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Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

The Pfizer/BioNTech booster lowers the risk for confirmed illness, severe illness, and death from COVID-19, according to two large studies from Israel published Dec. 8, 2021, in the New England Journal of Medicine.

Both studies were completed before the advent of the Omicron variant.

In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.

This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).

The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).

Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).

Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.

In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.

The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
 

Death risk down by 90%

A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.

Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.

The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.

The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.

The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”

The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.

None of the authors involved in both studies reported relevant financial relationships.

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

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”

The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.

Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.

The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.

In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.

The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”

Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”

But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”

Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”

The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

Women with epilepsy are more than twice as likely as those without the disorder to report physical, sexual, or emotional abuse during pregnancy, new research shows.

Study investigator Naveed Chaudhry, MD, a recent epilepsy fellow and assistant professor of neurology, University of Colorado School of Medicine, described the finding as “alarming” and called for more support for this patient population.

Investigators found that women with epilepsy are also more likely to report other stressors, including divorce, illness, lost pay, and partner discord, while expecting.

“As epilepsy physicians, it’s important that we ask the right questions and dive a little bit deeper with these patients, even if it’s uncomfortable and not something we’re used to,” said Dr. Chaudhry.

The findings were presented at the annual meeting of the American Epilepsy Society.
 

Cause for concern

Women with epilepsy may be under stress for a variety of social and economic reasons. In some women, stress can trigger seizures, and during pregnancy, this can lead to complications such as preterm labor and low birth weight.

For the study, researchers tapped into the Center for Disease Control and Prevention Pregnancy Risk Assessment and Monitoring System (PRAMS). This database includes information from surveys asking women across the U.S. about their pregnancy and postpartum period.

Thirteen states collected data on stresses in women with and without epilepsy. Respondents were asked about 14 economic and other worries in the year prior to their baby’s birth, including the pregnancy period.

The analysis included 64,951 women, 1,140 of whom had epilepsy, who were included in surveys from 2012-2020. There were no significant demographic differences between those with and those without the disorder.

After adjusting for maternal age, race, ethnicity, marital status, education, and socioeconomic status, the study found that women with epilepsy experienced an average of 2.41 of the stressors compared with 1.72 for women without epilepsy.

Women with epilepsy were more likely to have experienced family illness, divorce, homelessness, partner job loss, reduced work or pay, increased arguments, having a partner in jail, drug use, and the death of someone close to them.

The results showed that unmarried and younger women as well as those with lower incomes were particularly prone to experience stress during pregnancy.

It’s not clear why women with epilepsy report more stressors. “Looking at the literature, no one has really looked at the exact reason for this, but we postulate it could be a lack of supports and support systems,” said Dr. Chaudhry.

Women were asked about physical, sexual, and emotional abuse. Results showed that substantially more women with epilepsy than those without the disorder reported such abuse during pregnancy – 10.6% versus 4.1%. The adjusted odds ratio for women with epilepsy reporting abuse was 2.78 (95% CI, 2.07-3.74).

“That raises our concern and needs to be looked at in more detail,” said Dr. Chaudhry.

It is unclear whether some women might have had psychogenic non-epileptic seizures (PNES), which are linked to a higher rate of abuse, said Dr. Chaudhry. “But the prevalence of PNES in the general population is quite low, so we don’t think it’s contributing to a large extent to this finding.”

The findings highlight the importance of addressing stress in women with epilepsy during pregnancy, he said. “We need to have good support services and we need to counsel women to optimize good outcomes.”

This applies to all women of childbearing age. “We suspect abuse and stressors are going to be going on throughout that period,” said Dr. Chaudhry. “It’s important to ask about it and have appropriate support staff and social work and people available to help when an issue is identified.”
 

Stress a common seizure trigger

Commenting on the research, Kimford Meador, MD, professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine, noted the study was well conducted and had a large sample size.

The findings are important, as stress is a common trigger for seizures in people with epilepsy and is associated with mood and anxiety, which can affect quality of life, said Dr. Meador.

Results of his analysis from the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study, also presented at this year’s AES meeting, showed that women with epilepsy had more depressive symptoms during the postpartum period and more anxiety symptoms during pregnancy and postpartum in comparison with those without epilepsy.

