MDedge ObGyn

Cancer is becoming more common in younger generations. Data show that people under 50 are experiencing higher rates of cancer than any generation before them. As a genetic counselor, I hoped these upward trends in early-onset malignancies would slow with a better understanding of risk factors and prevention strategies. Unfortunately, the opposite is happening. Recent findings from the American Cancer Society reveal that the incidence of at least 17 of 34 cancer types is rising among GenX and Millennials. 

These statistics are alarming. I appreciate how easy it is for patients to get lost in the headlines about cancer, which may shape how they approach their healthcare. Each year, millions of Americans miss critical cancer screenings, with many citing fear of a positive test result as a leading reason. Others believe, despite the statistics, that cancer is not something they need to worry about until they are older. And then, of course, getting screened is not as easy as it should be. 

In my work, I meet with people from both younger and older generations who have either faced cancer themselves or witnessed a loved one experience the disease. One of the most common sentiments I hear from these patients is the desire to catch cancer earlier. My answer is always this: The first and most important step everyone can take is understanding their risk. 

For some, knowing they are at increased risk for cancer means starting screenings earlier — sometimes as early as age 25 — or getting screened with a more sensitive test. 

This proactive approach is the right one. Early detection can dramatically increase survival rates, sometimes by up to eightfold, depending on the type of cancer. It also significantly reduces the burden of total and cancer-specific healthcare costs. While screening may carry some potential risks, clinicians can minimize these risks by adhering to evidence-based guidelines, such as those from the American Cancer Society, and ensuring there is appropriate discussion of treatment options when a diagnosis is made.
 

Normalizing Cancer Risk Assessment and Screening 

A detailed cancer risk assessment and education about signs and symptoms should be part of every preventive care visit, regardless of someone’s age. Further, that cancer risk assessment should lead to clear recommendations and support for taking the next steps. 

This is where care advocacy and patient navigation come in. Care advocacy can improve outcomes at every stage of the cancer journey, from increasing screening rates to improving quality of life for survivors. I’ve seen first-hand how care advocates help patients overcome hurdles like long wait times for appointments they need, making both screening and diagnostic care easier to access. 

Now, with the finalization of a new rule from the Centers for Medicare & Medicaid Services, providers can bill for oncology navigation services that occur under their supervision. This formal recognition of care navigation affirms the value of these services not just clinically but financially as well. It will be through methods like care navigation, targeted outreach, and engaging educational resources — built into and covered by health plans — that patients will feel more in control over their health and have tools to help minimize the effects of cancer on the rest of their lives. 

These services benefit healthcare providers as well. Care navigation supports clinical care teams, from primary care providers to oncologists, by ensuring patients are seen before their cancer progresses to a more advanced stage. And even if patients follow screening recommendations for the rest of their lives and never get a positive result, they’ve still gained something invaluable: peace of mind, knowing they’ve taken an active role in their health. 
 

Fighting Fear With Routine

Treating cancer as a normal part of young people’s healthcare means helping them envision the disease as a condition that can be treated, much like a diagnosis of diabetes or high cholesterol. This mindset shift means quickly following up on a concerning symptom or screening result and reducing the time to start treatment if needed. And with treatment options and success rates for some cancers being better than ever, survivorship support must be built into every treatment plan from the start. Before treatment begins, healthcare providers should make time to talk about sometimes-overlooked key topics, such as reproductive options for people whose fertility may be affected by their cancer treatment, about plans for returning to work during or after treatment, and finding the right mental health support. 

Where we can’t prevent cancer, both primary care providers and oncologists can work together to help patients receive the right diagnosis and treatment as quickly as possible. Knowing insurance coverage has a direct effect on how early cancer is caught, for example, younger people need support in understanding and accessing benefits and resources that may be available through their existing healthcare channels, like some employer-sponsored health plans. Even if getting treated for cancer is inevitable for some, taking immediate action to get screened when it’s appropriate is the best thing we can do to lessen the impact of these rising cancer incidences across the country. At the end of the day, being afraid of cancer doesn’t decrease the chances of getting sick or dying from it. Proactive screening and early detection do. 
 

