Casas, MD, a Chicago plastic surgeon affiliated with the University of Chicago and a member of the board of directors of the American Society of Aesthetic Plastic Surgery (also know as the Aesthetic Society). During her testimony, Dr. Casas said “Over the past 2 days, we heard that patients need a structured educational checklist for informed consent. The Aesthetic Society hears you,” and promised that the website of the Society’s publication, the Aesthetic Surgery Journal, will soon feature a safety checklist for people receiving breast implants that will get updated as new information becomes available. She also highlighted the need for a comprehensive registry and long-term follow-up of implant recipients by the plastic surgeons who treated them.
In addition to better informed consent, patients who came to the hearing clearly also hoped to raise awareness in the general American public about the potential dangers from breast implants and the need to follow patients who receive implants. The 2 days of hearing accomplished that in part just by taking place. The New York Times and The Washington Post ran at least a couple of articles apiece on implant safety just before or during the hearings, while a more regional paper, the Philadelphia Inquirer, ran one article, as presumably did many other newspapers, broadcast outlets, and websites across America. Much of the coverage focused on compelling and moving personal stories from patients.
Women who have been having adverse effects from breast implants “have felt dismissed,” noted panel member Natalie C. Portis, PhD, a clinical psychologist from Oakland, Calif., and the patient representative on the advisory committee. “We need to listen to women that something real is happening.”
Dr. Tervaert, Dr. Chevray, Dr. McGuire, Dr. Clemens, Dr. Burke, Dr. Casas, and Dr. Portis had no relevant commercial disclosures.
What’s the role of anecdotal medical histories in the era of evidence-based medicine?
But the anecdotal histories fell short of producing a clear committee consensus on dramatic, immediate changes in FDA policy, such as joining a renewed ban on certain types of breast implants linked with a rare lymphoma, a step recently taken by 38 other countries, including 33 European countries acting in concert through the European Union.
The disconnect between gripping testimony and limited panel recommendations was most stark for a complication that’s been named Breast Implant Illness (BII) by patients on the Internet. Many breast implant recipients have reported life-changing symptoms that appeared after implant placement, most often fatigue, joint and muscle pain, brain fog, neurologic symptoms, immune dysfunction, skin manifestations, and autoimmune disease or symptoms. By my count, 22 people spoke about their harrowing experiences with BII symptoms out of the 77 who stepped to the panel’s public-comment mic during 4 hours of public testimony over 2-days of hearings, often saying that they had experienced dramatic improvements after their implants came out. The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee also heard presentations from two experts who ran some of the first reported studies on BII, or a BII-like syndrome called Autoimmune Syndrome Induced by Adjuvants (ASIA) described by Jan W.C. Tervaert, MD, professor of medicine and director of rheumatology at the University of Alberta in Edmonton. Dr. Tervaert and his associates published their findings about ASIA in the rheumatology literature last year (Clin Rheumatol. 2018 Feb;37[2]:483-93), and during his talk before the FDA panel, he said that silicone breast implants and the surgical mesh often used with them could be ASIA triggers.
Panel members seemed to mostly believe that the evidence they heard about BII did no more than hint at a possible association between breast implants and BII symptoms that required additional study. Many agreed on the need to include mention of the most common BII-linked patient complaints in informed consent material, but some were reluctant about even taking that step.
“I do not mention BII to patients. It’s not a disease; it’s a constellation of symptoms,” said panel member and plastic surgeon Pierre M. Chevray, MD, from Houston Methodist Hospital. The evidence for BII “is extremely anecdotal,” he said in an interview at the end of the 2-day session. Descriptions of BII “have been mainly published on social media. One reason why I don’t tell patients [about BII as part of informed consent] is because right now the evidence of a link is weak. We don’t yet even have a definition of this as an illness. A first step is to define it,” said Dr. Chevray, who has a very active implant practice. Other plastic surgeons were more accepting of BII as a real complication, although they agreed it needs much more study. During the testimony period, St. Louis plastic surgeon Patricia A. McGuire, MD, highlighted the challenge of teasing apart whether real symptoms are truly related to implants or are simply common ailments that accumulate during middle-age in many women. Dr. McGuire and some of her associates published an assessment of the challenges and possible solutions to studying BII that appeared shortly before the hearing (Plast Reconstr Surg. 2019 March;143[3S]:74S-81S),
Consensus recommendations from the panel to the FDA to address BII included having a single registry that would include all U.S. patients who receive breast implants (recently launched as the National Breast Implant Registry), inclusion of a control group, and collection of data at baseline and after regular follow-up intervals that includes a variety of measures relevant to autoimmune and rheumatologic disorders. Several panel members cited inadequate postmarketing safety surveillance by manufacturers in the years since breast implants returned to the U.S. market, and earlier in March, the FDA issued warning letters to two of the four companies that market U.S. breast implants over their inadequate long-term safety follow-up.
The panel’s decisions about the other major implant-associated health risk it considered, breast implant associated anaplastic large cell lymphoma (BIA-ALCL), faced a different sort of challenge. First described as linked to breast implants in 2011, today there is little doubt that BIA-ALCL is a consequence of breast implants, what several patients derisively called a “man-made cancer.” The key issue the committee grappled with was whether the calculated incidence of BIA-ALCL was at a frequency that warranted a ban on at least selected breast implant types. Mark W. Clemens, MD, a plastic surgeon at MD Anderson Cancer Center in Houston, told the panel that he calculated the Allergan Biocell group of implants, which have textured surfaces that allows for easier and more stable placement in patients, linked with an incidence of BIA-ALCL that was sevenfold to eightfold higher than that with smooth implants. That’s against a background of an overall incidence of about one case for every 20,000 U.S. implant recipients, Dr. Clemens said.
Many testifying patients, including several of the eight who described a personal history of BIA-ALCL, called for a ban on the sale of at least some breast implants because of their role in causing lymphoma. That sentiment was shared by Dr. Chevray, who endorsed a ban on “salt-loss” implants (the method that makes Biocell implants) during his closing comments to his fellow panel members. But earlier during panel discussions, others on the committee pushed back against implant bans, leaving the FDA’s eventual decision on this issue unclear. Evidence presented during the hearings suggests that implants cause ALCL by triggering a local “inflammatory milieu” and that different types of implants can have varying levels of potency for producing this milieu.
Perhaps the closest congruence between what patients called for and what the committee recommended was on informed consent. “No doubt, patients feel that informed consent failed them,” concluded panel member Karen E. Burke, MD, a New York dermatologist who was one of two panel discussants for the topic.
In addition to many suggestions on how to improve informed consent and public awareness lobbed at FDA staffers during the session by panel members, the final public comment of the 2 days came from Laurie A. Casas, MD, a Chicago plastic surgeon affiliated with the University of Chicago and a member of the board of directors of the American Society of Aesthetic Plastic Surgery (also know as the Aesthetic Society). During her testimony, Dr. Casas said “Over the past 2 days, we heard that patients need a structured educational checklist for informed consent. The Aesthetic Society hears you,” and promised that the website of the Society’s publication, the Aesthetic Surgery Journal, will soon feature a safety checklist for people receiving breast implants that will get updated as new information becomes available. She also highlighted the need for a comprehensive registry and long-term follow-up of implant recipients by the plastic surgeons who treated them.
In addition to better informed consent, patients who came to the hearing clearly also hoped to raise awareness in the general American public about the potential dangers from breast implants and the need to follow patients who receive implants. The 2 days of hearing accomplished that in part just by taking place. The New York Times and The Washington Post ran at least a couple of articles apiece on implant safety just before or during the hearings, while a more regional paper, the Philadelphia Inquirer, ran one article, as presumably did many other newspapers, broadcast outlets, and websites across America. Much of the coverage focused on compelling and moving personal stories from patients.
Women who have been having adverse effects from breast implants “have felt dismissed,” noted panel member Natalie C. Portis, PhD, a clinical psychologist from Oakland, Calif., and the patient representative on the advisory committee. “We need to listen to women that something real is happening.”
Dr. Tervaert, Dr. Chevray, Dr. McGuire, Dr. Clemens, Dr. Burke, Dr. Casas, and Dr. Portis had no relevant commercial disclosures.
Postpartum anxiety: More common than you think
THE CASE
Julia* is a 31-year-old woman, gravida 3 para 3, who presents to your office for evaluation after a recent emergency department (ED) visit. Her husband and children are with her. She is 4 months postpartum after an uncomplicated normal spontaneous vaginal delivery. She is breastfeeding her healthy baby boy and is using an intrauterine device for birth control. She went to the ED last week after “choking on a chip” while having lunch with her children. It felt like she “couldn’t breathe.” She called 911 herself. The ED evaluation was unremarkable. Her discharge diagnosis was “panic attack,” and she was sent home with a prescription for lorazepam.
Since the incident, she has been unable to eat any solid foods and has lost 7 pounds. She also reports a globus sensation, extreme fear of swallowing, insomnia, and pervasive thoughts that she could die at any moment and leave her children motherless. She has not taken the lorazepam.
She has a history of self-reported anxiety dating back to high school but no history of panic attacks. She has never been diagnosed with an anxiety disorder and has never before been prescribed anti-anxiety medication. She doesn’t have a history of postpartum depression in prior pregnancies, and a depression screening at her postpartum visit 2 months ago was negative.
●
*The patient’s name has been changed to protect her identity.
During the perinatal period, women are particularly vulnerable to affective disorders, and primary care physicians are encouraged to routinely screen for and treat depression in pregnant and postpartum women.1 However, anxiety disorders have a higher incidence than mood disorders in the general population,2 and perinatal anxiety may be more widely underrecognized and undertreated than depression.3 In addition, higher depression scores early in pregnancy have been shown to predict higher anxiety later in pregnancy.4
As family physicians, we are well-trained to recognize and treat anxiety disorders in the general patient population; however, we may lack the awareness and tools to identify these conditions in the perinatal period. Given our frequent encounters with both mom and baby in a child’s first year of life, we are uniquely positioned to promptly recognize, diagnose, and treat postpartum anxiety and thereby improve health outcomes for families.
DEFINING PERINATAL ANXIETY
Anxiety disorders (including generalized anxiety disorder, panic, phobia, and social anxiety) are the most common mental health disorders evaluated and treated in the primary care setting, with a lifetime prevalence of close to 30%.2
Continue to: A recent report from...
A recent report from the Centers for Disease Control and Prevention (CDC) estimates that 1 in 9 women experience symptoms of postpartum depression.5 The prevalence of anxiety disorders during pregnancy and the early postpartum period is not as well-known, but studies suggest that perinatal anxiety is much more prevalent than depression. In one study, generalized anxiety disorder (GAD) in the pre- and postnatal periods was 15.8% and 17.1%, respectively; an incidence far exceeding that of perinatal depression (3.9% and 4.8%, for the same periods).6 Additional evidence suggests that even more women in the postnatal period experience clinically significant levels of anxiety but do not meet full diagnostic criteria for an anxiety disorder.7
In another study, 9.5% of women met criteria for GAD at some point during pregnancy, with highest anxiety levels in the first trimester.8 Women with a history of GAD, lower education, lack of social support, and personal history of child abuse have the highest risk for postpartum anxiety. Women with a history of posttraumatic stress disorder (PTSD) may be twice as likely to develop postpartum anxiety as healthy women.9
It has been well-documented that sleep disruption—which is very common in new mothers in the postnatal period—contributes to mood and anxiety disorders.10,11
Clarifying a diagnosis of postpartum anxiety
The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)12 specifies no diagnosis of postpartum anxiety disorder. And no standardized diagnostic criteria exist. It is likely that in some cases, postpartum anxiety represents an exacerbation of underlying GAD, and in other cases it is a situational disorder brought about by specific circumstances of the peripartum period.
The DSM-5 does, however, provide a helpful diagnostic approach. It defines a diagnosis of postpartum depression as being a variant of major depressive disorder (MDD) in which a woman must 1) meet criteria for a major depressive episode; and 2) occur during pregnancy or within 4 weeks of delivery. In practice, many clinicians extend the second requirement to include the first year postpartum.13 There is a “with anxious distress” specifier for major depression in the DSM-5, but the 2 disorders are otherwise unlinked.
Continue to: To apply the...
To apply the DSM-5 principles for postpartum depression to postpartum anxiety, a patient would need to 1) meet the diagnostic criteria for an anxiety disorder that 2) have their onset within a specified perinatal period. Variant presentations of anxiety in the postpartum period might include panic disorder and phobias, which could also interfere with a woman’s ability to care for her child.
The DSM-5 offers the following criteria for GAD12:
- excessive worry about a variety of topics
- worry that is experienced as hard to control
- worry associated with at least 3 physical or cognitive symptoms: edginess/restlessness, tiring easily, impaired concentration, irritability
- anxiety, worry, or associated symptoms that make it hard to carry out day-to-day activities and responsibilities
- symptoms that are unrelated to any other medical conditions and cannot be explained by the effect of substances including a prescription medication, alcohol, or recreational drugs
- symptoms that are not better explained by a different mental disorder.
Debilitating effects of postpartum anxiety
Many women experience some level of anxiety during pregnancy and early postpartum—anxiety that may range from normal and adaptive to debilitating.14 While the challenges of caring for a newborn are likely to bring some level of anxiety, these symptoms should be transient and not interfere with a woman’s capacity to care for her infant, herself, or her family.
Postpartum anxiety has been associated with a prior fear of giving birth, fear of death (of both mother and baby), lack of control, lack of self-confidence, and lack of confidence in the medical system.9 The experience of such ongoing disturbing thoughts or feelings of worry and tension that affect a woman’s ability to manage from day to day should indicate an illness state that deserves medical attention.
Mothers with postpartum anxiety disorders report significantly less bonding with their infants than do mothers without anxiety.15 A recent narrative review describes numerous studies that illustrate the negative effects of postpartum anxiety on bonding, breastfeeding, infant temperament, early childhood development, and conduct disorders.16 Anxious women may be less likely to initiate breastfeeding, have more challenges with breastfeeding, and even have a different milk composition.17 Women with prenatal anxiety are also more likely to stop breastfeeding prematurely.18 Children of anxious mothers may be more likely to have a difficult temperament and to display more distress.19 There are small studies demonstrating deficits in early infant development and increases in conduct disorder in the male offspring of anxious women.20
Continue to: SCREENING FOR POSTPARTUM ANXIETY
SCREENING FOR POSTPARTUM ANXIETY
Screening for perinatal depression has become standard of care, and the Edinburgh Postnatal Depression Scale (EPDS) is a widely used instrument.1 The EPDS, a 10-question self-report scale, was created and validated to screen for perinatal depression, with a cutoff of > 10/30 usually considered a positive result.
Researchers have investigated the utility of the EPDS as a screening tool for perinatal anxiety as well.21-23 These studies show some promise, but there are questions as to whether a total score or a subscale score of the EPDS is most accurate in detecting anxiety. Women with perinatal anxiety may score low on the total EPDS, yet score higher on 3 anxiety-specific questions (TABLE 123). For this reason, several studies propose an EPDS anxiety subscore or subscale (referred to as EPDS-3A).
Of note, there are some women who will score high on the subscale who do not ultimately meet the criteria for an anxiety disorder diagnosis. Clinicians should not over-interpret these scores and should always use sound clinical judgment when making a diagnosis.
Research has also focused on using the GAD 7-item (GAD-7) scale (TABLE 224),25 and on the
Family physicians may consider using the EPDS subscale if they are already using the EPDS, or adding the GAD-7 as a separate screening instrument during a postpartum visit. To date there is no one standard recommendation or screening tool.
Continue to: NONPHARMACOLOGIC TREATMENT
NONPHARMACOLOGIC TREATMENT
As one would with any patient who has situational anxiety, help new mothers find ways to increase their coping skills, reduce stress, and mobilize social supports and family resources. Given the association between sleep disruption and perinatal anxiety, counsel new mothers, especially those at high risk for postpartum anxiety, to prioritize sleep during this vulnerable time. To that end, consider recommending that they ask partners, family members, or friends to help them take care of the infant at night (or during the day). Such nonmedical interventions may be sufficient for women with mild anxiety.
Very few studies have addressed nonpharmacologic management of postpartum anxiety, but cognitive behavioral therapy (CBT) has been shown to help in managing and treating anxiety disorders outside of pregnancy.28 A few small studies indicate promise for CBT and for mindfulness-based interventions (MBIs) during pregnancy.29
A 2016 systematic review of pharmacologic and nonpharmacologic treatment of anxiety in the perinatal period found support for the use of CBT for panic disorder and specific phobias both in pregnancy and postpartum.30 A very small study found that teaching mothers to massage their preterm infants decreased maternal anxiety.31
If the patient is amenable, it is reasonable to start with behavioral interventions like CBT or MBI before pharmacologic treatment—particularly when physicians have mental health professionals embedded in their primary care team.
PHARMACOLOGIC TREATMENT
Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) are considered first-line treatment for moderate to severe anxiety disorders in the perinatal and postnatal period.
Continue to: SSRIs in pregnancy
SSRIs in pregnancy. Lacking support of randomized controlled trials, most recommendations regarding SSRIs in pregnancy come from expert consensus or cohort and case control studies. Studies have raised concerns for an increased rate of congenital heart defects among fetuses exposed to paroxetine32 and primary pulmonary hypertension with all SSRIs.33 But the absolute risks are quite small. There have also been concerns regarding low birth weight and preterm birth, but it is possible that these outcomes result from the depression itself rather than the medication.34
Unfortunately, there are very few studies evaluating the efficacy of SSRIs in treating postpartum depression35 and even fewer that specifically evaluate their effect on perinatal anxiety. Many experts believe that not treating anxiety/depression is actually more harmful than the fetal effects of SSRIs, and that SSRIs are largely safe in both pregnancy and while breastfeeding, with benefits outweighing the risks.
SSRIs while breastfeeding. SSRIs have been found to be present in varying levels in breastmilk but may or may not be present in the serum of nursing infants.36 A 2008 guideline from the American College of Obstetricians and Gynecologists lists paroxetine, sertraline, and fluvoxamine as slightly safer than fluoxetine, escitalopram, and citalopram.37 A 2015 systematic review similarly concluded that sertraline and paroxetine have the most safety data on lactation.38 Lowest effective dose is always recommended to minimize exposure.
Benzodiazepines. As in the general population, benzodiazepines should be reserved for short-term use in acute anxiety and panic because they are associated with such adverse effects as worsening of depression/anxiety and risk of dependence and overdose. Longer-acting benzodiazepines (eg, clonazepam) are generally not recommended in lactation because of reported effects on infants, including sedation. Shorter-acting benzodiazepines (eg, lorazepam) are considered safer in lactation.39
THE CASE
Julia saw her family physician 4 more times, was evaluated by an ear-nose-and-throat specialist for her throat complaints, saw a therapist for CBT and a psychiatrist for medication, had 3 more ED visits, and lost 23 pounds before she finally agreed to start an SSRI for postpartum anxiety. She screened high on the EPDS-3A (9/9) despite scoring low on the full EPDS for perinatal depression (total, 9/30).
Continue to: Because of her swallowing impediments...
Because of her swallowing impediments and because she was breastfeeding, sertraline solution was started at very small doses. It was titrated weekly to obtain therapeutic levels. By 4 weeks, her weight stabilized. By 8 weeks, she started gaining weight and sleeping better. She saw the therapist regularly to continue CBT techniques. Over the next several months she started eating a normal diet. She is currently maintained on her SSRI, is still breastfeeding, and has achieved insight into her perinatal anxiety disorder.
CORRESPONDENCE
Veronica Jordan, MD, 3569 Round Barn Cir #200, Santa Rosa, CA 95403; [email protected].
1. O’Connor E, Rossom RC, Henninger M, et al. Primary care screening for and treatment of depression in pregnant and postpartum women: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:388-406.
2. Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593-602.
3. Giardinelli L, Innocenti A, Benni L, et al. Depression and anxiety in perinatal period: prevalence and risk factors in an Italian sample. Arch Womens Ment Health. 2012;15:21-30.
4. Rallis S, Skouteris H, McCabe M, et al. A prospective examination of depression, anxiety and stress throughout pregnancy. Women Birth. 2014;27:e36-e42.
5. Ko JY, Rockhill KM, Tong VT, et al. Trends in postpartum depressive symptoms — 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66:153-158.
6. Fairbrother N, Janssen P, Antony MM, et al. Perinatal anxiety disorder prevalence and incidence. J Affect Disord. 2016;200:148-155.
7. Phillips J, Sharpe L, Matthey S, et al. Maternally focused worry. Arch Womens Ment Health. 2009;12:409-418.
8. Buist A, Gotman N, Yonkers KA. Generalized anxiety disorder: course and risk factors in pregnancy. J Affect Disord. 2011;131:277-283.
9. Schlomi Polachek I, Huller Harari L, Baum M, et al. Postpartum anxiety in a cohort of women from the general population: risk factors and association with depression during last week of pregnancy, postpartum depression and postpartum PTSD. Isr J Psychiatry Relat Sci. 2014;51:128-134.
10. Bei B, Coo S, Trinder J. Sleep and mood during pregnancy and the postpartum period. Sleep Med Clin. 2015;10:25-33.
11. Lawson A, Murphy KE, Sloan E, et al. The relationship between sleep and postpartum mental disorders: a systematic review. J Affect Disord. 2015;176:65-77.
12. APA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington, DC: American Psychiatric Association Publishing; 2013.
13. Langan R, Goodbred AJ. Identification and management of peripartum depression. Am Fam Physician. 2016;93:852-858.
14. Ali E. Women’s experiences with postpartum anxiety disorders: a narrative literature review. Int J Womens Health. 2018;10:237-249.
15. Tietz A, Zietlow AL, Reck C. Maternal bonding in mothers with postpartum anxiety disorder: the crucial role of subclinical depressive symptoms and maternal avoidance behaviour. Arch Womens Ment Health. 2014;17:433-442.
16. Field T. Postnatal anxiety prevalence, predictors and effects on development: a narrative review. Infant Behav Dev. 2018;51:24-32.
17. Serim Demirgoren B, Ozbek A, Ormen M, et al. Do mothers with high sodium levels in their breast milk have high depression and anxiety scores? J Int Med Res. 2017;45:843-848.
18. Ystrom E. Breastfeeding cessation and symptoms of anxiety and depression: a longitudinal cohort study. BMC Pregnancy Childbirth. 2012;12:36.
19. Britton JR. Infant temperament and maternal anxiety and depressed mood in the early postpartum period. Women Health. 2011;51:55-71.
20. Glasheen C, Richardson GA, Kim KH, et al. Exposure to maternal pre- and postnatal depression and anxiety symptoms: risk for major depression, anxiety disorders, and conduct disorder in adolescent offspring. Dev Psychopathol. 2013;26:1045-1063.
21. Petrozzi A, Gagliardi L. Anxious and depressive components of Edinburgh Postnatal Depression Scale in maternal postpartum psychological problems. J Perinat Med. 2013;41:343-348.
22. Bina R, Harrington D. The Edinburgh Postnatal Depression Scale: screening tool for postpartum anxiety as well? Findings from a confirmatory factor analysis of the Hebrew version. Matern Child Health J. 2016;20:904-914.
23. Matthey S, Fisher J, Rowe H. Using the Edinburgh postnatal depression scale to screen for anxiety disorders: conceptual and methodological considerations J Affect Disord. 2013;146:224-230.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. Simpson W, Glazer M, Michalski N, et al. Comparative efficacy of the Generalized Anxiety Disorder 7-Item Scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014;59:434-440.
26. Moran TE, Polanin JR, Wenzel A. The Postpartum Worry Scale-Revised: an initial validation of a measure of postpartum worry. Arch Womens Ment Health. 2014;17:41-48.
27. Fallon V, Halford JCG, Bennett KM, et al. The Postpartum Specific Anxiety Scale: development and preliminary validation. Arch Womens Ment Health. 2016;19:1079-1090.
28. Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008;69:621-632.
29. Goodman JH, Guarino A, Chenausky K, et al. CALM Pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Arch Womens Ment Health. 2014;17:373-387.
30. Marchesi C, Ossola P, Amerio A, et al. Clinical management of perinatal anxiety disorders: a systematic review. J Affect Disord. 2016;190:543-550.