Dr. Meador’s group also recently conducted a study that was published in JAMA Neurology, showing that in women with epilepsy during the postpartum period, anxiety is associated with lower cognitive ability in their children at age 2 years.

“All these findings highlight the importance of assessing and managing stress, anxiety, and mood in women with epilepsy,” said Dr. Meador. “Interventions could impact seizures and quality of life in pregnant women with epilepsy and long-term outcomes in their children.”

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

“I might have to close my office,” a colleague wrote me recently. “I can’t find reliable medical assistants; no one good applies. Sad, but oh, well.”

A paucity of good employees is just one of many reasons given by physicians who have decided to close up shop. (See my recent column, “Finding Employees During a Pandemic”).

At this point, you should also begin thinking about disposition of your patients’ records. You can’t just shred them, much as you might be tempted. Your attorney and malpractice carrier will guide you in how long they must be retained; 7-10 years is typical in many states, but it could be longer in yours. Unless you are selling part or all of your practice to another physician, you will have to designate someone else to be the legal custodian of the records and obtain a written custodial agreement from that person or organization.

Once that is arranged, you can notify your patients. Send them a letter or e-mail (or both) informing them of the date that you intend to close the practice. Let them know where their records will be kept, who to contact for a copy, and that their written consent will be required to obtain it. Some states also require that a notice be placed in the local newspaper or online, including the date of closure and how to request records.

This is also the time to inform all your third-party payers, including Medicare and Medicaid if applicable, any hospitals where you have privileges, and referring physicians. Notify any business concerns not notified already, such as utilities and other ancillary services. Your state medical board and the Drug Enforcement Agency will need to know as well. Contact a liquidator or used equipment dealer to arrange for disposal of any office equipment that has resale value. It is also a good time to decide how you will handle patient collections that trickle in after closing, and where mail should be forwarded.

As the closing date approaches, determine how to properly dispose of any medications you have on-hand. Your state may have requirements for disposal of controlled substances, and possibly for noncontrolled pharmaceuticals as well. Check your state’s controlled substances reporting system and other applicable regulators. Once the office is closed, don’t forget to shred any blank prescription pads and dissolve your corporation, if you have one.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

“I might have to close my office,” a colleague wrote me recently. “I can’t find reliable medical assistants; no one good applies. Sad, but oh, well.”

A paucity of good employees is just one of many reasons given by physicians who have decided to close up shop. (See my recent column, “Finding Employees During a Pandemic”).

At this point, you should also begin thinking about disposition of your patients’ records. You can’t just shred them, much as you might be tempted. Your attorney and malpractice carrier will guide you in how long they must be retained; 7-10 years is typical in many states, but it could be longer in yours. Unless you are selling part or all of your practice to another physician, you will have to designate someone else to be the legal custodian of the records and obtain a written custodial agreement from that person or organization.

Once that is arranged, you can notify your patients. Send them a letter or e-mail (or both) informing them of the date that you intend to close the practice. Let them know where their records will be kept, who to contact for a copy, and that their written consent will be required to obtain it. Some states also require that a notice be placed in the local newspaper or online, including the date of closure and how to request records.

This is also the time to inform all your third-party payers, including Medicare and Medicaid if applicable, any hospitals where you have privileges, and referring physicians. Notify any business concerns not notified already, such as utilities and other ancillary services. Your state medical board and the Drug Enforcement Agency will need to know as well. Contact a liquidator or used equipment dealer to arrange for disposal of any office equipment that has resale value. It is also a good time to decide how you will handle patient collections that trickle in after closing, and where mail should be forwarded.

As the closing date approaches, determine how to properly dispose of any medications you have on-hand. Your state may have requirements for disposal of controlled substances, and possibly for noncontrolled pharmaceuticals as well. Check your state’s controlled substances reporting system and other applicable regulators. Once the office is closed, don’t forget to shred any blank prescription pads and dissolve your corporation, if you have one.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

“I might have to close my office,” a colleague wrote me recently. “I can’t find reliable medical assistants; no one good applies. Sad, but oh, well.”

