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FDA approves cell-based flu shot for ages 6 months and older
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.pdnews@mdedge.com
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.pdnews@mdedge.com
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.pdnews@mdedge.com
Midwife-assisted community births post low adverse outcomes
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
Adverse event rates were similarly low overall for women delivering at home or at community birth centers, based on data from a retrospective study of more than 10,000 births.
Increasing numbers of women in the United States are choosing to give birth at home or in freestanding out-of-hospital birth centers, prompted by high patient satisfaction and low intervention, wrote Elizabeth Nethery, MSc, MSM, of the University of British Columbia, Vancouver, and colleagues. Although data from other countries with well-integrated midwifery show no significant difference in outcomes between home or community births and hospital births, data in the United States are limited, and some studies have shown an increase in perinatal mortality for home births, the researchers said.
“ACOG identified elements for safe planned home birth: high degree of integration of midwives, education meeting International Confederation of Midwives standards, ready access to consultation and transfer, and ‘appropriate selection of candidates,’ all of which are present in Washington State,” the researchers wrote.
In a study published in Obstetrics & Gynecology, the researchers reviewed outcomes for 10,609 births attended by members of a professional midwifery association in Washington State between Jan. 1, 2015, and June 30, 2020. Of these, 40.9% (4,344) were planned to take place at home and 59.1% (6,265) were planned to take place at birth centers. The births were attended by a total of 139 midwives. A majority (84%) of the women planning a home or community center birth were White non-Hispanic, and 64% were multiparous.
Overall, 86% of the women gave birth in the location of their choice. Intrapartum transfers to hospitals were significantly more likely for nulliparous women, compared with multiparous women (30.5% vs. 4.2%). However, the cesarean birth rates were not significantly different based on birth location (11% for nulliparous women vs. 1% for multiparous women overall), and maternal and neonatal outcomes were similar for home births and birth center births.
Approximately two-thirds (66%) of the women who transferred to a hospital had a vaginal birth, including 37% of nulliparous women and 20% of multiparous women.
Overall perinatal mortality after the onset of labor and within 7 days was 0.57 per 1,000 births, which was similar to rates seen in other high-income countries with established systems for community birth and midwifery, the researchers noted.
“This large study population of planned home and planned birth center births in a single state with well-integrated midwifery enabled our study to overcome previous limitations to studying planned community births in the United States,” they said.
The study findings were limited by several other factors, notably the inclusion only of members of the Midwives’ Association of Washington State, the researchers said. Although demographics of the women in the study were similar to those in other states, the results may not be generalizable to other states with different programs for training midwives or to a more diverse population; however, better integration of community midwives in the United States overall could lead to comparable outcomes in other states, the researchers concluded.
Birth location should be an informed decision
The current study takes on the controversial topic of safety differences between planned birth locations, wrote Julia C. Phillippi, PhD, CNM, of Vanderbilt University, Nashville, Tenn., in an accompanying editorial.
“Rates of community birth in the United States have increased by 85% since 2004, to more than 62,000 births in 2017, and thousands more individuals planned community births but needed transfer to hospital care,” she said. The interest in and use of home or community births may have increased in the wake of the COVID-19 pandemic as families considered the perceived risks of being in a hospital, she noted.
“There is broad consensus among U.S. perinatal and neonatal health care leadership that informed choice should be a cornerstone of maternity care,” Dr. Phillippi emphasized. Although outcomes were favorable for most patients using community or home birth options in the current study, the selection criteria encouraged only low-risk women to plan home or community births, and they were not compared directly to outcomes for low-risk patients in planned hospital birth settings, she noted.
“Evidence-based information about systems-level and individual characteristics associated with safe, physiologic birth can be helpful in assisting individuals planning location of birth – in terms of selecting hospital birth or opting for community birth if key safety provisions are met,” said Dr. Phillippi. However, “For community birth to have favorable outcomes, systems need open channels for transfer when laboring individuals are no longer low risk or require interventions,” she added.
Larger, prospective studies and ongoing risk assessment is needed to support informed decision-making, said Dr. Phillippi. Publicizing safety considerations and developing transfer pathways can not only improve patient satisfaction, but also reduce preventable perinatal morbidity and mortality, she concluded.
Patient selection is key to successful community birth
The current study is important at this time because of the relatively limited evidence on outcomes with planned community births in the United States, said Iris Krishna, MD, of Emory University, Atlanta, in an interview.
“Most information available is based on observational studies, as is the case with this study, and it is important to continue to add to growing literature,” she said.
Overall, Dr. Krishna said she was not surprised by the study findings. “In the well-selected, low-risk patient with a certified or licensed nurse-midwife, a low rate of adverse outcomes is to be expected,” she said.
“Strict criteria are necessary to guide selection of appropriate candidates for planned community birth to reduce the risk of adverse maternal and/or fetal outcomes,” Dr. Krishna added. “In the appropriately selected low-risk patient with a certified or licensed nurse-midwife, a favorable outcome is achievable. It is also important to have ready access to safe and timely transport to nearby hospitals,” she noted.
“Physicians should counsel patients contemplating a planned community birth that available data may not be generalizable to all birth settings in the United States or to all patients,” Dr. Krishna emphasized. “For example, this cohort is predominantly non-Hispanic White patients, which typically have lower rates of adverse perinatal events in comparison to other ethnicities,” she explained.
“More research is needed, and in particular research comparing planned community births with planned hospital births in the appropriately selected low-risk patient,” Dr. Krishna said.
The study received no outside funding. Lead author Ms. Nethery disclosed support from a Canadian Vanier Graduate Scholarship. The researchers had no financial conflicts to disclose. Dr. Phillippi had no financial conflicts to disclose. Dr. Krishna had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Ob.Gyn News.
FROM OBSTETRICS & GYNECOLOGY
Avoidant attachment style may drive mood in movement disorders
Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.
The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.
Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.
To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.
In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.
The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.
The results were mainly in line with those from previous studies, the researchers said. However, than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.
The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.
However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.
The study received no outside funding, and the researchers disclosed no financial conflicts.
Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.
The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.
Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.
To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.
In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.
The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.
The results were mainly in line with those from previous studies, the researchers said. However, than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.
The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.
However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.
The study received no outside funding, and the researchers disclosed no financial conflicts.
Patients with functional neurological disorders demonstrate higher levels of depression and alexithymia – in addition to signs of an avoidant attachment style – compared with those with other neurological disorders and healthy controls, investigators report.
The pathological mechanism of functional neurological disorders (FND) remains poorly understood, but current models include both psychological and environmental factors, Sofia Cuoco, PhD, and colleagues wrote in a study published in the Journal of Psychosomatic Research.
Previous studies have suggested a relationship between attachment styles (AS) and psychiatric symptoms in FND patients but most have been limited to the FND population, noted Dr. Cuoco, of the University of Salerno, Italy, and colleagues. In FND, “it is unclear to what extent psychiatric features are explained by AS per se or are part of the FND spectrum,” they said.
To conduct the study, the investigators recruited 46 patients with FND, 34 patients with neurological disorders (ND) and 30 healthy controls. Demographic characteristics, including age, education, and gender, were similar among the groups. Overall, depression and alexithymia were significantly more prevalent in the FND group, compared with the other groups. Anxiety was more common in the FND group, compared with healthy controls, but similar compared with the ND group. Patients in the FND group reported significantly lower quality of life, compared with those in the other groups.
In a multivariate analysis aimed at examining AS and psychiatric features, the researchers found that the Experiences in Close Relationships–Revised questionnaire avoidance, Beck Depression Inventory, Somatic Affective, and the 20-item Toronto Alexithymia Scale Difficulty Identifying Feelings scale (TAS-20 Difficulty Identifying Feelings) were significant predictors of FND and accounted for about half of the variance.
The researchers also compared FND to functional seizures, and found that the TAS-20 Difficulty Identifying Feelings scale, the Hamilton Anxiety Scale–Anxiety, and female gender were significant predictors of functional seizures.
The results were mainly in line with those from previous studies, the researchers said. However, than ND, which might suggest that these psychiatric features would not be merely reactive to physical symptoms,” they noted.
The study findings were limited by several factors, including the absence of systematic interviews for personality disorders or traits, monitoring psychotropic medications, and conducting formal psychiatric assessments, the researchers noted. Other limitations include the heterogenous study population and absence of data on symptom severity, history of trauma, or other factors that might contributed to FND, they said.
