Ob.Gyn. News

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

A new study published in JAMA suggests that doctors with one paid malpractice claim are almost four times more likely than their peers to have additional paid claims in the future, regardless of specialty or whether a state publicly discloses paid claims.

In this retrospective case-control study, law and public health researchers from Georgetown University, the National Opinion Research Center, the University of Colorado, and Northwestern University analyzed paid malpractice claims for all licensed U.S. physicians.

The findings suggest that a single malpractice claim may not be a random stroke of bad luck but instead holds some predictive power into the risk for future paid claims.

“A four times increase in risk is huge, particularly since we observe a similar increase in both high-risk and lower-risk specialties,” David Hyman, JD, MD, professor of health law and policy at Georgetown University, Washington, and lead researcher on the study, told this news organization. “There are surely some false positives, but there must be lots of actual negligence too, or we would not see these results.”

For the 881,876 physicians analyzed, researchers looked at malpractice claims paid during two 5-year periods: 2009-2013 and 2014-2018. Nearly 96% of physicians had no paid malpractice claims between 2009 and 2013; 3% had one, and less than 1% had multiple claims. The proportion of physicians with paid claims between 2014 and 2018 was similar.

Compared with physicians with no 2009-2013 claims, a physician with just one paid claim in that time period had a 3.7 times higher risk for a future paid claim. Physicians with two paid claims were nearly 7 times more likely to have a future paid claim, and those with three or more paid claims were more than 11 times more likely to have one.

Approximately 3% of physicians with no paid claims between 2009 and 2013 had a future paid claim, growing to 12.4% of those with one paid claim during that time.

The study’s findings may have implications for medical licensing boards and hospitals granting staff privileges.

“After some number of paid claims, there should be an official response” from these entities, such as a hands-on assessment of technical skills or assignment of a peer mentor, said Dr. Hyman, who is also coauthor of a book titled “Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn’t Helped.” A graduated set of interventions, whether voluntary or mandatory, can reduce future claim risk and patient harm, Dr. Hyman added.

Interventions may include error avoidance and post-error communication training, counseling to improve bedside skills, and encouragement to move into nonclinical practice. Either way, Dr. Hyman says a nuanced intervention strategy would be a welcome shift away from the current “all or nothing approach” that too often ends in the revocation of a physician’s medical license.

Although there are strategies to proactively identify physicians with excess risk for malpractice claims and implement preventive measures – like Vanderbilt University’s Patient Advocacy Reporting System, for example – most hospitals and physician groups fail to initiate even informal interventions after a malpractice settlement or verdict, which is a missed opportunity, Dr. Hyman said.

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

Warming U.S. temperatures, the resumption of travel, and new knowledge about Zika’s long-term effects on children signal that Zika prevention and vaccine development should be on public health officials’, doctors’, and communities’ radar, even when community infection is not occurring.

“Although we haven’t seen confirmed Zika virus circulation in the continental United States or its territories for several years, it’s still something that we are closely monitoring, particularly as we move into the summer months,” Erin Staples, MD, PhD, medical epidemiologist at the Arboviral Diseases Branch of the Centers for Disease Control and Prevention in Fort Collins, Colo., told this news organization.

“This is because cases are still being reported in other countries, particularly in South America. Travel to these places is increasing following the pandemic, leaving more potential for individuals who might have acquired the infection to come back and restart community transmission.”
 

How Zika might reemerge

The Aedes aegypti mosquito is the vector by which Zika spreads, and “during the COVID pandemic, these mosquitoes moved further north in the United States, into southern California, and were identified as far north as Washington, D.C.,” said Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at UCLA Medical Center in Los Angeles.

“On a population level, Americans have essentially no immunity to Zika from prior infection, and there is no vaccine yet approved. If individuals infected with Zika came into a U.S. region where the Aedes aegypti mosquito was present, that population could be very susceptible to infection spread and even another outbreak. This would be a confluence of bad circumstances, but that’s exactly what infectious disease specialists continue to be watchful about, especially because Zika is so dangerous for fetuses,” said Dr. Silverman.
 

How the public can prepare

The CDC recommends that pregnant women or women who plan to become pregnant avoid traveling to regions where there are currently outbreaks of Zika, but this is not the only way that individuals can protect themselves.

“The message we want to deliver to people is that in the United States, people are at risk for several mosquito-borne diseases every summer beyond just Zika,” Dr. Staples said. “It’s really important that people are instructed to make a habit of wearing EPA [U.S. Environmental Protection Agency)–registered insect repellents when they go outside. Right now, that is the single best tool that we have to prevent mosquito-borne diseases in the U.S.

“From a community standpoint, there are several emerging mosquito control methods that are being evaluated right now, such as genetic modification and irradiation of mosquitoes. These methods are aimed at producing sterile mosquitoes that are released into the wild to mate with the local mosquito population, which will render them infertile. This leads, over time, to suppression of the overall Aedes aegypti mosquito population – the main vector of Zika transmission,” said Dr. Staples.

Monica Gandhi, MD, MPH, professor of medicine and associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, encourages her patients to wear mosquito repellent but cautioned that “there’s no antiviral that you can take for Zika. Until we have a vaccine, the key to controlling/preventing Zika is controlling the mosquitoes that spread the virus.”
 

Vaccines

The National Institute of Allergy and Infectious Diseases (NIAID) is currently investigating a variety of Zika vaccines, including a DNA-based vaccine, (phase 2), a purified inactivated virus vaccine (phase 1), live attenuated vaccines (phase 2), and mRNA vaccines (phase 2).

“I’m most excited about mRNA vaccines because they help patients produce a lot of proteins. The protein from a typical protein-adjuvant vaccine will break down, and patients can only raise an immune response to whatever proteins are left. On the other hand, mRNA vaccines provide the body [with] a recipe to make the protein from the pathogen in high amounts, so that a strong immune response can be raised for protection,” noted Dr. Gandhi.

Moderna’s mRNA-1893 vaccine was recently studied in a randomized, observer-blind, controlled, phase 1 trial among 120 adults in the United States and Puerto Rico, the results of which were published online in The Lancet. “The vaccine was found to be generally well tolerated with no serious adverse events considered related to vaccine. Furthermore, the vaccine was able to generate a potent immune response that was capable of neutralizing the virus in vitro,” said Brett Leav, MD, executive director of clinical development for public health vaccines at Moderna.

“Our mRNA platform technology ... can be very helpful against emerging pandemic threats, as we saw in response to COVID-19. What is unique in our approach is that if the genetic sequence of the virus is known, we can quickly generate vaccines to test for their capability to generate a functional immune response. In the case of the mRNA-1893 trial, the vaccine was developed with antigens that were present in the strain of virus circulating in 2016, but we could easily match whatever strain reemerges,” said Dr. Leav.

A phase 2 trial to confirm the dose of mRNA-1893 in a larger study population is underway.

Although it’s been demonstrated that Moderna’s mRNA vaccine is safe and effective, moving from a phase 2 to a phase 3 study presents a challenge, given the fact that currently, the disease burden from Zika is low. If an outbreak were to occur in the future, these mRNA vaccines could potentially be given emergency approval, as occurred during the COVID pandemic, according to Dr. Silverman.