Brockman, Genetic Counselor, Color Health, Buffalo, New York, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Cancer is becoming more common in younger generations. Data show that people under 50 are experiencing higher rates of cancer than any generation before them. As a genetic counselor, I hoped these upward trends in early-onset malignancies would slow with a better understanding of risk factors and prevention strategies. Unfortunately, the opposite is happening. Recent findings from the American Cancer Society reveal that the incidence of at least 17 of 34 cancer types is rising among GenX and Millennials. 

These statistics are alarming. I appreciate how easy it is for patients to get lost in the headlines about cancer, which may shape how they approach their healthcare. Each year, millions of Americans miss critical cancer screenings, with many citing fear of a positive test result as a leading reason. Others believe, despite the statistics, that cancer is not something they need to worry about until they are older. And then, of course, getting screened is not as easy as it should be. 

In my work, I meet with people from both younger and older generations who have either faced cancer themselves or witnessed a loved one experience the disease. One of the most common sentiments I hear from these patients is the desire to catch cancer earlier. My answer is always this: The first and most important step everyone can take is understanding their risk. 

For some, knowing they are at increased risk for cancer means starting screenings earlier — sometimes as early as age 25 — or getting screened with a more sensitive test. 

This proactive approach is the right one. Early detection can dramatically increase survival rates, sometimes by up to eightfold, depending on the type of cancer. It also significantly reduces the burden of total and cancer-specific healthcare costs. While screening may carry some potential risks, clinicians can minimize these risks by adhering to evidence-based guidelines, such as those from the American Cancer Society, and ensuring there is appropriate discussion of treatment options when a diagnosis is made.
 

Normalizing Cancer Risk Assessment and Screening 

A detailed cancer risk assessment and education about signs and symptoms should be part of every preventive care visit, regardless of someone’s age. Further, that cancer risk assessment should lead to clear recommendations and support for taking the next steps. 

This is where care advocacy and patient navigation come in. Care advocacy can improve outcomes at every stage of the cancer journey, from increasing screening rates to improving quality of life for survivors. I’ve seen first-hand how care advocates help patients overcome hurdles like long wait times for appointments they need, making both screening and diagnostic care easier to access. 

Now, with the finalization of a new rule from the Centers for Medicare & Medicaid Services, providers can bill for oncology navigation services that occur under their supervision. This formal recognition of care navigation affirms the value of these services not just clinically but financially as well. It will be through methods like care navigation, targeted outreach, and engaging educational resources — built into and covered by health plans — that patients will feel more in control over their health and have tools to help minimize the effects of cancer on the rest of their lives. 

These services benefit healthcare providers as well. Care navigation supports clinical care teams, from primary care providers to oncologists, by ensuring patients are seen before their cancer progresses to a more advanced stage. And even if patients follow screening recommendations for the rest of their lives and never get a positive result, they’ve still gained something invaluable: peace of mind, knowing they’ve taken an active role in their health. 
 

Fighting Fear With Routine

Treating cancer as a normal part of young people’s healthcare means helping them envision the disease as a condition that can be treated, much like a diagnosis of diabetes or high cholesterol. This mindset shift means quickly following up on a concerning symptom or screening result and reducing the time to start treatment if needed. And with treatment options and success rates for some cancers being better than ever, survivorship support must be built into every treatment plan from the start. Before treatment begins, healthcare providers should make time to talk about sometimes-overlooked key topics, such as reproductive options for people whose fertility may be affected by their cancer treatment, about plans for returning to work during or after treatment, and finding the right mental health support. 

Where we can’t prevent cancer, both primary care providers and oncologists can work together to help patients receive the right diagnosis and treatment as quickly as possible. Knowing insurance coverage has a direct effect on how early cancer is caught, for example, younger people need support in understanding and accessing benefits and resources that may be available through their existing healthcare channels, like some employer-sponsored health plans. Even if getting treated for cancer is inevitable for some, taking immediate action to get screened when it’s appropriate is the best thing we can do to lessen the impact of these rising cancer incidences across the country. At the end of the day, being afraid of cancer doesn’t decrease the chances of getting sick or dying from it. Proactive screening and early detection do. 
 