However, the results suggest that avoidant AS might play an important role in the occurrence of psychiatric features in FND patients and should be considered in managing these conditions. More research is needed to explore the impact of attachment on pathophysiology with more complex instruments, such as the Adult Attachment Interview, Dr. Cuoco and colleagues said.
The study received no outside funding, and the researchers disclosed no financial conflicts.
FROM THE JOURNAL OF PSYCHOSOMATIC RESEARCH
Therapeutic homework adherence improves tics in Tourette’s disorder
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
Homework adherence between behavior therapy sessions is a significant predictor of therapeutic improvement in patients with Tourette’s disorder (TD), a study of 119 youth and adults suggests.
The assigning of “homework” to be completed between sessions – often used in cognitive-behavioral therapy – has been shown to reinforce learning but has not been well studied in TD.
“Understanding the relationship between homework adherence and therapeutic improvement from behavior therapy for TD may offer new insights for enhancing tic severity reductions achieved during this evidence-based treatment,” wrote Joey Ka-Yee Essoe, PhD, of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, and colleagues.
To conduct the study, published in Behaviour Research and Therapy, the researchers recruited 70 youth and 49 adults with TD, ranging in age from 9 to 67 years, who underwent treatment at a single center. The average age was 21 years, and 80 participants were male. Treatment response was based on the Clinical Global Impressions of Improvement scale (CGI-I). Participants were assessed at baseline for tic severity and received eight sessions over 10 weeks. During those sessions, they were taught to perform a competing response to inhibit the expression of a tic when the tic or urge was detected.
Participants received homework at each weekly therapy session; most consisted of three to four practice sessions of about 30 minutes per week. Therapists reviewed the homework at the following session and adapted as needed to improve tic reduction skills.
After eight sessions of behavior therapy, overall greater homework adherence significantly predicted reduced tic severity and therapeutic improvement. However, early homework adherence predicted therapeutic improvement in youth, while late homework adherence predicted it in adults.
Overall,
However, homework adherence dipped midway through treatment in youth and showed a linear decline in adults, the researchers noted.
Among youth, baseline predictors of early homework adherence included lower levels of hyperactivity/impulsivity and caregiver strain. Among adults, baseline predictors of early homework adherence included lower anger scores, less social disability, and greater work disability.
The study findings were limited by several factors, including the absence of complete data on baseline predictors of homework adherence, reliance on a single measure of tic severity and improvement, and reliance on therapists’ reports of homework adherence, the researchers noted.
Future research should include objective measures of homework adherence, such as time-stamped videos, and different strategies may be needed for youth vs. adults, they added.
“Strategies that optimize homework adherence may enhance the efficacy of behavioral therapy, lead to greater tic severity reductions, and higher treatment response rates,” Dr. Essoe and colleagues wrote.
The study was supported by the Tourette Association of America, the National Institute of Mental Health, the American Academy of Neurology, and the American Psychological Foundation.
FROM BEHAVIOUR RESEARCH & THERAPY
Upadacitinib meets primary endpoints for improvement in ankylosing spondylitis and nonradiographic disease
The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.
Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.
In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).
The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.
Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.
Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).
COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.
Study 2 in patients with nr-axSpA
Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.
Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).
The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.
Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.
The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.
The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.
Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.
In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).
The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.
Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.
Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).
COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.
Study 2 in patients with nr-axSpA
Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.
Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).
The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.
Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.
The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.
The selective and reversible Janus kinase inhibitor upadacitinib (Rinvoq) significantly improved symptoms in adults with either ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA) when compared with placebo in a pair of studies from the phase 3 SELECT-AXIS 2 clinical trial, according to press releases issued Oct. 7 by manufacturer AbbVie.
Upadacitinib is currently approved in the European Union for patients with active AS, as well as patients with moderate to severe active rheumatoid arthritis and active psoriatic arthritis. Upadacitinib is approved by the Food and Drug Administration for adults with moderately to severely active RA, but is not currently approved for active AS or nr-axSpA.
In study 1, significantly more patients with AS who were randomly assigned to upadacitinib 15 mg once daily met the primary endpoint of 40% improvement in Assessment in Spondyloarthritis International Society (ASAS 40) response criteria at week 14, compared with placebo (45% vs. 18%) after 14 weeks (P < .0001).
The study of 420 patients with an inadequate response to biologic disease-modifying antirheumatic drug therapy gave half upadacitinib for 104 weeks and the other half placebo for 14 weeks, followed by upadacitinib for 90 weeks.
Patients treated with upadacitinib showed significant improvements in secondary endpoints of back pain, inflammation, physical function, and disease activity at week 14, compared with placebo.
Significantly more upadacitinib- than placebo-treated patients reached low disease activity on the AS Disease Activity Score (ASDAS) (44% vs. 10%). Upadacitinib also led to significantly greater improvements from baseline than did placebo on MRI Spondyloarthritis Research Consortium of Canada (SPARCC) Score for Spine, Patient’s Assessment of Total Back Pain, and Bath AS Functional Index (BASFI) score (–2.26 vs. –1.09).
COVID-19 and headache were the most common adverse events that were seen with upadacitinib during the first 14 weeks of the study (occurring in 3% or more). No adverse events led to study discontinuation among patients taking upadacitinib, compared with 1.4% on placebo, and serious adverse events were reported in 2.8% taking upadacitinib and in 0.5% on placebo. Serious infections with upadacitinib included four cases of COVID-19 and one case of uveitis.
Study 2 in patients with nr-axSpA
Study 2, which included 313 adults with nr-axSpA, yielded results similar to those of study 1 on the primary endpoint of meeting ASAS40 response criteria at week 14 (45% with upadacitinib 15 mg once daily vs. 23% with placebo; P < .0001), as well as on a variety of secondary efficacy endpoints and safety data.
Significantly better responses were observed at week 14 with upadacitinib for rate of low disease activity according to ASDAS (42% vs. 18%), changes in MRI SPARCC Scores for SI joints (–2.49 vs. 0.57), Patient’s Assessment of Total Back Pain (-2.91 vs. -2.00), and physical function based on the BASFI (–2.61 vs. –1.47).
The most common adverse events at 14 weeks, occurring in at least 3% of patients taking upadacitinib, included headache, COVID-19, nasopharyngitis, and nausea. Adverse events leading to study discontinuation occurred in 2.6% with upadacitinib and 1.3% with placebo; serious adverse events occurred in 2.6% and 1.3%, respectively.
Serious infections included COVID-19-induced pneumonia and pyelonephritis in patients taking upadacitinib and one case of hemorrhagic fever with renal syndrome with placebo.
The full results of the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal, according to AbbVie.
Homicide remains a top cause of maternal mortality
The prevalence of homicide was 16% higher in pregnant women or postpartum women than nonpregnant or nonpostpartum women in the United States, according to 2018 and 2019 mortality data from the National Center for Health Statistics.
Homicide has long been identified as a leading cause of death during pregnancy, but homicide is not counted in estimates of maternal mortality, nor is it emphasized as a target for prevention and intervention, wrote Maeve Wallace, PhD, of Tulane University, New Orleans, and colleagues.
Data on maternal mortality (defined as “death while pregnant or within 42 days of the end of pregnancy from causes related to or aggravated by pregnancy”) were limited until the addition of pregnancy to the U.S. Standard Certificate of Death in 2003; all 50 states had adopted it by 2018, the researchers noted.
In a study published in Obstetrics & Gynecology, the researchers analyzed the first 2 years of nationally available data to identify pregnancy-associated mortality and characterize other risk factors such as age and race.
The researchers identified 4,705 female homicides in 2018 and 2019. Of these, 273 (5.8%) occurred in women who were pregnant or within a year of the end of pregnancy. Approximately half (50.2%) of the pregnant or postpartum victims were non-Hispanic Black, 30% were non-Hispanic white, 9.5% were Hispanic, and 10.3% were other races; approximately one-third (35.5%) were in the 20- to 24-year age group.
Overall, the ratio was 3.62 homicides per 100,000 live births among females who were either pregnant or within 1 year post partum, compared to 3.12 homicides per 100,000 live births in nonpregnant, nonpostpartum females aged 10-44 years (P = .05).
“Patterns were similar in further stratification by both race and age such that pregnancy was associated with more than a doubled risk of homicide among girls and women aged 10–24 in both the non-Hispanic White and non-Hispanic Black populations,” the researchers wrote.
The findings are consistent with previous studies, which “implicates health and social system failures. Although we are unable to directly evaluate the involvement of intimate partner violence (IPV) in this report, we did find that a majority of pregnancy-associated homicides occurred in the home, implicating the likelihood of involvement by persons known to the victim,” they noted. In addition, the data showed that approximately 70% of the incidents of homicide in pregnant and postpartum women involved a firearm, an increase over previous estimates.