31. Feijó L, Hernandez-Reif M, Field T, et al. Mothers’ depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Devel. 2006;29:476-480.
32. Bérard A, Iessa N, Chaabane S, et al. The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81:589-604.
33. Huybrechts KF, Bateman BT, Palmsten K, et al. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA. 2015;313:2142-2151.
34. Cantarutti A, Merlino L, Monzani E, et al. Is the risk of preterm birth and low birth weight affected by the use of antidepressant agents during pregnancy? A population-based investigation. PLoS One. 2016;11:e0168115.
35. Molyneaux E, Howard LM, McGeown HR, et al. Antidepressant treatment for postnatal depression. Cochrane Database Syst Rev. 2014;11:CD002018.
36. Freeman MP. Postpartum depression treatment and breastfeeding. J Clin Psychiatry. 2009;70:e35.
37. ACOG Committee on Practice Bulletins—number 92. Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008;111:1001-1020.
38. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015;30:4-20.
39. NIH. Drugs and Lactation Database. https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm. Accessed February 26, 2019.
THE CASE
Julia* is a 31-year-old woman, gravida 3 para 3, who presents to your office for evaluation after a recent emergency department (ED) visit. Her husband and children are with her. She is 4 months postpartum after an uncomplicated normal spontaneous vaginal delivery. She is breastfeeding her healthy baby boy and is using an intrauterine device for birth control. She went to the ED last week after “choking on a chip” while having lunch with her children. It felt like she “couldn’t breathe.” She called 911 herself. The ED evaluation was unremarkable. Her discharge diagnosis was “panic attack,” and she was sent home with a prescription for lorazepam.
Since the incident, she has been unable to eat any solid foods and has lost 7 pounds. She also reports a globus sensation, extreme fear of swallowing, insomnia, and pervasive thoughts that she could die at any moment and leave her children motherless. She has not taken the lorazepam.
She has a history of self-reported anxiety dating back to high school but no history of panic attacks. She has never been diagnosed with an anxiety disorder and has never before been prescribed anti-anxiety medication. She doesn’t have a history of postpartum depression in prior pregnancies, and a depression screening at her postpartum visit 2 months ago was negative.
●
*The patient’s name has been changed to protect her identity.
During the perinatal period, women are particularly vulnerable to affective disorders, and primary care physicians are encouraged to routinely screen for and treat depression in pregnant and postpartum women.1 However, anxiety disorders have a higher incidence than mood disorders in the general population,2 and perinatal anxiety may be more widely underrecognized and undertreated than depression.3 In addition, higher depression scores early in pregnancy have been shown to predict higher anxiety later in pregnancy.4
As family physicians, we are well-trained to recognize and treat anxiety disorders in the general patient population; however, we may lack the awareness and tools to identify these conditions in the perinatal period. Given our frequent encounters with both mom and baby in a child’s first year of life, we are uniquely positioned to promptly recognize, diagnose, and treat postpartum anxiety and thereby improve health outcomes for families.
DEFINING PERINATAL ANXIETY
Anxiety disorders (including generalized anxiety disorder, panic, phobia, and social anxiety) are the most common mental health disorders evaluated and treated in the primary care setting, with a lifetime prevalence of close to 30%.2
Continue to: A recent report from...
A recent report from the Centers for Disease Control and Prevention (CDC) estimates that 1 in 9 women experience symptoms of postpartum depression.5 The prevalence of anxiety disorders during pregnancy and the early postpartum period is not as well-known, but studies suggest that perinatal anxiety is much more prevalent than depression. In one study, generalized anxiety disorder (GAD) in the pre- and postnatal periods was 15.8% and 17.1%, respectively; an incidence far exceeding that of perinatal depression (3.9% and 4.8%, for the same periods).6 Additional evidence suggests that even more women in the postnatal period experience clinically significant levels of anxiety but do not meet full diagnostic criteria for an anxiety disorder.7
In another study, 9.5% of women met criteria for GAD at some point during pregnancy, with highest anxiety levels in the first trimester.8 Women with a history of GAD, lower education, lack of social support, and personal history of child abuse have the highest risk for postpartum anxiety. Women with a history of posttraumatic stress disorder (PTSD) may be twice as likely to develop postpartum anxiety as healthy women.9
It has been well-documented that sleep disruption—which is very common in new mothers in the postnatal period—contributes to mood and anxiety disorders.10,11
Clarifying a diagnosis of postpartum anxiety
The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)12 specifies no diagnosis of postpartum anxiety disorder. And no standardized diagnostic criteria exist. It is likely that in some cases, postpartum anxiety represents an exacerbation of underlying GAD, and in other cases it is a situational disorder brought about by specific circumstances of the peripartum period.
The DSM-5 does, however, provide a helpful diagnostic approach. It defines a diagnosis of postpartum depression as being a variant of major depressive disorder (MDD) in which a woman must 1) meet criteria for a major depressive episode; and 2) occur during pregnancy or within 4 weeks of delivery. In practice, many clinicians extend the second requirement to include the first year postpartum.13 There is a “with anxious distress” specifier for major depression in the DSM-5, but the 2 disorders are otherwise unlinked.
Continue to: To apply the...
To apply the DSM-5 principles for postpartum depression to postpartum anxiety, a patient would need to 1) meet the diagnostic criteria for an anxiety disorder that 2) have their onset within a specified perinatal period. Variant presentations of anxiety in the postpartum period might include panic disorder and phobias, which could also interfere with a woman’s ability to care for her child.
The DSM-5 offers the following criteria for GAD12:
- excessive worry about a variety of topics
- worry that is experienced as hard to control
- worry associated with at least 3 physical or cognitive symptoms: edginess/restlessness, tiring easily, impaired concentration, irritability
- anxiety, worry, or associated symptoms that make it hard to carry out day-to-day activities and responsibilities
- symptoms that are unrelated to any other medical conditions and cannot be explained by the effect of substances including a prescription medication, alcohol, or recreational drugs
- symptoms that are not better explained by a different mental disorder.
Debilitating effects of postpartum anxiety
Many women experience some level of anxiety during pregnancy and early postpartum—anxiety that may range from normal and adaptive to debilitating.14 While the challenges of caring for a newborn are likely to bring some level of anxiety, these symptoms should be transient and not interfere with a woman’s capacity to care for her infant, herself, or her family.
Postpartum anxiety has been associated with a prior fear of giving birth, fear of death (of both mother and baby), lack of control, lack of self-confidence, and lack of confidence in the medical system.9 The experience of such ongoing disturbing thoughts or feelings of worry and tension that affect a woman’s ability to manage from day to day should indicate an illness state that deserves medical attention.
Mothers with postpartum anxiety disorders report significantly less bonding with their infants than do mothers without anxiety.15 A recent narrative review describes numerous studies that illustrate the negative effects of postpartum anxiety on bonding, breastfeeding, infant temperament, early childhood development, and conduct disorders.16 Anxious women may be less likely to initiate breastfeeding, have more challenges with breastfeeding, and even have a different milk composition.17 Women with prenatal anxiety are also more likely to stop breastfeeding prematurely.18 Children of anxious mothers may be more likely to have a difficult temperament and to display more distress.19 There are small studies demonstrating deficits in early infant development and increases in conduct disorder in the male offspring of anxious women.20
Continue to: SCREENING FOR POSTPARTUM ANXIETY
SCREENING FOR POSTPARTUM ANXIETY
Screening for perinatal depression has become standard of care, and the Edinburgh Postnatal Depression Scale (EPDS) is a widely used instrument.1 The EPDS, a 10-question self-report scale, was created and validated to screen for perinatal depression, with a cutoff of > 10/30 usually considered a positive result.
Researchers have investigated the utility of the EPDS as a screening tool for perinatal anxiety as well.21-23 These studies show some promise, but there are questions as to whether a total score or a subscale score of the EPDS is most accurate in detecting anxiety. Women with perinatal anxiety may score low on the total EPDS, yet score higher on 3 anxiety-specific questions (TABLE 123). For this reason, several studies propose an EPDS anxiety subscore or subscale (referred to as EPDS-3A).
Of note, there are some women who will score high on the subscale who do not ultimately meet the criteria for an anxiety disorder diagnosis. Clinicians should not over-interpret these scores and should always use sound clinical judgment when making a diagnosis.
Research has also focused on using the GAD 7-item (GAD-7) scale (TABLE 224),25 and on the
Family physicians may consider using the EPDS subscale if they are already using the EPDS, or adding the GAD-7 as a separate screening instrument during a postpartum visit. To date there is no one standard recommendation or screening tool.
Continue to: NONPHARMACOLOGIC TREATMENT
NONPHARMACOLOGIC TREATMENT
As one would with any patient who has situational anxiety, help new mothers find ways to increase their coping skills, reduce stress, and mobilize social supports and family resources. Given the association between sleep disruption and perinatal anxiety, counsel new mothers, especially those at high risk for postpartum anxiety, to prioritize sleep during this vulnerable time. To that end, consider recommending that they ask partners, family members, or friends to help them take care of the infant at night (or during the day). Such nonmedical interventions may be sufficient for women with mild anxiety.
Very few studies have addressed nonpharmacologic management of postpartum anxiety, but cognitive behavioral therapy (CBT) has been shown to help in managing and treating anxiety disorders outside of pregnancy.28 A few small studies indicate promise for CBT and for mindfulness-based interventions (MBIs) during pregnancy.29
A 2016 systematic review of pharmacologic and nonpharmacologic treatment of anxiety in the perinatal period found support for the use of CBT for panic disorder and specific phobias both in pregnancy and postpartum.30 A very small study found that teaching mothers to massage their preterm infants decreased maternal anxiety.31
If the patient is amenable, it is reasonable to start with behavioral interventions like CBT or MBI before pharmacologic treatment—particularly when physicians have mental health professionals embedded in their primary care team.
PHARMACOLOGIC TREATMENT
Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) are considered first-line treatment for moderate to severe anxiety disorders in the perinatal and postnatal period.
Continue to: SSRIs in pregnancy
SSRIs in pregnancy. Lacking support of randomized controlled trials, most recommendations regarding SSRIs in pregnancy come from expert consensus or cohort and case control studies. Studies have raised concerns for an increased rate of congenital heart defects among fetuses exposed to paroxetine32 and primary pulmonary hypertension with all SSRIs.33 But the absolute risks are quite small. There have also been concerns regarding low birth weight and preterm birth, but it is possible that these outcomes result from the depression itself rather than the medication.34
Unfortunately, there are very few studies evaluating the efficacy of SSRIs in treating postpartum depression35 and even fewer that specifically evaluate their effect on perinatal anxiety. Many experts believe that not treating anxiety/depression is actually more harmful than the fetal effects of SSRIs, and that SSRIs are largely safe in both pregnancy and while breastfeeding, with benefits outweighing the risks.
SSRIs while breastfeeding. SSRIs have been found to be present in varying levels in breastmilk but may or may not be present in the serum of nursing infants.36 A 2008 guideline from the American College of Obstetricians and Gynecologists lists paroxetine, sertraline, and fluvoxamine as slightly safer than fluoxetine, escitalopram, and citalopram.37 A 2015 systematic review similarly concluded that sertraline and paroxetine have the most safety data on lactation.38 Lowest effective dose is always recommended to minimize exposure.
Benzodiazepines. As in the general population, benzodiazepines should be reserved for short-term use in acute anxiety and panic because they are associated with such adverse effects as worsening of depression/anxiety and risk of dependence and overdose. Longer-acting benzodiazepines (eg, clonazepam) are generally not recommended in lactation because of reported effects on infants, including sedation. Shorter-acting benzodiazepines (eg, lorazepam) are considered safer in lactation.39
THE CASE
Julia saw her family physician 4 more times, was evaluated by an ear-nose-and-throat specialist for her throat complaints, saw a therapist for CBT and a psychiatrist for medication, had 3 more ED visits, and lost 23 pounds before she finally agreed to start an SSRI for postpartum anxiety. She screened high on the EPDS-3A (9/9) despite scoring low on the full EPDS for perinatal depression (total, 9/30).
Continue to: Because of her swallowing impediments...
Because of her swallowing impediments and because she was breastfeeding, sertraline solution was started at very small doses. It was titrated weekly to obtain therapeutic levels. By 4 weeks, her weight stabilized. By 8 weeks, she started gaining weight and sleeping better. She saw the therapist regularly to continue CBT techniques. Over the next several months she started eating a normal diet. She is currently maintained on her SSRI, is still breastfeeding, and has achieved insight into her perinatal anxiety disorder.
CORRESPONDENCE
Veronica Jordan, MD, 3569 Round Barn Cir #200, Santa Rosa, CA 95403; [email protected].
THE CASE
Julia* is a 31-year-old woman, gravida 3 para 3, who presents to your office for evaluation after a recent emergency department (ED) visit. Her husband and children are with her. She is 4 months postpartum after an uncomplicated normal spontaneous vaginal delivery. She is breastfeeding her healthy baby boy and is using an intrauterine device for birth control. She went to the ED last week after “choking on a chip” while having lunch with her children. It felt like she “couldn’t breathe.” She called 911 herself. The ED evaluation was unremarkable. Her discharge diagnosis was “panic attack,” and she was sent home with a prescription for lorazepam.
Since the incident, she has been unable to eat any solid foods and has lost 7 pounds. She also reports a globus sensation, extreme fear of swallowing, insomnia, and pervasive thoughts that she could die at any moment and leave her children motherless. She has not taken the lorazepam.
She has a history of self-reported anxiety dating back to high school but no history of panic attacks. She has never been diagnosed with an anxiety disorder and has never before been prescribed anti-anxiety medication. She doesn’t have a history of postpartum depression in prior pregnancies, and a depression screening at her postpartum visit 2 months ago was negative.
●
*The patient’s name has been changed to protect her identity.
During the perinatal period, women are particularly vulnerable to affective disorders, and primary care physicians are encouraged to routinely screen for and treat depression in pregnant and postpartum women.1 However, anxiety disorders have a higher incidence than mood disorders in the general population,2 and perinatal anxiety may be more widely underrecognized and undertreated than depression.3 In addition, higher depression scores early in pregnancy have been shown to predict higher anxiety later in pregnancy.4
As family physicians, we are well-trained to recognize and treat anxiety disorders in the general patient population; however, we may lack the awareness and tools to identify these conditions in the perinatal period. Given our frequent encounters with both mom and baby in a child’s first year of life, we are uniquely positioned to promptly recognize, diagnose, and treat postpartum anxiety and thereby improve health outcomes for families.
DEFINING PERINATAL ANXIETY
Anxiety disorders (including generalized anxiety disorder, panic, phobia, and social anxiety) are the most common mental health disorders evaluated and treated in the primary care setting, with a lifetime prevalence of close to 30%.2
Continue to: A recent report from...
A recent report from the Centers for Disease Control and Prevention (CDC) estimates that 1 in 9 women experience symptoms of postpartum depression.5 The prevalence of anxiety disorders during pregnancy and the early postpartum period is not as well-known, but studies suggest that perinatal anxiety is much more prevalent than depression. In one study, generalized anxiety disorder (GAD) in the pre- and postnatal periods was 15.8% and 17.1%, respectively; an incidence far exceeding that of perinatal depression (3.9% and 4.8%, for the same periods).6 Additional evidence suggests that even more women in the postnatal period experience clinically significant levels of anxiety but do not meet full diagnostic criteria for an anxiety disorder.7
In another study, 9.5% of women met criteria for GAD at some point during pregnancy, with highest anxiety levels in the first trimester.8 Women with a history of GAD, lower education, lack of social support, and personal history of child abuse have the highest risk for postpartum anxiety. Women with a history of posttraumatic stress disorder (PTSD) may be twice as likely to develop postpartum anxiety as healthy women.9
It has been well-documented that sleep disruption—which is very common in new mothers in the postnatal period—contributes to mood and anxiety disorders.10,11
Clarifying a diagnosis of postpartum anxiety
The Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)12 specifies no diagnosis of postpartum anxiety disorder. And no standardized diagnostic criteria exist. It is likely that in some cases, postpartum anxiety represents an exacerbation of underlying GAD, and in other cases it is a situational disorder brought about by specific circumstances of the peripartum period.
The DSM-5 does, however, provide a helpful diagnostic approach. It defines a diagnosis of postpartum depression as being a variant of major depressive disorder (MDD) in which a woman must 1) meet criteria for a major depressive episode; and 2) occur during pregnancy or within 4 weeks of delivery. In practice, many clinicians extend the second requirement to include the first year postpartum.13 There is a “with anxious distress” specifier for major depression in the DSM-5, but the 2 disorders are otherwise unlinked.
Continue to: To apply the...
To apply the DSM-5 principles for postpartum depression to postpartum anxiety, a patient would need to 1) meet the diagnostic criteria for an anxiety disorder that 2) have their onset within a specified perinatal period. Variant presentations of anxiety in the postpartum period might include panic disorder and phobias, which could also interfere with a woman’s ability to care for her child.
The DSM-5 offers the following criteria for GAD12:
- excessive worry about a variety of topics
- worry that is experienced as hard to control
- worry associated with at least 3 physical or cognitive symptoms: edginess/restlessness, tiring easily, impaired concentration, irritability
- anxiety, worry, or associated symptoms that make it hard to carry out day-to-day activities and responsibilities
- symptoms that are unrelated to any other medical conditions and cannot be explained by the effect of substances including a prescription medication, alcohol, or recreational drugs
- symptoms that are not better explained by a different mental disorder.
Debilitating effects of postpartum anxiety
Many women experience some level of anxiety during pregnancy and early postpartum—anxiety that may range from normal and adaptive to debilitating.14 While the challenges of caring for a newborn are likely to bring some level of anxiety, these symptoms should be transient and not interfere with a woman’s capacity to care for her infant, herself, or her family.
Postpartum anxiety has been associated with a prior fear of giving birth, fear of death (of both mother and baby), lack of control, lack of self-confidence, and lack of confidence in the medical system.9 The experience of such ongoing disturbing thoughts or feelings of worry and tension that affect a woman’s ability to manage from day to day should indicate an illness state that deserves medical attention.
Mothers with postpartum anxiety disorders report significantly less bonding with their infants than do mothers without anxiety.15 A recent narrative review describes numerous studies that illustrate the negative effects of postpartum anxiety on bonding, breastfeeding, infant temperament, early childhood development, and conduct disorders.16 Anxious women may be less likely to initiate breastfeeding, have more challenges with breastfeeding, and even have a different milk composition.17 Women with prenatal anxiety are also more likely to stop breastfeeding prematurely.18 Children of anxious mothers may be more likely to have a difficult temperament and to display more distress.19 There are small studies demonstrating deficits in early infant development and increases in conduct disorder in the male offspring of anxious women.20
Continue to: SCREENING FOR POSTPARTUM ANXIETY
SCREENING FOR POSTPARTUM ANXIETY
Screening for perinatal depression has become standard of care, and the Edinburgh Postnatal Depression Scale (EPDS) is a widely used instrument.1 The EPDS, a 10-question self-report scale, was created and validated to screen for perinatal depression, with a cutoff of > 10/30 usually considered a positive result.
Researchers have investigated the utility of the EPDS as a screening tool for perinatal anxiety as well.21-23 These studies show some promise, but there are questions as to whether a total score or a subscale score of the EPDS is most accurate in detecting anxiety. Women with perinatal anxiety may score low on the total EPDS, yet score higher on 3 anxiety-specific questions (TABLE 123). For this reason, several studies propose an EPDS anxiety subscore or subscale (referred to as EPDS-3A).
Of note, there are some women who will score high on the subscale who do not ultimately meet the criteria for an anxiety disorder diagnosis. Clinicians should not over-interpret these scores and should always use sound clinical judgment when making a diagnosis.
Research has also focused on using the GAD 7-item (GAD-7) scale (TABLE 224),25 and on the
Family physicians may consider using the EPDS subscale if they are already using the EPDS, or adding the GAD-7 as a separate screening instrument during a postpartum visit. To date there is no one standard recommendation or screening tool.
Continue to: NONPHARMACOLOGIC TREATMENT
NONPHARMACOLOGIC TREATMENT
As one would with any patient who has situational anxiety, help new mothers find ways to increase their coping skills, reduce stress, and mobilize social supports and family resources. Given the association between sleep disruption and perinatal anxiety, counsel new mothers, especially those at high risk for postpartum anxiety, to prioritize sleep during this vulnerable time. To that end, consider recommending that they ask partners, family members, or friends to help them take care of the infant at night (or during the day). Such nonmedical interventions may be sufficient for women with mild anxiety.
Very few studies have addressed nonpharmacologic management of postpartum anxiety, but cognitive behavioral therapy (CBT) has been shown to help in managing and treating anxiety disorders outside of pregnancy.28 A few small studies indicate promise for CBT and for mindfulness-based interventions (MBIs) during pregnancy.29
A 2016 systematic review of pharmacologic and nonpharmacologic treatment of anxiety in the perinatal period found support for the use of CBT for panic disorder and specific phobias both in pregnancy and postpartum.30 A very small study found that teaching mothers to massage their preterm infants decreased maternal anxiety.31
If the patient is amenable, it is reasonable to start with behavioral interventions like CBT or MBI before pharmacologic treatment—particularly when physicians have mental health professionals embedded in their primary care team.
PHARMACOLOGIC TREATMENT
Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) are considered first-line treatment for moderate to severe anxiety disorders in the perinatal and postnatal period.
Continue to: SSRIs in pregnancy
SSRIs in pregnancy. Lacking support of randomized controlled trials, most recommendations regarding SSRIs in pregnancy come from expert consensus or cohort and case control studies. Studies have raised concerns for an increased rate of congenital heart defects among fetuses exposed to paroxetine32 and primary pulmonary hypertension with all SSRIs.33 But the absolute risks are quite small. There have also been concerns regarding low birth weight and preterm birth, but it is possible that these outcomes result from the depression itself rather than the medication.34
Unfortunately, there are very few studies evaluating the efficacy of SSRIs in treating postpartum depression35 and even fewer that specifically evaluate their effect on perinatal anxiety. Many experts believe that not treating anxiety/depression is actually more harmful than the fetal effects of SSRIs, and that SSRIs are largely safe in both pregnancy and while breastfeeding, with benefits outweighing the risks.
SSRIs while breastfeeding. SSRIs have been found to be present in varying levels in breastmilk but may or may not be present in the serum of nursing infants.36 A 2008 guideline from the American College of Obstetricians and Gynecologists lists paroxetine, sertraline, and fluvoxamine as slightly safer than fluoxetine, escitalopram, and citalopram.37 A 2015 systematic review similarly concluded that sertraline and paroxetine have the most safety data on lactation.38 Lowest effective dose is always recommended to minimize exposure.
Benzodiazepines. As in the general population, benzodiazepines should be reserved for short-term use in acute anxiety and panic because they are associated with such adverse effects as worsening of depression/anxiety and risk of dependence and overdose. Longer-acting benzodiazepines (eg, clonazepam) are generally not recommended in lactation because of reported effects on infants, including sedation. Shorter-acting benzodiazepines (eg, lorazepam) are considered safer in lactation.39
THE CASE
Julia saw her family physician 4 more times, was evaluated by an ear-nose-and-throat specialist for her throat complaints, saw a therapist for CBT and a psychiatrist for medication, had 3 more ED visits, and lost 23 pounds before she finally agreed to start an SSRI for postpartum anxiety. She screened high on the EPDS-3A (9/9) despite scoring low on the full EPDS for perinatal depression (total, 9/30).
Continue to: Because of her swallowing impediments...
Because of her swallowing impediments and because she was breastfeeding, sertraline solution was started at very small doses. It was titrated weekly to obtain therapeutic levels. By 4 weeks, her weight stabilized. By 8 weeks, she started gaining weight and sleeping better. She saw the therapist regularly to continue CBT techniques. Over the next several months she started eating a normal diet. She is currently maintained on her SSRI, is still breastfeeding, and has achieved insight into her perinatal anxiety disorder.
CORRESPONDENCE
Veronica Jordan, MD, 3569 Round Barn Cir #200, Santa Rosa, CA 95403; [email protected].
1. O’Connor E, Rossom RC, Henninger M, et al. Primary care screening for and treatment of depression in pregnant and postpartum women: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:388-406.
2. Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593-602.
3. Giardinelli L, Innocenti A, Benni L, et al. Depression and anxiety in perinatal period: prevalence and risk factors in an Italian sample. Arch Womens Ment Health. 2012;15:21-30.
4. Rallis S, Skouteris H, McCabe M, et al. A prospective examination of depression, anxiety and stress throughout pregnancy. Women Birth. 2014;27:e36-e42.
5. Ko JY, Rockhill KM, Tong VT, et al. Trends in postpartum depressive symptoms — 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66:153-158.
6. Fairbrother N, Janssen P, Antony MM, et al. Perinatal anxiety disorder prevalence and incidence. J Affect Disord. 2016;200:148-155.
7. Phillips J, Sharpe L, Matthey S, et al. Maternally focused worry. Arch Womens Ment Health. 2009;12:409-418.
8. Buist A, Gotman N, Yonkers KA. Generalized anxiety disorder: course and risk factors in pregnancy. J Affect Disord. 2011;131:277-283.
9. Schlomi Polachek I, Huller Harari L, Baum M, et al. Postpartum anxiety in a cohort of women from the general population: risk factors and association with depression during last week of pregnancy, postpartum depression and postpartum PTSD. Isr J Psychiatry Relat Sci. 2014;51:128-134.
10. Bei B, Coo S, Trinder J. Sleep and mood during pregnancy and the postpartum period. Sleep Med Clin. 2015;10:25-33.
11. Lawson A, Murphy KE, Sloan E, et al. The relationship between sleep and postpartum mental disorders: a systematic review. J Affect Disord. 2015;176:65-77.
12. APA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington, DC: American Psychiatric Association Publishing; 2013.
13. Langan R, Goodbred AJ. Identification and management of peripartum depression. Am Fam Physician. 2016;93:852-858.
14. Ali E. Women’s experiences with postpartum anxiety disorders: a narrative literature review. Int J Womens Health. 2018;10:237-249.
15. Tietz A, Zietlow AL, Reck C. Maternal bonding in mothers with postpartum anxiety disorder: the crucial role of subclinical depressive symptoms and maternal avoidance behaviour. Arch Womens Ment Health. 2014;17:433-442.
16. Field T. Postnatal anxiety prevalence, predictors and effects on development: a narrative review. Infant Behav Dev. 2018;51:24-32.
17. Serim Demirgoren B, Ozbek A, Ormen M, et al. Do mothers with high sodium levels in their breast milk have high depression and anxiety scores? J Int Med Res. 2017;45:843-848.
18. Ystrom E. Breastfeeding cessation and symptoms of anxiety and depression: a longitudinal cohort study. BMC Pregnancy Childbirth. 2012;12:36.
19. Britton JR. Infant temperament and maternal anxiety and depressed mood in the early postpartum period. Women Health. 2011;51:55-71.
20. Glasheen C, Richardson GA, Kim KH, et al. Exposure to maternal pre- and postnatal depression and anxiety symptoms: risk for major depression, anxiety disorders, and conduct disorder in adolescent offspring. Dev Psychopathol. 2013;26:1045-1063.
21. Petrozzi A, Gagliardi L. Anxious and depressive components of Edinburgh Postnatal Depression Scale in maternal postpartum psychological problems. J Perinat Med. 2013;41:343-348.
22. Bina R, Harrington D. The Edinburgh Postnatal Depression Scale: screening tool for postpartum anxiety as well? Findings from a confirmatory factor analysis of the Hebrew version. Matern Child Health J. 2016;20:904-914.
23. Matthey S, Fisher J, Rowe H. Using the Edinburgh postnatal depression scale to screen for anxiety disorders: conceptual and methodological considerations J Affect Disord. 2013;146:224-230.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. Simpson W, Glazer M, Michalski N, et al. Comparative efficacy of the Generalized Anxiety Disorder 7-Item Scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014;59:434-440.
26. Moran TE, Polanin JR, Wenzel A. The Postpartum Worry Scale-Revised: an initial validation of a measure of postpartum worry. Arch Womens Ment Health. 2014;17:41-48.
27. Fallon V, Halford JCG, Bennett KM, et al. The Postpartum Specific Anxiety Scale: development and preliminary validation. Arch Womens Ment Health. 2016;19:1079-1090.
28. Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008;69:621-632.
29. Goodman JH, Guarino A, Chenausky K, et al. CALM Pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Arch Womens Ment Health. 2014;17:373-387.
30. Marchesi C, Ossola P, Amerio A, et al. Clinical management of perinatal anxiety disorders: a systematic review. J Affect Disord. 2016;190:543-550.
31. Feijó L, Hernandez-Reif M, Field T, et al. Mothers’ depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Devel. 2006;29:476-480.
32. Bérard A, Iessa N, Chaabane S, et al. The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81:589-604.
33. Huybrechts KF, Bateman BT, Palmsten K, et al. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA. 2015;313:2142-2151.
34. Cantarutti A, Merlino L, Monzani E, et al. Is the risk of preterm birth and low birth weight affected by the use of antidepressant agents during pregnancy? A population-based investigation. PLoS One. 2016;11:e0168115.
35. Molyneaux E, Howard LM, McGeown HR, et al. Antidepressant treatment for postnatal depression. Cochrane Database Syst Rev. 2014;11:CD002018.
36. Freeman MP. Postpartum depression treatment and breastfeeding. J Clin Psychiatry. 2009;70:e35.
37. ACOG Committee on Practice Bulletins—number 92. Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008;111:1001-1020.
38. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015;30:4-20.
39. NIH. Drugs and Lactation Database. https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm. Accessed February 26, 2019.
1. O’Connor E, Rossom RC, Henninger M, et al. Primary care screening for and treatment of depression in pregnant and postpartum women: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;315:388-406.
2. Kessler RC, Berglund P, Demler O, et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593-602.
3. Giardinelli L, Innocenti A, Benni L, et al. Depression and anxiety in perinatal period: prevalence and risk factors in an Italian sample. Arch Womens Ment Health. 2012;15:21-30.
4. Rallis S, Skouteris H, McCabe M, et al. A prospective examination of depression, anxiety and stress throughout pregnancy. Women Birth. 2014;27:e36-e42.
5. Ko JY, Rockhill KM, Tong VT, et al. Trends in postpartum depressive symptoms — 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017;66:153-158.
6. Fairbrother N, Janssen P, Antony MM, et al. Perinatal anxiety disorder prevalence and incidence. J Affect Disord. 2016;200:148-155.
7. Phillips J, Sharpe L, Matthey S, et al. Maternally focused worry. Arch Womens Ment Health. 2009;12:409-418.
8. Buist A, Gotman N, Yonkers KA. Generalized anxiety disorder: course and risk factors in pregnancy. J Affect Disord. 2011;131:277-283.
9. Schlomi Polachek I, Huller Harari L, Baum M, et al. Postpartum anxiety in a cohort of women from the general population: risk factors and association with depression during last week of pregnancy, postpartum depression and postpartum PTSD. Isr J Psychiatry Relat Sci. 2014;51:128-134.
10. Bei B, Coo S, Trinder J. Sleep and mood during pregnancy and the postpartum period. Sleep Med Clin. 2015;10:25-33.
11. Lawson A, Murphy KE, Sloan E, et al. The relationship between sleep and postpartum mental disorders: a systematic review. J Affect Disord. 2015;176:65-77.
12. APA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington, DC: American Psychiatric Association Publishing; 2013.
13. Langan R, Goodbred AJ. Identification and management of peripartum depression. Am Fam Physician. 2016;93:852-858.
14. Ali E. Women’s experiences with postpartum anxiety disorders: a narrative literature review. Int J Womens Health. 2018;10:237-249.
15. Tietz A, Zietlow AL, Reck C. Maternal bonding in mothers with postpartum anxiety disorder: the crucial role of subclinical depressive symptoms and maternal avoidance behaviour. Arch Womens Ment Health. 2014;17:433-442.
16. Field T. Postnatal anxiety prevalence, predictors and effects on development: a narrative review. Infant Behav Dev. 2018;51:24-32.
17. Serim Demirgoren B, Ozbek A, Ormen M, et al. Do mothers with high sodium levels in their breast milk have high depression and anxiety scores? J Int Med Res. 2017;45:843-848.
18. Ystrom E. Breastfeeding cessation and symptoms of anxiety and depression: a longitudinal cohort study. BMC Pregnancy Childbirth. 2012;12:36.
19. Britton JR. Infant temperament and maternal anxiety and depressed mood in the early postpartum period. Women Health. 2011;51:55-71.
20. Glasheen C, Richardson GA, Kim KH, et al. Exposure to maternal pre- and postnatal depression and anxiety symptoms: risk for major depression, anxiety disorders, and conduct disorder in adolescent offspring. Dev Psychopathol. 2013;26:1045-1063.
21. Petrozzi A, Gagliardi L. Anxious and depressive components of Edinburgh Postnatal Depression Scale in maternal postpartum psychological problems. J Perinat Med. 2013;41:343-348.
22. Bina R, Harrington D. The Edinburgh Postnatal Depression Scale: screening tool for postpartum anxiety as well? Findings from a confirmatory factor analysis of the Hebrew version. Matern Child Health J. 2016;20:904-914.
23. Matthey S, Fisher J, Rowe H. Using the Edinburgh postnatal depression scale to screen for anxiety disorders: conceptual and methodological considerations J Affect Disord. 2013;146:224-230.
24. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092-1097.
25. Simpson W, Glazer M, Michalski N, et al. Comparative efficacy of the Generalized Anxiety Disorder 7-Item Scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014;59:434-440.
26. Moran TE, Polanin JR, Wenzel A. The Postpartum Worry Scale-Revised: an initial validation of a measure of postpartum worry. Arch Womens Ment Health. 2014;17:41-48.
27. Fallon V, Halford JCG, Bennett KM, et al. The Postpartum Specific Anxiety Scale: development and preliminary validation. Arch Womens Ment Health. 2016;19:1079-1090.
28. Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008;69:621-632.
29. Goodman JH, Guarino A, Chenausky K, et al. CALM Pregnancy: results of a pilot study of mindfulness-based cognitive therapy for perinatal anxiety. Arch Womens Ment Health. 2014;17:373-387.
30. Marchesi C, Ossola P, Amerio A, et al. Clinical management of perinatal anxiety disorders: a systematic review. J Affect Disord. 2016;190:543-550.
31. Feijó L, Hernandez-Reif M, Field T, et al. Mothers’ depressed mood and anxiety levels are reduced after massaging their preterm infants. Infant Behav Devel. 2006;29:476-480.
32. Bérard A, Iessa N, Chaabane S, et al. The risk of major cardiac malformations associated with paroxetine use during the first trimester of pregnancy: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016;81:589-604.
33. Huybrechts KF, Bateman BT, Palmsten K, et al. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA. 2015;313:2142-2151.
34. Cantarutti A, Merlino L, Monzani E, et al. Is the risk of preterm birth and low birth weight affected by the use of antidepressant agents during pregnancy? A population-based investigation. PLoS One. 2016;11:e0168115.
35. Molyneaux E, Howard LM, McGeown HR, et al. Antidepressant treatment for postnatal depression. Cochrane Database Syst Rev. 2014;11:CD002018.
36. Freeman MP. Postpartum depression treatment and breastfeeding. J Clin Psychiatry. 2009;70:e35.
37. ACOG Committee on Practice Bulletins—number 92. Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008;111:1001-1020.
38. Orsolini L, Bellantuono C. Serotonin reuptake inhibitors and breastfeeding: a systematic review. Hum Psychopharmacol. 2015;30:4-20.
39. NIH. Drugs and Lactation Database. https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm. Accessed February 26, 2019.
It’s time to start asking all patients about intimate partner violence
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
Intimate partner violence (IPV) is a serious public health problem with considerable harmful health consequences. Decades of research have been dedicated to improving the identification of women in abusive heterosexual relationships and interventions that support healthier outcomes. A result of this work has been the recommendation of the US Preventive Services Task Force that all women of childbearing age be screened for IPV and provided with intervention or referral.1
The problem extends further, however: Epidemiologic studies and comprehensive reviews show: 1) a high rate of IPV victimization among heterosexual men and lesbian, gay, bisexual, and transsexual (LGBT) men and women2,3; 2) significant harmful effects on health and greater expectations of prejudice and discrimination among these populations4-6; and 3) evidence that screening and referral for IPV are likely to confer similar benefits for these populations.7 We argue that it is reasonable to ask all patients about abuse in their relationships while the research literature progresses.
We intend this article to serve a number of purposes:
- support national standards for IPV screening of female patients
- highlight the need for piloting universal IPV screening for all patients (ie, male and female, across the lifespan)
- offer recommendations for navigating the process from IPV screening to referral, using insights gained from the substance abuse literature.
We also provide supplemental materials that facilitate establishment of screening and referral protocols for physicians across practice settings.
What is intimate partner violence? How can you identify it?
Intimate partner violence includes physical and sexual violence and nonphysical forms of abuse, such as psychological aggression and emotional abuse, perpetrated by a current or former intimate partner.8 TABLE 19-14 provides definitions for each of these behavior categories and example behaviors. Nearly 25% of women and 20% of men report having experienced physical violence from a romantic partner and even higher rates of nonphysical IPV.15 Consequences of IPV victimization include acute and chronic medical illness, injury, and psychological problems, including depression, anxiety, and poor self-esteem.16
Intimate partner violence is heterogeneous, with differences in severity (eg, frequency and intensity of violence) and laterality (ie, is one partner violent? are both partners violent?). A recent comprehensive review of the literature revealed that, for 49.2%-69.7% of partner-violent couples across diverse samples, IPV is perpetrated by both partners.17 Furthermore, this bidirectionality is not due entirely to aggression perpetrated in self-defense; rather, across diverse patient samples, that is the case for fewer than one-quarter of males and no more than approximately one-third of females.18 In the remaining cases, bidirectionality may be attributed to other motivations, such as a maladaptive emotional expression or a means by which to get a partner’s attention.18
Women are disproportionately susceptible to harmful outcomes as a result of severe violence, including physical injury, psychological distress (eg, depression and anxiety), and substance abuse.16,19 Some patients in unidirectionally violent relationships experience severe physical violence that may be, or become, life-threatening (0.4%-2.4% of couples in community samples)20—victimization that is traditionally known as “battering.”21
Continue to: These tools can facilitate screening for IPV
These tools can facilitate screening for IPV
Physicians might have reservations asking about IPV because of 1) concern whether there is sufficient time during an office visit to interview, screen, and refer, 2) feelings of powerlessness to stop violence by or toward a patient, and 3) general discomfort with the topic.22 Additionally, mandated reporting laws regarding IPV vary by state, making it crucial to know one’s own state laws on this issue to protect the safety of the patient and those around them.
Research has shown that some patients prefer that their health care providers ask about relationship violence directly23; others are more willing to acknowledge IPV if asked using a paper-and-pencil measure, rather than face-to-face questions.24 Either way, screening increases the likelihood of engaging the patient in supportive services, thus decreasing the isolation that is typical of abuse.25 Based on this research, screening that utilizes face-valid items embedded within paperwork completed in the waiting room is recommended as an important first step toward identifying and helping patients who are experiencing IPV. Even under these conditions, however, heterosexual men and sexual minorities might be less willing than heterosexual women to admit experiencing IPV.26,27
A brief vignette that depicts how quickly the screening and referral process can be applied is presented in “IPV screening and referral: A real-world vignette." The vignette is a de-identified composite of heterosexual men experiencing IPV whom we have counseled.
SIDEBAR
IPV screening and referral: A real-world vignette
Physician: Before we wrap up: I noticed on your screening that you have been hurt and threatened a fair amount in the past year. Would it be OK if we spoke about that more?
Patient: My wife is emotional. Sometimes she gets really stressed out and just starts screaming and punching me. That’s just how she is.
Physician: Do you ever feel concerned for your safety?
Patient: Not really. She’s smaller than me and I can generally calm her down. I keep the guns locked up, so she can’t grab those any more. Mostly she just screams at me.
Physician: This may or may not fit with your perception but, based on what you are reporting, your relationship is what is called “at risk”—meaning you are at risk for having your physical or mental health negatively impacted. This actually happens to a lot of men, and there’s a brochure I can give you that has a lot more information about the risks and consequences of being hurt or threatened by a partner. Would you be willing to take a look at it?
Patient: I guess so.
Physician: OK. I’ll have the nurse bring you that brochure, and we can talk more about it next time you come in for an appointment. Would it be OK if we get you back in here 6 months from now?
Patient: Yeah, that could work.
Physician: Great. Let’s do that. Don’t hesitate to give me a call if your situation changes in any way in the meantime.
One model that provides a useful framework for IPV assessment is the Screening, Brief Intervention, and Referral to Treatment (SBIRT) model, which was developed to facilitate assessment of, and referral for, substance abuse—another heavily stigmatized health care problem. The SBIRT approach for substance abuse screening is associated with significant reduction in alcohol and drug abuse 6 months postintervention, as well as improvements in well-being, mental health, and functioning across gender, race and ethnicity, and age.28
IPASSPRT. Inspired by the SBIRT model for substance abuse, we created the Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment, or IPASSPRT (spoken as “i-passport”) project to provide tools that make IPV screening and referral accessible to a range of health care providers. These tools include a script and safety plan that guide providers through screening, safety planning, and referral in a manner that is collaborative and grounded in the spirit of motivational interviewing. We have made these tools available on the Web for ease of distribution (http://bit.ly/ipassprt; open by linking through “IPASSPRT-Script”).
Continue to: The IPASSPRT script appears lengthy...
The IPASSPRT script appears lengthy, but progress through its sections is directed by patient need; most patients will not require that all parts be completed. For example, a patient whose screen for IPV is negative and who feels safe in their relationship does not need assessment beyond page 2; on the other hand, the physician might need more information from a patient who is at greater risk for IPV. This response-based progression through the script makes the screening process dynamic, data-driven, and tailored to the patient’s needs—an approach that aids rapport and optimizes the physician’s limited time during the appointment.
In the sections that follow, we describe key components of this script.
What aggression, if any, is present? From whom? The Hurt, Insult, Threaten, and Scream inventory (HITS) (TABLE 2)29 is a widely used screen for IPV that has been validated for use in family medicine. A 4-item scale asks patients to report how often their partner physically hurts, insults, threatens, and screams at them using a 5-point scale (1 point, “never,” to 5 points, “frequently”). Although a score > 10 is indicative of IPV, item-level analysis is encouraged. Attending to which items the patient acknowledges and how often these behaviors occur yields a richer assessment than a summary score. In regard to simply asking a patient, “Do you feel safe at home?” (sensitivity of this question, 8.8%; specificity, 91.2%), the HITS better detects IPV with male and female patient populations in family practice and emergency care settings (sensitivity, 30%-100%; specificity, 86%-99%).27,30
What contextual factors and related concerns are present? It is important to understand proximal factors that might influence IPV risk to determine what kind of referral or treatment is appropriate—particularly for patients experiencing or engaging in infrequent, noninjurious, and bidirectional forms of IPV. Environmental and contextual stressors, such as financial hardship, unemployment, pregnancy, and discussion of divorce, can increase the risk for IPV.31,32 Situational influences, such as alcohol and drug intoxication, can also increase the risk for IPV. Victims of partner violence are at greater risk for mental health problems, including depression, anxiety, trauma- and stressor-related disorders, and substance use disorders. Risk goes both ways, however: Mental illness predicts subsequent IPV perpetration or victimization, and vice versa.31
Does the patient feel safe? Assessing the situation. Patient perception of safety in the relationship provides important information about the necessity of referral. Asking a patient if they feel unsafe because of the behavior of a current or former partner sheds light on the need for further safety assessment and immediate connection with appropriate resources.
Continue to: The Danger Assessment-5...
The Danger Assessment-5 (DA-5) (TABLE 333) is a useful 5-item tool for quickly assessing the risk for severe IPV.33 Patients respond to whether:
- the frequency or severity of violence has increased in the past year
- the partner has ever used, or threatened to use, a weapon
- the patient believes the partner is capable of killing her (him)
- the partner has ever tried to choke or strangle her (him)
- the partner is violently and constantly jealous.
Sensitivity and specificity analyses with a high-risk female sample suggested that 3 affirmative responses indicate a high risk for severe IPV and a need for adequate safety planning.
Brief motivational enhancement intervention. There are 3 components to this intervention.
- Assess interest in making changes or seeking help. IPV is paradoxical: Many factors complicate the decision to leave or stay, and patients across the spectrum of victimization might have some motivation to stay with their partner. It is important to assess the patient’s motivation to make changes in their relationship.4,34
- Provide feedback on screening. Sharing the results of screening with patients makes the assessment and referral process collaborative and transparent; collaborative engagement helps patients feel in control and invested in the follow-through.35 In the spirit of this endeavor, physicians are encouraged to refrain from providing raw or total scores from the measures; instead, share the interpretation of those scores, based on the participant’s responses to the screening items, in a matter-of-fact manner. At this point, elicit the patient’s response to this information, listen empathically, and answer questions before proceeding.
Consistent with screening for other serious health problems, we recommend that all patients be provided with information about abuse in romantic relationships. The National Center for Injury Prevention and Control Division of Violence Prevention has published a useful, easy-to-understand fact sheet (www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf) that provides an overview of IPV-related behavior, how it influences health outcomes, who is at risk for IPV, and sources for support.
Continue to: Our IPASSPRT interview script...
Our IPASSPRT interview script (http://bit.ly/ipassprt) outlines how this information can be presented to patients as a typical part of the screening process. Providers are encouraged to share and review the information from the fact sheet with all patients and present it as part of the normal screening process to mitigate the potential for defensiveness on the part of the patient. For patients who screen positive for IPV, it might be important to brainstorm ideas for a safe, secure place to store this fact sheet and other resources from the brief intervention and referral process below (eg, a safety plan and specific referral information) so that the patient can access them quickly and easily, if needed.
For patients who screen negative for IPV, their screen and interview conclude at this point.
- Provide recommendations based on the screen. Evidence suggests that collaborating with the patient on safety planning and referral can increase the likelihood of their engagement.7 Furthermore, failure to tailor the referral to the needs of the patient can be detrimental36—ie, overshooting the level of intervention might decrease the patient’s future treatment-seeking behavior and undermine their internal coping strategies, increasing the likelihood of future victimization. For that reason, we provide the following guidance on navigating the referral process for patients who screen positive for IPV.
Screening-based referral: A delicate and collaborative process
Referral for IPV victimization. Individual counseling, with or without an IPV focus, might be appropriate for patients at lower levels of risk; immediate connection with local IPV resources is strongly encouraged for patients at higher risk. This is a delicate, collaborative process, in which the physician offers recommendations for referral commensurate to the patient’s risk but must, ultimately, respect the patient’s autonomy by identifying referrals that fit the patient’s goals. We encourage providers to provide risk-informed recommendations and to elicit the patient’s thoughts about that information.
Several online resources are available to help physicians locate and connect with IPV-related resources in their community, including the National Health Resource Center on Domestic Violence (http://ipvhealth.org/), which provides a step-by-step guide to making such connections. We encourage physicians to develop these collaborative partnerships early to facilitate warm handoffs and increase the likelihood that a patient will follow through with the referral after screening.37
Referral for related concerns. As we’ve noted, IPV has numerous physical and mental health consequences, including depression, low self-esteem, trauma- and non-trauma-related anxiety, and substance abuse. In general, cognitive behavioral therapies appear most efficacious for treating these IPV-related consequences, but evidence is limited that such interventions diminish the likelihood of re-victimization.38 Intervention programs that foster problem-solving, solution-seeking, and cognitive restructuring for self-critical thoughts and misconceptions seem to produce the best physical and mental health outcomes.39 For patients who have a substance use disorder, treatment programs that target substance use have demonstrated a reduction in the rate of IPV recidivism.40 These findings indicate that establishing multiple treatment targets might reduce the risk for future aggression in relationships.
Continue to: The Substance Abuse and Mental Health Services Administration...
The Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services provides a useful online tool (https://findtreatment.samhsa.gov/) for locating local referrals that address behavioral health and substance-related concerns. The agency also provides a hotline (1-800-662-HELP [4357]) as an alternative resource for information and treatment referrals.
