MDedge ObGyn

CASE Patient wants to reduce her risk of cesarean delivery (CD)

A 30-year-old primigravid woman expresses concern about her increased risk for CD as a Black woman. She has been reading in the news about the increased risks of CD and birth complications, and she asks what she can do to decrease her risk of having a CD.

What is the problem?

Recently, attention has been called to the stark racial disparities in severe maternal morbidity and mortality. Cesarean delivery rates illustrate an area in obstetric management in which racial disparities exist. It is well known that morbidity associated with CD is much higher than morbidity associated with vaginal delivery, which begs the question of whether disparities in mode of delivery may play a role in the disparity in maternal morbidity and mortality.

In the United States, 32% of all births between 2018 and 2020 were by CD. However, only 31% of White women delivered via CD as compared with 36% of Black women and 33% of Asian women.¹ In 2021, the primary CD rates were 26% for Black women, 24% for Asian women, 21% for Hispanic women, and 22% for White women.² This racial disparity, particularly between Black and White women, has been seen across nulliparous, term, singleton, vertex (NTSV) groups as well as multiparous women with prior vaginal delivery.^3,4 The disparity persists after adjusting for risk factors.

A secondary analysis of groups deemed at low risk for CD within the ARRIVE trial study group reported the adjusted relative risk of CD birth for Black women as 1.21 (95% confidence interval [CI], 1.03–1.42) compared with White women and 1.26 (95% CI, 1.08–1.46) for Hispanic women.⁵ The investigators estimated that this accounted for 15% of excess maternal morbidity.⁵ These studies also have shown that a disparity exists in indication for CD, with Black women more likely to have a CD for the diagnosis of nonreassuring fetal tracing while White women are more likely to have a CD for failure to progress.

Patients who undergo CD are less likely to breastfeed, and they have a more difficult recovery, increased risks of infection, thromboembolic events, and increased risks for future pregnancy. Along with increased focus on racial disparities in obstetrics outcomes within the medical community, patients also have become more attuned to these racial disparities in maternal morbidity as this has increasingly become a topic of focus within the mainstream media.

What is behind differences in mode of delivery?

The drivers of racial inequities in mode of delivery remain unclear. One might question whether increased prevalence of morbidities in pregnancy, such as diabetes and hypertension, in minority women might influence the disparity in CD. However, the disparity persists in studies of low-risk women and in studies that statistically adjust for factors that include preeclampsia, obesity, diabetes, and fetal growth restriction, which argues that maternal morbidity alone is not responsible for the differences observed.

Race is a social construct, and as such there is no biologically plausible explanation for the racial disparities in CD rates. Differences in health outcomes should be considered a result of the impact of racism. Disparities can be influenced by patient level, provider level, and systemic level factors.⁶ Provider biases have a negative impact on care for minority groups and they influence disparities in health care.⁷ The subjectivity involved in diagnoses of nonreassuring fetal tracing as an indication for CD creates an opportunity for implicit biases and discrimination to enter decision-making for indications for CD. Furthermore, no differences have been seen in Apgar score or admission to the neonatal intensive care unit in studies where indication of nonreassuring fetal heart tracing drove the disparity for CD.⁵

A study that retrospectively compared labor management strategies intended to reduce CD rates, such as application of guidelines for failed induction of labor, arrest of dilation, arrest of descent, nonreassuring fetus status, or cervical ripening, did not observe differential use of labor management strategies intended to reduce CD rate.⁸ By contrast, Hamm and colleagues observed that implementation of a standardized induction protocol was associated with a decreased CD rate among Black women but not non-Black women and the standardized protocol was associated with a decrease in the racial disparity in CD.⁹ A theory behind their findings is that provider bias is less when there is implementation of a standardized protocol, algorithm, or guidelines, which in turn reduces disparity in mode of delivery.

Clearly, more research is needed for the mechanisms behind inequities in mode of delivery and the influence of provider factors. Future studies also are needed to evaluate how patient level factors, including belief systems and culture preferences, and how system level factors, such as access to prenatal care and the health system processes, are associated with CD rates.

Next steps

While the mechanisms that drive the disparities in CD rate and indication may remain unclear, there are potential areas of intervention to decrease CD rates among minority and Black women.

Continuous support from a doula or layperson has been shown to decrease rates of cesarean birth,^10,11 and evidence indicates that minority women are interested in doula support but are less likely than White women to have access to doula care.¹² Programs that provide doula support for Black women are an intervention that would increase access to support and advocacy during labor for Black women.

CASE Patient wants to reduce her risk of cesarean delivery (CD)

A 30-year-old primigravid woman expresses concern about her increased risk for CD as a Black woman. She has been reading in the news about the increased risks of CD and birth complications, and she asks what she can do to decrease her risk of having a CD.

What is the problem?

Recently, attention has been called to the stark racial disparities in severe maternal morbidity and mortality. Cesarean delivery rates illustrate an area in obstetric management in which racial disparities exist. It is well known that morbidity associated with CD is much higher than morbidity associated with vaginal delivery, which begs the question of whether disparities in mode of delivery may play a role in the disparity in maternal morbidity and mortality.

In the United States, 32% of all births between 2018 and 2020 were by CD. However, only 31% of White women delivered via CD as compared with 36% of Black women and 33% of Asian women.¹ In 2021, the primary CD rates were 26% for Black women, 24% for Asian women, 21% for Hispanic women, and 22% for White women.² This racial disparity, particularly between Black and White women, has been seen across nulliparous, term, singleton, vertex (NTSV) groups as well as multiparous women with prior vaginal delivery.^3,4 The disparity persists after adjusting for risk factors.

A secondary analysis of groups deemed at low risk for CD within the ARRIVE trial study group reported the adjusted relative risk of CD birth for Black women as 1.21 (95% confidence interval [CI], 1.03–1.42) compared with White women and 1.26 (95% CI, 1.08–1.46) for Hispanic women.⁵ The investigators estimated that this accounted for 15% of excess maternal morbidity.⁵ These studies also have shown that a disparity exists in indication for CD, with Black women more likely to have a CD for the diagnosis of nonreassuring fetal tracing while White women are more likely to have a CD for failure to progress.

Patients who undergo CD are less likely to breastfeed, and they have a more difficult recovery, increased risks of infection, thromboembolic events, and increased risks for future pregnancy. Along with increased focus on racial disparities in obstetrics outcomes within the medical community, patients also have become more attuned to these racial disparities in maternal morbidity as this has increasingly become a topic of focus within the mainstream media.

What is behind differences in mode of delivery?

The drivers of racial inequities in mode of delivery remain unclear. One might question whether increased prevalence of morbidities in pregnancy, such as diabetes and hypertension, in minority women might influence the disparity in CD. However, the disparity persists in studies of low-risk women and in studies that statistically adjust for factors that include preeclampsia, obesity, diabetes, and fetal growth restriction, which argues that maternal morbidity alone is not responsible for the differences observed.

Race is a social construct, and as such there is no biologically plausible explanation for the racial disparities in CD rates. Differences in health outcomes should be considered a result of the impact of racism. Disparities can be influenced by patient level, provider level, and systemic level factors.⁶ Provider biases have a negative impact on care for minority groups and they influence disparities in health care.⁷ The subjectivity involved in diagnoses of nonreassuring fetal tracing as an indication for CD creates an opportunity for implicit biases and discrimination to enter decision-making for indications for CD. Furthermore, no differences have been seen in Apgar score or admission to the neonatal intensive care unit in studies where indication of nonreassuring fetal heart tracing drove the disparity for CD.⁵

A study that retrospectively compared labor management strategies intended to reduce CD rates, such as application of guidelines for failed induction of labor, arrest of dilation, arrest of descent, nonreassuring fetus status, or cervical ripening, did not observe differential use of labor management strategies intended to reduce CD rate.⁸ By contrast, Hamm and colleagues observed that implementation of a standardized induction protocol was associated with a decreased CD rate among Black women but not non-Black women and the standardized protocol was associated with a decrease in the racial disparity in CD.⁹ A theory behind their findings is that provider bias is less when there is implementation of a standardized protocol, algorithm, or guidelines, which in turn reduces disparity in mode of delivery.

Clearly, more research is needed for the mechanisms behind inequities in mode of delivery and the influence of provider factors. Future studies also are needed to evaluate how patient level factors, including belief systems and culture preferences, and how system level factors, such as access to prenatal care and the health system processes, are associated with CD rates.

Next steps

While the mechanisms that drive the disparities in CD rate and indication may remain unclear, there are potential areas of intervention to decrease CD rates among minority and Black women.

Continuous support from a doula or layperson has been shown to decrease rates of cesarean birth,^10,11 and evidence indicates that minority women are interested in doula support but are less likely than White women to have access to doula care.¹² Programs that provide doula support for Black women are an intervention that would increase access to support and advocacy during labor for Black women.

CASE Patient wants to reduce her risk of cesarean delivery (CD)

A 30-year-old primigravid woman expresses concern about her increased risk for CD as a Black woman. She has been reading in the news about the increased risks of CD and birth complications, and she asks what she can do to decrease her risk of having a CD.