A paucity of good employees is just one of many reasons given by physicians who have decided to close up shop. (See my recent column, “Finding Employees During a Pandemic”).

At this point, you should also begin thinking about disposition of your patients’ records. You can’t just shred them, much as you might be tempted. Your attorney and malpractice carrier will guide you in how long they must be retained; 7-10 years is typical in many states, but it could be longer in yours. Unless you are selling part or all of your practice to another physician, you will have to designate someone else to be the legal custodian of the records and obtain a written custodial agreement from that person or organization.

Once that is arranged, you can notify your patients. Send them a letter or e-mail (or both) informing them of the date that you intend to close the practice. Let them know where their records will be kept, who to contact for a copy, and that their written consent will be required to obtain it. Some states also require that a notice be placed in the local newspaper or online, including the date of closure and how to request records.

This is also the time to inform all your third-party payers, including Medicare and Medicaid if applicable, any hospitals where you have privileges, and referring physicians. Notify any business concerns not notified already, such as utilities and other ancillary services. Your state medical board and the Drug Enforcement Agency will need to know as well. Contact a liquidator or used equipment dealer to arrange for disposal of any office equipment that has resale value. It is also a good time to decide how you will handle patient collections that trickle in after closing, and where mail should be forwarded.

As the closing date approaches, determine how to properly dispose of any medications you have on-hand. Your state may have requirements for disposal of controlled substances, and possibly for noncontrolled pharmaceuticals as well. Check your state’s controlled substances reporting system and other applicable regulators. Once the office is closed, don’t forget to shred any blank prescription pads and dissolve your corporation, if you have one.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A nose for the tooth

Have you ever had a stuffy nose that just wouldn’t go away? Those irritating head colds have nothing on the stuffy nose a man in New York recently had to go through. A stuffy nose to top all stuffy noses. One stuffy nose to rule them all, as it were.

John Oliver/Pixabay

This man went to a Mount Sinai clinic with difficulty breathing through his right nostril, a problem that had been going on for years. Let us repeat that: A stuffy nose that lasted for years. The exam revealed a white mass jutting through the back of the septum and a CT scan confirmed the diagnosis. Perhaps you’ve already guessed, since the headline does give things away. Yes, this man had a tooth growing into his nose.

The problem was a half-inch-long ectopic tooth. Ectopic teeth are rare, occurring in less than 1% of people, but an ectopic tooth growing backward into the nasal cavity? Well, that’s so uncommon that this man got a case report in the New England Journal of Medicine.

This story does have a happy ending. Not all ectopic teeth need to be treated, but this one really did have to go. The offending tooth was surgically removed and, at a 3-month follow-up, the stuffy nose issue was completely resolved. So our friend gets the best of both worlds: His issue gets cured and he gets a case report in a major medical publication. If that’s not living the dream, we don’t know what is, and that’s the tooth.
 

Lettuce recommend you a sleep aid

Lettuce is great for many things. The star in a salad? Of course. The fresh element in a BLT? Yep. A sleep aid? According to a TikTok hack with almost 5 million views, the pinch hitter in a sandwich is switching leagues to be used like a tea for faster sleep. But, does it really work? Researchers say yes and no, according to a recent report at Tyla.com.

PxHere

Studies conducted in 2013 and 2017 pointed toward a compound called lactucin, which is found in the plant’s n-butanol fraction. In the 2013 study, mice that received n-butanol fraction fell asleep faster and stayed asleep longer. In 2017, researchers found that lettuce made mice sleep longer and helped protect against cell inflammation and damage.

OK, so it works on mice. But what about humans? In the TikTok video, user Shapla Hoque pours hot water on a few lettuce leaves in a mug with a peppermint tea bag (for flavor). After 10 minutes, when the leaves are soaked and soggy, she removes them and drinks the lettuce tea. By the end of the video she’s visibly drowsy and ready to crash. Does this hold water?

Here’s the no. Dr. Charlotte Norton of the Slimming Clinic told Tyla.com that yeah, there are some properties in lettuce that will help you fall asleep, such as lactucarium, which is prominent in romaine. But you would need a massive amount of lettuce to get any effect. The TikTok video, she said, is an example of the placebo effect.
 