Brockman, Genetic Counselor, Color Health, Buffalo, New York, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Cancer is becoming more common in younger generations. Data show that people under 50 are experiencing higher rates of cancer than any generation before them. As a genetic counselor, I hoped these upward trends in early-onset malignancies would slow with a better understanding of risk factors and prevention strategies. Unfortunately, the opposite is happening. Recent findings from the American Cancer Society reveal that the incidence of at least 17 of 34 cancer types is rising among GenX and Millennials. 

These statistics are alarming. I appreciate how easy it is for patients to get lost in the headlines about cancer, which may shape how they approach their healthcare. Each year, millions of Americans miss critical cancer screenings, with many citing fear of a positive test result as a leading reason. Others believe, despite the statistics, that cancer is not something they need to worry about until they are older. And then, of course, getting screened is not as easy as it should be. 

In my work, I meet with people from both younger and older generations who have either faced cancer themselves or witnessed a loved one experience the disease. One of the most common sentiments I hear from these patients is the desire to catch cancer earlier. My answer is always this: The first and most important step everyone can take is understanding their risk. 

For some, knowing they are at increased risk for cancer means starting screenings earlier — sometimes as early as age 25 — or getting screened with a more sensitive test. 

This proactive approach is the right one. Early detection can dramatically increase survival rates, sometimes by up to eightfold, depending on the type of cancer. It also significantly reduces the burden of total and cancer-specific healthcare costs. While screening may carry some potential risks, clinicians can minimize these risks by adhering to evidence-based guidelines, such as those from the American Cancer Society, and ensuring there is appropriate discussion of treatment options when a diagnosis is made.
 

Normalizing Cancer Risk Assessment and Screening 

A detailed cancer risk assessment and education about signs and symptoms should be part of every preventive care visit, regardless of someone’s age. Further, that cancer risk assessment should lead to clear recommendations and support for taking the next steps. 

This is where care advocacy and patient navigation come in. Care advocacy can improve outcomes at every stage of the cancer journey, from increasing screening rates to improving quality of life for survivors. I’ve seen first-hand how care advocates help patients overcome hurdles like long wait times for appointments they need, making both screening and diagnostic care easier to access. 

Now, with the finalization of a new rule from the Centers for Medicare & Medicaid Services, providers can bill for oncology navigation services that occur under their supervision. This formal recognition of care navigation affirms the value of these services not just clinically but financially as well. It will be through methods like care navigation, targeted outreach, and engaging educational resources — built into and covered by health plans — that patients will feel more in control over their health and have tools to help minimize the effects of cancer on the rest of their lives. 

These services benefit healthcare providers as well. Care navigation supports clinical care teams, from primary care providers to oncologists, by ensuring patients are seen before their cancer progresses to a more advanced stage. And even if patients follow screening recommendations for the rest of their lives and never get a positive result, they’ve still gained something invaluable: peace of mind, knowing they’ve taken an active role in their health. 
 

Fighting Fear With Routine

Treating cancer as a normal part of young people’s healthcare means helping them envision the disease as a condition that can be treated, much like a diagnosis of diabetes or high cholesterol. This mindset shift means quickly following up on a concerning symptom or screening result and reducing the time to start treatment if needed. And with treatment options and success rates for some cancers being better than ever, survivorship support must be built into every treatment plan from the start. Before treatment begins, healthcare providers should make time to talk about sometimes-overlooked key topics, such as reproductive options for people whose fertility may be affected by their cancer treatment, about plans for returning to work during or after treatment, and finding the right mental health support. 

Where we can’t prevent cancer, both primary care providers and oncologists can work together to help patients receive the right diagnosis and treatment as quickly as possible. Knowing insurance coverage has a direct effect on how early cancer is caught, for example, younger people need support in understanding and accessing benefits and resources that may be available through their existing healthcare channels, like some employer-sponsored health plans. Even if getting treated for cancer is inevitable for some, taking immediate action to get screened when it’s appropriate is the best thing we can do to lessen the impact of these rising cancer incidences across the country. At the end of the day, being afraid of cancer doesn’t decrease the chances of getting sick or dying from it. Proactive screening and early detection do. 
 

Brockman, Genetic Counselor, Color Health, Buffalo, New York, has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

In Canada, switching to a one-dose, gender-neutral vaccination program for human papillomavirus (HPV) could use vaccine doses more efficiently and prevent a similar number of cervical cancer cases, compared with a two-dose program, according to a new modeling analysis.