What is the problem?

Recently, attention has been called to the stark racial disparities in severe maternal morbidity and mortality. Cesarean delivery rates illustrate an area in obstetric management in which racial disparities exist. It is well known that morbidity associated with CD is much higher than morbidity associated with vaginal delivery, which begs the question of whether disparities in mode of delivery may play a role in the disparity in maternal morbidity and mortality.

In the United States, 32% of all births between 2018 and 2020 were by CD. However, only 31% of White women delivered via CD as compared with 36% of Black women and 33% of Asian women.¹ In 2021, the primary CD rates were 26% for Black women, 24% for Asian women, 21% for Hispanic women, and 22% for White women.² This racial disparity, particularly between Black and White women, has been seen across nulliparous, term, singleton, vertex (NTSV) groups as well as multiparous women with prior vaginal delivery.^3,4 The disparity persists after adjusting for risk factors.

A secondary analysis of groups deemed at low risk for CD within the ARRIVE trial study group reported the adjusted relative risk of CD birth for Black women as 1.21 (95% confidence interval [CI], 1.03–1.42) compared with White women and 1.26 (95% CI, 1.08–1.46) for Hispanic women.⁵ The investigators estimated that this accounted for 15% of excess maternal morbidity.⁵ These studies also have shown that a disparity exists in indication for CD, with Black women more likely to have a CD for the diagnosis of nonreassuring fetal tracing while White women are more likely to have a CD for failure to progress.

Patients who undergo CD are less likely to breastfeed, and they have a more difficult recovery, increased risks of infection, thromboembolic events, and increased risks for future pregnancy. Along with increased focus on racial disparities in obstetrics outcomes within the medical community, patients also have become more attuned to these racial disparities in maternal morbidity as this has increasingly become a topic of focus within the mainstream media.

What is behind differences in mode of delivery?

The drivers of racial inequities in mode of delivery remain unclear. One might question whether increased prevalence of morbidities in pregnancy, such as diabetes and hypertension, in minority women might influence the disparity in CD. However, the disparity persists in studies of low-risk women and in studies that statistically adjust for factors that include preeclampsia, obesity, diabetes, and fetal growth restriction, which argues that maternal morbidity alone is not responsible for the differences observed.

Race is a social construct, and as such there is no biologically plausible explanation for the racial disparities in CD rates. Differences in health outcomes should be considered a result of the impact of racism. Disparities can be influenced by patient level, provider level, and systemic level factors.⁶ Provider biases have a negative impact on care for minority groups and they influence disparities in health care.⁷ The subjectivity involved in diagnoses of nonreassuring fetal tracing as an indication for CD creates an opportunity for implicit biases and discrimination to enter decision-making for indications for CD. Furthermore, no differences have been seen in Apgar score or admission to the neonatal intensive care unit in studies where indication of nonreassuring fetal heart tracing drove the disparity for CD.⁵

A study that retrospectively compared labor management strategies intended to reduce CD rates, such as application of guidelines for failed induction of labor, arrest of dilation, arrest of descent, nonreassuring fetus status, or cervical ripening, did not observe differential use of labor management strategies intended to reduce CD rate.⁸ By contrast, Hamm and colleagues observed that implementation of a standardized induction protocol was associated with a decreased CD rate among Black women but not non-Black women and the standardized protocol was associated with a decrease in the racial disparity in CD.⁹ A theory behind their findings is that provider bias is less when there is implementation of a standardized protocol, algorithm, or guidelines, which in turn reduces disparity in mode of delivery.

Clearly, more research is needed for the mechanisms behind inequities in mode of delivery and the influence of provider factors. Future studies also are needed to evaluate how patient level factors, including belief systems and culture preferences, and how system level factors, such as access to prenatal care and the health system processes, are associated with CD rates.

Next steps

While the mechanisms that drive the disparities in CD rate and indication may remain unclear, there are potential areas of intervention to decrease CD rates among minority and Black women.

Continuous support from a doula or layperson has been shown to decrease rates of cesarean birth,^10,11 and evidence indicates that minority women are interested in doula support but are less likely than White women to have access to doula care.¹² Programs that provide doula support for Black women are an intervention that would increase access to support and advocacy during labor for Black women.

Chawla S, Wyckoff MH, Rysavy MA, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of antenatal steroid exposure at 21 to 22 weeks of gestation with neonatal survival and survival without morbidities. JAMA Netw Open. 2022;5:e2233331. doi:10.1001/jamanet workopen.2022.33331.

EXPERT COMMENTARY

The single most important intervention available in obstetrics to improve the health outcomes of preterm newborns is the maternal administration of corticosteroids. The 27 randomized controlled trials that formed the basis for this knowledge¹ did not include infants delivered at 24 weeks’ gestation or less. This has not dissuaded us, over the last several decades, from using corticosteroids for impending delivery at 24 weeks’ gestation; in the absence of randomized data, this has been based on observational evidence of benefit.

Following the 2011 publication of a retrospective cohort study that analyzed data collected by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between 1993 and 2009 (the Carlo study),² ACS started to be used widely even for impending delivery at 23 weeks’ gestation. That study had found that the odds of death and neurodevelopmental impairment at 18 to 22 months of age were significantly lower in cases that received ACS and were born at 23 weeks (n = 1,978). The same benefit could not be verified for infants born at 22 weeks’ gestational age (n = 402).

In a recent study conducted by the same NICHD Neonatal Research Network, antenatal steroid exposure at 21 to 22 weeks of gestation was examined.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Details of the study

Using prospectively collected data from 2016 to 2019, Chawla and colleagues conducted a retrospective cohort study that analyzed data from 431 infants who were born between 22 0/7 and 23 6/7 weeks’ gestation and received neonatal intensive care (179 infants born at 22 weeks’ gestation).³ The infants not exposed to ACS were compared with those who had partial exposure (only 1 dose) and those with complete ACS exposure (2 doses).

Complete ACS exposure proved to be beneficial, increasing survival to discharge from 35.5% in the no-exposure group to 53.9% (adjusted odds ratio [aOR], 1.95; 95% confidence interval [CI], 1.07–3.56). Of the survivors, 26.9% in the complete-exposure group had no major morbidities compared with 10% in the no-exposure group (aOR, 2.74; 95% CI, 1.19–6.30).

Study strengths and limitations

The strengths of this study include the use of a diverse, multicenter cohort, with contemporary delivery data, which increases the generalizability of the findings. The analysis included aspects often overlooked in other similar studies, such as the dose of ACS exposure and the gestational age at the time of exposure.

The observational study design, however, can suggest only associations rather than causal relationships. Observational studies also are apt to be affected by residual confounding. Such limitations can only be overcome by a randomized controlled trial, but such a trial of ACS at periviable gestational ages seems unfeasible due to limited ethical justification.

Another limitation is the reporting on outcomes as a collective group (22–23 weeks’ gestation). It is important to consider each gestational age week separately due to differences in physiology and potential biological limitations. It cannot be assumed that 22 weeks behaves like 23 weeks, just as 21 weeks is not equivalent to 22 weeks.

The study results suggest that the protective effect of ACS was dose dependent. However, the interpretation that only a complete ACS exposure was beneficial should be viewed cautiously because the study had no power to assess the impact of a partial exposure.

A further limitation is the lack of consideration in analysis for maternal comorbidities and fetal growth restriction. In the Carlo study, the beneficial effect of corticosteroids in 23-week gestational age deliveries was not demonstrable in pregnancies affected by fetal growth restriction or maternal hypertension.

Other studies considered

Given all its limitations, can we assume that the study by Chawla and colleagues has reliably refuted the Carlo study’s suggestion of lack of ACS efficacy in infants born at 22 weeks’ gestation? Taken by itself, probably not. In the context of other recent investigations, yes.

A retrospective registry study that used data from the Vermont Oxford Network for the period 2012–2016 on 1,058 infants born at 22 weeks’ gestation found that infants who were exposed to ACS and received postnatal life support were more likely to survive to hospital discharge without major morbidity compared with infants who received postnatal life support alone.⁴ Overall survival was 38.5% versus 17.7% (adjusted risk ratio [aRR], 2.11; 95% CI, 1.68–2.65), and survival without major morbidity was 4.4% versus 1.0% (aRR, 4.35; 95% CI, 1.84–10.28).