If approved, provisionally or through a traditional route, the vaccine would “accelerate the ability to tamp down any further outbreaks, because vaccine-based immunity could be made available to a large portion of the population who were pregnant or planning a pregnancy, not just in the U.S. but also in these endemic areas,” said Dr. Silverman.


 

Takeaways from the last Zika outbreak

Practical steps such as mosquito eradication and development of vaccines are not the only takeaway from the recent Zika epidemics inside and outside the United States. A clearer picture of the short- and long-term stakes of the disease has emerged.

According to the CDC, most people who become infected with Zika experience only mild symptoms, such as fever, rash, headache, and muscle pain, but babies conceived by mothers infected with Zika are at risk for stillbirth, miscarriage, and microcephaly and other brain defects.

Although a pregnant woman who tests positive for Zika is in a very high-risk situation, “data show that only about 30% of mothers with Zika have a baby with birth defects. If a pregnant woman contracted Zika, what would happen is we would just do very close screening by ultrasound of the fetus. If microcephaly in utero or fetal brain defects were observed, then a mother would be counseled on her options,” said Dr. Gandhi.

Dr. Silverman noted that “new data on children who were exposed in utero and had normal exams, including head measurements when they were born, have raised concerns. In recently published long-term follow-up studies, even when children born to mothers infected with Zika during pregnancy had normal head growth at least 3 years after birth, they were still at risk for neurodevelopmental delay and behavioral disorders, including impact on coordination and executive function.

“This is another good reason to keep the potential risks of Zika active in the public’s consciousness and in public health planning.”

Dr. Silverman, Dr. Gandhi, and Dr. Staples have disclosed no relevant financial relationships. Dr. Leav is an employee of Moderna and owns stock in the company.

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

Warming U.S. temperatures, the resumption of travel, and new knowledge about Zika’s long-term effects on children signal that Zika prevention and vaccine development should be on public health officials’, doctors’, and communities’ radar, even when community infection is not occurring.

“Although we haven’t seen confirmed Zika virus circulation in the continental United States or its territories for several years, it’s still something that we are closely monitoring, particularly as we move into the summer months,” Erin Staples, MD, PhD, medical epidemiologist at the Arboviral Diseases Branch of the Centers for Disease Control and Prevention in Fort Collins, Colo., told this news organization.

“This is because cases are still being reported in other countries, particularly in South America. Travel to these places is increasing following the pandemic, leaving more potential for individuals who might have acquired the infection to come back and restart community transmission.”
 

How Zika might reemerge

The Aedes aegypti mosquito is the vector by which Zika spreads, and “during the COVID pandemic, these mosquitoes moved further north in the United States, into southern California, and were identified as far north as Washington, D.C.,” said Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at UCLA Medical Center in Los Angeles.

“On a population level, Americans have essentially no immunity to Zika from prior infection, and there is no vaccine yet approved. If individuals infected with Zika came into a U.S. region where the Aedes aegypti mosquito was present, that population could be very susceptible to infection spread and even another outbreak. This would be a confluence of bad circumstances, but that’s exactly what infectious disease specialists continue to be watchful about, especially because Zika is so dangerous for fetuses,” said Dr. Silverman.
 

How the public can prepare

The CDC recommends that pregnant women or women who plan to become pregnant avoid traveling to regions where there are currently outbreaks of Zika, but this is not the only way that individuals can protect themselves.

“The message we want to deliver to people is that in the United States, people are at risk for several mosquito-borne diseases every summer beyond just Zika,” Dr. Staples said. “It’s really important that people are instructed to make a habit of wearing EPA [U.S. Environmental Protection Agency)–registered insect repellents when they go outside. Right now, that is the single best tool that we have to prevent mosquito-borne diseases in the U.S.

“From a community standpoint, there are several emerging mosquito control methods that are being evaluated right now, such as genetic modification and irradiation of mosquitoes. These methods are aimed at producing sterile mosquitoes that are released into the wild to mate with the local mosquito population, which will render them infertile. This leads, over time, to suppression of the overall Aedes aegypti mosquito population – the main vector of Zika transmission,” said Dr. Staples.

Monica Gandhi, MD, MPH, professor of medicine and associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, encourages her patients to wear mosquito repellent but cautioned that “there’s no antiviral that you can take for Zika. Until we have a vaccine, the key to controlling/preventing Zika is controlling the mosquitoes that spread the virus.”
 

Vaccines

The National Institute of Allergy and Infectious Diseases (NIAID) is currently investigating a variety of Zika vaccines, including a DNA-based vaccine, (phase 2), a purified inactivated virus vaccine (phase 1), live attenuated vaccines (phase 2), and mRNA vaccines (phase 2).

“I’m most excited about mRNA vaccines because they help patients produce a lot of proteins. The protein from a typical protein-adjuvant vaccine will break down, and patients can only raise an immune response to whatever proteins are left. On the other hand, mRNA vaccines provide the body [with] a recipe to make the protein from the pathogen in high amounts, so that a strong immune response can be raised for protection,” noted Dr. Gandhi.

Moderna’s mRNA-1893 vaccine was recently studied in a randomized, observer-blind, controlled, phase 1 trial among 120 adults in the United States and Puerto Rico, the results of which were published online in The Lancet. “The vaccine was found to be generally well tolerated with no serious adverse events considered related to vaccine. Furthermore, the vaccine was able to generate a potent immune response that was capable of neutralizing the virus in vitro,” said Brett Leav, MD, executive director of clinical development for public health vaccines at Moderna.

“Our mRNA platform technology ... can be very helpful against emerging pandemic threats, as we saw in response to COVID-19. What is unique in our approach is that if the genetic sequence of the virus is known, we can quickly generate vaccines to test for their capability to generate a functional immune response. In the case of the mRNA-1893 trial, the vaccine was developed with antigens that were present in the strain of virus circulating in 2016, but we could easily match whatever strain reemerges,” said Dr. Leav.

A phase 2 trial to confirm the dose of mRNA-1893 in a larger study population is underway.

Although it’s been demonstrated that Moderna’s mRNA vaccine is safe and effective, moving from a phase 2 to a phase 3 study presents a challenge, given the fact that currently, the disease burden from Zika is low. If an outbreak were to occur in the future, these mRNA vaccines could potentially be given emergency approval, as occurred during the COVID pandemic, according to Dr. Silverman.

If approved, provisionally or through a traditional route, the vaccine would “accelerate the ability to tamp down any further outbreaks, because vaccine-based immunity could be made available to a large portion of the population who were pregnant or planning a pregnancy, not just in the U.S. but also in these endemic areas,” said Dr. Silverman.


 

Takeaways from the last Zika outbreak

Practical steps such as mosquito eradication and development of vaccines are not the only takeaway from the recent Zika epidemics inside and outside the United States. A clearer picture of the short- and long-term stakes of the disease has emerged.

According to the CDC, most people who become infected with Zika experience only mild symptoms, such as fever, rash, headache, and muscle pain, but babies conceived by mothers infected with Zika are at risk for stillbirth, miscarriage, and microcephaly and other brain defects.

Although a pregnant woman who tests positive for Zika is in a very high-risk situation, “data show that only about 30% of mothers with Zika have a baby with birth defects. If a pregnant woman contracted Zika, what would happen is we would just do very close screening by ultrasound of the fetus. If microcephaly in utero or fetal brain defects were observed, then a mother would be counseled on her options,” said Dr. Gandhi.