The study findings were limited by several factors including the lack of circumstantial information and incomplete data on victim characteristics, the researchers noted. Other key limitations included the potential for false-positives and false-negatives when recording pregnancy status, which could lead to underestimates of pregnancy-associated homicides, and the lack of data on pregnancy outcomes for women who experienced live birth, abortion, or miscarriage within a year of death.
However, the results highlight the need for increased awareness and training of physicians in completing the pregnancy checkbox on death certificates, and the need for action on recommendations and interventions to prevent maternal deaths from homicide, they emphasized.
“Although encouraging, a commitment to the actual implementation of policies and investments known to be effective at protecting and the promoting the health and safety of girls and women must follow,” they concluded.
Data highlight disparities
“This study could not be done effectively prior to now, as the adoption of the pregnancy checkbox on the U.S. Standard Certificate of Death was only available in all 50 states as of 2018,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview.
“This study also demonstrates what was already known, which is that pregnancy is a high-risk time period for intimate partner violence, including homicide. The differences in homicide rates based on race and ethnicity also highlight the clear disparities in maternal mortality in the U.S. that are attributable to racism. There is more attention being paid to maternal mortality and the differential experience based on race, and this demonstrates that simply addressing medical management during pregnancy is not enough – we need to address root causes of racism if we truly want to reduce maternal mortality,” Dr. Prager said.
“The primary take-home message for clinicians is to ascertain safety from every patient, and to try to reduce the impacts of racism on health care for patients, especially during pregnancy,” she said.
Although more detailed records would help with elucidating causes versus associations, “more research is not the answer,” Dr. Prager stated. “The real solution here is to have better gun safety laws, and to put significant resources toward reducing the impacts of racism on health care and our society.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose, but serves on the editorial advisory board of Ob.Gyn News.
The prevalence of homicide was 16% higher in pregnant women or postpartum women than nonpregnant or nonpostpartum women in the United States, according to 2018 and 2019 mortality data from the National Center for Health Statistics.
Homicide has long been identified as a leading cause of death during pregnancy, but homicide is not counted in estimates of maternal mortality, nor is it emphasized as a target for prevention and intervention, wrote Maeve Wallace, PhD, of Tulane University, New Orleans, and colleagues.
Data on maternal mortality (defined as “death while pregnant or within 42 days of the end of pregnancy from causes related to or aggravated by pregnancy”) were limited until the addition of pregnancy to the U.S. Standard Certificate of Death in 2003; all 50 states had adopted it by 2018, the researchers noted.
In a study published in Obstetrics & Gynecology, the researchers analyzed the first 2 years of nationally available data to identify pregnancy-associated mortality and characterize other risk factors such as age and race.
The researchers identified 4,705 female homicides in 2018 and 2019. Of these, 273 (5.8%) occurred in women who were pregnant or within a year of the end of pregnancy. Approximately half (50.2%) of the pregnant or postpartum victims were non-Hispanic Black, 30% were non-Hispanic white, 9.5% were Hispanic, and 10.3% were other races; approximately one-third (35.5%) were in the 20- to 24-year age group.
Overall, the ratio was 3.62 homicides per 100,000 live births among females who were either pregnant or within 1 year post partum, compared to 3.12 homicides per 100,000 live births in nonpregnant, nonpostpartum females aged 10-44 years (P = .05).
“Patterns were similar in further stratification by both race and age such that pregnancy was associated with more than a doubled risk of homicide among girls and women aged 10–24 in both the non-Hispanic White and non-Hispanic Black populations,” the researchers wrote.
The findings are consistent with previous studies, which “implicates health and social system failures. Although we are unable to directly evaluate the involvement of intimate partner violence (IPV) in this report, we did find that a majority of pregnancy-associated homicides occurred in the home, implicating the likelihood of involvement by persons known to the victim,” they noted. In addition, the data showed that approximately 70% of the incidents of homicide in pregnant and postpartum women involved a firearm, an increase over previous estimates.
The study findings were limited by several factors including the lack of circumstantial information and incomplete data on victim characteristics, the researchers noted. Other key limitations included the potential for false-positives and false-negatives when recording pregnancy status, which could lead to underestimates of pregnancy-associated homicides, and the lack of data on pregnancy outcomes for women who experienced live birth, abortion, or miscarriage within a year of death.
However, the results highlight the need for increased awareness and training of physicians in completing the pregnancy checkbox on death certificates, and the need for action on recommendations and interventions to prevent maternal deaths from homicide, they emphasized.
“Although encouraging, a commitment to the actual implementation of policies and investments known to be effective at protecting and the promoting the health and safety of girls and women must follow,” they concluded.
Data highlight disparities
“This study could not be done effectively prior to now, as the adoption of the pregnancy checkbox on the U.S. Standard Certificate of Death was only available in all 50 states as of 2018,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview.
“This study also demonstrates what was already known, which is that pregnancy is a high-risk time period for intimate partner violence, including homicide. The differences in homicide rates based on race and ethnicity also highlight the clear disparities in maternal mortality in the U.S. that are attributable to racism. There is more attention being paid to maternal mortality and the differential experience based on race, and this demonstrates that simply addressing medical management during pregnancy is not enough – we need to address root causes of racism if we truly want to reduce maternal mortality,” Dr. Prager said.
“The primary take-home message for clinicians is to ascertain safety from every patient, and to try to reduce the impacts of racism on health care for patients, especially during pregnancy,” she said.
Although more detailed records would help with elucidating causes versus associations, “more research is not the answer,” Dr. Prager stated. “The real solution here is to have better gun safety laws, and to put significant resources toward reducing the impacts of racism on health care and our society.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose, but serves on the editorial advisory board of Ob.Gyn News.
The prevalence of homicide was 16% higher in pregnant women or postpartum women than nonpregnant or nonpostpartum women in the United States, according to 2018 and 2019 mortality data from the National Center for Health Statistics.
Homicide has long been identified as a leading cause of death during pregnancy, but homicide is not counted in estimates of maternal mortality, nor is it emphasized as a target for prevention and intervention, wrote Maeve Wallace, PhD, of Tulane University, New Orleans, and colleagues.
Data on maternal mortality (defined as “death while pregnant or within 42 days of the end of pregnancy from causes related to or aggravated by pregnancy”) were limited until the addition of pregnancy to the U.S. Standard Certificate of Death in 2003; all 50 states had adopted it by 2018, the researchers noted.
In a study published in Obstetrics & Gynecology, the researchers analyzed the first 2 years of nationally available data to identify pregnancy-associated mortality and characterize other risk factors such as age and race.
The researchers identified 4,705 female homicides in 2018 and 2019. Of these, 273 (5.8%) occurred in women who were pregnant or within a year of the end of pregnancy. Approximately half (50.2%) of the pregnant or postpartum victims were non-Hispanic Black, 30% were non-Hispanic white, 9.5% were Hispanic, and 10.3% were other races; approximately one-third (35.5%) were in the 20- to 24-year age group.
Overall, the ratio was 3.62 homicides per 100,000 live births among females who were either pregnant or within 1 year post partum, compared to 3.12 homicides per 100,000 live births in nonpregnant, nonpostpartum females aged 10-44 years (P = .05).
“Patterns were similar in further stratification by both race and age such that pregnancy was associated with more than a doubled risk of homicide among girls and women aged 10–24 in both the non-Hispanic White and non-Hispanic Black populations,” the researchers wrote.
The findings are consistent with previous studies, which “implicates health and social system failures. Although we are unable to directly evaluate the involvement of intimate partner violence (IPV) in this report, we did find that a majority of pregnancy-associated homicides occurred in the home, implicating the likelihood of involvement by persons known to the victim,” they noted. In addition, the data showed that approximately 70% of the incidents of homicide in pregnant and postpartum women involved a firearm, an increase over previous estimates.
The study findings were limited by several factors including the lack of circumstantial information and incomplete data on victim characteristics, the researchers noted. Other key limitations included the potential for false-positives and false-negatives when recording pregnancy status, which could lead to underestimates of pregnancy-associated homicides, and the lack of data on pregnancy outcomes for women who experienced live birth, abortion, or miscarriage within a year of death.
However, the results highlight the need for increased awareness and training of physicians in completing the pregnancy checkbox on death certificates, and the need for action on recommendations and interventions to prevent maternal deaths from homicide, they emphasized.
“Although encouraging, a commitment to the actual implementation of policies and investments known to be effective at protecting and the promoting the health and safety of girls and women must follow,” they concluded.