An even larger cohort study that used data from the National Center for Health Statistics concluded that survival at age 1 year for infants born at 22 weeks (n = 2,635) during 2009–2014 was improved in those exposed to ACS followed by postnatal life support compared with postnatal life support alone (45.2% vs 27.8%; aRR, 1.6; 95% CI, 1.2–2.1).⁵

A meta-analysis of observational studies that reported on infants born between 22 0/7 and 22 6/7 weeks’ gestation (n = 2,226) who received proactive neonatal treatment found that administration of ACS doubled the rate of survival when compared with no ACS administration (39% vs 19.5%; P<.01).⁶

In September 2021, the recommendations from the American College of Obstetricians and Gynecologists changed, stating that ACS can be considered at 22 weeks’ gestation when active postnatal management is desired.⁷ This recommendation is largely congruent with those from several other national and international medical organizations, including the World Association of Perinatal Medicine, the Royal Collegeof Obstetricians and Gynaecologists, and the German, Austrian and Swiss societies of gynecology and obstetrics. The implication is that the limit of viability may have shifted again, from 23 to 22 weeks’ gestation, and considering the importance of adequate timing in ACS administration (within 1 week from delivery), Chawla and colleagues posited that ACS administration can be considered as early as 21 weeks’ gestation when birth is anticipated at 22 weeks and active postnatal management is planned (notably, this should be the correct interpretation of the article title, not that ACS may be beneficial in 21-weeks’ gestational age births). ●

Chawla S, Wyckoff MH, Rysavy MA, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of antenatal steroid exposure at 21 to 22 weeks of gestation with neonatal survival and survival without morbidities. JAMA Netw Open. 2022;5:e2233331. doi:10.1001/jamanet workopen.2022.33331.

EXPERT COMMENTARY

The single most important intervention available in obstetrics to improve the health outcomes of preterm newborns is the maternal administration of corticosteroids. The 27 randomized controlled trials that formed the basis for this knowledge¹ did not include infants delivered at 24 weeks’ gestation or less. This has not dissuaded us, over the last several decades, from using corticosteroids for impending delivery at 24 weeks’ gestation; in the absence of randomized data, this has been based on observational evidence of benefit.

Following the 2011 publication of a retrospective cohort study that analyzed data collected by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between 1993 and 2009 (the Carlo study),² ACS started to be used widely even for impending delivery at 23 weeks’ gestation. That study had found that the odds of death and neurodevelopmental impairment at 18 to 22 months of age were significantly lower in cases that received ACS and were born at 23 weeks (n = 1,978). The same benefit could not be verified for infants born at 22 weeks’ gestational age (n = 402).

In a recent study conducted by the same NICHD Neonatal Research Network, antenatal steroid exposure at 21 to 22 weeks of gestation was examined.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Details of the study

Using prospectively collected data from 2016 to 2019, Chawla and colleagues conducted a retrospective cohort study that analyzed data from 431 infants who were born between 22 0/7 and 23 6/7 weeks’ gestation and received neonatal intensive care (179 infants born at 22 weeks’ gestation).³ The infants not exposed to ACS were compared with those who had partial exposure (only 1 dose) and those with complete ACS exposure (2 doses).

Complete ACS exposure proved to be beneficial, increasing survival to discharge from 35.5% in the no-exposure group to 53.9% (adjusted odds ratio [aOR], 1.95; 95% confidence interval [CI], 1.07–3.56). Of the survivors, 26.9% in the complete-exposure group had no major morbidities compared with 10% in the no-exposure group (aOR, 2.74; 95% CI, 1.19–6.30).

Study strengths and limitations

The strengths of this study include the use of a diverse, multicenter cohort, with contemporary delivery data, which increases the generalizability of the findings. The analysis included aspects often overlooked in other similar studies, such as the dose of ACS exposure and the gestational age at the time of exposure.

The observational study design, however, can suggest only associations rather than causal relationships. Observational studies also are apt to be affected by residual confounding. Such limitations can only be overcome by a randomized controlled trial, but such a trial of ACS at periviable gestational ages seems unfeasible due to limited ethical justification.

Another limitation is the reporting on outcomes as a collective group (22–23 weeks’ gestation). It is important to consider each gestational age week separately due to differences in physiology and potential biological limitations. It cannot be assumed that 22 weeks behaves like 23 weeks, just as 21 weeks is not equivalent to 22 weeks.

The study results suggest that the protective effect of ACS was dose dependent. However, the interpretation that only a complete ACS exposure was beneficial should be viewed cautiously because the study had no power to assess the impact of a partial exposure.

A further limitation is the lack of consideration in analysis for maternal comorbidities and fetal growth restriction. In the Carlo study, the beneficial effect of corticosteroids in 23-week gestational age deliveries was not demonstrable in pregnancies affected by fetal growth restriction or maternal hypertension.

Other studies considered

Given all its limitations, can we assume that the study by Chawla and colleagues has reliably refuted the Carlo study’s suggestion of lack of ACS efficacy in infants born at 22 weeks’ gestation? Taken by itself, probably not. In the context of other recent investigations, yes.

A retrospective registry study that used data from the Vermont Oxford Network for the period 2012–2016 on 1,058 infants born at 22 weeks’ gestation found that infants who were exposed to ACS and received postnatal life support were more likely to survive to hospital discharge without major morbidity compared with infants who received postnatal life support alone.⁴ Overall survival was 38.5% versus 17.7% (adjusted risk ratio [aRR], 2.11; 95% CI, 1.68–2.65), and survival without major morbidity was 4.4% versus 1.0% (aRR, 4.35; 95% CI, 1.84–10.28).

An even larger cohort study that used data from the National Center for Health Statistics concluded that survival at age 1 year for infants born at 22 weeks (n = 2,635) during 2009–2014 was improved in those exposed to ACS followed by postnatal life support compared with postnatal life support alone (45.2% vs 27.8%; aRR, 1.6; 95% CI, 1.2–2.1).⁵

A meta-analysis of observational studies that reported on infants born between 22 0/7 and 22 6/7 weeks’ gestation (n = 2,226) who received proactive neonatal treatment found that administration of ACS doubled the rate of survival when compared with no ACS administration (39% vs 19.5%; P<.01).⁶

In September 2021, the recommendations from the American College of Obstetricians and Gynecologists changed, stating that ACS can be considered at 22 weeks’ gestation when active postnatal management is desired.⁷ This recommendation is largely congruent with those from several other national and international medical organizations, including the World Association of Perinatal Medicine, the Royal Collegeof Obstetricians and Gynaecologists, and the German, Austrian and Swiss societies of gynecology and obstetrics. The implication is that the limit of viability may have shifted again, from 23 to 22 weeks’ gestation, and considering the importance of adequate timing in ACS administration (within 1 week from delivery), Chawla and colleagues posited that ACS administration can be considered as early as 21 weeks’ gestation when birth is anticipated at 22 weeks and active postnatal management is planned (notably, this should be the correct interpretation of the article title, not that ACS may be beneficial in 21-weeks’ gestational age births). ●

Chawla S, Wyckoff MH, Rysavy MA, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of antenatal steroid exposure at 21 to 22 weeks of gestation with neonatal survival and survival without morbidities. JAMA Netw Open. 2022;5:e2233331. doi:10.1001/jamanet workopen.2022.33331.

EXPERT COMMENTARY

The single most important intervention available in obstetrics to improve the health outcomes of preterm newborns is the maternal administration of corticosteroids. The 27 randomized controlled trials that formed the basis for this knowledge¹ did not include infants delivered at 24 weeks’ gestation or less. This has not dissuaded us, over the last several decades, from using corticosteroids for impending delivery at 24 weeks’ gestation; in the absence of randomized data, this has been based on observational evidence of benefit.

Following the 2011 publication of a retrospective cohort study that analyzed data collected by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between 1993 and 2009 (the Carlo study),² ACS started to be used widely even for impending delivery at 23 weeks’ gestation. That study had found that the odds of death and neurodevelopmental impairment at 18 to 22 months of age were significantly lower in cases that received ACS and were born at 23 weeks (n = 1,978). The same benefit could not be verified for infants born at 22 weeks’ gestational age (n = 402).

In a recent study conducted by the same NICHD Neonatal Research Network, antenatal steroid exposure at 21 to 22 weeks of gestation was examined.

ILLUSTRATION: KIMBERLY MARTENS FOR OBG MANAGEMENT

Details of the study

Using prospectively collected data from 2016 to 2019, Chawla and colleagues conducted a retrospective cohort study that analyzed data from 431 infants who were born between 22 0/7 and 23 6/7 weeks’ gestation and received neonatal intensive care (179 infants born at 22 weeks’ gestation).³ The infants not exposed to ACS were compared with those who had partial exposure (only 1 dose) and those with complete ACS exposure (2 doses).

Complete ACS exposure proved to be beneficial, increasing survival to discharge from 35.5% in the no-exposure group to 53.9% (adjusted odds ratio [aOR], 1.95; 95% confidence interval [CI], 1.07–3.56). Of the survivors, 26.9% in the complete-exposure group had no major morbidities compared with 10% in the no-exposure group (aOR, 2.74; 95% CI, 1.19–6.30).

Study strengths and limitations

The strengths of this study include the use of a diverse, multicenter cohort, with contemporary delivery data, which increases the generalizability of the findings. The analysis included aspects often overlooked in other similar studies, such as the dose of ACS exposure and the gestational age at the time of exposure.

The observational study design, however, can suggest only associations rather than causal relationships. Observational studies also are apt to be affected by residual confounding. Such limitations can only be overcome by a randomized controlled trial, but such a trial of ACS at periviable gestational ages seems unfeasible due to limited ethical justification.

Another limitation is the reporting on outcomes as a collective group (22–23 weeks’ gestation). It is important to consider each gestational age week separately due to differences in physiology and potential biological limitations. It cannot be assumed that 22 weeks behaves like 23 weeks, just as 21 weeks is not equivalent to 22 weeks.