Dr. Silverman noted that “new data on children who were exposed in utero and had normal exams, including head measurements when they were born, have raised concerns. In recently published long-term follow-up studies, even when children born to mothers infected with Zika during pregnancy had normal head growth at least 3 years after birth, they were still at risk for neurodevelopmental delay and behavioral disorders, including impact on coordination and executive function.

“This is another good reason to keep the potential risks of Zika active in the public’s consciousness and in public health planning.”

Dr. Silverman, Dr. Gandhi, and Dr. Staples have disclosed no relevant financial relationships. Dr. Leav is an employee of Moderna and owns stock in the company.

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

Warming U.S. temperatures, the resumption of travel, and new knowledge about Zika’s long-term effects on children signal that Zika prevention and vaccine development should be on public health officials’, doctors’, and communities’ radar, even when community infection is not occurring.

“Although we haven’t seen confirmed Zika virus circulation in the continental United States or its territories for several years, it’s still something that we are closely monitoring, particularly as we move into the summer months,” Erin Staples, MD, PhD, medical epidemiologist at the Arboviral Diseases Branch of the Centers for Disease Control and Prevention in Fort Collins, Colo., told this news organization.

“This is because cases are still being reported in other countries, particularly in South America. Travel to these places is increasing following the pandemic, leaving more potential for individuals who might have acquired the infection to come back and restart community transmission.”
 

How Zika might reemerge

The Aedes aegypti mosquito is the vector by which Zika spreads, and “during the COVID pandemic, these mosquitoes moved further north in the United States, into southern California, and were identified as far north as Washington, D.C.,” said Neil Silverman, MD, professor of clinical obstetrics and gynecology and director of the Infections in Pregnancy Program at UCLA Medical Center in Los Angeles.

“On a population level, Americans have essentially no immunity to Zika from prior infection, and there is no vaccine yet approved. If individuals infected with Zika came into a U.S. region where the Aedes aegypti mosquito was present, that population could be very susceptible to infection spread and even another outbreak. This would be a confluence of bad circumstances, but that’s exactly what infectious disease specialists continue to be watchful about, especially because Zika is so dangerous for fetuses,” said Dr. Silverman.
 

How the public can prepare

The CDC recommends that pregnant women or women who plan to become pregnant avoid traveling to regions where there are currently outbreaks of Zika, but this is not the only way that individuals can protect themselves.

“The message we want to deliver to people is that in the United States, people are at risk for several mosquito-borne diseases every summer beyond just Zika,” Dr. Staples said. “It’s really important that people are instructed to make a habit of wearing EPA [U.S. Environmental Protection Agency)–registered insect repellents when they go outside. Right now, that is the single best tool that we have to prevent mosquito-borne diseases in the U.S.

“From a community standpoint, there are several emerging mosquito control methods that are being evaluated right now, such as genetic modification and irradiation of mosquitoes. These methods are aimed at producing sterile mosquitoes that are released into the wild to mate with the local mosquito population, which will render them infertile. This leads, over time, to suppression of the overall Aedes aegypti mosquito population – the main vector of Zika transmission,” said Dr. Staples.

Monica Gandhi, MD, MPH, professor of medicine and associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, encourages her patients to wear mosquito repellent but cautioned that “there’s no antiviral that you can take for Zika. Until we have a vaccine, the key to controlling/preventing Zika is controlling the mosquitoes that spread the virus.”
 

Vaccines

The National Institute of Allergy and Infectious Diseases (NIAID) is currently investigating a variety of Zika vaccines, including a DNA-based vaccine, (phase 2), a purified inactivated virus vaccine (phase 1), live attenuated vaccines (phase 2), and mRNA vaccines (phase 2).

“I’m most excited about mRNA vaccines because they help patients produce a lot of proteins. The protein from a typical protein-adjuvant vaccine will break down, and patients can only raise an immune response to whatever proteins are left. On the other hand, mRNA vaccines provide the body [with] a recipe to make the protein from the pathogen in high amounts, so that a strong immune response can be raised for protection,” noted Dr. Gandhi.

Moderna’s mRNA-1893 vaccine was recently studied in a randomized, observer-blind, controlled, phase 1 trial among 120 adults in the United States and Puerto Rico, the results of which were published online in The Lancet. “The vaccine was found to be generally well tolerated with no serious adverse events considered related to vaccine. Furthermore, the vaccine was able to generate a potent immune response that was capable of neutralizing the virus in vitro,” said Brett Leav, MD, executive director of clinical development for public health vaccines at Moderna.

“Our mRNA platform technology ... can be very helpful against emerging pandemic threats, as we saw in response to COVID-19. What is unique in our approach is that if the genetic sequence of the virus is known, we can quickly generate vaccines to test for their capability to generate a functional immune response. In the case of the mRNA-1893 trial, the vaccine was developed with antigens that were present in the strain of virus circulating in 2016, but we could easily match whatever strain reemerges,” said Dr. Leav.

A phase 2 trial to confirm the dose of mRNA-1893 in a larger study population is underway.

Although it’s been demonstrated that Moderna’s mRNA vaccine is safe and effective, moving from a phase 2 to a phase 3 study presents a challenge, given the fact that currently, the disease burden from Zika is low. If an outbreak were to occur in the future, these mRNA vaccines could potentially be given emergency approval, as occurred during the COVID pandemic, according to Dr. Silverman.

If approved, provisionally or through a traditional route, the vaccine would “accelerate the ability to tamp down any further outbreaks, because vaccine-based immunity could be made available to a large portion of the population who were pregnant or planning a pregnancy, not just in the U.S. but also in these endemic areas,” said Dr. Silverman.


 

Takeaways from the last Zika outbreak

Practical steps such as mosquito eradication and development of vaccines are not the only takeaway from the recent Zika epidemics inside and outside the United States. A clearer picture of the short- and long-term stakes of the disease has emerged.

According to the CDC, most people who become infected with Zika experience only mild symptoms, such as fever, rash, headache, and muscle pain, but babies conceived by mothers infected with Zika are at risk for stillbirth, miscarriage, and microcephaly and other brain defects.

Although a pregnant woman who tests positive for Zika is in a very high-risk situation, “data show that only about 30% of mothers with Zika have a baby with birth defects. If a pregnant woman contracted Zika, what would happen is we would just do very close screening by ultrasound of the fetus. If microcephaly in utero or fetal brain defects were observed, then a mother would be counseled on her options,” said Dr. Gandhi.

Dr. Silverman noted that “new data on children who were exposed in utero and had normal exams, including head measurements when they were born, have raised concerns. In recently published long-term follow-up studies, even when children born to mothers infected with Zika during pregnancy had normal head growth at least 3 years after birth, they were still at risk for neurodevelopmental delay and behavioral disorders, including impact on coordination and executive function.

“This is another good reason to keep the potential risks of Zika active in the public’s consciousness and in public health planning.”

Dr. Silverman, Dr. Gandhi, and Dr. Staples have disclosed no relevant financial relationships. Dr. Leav is an employee of Moderna and owns stock in the company.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

Women across the world face high levels of financial burden from breast cancer, a new systematic review and analysis finds. While the burden of the disease is much higher in less-developed countries, about a third of women in Western nations like the United States say the disease has hurt their financial well-being.