If vaccine protection remains high during the ages of peak sexual activity, all one-dose vaccination options are projected to be “substantially more efficient” than two-dose programs, even in the most pessimistic scenarios, the study authors wrote.

In addition, the scenarios projected the elimination of cervical cancer in Canada between 2032 and 2040. HPV can also lead to oral, throat, and penile cancers, and most are preventable through vaccination.

“The COVID-19 pandemic has impacted HPV vaccination in Canada, particularly among vulnerable population subgroups,” said study author Chantal Sauvageau, MD, a consultant in infectious diseases at the National Institute of Public Health of Quebec and associate professor of social and preventive medicine at the University of Laval, Quebec City, Canada.

Switching to one-dose vaccination would offer potential economic savings and programmatic flexibility, she added. The change also could enable investments aimed at increasing vaccination rates in regions where coverage is suboptimal, as well as in subgroups with a high HPV burden. Such initiatives could mitigate the pandemic’s impact on health programs and reduce inequalities.

The study was published online in CMAJ.
 

Vaccination Program Changes

Globally, countries have been investigating whether to shift from a two-dose to a one-dose HPV vaccine strategy since the World Health Organization’s Strategic Advisory Group of Experts on Immunization issued a single-dose recommendation in 2022.

In July, Canada’s National Advisory Committee on Immunization (NACI) updated its guidelines to recommend the single-dose approach for ages 9-20 years. The change aligns Canada with 35 other countries, including Australia and the United Kingdom. Canada›s vaccine advisory group still recommends two doses for ages 21-26 years and three doses for patients who are immunocompromised or have HIV.

To help inform new NACI policies, Sauvageau and colleagues modeled several one-dose and two-dose strategies using HPV-ADVISE, an individual-based transmission-dynamic model of HPV infections and diseases. They looked at vaccination programs in Quebec, which has a high HPV vaccine coverage rate of around 85%, and Ontario, which has lower coverage of around 65%.

For one-dose programs, the researchers analyzed noninferior (98% efficacy) and pessimistic (90% efficacy) scenarios and different average vaccine duration periods, including lifelong, 30-year, and 25-year coverage. They compared the scenarios with a two-dose program with 98% efficacy and lifelong duration, estimating the relative reduction in HPV-16 infection and cervical cancer incidence and the number of doses needed to prevent one cervical cancer case.

Overall, the model projected that gender-neutral HPV vaccine programs with either two doses or a noninferior one dose would nearly eliminate HPV-16 infection by 2040-2045 in Quebec and reduce infection by more than 90% in Ontario. Under a one-dose strategy with 90% vaccine efficacy, rebounds in HPV-16 infection would start more than 25-30 years after a switch to a lower-dose strategy, thus providing time for officials to detect any signs of waning efficacy and change policies, if needed, the authors wrote.

In addition, the model projected that a noninferior one-dose, gender-neutral HPV vaccination program would avert a similar number of cervical cancer cases, compared with a two-dose program. The reduction would be about 60% in Quebec and 55% in Ontario, compared with no vaccination. Under the most pessimistic scenario with 25-year vaccine duration, a one-dose program would be slightly less effective in averting cancer: about 3% lower than a two-dose program over 100 years.

All one-dose scenarios were projected to lead to the elimination of cervical cancer in 8-16 years — at fewer than four cervical cancer cases per 100,000 female-years.

One-dose programs would also lead to more efficient use of vaccine doses, with about 800-1000 doses needed to prevent one cervical cancer case in a one-dose program and more than 10,000 incremental doses needed to prevent one additional cervical cancer case in a two-dose program.
 

What Next?

In Canada, the HPV vaccine is authorized for patients aged 9-45 years. Current immunization coverage among adolescents and young adults varies across provinces and falls below the national target of 90%. In its July 2024 update, NACI estimated that 76% of 14-year-olds of both genders received at least one vaccine dose and that 67% received two doses in 2023. Vaccine uptake was slightly higher among girls than boys.

To boost the coverage rate, shifting to a one-dose schedule could appeal to young people, as well as maintain vaccination efficacy.