The study results suggest that the protective effect of ACS was dose dependent. However, the interpretation that only a complete ACS exposure was beneficial should be viewed cautiously because the study had no power to assess the impact of a partial exposure.

A further limitation is the lack of consideration in analysis for maternal comorbidities and fetal growth restriction. In the Carlo study, the beneficial effect of corticosteroids in 23-week gestational age deliveries was not demonstrable in pregnancies affected by fetal growth restriction or maternal hypertension.

Other studies considered

Given all its limitations, can we assume that the study by Chawla and colleagues has reliably refuted the Carlo study’s suggestion of lack of ACS efficacy in infants born at 22 weeks’ gestation? Taken by itself, probably not. In the context of other recent investigations, yes.

A retrospective registry study that used data from the Vermont Oxford Network for the period 2012–2016 on 1,058 infants born at 22 weeks’ gestation found that infants who were exposed to ACS and received postnatal life support were more likely to survive to hospital discharge without major morbidity compared with infants who received postnatal life support alone.⁴ Overall survival was 38.5% versus 17.7% (adjusted risk ratio [aRR], 2.11; 95% CI, 1.68–2.65), and survival without major morbidity was 4.4% versus 1.0% (aRR, 4.35; 95% CI, 1.84–10.28).

An even larger cohort study that used data from the National Center for Health Statistics concluded that survival at age 1 year for infants born at 22 weeks (n = 2,635) during 2009–2014 was improved in those exposed to ACS followed by postnatal life support compared with postnatal life support alone (45.2% vs 27.8%; aRR, 1.6; 95% CI, 1.2–2.1).⁵

A meta-analysis of observational studies that reported on infants born between 22 0/7 and 22 6/7 weeks’ gestation (n = 2,226) who received proactive neonatal treatment found that administration of ACS doubled the rate of survival when compared with no ACS administration (39% vs 19.5%; P<.01).⁶

In September 2021, the recommendations from the American College of Obstetricians and Gynecologists changed, stating that ACS can be considered at 22 weeks’ gestation when active postnatal management is desired.⁷ This recommendation is largely congruent with those from several other national and international medical organizations, including the World Association of Perinatal Medicine, the Royal Collegeof Obstetricians and Gynaecologists, and the German, Austrian and Swiss societies of gynecology and obstetrics. The implication is that the limit of viability may have shifted again, from 23 to 22 weeks’ gestation, and considering the importance of adequate timing in ACS administration (within 1 week from delivery), Chawla and colleagues posited that ACS administration can be considered as early as 21 weeks’ gestation when birth is anticipated at 22 weeks and active postnatal management is planned (notably, this should be the correct interpretation of the article title, not that ACS may be beneficial in 21-weeks’ gestational age births). ●

This transcript has been edited for clarity.

Hello. This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Cardiology on atrial fibrillation (AF), sex differences, and modifiable risk factors.

We looked at these questions in our vitamin D and omega-3 trial VITAL in an ancillary study called VITAL Rhythm, led by Dr. Christine Albert at Cedars-Sinai. And this particular project was led by Dr. Hasan Siddiqi at Vanderbilt.

As you know, AF is the most common arrhythmia in the world, and it’s burgeoning in numbers, primarily because of the aging of the population. It’s also a major cause of stroke, heart failure, and cardiovascular mortality. Although women are known to have lower rates of AF than men, they’re also known to have a higher risk for cardiovascular complications and sequelae, such as higher risk for stroke and CVD mortality. Therefore, we thought that understanding sex differences in risk and modifiable risk factors for AF that could reduce the burden of disease would be important.

It’s known that greater height is a risk factor for AF, but the extent to which it explains the differences in AF risk between men and women isn’t really known. So we looked at these questions in the VITAL cohort. VITAL has more than 25,000 participants. It’s a large, diverse, nationwide cohort. About 51% are women, and all are aged 50 years or older, with a mean age of 67. All were free of known clinical cardiovascular disease at the start of the study.

AF reports were confirmed by medical records and also supplemented by Medicare CMS linkage for fuller ascertainment of outcomes. We had 900 incident cases of AF in the study, and we did see that women were less likely to be diagnosed with AF. They had a 32% lower risk – strongly statistically significant compared with men, with a P < .001. Women were also more likely to be symptomatic: About 77% of women vs. 63% of men had symptoms prior to or at diagnosis.

It was very interesting that adjustment for height eliminated the lower risk for AF in women compared with men. After accounting for height, there was not only no reduction in risk for AF among the women, there was actually a reversal of the association so that there was a slightly higher risk for AF in the women. Other risk factors for AF in the cohort included older age, higher body mass index, hypertension, and higher consumption of alcohol. We did not see an association between diabetes and higher risk for AF. We also saw no clear association with physical activity, although very strenuous physical activity has been linked to AF in some other studies.

We looked at the interventions of vitamin D (2,000 IU/day) and omega-3 fatty acids (460 mg/day of EPA and 380 mg/day of DHA) and found no association with AF, although some other studies have seen increased risk for AF with higher doses of the marine omega-3s > 1 g/day and certainly at doses of 4 g/day. So overall, the findings highlight the fact that many of the risk factors for AF do seem to be modifiable, and it is really important to identify and try to reduce these risk factors in order to reduce the burden of AF. This may be particularly important in women because women are more likely to have stroke and cardiovascular mortality in these adverse cardiovascular outcomes.

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

This transcript has been edited for clarity.

Hello. This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Cardiology on atrial fibrillation (AF), sex differences, and modifiable risk factors.

We looked at these questions in our vitamin D and omega-3 trial VITAL in an ancillary study called VITAL Rhythm, led by Dr. Christine Albert at Cedars-Sinai. And this particular project was led by Dr. Hasan Siddiqi at Vanderbilt.

As you know, AF is the most common arrhythmia in the world, and it’s burgeoning in numbers, primarily because of the aging of the population. It’s also a major cause of stroke, heart failure, and cardiovascular mortality. Although women are known to have lower rates of AF than men, they’re also known to have a higher risk for cardiovascular complications and sequelae, such as higher risk for stroke and CVD mortality. Therefore, we thought that understanding sex differences in risk and modifiable risk factors for AF that could reduce the burden of disease would be important.

It’s known that greater height is a risk factor for AF, but the extent to which it explains the differences in AF risk between men and women isn’t really known. So we looked at these questions in the VITAL cohort. VITAL has more than 25,000 participants. It’s a large, diverse, nationwide cohort. About 51% are women, and all are aged 50 years or older, with a mean age of 67. All were free of known clinical cardiovascular disease at the start of the study.

AF reports were confirmed by medical records and also supplemented by Medicare CMS linkage for fuller ascertainment of outcomes. We had 900 incident cases of AF in the study, and we did see that women were less likely to be diagnosed with AF. They had a 32% lower risk – strongly statistically significant compared with men, with a P < .001. Women were also more likely to be symptomatic: About 77% of women vs. 63% of men had symptoms prior to or at diagnosis.

It was very interesting that adjustment for height eliminated the lower risk for AF in women compared with men. After accounting for height, there was not only no reduction in risk for AF among the women, there was actually a reversal of the association so that there was a slightly higher risk for AF in the women. Other risk factors for AF in the cohort included older age, higher body mass index, hypertension, and higher consumption of alcohol. We did not see an association between diabetes and higher risk for AF. We also saw no clear association with physical activity, although very strenuous physical activity has been linked to AF in some other studies.

We looked at the interventions of vitamin D (2,000 IU/day) and omega-3 fatty acids (460 mg/day of EPA and 380 mg/day of DHA) and found no association with AF, although some other studies have seen increased risk for AF with higher doses of the marine omega-3s > 1 g/day and certainly at doses of 4 g/day. So overall, the findings highlight the fact that many of the risk factors for AF do seem to be modifiable, and it is really important to identify and try to reduce these risk factors in order to reduce the burden of AF. This may be particularly important in women because women are more likely to have stroke and cardiovascular mortality in these adverse cardiovascular outcomes.

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

This transcript has been edited for clarity.

Hello. This is Dr. JoAnn Manson, professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. I’d like to talk with you about a recent report in JAMA Cardiology on atrial fibrillation (AF), sex differences, and modifiable risk factors.

We looked at these questions in our vitamin D and omega-3 trial VITAL in an ancillary study called VITAL Rhythm, led by Dr. Christine Albert at Cedars-Sinai. And this particular project was led by Dr. Hasan Siddiqi at Vanderbilt.

As you know, AF is the most common arrhythmia in the world, and it’s burgeoning in numbers, primarily because of the aging of the population. It’s also a major cause of stroke, heart failure, and cardiovascular mortality. Although women are known to have lower rates of AF than men, they’re also known to have a higher risk for cardiovascular complications and sequelae, such as higher risk for stroke and CVD mortality. Therefore, we thought that understanding sex differences in risk and modifiable risk factors for AF that could reduce the burden of disease would be important.