When it comes to financial burden, patients with breast cancer are “a highly vulnerable patient population,” said study coauthor Kavitha Ranganathan, MD, of Brigham and Women’s Hospital, Boston, in an interview. “We need to be both strategic and comprehensive with our approach and use evidence-based methods to come up with these comprehensive solutions,” said Dr. Ranganathan, who noted that she’s hearing more from patients who face monetary hurdles.

The findings were published online in JAMA Network Open.

The researchers believe their analysis is the first to attempt to understand financial toxicity (FT) – excessive financial burden – in breast cancer on a global level. This turned out to be a challenge since there’s no standard way to measure FT.

One approach is to look at financial burden in terms of whether patients are suffering from “catastrophic expenditure,” Dr. Ranganathan said. “That’s what the World Bank and other top health and economic organizations have focused on. It means that the cost of care and – whatever it takes to get care – exceeds 10% of total annual household income.”

Another approach is more subjective and based on patient-reported outcomes, she said: “Are patients having to forgo basic subsistence needs like rent and food?”

For the report, researchers analyzed studies that use both approaches to measure FT from breast cancer. The studies came from high-income countries (n = 24, including 19 from the United States) and middle- and low-income countries (n = 10), and ranged in size from 5 to 2,445 subjects.

The analyzed studies were a range of cross-sectional (n = 26), prospective (n = 7), and retrospective designs (n = 1).

The authors pooled the data from 18 studies and estimated that the rate of patients with FT was 35.3% (14 studies, 27.3%-44.4%) in high-income countries and 78.8% (4 studies, 60.4%-90.0%) in the other countries.

The researchers also conducted a separate pooled analysis of only the U.S. studies (n = 11). It found that 34% (27%-43%) of subjects reported FT. The researchers also conducted a new analysis of Canada-only studies (n = 2) and found that 19% (9%-35%) reported FT.

The researchers weren’t able to provide insight into trends in FT in the United States prior to the period of the studies (2014-2021). But raw numbers suggest the percentage of patients facing financial challenges rose over that time, suggesting a possible increase in burden.

Previous research has suggested that breast cancer poses a higher financial burden than other chronic conditions. “Breast cancer care in particular may be associated with high FT given the need for screening and diagnosis, multidisciplinary care, and longitudinal follow-up,” the researchers write. They add that “notably, gender also affects financial security.”

As for limitations, the researchers report that they only analyzed studies in English, and there was a wide variation in approaches used to analyze FT. The analysis “did not account for different health care systems or control for health care–dedicated gross domestic product,” meaning that there’s no way to know for sure that rates were lower in nations with universal health care.

How could the new findings be useful? “They’re eye-opening for health policymakers. Whenever they see these numbers, they will say, ‘Wow, it is really a problem,’ and they’ll start thinking about solutions,” said study coauthor Rania A. Mekary, PhD, MSc, MSc, of Massachusetts College of Pharmacy and Health Sciences in Boston. “When you give them evidence-based data, then they will take it more seriously.”

The researchers call for interventions in several areas including education about early diagnosis and treatment of breast cancer, expansion of health care coverage, programs to help with nonmedical costs, and better resources for breast cancer care.

In an interview, Mary C. Politi, PhD, of Washington University, St. Louis, said the new report is useful “because it examines financial hardship internationally. Some people wonder whether financial hardship is a U.S. problem because of our health care system, which often relies on insurance and a lot of cost-sharing between insurance and patients. However, financial toxicity is prevalent across countries.”

And, she said, “the study is also useful because it encourages us to measure financial hardship and burden in a more uniform way so we can better compare and pool studies.”

Dr. Politi noted that there are ways to help patients now. “Most hospitals and health centers have staff who can talk to patients about their bills. Sometimes, a payment plan can be set up to space out payments,” she said. “Health care teams can try to consolidate care for patients on the same day to reduce parking expenses or time off for work or child care. Sometimes, changing to less expensive but effective generic medications is an option.”

The study authors received support from the National Cancer Institute, the United Nations Institute for Training and Research, the Global Surgery Foundation, the Harvard Global Health Institute, the Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan and Dr. Mekary report no disclosures. One coauthor reported a patent (BREAST-Q) and codevelopment of QPROMS, owned by Memorial Sloan Kettering Cancer Center. Another author reports salary support from Blue Cross Blue Shield of Michigan through the collaborative quality initiative known as Michigan Social Health Interventions to Eliminate Disparities. Dr. Politi has no disclosures.

It’s safe to skip radiation in older women with early, low-risk, estrogen receptor (ER)–positive breast tumors, say researchers reporting 10-year outcomes from the large phase 3 trial known as PRIME II.

“Our trial provides robust evidence indicating that irradiation can be safely omitted in women 65 years of age or older who have grade 1 or 2 ER-high cancers treated by breast-conserving therapy, provided that they receive 5 years of adjuvant endocrine therapy,” concluded investigators led by Ian Kunkler, MB, a clinical oncology professor at the University of Edinburgh.

The trial randomly assigned 1,326 women who had undergone a lumpectomy to either whole-breast irradiation or no radiation on a background of tamoxifen.

The incidence of local recurrence was lower with radiation (0.9% vs. 9.5%), but there was no significant difference in distant metastases or breast cancer–specific or overall survival.

The findings will “help clinicians guide older patients on whether this particular aspect of early breast cancer treatment can be omitted,” Dr. Kunkler said in a press release. Radiation carries risks of heart and lung damage, and these results show that skipping it does not increase the odds of dying from breast cancer.

The new study was published in the New England Journal of Medicine.

“Any doubt that radiotherapy cannot be omitted in women” who meet the criteria “can be put to rest,” commented breast radiation oncologists Alice Ho, MD, of Duke University in Durham, N.C., and Jennifer Bellon, MD, of Harvard Medical School, Boston, in an accompanying editorial.

Clinical guidelines already support omitting radiation therapy in older women with low-risk tumors treated with lumpectomy and endocrine therapy, but the move has been controversial owing to a lack of long-term data, and use of radiation for such women remains common in the United States, the investigators explain.

The “highly anticipated” results for 10-year outcomes from this trial should help address that issue, as well as “the long-standing problem of overtreatment in older women with low-risk breast cancer,” the editorialists comment.
 

Study details

PRIME II was conducted from 2003 to 2009 mainly in the United Kingdom. Participants were aged 65 years or older and had T1 or T2 ER-positive tumors no larger than 3 cm and were without nodal involvement.

Following lumpectomies with clear margins, the women underwent endocrine therapy; the investigators recommended tamoxifen at 20 mg/day for 5 years.

Women who were randomly assigned to radiation also received 40-50 Gy of whole-breast irradiation in 20-25 fractions over 3-5 weeks.

At 10 years, 1.6% of women in the no-radiation arm had distant metastases as their first recurrence vs. 3% of women who underwent radiation.

Ten-year breast cancer–specific survival was 97.9% with radiation and 97.4% with no radiation. Ten-year overall survival was 80.7% in the radiotherapy arm vs. 80.8% in the no-radiotherapy group.

In addition, the recurrence rate was lower after radiation. The investigators suggest that lower adherence to endocrine therapy and lower levels of ER positivity increased the risk of local recurrence among women who didn’t receive radiation.