“When you look at the studies that have been published worldwide, the effectiveness of one dose of the HPV vaccine is actually quite high,” said Caroline Quach-Thanh, MD, professor of microbiology, infectious diseases, immunology, and pediatrics at the University of Montreal, Quebec, Canada.

Quach-Thanh, who wasn’t involved with this study, previously served as NACI chair and now serves as chair of the Quebec Immunization Committee.

“In terms of prevention of HPV infections that may lead to cancer, whether you give one dose or two doses basically gives you the same amount of protection,” she said.

However, not all physicians agree about the switch in vaccination approaches. In early October, the Federation of Medical Women of Canada released a report with 12 recommendations to increase HPV vaccination rates, including a call for healthcare providers to continue with multidose immunization schedules for now.

“Vaccination is the most powerful action we can take in preventing HPV-related cancers. Canada is falling behind, but we can get back on track if we act quickly,” said Vivien Brown, MD, chair of the group’s HPV Immunization Task Force, chair and cofounder of HPV Prevention Week in Canada, and a past president of the federation.

After the NACI update in July, the task force evaluated the risks and benefits of a single-dose vaccine regimen, she said. They concluded that a multidose schedule should continue at this time because of its proven effectiveness.

“Until more research on the efficacy of a single-dose schedule becomes available, healthcare providers and public health agencies should continue to offer patients a multidose schedule,” said Brown. “This is the only way to ensure individuals are protected against HPV infection and cancer over the long term.”

The study was supported by the Public Health Agency of Canada, the Canadian Institutes of Health Research, the Bill & Melinda Gates Foundation, and Canadian Immunization Research Network. Sauvageau, Quach-Thanh, and Brown declared no relevant financial disclosures.

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

Physicians shared their views on frequently discussed (and sometimes controversial) topics ranging from romances with patients to age-related competency tests in the latest report from Medscape Medical News.

The report captured data from over 1000 full- or part-time US physicians across more than 29 specialties who were surveyed over a 3-month period in 2024.

Responsibility toward their patients was a clear priority among the doctors surveyed.

While around 6 in 10 physicians said they would immediately discharge a patient who refused to follow their treatment recommendations, 8% said they would wait, and 31% indicated they would keep the patient.

Asked whether physicians should have to undergo competency testing at a certain age, 30% of respondents said yes vs 22% no, and 48% felt it depended on multiple factors.

Most doctors (91%) said they would not accept a gift of substantial monetary or sentimental value from a patient, adhering to the AMA Code of Medical Ethics.

Big gifts “may signal psychological issues, and it is not fair to patients who can’t afford big gifts, since they may encourage better care,” said Jason Doctor, PhD, a senior scholar at the USC Leonard D. Schaeffer Center for Health Policy & Economics in Los Angeles, California. “It also taints the doctor-patient relationship, which should not involve large gifts of expectations of reciprocity.”

The vast majority of doctors said a romantic relationship with a patient still in their care was unacceptable, although 1% felt it would be OK, and 9% said, “it depends.”

When asked if they might withhold information about a patient’s condition if disclosure could do more harm than good, the majority of doctors said no. But 38% said it depended on the situation.

“This is how the profession and public expectations are evolving from the old paternalistic approach,” said Peter Angood, MD, president and CEO of the American Association for Physician Leadership.

Meanwhile, most doctors (62%) said that an annual flu shot should be mandatory for physicians who see patients. And a substantial majority of doctors surveyed agreed that taking care of their physical and mental health amounts to an ethical duty.

Around three in four physicians surveyed said felt periodic bias training was necessary for doctors.

“We all need refreshers about our own bias and how to manage it,” one respondent said. But another physician said, “I think we all know what appropriate behavior is and don’t need to add yet another CME course, ugh.”

Roughly equal shares of doctors surveyed felt some obligation to take at least some Medicaid patients or felt no societal obligation. The remaining 18% were willing to treat Medicaid patients once states streamlined the rules and improved reimbursements.

And finally, nearly all the survey respondents said physicians should advise patients on the risks of marijuana, notwithstanding the number of states and localities that recently have legalized pot or cannabis products.
 

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

Physicians shared their views on frequently discussed (and sometimes controversial) topics ranging from romances with patients to age-related competency tests in the latest report from Medscape Medical News.