It’s known that greater height is a risk factor for AF, but the extent to which it explains the differences in AF risk between men and women isn’t really known. So we looked at these questions in the VITAL cohort. VITAL has more than 25,000 participants. It’s a large, diverse, nationwide cohort. About 51% are women, and all are aged 50 years or older, with a mean age of 67. All were free of known clinical cardiovascular disease at the start of the study.

AF reports were confirmed by medical records and also supplemented by Medicare CMS linkage for fuller ascertainment of outcomes. We had 900 incident cases of AF in the study, and we did see that women were less likely to be diagnosed with AF. They had a 32% lower risk – strongly statistically significant compared with men, with a P < .001. Women were also more likely to be symptomatic: About 77% of women vs. 63% of men had symptoms prior to or at diagnosis.

It was very interesting that adjustment for height eliminated the lower risk for AF in women compared with men. After accounting for height, there was not only no reduction in risk for AF among the women, there was actually a reversal of the association so that there was a slightly higher risk for AF in the women. Other risk factors for AF in the cohort included older age, higher body mass index, hypertension, and higher consumption of alcohol. We did not see an association between diabetes and higher risk for AF. We also saw no clear association with physical activity, although very strenuous physical activity has been linked to AF in some other studies.

We looked at the interventions of vitamin D (2,000 IU/day) and omega-3 fatty acids (460 mg/day of EPA and 380 mg/day of DHA) and found no association with AF, although some other studies have seen increased risk for AF with higher doses of the marine omega-3s > 1 g/day and certainly at doses of 4 g/day. So overall, the findings highlight the fact that many of the risk factors for AF do seem to be modifiable, and it is really important to identify and try to reduce these risk factors in order to reduce the burden of AF. This may be particularly important in women because women are more likely to have stroke and cardiovascular mortality in these adverse cardiovascular outcomes.

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

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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

If you smoke, vape, or ingest cannabis, your anesthesiologist should know before you undergo a surgical procedure, according to new medical guidelines.

All patients who undergo procedures that require regional or general anesthesia should be asked if, how often, and in what forms they use the drug, according to recommendations from the American Society of Regional Anesthesia and Pain Medicine.

One reason: Patients who regularly use cannabis may experience worse pain and nausea after surgery and may require more opioid analgesia, the group said.

The society’s recommendations – published in Regional Anesthesia and Pain Medicine – are the first guidelines in the United States to cover cannabis use as it relates to surgery, the group said.
 

Possible interactions

Use of cannabis has increased in recent years, and researchers have been concerned that the drug may interact with anesthesia and complicate pain management. Few studies have evaluated interactions between cannabis and anesthetic agents, however, according to the authors of the new guidelines.

“With the rising prevalence of both medical and recreational cannabis use in the general population, anesthesiologists, surgeons, and perioperative physicians must have an understanding of the effects of cannabis on physiology in order to provide safe perioperative care,” the guideline said.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, PhD, ASRA president and senior author of the guidelines, said in a news release about the recommendations.

Although some patients may use cannabis to relieve pain, research shows that “regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort,” said Dr. Narouze, chairman of the Center for Pain Medicine at Western Reserve Hospital in Cuyahoga Falls, Ohio.
 

Risks for vomiting, heart attack

The new recommendations were created by a committee of 13 experts, including anesthesiologists, chronic pain physicians, and a patient advocate. Shalini Shah, MD, vice chair of anesthesiology at the University of California, Irvine, was lead author of the document.

Four of 21 recommendations were classified as grade A, meaning that following them would be expected to provide substantial benefits. Those recommendations are to screen all patients before surgery; postpone elective surgery for patients who have altered mental status or impaired decision-making capacity at the time of surgery; counsel frequent, heavy users about the potential for cannabis use to impair postoperative pain control; and counsel pregnant patients about the risks of cannabis use to unborn children.

The authors cited studies to support their recommendations, including one showing that long-term cannabis use was associated with a 20% increase in the incidence of postoperative nausea and vomiting, a leading complaint of surgery patients. Other research has shown that cannabis use is linked to more pain and use of opioids after surgery.

Other recommendations include delaying elective surgery for at least 2 hours after a patient has smoked cannabis, owing to an increased risk for heart attack, and considering adjustment of ventilation settings during surgery for regular smokers of cannabis. Research has shown that smoking cannabis may be a rare trigger for myocardial infarction and is associated with airway inflammation and self-reported respiratory symptoms.

Nevertheless, doctors should not conduct universal toxicology screening, given a lack of evidence supporting this practice, the guideline stated.

The authors did not have enough information to make recommendations about reducing cannabis use before surgery or adjusting opioid prescriptions after surgery for patients who use cannabis, they said.

Kenneth Finn, MD, president of the American Board of Pain Medicine, welcomed the publication of the new guidelines. Dr. Finn, who practices at Springs Rehabilitation in Colorado Springs, has edited a textbook about cannabis in medicine and founded the International Academy on the Science and Impact of Cannabis.

“The vast majority of medical providers really have no idea about cannabis and what its impacts are on the human body,” Dr. Finn said.

For one, it can interact with numerous other drugs, including warfarin.

Guideline coauthor Eugene R. Viscusi, MD, professor of anesthesiology at the Sidney Kimmel Medical College, Philadelphia, emphasized that, while cannabis may be perceived as “natural,” it should not be considered differently from manufactured drugs.

Cannabis and cannabinoids represent “a class of very potent and pharmacologically active compounds,” Dr. Viscusi said in an interview. While researchers continue to assess possible medically beneficial effects of cannabis compounds, clinicians also need to be aware of the risks.

“The literature continues to emerge, and while we are always hopeful for good news, as physicians, we need to be very well versed on potential risks, especially in a high-risk situation like surgery,” he said.

Dr. Shah has consulted for companies that develop medical devices and drugs. Dr. Finn is the editor of the textbook, “Cannabis in Medicine: An Evidence-Based Approach” (Springer: New York, 2020), for which he receives royalties.

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

The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

The obvious first statement is that it’s neither wise nor appropriate to speculate on the specifics of Damar Hamlin’s cardiac event during a football game on Jan. 2 (including the possibility of commotio cordis) or his ongoing care. The public nature of his collapse induces intense curiosity but people with illness deserve privacy. Privacy in health care is in short supply. I disagree strongly with those who say his doctors ought to be giving public updates. That’s up to the family.

But there are important general concepts to consider about this incident. These include ...

Cardiac arrest can happen to anyone

People with structural heart disease or other chronic illnesses have a higher risk of arrhythmia, but the notion that athletes are immune from cardiac arrest is wrong. This sentence almost seems too obvious to write, but to this day, I hear clinicians express surprise that an athletic person has heart disease.

Survival turns on rapid and effective intervention

In the old days of electrophysiology, we used to test implantable cardioverter-defibrillators during an implant procedure by inducing ventricular fibrillation (VF) and watching the device convert it. Thankfully, trials have shown that this is no longer necessary for most implants.

When you induce VF In the EP lab, you learn quickly that a) it causes loss of consciousness in a matter of seconds, b) rapid defibrillation restores consciousness, often without the patients knowing or remembering they passed out, and c) the failure of the shock to terminate VF results in deterioration in a matter of 1-2 minutes. Even 1 minute in VF feels so long.

Need is an appropriate word in VF treatment

Clinicians often use the verb need. As in, this patient needs this pill or this procedure. It’s rarely appropriate.

But in the case of treating VF, patients truly need rapid defibrillation. Survival of out-of-hospital cardiac arrest is low because there just aren’t enough automated external defibrillators (AEDs) or people trained to use them. A study of patients who had out-of-hospital cardiac arrest in Denmark found that 30-day survival almost doubled (28.8% vs. 16.4%), when the nearest AED was accessible.

Bystanders must act

The public messages are simple: If a person loses consciousness in front of you, and is not breathing normally, assume it is a cardiac arrest, call 911 to get professional help, and start hands-only chest compressions. Don’t spend time checking for a pulse or trying to wake the person. If this is not a cardiac arrest, they will soon tell you to stop compressing their chest. Seconds matter.

Chest compressions are important but what is really needed is defibrillation. A crucial step in CPR is to send someone to get an AED and get the pads attached. If this is a shockable rhythm, deliver the shock. Hamlin’s collapse emphasizes the importance of the AED; without it, his survival to the hospital would have been unlikely.

Widespread preparticipation screening of young athletes remains a bad idea

Whenever cardiac arrest occurs in an athlete, in such a public way, people think about prevention. Surely it is better to prevent such an event than react to it, goes the thinking. The argument against this idea has four prongs:

The incidence of cardiac disease in a young athlete is extremely low, which sets up a situation where most “positive” tests are false positive. A false positive screening ECG or echocardiogram can create harm in multiple ways. One is the risk from downstream procedures, but worse is the inappropriate disqualification from sport. Healthwise, few harms could be greater than creating long-term fear of exercise in someone.

There is also the problem of false-negative screening tests. An ECG may be normal in the setting of hypertrophic cardiomyopathy. And a normal echocardiogram does not exclude arrhythmogenic right ventricular cardiomyopathy or other genetic causes of cardiac arrest. In a 2018 study from a major sports cardiology center in London, 6 of the 8 sudden cardiac deaths in their series were in athletes who had no detectable abnormalities on screening.