Almost 10% of the women who did not receive radiation had local recurrences by 10 years, but the investigators note that if tumors do recur locally, women still have the option of a second lumpectomy, and if they so choose, they can then receive radiation, so local recurrence “does not necessarily mean loss of the breast.”

PRIME II was funded by the Scottish Government’s chief scientist office and the Breast Cancer Institute at Western General Hospital, Edinburgh. Dr. Kunkler reported no conflicts of interest. A coauthor has acted as a speaker, adviser, and/or researcher for many companies, including Hoffmann-La Roche, Exact Sciences, and Eli Lilly. Dr. Ho reported grants from and/or being a consultant for GlaxoSmithKline, Roche, Merck, and others. Dr. Bellon reported ties to Varian Medical Systems and Veracyte.

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

It’s safe to skip radiation in older women with early, low-risk, estrogen receptor (ER)–positive breast tumors, say researchers reporting 10-year outcomes from the large phase 3 trial known as PRIME II.

“Our trial provides robust evidence indicating that irradiation can be safely omitted in women 65 years of age or older who have grade 1 or 2 ER-high cancers treated by breast-conserving therapy, provided that they receive 5 years of adjuvant endocrine therapy,” concluded investigators led by Ian Kunkler, MB, a clinical oncology professor at the University of Edinburgh.

The trial randomly assigned 1,326 women who had undergone a lumpectomy to either whole-breast irradiation or no radiation on a background of tamoxifen.

The incidence of local recurrence was lower with radiation (0.9% vs. 9.5%), but there was no significant difference in distant metastases or breast cancer–specific or overall survival.

The findings will “help clinicians guide older patients on whether this particular aspect of early breast cancer treatment can be omitted,” Dr. Kunkler said in a press release. Radiation carries risks of heart and lung damage, and these results show that skipping it does not increase the odds of dying from breast cancer.

The new study was published in the New England Journal of Medicine.

“Any doubt that radiotherapy cannot be omitted in women” who meet the criteria “can be put to rest,” commented breast radiation oncologists Alice Ho, MD, of Duke University in Durham, N.C., and Jennifer Bellon, MD, of Harvard Medical School, Boston, in an accompanying editorial.

Clinical guidelines already support omitting radiation therapy in older women with low-risk tumors treated with lumpectomy and endocrine therapy, but the move has been controversial owing to a lack of long-term data, and use of radiation for such women remains common in the United States, the investigators explain.

The “highly anticipated” results for 10-year outcomes from this trial should help address that issue, as well as “the long-standing problem of overtreatment in older women with low-risk breast cancer,” the editorialists comment.
 

Study details

PRIME II was conducted from 2003 to 2009 mainly in the United Kingdom. Participants were aged 65 years or older and had T1 or T2 ER-positive tumors no larger than 3 cm and were without nodal involvement.

Following lumpectomies with clear margins, the women underwent endocrine therapy; the investigators recommended tamoxifen at 20 mg/day for 5 years.

Women who were randomly assigned to radiation also received 40-50 Gy of whole-breast irradiation in 20-25 fractions over 3-5 weeks.

At 10 years, 1.6% of women in the no-radiation arm had distant metastases as their first recurrence vs. 3% of women who underwent radiation.

Ten-year breast cancer–specific survival was 97.9% with radiation and 97.4% with no radiation. Ten-year overall survival was 80.7% in the radiotherapy arm vs. 80.8% in the no-radiotherapy group.

In addition, the recurrence rate was lower after radiation. The investigators suggest that lower adherence to endocrine therapy and lower levels of ER positivity increased the risk of local recurrence among women who didn’t receive radiation.

Almost 10% of the women who did not receive radiation had local recurrences by 10 years, but the investigators note that if tumors do recur locally, women still have the option of a second lumpectomy, and if they so choose, they can then receive radiation, so local recurrence “does not necessarily mean loss of the breast.”

PRIME II was funded by the Scottish Government’s chief scientist office and the Breast Cancer Institute at Western General Hospital, Edinburgh. Dr. Kunkler reported no conflicts of interest. A coauthor has acted as a speaker, adviser, and/or researcher for many companies, including Hoffmann-La Roche, Exact Sciences, and Eli Lilly. Dr. Ho reported grants from and/or being a consultant for GlaxoSmithKline, Roche, Merck, and others. Dr. Bellon reported ties to Varian Medical Systems and Veracyte.

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

It’s safe to skip radiation in older women with early, low-risk, estrogen receptor (ER)–positive breast tumors, say researchers reporting 10-year outcomes from the large phase 3 trial known as PRIME II.

“Our trial provides robust evidence indicating that irradiation can be safely omitted in women 65 years of age or older who have grade 1 or 2 ER-high cancers treated by breast-conserving therapy, provided that they receive 5 years of adjuvant endocrine therapy,” concluded investigators led by Ian Kunkler, MB, a clinical oncology professor at the University of Edinburgh.

The trial randomly assigned 1,326 women who had undergone a lumpectomy to either whole-breast irradiation or no radiation on a background of tamoxifen.

The incidence of local recurrence was lower with radiation (0.9% vs. 9.5%), but there was no significant difference in distant metastases or breast cancer–specific or overall survival.

The findings will “help clinicians guide older patients on whether this particular aspect of early breast cancer treatment can be omitted,” Dr. Kunkler said in a press release. Radiation carries risks of heart and lung damage, and these results show that skipping it does not increase the odds of dying from breast cancer.

The new study was published in the New England Journal of Medicine.

“Any doubt that radiotherapy cannot be omitted in women” who meet the criteria “can be put to rest,” commented breast radiation oncologists Alice Ho, MD, of Duke University in Durham, N.C., and Jennifer Bellon, MD, of Harvard Medical School, Boston, in an accompanying editorial.

Clinical guidelines already support omitting radiation therapy in older women with low-risk tumors treated with lumpectomy and endocrine therapy, but the move has been controversial owing to a lack of long-term data, and use of radiation for such women remains common in the United States, the investigators explain.

The “highly anticipated” results for 10-year outcomes from this trial should help address that issue, as well as “the long-standing problem of overtreatment in older women with low-risk breast cancer,” the editorialists comment.
 

Study details

PRIME II was conducted from 2003 to 2009 mainly in the United Kingdom. Participants were aged 65 years or older and had T1 or T2 ER-positive tumors no larger than 3 cm and were without nodal involvement.

Following lumpectomies with clear margins, the women underwent endocrine therapy; the investigators recommended tamoxifen at 20 mg/day for 5 years.

Women who were randomly assigned to radiation also received 40-50 Gy of whole-breast irradiation in 20-25 fractions over 3-5 weeks.

At 10 years, 1.6% of women in the no-radiation arm had distant metastases as their first recurrence vs. 3% of women who underwent radiation.

Ten-year breast cancer–specific survival was 97.9% with radiation and 97.4% with no radiation. Ten-year overall survival was 80.7% in the radiotherapy arm vs. 80.8% in the no-radiotherapy group.

In addition, the recurrence rate was lower after radiation. The investigators suggest that lower adherence to endocrine therapy and lower levels of ER positivity increased the risk of local recurrence among women who didn’t receive radiation.