Safety planning can improve outcomes
For a patient who screens above low risk, safety planning with the patient is an important part of improving outcomes and can take several forms. Online resources, such as the Path to Safety interactive Web page (www.thehotline.org/help/path-to-safety/) maintained by The National Domestic Violence Hotline ([800]799-SAFE [7233]), provide information regarding important considerations for safety planning when:
- living with an abusive partner
- children are in the home
- the patient is pregnant
- pets are involved.
The Web site also provides information regarding legal options and resources related to IPV (eg, an order of protection) and steps for improving safety when leaving an abusive relationship. Patients at risk for IPV can explore the online tool and call the hotline.
For physicians who want to engage in provider-assisted safety planning, we’ve provided further guidance in the IPASSPRT screening script and safety plan (http://bit.ly/ipassprt) (TABLE 4).
Goal: Affirm patients’ strengths and reinforce hope
Psychological aggression is the most common form of relationship aggression; repeated denigration might leave a person with little confidence in their ability to change their relationship or seek out identified resources. That’s why it’s useful to inquire—with genuine curiosity—about a time in the past when the patient accomplished something challenging. The physician’s enthusiastic reflection on this achievement can be a means of highlighting the patient’s ability to accomplish a meaningful goal; of reinforcing their hope; and of eliciting important resources within and around the patient that can facilitate action on their safety plan. (See “IPV-related resources for physicians and patients.”)
SIDEBAR
IPV-related resources for physicians and patients
Intimate Partner Aggression Screening, Safety Planning, and Referral to Treatment (IPASSPRT) Project
› http://bit.ly/ipassprt
Online resource with tools designed by the authors, including an SBIRT-inspired script and safety plan template for IPV screening, safety planning, and referral
National Center for Injury Prevention and Control Division of Violence Prevention
› www.cdc.gov/violenceprevention/pdf/ipv-factsheet.pdf
Overview of IPV-related behavior, influence on health outcomes, people at risk of IPV, and sources of support, all in a format easily understood by patients
National Health Resource Center on Domestic Violence
› http://ipvhealth.org/
Includes guidance on connecting with IPV-related community resources; establishing such connections can facilitate warm handoffs and improve the likelihood that patients will follow through
Path to Safety, a service of The National Domestic Violence Hotline
› www.thehotline.org/help/path-to-safety/
Extensive primer on safety plans for patients intending to stay in (or leave) an abusive relationship; includes important considerations for children, pets, and pregnancy, as well as emotional safety and legal options
The National Domestic Violence Hotline
› (800) 799-SAFE (7233)
Substance Abuse and Mental Health Services Administration
› www.samhsa.gov/sbirt
Learning resources for the SBIRT protocol for substance abuse
› https://findtreatment.samhsa.gov/
Search engine and resources for locating local referrals
› (800) 662-HELP (4357)
Hotline for information and assistance with locating local treatment referral
IPV, intimate partner violence; SBIRT, screening, brief intervention, and referral to treatment.
Continue to: Closing the screen and making a referral
Closing the screen and making a referral
The end of the interview should consist of a summary of topics discussed, including:
- changes that the patient wants to make (if any)
- their stated reasons for making those changes
- the patient’s plan for accomplishing changes.
Physicians should also include their own role in next steps—whether providing a warm handoff to a local IPV referral, agreeing to a follow-up schedule with the patient, or making a call as a mandated reporter. To close out the interview, it is important to affirm respect for the patient’s autonomy in executing the plan.
It’s important to screen all patients—here’s why
A major impetus for this article has been to raise awareness about the need for expanded IPV screening across primary care settings. As mentioned, much of the literature on IPV victimization has focused on women; however, the few epidemiological investigations of victimization rates among men and members of LGBT couples show a high rate of victimization and considerable harmful health outcomes. Driven by stigma surrounding IPV, sex, and sexual minority status, patients might have expectations that they will be judged by a provider or “outed.”
Such barriers can lead many to suffer in silence until the problem can no longer be hidden or the danger becomes more emergent. Compassionate, nonjudgmental screening and collaborative safety planning—such as the approach we describe in this article—help ease the concerns of LGBT victims of IPV and improve the likelihood that conversations you have with them will occur earlier, rather than later, in care.*
Underassessment of IPV (ie, underreporting as well as under-inquiry) because of stigma, misconception, and other factors obscures an accurate estimate of the rate of partner violence and its consequences for all couples. As a consequence, we know little about the dynamics of IPV, best practices for screening, and appropriate referral for couples from these populations. Furthermore, few resources are available to these understudied and underserved groups (eg, shelters for men and for transgender people).
Continue to: Although our immediate approach to IPV screening...
Although our immediate approach to IPV screening, safety planning, and referral with understudied patient populations might be informed by what we have learned from the experiences of heterosexual women in abusive relationships, such a practice is unsustainable. Unless we expand our scope of screening to all patients, it is unlikely that we will develop the evidence base necessary to 1) warrant stronger IPV screening recommendations for patient groups apart from women of childbearing age, let alone 2) demonstrate the need for additional community resources, and 3) provide comprehensive care in family practice of comparable quality.
The benefits of screening go beyond the individual patient
Screening for violence in the relationship does not take long; the value of asking about its presence in a relationship might offer benefits beyond the individual patient by raising awareness and providing the field of study with more data to increase attention and resources for under-researched and underserved populations. Screening might also combat the stigma that perpetuates the silence of many who deserve access to care.
CORRESPONDENCE
Joel G. Sprunger, PhD, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson St, Suite 3200, Cincinnati OH 45219; [email protected].
ACKNOWLEDGMENTS
The authors thank Jeffrey M. Girard, PhD, and Daniel C. Williams, PhD, for their input on the design and content, respectively, of the IPASSPRT screening materials; the authors of the DA-5 and the HITS screening tools, particularly Jacquelyn Campbell, PhD, RN, FAAN, and Kevin Sherin, MD, MPH, MBA, respectively, for permission to include these measures in this article and for their support of its goals; and The Journal of Family Practice’s peer reviewers for their thoughtful feedback throughout the prepublication process.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
1. Campos-Outcalt D. USPSTF: What’s recommended, what’s not. J Fam Pract. 2014;63:265-269.
2. Black MC, Basile KC, Breiding MJ, et al. National Intimate Partner and Sexual Violence Survey: 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011:113. www.cdc.gov/violenceprevention/pdf/NISVS_Report2010-a.pdf. Accessed February 20, 2019.
3. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
4. Hines DA, Malley-Morrison K. Psychological effects of partner abuse against men: a neglected research area. Psychology of Men & Masculinities. 2001;2:75-85.
5. Houston E, McKirnan DJ. Intimate partner abuse among gay and bisexual men: risk correlates and health outcomes. J Urban Health. 2007;84:681-690.
6. Carvalho AF, Lewis RJ, Derlega VJ, et al. Internalized sexual minority stressors and same-sex intimate partner violence. J Fam Violence. 2011;26:501-509.
7. Nicholls TL, Pritchard MM, Reeves KA, et al. Risk assessment in intimate partner violence: a systematic review of contemporary approaches. Partner Abuse. 2013;4:76-168.
8. Intimate partner violence: definitions. Atlanta, GA: National Center for Injury Prevention and Control, Division of Violence Prevention, Centers for Disease Control and Prevention, August 22, 2017. www.cdc.gov/violenceprevention/intimatepartnerviolence/definitions.html. Accessed February 20, 2019.
9. Archer J. Sex differences in aggression between heterosexual partners: a meta-analytic review. Psychol Bull. 2000;126:651-680.
10. Baron RA, Richardson DR. Human Aggression. New York, NY: Springer Science+Business Media; 2004.
11. Breiding MJ, Basile KC, Smith SG, et al. Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2015.
12. Murphy CM, Eckhardt CI. Treating the Abusive Partner: An Individualized Cognitive-Behavioral Approach. New York, NY: Guilford Press; 2005.
13. Straus MA, Hamby SL, Boney-McCoy S, et al. The revised Conflict Tactics Scales (CTS2): development and preliminary psychometric data. J Fam Issues. 1996;17:283-316.
14. West CM. Partner abuse in ethnic minority and gay, lesbian, bisexual, and transgender populations. Partner Abuse. 2012;3:336-357.
15. Desmarais SL, Reeves KA, Nicholls TL, et al. Prevalence of physical violence in intimate relationships. Part 1: rates of male and female victimization. Partner Abuse. 2012;3:140-169.
16. Lawrence E, Orengo-Aguayo R, Langer A, et al. The impact and consequences of partner abuse on partners. Partner Abuse. 2012;3:406-428.
17. Langhinrichsen-Rohling J, Selwyn C, Rohling ML. Rates of bidirectional versus unidirectional intimate partner violence across samples, sexual orientations, and race/ethnicities: a comprehensive review. Partner Abuse. 2012;3:199-230.
18. Langhinrichsen-Rohling J, McCullars A, Misra TA. Motivations for men and women’s intimate partner violence perpetration: a comprehensive review. Partner Abuse. 2012;3:429-468.
19. Anderson CA, Bushman BJ. Human aggression. Annu Rev Psychol. 2002;53:27-51.
20. Straus MA, Gozjolko KL. “Intimate terrorism” and gender differences in injury of dating partners by male and female university students. J Fam Violence. 2014;29:51-65.
21. Ferraro KJ, Johnson JM. How women experience battering: the process of victimization. Soc Probl. 1983;30:325-339.
22. Sugg NK, Inui T. Primary care physicians’ response to domestic violence: opening Pandora’s box. JAMA. 1992;267:3157-3160.
23. Morgan KJ, Williamson E, Hester M, et al. Asking men about domestic violence and abuse in a family medicine context: help seeking and views on the general practitioner role. Aggress Violent Behav. 2014;19:637-642.
24. MacMillan HL, Wathen CN, Jamieson E, et al; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006;296:530-536.
25. Thompson RS, Rivara FP, Thompson DC, et al. Identification and management of domestic violence: a randomized trial. Am J Prev Med. 2000;19:253-263.
26. Ard KL, Makadon HJ. Addressing intimate partner violence in lesbian, gay, bisexual, and transgender patients. J Gen Intern Med. 2011;26:930-933.
27. Rabin RF, Jennings JM, Campbell JC, et al. Intimate partner violence screening tools: a systematic review. Am J Prev Med. 2009;36:439-445.e4.
28. Madras BK, Compton WM, Avula D, et al. Screening, brief interventions, referral to treatment (SBIRT) for illicit drug and alcohol use at multiple healthcare sites: comparison at intake and 6 months later. Drug Alcohol Depend. 2009;99:280-295.
29. Sherin KM, Sinacore JM, Li XQ, et al. HITS: A short domestic violence screening tool for use in a family practice setting. Fam Med. 1998;30:508-512.
30. Peralta RL, Fleming MF. Screening for intimate partner violence in a primary care setting: the validity of “feeling safe at home” and prevalence results. J Am Board Fam Pract. 2003;16:525-532.
31. Capaldi DM, Knoble NB, Shortt JW, et al. A systematic review of risk factors for intimate partner violence. Partner Abuse. 2012;3:231-280.
32. Brownridge DA, Taillieu TL, Tyler KA, et al. Pregnancy and intimate partner violence: risk factors, severity, and health effects. Violence Against Women. 2011;17:858-881.
33. Messing JT, Campbell JC, Snider C. Validation and adaptation of the danger assessment-5: a brief intimate partner violence risk assessment. J Adv Nurs. 2017;73:3220-3230.
34. Grigsby N, Hartman BR. The Barriers Model: an integrated strategy for intervention with battered women. Psychotherapy: Theory, Research, Practice, Training. 1997;34:485-497.
35. Moyers TB, Rollnick S. A motivational interviewing perspective on resistance in psychotherapy. J Clin Psychol. 2002;58:185-193.
36. Belfrage H, Strand S, Storey JE, et al. Assessment and management of risk for intimate partner violence by police officers using the Spousal Assault Risk Assessment Guide. Law Hum Behav. 2012;36:60-67.
37. McCloskey LA, Lichter E, Williams C, et al. Assessing intimate partner violence in health care settings leads to women’s receipt of interventions and improved health. Publ Health Rep. 2006;121:435-444.
38. Eckhardt CI, Murphy CM, Whitaker DJ, et al. The effectiveness of intervention programs for perpetrators and victims of intimate partner violence. Partner Abuse. 2013;4:196-231.
39. Trabold N, McMahon J, Alsobrooks S, et al. A systematic review of intimate partner violence interventions: state of the field and implications for practitioners. Trauma Violence Abuse. January 2018:1524838018767934.
40. Kraanen FL, Vedel E, Scholing A, et al. The comparative effectiveness of Integrated treatment for Substance abuse and Partner violence (I-StoP) and substance abuse treatment alone: a randomized controlled trial. BMC Psychiatry. 2013;13:189.
PRACTICE RECOMMENDATIONS
› Perform annual screening for intimate partner violence of all female patients of childbearing age; strongly consider a pilot program of universal screening (all male and female patients, across the lifespan). B
› Establish a protocol for intimate partner violence screening and referral—possibly the most effective means of identifying intimate partner violence at early and severe stages. B
› Collaborate with the patient in the safety planning and referral process; benefits include improved likelihood that the patient will adhere to a safety plan and follow through with the referral. B
› Utilize online resources to 1) ease the process of establishing relationships with local intimate partner violence referrals and 2) facilitate warm handoffs to increase the likelihood of patient engagement. B
Strength of recommendation (SOR)
A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series
Screening and counseling interventions to prevent peripartum depression: A practical approach
Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers.1 Perinatal depression adversely impacts mothers, children, and their families. Pregnant women with depression are at increased risk for preterm birth and low birth weight.2 Infants of mothers with postpartum depression have reduced bonding, lower rates of breastfeeding, delayed cognitive and social development, and an increased risk of future mental health issues.3 Timely treatment of perinatal depression can improve health outcomes for the woman, her children, and their family.
Clinicians follow current screening recommendations
The American College of Obstetricians and Gynecologists (ACOG) currently recommends that ObGynsscreen all pregnant women for depression and anxiety symptoms at least once during the perinatal period.1 Many practices use the Edinburgh Postnatal Depression Scale (EPDS) during pregnancy and postpartum. Women who screen positive are referred to mental health clinicians or have treatment initiated by their primary obstetrician.
Clinicians have been phenomenally successful in screening for perinatal depression. In a recent study from Kaiser Permanente Northern California, 98% of pregnant women were screened for perinatal depression, and a diagnosis of depression was made in 12%.4 Of note, only 47% of women who screened positive for depression initiated treatment, although 82% of women with the most severe symptoms initiated treatment. These data demonstrate that ObGyns consistently screen pregnant women for depression but, due to patient and system issues, treatment of all screen-positive women remains a yet unattained goal.5,6
New USPSTF guideline: Identify women at risk for perinatal depression and refer for counseling
In 2016 the United States Preventive Services Task Force (USPSTF) recommended that pregnant and postpartum women be screened for depression with adequate systems in place to ensure diagnosis, effective treatment, and follow-up.7 The 2016 USPSTF recommendation was consistent with prior guidelines from both the American Academy of Pediatrics in 20108 and ACOG in 2015.9
Now, the USPSTF is making a bold new recommendation, jumping ahead of professional societies: screen pregnant women to identify those at risk for perinatal depression and refer them for counseling (B recommendation; net benefit is moderate).10,11 The USPSTF recommendation is based on growing literature that shows counseling women at risk for perinatal depression reduces the risk of having an episode of major depression by 40%.11 Both interpersonal psychotherapy and cognitive behavioral therapy have been reported to be effective for preventing perinatal depression.12,13
As an example of the relevant literature, in one trial performed in Rhode Island, women who were 20 to 35 weeks pregnant with a high score (≥27) on the Cooper Survey Questionnaire and on public assistance were randomized to counseling or usual care. The counseling intervention involved 4 small group (2 to 5 women) sessions of 90 minutes and one individual session of 50 minutes.14 The treatment focused on managing the transition to motherhood, developing a support system, improving communication skills to manage conflict, goal setting, and identifying psychosocial supports for new mothers. At 6 months after birth, a depressive episode had occurred in 31% of the control women and 16% of the women who had experienced the intervention (P = .041). At 12 months after birth, a depressive episode had occurred in 40% of control women and 26% of women in the intervention group (P = .052).
Of note, most cases of postpartum depression were diagnosed more than 3 months after birth, a time when new mothers generally no longer are receiving regular postpartum care by an obstetrician. The timing of the diagnosis of perinatal depression indicates that an effective handoff between the obstetrician and primary care and/or mental health clinicians is of great importance. The investigators concluded that pregnant women at very high risk for perinatal depression who receive interpersonal therapy have a lower rate of a postpartum depressive episode than women receiving usual care.14
Pregnancy, delivery, and the first year following birth are stressful for many women and their families. Women who are young, poor, and with minimal social supports are at especially high risk for developing perinatal depression. However, it will be challenging for obstetric practices to rapidly implement the new USPSTF recommendations because there is no professional consensus on how to screen women to identify those at high risk for perinatal depression, and mental health resources to care for the screen-positive women are not sufficient.
Continue to: Challenges to implementing new USPSTF guideline...
Challenges to implementing new USPSTF guideline
Obstetricians have had great success in screening for perinatal depression because validated screening tools are available. Professional societies need to reach a consensus on recommending a specific screening tool for perinatal depression risk that can be used in all obstetric practices.
- personal history of depression
- current depressive symptoms that do not reach a diagnostic threshold
- low income
- all adolescents
- all single mothers
- recent exposure to intimate partner violence
- elevated anxiety symptoms
- a history of significant negative life events.
For many obstetricians, most of their pregnant patients meet the USPSTF criteria for being at high risk for perinatal depression and, per the guideline, these women should have a counseling intervention.
For many health systems, the resources available to provide mental health services are very limited. If most pregnant women need a counseling intervention, the health system must evolve to meet this need. In addition, risk factors for perinatal depression are also risk factors for having difficulty in participating in mental health interventions due to limitations, such as lack of transportation, social support, and money.4
Fortunately, clinicians from many backgrounds, including psychologists, social workers, nurse practitioners, and public health workers have the experience and/or training to provide the counseling interventions that have been shown to reduce the risk of perinatal depression. Health systems will need to tap all these resources to accommodate the large numbers of pregnant women who will be referred for counseling interventions. Pilot projects using electronic interventions, including telephone counseling, smartphone apps, and internet programs show promise.15,16 Electronic interventions have the potential to reach many pregnant women without over-taxing limited mental health resources.
A practical approach
Identify women at the greatest risk for perinatal depression and focus counseling interventions on this group. In my opinion, implementation of the USPSTF recommendation will take time. A practical approach would be to implement them in a staged sequence, focusing first on the women at highest risk, later extending the program to women at lesser risk. The two factors that confer the greatest risk of perinatal depression are a personal history of depression and high depression symptoms that do not meet criteria for depression.17 Many women with depression who take antidepressants discontinue their medications during pregnancy. These women are at very high risk for perinatal depression and deserve extra attention.18
Continue to: To identify women with a prior personal history of depression...
To identify women with a prior personal history of depression, it may be helpful to ask open-ended questions about a past diagnosis of depression or a mood disorder or use of antidepressant medications. To identify women with the greatest depression symptoms, utilize a lower cut-off for screening positive in the Edinburgh questionnaire. Practices that use an EPDS screen-positive score of 13 or greater could reduce the cut-off to 10 or 11, which would increase the number of women referred for evaluation and treatment.19
Clinical judgment and screening
Screening for prevalent depression and screening for women at increased risk for perinatal depression is challenging. ACOG highlights two important clinical issues1:
“Women with current depression or anxiety, a history of perinatal mood disorders, risk factors for perinatal mood disorders or suicidal thoughts warrant particularly close monitoring, evaluation and assessment.”
When screening for perinatal depression, screening test results should be interpreted within the clinical context. “A normal score for a tearful patient with a flat affect does not exclude depression; an elevated score in the context of an acute stressful event may resolve with close follow-up.”
In addition, women who screen-positive for prevalent depression and are subsequently evaluated by a mental health specialist may be identified as having mental health problems such as an anxiety disorder, substance misuse, or borderline personality disorder.20
Policy changes that support pregnant women and mothers could help to reduce the stress of pregnancy, birth, and childrearing, thereby reducing the risk of perinatal depression. The United States stands alone among rich nations in not providing paid parental leave. Paid maternity and parental leave would help many families respond more effectively to the initial stresses of parenthood.21 For women and families living in poverty, improved social support, including secure housing, protection from abusive partners, transportation resources, and access to healthy foods likely will reduce both stress and the risk of depression.
The ultimate goal: A healthy pregnancy
Clinicians have been phenomenally successful in screening for perinatal depression. The new USPSTF recommendation adds the prevention of perinatal depression to the goals of a healthy pregnancy. This recommendation builds upon the foundation of screening for acute illness (depression), pivoting to the public health perspective of disease prevention.
- American College of Obstetricians and Gynecologists. Screening for perinatal depression. ACOG Committee Opinion No 757. Obstet Gynecol. 2018;132:e208-e212.
- Grote NK, Bridge JA, Gavin AR, et al. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67:1012-1024.
- Pearlstein T, Howard M, Salisbury A, et al. Postpartum depression. Am J Obstet Gynecol. 2009;200:357-364.
- Avalos LA, Raine-Bennett T, Chen H, et al. Improved perinatal depression screening, treatment and outcomes with a universal obstetric program. Obstet Gynecol. 2016;127:917-925.
- Cox EQ, Sowa NA, Meltzer-Brody SE, et al. The perinatal depression treatment cascade: baby steps toward improving outcomes. J Clin Psychiatry. 2016;77:1189-1200.
- Byatt N, Simas TA, Lundquist RS, et al. Strategies for improving perinatal depression treatment in North American outpatient obstetric settings. J Psychosom Obstet Gynaecol. 2012;33:143-161.
- Siu AL, Bibbins-Domingo K, Grossman DC, et al. US Preventive Services Task Force (USPSTF). Screening for depression in adults. JAMA. 2016;315:380-387.
- Earls MF. Committee on Psychological Aspects of Child and Family Health. American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010;126:1032-1039.
- The American College of Obstetricians and Gynecologists. Committee on Obstetric Practice. Committee Opinion No 630. Screening for perinatal depression. Obstet Gynecol. 2015;125:1268-1271.
- US Preventive Services Task Force. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendations statement. JAMA. 2019;321:580-587.
- O’Connor E, Senger CA, Henninger ML, et al. Interventions to prevent perinatal depression: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;321:588-601.
- Sockol LE. A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. J Affective Disorders. 2018;232:316-328.
- Sockol LE. A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. J Affective Disorders. 2015;177:7-21.
- Zlotnick C, Tzilos G, Miller I, et al. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affective Disorders. 2016;189:263-268.
- Haga SM, Drozd F, Lisoy C, et al. Mamma Mia—a randomized controlled trial of an internet-based intervention for perinatal depression. Psycholog Med. 2018;1-9.
- Shorey S, Ng YM, Ng ED, et al. Effectiveness of a technology-based supportive educational parenting program on parent outcomes (Part 1): Randomized controlled trial. J Med Internet Res. 2019;21:e10816.
- Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.
- Goodman JH. Women’s attitudes, preferences and perceived barriers to treatment for perinatal depression. Birth. 2009;36:60-69.
- Smith-Nielsen J, Matthey S, Lange T, Vaever MS. Validation of the Edinburgh Postnatal Depression Scale against both DSM-5 and ICD-10 diagnostic criteria for depression. BMC Psychiatry. 2018;18:393.
- Judd F, Lorimer S, Thomson RH, et al. Screening for depression with the Edinburgh Postnatal Depression Scale and finding borderline personality disorder. Aust N Z J Psychiatry. 2018;Epub Oct 12. doi: 10.1177/0004867418804067.
- Diamond R. Promoting sensible parenting policies. Leading by example. JAMA. 2019;321:645- 646.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers.1 Perinatal depression adversely impacts mothers, children, and their families. Pregnant women with depression are at increased risk for preterm birth and low birth weight.2 Infants of mothers with postpartum depression have reduced bonding, lower rates of breastfeeding, delayed cognitive and social development, and an increased risk of future mental health issues.3 Timely treatment of perinatal depression can improve health outcomes for the woman, her children, and their family.