Brains get a rise out of Viagra

A lot of medications are used off label. Antidepressants for COVID have taken the cake recently, but here’s a new one: Viagra for Alzheimer’s disease.

©roberthyrons/thinkstockphotos.com

Omicron is not a social-distancing robot

COVID, safe to say, has not been your typical, run-of-the-mill pandemic. People have protested social distancing. People have protested lockdowns. People have protested mask mandates. People have protested vaccine mandates. People have protested people protesting vaccine mandates.

neo tam/Pixabay

Someone used a fake arm to get a COVID vaccine card. People have tried to reverse their COVID vaccinations. People had COVID contamination parties.

The common denominator? People. Humans. Maybe what we need is a nonhuman intervention. To fight COVID, we need a hero. A robotic hero.

And where can we find such a hero? The University of Maryland, of course, where computer scientists and engineers are working on an autonomous mobile robot to enforce indoor social-distancing rules.

Their robot can detect lapses in social distancing using cameras, both thermal and visual, along with a LiDAR (Light Detection and Ranging) sensor. It then sorts the offenders into various groups depending on whether they are standing still or moving and predicts their future movement using a state-of-the-art hybrid collision avoidance method known as Frozone, Adarsh Jagan Sathyamoorthy and associates explained in PLOS One.

“Once it reaches the breach, the robot encourages people to move apart via text that appears on a mounted display,” ScienceDaily said.

Maybe you were expecting a Terminator-type robot coming to enforce social distancing requirements rather than a simple text message. Let’s just hope that all COVID guidelines are followed, including social distancing, so the pandemic will finally end and won’t “be back.”

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

A raft of new studies that looked at the ability of Omicron to evade an array of currently available vaccines suggest a substantial loss of protection against the highly mutated variant.

Medscape Illustration/Dreamstime

The new studies, from teams of researchers in Germany, South Africa, Sweden, and the drug company Pfizer, showed 25 to 40-fold drops in the ability of antibodies created by two doses of the Pfizer-BioNTech vaccine to neutralize the virus.  

But there seemed to be a bright spot in the studies too. The virus didn’t completely escape the immunity from the vaccines, and giving a third, booster dose appeared to restore antibodies to a level that’s been associated with protection against variants in the past.

“One of the silver linings of this pandemic so far is that mRNA vaccines manufactured based on the ancestral SARS-CoV-2 continue to work in the laboratory and, importantly, in real life against variant strains,” said Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston. “The strains so far vary by their degree of being neutralized by the antibodies from these vaccines, but they are being neutralized nonetheless.” 

Dr. El Sahly points out that the Beta variant was associated with a 10-fold drop in antibodies, but two doses of the vaccines still protected against it.

President Biden hailed the study results as good news.

“That Pfizer lab report came back saying that the expectation is that the existing vaccines protect against Omicron. But if you get the booster, you’re really in good shape. And so that’s very encouraging,” he said in a press briefing Dec. 8.
 

More research needed

Other scientists, however, stressed that these studies are from lab tests, and don’t necessarily reflect what will happen with Omicron in the real world. They cautioned about a worldwide push for boosters with so many countries still struggling to give first doses of vaccines.

Soumya Swaminathan, MD, chief scientist for the World Health Organization, stressed in a press briefing Dec. 8 that the results from the four studies varied widely, showing dips in neutralizing activity with Omicron that ranged from 5-fold to 40-fold.

The types of lab tests that were run were different, too, and involved small numbers of blood samples from patients.

She stressed that immunity depends not just on neutralizing antibodies, which act as a first line of defense when a virus invades, but also on B cells and T cells, and so far, tests show that these crucial components — which are important for preventing severe disease and death — had been less impacted than antibodies.

“So, I think it’s premature to conclude that this reduction in neutralizing activity would result in a significant reduction in vaccine effectiveness,” she said.

Whether or not these first-generation vaccines will be enough to stop Omicron, though, remains to be seen. A study of the Pfizer, Moderna, and AstraZeneca vaccines, led by German physician Sandra Ciesek, MD, who directs the Institute of Medical Virology at the University of Frankfurt, shows a booster didn’t appear to hold up well over time.