Data highlight disparities
“This study could not be done effectively prior to now, as the adoption of the pregnancy checkbox on the U.S. Standard Certificate of Death was only available in all 50 states as of 2018,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview.
“This study also demonstrates what was already known, which is that pregnancy is a high-risk time period for intimate partner violence, including homicide. The differences in homicide rates based on race and ethnicity also highlight the clear disparities in maternal mortality in the U.S. that are attributable to racism. There is more attention being paid to maternal mortality and the differential experience based on race, and this demonstrates that simply addressing medical management during pregnancy is not enough – we need to address root causes of racism if we truly want to reduce maternal mortality,” Dr. Prager said.
“The primary take-home message for clinicians is to ascertain safety from every patient, and to try to reduce the impacts of racism on health care for patients, especially during pregnancy,” she said.
Although more detailed records would help with elucidating causes versus associations, “more research is not the answer,” Dr. Prager stated. “The real solution here is to have better gun safety laws, and to put significant resources toward reducing the impacts of racism on health care and our society.”
The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose, but serves on the editorial advisory board of Ob.Gyn News.
FROM OBSTETRICS & GYNECOLOGY
Benzene prompts recalls of spray antifungals and sunscreens
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Bayer has voluntarily recalled batches of its Lotrimin and Tinactin products because of benzene detected in some samples, according to an Oct. 1 company announcement, available on the Food and Drug Administration website. “It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers,” the announcement said.
Benzene is classified as a human carcinogen present in the environment from both natural sources and human activity, and it has been shown to cause cancer with long-term exposure.
The products included in the recall – all in aerosol spray cans – are unexpired Lotrimin and Tinactin sprays with lot numbers starting with TN, CV, or NAA that were distributed to consumer venues between September 2018 and September 2021. The over-the-counter products are Lotrimin Anti-Fungal Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal Jock Itch (AFJI) Athlete’s Foot Powder Spray, Lotrimin Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray, Lotrimin AF Athlete’s Foot Liquid Spray, Lotrimin AF Athlete’s Foot Daily Prevention Deodorant Powder Spray, Tinactin Jock Itch (JI) Powder Spray, Tinactin Athlete’s Foot Deodorant Powder Spray, Tinactin Athlete’s Foot Powder Spray, and Tinactin Athlete’s Foot Liquid Spray.
Bayer has received no reports of adverse events related to the recall. The company also reported no concerns with its antifungal creams or other products.
In addition, Coppertone has issued a voluntary recall of specific lots of five spray sunscreen products because of the presence of benzene, according to a Sept. 30th company announcement, also posted on the FDA website. The recall includes Pure&Simple spray for babies, children, and adults; Coppertone Sport Mineral Spray; and Travel-sized Coppertone Sport spray. The specific lots were manufactured between January and June 2021, and are listed on the company announcement.
“Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies,” according to the announcement. Coppertone has received no reports of adverse events related to the recall.
In the announcement, Coppertone advised consumers to discontinue use of the impacted products, dispose of the aerosol cans properly, and contact their physician or health care provider if they experience any problems related to the sunscreen sprays.
In May 2021, online pharmacy Valisure, which routinely tests their medications, petitioned the FDA to recall specific sunscreens after detecting high benzene levels in several brands and batches of sunscreen products. The FDA evaluated the petition, but the agency itself did not issue any recalls of sunscreens.
Clinicians are advised to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail or fax using this form.
Taper, withdrawal of RA meds tested in real-life randomized trial setting
About half of patients with rheumatoid arthritis who taper or stop disease-modifying antirheumatic drugs (DMARDs) retain stable remission after 12 months, and a majority of those who do relapse regain remission when back on their original treatments, according to data from the open-label, randomized Rheumatoid Arthritis in Ongoing Remission (RETRO) study.
“Currently, 40%-50% of patients with rheumatoid arthritis reach stable remission,” as a result of factors including earlier diagnosis and a wider range of treatments, Koray Tascilar, MD, of Friedrich Alexander University Erlangen-Nuremberg (Germany) and colleagues wrote in their publication of the RETRO trial results in Lancet Rheumatology.
Previous studies have suggested that patients with RA in sustained remission may be able to taper or withdraw treatment, but data from randomized trials are limited, the researchers said.
In the RETRO trial, researchers compared three strategies for RA patients in remission, which was defined as <2.6 on the 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR). They randomized 100 adults to continue DMARDs and glucocorticoids, 102 to taper DMARDs and glucocorticoids to half their prior doses, and 101 to reduce the doses to half for 6 months and then stop DMARDs. Patients were enrolled between May 26, 2010, and May 29, 2018, from 14 treatment centers in Germany. The final analysis included 282 patients; 92 in the continuation group, 93 in the taper group, and 96 in the stop group. The mean age of the patients was 56.5 years, and 59% were women. The mean duration of RA was 7.4 years, and the mean duration of remission was 20 months.
Overall, at 12 months, 61% of the patients remained in remission without relapse; 81.2% of the continuation group, 58.6% of the taper group, and 43.3% of the stop group. Relapses occurred in 17%, 43%, and 55% of patients in the continuation, taper, and stop groups, respectively. The median times to relapse in the three groups were 30.6 weeks, 24.3 weeks, and 26.1 weeks, respectively.
Most of the relapses occurred between weeks 24 and 36 after stopping treatment, the researchers wrote. Corresponding hazard ratios for relapse were 3.02 for the taper group and 4.34 for the stop group, compared with the continuation group. In comparison to continuing treatment, the number needed to treat for one more relapse to occur during the 12-month observation period was four for tapering and three for stopping, they noted.
The study protocol called for a return to baseline treatment for any patients who relapsed in the taper and stop groups, and most patients who relapsed regained remission after restarting their baseline treatments. Among patients who had a follow-up visit after a relapse, 10 (63%) of 16 patients in the continuation group reachieved remission before the end of the study, as did 21 (62%) of 34 in the taper group and 35 (76%) of 46 in the stop group.
The most common treatments at baseline were methotrexate (76%) and tumor necrosis factor (TNF) inhibitors (32%).
The researchers also identified several baseline characteristics associated with relapse. Overall, relapse occurred more often in biologic DMARD users than in participants treated with other drugs, more often in women than men, and more often in those with a longer disease duration, higher baseline DAS28-ESR and Health Assessment Questionnaire scores, and in those who were positive for rheumatoid factor or anti–citrullinated protein antibodies.
A total of 38 serious adverse events occurred in 29 participants during the study period, but none were deemed treatment related, and none led to study withdrawal.
The study findings were limited by several factors including the lack of masking of patients and assessors and potential underestimation of disease activity, the researchers noted. Also, the study did not include radiographic data that might have been used to confirm progression; however, such data could have produced a null result and were not feasible in the study population, they wrote.
“If RETRO had been a trial to test the superiority of 100% dose continuation, compared with tapering plus rescue treatment or stopping plus rescue treatment, we would not be able to show that continuation is superior to tapering or stopping,” the researchers noted.
The study results support “an increasingly dynamic management approach in patients with rheumatoid arthritis in stable remission,” given the changing nature of RA management, that may help reduce overtreatment in many RA patients, the researchers concluded. “Furthermore, the observation that most of the patients regained remission after reintroduction of antirheumatic treatments is helpful with regard to the benefit-risk aspect of treatment reduction.”
Real-world setting serves as starting point
The RETRO study is unique in that it tried to reflect a real-life setting by enrolling patients on baseline treatment with combinations of conventional synthetic DMARDs and biologic DMARDs seen in clinical practice rather than only patients taking biologic DMARDs – primarily TNF inhibitors – as done in previous studies of tapering and stopping DMARDs, wrote Catherine L. Hill, MD, of the University of Adelaide (Australia), in an accompanying editorial. It is also “used a simple, pragmatic one-size-fits-all treatment-tapering strategy,” she wrote.
However, she emphasized that answers are needed to questions about what relapse rates are acceptable, what duration of treatment-free time is ideal, and whether benefits to the patient outweigh risks.
Dr. Hill also highlighted the issue of identifying patients who are appropriate candidates for tapering or withdrawal. Stricter remission criteria may not be feasible in routine practice, and so “the development of algorithms to guide patient selection is likely to be the most practical way forward for clinicians and patients,” she wrote.
“Contemplation of treatment tapering or discontinuation in some patients with rheumatoid arthritis is remarkable and a measure of how far treatments have advanced,” Dr. Hill wrote. “However, further work to address outstanding questions on who should taper and how best to do it is still required,” she concluded.