Almost 10% of the women who did not receive radiation had local recurrences by 10 years, but the investigators note that if tumors do recur locally, women still have the option of a second lumpectomy, and if they so choose, they can then receive radiation, so local recurrence “does not necessarily mean loss of the breast.”

PRIME II was funded by the Scottish Government’s chief scientist office and the Breast Cancer Institute at Western General Hospital, Edinburgh. Dr. Kunkler reported no conflicts of interest. A coauthor has acted as a speaker, adviser, and/or researcher for many companies, including Hoffmann-La Roche, Exact Sciences, and Eli Lilly. Dr. Ho reported grants from and/or being a consultant for GlaxoSmithKline, Roche, Merck, and others. Dr. Bellon reported ties to Varian Medical Systems and Veracyte.

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

A frustrated physician recently voiced some strong words in Medscape’s US Physician Burnout & Depression Report: “Only a sociopath could work for a large health system and not be burned out. Anyone who cares about patients is doomed to burnout.”

It’s no secret that today’s large health care organizations are leaving physicians feeling overwhelmed, beaten up, and exhausted. Medscape’s report showed that 53% of physicians feel burned out by job requirements; 65% say that burnout has impacted their relationships, and other statistics say that physicians are leaving clinical medicine because of all this pressure.

What is it about being employed by large organizations that can be so negative?  In another study, MEMO – Minimizing Error, Maximizing Outcomes – researchers at the University of Wisconsin surveyed more than 400 doctors to learn about how their working environments corresponded with medical errors. More than half of the physicians reported time pressures when conducting physical examinations. Nearly a third felt they needed at least 50% more time than was allotted for this patient care function, and nearly a quarter said they needed at least 50% more time for follow-up appointments.

Some have asked: Can anyone, then, thrive in today’s health care environment and avoid burnout?

Although the frustrated physician noted above may sardonically say that a doctor needs to be sociopathic to enjoy it – lacking in feelings for others – “It’s a very small number of doctors who get in it for the wrong reasons and therefore care about their own benefit and not their patients,” said psychiatrist Wendy Dean, MD, CEO and cofounder of Moral Injury of Healthcare, a nonprofit organization addressing workforce distress in health care. “Those are the outliers.”

The vast majority of physicians do care about their patients – deeply, said Dr. Dean. They struggle under the weight of the health care system and yet must find ways to get through. Today, thriving in an imperfect system requires honing new skills, asking for help when needed, and pushing for systemic and cultural change.

“We’ve been assessing and trying to address burnout for half a century,” said Dr. Dean. “Despite all the good intentions, and people dedicating their entire careers to solving the issue, we’ve barely made a dent.”

With the advent of new technological requirements on the job and more demands from increasingly larger health care organizations, the risk for burnout is higher than ever before. “There’s an increased burden of regulatory-mandated and cumbersome administrative workload per patient,” said Shomron Ben-Horin, MD, cofounder of Evinature. “Often the computer/paperwork before and after a procedure is much longer than the procedure itself.”

Meeting insurance requirements is increasingly cumbersome, too, and preauthorizations and debates with payers over medical approval may put physicians frustratingly in the middle.

“This increases the psychological burden for physicians who may feel responsible for wrongdoing no matter which option they deem better,” Dr. Ben-Horin said. “Add in physician accessibility around the clock via mobile phones, emails, and apps, and you end up on call even if you’re not officially on call.”
 

Why some physicians suffer more

Some physicians are more likely to suffer burnout than others, said Jessi Gold, MD, assistant professor in the department of psychiatry at Washington University in St. Louis. “The self-valuation concept comes into play here,” she said. “If you make a mistake, do you blame yourself or see it as a growth opportunity? If it’s the former, you’re more likely to burn out.”

Dr. Ben-Horin added that the most patient-centric doctors are the ones who struggle most. “These are the doctors we’d all love to have as a patient,” he said. “But they are burdened by the extra tasks of the job, and they are the most stressed by the environment.”

So too are those physicians who never master compartmentalizing their feelings and emotions. “We learn in training to compartmentalize our emotions,” said Dr. Dean. “You can’t allow yourself to get emotional while performing chest compressions on an 18-year-old kid. So you shut it all away; otherwise, you might lose the patient.”

This turn-off switch becomes automatic, but it also comes at a cost. “When doctors were interviewed about [Buffalo Bills player] Damar Hamlin going into cardiac arrest on the football field, they talked about how a life-and-death situation is so common that they have to put the emotions away, work on the patient, and move onto the next,” said Dr. Dean. “The next patient needs you just as much. We must lock away our feelings and manage the situation.”

Dr. Gold explained that burying feelings, however, is a symptom of burnout. “We have to remove ourselves from the situation to protect ourselves,” she said. “We can’t cry in these situations, but we can’t bury our feelings either.”

Instead, Dr. Gold suggested, a good medium may exist. “You may not be able to address them in the moment, but you should sometime after,” she said.

This is just a starting point on how to remain a dedicated, caring physician without burning out. “The system is pretty broken, and to survive it first means wanting to survive it,” Dr. Gold said. “There’s a lot of focus on resiliency and lack thereof if a physician expresses burnout, but that’s a false notion. Doctors are a resilient bunch but even they get burned out.”

Change for the better must come from several places. One is asking for help, something that can be hard for a group conditioned to keeping a stiff upper lip. “Just because your peers might look healthy (emotionally) doesn’t mean they are,” said Dr. Gold. “We’ve normalized this culture of burying feelings, but that doesn’t mean it’s right.”

Dr. Ben-Horin also advocates diversifying your work. This might include engaging in research and academics, for instance. “This not only makes you a better broad-perspective doctor but allows you to psychologically switch gears on research days,” he said.

The biggest place to make change, however, is within the health care system culture itself. The AMA created a series of recommendations to address burnout at the resident and fellow level, a good starting point to carry through into staff work. The steps include creating a well-being framework, gathering a team to support a well-being program, developing the program in a way to foster fun and connectivity among the staff, fostering individual well-being that addresses emotional and physical well-being, and confronting burnout and creating a sustainable culture of well-being.

On a personal level, it’s essential that physicians keep close tabs on themselves and peers. “Understand the signs and symptoms of burnout by taking stock of where you are emotionally,” said Dr. Gold. “Have a place and time at the end of a hard day to reflect or find a ritual that helps you and stay with it.”

You might also reach out to a therapist or a peer when you’re struggling. Having honest conversations with peers can go a long way. “Find a confidant that allows you to be vulnerable,” Dr. Gold recommended. “Acknowledge that this is hard and that you might need help taking care of yourself. The system needs to change, but we can also learn to survive in the meantime. You don’t have to be a sociopath to make it.”

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

Many companies, government agencies, and organizations have implemented policies and procedures to shield employees from sexual and other forms of harassment. The U.S. Department of Health & Human Services and the American Medical Association are just two examples.

Employers can tap a rich lode of guidance and resources to craft these antiharassment policies. The National Institutes of Health’s resource page is a good site for hospitals to check out.

But how effective have official policies proved in deterring harassment in medical workplaces? After all, in a study by the American Association of Medical Colleges, 34% of female faculty said they had experienced sexual harassment irrespective of such policies. And in a recent Medscape survey of more than 3,000 physicians, 27% reported that they had either witnessed or been subjected to sexual harassment or misconduct at work during the past 4 years.
 