Dr. Ciesek and her team exposed Omicron viruses to the antibodies of volunteers who had been boosted with the Pfizer vaccine 3 months prior.  

She also compared the results to what happened to those same 3-month antibody levels against Delta variant viruses. She found only a 25% neutralization of Omicron compared with a 95% neutralization of Delta. That represented about a 37-fold reduction in the ability of the antibodies to neutralize Omicron vs Delta.

“The data confirm that developing a vaccine adapted for Omicron makes sense,” she tweeted as part of a long thread she posted on her results.
 

Retool the vaccines?

Both Pfizer and Moderna are retooling their vaccines to better match them to the changes in the Omicron variant. In a press release, Pfizer said it could start deliveries of that updated vaccine by March, pending U.S. Food and Drug Administration authorization.

“What the booster really does in neutralizing Omicron right now, they don’t know, they have no idea,” said Peter Palese, PhD, chair of the department of microbiology at the Mount Sinai School of Medicine in New York City.

Dr. Palese said he was definitely concerned about a possible Omicron wave.

“There are four major sites on the spike protein targeted by antibodies from the vaccines, and all four sites have mutations,” he said. “All these important antigenic sites are changed.

“If Omicron becomes the new Delta, and the old vaccines really aren’t good enough, then we have to make new Omicron vaccines. Then we have to revaccinate everybody twice,” he said, and the costs could be staggering. “I am worried.”

Tedros Adhanom Ghebreyesus, PhD, director general of the WHO, urged countries to move quickly.

“Don’t wait. Act now,” he said, even before all the science is in hand. “All of us, every government, every individual should use all the tools we have right now,” to drive down transmission, increase testing and surveillance, and share scientific findings.

“We can prevent Omicron [from] becoming a global crisis right now,” he said.

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

A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.

The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.

In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”

Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”

This news organization was among the publications that reported the results of that study.

But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.

Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”

Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
 

Different conclusion for home birth safety

Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.

They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.

Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.

She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.

“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.

She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.

The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.

“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.

Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”

Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”

Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”

“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”

She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.

“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.

Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”

Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.

He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.

The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.

“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”

“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”

She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.

“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”

Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.

Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.

“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”

Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
 

A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.

The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.

In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”

Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”

This news organization was among the publications that reported the results of that study.

But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.

Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”

Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
 

Different conclusion for home birth safety

Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.

They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.

Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.

She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.

“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.

She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.

The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.

“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.

Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”

Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”

Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”

“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”

She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.

“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.

Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”

Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.

He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.

The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.

“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”

“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”

She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.

“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”

Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.

Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.

“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”

Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
 

A research letter published recently in the American Journal of Obstetrics and Gynecology argues that the methodology of a recent paper on the safety of planned home births presented a biased analysis.

The paper that Amos Grünebaum, MD, and colleagues with the department of obstetrics and gynecology at Lenox Hill Hospital in Hempstead, N.J., referred to is a study in Obstetrics & Gynecology which concluded that planned home births in Washington state are low risk.

In that paper, Elizabeth Nethery, RM, MS, MSM, a midwife and PhD candidate at the University of British Columbia, Vancouver, calculated the outcomes from 2015 to 2020 for “all births attended by members of a statewide midwifery professional association that were within professional association guidelines and met eligibility criteria for planned birth center birth.”

Ms. Nethery’s team concluded: “Rates of adverse outcomes for this cohort in a U.S. state with well-established and integrated community midwifery were low overall. Birth outcomes were similar for births planned at home or at a state-licensed, freestanding birth center.”

This news organization was among the publications that reported the results of that study.

But it’s the exclusion criteria in that study, primarily, that Dr. Grünebaum and colleagues take issue with.

Births excluded from the main analysis of the study by Ms. Nethery and coauthors involved “multifetal pregnancy, prior cesarean delivery, onset of labor at more than 42 0/7 weeks of gestation or preterm (less than 37 weeks), preexisting hypertension or diabetes, known amniotic fluid abnormality, gestational hypertension or preeclampsia, or malpresentation.”

Those are conditions that fall outside guidelines for planned home births. But both Ms. Nethery and Dr. Grünebaum said that sometimes these high-risk conditions are present in home births.
 