Even when disease is found, it’s not clear that prohibiting participation in sports prevents sudden death. Many previous class III recommendations against participation in sport now carry class II – may be considered – designations.

Finally, screening for any disease loses value as treatments improve. Public education regarding rapid intervention with CPR and AED use is the best treatment option. A great example is the case of Christian Erikson, a Danish soccer player who suffered cardiac arrest during a match at the European Championships in 2021 and was rapidly defibrillated on the field. Therapy was so effective that he was conscious and able to wave to fans on his way out of the stadium. He has now returned to elite competition.

Proponents of screening might oppose my take by saying that National Football League players are intensely screened. But this is different from widespread screening of high school and college athletes. It might sound harsh to say, but professional teams have dualities of interests in the health of their athletes given the million-dollar contracts.

What’s more, professional teams can afford to hire expert cardiologists to perform the testing. This would likely reduce the rate of false-positive findings, compared with screening in the community setting. I often have young people referred to me because of asymptomatic bradycardia found during athletic screening – an obviously normal finding.

Conclusions

As long as there are sports, there will be athletes who suffer cardiac arrest.

We can both hope for Hamlin’s full recovery and learn lessons to help reduce the rate of death from out-of-hospital cardiac arrest. This mostly involves education on how to help fellow humans and a public health commitment to access to AEDs.

John Mandrola, MD, practices cardiac electrophysiology in Louisville, Ky. and is a writer and podcaster for Medscape. He has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

A group of emergency physicians and consumer advocates in multiple states is pushing for stiffer enforcement of decades-old statutes that prohibit the ownership of medical practices by corporations not owned by licensed doctors.

Thirty-three states plus the District of Columbia have rules on their books against the so-called corporate practice of medicine. But over the years, critics say, companies have successfully sidestepped bans on owning medical practices by buying or establishing local staffing groups that are nominally owned by doctors and restricting the physicians’ authority so they have no direct control.

These laws and regulations, which started appearing nearly a century ago, were meant to fight the commercialization of medicine, maintain the independence and authority of physicians, and prioritize the doctor-patient relationship over the interests of investors and shareholders.

Those campaigning for stiffer enforcement of the laws say that physician-staffing firms owned by private equity investors are the most egregious offenders. Private equity-backed staffing companies manage a quarter of the nation’s emergency departments, according to a Raleigh, N.C.–based doctor who runs a job site for ED physicians. The two largest are Nashville, Tenn.–based Envision Healthcare, owned by investment giant KKR & Co., and Knoxville, Tenn.–based TeamHealth, owned by Blackstone.

Court filings in multiple states, including California, Missouri, Texas, and Tennessee, have called out Envision and TeamHealth for allegedly using doctor groups as straw men to sidestep corporate practice laws. But those filings have typically been in financial cases involving wrongful termination, breach of contract, and overbilling.

Now, physicians and consumer advocates around the country are anticipating a California lawsuit against Envision, scheduled to start in January 2024 in federal court. The plaintiff in the case, Milwaukee-based American Academy of Emergency Medicine Physician Group, alleges that Envision uses shell business structures to retain de facto ownership of ED staffing groups, and it is asking the court to declare them illegal.

“We’re not asking them to pay money, and we will not accept being paid to drop the case,” said David Millstein, lead attorney for the plaintiff. “We are simply asking the court to ban this practice model.”
 

‘Possibility to reverberate throughout the country’

The physician group believes a victory would lead to a prohibition of the practice across California – and not just in ERs, but for other staff provided by Envision and TeamHealth, including in anesthesiology and hospital medicine. The California Medical Association supports the lawsuit, saying it “will shape the boundaries of California’s prohibition on the corporate practice of medicine.”

The plaintiff – along with many doctors, nurses, and consumer advocates, as well as some lawmakers – hopes that success in the case will spur regulators and prosecutors in other states to take corporate medicine prohibitions more seriously. “Any decision anywhere in the country that says the corporate ownership of a medical practice is illegal has the possibility to reverberate throughout the country, absolutely – and I hope that it would,” said Julie Mayfield, a state senator in North Carolina.

But the push to reinvigorate laws restricting the corporate practice of medicine has plenty of skeptics, who view it as an effort to return to a golden era in medicine that is long gone or may never have existed to begin with. The genie is out of the bottle, they say, noting that the profit motive has penetrated every corner of health care and that nearly 70% of physicians in the United States are now employed by corporations and hospitals.

The corporate practice of medicine doctrine has “a very interesting and not a very flattering history,” said Barak Richman, a law professor at Duke University. “The medical profession was trying to assert its professional dominance that accrued a lot of benefits to itself in ways that were not terribly beneficial to patients or to the market.”

The California case involves Placentia-Linda Hospital in Orange County, where the plaintiff physician group lost its ED management contract to Envision. The complaint alleges that Envision uses the same business model at numerous hospitals around the state.

“Envision exercises profound and pervasive direct and indirect control and/or influence over the medical practice, making decisions which bear directly and indirectly on the practice of medicine, rendering physicians as mere employees, and diminishing physician independence and freedom from commercial interests,” according to the complaint.

Envision said the company is compliant with state laws and that its operating structure is common in the health care industry. “Legal challenges to that structure have proved meritless,” Envision wrote in an email. It added that “care decisions have and always will be between clinicians and patients.”

TeamHealth, an indirect target in the case, said its “world-class operating team” provides management services that “allow clinicians to focus on the practice of medicine and patient care through a structure commonly utilized by hospitals, health systems, and other providers across the country.”
 

State rules vary widely

State laws and regulations governing the corporate practice of medicine vary widely on multiple factors, including whether there are exceptions for nonprofit organizations, how much of doctors’ revenue outside management firms can keep, who can own the equipment, and how violations are punished. New York, Texas, and California are considered to have among the toughest restrictions, while Florida and 16 other states have none.

Kirk Ogrosky, a partner at the law firm Goodwin Procter, said this kind of management structure predates the arrival of private equity in the industry. “I would be surprised if a company that is interested in investing in this space screwed up the formation documents; it would shock me,” Mr. Ogrosky said.

Private equity–backed firms have been attracted to EDs in recent years because they are profitable and because they have been able to charge inflated amounts for out-of-network care – at least until a federal law cracked down on surprise billing. Envision and TeamHealth prioritize profits, critics say, by maximizing revenue, cutting costs, and consolidating smaller practices into ever-larger groups – to the point of regional dominance.

Envision and TeamHealth are privately owned, which makes it difficult to find reliable data on their finances and the extent of their market penetration.

Leon Adelman, MD, cofounder and CEO of Ivy Clinicians, a Raleigh, N.C.–based startup job site for emergency physicians, has spent 18 months piecing together data and found that private equity–backed staffing firms run 25% of the nation’s EDs. TeamHealth and Envision have the two largest shares, with 8.6% and 8.3%, respectively, Dr. Adelman said.

Other estimates put private equity’s penetration of ERs at closer to 40%.
 

Doctors push for investigations

So far, efforts by emergency physicians and others to challenge private equity staffing firms over their alleged violations have yielded frustrating results.

An advocacy group called Take Medicine Back, formed last year by a handful of ED physicians, sent a letter in July to North Carolina Attorney General Josh Stein, asking him to investigate violations of the ban on the corporate practice of medicine. And because Mr. Stein holds a senior position at the National Association of Attorneys General, the letter also asked him to take the lead in persuading his fellow AGs to “launch a multi-state investigation into the widespread lack of enforcement” of corporate practice of medicine laws.

The group’s leader, Mitchell Li, MD, said he was initially disappointed by the response he received from Mr. Stein’s office, which promised to review his request, saying it raised complex legal issues about the corporate practice of medicine in the state. But Dr. Li is now more hopeful, since he has secured a January appointment with officials in Mr. Stein’s office.

Robert McNamara, MD, a cofounder of Dr. Li’s group and chair of emergency medicine at Temple University’s Lewis Katz School of Medicine, drafted complaints to the Texas Medical Board, along with Houston physician David Hoyer, MD, asking the board to intervene against two doctors accused of fronting for professional entities controlled by Envision and TeamHealth. In both cases, the board declined to intervene.

Dr. McNamara, who serves as the chief medical officer of the physicians’ group in the California Envision case, also filed a complaint with Pennsylvania Attorney General Josh Shapiro, alleging that a group called Emergency Care Services of Pennsylvania PC, which was trying to contract with ED physicians of the Crozer Keystone Health System, was wholly owned by TeamHealth and serving as a shell to avoid scrutiny.

A senior official in Mr. Shapiro’s office responded, saying the complaint had been referred to two state agencies, but Dr. McNamara said he has heard nothing back in more than 3 years.
 

Differing views on private equity’s role

Proponents of private equity ownership say it has brought a lot of good to health care. Jamal Hagler, vice president of research at the American Investment Council, said private equity brings expertise to hospital systems, “whether it’s to hire new staff, grow and open up to new markets, integrate new technologies, or develop new technologies.”