When policies are absent or unenforced

“Not all institutions have antiharassment rules and policies, and even when they exist, they’re not always enforced,” says Theresa Rohr-Kirchgraber, MD, president of the American Medical Women’s Association and professor of medicine at the Medical College of Georgia, Augusta.

She believes employer rules and policies generally are helpful in establishing who fields harassment complaints and in creating at least some accountability.

On the other hand, policies that don’t recognize anonymous complaints effectively discourage harassment victims from coming forward, Dr. Rohr-Kirchgraber argues. Even those policies that do allow anonymous complaints may have limitations.

For example, the NIH policy on reporting harassment acknowledges that “officials must follow up on all allegations of harassment and cannot guarantee that your identity will not become apparent during the process. Please note that if you remain anonymous, key details about the allegation or concern [may] be omitted. This will limit the NIH’s ability to conduct an inquiry and take corrective action as warranted.”
 

Risks in pressing a harassment case

A complainant whose name becomes public risks getting a reputation as a problem employee or suffering workplace retaliation, according to Dr. Rohr-Kirchgraber. She recalls a colleague who was on a clinical education track until she lodged a harassment complaint. Abruptly, she was told she was needed on a service with fewer teaching opportunities.

With such risks in mind, respondents to the Medscape survey advised employees in medical workplaces to familiarize themselves with policies and procedures before pressing a case.

“Document everything,” an ophthalmologist urged, including time, place, offender, and witnesses. Present that information to your supervisor, and if nothing is done, hire a lawyer, a gastroenterologist suggested.

But taking the situation to the Equal Employment Opportunity Commission can be complicated, Roberta Gebhard, DO, past AMWA president and founder of its Gender Equity Task Force, told this news organization.

“They talk to the employer and get the employer’s side of the story and eventually render a decision about whether you have a case you can put through and file a lawsuit,” she said. “I don’t know of any other situation in which you need ‘permission’ to file a lawsuit.”

Nevertheless, an attorney can be helpful with cases, and when someone is terminated, a lawyer can possibly have it overturned or converted to a resignation, Dr. Gebhard said.

“And always have a lawyer review your contract before you take the job,” she advised. The lawyer might adjust the contract’s verbiage in ways that can protect one down the road in the event of a potential termination. “It’s money very well spent.”
 

More education needed

Dr. Rohr-Kirchgraber said that protection against harassment goes beyond the employer’s policies and procedures. Building an overall consciousness of what harassment is should begin with employee onboarding, she said.

“The harasser may not even recognize that what they’re doing or saying is a form of harassment, so we need better education,” Dr. Rohr-Kirchgraber emphasized.

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

According to the Centers for Disease Control and Preventions, in 2019 2.1% of all infants born in the United States were conceived by assisted reproductive technology (ART). Now 45 years old, ART, namely in vitro fertilization (IVF), is offered in nearly 500 clinics in the United States, contributing to over 300,000 treatment cycles per year.

A tubal factor is responsible for 30% of female infertility and may involve proximal and/or distal tubal occlusion, irrespective of pelvic adhesions.¹ Before the advent of IVF, the sole approach to the treatment of a tubal factor had been surgery. Given its success and minimal invasiveness, IVF is increasingly being offered to circumvent a tubal factor for infertility. This month we examine the utility of surgical treatment of tubal factor infertility. The options for fertility with a history of bilateral tubal ligation was covered in a prior Reproductive Rounds column.

Tubal disease and pelvic adhesions prevent the normal transport of the oocyte and sperm through the fallopian tube. The primary etiology of tubal factor infertility is pelvic inflammatory disease, mainly caused by chlamydia or gonorrhea. Other conditions that may interfere with tubal transport include severe endometriosis, adhesions from previous surgery, or nontubal infection (for example, appendicitis, inflammatory bowel disease), pelvic tuberculosis, and salpingitis isthmica nodosa (that is, diverticulosis of the fallopian tube).
 

Proximal tubal occlusion

During a hysterosalpingogram (HSG), transient uterine cornual spasm can result if a woman experiences significant uterine cramping, thereby resulting in a false-positive diagnosis of proximal tubal occlusion. When a repeat HSG is gently performed with slow instillation of contrast, uterine cramping is less likely, and the tubal patency rate is 60%. PTO may also result from plugs of mucus and amorphous debris, but this is not true occlusion.² In cases with unilateral PTO, controlled ovarian hyperstimulation with intrauterine insemination has resulted in pregnancy rates similar to those in patients with unexplained infertility.³

Reconstructive surgery for bilateral PTO has limited effectiveness and the risk of subsequent ectopic pregnancy is as high as 20%.⁴ A more successful option is fluoroscopic tubal catheterization (FTC), an outpatient procedure performed in a radiology or infertility center. FTC uses a coaxial catheter system where the outer catheter is guided through the tubal ostium and an inner catheter is atraumatically advanced to overcome the blockage. This procedure is 85% successful for tubal patency with 50% of patients conceiving in the first 12 months; one-third of time the tubes reocclude. After the reestablishment of patency with FTC, the chance of achieving a live birth is 22% and the risk of ectopic pregnancy is 4%.⁵

Treatment of distal tubal occlusion – the hydrosalpinx

Surgery for treating tubal factor infertility is most successful in women with distal tubal obstruction (DTO), often caused by a hydrosalpinx. Fimbrioplasty is the lysis of fimbrial adhesions or dilatation of fimbrial strictures; the tube is patent, but there are adhesive bands that surround the terminal end with preserved tubal rugae. Gentle introduction of an alligator laparoscopic forceps into the tubal ostium followed by opening and withdrawal of the forceps helps to stretch the tube and release minor degrees of fimbrial agglutination.⁶

A hydrosalpinx is diagnosed by DTO with dilation and intraluminal fluid accumulation along with the reduction/loss of endothelial cilia. Left untreated, a hydrosalpinx can lead to a 50% reduction in IVF pregnancy rates.⁷ Tube-sparing treatment involves neosalpingostomy to create a new tubal opening. A nonsurgical approach, ultrasound-guided aspiration of hydrosalpinges, has not been shown to significantly increase the rate of clinical pregnancy. Efficacy for improving fertility is generally poor, but depends upon tubal wall thickness, ampullary dilation, presence of mucosal folds, percentage of ciliated cells in the fimbrial end, and peritubal adhesions.⁸

Evidence supports that laparoscopic salpingectomy in women with hydrosalpinges improves the outcomes of IVF treatment, compared with no surgical intervention.⁹ The improvement in pregnancy and live birth rates likely stems from the elimination of the retrograde flow of embryotoxic fluid that disrupts implantation. Endometrial receptivity markers (endometrial cell adhesion molecules, integrins, and HOXA10) have been shown to be reduced in the presence of hydrosalpinx.¹⁰ A small, randomized trial demonstrated that bipolar diathermy prior to IVF improved pregnancy outcomes.¹¹ PTO was not more effective than salpingectomy. Conceptions, without IVF, have been reported following salpingectomy for unilateral hydrosalpinx.¹²

In a series including 434 patients with DTO who underwent laparoscopic fimbrioplasty (enlargement of the ostium) or neosalpingostomy (creation of a new ostium) by a single surgeon, 5-year actuarial delivery rates decreased as the severity of tubal occlusion increased; the ectopic rate was stable at approximately 15%.¹³ A prospective study reported that the relative increase in the pregnancy rate after salpingectomy was greatest in women with a large hydrosalpinx visible on ultrasound.¹⁴

Because of the possible risks of decreased ovarian reserve secondary to interruption of ovarian blood supply, salpingectomy should be done with minimal thermal injury and very close to the fallopian tube.