The study received no outside funding. Lead author Dr. Tascilar disclosed lecture fees from Gilead and Union Chimique Belge; several coauthors disclosed relationships with multiple companies outside the current study. Dr. Hill had no financial conflicts to disclose.
About half of patients with rheumatoid arthritis who taper or stop disease-modifying antirheumatic drugs (DMARDs) retain stable remission after 12 months, and a majority of those who do relapse regain remission when back on their original treatments, according to data from the open-label, randomized Rheumatoid Arthritis in Ongoing Remission (RETRO) study.
“Currently, 40%-50% of patients with rheumatoid arthritis reach stable remission,” as a result of factors including earlier diagnosis and a wider range of treatments, Koray Tascilar, MD, of Friedrich Alexander University Erlangen-Nuremberg (Germany) and colleagues wrote in their publication of the RETRO trial results in Lancet Rheumatology.
Previous studies have suggested that patients with RA in sustained remission may be able to taper or withdraw treatment, but data from randomized trials are limited, the researchers said.
In the RETRO trial, researchers compared three strategies for RA patients in remission, which was defined as <2.6 on the 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR). They randomized 100 adults to continue DMARDs and glucocorticoids, 102 to taper DMARDs and glucocorticoids to half their prior doses, and 101 to reduce the doses to half for 6 months and then stop DMARDs. Patients were enrolled between May 26, 2010, and May 29, 2018, from 14 treatment centers in Germany. The final analysis included 282 patients; 92 in the continuation group, 93 in the taper group, and 96 in the stop group. The mean age of the patients was 56.5 years, and 59% were women. The mean duration of RA was 7.4 years, and the mean duration of remission was 20 months.
Overall, at 12 months, 61% of the patients remained in remission without relapse; 81.2% of the continuation group, 58.6% of the taper group, and 43.3% of the stop group. Relapses occurred in 17%, 43%, and 55% of patients in the continuation, taper, and stop groups, respectively. The median times to relapse in the three groups were 30.6 weeks, 24.3 weeks, and 26.1 weeks, respectively.
Most of the relapses occurred between weeks 24 and 36 after stopping treatment, the researchers wrote. Corresponding hazard ratios for relapse were 3.02 for the taper group and 4.34 for the stop group, compared with the continuation group. In comparison to continuing treatment, the number needed to treat for one more relapse to occur during the 12-month observation period was four for tapering and three for stopping, they noted.
The study protocol called for a return to baseline treatment for any patients who relapsed in the taper and stop groups, and most patients who relapsed regained remission after restarting their baseline treatments. Among patients who had a follow-up visit after a relapse, 10 (63%) of 16 patients in the continuation group reachieved remission before the end of the study, as did 21 (62%) of 34 in the taper group and 35 (76%) of 46 in the stop group.
The most common treatments at baseline were methotrexate (76%) and tumor necrosis factor (TNF) inhibitors (32%).
The researchers also identified several baseline characteristics associated with relapse. Overall, relapse occurred more often in biologic DMARD users than in participants treated with other drugs, more often in women than men, and more often in those with a longer disease duration, higher baseline DAS28-ESR and Health Assessment Questionnaire scores, and in those who were positive for rheumatoid factor or anti–citrullinated protein antibodies.
A total of 38 serious adverse events occurred in 29 participants during the study period, but none were deemed treatment related, and none led to study withdrawal.
The study findings were limited by several factors including the lack of masking of patients and assessors and potential underestimation of disease activity, the researchers noted. Also, the study did not include radiographic data that might have been used to confirm progression; however, such data could have produced a null result and were not feasible in the study population, they wrote.
“If RETRO had been a trial to test the superiority of 100% dose continuation, compared with tapering plus rescue treatment or stopping plus rescue treatment, we would not be able to show that continuation is superior to tapering or stopping,” the researchers noted.
The study results support “an increasingly dynamic management approach in patients with rheumatoid arthritis in stable remission,” given the changing nature of RA management, that may help reduce overtreatment in many RA patients, the researchers concluded. “Furthermore, the observation that most of the patients regained remission after reintroduction of antirheumatic treatments is helpful with regard to the benefit-risk aspect of treatment reduction.”
Real-world setting serves as starting point
The RETRO study is unique in that it tried to reflect a real-life setting by enrolling patients on baseline treatment with combinations of conventional synthetic DMARDs and biologic DMARDs seen in clinical practice rather than only patients taking biologic DMARDs – primarily TNF inhibitors – as done in previous studies of tapering and stopping DMARDs, wrote Catherine L. Hill, MD, of the University of Adelaide (Australia), in an accompanying editorial. It is also “used a simple, pragmatic one-size-fits-all treatment-tapering strategy,” she wrote.
However, she emphasized that answers are needed to questions about what relapse rates are acceptable, what duration of treatment-free time is ideal, and whether benefits to the patient outweigh risks.
Dr. Hill also highlighted the issue of identifying patients who are appropriate candidates for tapering or withdrawal. Stricter remission criteria may not be feasible in routine practice, and so “the development of algorithms to guide patient selection is likely to be the most practical way forward for clinicians and patients,” she wrote.
“Contemplation of treatment tapering or discontinuation in some patients with rheumatoid arthritis is remarkable and a measure of how far treatments have advanced,” Dr. Hill wrote. “However, further work to address outstanding questions on who should taper and how best to do it is still required,” she concluded.
The study received no outside funding. Lead author Dr. Tascilar disclosed lecture fees from Gilead and Union Chimique Belge; several coauthors disclosed relationships with multiple companies outside the current study. Dr. Hill had no financial conflicts to disclose.
About half of patients with rheumatoid arthritis who taper or stop disease-modifying antirheumatic drugs (DMARDs) retain stable remission after 12 months, and a majority of those who do relapse regain remission when back on their original treatments, according to data from the open-label, randomized Rheumatoid Arthritis in Ongoing Remission (RETRO) study.
“Currently, 40%-50% of patients with rheumatoid arthritis reach stable remission,” as a result of factors including earlier diagnosis and a wider range of treatments, Koray Tascilar, MD, of Friedrich Alexander University Erlangen-Nuremberg (Germany) and colleagues wrote in their publication of the RETRO trial results in Lancet Rheumatology.
Previous studies have suggested that patients with RA in sustained remission may be able to taper or withdraw treatment, but data from randomized trials are limited, the researchers said.
In the RETRO trial, researchers compared three strategies for RA patients in remission, which was defined as <2.6 on the 28-joint Disease Activity Score with erythrocyte sedimentation rate (DAS28-ESR). They randomized 100 adults to continue DMARDs and glucocorticoids, 102 to taper DMARDs and glucocorticoids to half their prior doses, and 101 to reduce the doses to half for 6 months and then stop DMARDs. Patients were enrolled between May 26, 2010, and May 29, 2018, from 14 treatment centers in Germany. The final analysis included 282 patients; 92 in the continuation group, 93 in the taper group, and 96 in the stop group. The mean age of the patients was 56.5 years, and 59% were women. The mean duration of RA was 7.4 years, and the mean duration of remission was 20 months.
Overall, at 12 months, 61% of the patients remained in remission without relapse; 81.2% of the continuation group, 58.6% of the taper group, and 43.3% of the stop group. Relapses occurred in 17%, 43%, and 55% of patients in the continuation, taper, and stop groups, respectively. The median times to relapse in the three groups were 30.6 weeks, 24.3 weeks, and 26.1 weeks, respectively.
Most of the relapses occurred between weeks 24 and 36 after stopping treatment, the researchers wrote. Corresponding hazard ratios for relapse were 3.02 for the taper group and 4.34 for the stop group, compared with the continuation group. In comparison to continuing treatment, the number needed to treat for one more relapse to occur during the 12-month observation period was four for tapering and three for stopping, they noted.
The study protocol called for a return to baseline treatment for any patients who relapsed in the taper and stop groups, and most patients who relapsed regained remission after restarting their baseline treatments. Among patients who had a follow-up visit after a relapse, 10 (63%) of 16 patients in the continuation group reachieved remission before the end of the study, as did 21 (62%) of 34 in the taper group and 35 (76%) of 46 in the stop group.
The most common treatments at baseline were methotrexate (76%) and tumor necrosis factor (TNF) inhibitors (32%).
The researchers also identified several baseline characteristics associated with relapse. Overall, relapse occurred more often in biologic DMARD users than in participants treated with other drugs, more often in women than men, and more often in those with a longer disease duration, higher baseline DAS28-ESR and Health Assessment Questionnaire scores, and in those who were positive for rheumatoid factor or anti–citrullinated protein antibodies.