Clinicians follow current screening recommendations
The American College of Obstetricians and Gynecologists (ACOG) currently recommends that ObGynsscreen all pregnant women for depression and anxiety symptoms at least once during the perinatal period.1 Many practices use the Edinburgh Postnatal Depression Scale (EPDS) during pregnancy and postpartum. Women who screen positive are referred to mental health clinicians or have treatment initiated by their primary obstetrician.
Clinicians have been phenomenally successful in screening for perinatal depression. In a recent study from Kaiser Permanente Northern California, 98% of pregnant women were screened for perinatal depression, and a diagnosis of depression was made in 12%.4 Of note, only 47% of women who screened positive for depression initiated treatment, although 82% of women with the most severe symptoms initiated treatment. These data demonstrate that ObGyns consistently screen pregnant women for depression but, due to patient and system issues, treatment of all screen-positive women remains a yet unattained goal.5,6
New USPSTF guideline: Identify women at risk for perinatal depression and refer for counseling
In 2016 the United States Preventive Services Task Force (USPSTF) recommended that pregnant and postpartum women be screened for depression with adequate systems in place to ensure diagnosis, effective treatment, and follow-up.7 The 2016 USPSTF recommendation was consistent with prior guidelines from both the American Academy of Pediatrics in 20108 and ACOG in 2015.9
Now, the USPSTF is making a bold new recommendation, jumping ahead of professional societies: screen pregnant women to identify those at risk for perinatal depression and refer them for counseling (B recommendation; net benefit is moderate).10,11 The USPSTF recommendation is based on growing literature that shows counseling women at risk for perinatal depression reduces the risk of having an episode of major depression by 40%.11 Both interpersonal psychotherapy and cognitive behavioral therapy have been reported to be effective for preventing perinatal depression.12,13
As an example of the relevant literature, in one trial performed in Rhode Island, women who were 20 to 35 weeks pregnant with a high score (≥27) on the Cooper Survey Questionnaire and on public assistance were randomized to counseling or usual care. The counseling intervention involved 4 small group (2 to 5 women) sessions of 90 minutes and one individual session of 50 minutes.14 The treatment focused on managing the transition to motherhood, developing a support system, improving communication skills to manage conflict, goal setting, and identifying psychosocial supports for new mothers. At 6 months after birth, a depressive episode had occurred in 31% of the control women and 16% of the women who had experienced the intervention (P = .041). At 12 months after birth, a depressive episode had occurred in 40% of control women and 26% of women in the intervention group (P = .052).
Of note, most cases of postpartum depression were diagnosed more than 3 months after birth, a time when new mothers generally no longer are receiving regular postpartum care by an obstetrician. The timing of the diagnosis of perinatal depression indicates that an effective handoff between the obstetrician and primary care and/or mental health clinicians is of great importance. The investigators concluded that pregnant women at very high risk for perinatal depression who receive interpersonal therapy have a lower rate of a postpartum depressive episode than women receiving usual care.14
Pregnancy, delivery, and the first year following birth are stressful for many women and their families. Women who are young, poor, and with minimal social supports are at especially high risk for developing perinatal depression. However, it will be challenging for obstetric practices to rapidly implement the new USPSTF recommendations because there is no professional consensus on how to screen women to identify those at high risk for perinatal depression, and mental health resources to care for the screen-positive women are not sufficient.
Continue to: Challenges to implementing new USPSTF guideline...
Challenges to implementing new USPSTF guideline
Obstetricians have had great success in screening for perinatal depression because validated screening tools are available. Professional societies need to reach a consensus on recommending a specific screening tool for perinatal depression risk that can be used in all obstetric practices.
- personal history of depression
- current depressive symptoms that do not reach a diagnostic threshold
- low income
- all adolescents
- all single mothers
- recent exposure to intimate partner violence
- elevated anxiety symptoms
- a history of significant negative life events.
For many obstetricians, most of their pregnant patients meet the USPSTF criteria for being at high risk for perinatal depression and, per the guideline, these women should have a counseling intervention.
For many health systems, the resources available to provide mental health services are very limited. If most pregnant women need a counseling intervention, the health system must evolve to meet this need. In addition, risk factors for perinatal depression are also risk factors for having difficulty in participating in mental health interventions due to limitations, such as lack of transportation, social support, and money.4
Fortunately, clinicians from many backgrounds, including psychologists, social workers, nurse practitioners, and public health workers have the experience and/or training to provide the counseling interventions that have been shown to reduce the risk of perinatal depression. Health systems will need to tap all these resources to accommodate the large numbers of pregnant women who will be referred for counseling interventions. Pilot projects using electronic interventions, including telephone counseling, smartphone apps, and internet programs show promise.15,16 Electronic interventions have the potential to reach many pregnant women without over-taxing limited mental health resources.
A practical approach
Identify women at the greatest risk for perinatal depression and focus counseling interventions on this group. In my opinion, implementation of the USPSTF recommendation will take time. A practical approach would be to implement them in a staged sequence, focusing first on the women at highest risk, later extending the program to women at lesser risk. The two factors that confer the greatest risk of perinatal depression are a personal history of depression and high depression symptoms that do not meet criteria for depression.17 Many women with depression who take antidepressants discontinue their medications during pregnancy. These women are at very high risk for perinatal depression and deserve extra attention.18
Continue to: To identify women with a prior personal history of depression...
To identify women with a prior personal history of depression, it may be helpful to ask open-ended questions about a past diagnosis of depression or a mood disorder or use of antidepressant medications. To identify women with the greatest depression symptoms, utilize a lower cut-off for screening positive in the Edinburgh questionnaire. Practices that use an EPDS screen-positive score of 13 or greater could reduce the cut-off to 10 or 11, which would increase the number of women referred for evaluation and treatment.19
Clinical judgment and screening
Screening for prevalent depression and screening for women at increased risk for perinatal depression is challenging. ACOG highlights two important clinical issues1:
“Women with current depression or anxiety, a history of perinatal mood disorders, risk factors for perinatal mood disorders or suicidal thoughts warrant particularly close monitoring, evaluation and assessment.”
When screening for perinatal depression, screening test results should be interpreted within the clinical context. “A normal score for a tearful patient with a flat affect does not exclude depression; an elevated score in the context of an acute stressful event may resolve with close follow-up.”
In addition, women who screen-positive for prevalent depression and are subsequently evaluated by a mental health specialist may be identified as having mental health problems such as an anxiety disorder, substance misuse, or borderline personality disorder.20
Policy changes that support pregnant women and mothers could help to reduce the stress of pregnancy, birth, and childrearing, thereby reducing the risk of perinatal depression. The United States stands alone among rich nations in not providing paid parental leave. Paid maternity and parental leave would help many families respond more effectively to the initial stresses of parenthood.21 For women and families living in poverty, improved social support, including secure housing, protection from abusive partners, transportation resources, and access to healthy foods likely will reduce both stress and the risk of depression.
The ultimate goal: A healthy pregnancy
Clinicians have been phenomenally successful in screening for perinatal depression. The new USPSTF recommendation adds the prevention of perinatal depression to the goals of a healthy pregnancy. This recommendation builds upon the foundation of screening for acute illness (depression), pivoting to the public health perspective of disease prevention.
Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers.1 Perinatal depression adversely impacts mothers, children, and their families. Pregnant women with depression are at increased risk for preterm birth and low birth weight.2 Infants of mothers with postpartum depression have reduced bonding, lower rates of breastfeeding, delayed cognitive and social development, and an increased risk of future mental health issues.3 Timely treatment of perinatal depression can improve health outcomes for the woman, her children, and their family.
Clinicians follow current screening recommendations
The American College of Obstetricians and Gynecologists (ACOG) currently recommends that ObGynsscreen all pregnant women for depression and anxiety symptoms at least once during the perinatal period.1 Many practices use the Edinburgh Postnatal Depression Scale (EPDS) during pregnancy and postpartum. Women who screen positive are referred to mental health clinicians or have treatment initiated by their primary obstetrician.
Clinicians have been phenomenally successful in screening for perinatal depression. In a recent study from Kaiser Permanente Northern California, 98% of pregnant women were screened for perinatal depression, and a diagnosis of depression was made in 12%.4 Of note, only 47% of women who screened positive for depression initiated treatment, although 82% of women with the most severe symptoms initiated treatment. These data demonstrate that ObGyns consistently screen pregnant women for depression but, due to patient and system issues, treatment of all screen-positive women remains a yet unattained goal.5,6
New USPSTF guideline: Identify women at risk for perinatal depression and refer for counseling
In 2016 the United States Preventive Services Task Force (USPSTF) recommended that pregnant and postpartum women be screened for depression with adequate systems in place to ensure diagnosis, effective treatment, and follow-up.7 The 2016 USPSTF recommendation was consistent with prior guidelines from both the American Academy of Pediatrics in 20108 and ACOG in 2015.9
Now, the USPSTF is making a bold new recommendation, jumping ahead of professional societies: screen pregnant women to identify those at risk for perinatal depression and refer them for counseling (B recommendation; net benefit is moderate).10,11 The USPSTF recommendation is based on growing literature that shows counseling women at risk for perinatal depression reduces the risk of having an episode of major depression by 40%.11 Both interpersonal psychotherapy and cognitive behavioral therapy have been reported to be effective for preventing perinatal depression.12,13
As an example of the relevant literature, in one trial performed in Rhode Island, women who were 20 to 35 weeks pregnant with a high score (≥27) on the Cooper Survey Questionnaire and on public assistance were randomized to counseling or usual care. The counseling intervention involved 4 small group (2 to 5 women) sessions of 90 minutes and one individual session of 50 minutes.14 The treatment focused on managing the transition to motherhood, developing a support system, improving communication skills to manage conflict, goal setting, and identifying psychosocial supports for new mothers. At 6 months after birth, a depressive episode had occurred in 31% of the control women and 16% of the women who had experienced the intervention (P = .041). At 12 months after birth, a depressive episode had occurred in 40% of control women and 26% of women in the intervention group (P = .052).
Of note, most cases of postpartum depression were diagnosed more than 3 months after birth, a time when new mothers generally no longer are receiving regular postpartum care by an obstetrician. The timing of the diagnosis of perinatal depression indicates that an effective handoff between the obstetrician and primary care and/or mental health clinicians is of great importance. The investigators concluded that pregnant women at very high risk for perinatal depression who receive interpersonal therapy have a lower rate of a postpartum depressive episode than women receiving usual care.14
Pregnancy, delivery, and the first year following birth are stressful for many women and their families. Women who are young, poor, and with minimal social supports are at especially high risk for developing perinatal depression. However, it will be challenging for obstetric practices to rapidly implement the new USPSTF recommendations because there is no professional consensus on how to screen women to identify those at high risk for perinatal depression, and mental health resources to care for the screen-positive women are not sufficient.
Continue to: Challenges to implementing new USPSTF guideline...
Challenges to implementing new USPSTF guideline
Obstetricians have had great success in screening for perinatal depression because validated screening tools are available. Professional societies need to reach a consensus on recommending a specific screening tool for perinatal depression risk that can be used in all obstetric practices.
- personal history of depression
- current depressive symptoms that do not reach a diagnostic threshold
- low income
- all adolescents
- all single mothers
- recent exposure to intimate partner violence
- elevated anxiety symptoms
- a history of significant negative life events.
For many obstetricians, most of their pregnant patients meet the USPSTF criteria for being at high risk for perinatal depression and, per the guideline, these women should have a counseling intervention.
For many health systems, the resources available to provide mental health services are very limited. If most pregnant women need a counseling intervention, the health system must evolve to meet this need. In addition, risk factors for perinatal depression are also risk factors for having difficulty in participating in mental health interventions due to limitations, such as lack of transportation, social support, and money.4
Fortunately, clinicians from many backgrounds, including psychologists, social workers, nurse practitioners, and public health workers have the experience and/or training to provide the counseling interventions that have been shown to reduce the risk of perinatal depression. Health systems will need to tap all these resources to accommodate the large numbers of pregnant women who will be referred for counseling interventions. Pilot projects using electronic interventions, including telephone counseling, smartphone apps, and internet programs show promise.15,16 Electronic interventions have the potential to reach many pregnant women without over-taxing limited mental health resources.
A practical approach
Identify women at the greatest risk for perinatal depression and focus counseling interventions on this group. In my opinion, implementation of the USPSTF recommendation will take time. A practical approach would be to implement them in a staged sequence, focusing first on the women at highest risk, later extending the program to women at lesser risk. The two factors that confer the greatest risk of perinatal depression are a personal history of depression and high depression symptoms that do not meet criteria for depression.17 Many women with depression who take antidepressants discontinue their medications during pregnancy. These women are at very high risk for perinatal depression and deserve extra attention.18
Continue to: To identify women with a prior personal history of depression...
To identify women with a prior personal history of depression, it may be helpful to ask open-ended questions about a past diagnosis of depression or a mood disorder or use of antidepressant medications. To identify women with the greatest depression symptoms, utilize a lower cut-off for screening positive in the Edinburgh questionnaire. Practices that use an EPDS screen-positive score of 13 or greater could reduce the cut-off to 10 or 11, which would increase the number of women referred for evaluation and treatment.19
Clinical judgment and screening
Screening for prevalent depression and screening for women at increased risk for perinatal depression is challenging. ACOG highlights two important clinical issues1:
“Women with current depression or anxiety, a history of perinatal mood disorders, risk factors for perinatal mood disorders or suicidal thoughts warrant particularly close monitoring, evaluation and assessment.”
When screening for perinatal depression, screening test results should be interpreted within the clinical context. “A normal score for a tearful patient with a flat affect does not exclude depression; an elevated score in the context of an acute stressful event may resolve with close follow-up.”
In addition, women who screen-positive for prevalent depression and are subsequently evaluated by a mental health specialist may be identified as having mental health problems such as an anxiety disorder, substance misuse, or borderline personality disorder.20
Policy changes that support pregnant women and mothers could help to reduce the stress of pregnancy, birth, and childrearing, thereby reducing the risk of perinatal depression. The United States stands alone among rich nations in not providing paid parental leave. Paid maternity and parental leave would help many families respond more effectively to the initial stresses of parenthood.21 For women and families living in poverty, improved social support, including secure housing, protection from abusive partners, transportation resources, and access to healthy foods likely will reduce both stress and the risk of depression.
The ultimate goal: A healthy pregnancy
Clinicians have been phenomenally successful in screening for perinatal depression. The new USPSTF recommendation adds the prevention of perinatal depression to the goals of a healthy pregnancy. This recommendation builds upon the foundation of screening for acute illness (depression), pivoting to the public health perspective of disease prevention.
- American College of Obstetricians and Gynecologists. Screening for perinatal depression. ACOG Committee Opinion No 757. Obstet Gynecol. 2018;132:e208-e212.
- Grote NK, Bridge JA, Gavin AR, et al. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67:1012-1024.
- Pearlstein T, Howard M, Salisbury A, et al. Postpartum depression. Am J Obstet Gynecol. 2009;200:357-364.
- Avalos LA, Raine-Bennett T, Chen H, et al. Improved perinatal depression screening, treatment and outcomes with a universal obstetric program. Obstet Gynecol. 2016;127:917-925.
- Cox EQ, Sowa NA, Meltzer-Brody SE, et al. The perinatal depression treatment cascade: baby steps toward improving outcomes. J Clin Psychiatry. 2016;77:1189-1200.
- Byatt N, Simas TA, Lundquist RS, et al. Strategies for improving perinatal depression treatment in North American outpatient obstetric settings. J Psychosom Obstet Gynaecol. 2012;33:143-161.
- Siu AL, Bibbins-Domingo K, Grossman DC, et al. US Preventive Services Task Force (USPSTF). Screening for depression in adults. JAMA. 2016;315:380-387.
- Earls MF. Committee on Psychological Aspects of Child and Family Health. American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010;126:1032-1039.
- The American College of Obstetricians and Gynecologists. Committee on Obstetric Practice. Committee Opinion No 630. Screening for perinatal depression. Obstet Gynecol. 2015;125:1268-1271.
- US Preventive Services Task Force. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendations statement. JAMA. 2019;321:580-587.
- O’Connor E, Senger CA, Henninger ML, et al. Interventions to prevent perinatal depression: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;321:588-601.
- Sockol LE. A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. J Affective Disorders. 2018;232:316-328.
- Sockol LE. A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. J Affective Disorders. 2015;177:7-21.
- Zlotnick C, Tzilos G, Miller I, et al. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affective Disorders. 2016;189:263-268.
- Haga SM, Drozd F, Lisoy C, et al. Mamma Mia—a randomized controlled trial of an internet-based intervention for perinatal depression. Psycholog Med. 2018;1-9.
- Shorey S, Ng YM, Ng ED, et al. Effectiveness of a technology-based supportive educational parenting program on parent outcomes (Part 1): Randomized controlled trial. J Med Internet Res. 2019;21:e10816.
- Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.
- Goodman JH. Women’s attitudes, preferences and perceived barriers to treatment for perinatal depression. Birth. 2009;36:60-69.
- Smith-Nielsen J, Matthey S, Lange T, Vaever MS. Validation of the Edinburgh Postnatal Depression Scale against both DSM-5 and ICD-10 diagnostic criteria for depression. BMC Psychiatry. 2018;18:393.
- Judd F, Lorimer S, Thomson RH, et al. Screening for depression with the Edinburgh Postnatal Depression Scale and finding borderline personality disorder. Aust N Z J Psychiatry. 2018;Epub Oct 12. doi: 10.1177/0004867418804067.
- Diamond R. Promoting sensible parenting policies. Leading by example. JAMA. 2019;321:645- 646.
- American College of Obstetricians and Gynecologists. Screening for perinatal depression. ACOG Committee Opinion No 757. Obstet Gynecol. 2018;132:e208-e212.
- Grote NK, Bridge JA, Gavin AR, et al. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67:1012-1024.
- Pearlstein T, Howard M, Salisbury A, et al. Postpartum depression. Am J Obstet Gynecol. 2009;200:357-364.
- Avalos LA, Raine-Bennett T, Chen H, et al. Improved perinatal depression screening, treatment and outcomes with a universal obstetric program. Obstet Gynecol. 2016;127:917-925.
- Cox EQ, Sowa NA, Meltzer-Brody SE, et al. The perinatal depression treatment cascade: baby steps toward improving outcomes. J Clin Psychiatry. 2016;77:1189-1200.
- Byatt N, Simas TA, Lundquist RS, et al. Strategies for improving perinatal depression treatment in North American outpatient obstetric settings. J Psychosom Obstet Gynaecol. 2012;33:143-161.
- Siu AL, Bibbins-Domingo K, Grossman DC, et al. US Preventive Services Task Force (USPSTF). Screening for depression in adults. JAMA. 2016;315:380-387.
- Earls MF. Committee on Psychological Aspects of Child and Family Health. American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010;126:1032-1039.
- The American College of Obstetricians and Gynecologists. Committee on Obstetric Practice. Committee Opinion No 630. Screening for perinatal depression. Obstet Gynecol. 2015;125:1268-1271.
- US Preventive Services Task Force. Interventions to prevent perinatal depression: US Preventive Services Task Force recommendations statement. JAMA. 2019;321:580-587.
- O’Connor E, Senger CA, Henninger ML, et al. Interventions to prevent perinatal depression: evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2019;321:588-601.
- Sockol LE. A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. J Affective Disorders. 2018;232:316-328.
- Sockol LE. A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. J Affective Disorders. 2015;177:7-21.
- Zlotnick C, Tzilos G, Miller I, et al. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affective Disorders. 2016;189:263-268.
- Haga SM, Drozd F, Lisoy C, et al. Mamma Mia—a randomized controlled trial of an internet-based intervention for perinatal depression. Psycholog Med. 2018;1-9.
- Shorey S, Ng YM, Ng ED, et al. Effectiveness of a technology-based supportive educational parenting program on parent outcomes (Part 1): Randomized controlled trial. J Med Internet Res. 2019;21:e10816.
- Cohen LS, Altshuler LL, Harlow BL, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295:499-507.
- Goodman JH. Women’s attitudes, preferences and perceived barriers to treatment for perinatal depression. Birth. 2009;36:60-69.
- Smith-Nielsen J, Matthey S, Lange T, Vaever MS. Validation of the Edinburgh Postnatal Depression Scale against both DSM-5 and ICD-10 diagnostic criteria for depression. BMC Psychiatry. 2018;18:393.
- Judd F, Lorimer S, Thomson RH, et al. Screening for depression with the Edinburgh Postnatal Depression Scale and finding borderline personality disorder. Aust N Z J Psychiatry. 2018;Epub Oct 12. doi: 10.1177/0004867418804067.
- Diamond R. Promoting sensible parenting policies. Leading by example. JAMA. 2019;321:645- 646.
Noninfected children of HIV-positive mothers have high rates of obesity
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
NEW ORLEANS – than are those with no such exposure, according to research that provides a compelling link between inflammatory activity in utero and subsequent risk of metabolic disorders.
Most supportive of that link was a near-linear inverse relationship between CD4 counts during the time of pregnancy and risk of both obesity and reactive respiratory disease more than a decade later, according to research presented by Lindsay Fourman, MD, an instructor in medicine at Massachusetts General Hospital, Boston, during the annual meeting of the Endocrine Society.
In this video interview, Dr. Fourman discusses the effort to understand the long-term health consequences of being exposed to HIV and antiretroviral therapies while in utero, a group known by the acronym HIV-exposed uninfected (HEU). With effective therapies now routinely preventing mother-to-child transmission, this population of children is growing quickly.
For this study, 50 HEU individuals were identified from a patient database. They were matched in a 3:1 ratio to a control group for a variety of demographic and socioeconomic variables. At a median age of 18 years, the HEU population was found to have a “strikingly” higher rate of obesity, compared with controls (42% vs. 25%, respectively; P = .04). The rate of reactive airway disease was similarly increased in the HEU group (40% vs. 24%; P = .04).
These data are important for considering health risks in an HEU population, but Dr. Fourman explained that it provides support for looking at metabolic risks from other in utero exposures linked to upregulated inflammation, such as gestational diabetes or obesity.
Dr Fourman and her colleagues reported no disclosures or financial conflicts of interest.
SOURCE: Fourman L et al. ENDO 2019, Session P10 (SAT-256).
REPORTING FROM ENDO 2019
Valproate, topiramate prescribed in young women despite known teratogenicity risks
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
results of a retrospective analysis suggest.
Topiramate, linked to increased risk of cleft palate and smaller-than-gestational-age newborns, was among the top three antiepileptic drugs (AEDs) prescribed to women 15-44 years of age in the population-based cohort study.
Valproate, linked to increases in both anatomic and behavioral teratogenicity, was less often prescribed, but nevertheless still prescribed in a considerable proportion of patients in the study, which looked at U.S. commercial, Medicare, and Medicaid claims data from 2009 to 2013.
Presence of comorbidities could be influencing whether or not a woman of childbearing age receives one of these AEDs, the investigators said. Specifically, they found valproate more often prescribed for women with epilepsy who also had mood or anxiety and dissociative disorder, while topiramate was more often prescribed in women with headaches or migraines.
Taken together, these findings suggest a lack of awareness of the teratogenic risks of valproate and topiramate, said the investigators, led by Hyunmi Kim, MD, PhD, MPH, of the department of neurology at Stanford (Calif.) University.
“To improve current practice, knowledge of the teratogenicity of certain AEDs should be disseminated to health care professionals and patients,” they wrote. The report is in JAMA Neurology.
The findings of Dr. Kim and her colleagues were based on data for 46,767 women of childbearing age: 8,003 incident (new) cases with a mean age of 27 years, and 38,764 prevalent cases with a mean age of 30 years.
Topiramate was the second- or third-most prescribed AED in the analyses, alongside levetiracetam and lamotrigine. In particular, topiramate prescriptions were found in incident cases receiving first-line monotherapy (15%), prevalent cases receiving first-line monotherapy (13%), and prevalent cases receiving polytherapy (29%).
Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy (5% and 10%, respectively), and came in fourth place among prevalent cases receiving polytherapy (22%).