Different conclusion for home birth safety

Dr. Grünebaum and colleagues’ analysis of the risk profiles and outcomes for U.S. planned home births for the years 2016-2020 came to a different conclusion about the safety of home births.

They used a retrospective population-based cohort study that used the Centers for Disease Control and Prevention WONDER natality online database. They included planned home births and compared the outcomes with and without certain risk factors, including some high-risk factors such as twin deliveries, breech births, and previous cesarean.

Dr. Grünebaum’s analysis concluded that “it is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Ms. Nethery said though the high-risk conditions were excluded from their main analysis, they are mentioned in the paper and detailed in the supplement.

She acknowledged in the paper that some midwives practice outside the guidelines and that was the case in 7% of births or for 800 people in the Washington state study. But she told this publication it’s a small number and high-risk births should be handled in a hospital so the team focused its research on low-risk births.

“People plan home births who are outside the guidelines everywhere in the world. There are a lot of reasons why people do it,” she said. Among them are not feeling safe in the hospital, being rejected by an obstetrician for a desired procedure, or, in some cases, because they are misinformed.

She said midwives are sometimes faced with a difficult choice, when a patient wants, for instance, a vaginal birth after cesarean (VBAC), one of the conditions not recommended for home births.

The midwife is left with the choice of saying she will not do a VBAC in the home, or she can explain to the patient why it is not recommended and explain all the reasons it is not recommended, such as an elevated risk of rupture, but honor the patient’s choice.

“Do you tell the person: ‘Sorry, go have the cesarean anyway or do you do your best to support this person?’ Birthing people have the right to autonomy of choice,” Ms. Nethery said.

Dr. Grünebaum and colleagues said: “The recent study by Nethery et al. concluded that planned home births in the state of Washington have good neonatal outcomes by focusing on results of low-risk patients.”

Dr. Grünebaum said in an interview: “It’s like reporting on smoking and lung cancer and saying I’m only going to report on patients who have smoked for less than 5 years. You need to take the whole picture into consideration.”

Ms. Nethery gave this explanation for excluding the high-risk patients: “If you are studying a drug, you exclude people from your study who got the drug even though they had risk factors that were ‘contraindications’ to that drug. Likely there was a reason they got the drug – in consultation with their doctor, the patient and the doctor decided that the potential benefit outweighed the risk – but they are not relevant to understanding how that drug impacts people who were ‘eligible’ for the drug in the first place.”

“That is part of the reason we excluded ‘high-risk’ people from our study,” she said. “The other reason is that that is what is commonly done in most research on this topic – we focus on ‘low-risk’ people who are within standards and eligibility criteria.”

She gave examples such as a 2019 meta-analysis and a 2011 Birthplace in England national prospective cohort study, both of which excluded high-risk home births.

“Third, we wanted to compare apples to apples (for our analysis of home vs. hospital) – and licensed birth centers in Washington state have restrictions based on risk,” Ms. Nethery said.

Dr. Grünebaum said his team supports the right of all women to give birth where they wish. “But you cannot choose unless you are given the right information.”

Dr. Grünebaum also said planned home births in the United States cannot be compared with home births delivered by midwives in other countries. Different from the United States, he said, in countries such as Canada, Germany, and England, midwives are well integrated in the medical system and they are typically affiliated with hospitals and they belong to organizations which support very strong guidelines.

He added that, while Washington state has its own set of guidelines, there are no national guidelines for home births and practice varies greatly by state.

The authors concluded: “It is the professional responsibility of all health care providers, obstetricians, and midwives to present unbiased information. Focusing the reporting of outcomes on low-risk deliveries underreports true adverse outcomes in U.S. home births and provides biased information to patients considering planned home births. It is an immutable truth that planned home births in the United States result in avoidable risks of increased adverse neonatal outcomes.”

Angela Martin, MD, assistant professor of maternal-fetal medicine and medical director of the labor and delivery department at University of Kansas Medical Center, Kansas City, who was not part of either study, said she did not believe it was a problem that Ms. Nethery’s study excluded the high-risk conditions in the main analysis because it was disclosed.