Summary

Surgery may be considered for young women with mild distal tubal disease as one surgical procedure can lead to several pregnancies whereas IVF must be performed each time pregnancy is desired. IVF is more likely than surgery to be successful in women with bilateral hydrosalpinx, in those with pelvic adhesions, in older reproductive aged women, and for both proximal and distal tubal occlusion.¹⁵ An online prediction calculator from the Society for Assisted Reproductive Technology (SART) can be helpful in counseling patients on personalized expectations for IVF pregnancy outcomes.

Dr. Trolice is director of The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando.
 

References

1. Ambildhuke K et al. Cureus. 2022;1:14(11):e30990.

2. Fatemeh Z et al. Br J Radiol. 2021 Jun 1;94(1122):20201386.

3. Farhi J et al. Fertil Steril. 2007 Aug;88(2):396.

4. Honoré GM et al. Fertil Steril. 1999;71(5):785.

5. De Silva PM et al. Hum Reprod. 2017;32(4):836.

6. Namnoum A and Murphy A. “Diagnostic and Operative Laparoscopy,” in Te Linde’s Operative Gynecology, 8th ed. Philadelphia: Lippincott-Raven, 1997, pp. 389.

7. Camus E et al.Hum Reprod. 1999;14(5):1243.

8. Marana R et al. Hum Reprod. 1999;14(12):2991-5.

9. Johnson N et al. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD002125.

10. Savaris RF et al. Fertil Steril. 2006 Jan;85(1):188.

11. Kontoravdis A et al. Fertil Steril. 2006;86(6):1642.

12. Sagoskin AW et al. Hum Reprod. 2003;18(12):2634.

13. Audebert A et al. Fertil Steril. 2014;102(4):1203.

14. Bildirici I et al. Hum Reprod. 2001;16(11):2422.

15. Practice Committee of the American Society for Reproductive Medicine. Fertil Steril. 2012;97(3):539.

According to the Centers for Disease Control and Preventions, in 2019 2.1% of all infants born in the United States were conceived by assisted reproductive technology (ART). Now 45 years old, ART, namely in vitro fertilization (IVF), is offered in nearly 500 clinics in the United States, contributing to over 300,000 treatment cycles per year.

A tubal factor is responsible for 30% of female infertility and may involve proximal and/or distal tubal occlusion, irrespective of pelvic adhesions.¹ Before the advent of IVF, the sole approach to the treatment of a tubal factor had been surgery. Given its success and minimal invasiveness, IVF is increasingly being offered to circumvent a tubal factor for infertility. This month we examine the utility of surgical treatment of tubal factor infertility. The options for fertility with a history of bilateral tubal ligation was covered in a prior Reproductive Rounds column.

Tubal disease and pelvic adhesions prevent the normal transport of the oocyte and sperm through the fallopian tube. The primary etiology of tubal factor infertility is pelvic inflammatory disease, mainly caused by chlamydia or gonorrhea. Other conditions that may interfere with tubal transport include severe endometriosis, adhesions from previous surgery, or nontubal infection (for example, appendicitis, inflammatory bowel disease), pelvic tuberculosis, and salpingitis isthmica nodosa (that is, diverticulosis of the fallopian tube).
 

Proximal tubal occlusion

During a hysterosalpingogram (HSG), transient uterine cornual spasm can result if a woman experiences significant uterine cramping, thereby resulting in a false-positive diagnosis of proximal tubal occlusion. When a repeat HSG is gently performed with slow instillation of contrast, uterine cramping is less likely, and the tubal patency rate is 60%. PTO may also result from plugs of mucus and amorphous debris, but this is not true occlusion.² In cases with unilateral PTO, controlled ovarian hyperstimulation with intrauterine insemination has resulted in pregnancy rates similar to those in patients with unexplained infertility.³

Reconstructive surgery for bilateral PTO has limited effectiveness and the risk of subsequent ectopic pregnancy is as high as 20%.⁴ A more successful option is fluoroscopic tubal catheterization (FTC), an outpatient procedure performed in a radiology or infertility center. FTC uses a coaxial catheter system where the outer catheter is guided through the tubal ostium and an inner catheter is atraumatically advanced to overcome the blockage. This procedure is 85% successful for tubal patency with 50% of patients conceiving in the first 12 months; one-third of time the tubes reocclude. After the reestablishment of patency with FTC, the chance of achieving a live birth is 22% and the risk of ectopic pregnancy is 4%.⁵

Treatment of distal tubal occlusion – the hydrosalpinx

Surgery for treating tubal factor infertility is most successful in women with distal tubal obstruction (DTO), often caused by a hydrosalpinx. Fimbrioplasty is the lysis of fimbrial adhesions or dilatation of fimbrial strictures; the tube is patent, but there are adhesive bands that surround the terminal end with preserved tubal rugae. Gentle introduction of an alligator laparoscopic forceps into the tubal ostium followed by opening and withdrawal of the forceps helps to stretch the tube and release minor degrees of fimbrial agglutination.⁶

A hydrosalpinx is diagnosed by DTO with dilation and intraluminal fluid accumulation along with the reduction/loss of endothelial cilia. Left untreated, a hydrosalpinx can lead to a 50% reduction in IVF pregnancy rates.⁷ Tube-sparing treatment involves neosalpingostomy to create a new tubal opening. A nonsurgical approach, ultrasound-guided aspiration of hydrosalpinges, has not been shown to significantly increase the rate of clinical pregnancy. Efficacy for improving fertility is generally poor, but depends upon tubal wall thickness, ampullary dilation, presence of mucosal folds, percentage of ciliated cells in the fimbrial end, and peritubal adhesions.⁸

Evidence supports that laparoscopic salpingectomy in women with hydrosalpinges improves the outcomes of IVF treatment, compared with no surgical intervention.⁹ The improvement in pregnancy and live birth rates likely stems from the elimination of the retrograde flow of embryotoxic fluid that disrupts implantation. Endometrial receptivity markers (endometrial cell adhesion molecules, integrins, and HOXA10) have been shown to be reduced in the presence of hydrosalpinx.¹⁰ A small, randomized trial demonstrated that bipolar diathermy prior to IVF improved pregnancy outcomes.¹¹ PTO was not more effective than salpingectomy. Conceptions, without IVF, have been reported following salpingectomy for unilateral hydrosalpinx.¹²

In a series including 434 patients with DTO who underwent laparoscopic fimbrioplasty (enlargement of the ostium) or neosalpingostomy (creation of a new ostium) by a single surgeon, 5-year actuarial delivery rates decreased as the severity of tubal occlusion increased; the ectopic rate was stable at approximately 15%.¹³ A prospective study reported that the relative increase in the pregnancy rate after salpingectomy was greatest in women with a large hydrosalpinx visible on ultrasound.¹⁴

Because of the possible risks of decreased ovarian reserve secondary to interruption of ovarian blood supply, salpingectomy should be done with minimal thermal injury and very close to the fallopian tube.