But many physicians who have worked for private equity companies say their mission is not compatible with the best practice of medicine. They cite an emphasis on speed and high patient volume over safety; a preference for lesser-trained, cheaper medical providers; and treatment protocols unsuitable for certain patients.

Sean Jones, MD, an emergency physician in Asheville, N.C., said his first full-time job was at a Florida hospital, where EmCare, a subsidiary of Envision, ran the ED. Dr. Jones said EmCare, in collaboration with the hospital’s owner, pushed doctors to meet performance goals related to wait times and treatments, which were not always good for patients.

For example, if a patient came in with abnormally high heart and respiratory rates – signs of sepsis – doctors were expected to give them large amounts of fluids and antibiotics within an hour, Dr. Jones said. But those symptoms could also be caused by a panic attack or heart failure.

“You don’t want to give a patient with heart failure 2 or 3 liters of fluid, and I would get emails saying, ‘You didn’t do this,’ ” he said. “Well, no, I didn’t, because the reason they couldn’t breathe was they had too much fluid in their lungs.”

Envision said the company’s 25,000 clinicians, “like all clinicians, exercise their independent judgment to provide quality, compassionate, clinically appropriate care.”

Dr. Jones felt otherwise. “We don’t need some MBAs telling us what to do,” he said.
 

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

As holiday celebrations wind down in the United States, COVID is on the rise.

While many would like to take a vacation from even thinking about COVID, the question of what’s next with the virus is always looming. Will there be another winter surge? If so, can we minimize it? How big a role might the boosters play in that? Are more mandates coming, along with a return to closed offices and businesses? Read on for a look at the latest info. 
 

Cases, hospitalizations, deaths

As of Dec. 27, the latest statistics, the Centers for Disease Control and Prevention reports more than 487,000 weekly cases, compared to about 265,000 for the week ending Oct. 12. On average, 4,938 people were admitted to the hospital daily from Dec. 19 to 25, down about 6% from the 5,257 admitted daily the week before. 

Deaths totaled 2,952 weekly as of Dec. 21, up from 2,699 on Dec. 14.  

“What’s sobering overall is still seeing about 400 deaths a day in the U.S.,” said Peter Chin-Hong, MD, professor of medicine and infectious disease specialist at the University of California, San Francisco. “It’s still very high.”

As of Dec. 17, the variants predominating are BQ.1, BQ.1.1, and XBB. Experts said they are paying close attention to XBB, which is increasing quickly in the Northeast. 
 

Predicting a winter surge

Experts tracking the pandemic agree there will be a surge. 

“We are in the midst of it now,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute, La Jolla, Calif., and editor-in-chief of Medscape (MDedge’s sister site). “It’s not nearly like what we’ve had in Omicron or other waves; it’s not as severe. But it’s being particularly felt by seniors.”  

One bit of good news: “Outside of that group it doesn’t look like – so far – it is going to be as bad a wave [as in the past],” Dr. Topol said. 

Predicting the extent of the post-holiday surge “is the billion-dollar question right now,” said Katelyn Jetelina, PhD, a San Diego epidemiologist and author of the newsletter Your Local Epidemiologist.

“Much of these waves are not being driven by subvariants of concern but rather behavior,” she said. 

People are opening up their social networks to gather for celebrations and family time. That’s unique to this winter, she said.

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

Others point out that the surge doesn’t involve just COVID. 

“We are expecting a Christmas surge and we are concerned it might be a triple surge,” said William Schaffner, MD, professor of infectious diseases at Vanderbilt University, Nashville, Tenn., referring to the rising cases of flu and RSV (respiratory syncytial virus). 

Dr. Jetelina shares that concern, worrying that those illnesses may be what overwhelms hospital capacity.

Another wild card is the situation in China. With the easing of China’s “zero COVID” policies, cases there are rising dramatically. Some models are predicting up to 1 million COVID deaths could occur in China in 2023. (The United States is now requiring travelers from China to show a negative COVID test before entering. Italy and Japan have taken similar measures.) 

“The suffering that is going to occur in China is not good news at all,” Dr. Topol said. “We are going to be seeing that for many weeks if not months ahead.” 

Theoretically, uncontained spread such as what is expected there could generate a whole new family of variants, he said. But “the main hit is going to be in China,” he predicted. “But it’s hard to project with accuracy.”

“China is 20% of the global population, so we can’t ignore it,” Dr. Jetelina said. “The question is, what’s the probability of a subvariant of concern coming from China? I think the probability is pretty low, but the possibility is there.”

What happens with cases in China may “throw a wrench” in the transition from pandemic to endemic, Dr. Chin-Hong said. But even if the rising cases in China do result in a new variant, “there’s so much T cell and B cell immunity [here], your average person is still not going to get seriously ill, even if the variant looks really scary.”


 

Minimizing the damage

Experts echo the same advice on stemming the surge, especially for adults who are 65 or older: Get the bivalent booster, and get it now. 

“The same with the influenza vaccine,” Dr. Schaffner said. 

Both the booster vaccine and the flu vaccine have been underused this year, he said. “It’s part of the general vaccine fatigue.”

The low uptake of the booster vaccine is concerning, Dr. Topol said, especially among adults aged 65 and older, the age group most vulnerable to severe disease. Just 35.7% of U.S. adults 65 and older have gotten the booster, according to the CDC. Dr. Topol calls that a tragedy.

Younger people have not taken to the booster, either. Overall, only 14.1% of people aged 5 and up have gotten an updated booster dose, according to the CDC. 

Recent studies find value in the boosters. One study looked only at adults age 65 or older, finding that the bivalent booster reduced the risk of hospitalization by 84% compared to someone not vaccinated, and 73% compared to someone who had received only the monovalent vaccine. Another study of adults found those who had gotten the bivalent were less likely to need COVID-related emergency room care or urgent care.  

In a Dec. 21 report in the New England Journal of Medicine, researchers took plasma samples from people who had gotten either one or two monovalent boosters or the bivalent to determine how well they worked against the circulating Omicron subvariants BA.1, BA.5, BA.2.75.2, BQ.1.1, and XBB. The bivalent worked better than the monovalent against all the Omicron subvariants, but especially against BA.2.75.2, BQ.1.1, and XBB.

Rapid testing can help minimize transmission. On Dec. 15, the Biden administration announced its Winter Preparedness Plan, urging Americans to test before and after travel as well as indoor visiting with vulnerable individuals, providing another round of free at-home tests, continuing to make community testing available and continuing to provide vaccines. 

Besides the general precautions, Dr. Schaffner suggested: “Look at yourself. Who are you? If you are older than 65, or have underlying illness or are immunocompromised, or are pregnant, please put your mask back on. And think about social distancing. It might be time to worship at home and stream a movie,” instead of going to the theaters, he said. 
 

Back to mandates?

On Dec. 9, the New York City Commissioner of Health and Mental Hygiene urged a return to masking indoors, saying people “should” mask up, including in schools, stores, offices, and when in crowded outdoor settings.

On the same date, the County of Los Angeles Public Health urged a return to masking for everyone aged 2 and older when indoors, including at schools, in transit, or in work sites when around others.

While the CDC order requiring masks on public transportation is no longer in effect,  the agency continues to recommend that those using public transportation do so.

But some are taking that further. In Philadelphia, for example, School Superintendent Tony B. Watlington Sr., EdD, announced before the winter break that indoor masking would be required for all students and staff for the first 2 weeks of school return, through Jan. 13, citing guidance from the Philadelphia Department of Public Health.

Universal masking in schools does reduce COVID transmission, as a study published in late November suggests. After Massachusetts dropped the statewide universal masking policy in public schools in February 2022, researchers compared the incidence of COVID in 70 school districts there that dropped the mandate with two school districts that kept it. In the 15 weeks after the policy was rescinded, the lifting of the mandate was linked with an additional 44.9 cases of COVID per 1,000 students and staff. That corresponded to an estimated 11,901 cases and to nearly 30% of the cases in all districts during that time.

That said, experts see mandates as the exception rather than the rule, at least for now, citing public backlash against mandates to mask or follow other restrictions. 

“Mandating, we know, it shuts people off,” Dr. Topol said. “It’s unenforceable. If you have a very strong recommendation, that’s probably as good as you’re going to be able to do right now.”

There may be communities where mandates go over better than others, Dr. Schaffner said, such as communities where people have confidence in their public health authorities.
 

Glimmers of hope

Despite uncertainties, experts offered some not-so-dismal perspectives as well. 

“I think our numbers will continue to go up, but certainly not like 2021 or 2020,” Dr. Chin-Hong said.

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

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

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

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

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

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

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

We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

We wish you a merry Christmas and a happy heart failure

Does anyone really like it when places of business send out cards or messages for the holidays? A card from a truly small family business is one thing, but when you start getting emails from multibillion dollar corporations, it feels a bit dishonest. And that’s not even mentioning the potential blowback when things go wrong.