“The authors were clear that they excluded high-risk conditions,” she said. “Therefore, the study should not be extrapolated to women with these conditions.”

“I believe her results do make that case for low-risk women in Washington state,” Dr. Martin said. “Again, it is important that findings are not extrapolated to women outside of those included in the study.”

She said there are several things that make Washington unusual in midwifery care. Consequently, the results should not be seen as representative of the United States.

“It is one of the most integrated states for midwife care in the country,” Dr. Martin said. “Washington has licensure available for midwives, which is not true of all states. It also has a robust state professional association that publishes guidelines for midwives to follow. And midwives in Washington have a wide formulary. For example, they can administer antibiotics, carry and administer hemorrhage medications, they can carry oxygen, and they are allowed to suture.”

Iris Krishna, MD, MPH, director of perinatal quality, Emory Perinatal Center and assistant professor in the division of maternal-fetal medicine at Emory University, Atlanta, said in an interview that the arguments by Ms. Nethery and Dr. Grünebaum illustrate the controversy over home births.

Dr. Krishna, who was not part of either study, said physicians and midwives should counsel patients contemplating a planned community birth that available data is not generalizable to all birth settings or all patients.

“Women should be counseled that delivery in a hospital setting or accredited birth center is safer than home birth,” she said. “Ultimately, each woman has the right to make a medically informed decision about delivery after adequate counseling on the risks and benefits of community birth.”

Dr. Grünebaum and colleagues reported no relevant financial relationships. Ms. Nethery, Dr. Martin, and Dr. Krishna also reported no relevant financial relationships.
 

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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

Adolescents and adults younger than age 21 who develop myocarditis after mRNA COVID-19 vaccination frequently have abnormal findings on cardiac MRI (cMRI) but most have a mild clinical course with rapid resolution of symptoms, a new study concludes.

• Most patients were male (90.6%), White (66.2%) and with a median age of 15.8 years.
• Suspected myocarditis occurred in 136 patients (97.8%) following mRNA vaccine, with 131 (94.2%) following the Pfizer-BioNTech vaccine; 128 cases (91.4%) occurred after the second dose.
• Symptoms started a median of 2 days (range 0 to 22 days) following vaccination administration.
• Chest pain was the most common symptom (99.3%), with fever present in 30.9% of patients and shortness of breath in 27.3%.
• Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%) or no anti-inflammatory therapies (8.6%).
• Twenty-six patients (18.7%) were admitted to the intensive care unit; 2 received inotropic/vasoactive support; none required extracorporeal membrane oxygenation or died.
• Median time spent in the hospital was 2 days.
• A total of 111 patients had elevated troponin I (8.12 ng/mL) and 28 had elevated troponin T (0.61 ng/mL).
• More than two-thirds (69.8%) had abnormal electrocardiograms and/or arrhythmias (7 with nonsustained ventricular tachycardia).
• Twenty-six patients (18.7%) had left ventricular ejection fraction (LVEF) less than 55% on echocardiogram; LVEF had returned to normal in the 25 who returned for follow-up.
• 75 of 97 patients (77.3%) who underwent cMRI at a median of 5 days from symptom onset had abnormal findings; 74 (76.3%) had late gadolinium enhancement, 54 (55.7%) had myocardial edema, and 49 (50.5%) met Lake Louise criteria for myocarditis.

“These data suggest that most cases of suspected COVID-19 vaccine–related myocarditis in people younger than 21 are mild and resolve quickly,” corresponding author Dongngan Truong, MD, Division of Pediatric Cardiology, University of Utah and Primary Children’s Hospital, Salt Lake City, said in a statement.

“We were very happy to see that type of recovery. However, we are awaiting further studies to better understand the long-term outcomes of patients who have had COVID-19 vaccination-related myocarditis. We also need to study the risk factors and mechanisms for this rare complication,” Dr. Truong added.

Dr. Lloyd-Jones said these findings support the AHA’s position that COVID-19 vaccines are “safe, highly effective, and fundamental to saving lives, protecting our families and communities against COVID-19, and ending the pandemic.”

The study received no funding. Dr. Truong consults for Pfizer on vaccine-associated myocarditis. A complete list of author disclosures is available with the original article.

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