The somewhat lower rate of valproate prescriptions tracks with other recent analyses showing that valproate use decreased among women of childbearing age following recommendations against its use during pregnancy, according to Dr. Kim and her coauthors.
However, topiramate is another story: “Although the magnitude of risk and range of adverse reproductive outcomes associated with topiramate use appear substantially less than those associated with valproate, some reduction in the use of topiramate in this population might be expected after evidence emerged in 2008 of its association with cleft palate,” they said in their report.
UCB Pharma sponsored this study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
SOURCE: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
FROM JAMA NEUROLOGY
Key clinical point: Both valproate and topiramate are prescribed relatively often in women of childbearing age despite known teratogenic risks.
Major finding: Topiramate was the second- or third-most prescribed AED in the analyses. Valproate was the fifth-most prescribed AED for incident and prevalent cases receiving first-line monotherapy.
Study details: Retrospective cohort study including nearly 47,000 women of childbearing age enrolled in claims databases between 2009 and 2013.
Disclosures: UCB Pharma sponsored the study. Study authors reported disclosures related to UCB Pharma, Biogen, Eisai, SK Life Science, Brain Sentinel, UCB Pharma, and the University of Alabama at Birmingham.
Source: Kim H et al. JAMA Neurol. 2019 Apr 1. doi: 10.1001/jamaneurol.2019.0447.
Spontaneous coronary artery dissection: An often unrecognized cause of acute coronary syndrome
A 12-lead electrocardiogram (Figure 1) showed ST-segment elevation of more than 2 mm in leads V2, V3, V4, and V5, with no reciprocal changes.
Based on the classic angiographic appearance and the absence of atherosclerotic disease in other coronary arteries, type 2 spontaneous coronary artery dissection (SCAD) was diagnosed.
CORONARY ARTERY WALL SEPARATION
SCAD is defined as a nontraumatic, noniatrogenic intramural hemorrhage leading to separation of the coronary arterial wall and the formation of a false lumen. The separation can occur between any of the coronary artery wall layers and may or may not involve an intimal tear. The bleeding may result in an intramural hematoma and possible narrowing of the arterial lumen. Depending on the severity of narrowing, blood supply to the myocardium could be compromised, resulting in symptoms of ischemia.1
SCAD usually involves a single coronary artery, although multiple coronary artery involvement has been reported.2
CASE CONTINUED: MANAGEMENT
The patient recovered completely and was discharged home with plans to return for outpatient imaging for fibromuscular dysplasia.
SCAD: RARE OR JUST RARELY RECOGNIZED?
SCAD appears to be a rare cause of acute coronary syndrome, but it is likely underdiagnosed and is becoming increasingly recognized worldwide. Typically, it affects women younger than 50, with women in general outnumbering men 9 to 1.3 Overall, SCAD causes up to 4% of acute myocardial infarctions, but in women age 50 or younger, it is responsible for 24% to 35% of acute myocardial infarctions, and the proportion is even higher in pregnant women.4
Not just pregnancy-associated
SCAD was previously thought to be mainly idiopathic and mostly affecting women peripartum. Current understanding paints a different picture: pregnancy-associated SCAD does not account for the majority of cases. That said, SCAD is the most common cause of myocardial infarction peripartum, with the third trimester and early postpartum period being the times of highest risk.5 SCAD development at those times is believed to be related to hormonal changes causing weakening of coronary artery walls.6
Weakening of the coronary artery wall also may occur in the setting of fibromuscular dysplasia, connective tissue disease, recurrent pregnancies, systemic inflammatory disease, hormonal therapy, and other disease states that cause arteriopathy. Exposure to a stressor in a patient with underlying risk factors can lead to either an intimal tear or rupture of the vasa vasorum, with subsequent formation of intramural hemorrhage and eventually SCAD.7 Stressors can be emotional or physical and can include labor and delivery, intense physical exercise, the Valsalva maneuver, and drug abuse.8
Presentation is variable
SCAD presentation depends on the degree of flow limitation and extent of the dissection. Presentation can range from asymptomatic to sudden cardiac death and can include signs and symptoms of acute coronary syndrome caused by ST-segment elevation or non-ST-segment elevation myocardial infarction.
DIAGNOSIS BY ANGIOGRAPHY
SCAD can be diagnosed by coronary angiography. There are 3 angiographic types:
Type 1 (about 25% of SCAD cases) has typical contrast dye staining of the arterial wall and multiple radiolucent luminal abnormalities, with or without dye hang-up.
Type 2 (about 70%) has diffuse, smooth narrowing of the coronary artery, with the left anterior descending artery the most frequently affected.8
Type 3 (about 5%) mimics atherosclerosis, with focal or tubular stenosis.9
Types 1 and 2 are usually easy to recognize. To diagnose type 2, intravenous nitroglycerin should first be administered to rule out coronary spasm.
Type 3 SCAD is more challenging to diagnose because its appearance on angiography is similar to that of atherosclerosis. For equivocal findings in any type, but especially in type 3, intravascular ultrasonography or optical coherence tomography can help.10 Optical coherence tomography is preferred because of superior image resolution, although ultrasonography offers better tissue penetration.11
MANAGE MOST CASES CONSERVATIVELY
Management algorithms for SCAD are available.8,12
The initial and most critical step is to make the correct diagnosis. Although the presentation of acute coronary syndrome caused by SCAD is often identical to that of atherosclerosis, the conditions have different pathophysiologies and thus require different management. Theoretically, systemic anticoagulation may worsen an intramural hemorrhage.
First-line therapy for most patients with SCAD is conservative management and close inpatient monitoring for 3 to 5 days.13 More aggressive management is indicated for any of the following:
- Left main or severe proximal 2-vessel dissection
- Hemodynamic instability
- Ongoing ischemic symptoms.
In a prospective cohort of 168 patients, 134 (80%) were initially treated conservatively; of those, in-hospital myocardial infarction recurred in 4.5%, a major cardiac event occurred within 2 years in 17%, and SCAD recurred in 13%.8
Observational data on patients with SCAD who had repeat angiography weeks to months after the initial event has shown that lesions heal in 70% to 97% of patients.12
WHEN TO CONSIDER AGGRESSIVE MANAGEMENT
Under the circumstances listed above, revascularization with PCI or coronary artery bypass grafting (CABG) should be considered, with choice of procedure determined by feasibility, technical considerations, and local expertise.
The American Heart Association recommendations are as follows12:
- For left main or severe proximal 2-vessel dissection in clinically stable patients, consider CABG
- For active ischemia or hemodynamic instability, consider PCI if feasible or perform urgent CABG.
A few series have shown that the prognosis with conservative management or CABG is better than with PCI.8,13,14 The success rate for revascularization with PCI is only about 60% because of challenges including risk of inducing iatrogenic dissection, passing the wire into the false lumen and worsening a dissection, and propagating an intramural hematoma with stenting and further compromising coronary blood flow. In addition, dissection tends to extend into distal arteries that are difficult to stent. There is also the risk of stent malapposition after resorption of the intramural hematoma, causing late stent thrombosis.7
SCREEN FOR OTHER VASCULAR PROBLEMS
Imaging of the renal, iliac, and cerebral vasculature is recommended for all patients with SCAD.12 Screening for fibromuscular dysplasia can be done with angiography, computed tomographic angiography (CTA), or magnetic resonance angiography (MRA).12
Multifocal fibromuscular dysplasia in extracoronary arteries occurs with SCAD in 25% to 86% of cases. In a single-center series of 115 patients with confirmed SCAD who underwent CTA from 2010 to 2014, extracoronary vascular abnormalities were found in 66%, with fibromuscular dysplasia being the most common type (45%).15 In another single-center study, 327 patients with SCAD were prospectively followed from 2012 to 2016 with screening for cerebrovascular, renal, and iliac fibromuscular dysplasia using CTA or catheter angiography. Fibromuscular dysplasia was found in 63%, and intracranial aneurysm was found in 14% of patients with fibromuscular dysplasia.9
SCAD can also be associated with connective tissue disorders such as Ehlers-Danlos syndrome type IV and Marfan syndrome.16,17
LONG-TERM MANAGEMENT
Patients with SCAD should start long-term aspirin and 1 year of clopidogrel. Statins are indicated for patients with hyperlipidemia8,18 but otherwise offer no clear benefit for SCAD alone. If there are no contraindications, a beta-adrenergic blocker should be considered, especially if left ventricular dysfunction or arrhythmias are present. Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers should also be considered with concomitant left ventricular dysfunction. Antianginal therapy can be used for post-SCAD chest pain syndromes.12
Repeat angiography is recommended only to evaluate recurrent symptoms, to confirm an unclear initial diagnosis, to assess for atherosclerosis-related stenosis, or to evaluate high-risk anatomy, eg, involvement of the left main coronary artery.12
Genetic testing is reserved for patients with a high clinical suspicion of connective tissue disease or systemic arteriopathy.19
- Garcia NA, Khan AN, Boppana RC, Smith HL. Spontaneous coronary artery dissection: a case series and literature review. J Community Hosp Intern Med Perspect 2014; 4(4). doi:10.3402/jchimp.v4.25261
- Lempereur M, Gin K, Saw J. Multivessel spontaneous coronary artery dissection mimicking atherosclerosis. JACC Cardiovasc Interv 2014; 7(7):e87–e88. doi:10.1016/j.jcin.2013.12.207
- Mahmoud AN, Taduru SS, Mentias A, et al. Trends of incidence, clinical presentation, and in-hospital mortality among women with acute myocardial infarction with or without spontaneous coronary artery dissection: a population-based analysis. JACC Cardiovasc Interv 2018; 11(1):80–90. doi:10.1016/j.jcin.2017.08.016
- Saw J. Pregnancy-associated spontaneous coronary artery dissection represents an exceptionally high-risk spontaneous coronary artery dissection cohort. Circ Cardiovasc Interv 2017; 10(3)pii:e005119. doi:10.1161/CIRCINTERVENTIONS.117.005119
- Elkayam U, Jalnapurkar S, Barakkat MN, et al. Pregnancy-associated acute myocardial infarction: a review of contemporary experience in 150 cases between 2006 and 2011. Circulation 2014; 129(16):1695–1702. doi:10.1161/CIRCULATIONAHA.113.002054
- Vijayaraghavan R, Verma S, Gupta N, Saw J. Pregnancy-related spontaneous coronary artery dissection. Circulation 2014; 130(21):1915–1920. doi:10.1161/CIRCULATIONAHA.114.011422
- Saw J, Mancini GBJ, Humphries KH. Contemporary review on spontaneous coronary artery dissection. J Am Coll Cardiol 2016; 68(3):297–312. doi:10.1016/j.jacc.2016.05.034
- Saw J, Aymong E, Sedlak T, et al. Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes. Circ Cardiovasc Interv 2014; 7(5):645–655. doi:10.1161/CIRCINTERVENTIONS.114.001760
- Saw J, Humphries K ,Aymong E, et al. Spontaneous coronary artery dissection: clinical outcomes and risk of recurrence. J Am Coll Cardiol 2017; 70(9):1148–1158. doi:10.1016/j.jacc.2017.06.053
- Alfonso F, Bastante T, Cuesta J, Rodríguez D, Benedicto A, Rivero F. Spontaneous coronary artery dissection: novel insights on diagnosis and management. Cardiovasc Diagn Ther 2015; 5(2):133–140. doi:10.3978/j.issn.2223-3652.2015.03.05
- Kern MJ, Meier B. Evaluation of the culprit plaque and the physiological significance of coronary atherosclerotic narrowings. Circulation 2001; 103(25):3142–3149. pmid:11425782
- Hayes SN, Kim ESH, Saw J, et al; American Heart Association Council on Peripheral Vascular Disease; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; and Stroke Council. Spontaneous coronary artery dissection: current state of the science: a scientific statement from the American Heart Association. Circulation 2018; 137(19):e523–e557. doi:10.1161/CIR.0000000000000564
- Tweet MS, Eleid MF, Best PJ, et al. Spontaneous coronary artery dissection: revascularization versus conservative therapy. Circ Cardiovasc Interv 2014; 7(6):777–786. doi:10.1161/CIRCINTERVENTIONS.114.001659
- Tweet MS, Hayes SN, Pitta SR, et al. Clinical features, management, and prognosis of spontaneous coronary artery dissection. Circulation 2012; 126(5):579–588. doi:10.1161/CIRCULATIONAHA.112.105718
- Prasad M, Tweet MS, Hayes SN, et al. Prevalence of extracoronary vascular abnormalities and fibromuscular dysplasia in patients with spontaneous coronary artery dissection. Am J Cardiol 2015; 115(12):1672–1677. doi:10.1016/j.amjcard.2015.03.011
- Adès LC, Waltham RD, Chiodo AA, Bateman JF. Myocardial infarction resulting from coronary artery dissection in an adolescent with Ehlers-Danlos syndrome type IV due to a type III collagen mutation. Br Heart J 1995; 74(2):112–116. pmid:7546986
- Judge DP, Dietz HC. Marfan’s syndrome. Lancet 2005; 366(9501):1965–1976. doi:10.1016/S0140-6736(05)67789-6
- Saw J. Spontaneous coronary artery dissection. Can J Cardiol 2013; 29(9):1027–1033. doi:10.1016/j.cjca.2012.12.018
- Poloskey SL, Kim ES, Sanghani R, et al. Low yield of genetic testing for known vascular connective tissue disorders in patients with fibromuscular dysplasia. Vasc Med 2012; 17(6):371–378. doi:10.1177/1358863X12459650
A 12-lead electrocardiogram (Figure 1) showed ST-segment elevation of more than 2 mm in leads V2, V3, V4, and V5, with no reciprocal changes.
Based on the classic angiographic appearance and the absence of atherosclerotic disease in other coronary arteries, type 2 spontaneous coronary artery dissection (SCAD) was diagnosed.
CORONARY ARTERY WALL SEPARATION
SCAD is defined as a nontraumatic, noniatrogenic intramural hemorrhage leading to separation of the coronary arterial wall and the formation of a false lumen. The separation can occur between any of the coronary artery wall layers and may or may not involve an intimal tear. The bleeding may result in an intramural hematoma and possible narrowing of the arterial lumen. Depending on the severity of narrowing, blood supply to the myocardium could be compromised, resulting in symptoms of ischemia.1
SCAD usually involves a single coronary artery, although multiple coronary artery involvement has been reported.2
CASE CONTINUED: MANAGEMENT
The patient recovered completely and was discharged home with plans to return for outpatient imaging for fibromuscular dysplasia.
SCAD: RARE OR JUST RARELY RECOGNIZED?
SCAD appears to be a rare cause of acute coronary syndrome, but it is likely underdiagnosed and is becoming increasingly recognized worldwide. Typically, it affects women younger than 50, with women in general outnumbering men 9 to 1.3 Overall, SCAD causes up to 4% of acute myocardial infarctions, but in women age 50 or younger, it is responsible for 24% to 35% of acute myocardial infarctions, and the proportion is even higher in pregnant women.4
Not just pregnancy-associated
SCAD was previously thought to be mainly idiopathic and mostly affecting women peripartum. Current understanding paints a different picture: pregnancy-associated SCAD does not account for the majority of cases. That said, SCAD is the most common cause of myocardial infarction peripartum, with the third trimester and early postpartum period being the times of highest risk.5 SCAD development at those times is believed to be related to hormonal changes causing weakening of coronary artery walls.6
Weakening of the coronary artery wall also may occur in the setting of fibromuscular dysplasia, connective tissue disease, recurrent pregnancies, systemic inflammatory disease, hormonal therapy, and other disease states that cause arteriopathy. Exposure to a stressor in a patient with underlying risk factors can lead to either an intimal tear or rupture of the vasa vasorum, with subsequent formation of intramural hemorrhage and eventually SCAD.7 Stressors can be emotional or physical and can include labor and delivery, intense physical exercise, the Valsalva maneuver, and drug abuse.8
Presentation is variable
SCAD presentation depends on the degree of flow limitation and extent of the dissection. Presentation can range from asymptomatic to sudden cardiac death and can include signs and symptoms of acute coronary syndrome caused by ST-segment elevation or non-ST-segment elevation myocardial infarction.
DIAGNOSIS BY ANGIOGRAPHY
SCAD can be diagnosed by coronary angiography. There are 3 angiographic types:
Type 1 (about 25% of SCAD cases) has typical contrast dye staining of the arterial wall and multiple radiolucent luminal abnormalities, with or without dye hang-up.
Type 2 (about 70%) has diffuse, smooth narrowing of the coronary artery, with the left anterior descending artery the most frequently affected.8
Type 3 (about 5%) mimics atherosclerosis, with focal or tubular stenosis.9
Types 1 and 2 are usually easy to recognize. To diagnose type 2, intravenous nitroglycerin should first be administered to rule out coronary spasm.
Type 3 SCAD is more challenging to diagnose because its appearance on angiography is similar to that of atherosclerosis. For equivocal findings in any type, but especially in type 3, intravascular ultrasonography or optical coherence tomography can help.10 Optical coherence tomography is preferred because of superior image resolution, although ultrasonography offers better tissue penetration.11
MANAGE MOST CASES CONSERVATIVELY
Management algorithms for SCAD are available.8,12
The initial and most critical step is to make the correct diagnosis. Although the presentation of acute coronary syndrome caused by SCAD is often identical to that of atherosclerosis, the conditions have different pathophysiologies and thus require different management. Theoretically, systemic anticoagulation may worsen an intramural hemorrhage.
First-line therapy for most patients with SCAD is conservative management and close inpatient monitoring for 3 to 5 days.13 More aggressive management is indicated for any of the following:
- Left main or severe proximal 2-vessel dissection
- Hemodynamic instability
- Ongoing ischemic symptoms.
In a prospective cohort of 168 patients, 134 (80%) were initially treated conservatively; of those, in-hospital myocardial infarction recurred in 4.5%, a major cardiac event occurred within 2 years in 17%, and SCAD recurred in 13%.8
Observational data on patients with SCAD who had repeat angiography weeks to months after the initial event has shown that lesions heal in 70% to 97% of patients.12
WHEN TO CONSIDER AGGRESSIVE MANAGEMENT
Under the circumstances listed above, revascularization with PCI or coronary artery bypass grafting (CABG) should be considered, with choice of procedure determined by feasibility, technical considerations, and local expertise.
The American Heart Association recommendations are as follows12:
- For left main or severe proximal 2-vessel dissection in clinically stable patients, consider CABG
- For active ischemia or hemodynamic instability, consider PCI if feasible or perform urgent CABG.
A few series have shown that the prognosis with conservative management or CABG is better than with PCI.8,13,14 The success rate for revascularization with PCI is only about 60% because of challenges including risk of inducing iatrogenic dissection, passing the wire into the false lumen and worsening a dissection, and propagating an intramural hematoma with stenting and further compromising coronary blood flow. In addition, dissection tends to extend into distal arteries that are difficult to stent. There is also the risk of stent malapposition after resorption of the intramural hematoma, causing late stent thrombosis.7
SCREEN FOR OTHER VASCULAR PROBLEMS
Imaging of the renal, iliac, and cerebral vasculature is recommended for all patients with SCAD.12 Screening for fibromuscular dysplasia can be done with angiography, computed tomographic angiography (CTA), or magnetic resonance angiography (MRA).12
Multifocal fibromuscular dysplasia in extracoronary arteries occurs with SCAD in 25% to 86% of cases. In a single-center series of 115 patients with confirmed SCAD who underwent CTA from 2010 to 2014, extracoronary vascular abnormalities were found in 66%, with fibromuscular dysplasia being the most common type (45%).15 In another single-center study, 327 patients with SCAD were prospectively followed from 2012 to 2016 with screening for cerebrovascular, renal, and iliac fibromuscular dysplasia using CTA or catheter angiography. Fibromuscular dysplasia was found in 63%, and intracranial aneurysm was found in 14% of patients with fibromuscular dysplasia.9
SCAD can also be associated with connective tissue disorders such as Ehlers-Danlos syndrome type IV and Marfan syndrome.16,17
LONG-TERM MANAGEMENT
Patients with SCAD should start long-term aspirin and 1 year of clopidogrel. Statins are indicated for patients with hyperlipidemia8,18 but otherwise offer no clear benefit for SCAD alone. If there are no contraindications, a beta-adrenergic blocker should be considered, especially if left ventricular dysfunction or arrhythmias are present. Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers should also be considered with concomitant left ventricular dysfunction. Antianginal therapy can be used for post-SCAD chest pain syndromes.12
Repeat angiography is recommended only to evaluate recurrent symptoms, to confirm an unclear initial diagnosis, to assess for atherosclerosis-related stenosis, or to evaluate high-risk anatomy, eg, involvement of the left main coronary artery.12
Genetic testing is reserved for patients with a high clinical suspicion of connective tissue disease or systemic arteriopathy.19
A 12-lead electrocardiogram (Figure 1) showed ST-segment elevation of more than 2 mm in leads V2, V3, V4, and V5, with no reciprocal changes.
Based on the classic angiographic appearance and the absence of atherosclerotic disease in other coronary arteries, type 2 spontaneous coronary artery dissection (SCAD) was diagnosed.
CORONARY ARTERY WALL SEPARATION
SCAD is defined as a nontraumatic, noniatrogenic intramural hemorrhage leading to separation of the coronary arterial wall and the formation of a false lumen. The separation can occur between any of the coronary artery wall layers and may or may not involve an intimal tear. The bleeding may result in an intramural hematoma and possible narrowing of the arterial lumen. Depending on the severity of narrowing, blood supply to the myocardium could be compromised, resulting in symptoms of ischemia.1
SCAD usually involves a single coronary artery, although multiple coronary artery involvement has been reported.2
CASE CONTINUED: MANAGEMENT
The patient recovered completely and was discharged home with plans to return for outpatient imaging for fibromuscular dysplasia.
SCAD: RARE OR JUST RARELY RECOGNIZED?
SCAD appears to be a rare cause of acute coronary syndrome, but it is likely underdiagnosed and is becoming increasingly recognized worldwide. Typically, it affects women younger than 50, with women in general outnumbering men 9 to 1.3 Overall, SCAD causes up to 4% of acute myocardial infarctions, but in women age 50 or younger, it is responsible for 24% to 35% of acute myocardial infarctions, and the proportion is even higher in pregnant women.4
Not just pregnancy-associated
SCAD was previously thought to be mainly idiopathic and mostly affecting women peripartum. Current understanding paints a different picture: pregnancy-associated SCAD does not account for the majority of cases. That said, SCAD is the most common cause of myocardial infarction peripartum, with the third trimester and early postpartum period being the times of highest risk.5 SCAD development at those times is believed to be related to hormonal changes causing weakening of coronary artery walls.6
Weakening of the coronary artery wall also may occur in the setting of fibromuscular dysplasia, connective tissue disease, recurrent pregnancies, systemic inflammatory disease, hormonal therapy, and other disease states that cause arteriopathy. Exposure to a stressor in a patient with underlying risk factors can lead to either an intimal tear or rupture of the vasa vasorum, with subsequent formation of intramural hemorrhage and eventually SCAD.7 Stressors can be emotional or physical and can include labor and delivery, intense physical exercise, the Valsalva maneuver, and drug abuse.8
Presentation is variable
SCAD presentation depends on the degree of flow limitation and extent of the dissection. Presentation can range from asymptomatic to sudden cardiac death and can include signs and symptoms of acute coronary syndrome caused by ST-segment elevation or non-ST-segment elevation myocardial infarction.
DIAGNOSIS BY ANGIOGRAPHY
SCAD can be diagnosed by coronary angiography. There are 3 angiographic types:
Type 1 (about 25% of SCAD cases) has typical contrast dye staining of the arterial wall and multiple radiolucent luminal abnormalities, with or without dye hang-up.
Type 2 (about 70%) has diffuse, smooth narrowing of the coronary artery, with the left anterior descending artery the most frequently affected.8
Type 3 (about 5%) mimics atherosclerosis, with focal or tubular stenosis.9
Types 1 and 2 are usually easy to recognize. To diagnose type 2, intravenous nitroglycerin should first be administered to rule out coronary spasm.