A total of 38 serious adverse events occurred in 29 participants during the study period, but none were deemed treatment related, and none led to study withdrawal.
The study findings were limited by several factors including the lack of masking of patients and assessors and potential underestimation of disease activity, the researchers noted. Also, the study did not include radiographic data that might have been used to confirm progression; however, such data could have produced a null result and were not feasible in the study population, they wrote.
“If RETRO had been a trial to test the superiority of 100% dose continuation, compared with tapering plus rescue treatment or stopping plus rescue treatment, we would not be able to show that continuation is superior to tapering or stopping,” the researchers noted.
The study results support “an increasingly dynamic management approach in patients with rheumatoid arthritis in stable remission,” given the changing nature of RA management, that may help reduce overtreatment in many RA patients, the researchers concluded. “Furthermore, the observation that most of the patients regained remission after reintroduction of antirheumatic treatments is helpful with regard to the benefit-risk aspect of treatment reduction.”
Real-world setting serves as starting point
The RETRO study is unique in that it tried to reflect a real-life setting by enrolling patients on baseline treatment with combinations of conventional synthetic DMARDs and biologic DMARDs seen in clinical practice rather than only patients taking biologic DMARDs – primarily TNF inhibitors – as done in previous studies of tapering and stopping DMARDs, wrote Catherine L. Hill, MD, of the University of Adelaide (Australia), in an accompanying editorial. It is also “used a simple, pragmatic one-size-fits-all treatment-tapering strategy,” she wrote.
However, she emphasized that answers are needed to questions about what relapse rates are acceptable, what duration of treatment-free time is ideal, and whether benefits to the patient outweigh risks.
Dr. Hill also highlighted the issue of identifying patients who are appropriate candidates for tapering or withdrawal. Stricter remission criteria may not be feasible in routine practice, and so “the development of algorithms to guide patient selection is likely to be the most practical way forward for clinicians and patients,” she wrote.
“Contemplation of treatment tapering or discontinuation in some patients with rheumatoid arthritis is remarkable and a measure of how far treatments have advanced,” Dr. Hill wrote. “However, further work to address outstanding questions on who should taper and how best to do it is still required,” she concluded.
The study received no outside funding. Lead author Dr. Tascilar disclosed lecture fees from Gilead and Union Chimique Belge; several coauthors disclosed relationships with multiple companies outside the current study. Dr. Hill had no financial conflicts to disclose.
FROM LANCET RHEUMATOLOGY
Mentoring is key to growing women’s leadership in medicine
Men may think they are supportive of women in the workplace, but if you ask women, they say there is a discrepancy, according to W. Brad Johnson, PhD, a clinical psychologist and professor at the United States Naval Academy in Annapolis, Md.
“We may think we are acting as allies to women because we believe in it, but it may not be showing up in the execution,” he said in a presentation at the virtual Advance PHM Gender Equity Conference.
Although women currently account for the majority of medical school students, they make up only 16% of the population of medical school deans, 18% of department chairs, and 25% of full professors, according to 2019 data from the Association of American Medical Colleges, Dr. Johnson said.
The “missing ingredient” in increasing the number of women in medical faculty positions is that women are less mentored. Some barriers to mentorship include men’s concerns that women will take offers of mentorship the wrong way, but “it is incredibly rare for women to make a false accusation” of harassment in a mentorship situation, said Dr. Johnson.
Dr. Johnson offered some guidance for how men can become better allies for women in the workplace through interpersonal allyship, public allyship, and systemic allyship.
Interpersonal allyship and opportunities for mentoring women in medicine start by building trust, friendship, and collegiality between men and women colleagues, Dr. Johnson explained.
He provided some guidance for men to “sharpen their gender intelligence,” which starts with listening. Surveys of women show that they would like male colleagues to be a sounding board, rather than simply offering to jump in with a fix for a problem. “Show humility,” he said, don’t be afraid to ask questions, and don’t assume that a colleague wants something in particular because she is a woman.
“A lot of men get stuck on breaking the ice and getting started with a mentoring conversation,” Dr. Johnson said. One way to is by telling a female colleague who gave an outstanding presentation, or has conducted outstanding research, that you want to keep her in your organization and that she is welcome to talk about her goals. Women appreciate mentoring as “a constellation” and a way to build support, and have one person introduce them to others who can build a network and promote opportunities for leadership. Also, he encouraged men to be open to feedback from female colleagues on how they can be more supportive in the workplace. Sincerity and genuine effort go a long way towards improving gender equity.
Public allyship can take many forms, including putting women center stage to share their own ideas, Dr. Johnson said. Surveys of women show that they often feel dismissed or slighted and not given credit for an idea that was ultimately presented by a male colleague, he noted. Instead, be a female colleague’s biggest fan, and put her in the spotlight if she is truly the expert on the topic at hand.
Women also may be hamstrung in acceding to leadership positions by the use of subjective evaluations, said Dr. Johnson. He cited a 2018 analysis of 81,000 performance evaluations by the Harvard Business Review in which the top positive term used to describe men was analytical, while the top positive term used to describe women was compassionate. “All these things go with pay and promotions, and they tend to disadvantage women,” he said.
Dr. Johnson provided two avenues for how men can effectively show up as allies for women in the workplace.
First, start at the top. CEOs and senior men in an organization have a unique opportunity to set an example and talk publicly about supporting and promoting women, said Dr. Johnson.
Second, work at the grassroots level. He encouraged men to educate themselves with gender equity workshops, and act as collaborators. “Don’t tell women how to do gender equity,” he said, but show up, be present, be mindful, and be patient if someone seems not to respond immediately to opportunities for mentoring or sponsorship.
“Claiming ally or mentor status with someone from a nondominant group may invoke power, privilege, or even ownership” without intention, he said. Instead, “Always let others label you and the nature of the relationship [such as ally or mentor].”
For more information about allyship, visit Dr. Johnson’s website, workplaceallies.com.
Men may think they are supportive of women in the workplace, but if you ask women, they say there is a discrepancy, according to W. Brad Johnson, PhD, a clinical psychologist and professor at the United States Naval Academy in Annapolis, Md.
“We may think we are acting as allies to women because we believe in it, but it may not be showing up in the execution,” he said in a presentation at the virtual Advance PHM Gender Equity Conference.
Although women currently account for the majority of medical school students, they make up only 16% of the population of medical school deans, 18% of department chairs, and 25% of full professors, according to 2019 data from the Association of American Medical Colleges, Dr. Johnson said.
The “missing ingredient” in increasing the number of women in medical faculty positions is that women are less mentored. Some barriers to mentorship include men’s concerns that women will take offers of mentorship the wrong way, but “it is incredibly rare for women to make a false accusation” of harassment in a mentorship situation, said Dr. Johnson.
Dr. Johnson offered some guidance for how men can become better allies for women in the workplace through interpersonal allyship, public allyship, and systemic allyship.
Interpersonal allyship and opportunities for mentoring women in medicine start by building trust, friendship, and collegiality between men and women colleagues, Dr. Johnson explained.
He provided some guidance for men to “sharpen their gender intelligence,” which starts with listening. Surveys of women show that they would like male colleagues to be a sounding board, rather than simply offering to jump in with a fix for a problem. “Show humility,” he said, don’t be afraid to ask questions, and don’t assume that a colleague wants something in particular because she is a woman.
“A lot of men get stuck on breaking the ice and getting started with a mentoring conversation,” Dr. Johnson said. One way to is by telling a female colleague who gave an outstanding presentation, or has conducted outstanding research, that you want to keep her in your organization and that she is welcome to talk about her goals. Women appreciate mentoring as “a constellation” and a way to build support, and have one person introduce them to others who can build a network and promote opportunities for leadership. Also, he encouraged men to be open to feedback from female colleagues on how they can be more supportive in the workplace. Sincerity and genuine effort go a long way towards improving gender equity.
Public allyship can take many forms, including putting women center stage to share their own ideas, Dr. Johnson said. Surveys of women show that they often feel dismissed or slighted and not given credit for an idea that was ultimately presented by a male colleague, he noted. Instead, be a female colleague’s biggest fan, and put her in the spotlight if she is truly the expert on the topic at hand.
Women also may be hamstrung in acceding to leadership positions by the use of subjective evaluations, said Dr. Johnson. He cited a 2018 analysis of 81,000 performance evaluations by the Harvard Business Review in which the top positive term used to describe men was analytical, while the top positive term used to describe women was compassionate. “All these things go with pay and promotions, and they tend to disadvantage women,” he said.