Petr Kratochvil

Now, you may wonder how a company could possibly mess up something so simple. “We wish you a merry Christmas and a happy New Year.” Not that difficult. Unless you’re Askern Medical Practice in Doncaster, England. Instead of expressing a simple expression of joy for the holiday season, Askern informed all 8,000 of its patients that they had aggressive lung cancer with metastases and they needed to fill out a DS1500 form, which entitles terminal patients to certain benefits.

It only took an hour for Askern to recognize its mistake and send a second text apologizing and adding in the appropriate season’s greetings, but obviously the damage was done. Presumably patients who were last at the doctor to have their cold treated were able to shrug off the text, or simply didn’t see it before the correction came through, but obviously many patients had concerns directly related to cancer and panicked. They called in but were by and large unable to reach anyone at the practice. Some patients close by even went to center itself to clear things up.

One patient, Mr. Carl Chegwin, raised an excellent point about the debacle: “What if that message was meant for someone, and then they are told it’s a Christmas message, then again told, ‘Oh no, that was actually meant for you?’ ” The old double backtrack into yes, you actually do have cancer has got to be a candidate for worst Christmas gift of all. Yes, even worse than socks.
 

Genes know it: You are when you eat

There’s been a lot of recent research on intermittent fasting and what it can and can’t do for one’s health. Much of it has focused on participants’ metabolic rates, but a study just published in Cell Metabolism shows how time-restricted feeding (TRF) has an impact on gene expression, the process through which genes are activated and respond to their environment by creating proteins.

Salk Institute

The research conducted by Satchidananda Panda, PhD, of the Salk Institute and his team involved two groups of mice, one with free access to food and the other with a daily 9-hour feeding window. Analysis of tissue samples collected from 22 organ groups revealed that nearly 80% of mouse genes responded to TRF. Interestingly, 40% of the genes in the hypothalamus, adrenal gland, and pancreas, which handle hormone regulation, were affected, suggesting that TRF could potentially aid in diabetes and stress disorder management, the investigators said in a written statement.

The researchers also found that TRF aligned the circadian rhythms of multiple organs of the body, which brings sleep into the picture. “Time-restricted eating synchronized the circadian rhythms to have two major waves: one during fasting, and another just after eating. We suspect this allows the body to coordinate different processes,” said Dr. Panda, whose previous research looked at TRF in firefighters, who typically work on shift schedules.

Time-restricted eating, it appears, affects gene expression throughout the body and allows interconnected organ systems to work smoothly. It’s not just about eating. Go figure.
 

This group practice reduced stress for everyone

It’s been awhile since we checked in on the good folks at Maharishi International University in Fairfield, Iowa – fictional home of the Fighting Transcendentalists [MAHARISHI RULES!] – but we just have to mention their long-term effort to reduce the national stress.

Goodboy Picture Company/E+/Getty Images

Way back in the year 2000, a group from MIU began practicing transcendental meditation. The size of the group increased over the next few years and eventually reached 1,725 in 2006. That number is important because it represents the square root of 1% of the U.S. population. When that “transition threshold was achieved,” the university explained in a written statement, “all stress indicators immediately started decreasing.”

By stress indicators they mean the U.S. stress index, the mean of eight variables – murder, rape, assault, robbery, infant mortality, drug deaths, vehicle fatalities, and child deaths by injuries – that the study investigators used to track the effectiveness of the meditation program, they said in the World Journal of Social Science.

After 2011, “when the size of the group size began to decline the rate of decrease in stress slowed and then it reversed and began to increase,” MIU reported.

Coauthor Dr. Kenneth Cavanaugh of MIU explained the process: “This study used state-of-the-art methods of time series regression analysis for eliminating potential alternative explanations due to intrinsic preexisting trends and fluctuations in the data. We carefully studied potential alternative explanations in terms of changes in economic conditions, political leadership, population demographics, and policing strategies. None of these factors could account for the results.”

Since we here at LOTME are serious professional journalists, the use of quotes means we are not making this up. Here’s one more thing in quotes: “A grant for 75 million dollars from the Howard and Alice Settle Foundation provided stipends for participants to be in the group and provided funding to bring several hundred visiting [meditation] experts from India to further augment the MIU group.”

Who needs to make up stuff? Not us.

States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.

Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
 

Mortality increases with number of laws

“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.

Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.

Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.

Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.

Findings were published ahead of print in February’s Obstetrics & Gynecology.

Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.

In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
 

State abortion laws changed dramatically in the study period

The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.

The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.

Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.

Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
 

Trigger-law states have strong mortality association

Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.

The existence of trigger laws is likely a proxy for other factors, they write.

“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.

Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.

The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.

“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.

They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.

Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.

One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.
 

States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.

Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
 

Mortality increases with number of laws

“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.

Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.

Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.

Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.

Findings were published ahead of print in February’s Obstetrics & Gynecology.

Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.

In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
 

State abortion laws changed dramatically in the study period

The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.

The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.

Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.

Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
 

Trigger-law states have strong mortality association

Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.

The existence of trigger laws is likely a proxy for other factors, they write.

“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.

Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.

The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.

“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.

They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.

Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.

One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.
 

States that have moderate state abortion laws had lower rates of maternal, fetal, and infant mortality, but not lower all-cause mortality, in reproductive-aged females compared with states that have restrictive laws, new research using 2000-2019 data indicates.

Additionally, having a higher number of laws that restrict abortion in a state was linked with higher maternal and infant mortality in the state, the study states.
 

Mortality increases with number of laws

“Each additional abortion regulation was associated with an increase in maternal mortality (1.09/100,000 live births; 95% confidence interval, 0.36-1.82) and infant mortality (0.20/1,000 live births; 95% CI, 0.12-0.26),” the authors write.

Lorie M. Harper, MD, MSCI, with the department of women’s health, University of Texas at Austin, led a team that simultaneously studied four categories of mortality: all-cause mortality in females ages 15-49 years; maternal mortality; infant mortality; and fetal mortality.

Her team did a retrospective cohort study using the Centers for Disease Control and Prevention’s WONDER (Wide-ranging ONline Data for Epidemiologic Research) database. WONDER collects publicly available data with information on mortality by state.

Data were available from 2000 to 2019 for all-cause, maternal, and infant mortality. Fetal mortality data were available from 2005 to 2019.

Findings were published ahead of print in February’s Obstetrics & Gynecology.

Though the study was done before the Supreme Court decision overturning Roe v. Wade in June 2022, its findings may shed light on potential trends depending on states’ decisions.

In the wake of the Dobbs v. Jackson Women’s Health Organization, an estimated 33 million U.S. women will live in states without available abortion services, the authors note.
 

State abortion laws changed dramatically in the study period

The authors chose the 2-decade time frame because data could be accessed for both maternal and infant mortality for all the years and because state level abortion laws changed dramatically in that time.

The Guttmacher Institute has analyzed each state’s abortion policy landscape and scored states as restrictive, moderate, or supportive. Certain types of abortion laws were associated with higher rates of all-cause mortality in reproductive-age females.

Those laws included trigger laws (the laws that automatically outlaw abortion in a state when federal law is overturned), laws that limit access to medication abortion, and parental consent laws, according to the paper.

Additionally, states that restrict access to abortion have higher rates of maternal and infant death, even after accounting for the general health of the population.
 

Trigger-law states have strong mortality association

Blair G. Darney, PhD, MPH, with the department of obstetrics and gynecology, Oregon Health & Science University and the OHSU-PSU School of Public Health in Portland, and two OHSU coauthors note in an accompanying editorial that having a trigger law in place was associated with elevations in all four mortality measures. However, trigger laws had not yet been enacted during the study.

The existence of trigger laws is likely a proxy for other factors, they write.

“[T]he relationship between trigger laws and increased mortality may more likely be explained by other factors that were not considered in the analysis than by laws that were not enacted at the time of the study,” the editorialists write.

Those factors may include lack of Medicaid expansion, socioeconomic inequities, and other policies.

The editorialists also caution that just because some types of abortion restrictions don’t appear to increase mortality, it doesn’t mean they aren’t harmful.

“For example, laws prohibiting private or Medicaid insurance coverage for abortions were not associated with maternal mortality, but these laws may simply shift the burden of payment to the individual seeking an abortion or be mitigated by funds that support an individual’s out-of-pocket cost for care. The lack of an association may therefore reflect women’s resilience and their ability to obtain needed health care in the face of financial challenges,” they write.

They point out that, conversely, Targeted Regulation of Abortion Providers (TRAP) laws, which supporters say protect women, have been associated instead with increases in maternal mortality.

Dr. Harper and study coauthors, noting that the relationship between abortion laws and mortality is complex, urge states with restrictive abortion laws to consider proven countermeasures to offset the rates, including Medicaid expansion.

One coauthor served on a medical advisory board, was a site primary investigator for several clinical trials, and received royalties from UpToDate for two topics related to trial of labor after cesarean. The other authors did not report any potential conflicts of interest. Dr. Darney’s institution receives research funding from Organon and the Office of Population Affairs on which she is the primary investigator, and she is a member of the board of directors of the Society of Family Planning and a deputy editor at Contraception. She has received an honorarium from ACOG for committee work. The other editorialists did not report any potential conflicts of interest.