Type 3 SCAD is more challenging to diagnose because its appearance on angiography is similar to that of atherosclerosis. For equivocal findings in any type, but especially in type 3, intravascular ultrasonography or optical coherence tomography can help.10 Optical coherence tomography is preferred because of superior image resolution, although ultrasonography offers better tissue penetration.11
MANAGE MOST CASES CONSERVATIVELY
Management algorithms for SCAD are available.8,12
The initial and most critical step is to make the correct diagnosis. Although the presentation of acute coronary syndrome caused by SCAD is often identical to that of atherosclerosis, the conditions have different pathophysiologies and thus require different management. Theoretically, systemic anticoagulation may worsen an intramural hemorrhage.
First-line therapy for most patients with SCAD is conservative management and close inpatient monitoring for 3 to 5 days.13 More aggressive management is indicated for any of the following:
- Left main or severe proximal 2-vessel dissection
- Hemodynamic instability
- Ongoing ischemic symptoms.
In a prospective cohort of 168 patients, 134 (80%) were initially treated conservatively; of those, in-hospital myocardial infarction recurred in 4.5%, a major cardiac event occurred within 2 years in 17%, and SCAD recurred in 13%.8
Observational data on patients with SCAD who had repeat angiography weeks to months after the initial event has shown that lesions heal in 70% to 97% of patients.12
WHEN TO CONSIDER AGGRESSIVE MANAGEMENT
Under the circumstances listed above, revascularization with PCI or coronary artery bypass grafting (CABG) should be considered, with choice of procedure determined by feasibility, technical considerations, and local expertise.
The American Heart Association recommendations are as follows12:
- For left main or severe proximal 2-vessel dissection in clinically stable patients, consider CABG
- For active ischemia or hemodynamic instability, consider PCI if feasible or perform urgent CABG.
A few series have shown that the prognosis with conservative management or CABG is better than with PCI.8,13,14 The success rate for revascularization with PCI is only about 60% because of challenges including risk of inducing iatrogenic dissection, passing the wire into the false lumen and worsening a dissection, and propagating an intramural hematoma with stenting and further compromising coronary blood flow. In addition, dissection tends to extend into distal arteries that are difficult to stent. There is also the risk of stent malapposition after resorption of the intramural hematoma, causing late stent thrombosis.7
SCREEN FOR OTHER VASCULAR PROBLEMS
Imaging of the renal, iliac, and cerebral vasculature is recommended for all patients with SCAD.12 Screening for fibromuscular dysplasia can be done with angiography, computed tomographic angiography (CTA), or magnetic resonance angiography (MRA).12
Multifocal fibromuscular dysplasia in extracoronary arteries occurs with SCAD in 25% to 86% of cases. In a single-center series of 115 patients with confirmed SCAD who underwent CTA from 2010 to 2014, extracoronary vascular abnormalities were found in 66%, with fibromuscular dysplasia being the most common type (45%).15 In another single-center study, 327 patients with SCAD were prospectively followed from 2012 to 2016 with screening for cerebrovascular, renal, and iliac fibromuscular dysplasia using CTA or catheter angiography. Fibromuscular dysplasia was found in 63%, and intracranial aneurysm was found in 14% of patients with fibromuscular dysplasia.9
SCAD can also be associated with connective tissue disorders such as Ehlers-Danlos syndrome type IV and Marfan syndrome.16,17
LONG-TERM MANAGEMENT
Patients with SCAD should start long-term aspirin and 1 year of clopidogrel. Statins are indicated for patients with hyperlipidemia8,18 but otherwise offer no clear benefit for SCAD alone. If there are no contraindications, a beta-adrenergic blocker should be considered, especially if left ventricular dysfunction or arrhythmias are present. Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers should also be considered with concomitant left ventricular dysfunction. Antianginal therapy can be used for post-SCAD chest pain syndromes.12
Repeat angiography is recommended only to evaluate recurrent symptoms, to confirm an unclear initial diagnosis, to assess for atherosclerosis-related stenosis, or to evaluate high-risk anatomy, eg, involvement of the left main coronary artery.12
Genetic testing is reserved for patients with a high clinical suspicion of connective tissue disease or systemic arteriopathy.19
- Garcia NA, Khan AN, Boppana RC, Smith HL. Spontaneous coronary artery dissection: a case series and literature review. J Community Hosp Intern Med Perspect 2014; 4(4). doi:10.3402/jchimp.v4.25261
- Lempereur M, Gin K, Saw J. Multivessel spontaneous coronary artery dissection mimicking atherosclerosis. JACC Cardiovasc Interv 2014; 7(7):e87–e88. doi:10.1016/j.jcin.2013.12.207
- Mahmoud AN, Taduru SS, Mentias A, et al. Trends of incidence, clinical presentation, and in-hospital mortality among women with acute myocardial infarction with or without spontaneous coronary artery dissection: a population-based analysis. JACC Cardiovasc Interv 2018; 11(1):80–90. doi:10.1016/j.jcin.2017.08.016
- Saw J. Pregnancy-associated spontaneous coronary artery dissection represents an exceptionally high-risk spontaneous coronary artery dissection cohort. Circ Cardiovasc Interv 2017; 10(3)pii:e005119. doi:10.1161/CIRCINTERVENTIONS.117.005119
- Elkayam U, Jalnapurkar S, Barakkat MN, et al. Pregnancy-associated acute myocardial infarction: a review of contemporary experience in 150 cases between 2006 and 2011. Circulation 2014; 129(16):1695–1702. doi:10.1161/CIRCULATIONAHA.113.002054
- Vijayaraghavan R, Verma S, Gupta N, Saw J. Pregnancy-related spontaneous coronary artery dissection. Circulation 2014; 130(21):1915–1920. doi:10.1161/CIRCULATIONAHA.114.011422
- Saw J, Mancini GBJ, Humphries KH. Contemporary review on spontaneous coronary artery dissection. J Am Coll Cardiol 2016; 68(3):297–312. doi:10.1016/j.jacc.2016.05.034
- Saw J, Aymong E, Sedlak T, et al. Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes. Circ Cardiovasc Interv 2014; 7(5):645–655. doi:10.1161/CIRCINTERVENTIONS.114.001760
- Saw J, Humphries K ,Aymong E, et al. Spontaneous coronary artery dissection: clinical outcomes and risk of recurrence. J Am Coll Cardiol 2017; 70(9):1148–1158. doi:10.1016/j.jacc.2017.06.053
- Alfonso F, Bastante T, Cuesta J, Rodríguez D, Benedicto A, Rivero F. Spontaneous coronary artery dissection: novel insights on diagnosis and management. Cardiovasc Diagn Ther 2015; 5(2):133–140. doi:10.3978/j.issn.2223-3652.2015.03.05
- Kern MJ, Meier B. Evaluation of the culprit plaque and the physiological significance of coronary atherosclerotic narrowings. Circulation 2001; 103(25):3142–3149. pmid:11425782
- Hayes SN, Kim ESH, Saw J, et al; American Heart Association Council on Peripheral Vascular Disease; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; and Stroke Council. Spontaneous coronary artery dissection: current state of the science: a scientific statement from the American Heart Association. Circulation 2018; 137(19):e523–e557. doi:10.1161/CIR.0000000000000564
- Tweet MS, Eleid MF, Best PJ, et al. Spontaneous coronary artery dissection: revascularization versus conservative therapy. Circ Cardiovasc Interv 2014; 7(6):777–786. doi:10.1161/CIRCINTERVENTIONS.114.001659
- Tweet MS, Hayes SN, Pitta SR, et al. Clinical features, management, and prognosis of spontaneous coronary artery dissection. Circulation 2012; 126(5):579–588. doi:10.1161/CIRCULATIONAHA.112.105718
- Prasad M, Tweet MS, Hayes SN, et al. Prevalence of extracoronary vascular abnormalities and fibromuscular dysplasia in patients with spontaneous coronary artery dissection. Am J Cardiol 2015; 115(12):1672–1677. doi:10.1016/j.amjcard.2015.03.011
- Adès LC, Waltham RD, Chiodo AA, Bateman JF. Myocardial infarction resulting from coronary artery dissection in an adolescent with Ehlers-Danlos syndrome type IV due to a type III collagen mutation. Br Heart J 1995; 74(2):112–116. pmid:7546986
- Judge DP, Dietz HC. Marfan’s syndrome. Lancet 2005; 366(9501):1965–1976. doi:10.1016/S0140-6736(05)67789-6
- Saw J. Spontaneous coronary artery dissection. Can J Cardiol 2013; 29(9):1027–1033. doi:10.1016/j.cjca.2012.12.018
- Poloskey SL, Kim ES, Sanghani R, et al. Low yield of genetic testing for known vascular connective tissue disorders in patients with fibromuscular dysplasia. Vasc Med 2012; 17(6):371–378. doi:10.1177/1358863X12459650
- Garcia NA, Khan AN, Boppana RC, Smith HL. Spontaneous coronary artery dissection: a case series and literature review. J Community Hosp Intern Med Perspect 2014; 4(4). doi:10.3402/jchimp.v4.25261
- Lempereur M, Gin K, Saw J. Multivessel spontaneous coronary artery dissection mimicking atherosclerosis. JACC Cardiovasc Interv 2014; 7(7):e87–e88. doi:10.1016/j.jcin.2013.12.207
- Mahmoud AN, Taduru SS, Mentias A, et al. Trends of incidence, clinical presentation, and in-hospital mortality among women with acute myocardial infarction with or without spontaneous coronary artery dissection: a population-based analysis. JACC Cardiovasc Interv 2018; 11(1):80–90. doi:10.1016/j.jcin.2017.08.016
- Saw J. Pregnancy-associated spontaneous coronary artery dissection represents an exceptionally high-risk spontaneous coronary artery dissection cohort. Circ Cardiovasc Interv 2017; 10(3)pii:e005119. doi:10.1161/CIRCINTERVENTIONS.117.005119
- Elkayam U, Jalnapurkar S, Barakkat MN, et al. Pregnancy-associated acute myocardial infarction: a review of contemporary experience in 150 cases between 2006 and 2011. Circulation 2014; 129(16):1695–1702. doi:10.1161/CIRCULATIONAHA.113.002054
- Vijayaraghavan R, Verma S, Gupta N, Saw J. Pregnancy-related spontaneous coronary artery dissection. Circulation 2014; 130(21):1915–1920. doi:10.1161/CIRCULATIONAHA.114.011422
- Saw J, Mancini GBJ, Humphries KH. Contemporary review on spontaneous coronary artery dissection. J Am Coll Cardiol 2016; 68(3):297–312. doi:10.1016/j.jacc.2016.05.034
- Saw J, Aymong E, Sedlak T, et al. Spontaneous coronary artery dissection: association with predisposing arteriopathies and precipitating stressors and cardiovascular outcomes. Circ Cardiovasc Interv 2014; 7(5):645–655. doi:10.1161/CIRCINTERVENTIONS.114.001760
- Saw J, Humphries K ,Aymong E, et al. Spontaneous coronary artery dissection: clinical outcomes and risk of recurrence. J Am Coll Cardiol 2017; 70(9):1148–1158. doi:10.1016/j.jacc.2017.06.053
- Alfonso F, Bastante T, Cuesta J, Rodríguez D, Benedicto A, Rivero F. Spontaneous coronary artery dissection: novel insights on diagnosis and management. Cardiovasc Diagn Ther 2015; 5(2):133–140. doi:10.3978/j.issn.2223-3652.2015.03.05
- Kern MJ, Meier B. Evaluation of the culprit plaque and the physiological significance of coronary atherosclerotic narrowings. Circulation 2001; 103(25):3142–3149. pmid:11425782
- Hayes SN, Kim ESH, Saw J, et al; American Heart Association Council on Peripheral Vascular Disease; Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; and Stroke Council. Spontaneous coronary artery dissection: current state of the science: a scientific statement from the American Heart Association. Circulation 2018; 137(19):e523–e557. doi:10.1161/CIR.0000000000000564
- Tweet MS, Eleid MF, Best PJ, et al. Spontaneous coronary artery dissection: revascularization versus conservative therapy. Circ Cardiovasc Interv 2014; 7(6):777–786. doi:10.1161/CIRCINTERVENTIONS.114.001659
- Tweet MS, Hayes SN, Pitta SR, et al. Clinical features, management, and prognosis of spontaneous coronary artery dissection. Circulation 2012; 126(5):579–588. doi:10.1161/CIRCULATIONAHA.112.105718
- Prasad M, Tweet MS, Hayes SN, et al. Prevalence of extracoronary vascular abnormalities and fibromuscular dysplasia in patients with spontaneous coronary artery dissection. Am J Cardiol 2015; 115(12):1672–1677. doi:10.1016/j.amjcard.2015.03.011
- Adès LC, Waltham RD, Chiodo AA, Bateman JF. Myocardial infarction resulting from coronary artery dissection in an adolescent with Ehlers-Danlos syndrome type IV due to a type III collagen mutation. Br Heart J 1995; 74(2):112–116. pmid:7546986
- Judge DP, Dietz HC. Marfan’s syndrome. Lancet 2005; 366(9501):1965–1976. doi:10.1016/S0140-6736(05)67789-6
- Saw J. Spontaneous coronary artery dissection. Can J Cardiol 2013; 29(9):1027–1033. doi:10.1016/j.cjca.2012.12.018
- Poloskey SL, Kim ES, Sanghani R, et al. Low yield of genetic testing for known vascular connective tissue disorders in patients with fibromuscular dysplasia. Vasc Med 2012; 17(6):371–378. doi:10.1177/1358863X12459650
KEY POINTS
- SCAD often presents with symptoms of acute coronary syndrome but can be asymptomatic or cause sudden death.
- Management is generally conservative, but a left main or severe proximal 2-vessel dissection, hemodynamic instability, or ongoing ischemic symptoms may warrant revascularization.
- All patients with SCAD should be screened for other vascular problems, especially fibromuscular dysplasia.
- Long-term aspirin therapy and 1 year of clopidogrel are recommended after an episode of SCAD.
How should I treat acute agitation in pregnancy?
Acute agitation in the pregnant patient should be treated as an obstetric emergency, as it jeopardizes the safety of the patient and fetus, as well as others in the emergency room. Uncontrolled agitation is associated with obstetric complications such as preterm delivery, placental abnormalities, postnatal death, and spontaneous abortion.1
Current data on the reproductive safety of drugs commonly used to treat acute agitation—benzodiazepines, typical (first-generation) antipsychotics, atypical (second-generation) antipsychotics, and diphenhydramine—suggest no increase in risk beyond the 2% to 3% risk of congenital malformations in the general population when used in the first trimester.2,3
FOCUS OF THE EMERGENCY EVALUATION
Agitation is defined as the physical manifestation of internal distress, due to an underlying medical condition such as delirium or to a psychiatric condition such as acute intoxication or withdrawal, psychosis, mania, or personality disorder.4
For the agitated pregnant woman who is not belligerent at presentation, triage should start with a basic assessment of airways, breathing, and circulation, as well as vital signs and glucose level.5 A thorough medical history and a description of events leading to the presentation, obtained from the patient or the patient’s family or friends, are vital for narrowing the diagnosis and deciding treatment.
The initial evaluation should include consideration of delirium, trauma, intracranial hemorrhage, coagulopathy, thrombocytopenia, amniotic and venous thromboembolism, hypoxia and hypercapnia, and signs and symptoms of intoxication or withdrawal from substances such as alcohol, cocaine, phencyclidine, methamphetamine, and substituted cathinones (“bath salts”). From 20 weeks of gestation to 6 weeks postpartum, eclampsia should also be considered in the differential diagnosis.1 Ruling out these conditions is important since the management of each differs vastly from the protocol for agitation secondary to psychosis, mania, or delirium.
NEW SYSTEM TO DETERMINE RISK DURING PREGNANCY, LACTATION
The US Food and Drug Administration (FDA) has discontinued its pregnancy category labeling system that used the letters A, B, C, D, and X to convey reproductive and lactation safety. The new system, established under the FDA Pregnancy and Lactation Labeling Rule,6 provides descriptive, up-to-date explanations of risk, as well as previously absent context regarding baseline risk for major malformations in the general population to help with informed decision-making.7 This allows the healthcare provider to interpret the risk for an individual patient.
FIRST-GENERATION ANTIPSYCHOTICS SAFE, EFFECTIVE IN PREGNANCY
Reproductive safety of first-generation (ie, typical) neuroleptics such as haloperidol is supported by extensive data accumulated over the past 50 years.2,3,8 No significant teratogenic effect has been documented with this drug class,7 although a 1996 meta-analysis found a small increase in the relative risk of congenital malformations in offspring exposed to low-potency antipsychotics compared with those exposed to high-potency antipsychotics.2
In general, mid- and high-potency antipsychotics (eg, haloperidol, perphenazine) are often recommended because they are less likely to have associated sedative or hypotensive effects than low-potency antipsychotics (eg, chlorpromazine, perphenazine), which may be a significant consideration for a pregnant patient.2,8
There is a theoretical risk of neonatal extrapyramidal symptoms with exposure to first-generation antipsychotics in the third trimester, but the data to support this are from sparse case reports and small observational cohorts.9
NEWER ANTIPSYCHOTICS ALSO SAFE IN PREGNANCY
Newer antipsychotics such as the second-generation antipsychotics, available since the mid-1990s, are increasingly used as primary or adjunctive therapy across a wide range of psychiatric disorders.10 Recent data from large, prospective cohort studies investigating reproductive safety of these agents are reassuring, with no specific patterns of organ malformation.11,12
DIPHENHYDRAMINE
Recent studies of antihistamines such as diphenhydramine have not reported any risk of major malformations with first-trimester exposure to antihistamines.13,14 Dose-dependent anticholinergic adverse effects of antihistamines can induce or exacerbate delirium and agitation, although these effects are classically seen in elderly, nonpregnant patients.15 Thus, given the paucity of adverse effects and the low risk, diphenhydramine is considered safe to use in pregnancy.13
BENZODIAZEPINES
Benzodiazepines are not contraindicated for the treatment of acute agitation in pregnancy.16 Reproductive safety data from meta-analyses and large population-based cohort studies have found no evidence of increased risk of major malformations in neonates born to mothers on prescription benzodiazepines in the first trimester.17,18 While third-trimester exposure to benzodiazepines has been associated with “floppy-baby” syndrome and neonatal withdrawal syndrome,16 these are more likely to occur in women on long-term prescription benzodiazepine therapy. No study has yet assessed the risk of these outcomes with a 1-time acute exposure in the emergency department; however, the risk is likely minimal given the aforementioned data observed in women on long-term prescription benzodiazepine therapy.
STEPWISE MANAGEMENT OF AGITATION IN PREGNANCY
If untreated, agitation in pregnancy is independently associated with outcomes that include premature delivery, low birth weight, growth retardation, postnatal death, and spontaneous abortion.1 The risk of these outcomes greatly outweighs any potential risk from psychotropic medications during pregnancy.
Nevertheless, intervention should progress in a stepwise manner, starting with the least restrictive and progressing toward more restrictive interventions, including pharmacotherapy, use of a seclusion room, and physical restraints (Figure 1).4,19
Before medications are considered, attempts should be made to engage with and “de-escalate” the patient in a safe, nonstimulating environment.19 If this approach is not effective, the patient should be offered oral medications to help with her agitation. However, if the patient’s behavior continues to escalate, presenting a danger to herself or staff, the use of emergency medications is clearly indicated. Providers should succinctly inform the patient of the need for immediate intervention.
If the patient has had a good response in the past to one of these medications or is currently taking one as needed, the same medication should be offered. If the patient has never been treated for agitation, it is important to consider the presenting symptoms, differential diagnosis, and the route and rapidity of administration of medication. If the patient has experienced a fall or other trauma, confirming a viable fetal heart rate between 10 to 22 weeks of gestation with Doppler ultrasonography and obstetric consultation should be considered.
DRUG THERAPY RECOMMENDATIONS
Mild to moderate agitation in pregnancy should be managed conservatively with diphenhydramine. Other options include a benzodiazepine, particularly lorazepam, if alcohol withdrawal is suspected. A second-generation antipsychotic such as olanzapine in a rapidly dissolving form or ziprasidone is another option if a rapid response is required.20Table 1 provides a summary of pharmacotherapy recommendations.
Severe agitation may require a combination of agents. A commonly used, safe regimen—colloquially called the “B52 bomb”—is haloperidol 5 mg, lorazepam 2 mg, and diphenhydramine 25 to 50 mg for prophylaxis of dystonia.20
The patient’s response should be monitored closely, as dosing may require modification as a result of pregnancy-related changes in drug distribution, metabolism, and clearance.21
Although no study to our knowledge has assessed risk associated with 1-time exposure to any of these classes of medications in pregnant women, the aforementioned data on long-term exposure provide reassurance that single exposure in emergency departments likely has little or no effect for the developing fetus.
PHYSICAL RESTRAINTS FOR AGITATION IN PREGNANCY
Physical restraints along with emergency medications (ie, chemical restraint) may be indicated when the patient poses a danger to herself or others. In some cases, both types of restraint may be required, whether in the emergency room or an inpatient setting.
However, during the second and third trimesters, physical restraints such as 4-point restraints may predispose the patient to inferior vena cava compression syndrome and compromise placental blood flow.4 Therefore, pregnant patients after 20 weeks of gestation should be positioned in the left lateral decubitus position, with the right hip positioned 10 to 12 cm off the bed with pillows or blankets. And when restraints are used in pregnant patients, frequent checking of vital signs and physical assessment is needed to mitigate risks.4
- Aftab A, Shah AA. Behavioral emergencies: special considerations in the pregnant patient. Psychiatr Clin North Am 2017; 40(3):435–448. doi:10.1016/j.psc.2017.05.017
- Altshuler LL, Cohen L, Szuba MP, Burt VK, Gitlin M, Mintz J. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry 1996; 153(5):592–606. doi:10.1176/ajp.153.5.592
- Einarson A. Safety of psychotropic drug use during pregnancy: a review. MedGenMed 2005; 7(4):3. pmid:16614625
- Wilson MP, Nordstrom K, Shah AA, Vilke GM. Psychiatric emergencies in pregnant women. Emerg Med Clin North Am 2015; 33(4):841–851. doi:10.1016/j.emc.2015.07.010
- Brown HE, Stoklosa J, Freundenreich O. How to stabilize an acutely psychotic patient. Curr Psychiatry 2012; 11(12):10–16.
- US Food and Drug Administration. Pregnancy and lactation labeling (drugs) final rule. www.fda.gov/drugs/developmentapprovalprocess/developmentresources/labeling/ucm093307.htm. Accessed January 8, 2019.
- Brucker MC, King TL. The 2015 US Food and Drug Administration pregnancy and lactation labeling rule. J Midwifery Womens Health 2017; 62(3):308–316. doi:10.1111/jmwh.12611
- Diav-Citrin O, Shechtman S, Ornoy S, et al. Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study. J Clin Psychiatry 2005; 66(3):317–322. pmid:15766297
- Galbally M, Snellen M, Power J. Antipsychotic drugs in pregnancy: a review of their maternal and fetal effects. Ther Adv Drug Saf 2014; 5(2):100–109. doi:10.1177/2042098614522682
- Kulkarni J, Storch A, Baraniuk A, Gilbert H, Gavrilidis E, Worsley R. Antipsychotic use in pregnancy. Expert Opin Pharmacother 2015; 16(9):1335–1345. doi:10.1517/14656566.2015.1041501
- Huybrechts KF, Hernández-Díaz S, Patorno E, et al. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 2016; 73(9):938–946. doi:10.1001/jamapsychiatry.2016.1520
- Cohen LS, Viguera AC, McInerney KA, et al. Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital national pregnancy registry for atypical antipsychotics. Am J Psychiatry 2016; 173(3):263–270. doi:10.1176/appi.ajp.2015.15040506
- Li Q, Mitchell AA, Werler MM, Yau WP, Hernández-Díaz S. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract 2013; 1(6):666–674.e1. doi:10.1016/j.jaip.2013.07.008
- Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 2009; 85(2):137–150. doi:10.1002/bdra.20513
- Meuleman JR. Association of diphenhydramine use with adverse effects in hospitalized older patients: possible confounders. Arch Intern Med 2002; 162(6):720–721. pmid:11911733
- Enato E, Moretti M, Koren G. The fetal safety of benzodiazepines: an updated meta-analysis. J Obstet Gynaecol Can 2011; 33(1):46–48. doi:10.1016/S1701-2163(16)34772-7
- Dolovich LR, Addis A, Vaillancourt JM, Power JD, Koren G, Einarson TR. Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies. BMJ 1998; 317(7162):839–843. pmid:9748174
- Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry 2013; 35(1):3–8. doi:10.1016/j.genhosppsych.2012.09.003
- Richmond JS, Berlin JS, Fishkind AB, et al. Verbal de-escalation of the agitated patient: consensus statement of the American Association for Emergency Psychiatry project BETA De-escalation Workgroup. West J Emerg Med 2012; 13(1):17–25. doi:10.5811/westjem.2011.9.6864
- Prager LM, Ivkovic A. Emergency psychiatry. In: Stern TA, Fava M, Wilens TE, Rosenbaum JF, eds. The Massachusetts General Hospital Comprehensive Clinical Psychiatry. 2nd ed. London: Elsevier; 2016:937–949.
- Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol 2015; 39(7):512–519. doi:10.1053/j.semperi.2015.08.003
Acute agitation in the pregnant patient should be treated as an obstetric emergency, as it jeopardizes the safety of the patient and fetus, as well as others in the emergency room. Uncontrolled agitation is associated with obstetric complications such as preterm delivery, placental abnormalities, postnatal death, and spontaneous abortion.1
Current data on the reproductive safety of drugs commonly used to treat acute agitation—benzodiazepines, typical (first-generation) antipsychotics, atypical (second-generation) antipsychotics, and diphenhydramine—suggest no increase in risk beyond the 2% to 3% risk of congenital malformations in the general population when used in the first trimester.2,3
FOCUS OF THE EMERGENCY EVALUATION
Agitation is defined as the physical manifestation of internal distress, due to an underlying medical condition such as delirium or to a psychiatric condition such as acute intoxication or withdrawal, psychosis, mania, or personality disorder.4
For the agitated pregnant woman who is not belligerent at presentation, triage should start with a basic assessment of airways, breathing, and circulation, as well as vital signs and glucose level.5 A thorough medical history and a description of events leading to the presentation, obtained from the patient or the patient’s family or friends, are vital for narrowing the diagnosis and deciding treatment.
The initial evaluation should include consideration of delirium, trauma, intracranial hemorrhage, coagulopathy, thrombocytopenia, amniotic and venous thromboembolism, hypoxia and hypercapnia, and signs and symptoms of intoxication or withdrawal from substances such as alcohol, cocaine, phencyclidine, methamphetamine, and substituted cathinones (“bath salts”). From 20 weeks of gestation to 6 weeks postpartum, eclampsia should also be considered in the differential diagnosis.1 Ruling out these conditions is important since the management of each differs vastly from the protocol for agitation secondary to psychosis, mania, or delirium.
NEW SYSTEM TO DETERMINE RISK DURING PREGNANCY, LACTATION
The US Food and Drug Administration (FDA) has discontinued its pregnancy category labeling system that used the letters A, B, C, D, and X to convey reproductive and lactation safety. The new system, established under the FDA Pregnancy and Lactation Labeling Rule,6 provides descriptive, up-to-date explanations of risk, as well as previously absent context regarding baseline risk for major malformations in the general population to help with informed decision-making.7 This allows the healthcare provider to interpret the risk for an individual patient.
FIRST-GENERATION ANTIPSYCHOTICS SAFE, EFFECTIVE IN PREGNANCY
Reproductive safety of first-generation (ie, typical) neuroleptics such as haloperidol is supported by extensive data accumulated over the past 50 years.2,3,8 No significant teratogenic effect has been documented with this drug class,7 although a 1996 meta-analysis found a small increase in the relative risk of congenital malformations in offspring exposed to low-potency antipsychotics compared with those exposed to high-potency antipsychotics.2
In general, mid- and high-potency antipsychotics (eg, haloperidol, perphenazine) are often recommended because they are less likely to have associated sedative or hypotensive effects than low-potency antipsychotics (eg, chlorpromazine, perphenazine), which may be a significant consideration for a pregnant patient.2,8
There is a theoretical risk of neonatal extrapyramidal symptoms with exposure to first-generation antipsychotics in the third trimester, but the data to support this are from sparse case reports and small observational cohorts.9
NEWER ANTIPSYCHOTICS ALSO SAFE IN PREGNANCY
Newer antipsychotics such as the second-generation antipsychotics, available since the mid-1990s, are increasingly used as primary or adjunctive therapy across a wide range of psychiatric disorders.10 Recent data from large, prospective cohort studies investigating reproductive safety of these agents are reassuring, with no specific patterns of organ malformation.11,12
DIPHENHYDRAMINE
Recent studies of antihistamines such as diphenhydramine have not reported any risk of major malformations with first-trimester exposure to antihistamines.13,14 Dose-dependent anticholinergic adverse effects of antihistamines can induce or exacerbate delirium and agitation, although these effects are classically seen in elderly, nonpregnant patients.15 Thus, given the paucity of adverse effects and the low risk, diphenhydramine is considered safe to use in pregnancy.13
BENZODIAZEPINES
Benzodiazepines are not contraindicated for the treatment of acute agitation in pregnancy.16 Reproductive safety data from meta-analyses and large population-based cohort studies have found no evidence of increased risk of major malformations in neonates born to mothers on prescription benzodiazepines in the first trimester.17,18 While third-trimester exposure to benzodiazepines has been associated with “floppy-baby” syndrome and neonatal withdrawal syndrome,16 these are more likely to occur in women on long-term prescription benzodiazepine therapy. No study has yet assessed the risk of these outcomes with a 1-time acute exposure in the emergency department; however, the risk is likely minimal given the aforementioned data observed in women on long-term prescription benzodiazepine therapy.
STEPWISE MANAGEMENT OF AGITATION IN PREGNANCY
If untreated, agitation in pregnancy is independently associated with outcomes that include premature delivery, low birth weight, growth retardation, postnatal death, and spontaneous abortion.1 The risk of these outcomes greatly outweighs any potential risk from psychotropic medications during pregnancy.
Nevertheless, intervention should progress in a stepwise manner, starting with the least restrictive and progressing toward more restrictive interventions, including pharmacotherapy, use of a seclusion room, and physical restraints (Figure 1).4,19
Before medications are considered, attempts should be made to engage with and “de-escalate” the patient in a safe, nonstimulating environment.19 If this approach is not effective, the patient should be offered oral medications to help with her agitation. However, if the patient’s behavior continues to escalate, presenting a danger to herself or staff, the use of emergency medications is clearly indicated. Providers should succinctly inform the patient of the need for immediate intervention.
If the patient has had a good response in the past to one of these medications or is currently taking one as needed, the same medication should be offered. If the patient has never been treated for agitation, it is important to consider the presenting symptoms, differential diagnosis, and the route and rapidity of administration of medication. If the patient has experienced a fall or other trauma, confirming a viable fetal heart rate between 10 to 22 weeks of gestation with Doppler ultrasonography and obstetric consultation should be considered.
DRUG THERAPY RECOMMENDATIONS
Mild to moderate agitation in pregnancy should be managed conservatively with diphenhydramine. Other options include a benzodiazepine, particularly lorazepam, if alcohol withdrawal is suspected. A second-generation antipsychotic such as olanzapine in a rapidly dissolving form or ziprasidone is another option if a rapid response is required.20Table 1 provides a summary of pharmacotherapy recommendations.
Severe agitation may require a combination of agents. A commonly used, safe regimen—colloquially called the “B52 bomb”—is haloperidol 5 mg, lorazepam 2 mg, and diphenhydramine 25 to 50 mg for prophylaxis of dystonia.20
The patient’s response should be monitored closely, as dosing may require modification as a result of pregnancy-related changes in drug distribution, metabolism, and clearance.21
Although no study to our knowledge has assessed risk associated with 1-time exposure to any of these classes of medications in pregnant women, the aforementioned data on long-term exposure provide reassurance that single exposure in emergency departments likely has little or no effect for the developing fetus.
PHYSICAL RESTRAINTS FOR AGITATION IN PREGNANCY
Physical restraints along with emergency medications (ie, chemical restraint) may be indicated when the patient poses a danger to herself or others. In some cases, both types of restraint may be required, whether in the emergency room or an inpatient setting.
However, during the second and third trimesters, physical restraints such as 4-point restraints may predispose the patient to inferior vena cava compression syndrome and compromise placental blood flow.4 Therefore, pregnant patients after 20 weeks of gestation should be positioned in the left lateral decubitus position, with the right hip positioned 10 to 12 cm off the bed with pillows or blankets. And when restraints are used in pregnant patients, frequent checking of vital signs and physical assessment is needed to mitigate risks.4
Acute agitation in the pregnant patient should be treated as an obstetric emergency, as it jeopardizes the safety of the patient and fetus, as well as others in the emergency room. Uncontrolled agitation is associated with obstetric complications such as preterm delivery, placental abnormalities, postnatal death, and spontaneous abortion.1
Current data on the reproductive safety of drugs commonly used to treat acute agitation—benzodiazepines, typical (first-generation) antipsychotics, atypical (second-generation) antipsychotics, and diphenhydramine—suggest no increase in risk beyond the 2% to 3% risk of congenital malformations in the general population when used in the first trimester.2,3
FOCUS OF THE EMERGENCY EVALUATION
Agitation is defined as the physical manifestation of internal distress, due to an underlying medical condition such as delirium or to a psychiatric condition such as acute intoxication or withdrawal, psychosis, mania, or personality disorder.4
For the agitated pregnant woman who is not belligerent at presentation, triage should start with a basic assessment of airways, breathing, and circulation, as well as vital signs and glucose level.5 A thorough medical history and a description of events leading to the presentation, obtained from the patient or the patient’s family or friends, are vital for narrowing the diagnosis and deciding treatment.
The initial evaluation should include consideration of delirium, trauma, intracranial hemorrhage, coagulopathy, thrombocytopenia, amniotic and venous thromboembolism, hypoxia and hypercapnia, and signs and symptoms of intoxication or withdrawal from substances such as alcohol, cocaine, phencyclidine, methamphetamine, and substituted cathinones (“bath salts”). From 20 weeks of gestation to 6 weeks postpartum, eclampsia should also be considered in the differential diagnosis.1 Ruling out these conditions is important since the management of each differs vastly from the protocol for agitation secondary to psychosis, mania, or delirium.
NEW SYSTEM TO DETERMINE RISK DURING PREGNANCY, LACTATION
The US Food and Drug Administration (FDA) has discontinued its pregnancy category labeling system that used the letters A, B, C, D, and X to convey reproductive and lactation safety. The new system, established under the FDA Pregnancy and Lactation Labeling Rule,6 provides descriptive, up-to-date explanations of risk, as well as previously absent context regarding baseline risk for major malformations in the general population to help with informed decision-making.7 This allows the healthcare provider to interpret the risk for an individual patient.
FIRST-GENERATION ANTIPSYCHOTICS SAFE, EFFECTIVE IN PREGNANCY
Reproductive safety of first-generation (ie, typical) neuroleptics such as haloperidol is supported by extensive data accumulated over the past 50 years.2,3,8 No significant teratogenic effect has been documented with this drug class,7 although a 1996 meta-analysis found a small increase in the relative risk of congenital malformations in offspring exposed to low-potency antipsychotics compared with those exposed to high-potency antipsychotics.2
In general, mid- and high-potency antipsychotics (eg, haloperidol, perphenazine) are often recommended because they are less likely to have associated sedative or hypotensive effects than low-potency antipsychotics (eg, chlorpromazine, perphenazine), which may be a significant consideration for a pregnant patient.2,8
There is a theoretical risk of neonatal extrapyramidal symptoms with exposure to first-generation antipsychotics in the third trimester, but the data to support this are from sparse case reports and small observational cohorts.9
NEWER ANTIPSYCHOTICS ALSO SAFE IN PREGNANCY
Newer antipsychotics such as the second-generation antipsychotics, available since the mid-1990s, are increasingly used as primary or adjunctive therapy across a wide range of psychiatric disorders.10 Recent data from large, prospective cohort studies investigating reproductive safety of these agents are reassuring, with no specific patterns of organ malformation.11,12
DIPHENHYDRAMINE
Recent studies of antihistamines such as diphenhydramine have not reported any risk of major malformations with first-trimester exposure to antihistamines.13,14 Dose-dependent anticholinergic adverse effects of antihistamines can induce or exacerbate delirium and agitation, although these effects are classically seen in elderly, nonpregnant patients.15 Thus, given the paucity of adverse effects and the low risk, diphenhydramine is considered safe to use in pregnancy.13
BENZODIAZEPINES
Benzodiazepines are not contraindicated for the treatment of acute agitation in pregnancy.16 Reproductive safety data from meta-analyses and large population-based cohort studies have found no evidence of increased risk of major malformations in neonates born to mothers on prescription benzodiazepines in the first trimester.17,18 While third-trimester exposure to benzodiazepines has been associated with “floppy-baby” syndrome and neonatal withdrawal syndrome,16 these are more likely to occur in women on long-term prescription benzodiazepine therapy. No study has yet assessed the risk of these outcomes with a 1-time acute exposure in the emergency department; however, the risk is likely minimal given the aforementioned data observed in women on long-term prescription benzodiazepine therapy.
STEPWISE MANAGEMENT OF AGITATION IN PREGNANCY
If untreated, agitation in pregnancy is independently associated with outcomes that include premature delivery, low birth weight, growth retardation, postnatal death, and spontaneous abortion.1 The risk of these outcomes greatly outweighs any potential risk from psychotropic medications during pregnancy.
Nevertheless, intervention should progress in a stepwise manner, starting with the least restrictive and progressing toward more restrictive interventions, including pharmacotherapy, use of a seclusion room, and physical restraints (Figure 1).4,19
Before medications are considered, attempts should be made to engage with and “de-escalate” the patient in a safe, nonstimulating environment.19 If this approach is not effective, the patient should be offered oral medications to help with her agitation. However, if the patient’s behavior continues to escalate, presenting a danger to herself or staff, the use of emergency medications is clearly indicated. Providers should succinctly inform the patient of the need for immediate intervention.
If the patient has had a good response in the past to one of these medications or is currently taking one as needed, the same medication should be offered. If the patient has never been treated for agitation, it is important to consider the presenting symptoms, differential diagnosis, and the route and rapidity of administration of medication. If the patient has experienced a fall or other trauma, confirming a viable fetal heart rate between 10 to 22 weeks of gestation with Doppler ultrasonography and obstetric consultation should be considered.
DRUG THERAPY RECOMMENDATIONS
Mild to moderate agitation in pregnancy should be managed conservatively with diphenhydramine. Other options include a benzodiazepine, particularly lorazepam, if alcohol withdrawal is suspected. A second-generation antipsychotic such as olanzapine in a rapidly dissolving form or ziprasidone is another option if a rapid response is required.20Table 1 provides a summary of pharmacotherapy recommendations.
Severe agitation may require a combination of agents. A commonly used, safe regimen—colloquially called the “B52 bomb”—is haloperidol 5 mg, lorazepam 2 mg, and diphenhydramine 25 to 50 mg for prophylaxis of dystonia.20
The patient’s response should be monitored closely, as dosing may require modification as a result of pregnancy-related changes in drug distribution, metabolism, and clearance.21
Although no study to our knowledge has assessed risk associated with 1-time exposure to any of these classes of medications in pregnant women, the aforementioned data on long-term exposure provide reassurance that single exposure in emergency departments likely has little or no effect for the developing fetus.
PHYSICAL RESTRAINTS FOR AGITATION IN PREGNANCY
Physical restraints along with emergency medications (ie, chemical restraint) may be indicated when the patient poses a danger to herself or others. In some cases, both types of restraint may be required, whether in the emergency room or an inpatient setting.
However, during the second and third trimesters, physical restraints such as 4-point restraints may predispose the patient to inferior vena cava compression syndrome and compromise placental blood flow.4 Therefore, pregnant patients after 20 weeks of gestation should be positioned in the left lateral decubitus position, with the right hip positioned 10 to 12 cm off the bed with pillows or blankets. And when restraints are used in pregnant patients, frequent checking of vital signs and physical assessment is needed to mitigate risks.4
- Aftab A, Shah AA. Behavioral emergencies: special considerations in the pregnant patient. Psychiatr Clin North Am 2017; 40(3):435–448. doi:10.1016/j.psc.2017.05.017
- Altshuler LL, Cohen L, Szuba MP, Burt VK, Gitlin M, Mintz J. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry 1996; 153(5):592–606. doi:10.1176/ajp.153.5.592
- Einarson A. Safety of psychotropic drug use during pregnancy: a review. MedGenMed 2005; 7(4):3. pmid:16614625
- Wilson MP, Nordstrom K, Shah AA, Vilke GM. Psychiatric emergencies in pregnant women. Emerg Med Clin North Am 2015; 33(4):841–851. doi:10.1016/j.emc.2015.07.010
- Brown HE, Stoklosa J, Freundenreich O. How to stabilize an acutely psychotic patient. Curr Psychiatry 2012; 11(12):10–16.
- US Food and Drug Administration. Pregnancy and lactation labeling (drugs) final rule. www.fda.gov/drugs/developmentapprovalprocess/developmentresources/labeling/ucm093307.htm. Accessed January 8, 2019.
- Brucker MC, King TL. The 2015 US Food and Drug Administration pregnancy and lactation labeling rule. J Midwifery Womens Health 2017; 62(3):308–316. doi:10.1111/jmwh.12611
- Diav-Citrin O, Shechtman S, Ornoy S, et al. Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study. J Clin Psychiatry 2005; 66(3):317–322. pmid:15766297
- Galbally M, Snellen M, Power J. Antipsychotic drugs in pregnancy: a review of their maternal and fetal effects. Ther Adv Drug Saf 2014; 5(2):100–109. doi:10.1177/2042098614522682
- Kulkarni J, Storch A, Baraniuk A, Gilbert H, Gavrilidis E, Worsley R. Antipsychotic use in pregnancy. Expert Opin Pharmacother 2015; 16(9):1335–1345. doi:10.1517/14656566.2015.1041501
- Huybrechts KF, Hernández-Díaz S, Patorno E, et al. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 2016; 73(9):938–946. doi:10.1001/jamapsychiatry.2016.1520
- Cohen LS, Viguera AC, McInerney KA, et al. Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital national pregnancy registry for atypical antipsychotics. Am J Psychiatry 2016; 173(3):263–270. doi:10.1176/appi.ajp.2015.15040506
- Li Q, Mitchell AA, Werler MM, Yau WP, Hernández-Díaz S. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract 2013; 1(6):666–674.e1. doi:10.1016/j.jaip.2013.07.008
- Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 2009; 85(2):137–150. doi:10.1002/bdra.20513
- Meuleman JR. Association of diphenhydramine use with adverse effects in hospitalized older patients: possible confounders. Arch Intern Med 2002; 162(6):720–721. pmid:11911733
- Enato E, Moretti M, Koren G. The fetal safety of benzodiazepines: an updated meta-analysis. J Obstet Gynaecol Can 2011; 33(1):46–48. doi:10.1016/S1701-2163(16)34772-7
- Dolovich LR, Addis A, Vaillancourt JM, Power JD, Koren G, Einarson TR. Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies. BMJ 1998; 317(7162):839–843. pmid:9748174
- Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry 2013; 35(1):3–8. doi:10.1016/j.genhosppsych.2012.09.003
- Richmond JS, Berlin JS, Fishkind AB, et al. Verbal de-escalation of the agitated patient: consensus statement of the American Association for Emergency Psychiatry project BETA De-escalation Workgroup. West J Emerg Med 2012; 13(1):17–25. doi:10.5811/westjem.2011.9.6864
- Prager LM, Ivkovic A. Emergency psychiatry. In: Stern TA, Fava M, Wilens TE, Rosenbaum JF, eds. The Massachusetts General Hospital Comprehensive Clinical Psychiatry. 2nd ed. London: Elsevier; 2016:937–949.
- Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol 2015; 39(7):512–519. doi:10.1053/j.semperi.2015.08.003
- Aftab A, Shah AA. Behavioral emergencies: special considerations in the pregnant patient. Psychiatr Clin North Am 2017; 40(3):435–448. doi:10.1016/j.psc.2017.05.017
- Altshuler LL, Cohen L, Szuba MP, Burt VK, Gitlin M, Mintz J. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry 1996; 153(5):592–606. doi:10.1176/ajp.153.5.592
- Einarson A. Safety of psychotropic drug use during pregnancy: a review. MedGenMed 2005; 7(4):3. pmid:16614625
- Wilson MP, Nordstrom K, Shah AA, Vilke GM. Psychiatric emergencies in pregnant women. Emerg Med Clin North Am 2015; 33(4):841–851. doi:10.1016/j.emc.2015.07.010
- Brown HE, Stoklosa J, Freundenreich O. How to stabilize an acutely psychotic patient. Curr Psychiatry 2012; 11(12):10–16.
- US Food and Drug Administration. Pregnancy and lactation labeling (drugs) final rule. www.fda.gov/drugs/developmentapprovalprocess/developmentresources/labeling/ucm093307.htm. Accessed January 8, 2019.
- Brucker MC, King TL. The 2015 US Food and Drug Administration pregnancy and lactation labeling rule. J Midwifery Womens Health 2017; 62(3):308–316. doi:10.1111/jmwh.12611
- Diav-Citrin O, Shechtman S, Ornoy S, et al. Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study. J Clin Psychiatry 2005; 66(3):317–322. pmid:15766297
- Galbally M, Snellen M, Power J. Antipsychotic drugs in pregnancy: a review of their maternal and fetal effects. Ther Adv Drug Saf 2014; 5(2):100–109. doi:10.1177/2042098614522682
- Kulkarni J, Storch A, Baraniuk A, Gilbert H, Gavrilidis E, Worsley R. Antipsychotic use in pregnancy. Expert Opin Pharmacother 2015; 16(9):1335–1345. doi:10.1517/14656566.2015.1041501
- Huybrechts KF, Hernández-Díaz S, Patorno E, et al. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 2016; 73(9):938–946. doi:10.1001/jamapsychiatry.2016.1520
- Cohen LS, Viguera AC, McInerney KA, et al. Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital national pregnancy registry for atypical antipsychotics. Am J Psychiatry 2016; 173(3):263–270. doi:10.1176/appi.ajp.2015.15040506
- Li Q, Mitchell AA, Werler MM, Yau WP, Hernández-Díaz S. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract 2013; 1(6):666–674.e1. doi:10.1016/j.jaip.2013.07.008
- Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol 2009; 85(2):137–150. doi:10.1002/bdra.20513
- Meuleman JR. Association of diphenhydramine use with adverse effects in hospitalized older patients: possible confounders. Arch Intern Med 2002; 162(6):720–721. pmid:11911733
- Enato E, Moretti M, Koren G. The fetal safety of benzodiazepines: an updated meta-analysis. J Obstet Gynaecol Can 2011; 33(1):46–48. doi:10.1016/S1701-2163(16)34772-7
- Dolovich LR, Addis A, Vaillancourt JM, Power JD, Koren G, Einarson TR. Benzodiazepine use in pregnancy and major malformations or oral cleft: meta-analysis of cohort and case-control studies. BMJ 1998; 317(7162):839–843. pmid:9748174
- Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry 2013; 35(1):3–8. doi:10.1016/j.genhosppsych.2012.09.003
- Richmond JS, Berlin JS, Fishkind AB, et al. Verbal de-escalation of the agitated patient: consensus statement of the American Association for Emergency Psychiatry project BETA De-escalation Workgroup. West J Emerg Med 2012; 13(1):17–25. doi:10.5811/westjem.2011.9.6864
- Prager LM, Ivkovic A. Emergency psychiatry. In: Stern TA, Fava M, Wilens TE, Rosenbaum JF, eds. The Massachusetts General Hospital Comprehensive Clinical Psychiatry. 2nd ed. London: Elsevier; 2016:937–949.
- Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol 2015; 39(7):512–519. doi:10.1053/j.semperi.2015.08.003