Dr. Johnson provided two avenues for how men can effectively show up as allies for women in the workplace.
First, start at the top. CEOs and senior men in an organization have a unique opportunity to set an example and talk publicly about supporting and promoting women, said Dr. Johnson.
Second, work at the grassroots level. He encouraged men to educate themselves with gender equity workshops, and act as collaborators. “Don’t tell women how to do gender equity,” he said, but show up, be present, be mindful, and be patient if someone seems not to respond immediately to opportunities for mentoring or sponsorship.
“Claiming ally or mentor status with someone from a nondominant group may invoke power, privilege, or even ownership” without intention, he said. Instead, “Always let others label you and the nature of the relationship [such as ally or mentor].”
For more information about allyship, visit Dr. Johnson’s website, workplaceallies.com.
Men may think they are supportive of women in the workplace, but if you ask women, they say there is a discrepancy, according to W. Brad Johnson, PhD, a clinical psychologist and professor at the United States Naval Academy in Annapolis, Md.
“We may think we are acting as allies to women because we believe in it, but it may not be showing up in the execution,” he said in a presentation at the virtual Advance PHM Gender Equity Conference.
Although women currently account for the majority of medical school students, they make up only 16% of the population of medical school deans, 18% of department chairs, and 25% of full professors, according to 2019 data from the Association of American Medical Colleges, Dr. Johnson said.
The “missing ingredient” in increasing the number of women in medical faculty positions is that women are less mentored. Some barriers to mentorship include men’s concerns that women will take offers of mentorship the wrong way, but “it is incredibly rare for women to make a false accusation” of harassment in a mentorship situation, said Dr. Johnson.
Dr. Johnson offered some guidance for how men can become better allies for women in the workplace through interpersonal allyship, public allyship, and systemic allyship.
Interpersonal allyship and opportunities for mentoring women in medicine start by building trust, friendship, and collegiality between men and women colleagues, Dr. Johnson explained.
He provided some guidance for men to “sharpen their gender intelligence,” which starts with listening. Surveys of women show that they would like male colleagues to be a sounding board, rather than simply offering to jump in with a fix for a problem. “Show humility,” he said, don’t be afraid to ask questions, and don’t assume that a colleague wants something in particular because she is a woman.
“A lot of men get stuck on breaking the ice and getting started with a mentoring conversation,” Dr. Johnson said. One way to is by telling a female colleague who gave an outstanding presentation, or has conducted outstanding research, that you want to keep her in your organization and that she is welcome to talk about her goals. Women appreciate mentoring as “a constellation” and a way to build support, and have one person introduce them to others who can build a network and promote opportunities for leadership. Also, he encouraged men to be open to feedback from female colleagues on how they can be more supportive in the workplace. Sincerity and genuine effort go a long way towards improving gender equity.
Public allyship can take many forms, including putting women center stage to share their own ideas, Dr. Johnson said. Surveys of women show that they often feel dismissed or slighted and not given credit for an idea that was ultimately presented by a male colleague, he noted. Instead, be a female colleague’s biggest fan, and put her in the spotlight if she is truly the expert on the topic at hand.
Women also may be hamstrung in acceding to leadership positions by the use of subjective evaluations, said Dr. Johnson. He cited a 2018 analysis of 81,000 performance evaluations by the Harvard Business Review in which the top positive term used to describe men was analytical, while the top positive term used to describe women was compassionate. “All these things go with pay and promotions, and they tend to disadvantage women,” he said.
Dr. Johnson provided two avenues for how men can effectively show up as allies for women in the workplace.
First, start at the top. CEOs and senior men in an organization have a unique opportunity to set an example and talk publicly about supporting and promoting women, said Dr. Johnson.
Second, work at the grassroots level. He encouraged men to educate themselves with gender equity workshops, and act as collaborators. “Don’t tell women how to do gender equity,” he said, but show up, be present, be mindful, and be patient if someone seems not to respond immediately to opportunities for mentoring or sponsorship.
“Claiming ally or mentor status with someone from a nondominant group may invoke power, privilege, or even ownership” without intention, he said. Instead, “Always let others label you and the nature of the relationship [such as ally or mentor].”
For more information about allyship, visit Dr. Johnson’s website, workplaceallies.com.
FROM THE ADVANCE PHM GENDER EQUITY CONFERENCE
Hospitals must identify and empower women leaders
Many potential leaders in academic medicine go unidentified, and finding those leaders is key to improving gender equity in academic medicine, said Nancy Spector, MD, in a presentation at the virtual Advance PHM Gender Equity Conference.
“I think it is important to reframe what it means to be a leader, and to empower yourself to think of yourself as a leader,” said Dr. Spector, executive director for executive leadership in academic medicine program at Drexel University, Philadelphia.
“Some of the best leaders I know do not have titles,” she emphasized.
Steps to stimulate the system changes needed to promote gender equity include building policies around the life cycle, revising departmental and division governance, and tracking metrics at the individual, departmental, and organizational level, Dr. Spector said.
Aligning gender-equity efforts with institutional priorities and navigating politics to effect changes in the gender equity landscape are ongoing objectives, she said.
Dr. Spector offered advice to men and women looking to shift the system and promote gender equity. She emphasized the challenge of overcoming psychological associations of men and women in leadership roles. “Men are more often associated with agentic qualities, which convey assertion and control,” she said. Men in leadership are more often described as aggressive, ambitious, dominant, self-confident, forceful, self-reliant, and individualistic.
By contrast, “women are associated with communal qualities, which convey a concern for compassionate treatment of others,” and are more often described as affectionate, helpful, kind, sympathetic, sensitive, gentle, and well spoken, she noted.
Although agentic traits are most often associated with effective leadership, in fact, “the most effective contemporary leaders have both agentic and communal traits,” said Dr. Spector.
However, “if a woman leader is very communal, she may be viewed as not assertive enough, and it she is highly agentic, she is criticized for being too domineering or controlling,” she said.
To help get past these associations, changes are needed at the individual level, leader level, and institutional level, Dr. Spector said.
On the individual level, women seeking to improve the situation for gender equity should engage with male allies and build a pipeline of mentorship and sponsorship to help identify future leaders, she said.
Women and men should obtain leadership training, and “become a student of leadership,” she advised. “Be in a learning mode,” and then think how to apply what you have learned, which may include setting challenging learning goals, experimenting with alternative strategies, learning about different leadership styles, and learning about differences in leaders’ values and attitudes.
For women, being pulled in many directions is the norm. “Are you being strategic with how you serve on committees?” Dr. Spector asked.
Make the most of how you choose to share your time, and “garner the skill of graceful self-promotion, which is often a hard skill for women,” she noted. She also urged women to make the most of professional networking and social capital.
At the leader level, the advice Dr. Spector offered to leaders on building gender equity in their institutions include ensuring a critical mass of women in leadership track positions. “Avoid having a sole woman member of a team,” she said.
Dr. Spector also emphasized the importance of giving employees with family responsibilities more time for promotion, and welcoming back women who step away from the workforce and choose to return. Encourage men to participate in family-friendly benefits. “Standardize processes that support the life cycle of a faculty member or the person you’re hiring,” and ensure inclusive times and venues for major meetings, committee work, and social events, she added.
Dr. Spector’s strategies for institutions include quantifying disparities by using real time dashboards to show both leading and lagging indicators, setting goals, and measuring achievements.
“Create an infrastructure to support women’s leadership,” she said. Such an infrastructure could include not only robust committees for women in science and medicine, but also supporting women to attend leadership training both inside and outside their institutions.
Dr. Spector noted that professional organizations also have a role to play in support of women’s leadership.
“Make a public pledge to gender equity,” she said. She encouraged professional organizations to tie diversity and inclusion metrics to performance reviews, and to prioritize the examination and mitigation of disparities, and report challenges and successes.
When creating policies to promote gender equity, “get out of your silo,” Dr. Spector emphasized. Understand the drivers rather than simply judging the behaviors.
“Even if we disagree on something, we need to work together, and empower everyone to be thoughtful drivers of change,” she concluded.
Dr. Spector disclosed grant funding from the Department of Health & Human Services, the Agency for Healthcare Research and Quality, and the Patient-Centered Outcomes Research Institute. She also disclosed receiving monetary awards, honoraria, and travel reimbursement from multiple academic and professional organization for teaching and consulting programs. Dr. Spector also cofunded and holds equity interest in the I-PASS Patient Safety Institute, a company created to assist institutions in implementing the I-PASS Handoff Program.
Many potential leaders in academic medicine go unidentified, and finding those leaders is key to improving gender equity in academic medicine, said Nancy Spector, MD, in a presentation at the virtual Advance PHM Gender Equity Conference.
“I think it is important to reframe what it means to be a leader, and to empower yourself to think of yourself as a leader,” said Dr. Spector, executive director for executive leadership in academic medicine program at Drexel University, Philadelphia.
“Some of the best leaders I know do not have titles,” she emphasized.
Steps to stimulate the system changes needed to promote gender equity include building policies around the life cycle, revising departmental and division governance, and tracking metrics at the individual, departmental, and organizational level, Dr. Spector said.
Aligning gender-equity efforts with institutional priorities and navigating politics to effect changes in the gender equity landscape are ongoing objectives, she said.
Dr. Spector offered advice to men and women looking to shift the system and promote gender equity. She emphasized the challenge of overcoming psychological associations of men and women in leadership roles. “Men are more often associated with agentic qualities, which convey assertion and control,” she said. Men in leadership are more often described as aggressive, ambitious, dominant, self-confident, forceful, self-reliant, and individualistic.
By contrast, “women are associated with communal qualities, which convey a concern for compassionate treatment of others,” and are more often described as affectionate, helpful, kind, sympathetic, sensitive, gentle, and well spoken, she noted.
Although agentic traits are most often associated with effective leadership, in fact, “the most effective contemporary leaders have both agentic and communal traits,” said Dr. Spector.
However, “if a woman leader is very communal, she may be viewed as not assertive enough, and it she is highly agentic, she is criticized for being too domineering or controlling,” she said.
To help get past these associations, changes are needed at the individual level, leader level, and institutional level, Dr. Spector said.
On the individual level, women seeking to improve the situation for gender equity should engage with male allies and build a pipeline of mentorship and sponsorship to help identify future leaders, she said.
Women and men should obtain leadership training, and “become a student of leadership,” she advised. “Be in a learning mode,” and then think how to apply what you have learned, which may include setting challenging learning goals, experimenting with alternative strategies, learning about different leadership styles, and learning about differences in leaders’ values and attitudes.
For women, being pulled in many directions is the norm. “Are you being strategic with how you serve on committees?” Dr. Spector asked.
Make the most of how you choose to share your time, and “garner the skill of graceful self-promotion, which is often a hard skill for women,” she noted. She also urged women to make the most of professional networking and social capital.
At the leader level, the advice Dr. Spector offered to leaders on building gender equity in their institutions include ensuring a critical mass of women in leadership track positions. “Avoid having a sole woman member of a team,” she said.
Dr. Spector also emphasized the importance of giving employees with family responsibilities more time for promotion, and welcoming back women who step away from the workforce and choose to return. Encourage men to participate in family-friendly benefits. “Standardize processes that support the life cycle of a faculty member or the person you’re hiring,” and ensure inclusive times and venues for major meetings, committee work, and social events, she added.
Dr. Spector’s strategies for institutions include quantifying disparities by using real time dashboards to show both leading and lagging indicators, setting goals, and measuring achievements.
“Create an infrastructure to support women’s leadership,” she said. Such an infrastructure could include not only robust committees for women in science and medicine, but also supporting women to attend leadership training both inside and outside their institutions.
Dr. Spector noted that professional organizations also have a role to play in support of women’s leadership.
“Make a public pledge to gender equity,” she said. She encouraged professional organizations to tie diversity and inclusion metrics to performance reviews, and to prioritize the examination and mitigation of disparities, and report challenges and successes.
When creating policies to promote gender equity, “get out of your silo,” Dr. Spector emphasized. Understand the drivers rather than simply judging the behaviors.
“Even if we disagree on something, we need to work together, and empower everyone to be thoughtful drivers of change,” she concluded.
Dr. Spector disclosed grant funding from the Department of Health & Human Services, the Agency for Healthcare Research and Quality, and the Patient-Centered Outcomes Research Institute. She also disclosed receiving monetary awards, honoraria, and travel reimbursement from multiple academic and professional organization for teaching and consulting programs. Dr. Spector also cofunded and holds equity interest in the I-PASS Patient Safety Institute, a company created to assist institutions in implementing the I-PASS Handoff Program.
Many potential leaders in academic medicine go unidentified, and finding those leaders is key to improving gender equity in academic medicine, said Nancy Spector, MD, in a presentation at the virtual Advance PHM Gender Equity Conference.
“I think it is important to reframe what it means to be a leader, and to empower yourself to think of yourself as a leader,” said Dr. Spector, executive director for executive leadership in academic medicine program at Drexel University, Philadelphia.
“Some of the best leaders I know do not have titles,” she emphasized.
Steps to stimulate the system changes needed to promote gender equity include building policies around the life cycle, revising departmental and division governance, and tracking metrics at the individual, departmental, and organizational level, Dr. Spector said.
Aligning gender-equity efforts with institutional priorities and navigating politics to effect changes in the gender equity landscape are ongoing objectives, she said.
Dr. Spector offered advice to men and women looking to shift the system and promote gender equity. She emphasized the challenge of overcoming psychological associations of men and women in leadership roles. “Men are more often associated with agentic qualities, which convey assertion and control,” she said. Men in leadership are more often described as aggressive, ambitious, dominant, self-confident, forceful, self-reliant, and individualistic.
By contrast, “women are associated with communal qualities, which convey a concern for compassionate treatment of others,” and are more often described as affectionate, helpful, kind, sympathetic, sensitive, gentle, and well spoken, she noted.
Although agentic traits are most often associated with effective leadership, in fact, “the most effective contemporary leaders have both agentic and communal traits,” said Dr. Spector.
However, “if a woman leader is very communal, she may be viewed as not assertive enough, and it she is highly agentic, she is criticized for being too domineering or controlling,” she said.
To help get past these associations, changes are needed at the individual level, leader level, and institutional level, Dr. Spector said.
On the individual level, women seeking to improve the situation for gender equity should engage with male allies and build a pipeline of mentorship and sponsorship to help identify future leaders, she said.
Women and men should obtain leadership training, and “become a student of leadership,” she advised. “Be in a learning mode,” and then think how to apply what you have learned, which may include setting challenging learning goals, experimenting with alternative strategies, learning about different leadership styles, and learning about differences in leaders’ values and attitudes.
For women, being pulled in many directions is the norm. “Are you being strategic with how you serve on committees?” Dr. Spector asked.
Make the most of how you choose to share your time, and “garner the skill of graceful self-promotion, which is often a hard skill for women,” she noted. She also urged women to make the most of professional networking and social capital.
At the leader level, the advice Dr. Spector offered to leaders on building gender equity in their institutions include ensuring a critical mass of women in leadership track positions. “Avoid having a sole woman member of a team,” she said.
Dr. Spector also emphasized the importance of giving employees with family responsibilities more time for promotion, and welcoming back women who step away from the workforce and choose to return. Encourage men to participate in family-friendly benefits. “Standardize processes that support the life cycle of a faculty member or the person you’re hiring,” and ensure inclusive times and venues for major meetings, committee work, and social events, she added.
Dr. Spector’s strategies for institutions include quantifying disparities by using real time dashboards to show both leading and lagging indicators, setting goals, and measuring achievements.
“Create an infrastructure to support women’s leadership,” she said. Such an infrastructure could include not only robust committees for women in science and medicine, but also supporting women to attend leadership training both inside and outside their institutions.
Dr. Spector noted that professional organizations also have a role to play in support of women’s leadership.
“Make a public pledge to gender equity,” she said. She encouraged professional organizations to tie diversity and inclusion metrics to performance reviews, and to prioritize the examination and mitigation of disparities, and report challenges and successes.
When creating policies to promote gender equity, “get out of your silo,” Dr. Spector emphasized. Understand the drivers rather than simply judging the behaviors.
“Even if we disagree on something, we need to work together, and empower everyone to be thoughtful drivers of change,” she concluded.
Dr. Spector disclosed grant funding from the Department of Health & Human Services, the Agency for Healthcare Research and Quality, and the Patient-Centered Outcomes Research Institute. She also disclosed receiving monetary awards, honoraria, and travel reimbursement from multiple academic and professional organization for teaching and consulting programs. Dr. Spector also cofunded and holds equity interest in the I-PASS Patient Safety Institute, a company created to assist institutions in implementing the I-PASS Handoff Program.
FROM THE ADVANCE PHM GENDER EQUITY CONFERENCE