The report captured data from over 1000 full- or part-time US physicians across more than 29 specialties who were surveyed over a 3-month period in 2024.

Responsibility toward their patients was a clear priority among the doctors surveyed.

While around 6 in 10 physicians said they would immediately discharge a patient who refused to follow their treatment recommendations, 8% said they would wait, and 31% indicated they would keep the patient.

Asked whether physicians should have to undergo competency testing at a certain age, 30% of respondents said yes vs 22% no, and 48% felt it depended on multiple factors.

Most doctors (91%) said they would not accept a gift of substantial monetary or sentimental value from a patient, adhering to the AMA Code of Medical Ethics.

Big gifts “may signal psychological issues, and it is not fair to patients who can’t afford big gifts, since they may encourage better care,” said Jason Doctor, PhD, a senior scholar at the USC Leonard D. Schaeffer Center for Health Policy & Economics in Los Angeles, California. “It also taints the doctor-patient relationship, which should not involve large gifts of expectations of reciprocity.”

The vast majority of doctors said a romantic relationship with a patient still in their care was unacceptable, although 1% felt it would be OK, and 9% said, “it depends.”

When asked if they might withhold information about a patient’s condition if disclosure could do more harm than good, the majority of doctors said no. But 38% said it depended on the situation.

“This is how the profession and public expectations are evolving from the old paternalistic approach,” said Peter Angood, MD, president and CEO of the American Association for Physician Leadership.

Meanwhile, most doctors (62%) said that an annual flu shot should be mandatory for physicians who see patients. And a substantial majority of doctors surveyed agreed that taking care of their physical and mental health amounts to an ethical duty.

Around three in four physicians surveyed said felt periodic bias training was necessary for doctors.

“We all need refreshers about our own bias and how to manage it,” one respondent said. But another physician said, “I think we all know what appropriate behavior is and don’t need to add yet another CME course, ugh.”

Roughly equal shares of doctors surveyed felt some obligation to take at least some Medicaid patients or felt no societal obligation. The remaining 18% were willing to treat Medicaid patients once states streamlined the rules and improved reimbursements.

And finally, nearly all the survey respondents said physicians should advise patients on the risks of marijuana, notwithstanding the number of states and localities that recently have legalized pot or cannabis products.
 

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

Physicians shared their views on frequently discussed (and sometimes controversial) topics ranging from romances with patients to age-related competency tests in the latest report from Medscape Medical News.

The report captured data from over 1000 full- or part-time US physicians across more than 29 specialties who were surveyed over a 3-month period in 2024.

Responsibility toward their patients was a clear priority among the doctors surveyed.

While around 6 in 10 physicians said they would immediately discharge a patient who refused to follow their treatment recommendations, 8% said they would wait, and 31% indicated they would keep the patient.

Asked whether physicians should have to undergo competency testing at a certain age, 30% of respondents said yes vs 22% no, and 48% felt it depended on multiple factors.

Most doctors (91%) said they would not accept a gift of substantial monetary or sentimental value from a patient, adhering to the AMA Code of Medical Ethics.

Big gifts “may signal psychological issues, and it is not fair to patients who can’t afford big gifts, since they may encourage better care,” said Jason Doctor, PhD, a senior scholar at the USC Leonard D. Schaeffer Center for Health Policy & Economics in Los Angeles, California. “It also taints the doctor-patient relationship, which should not involve large gifts of expectations of reciprocity.”

The vast majority of doctors said a romantic relationship with a patient still in their care was unacceptable, although 1% felt it would be OK, and 9% said, “it depends.”

When asked if they might withhold information about a patient’s condition if disclosure could do more harm than good, the majority of doctors said no. But 38% said it depended on the situation.

“This is how the profession and public expectations are evolving from the old paternalistic approach,” said Peter Angood, MD, president and CEO of the American Association for Physician Leadership.

Meanwhile, most doctors (62%) said that an annual flu shot should be mandatory for physicians who see patients. And a substantial majority of doctors surveyed agreed that taking care of their physical and mental health amounts to an ethical duty.

Around three in four physicians surveyed said felt periodic bias training was necessary for doctors.

“We all need refreshers about our own bias and how to manage it,” one respondent said. But another physician said, “I think we all know what appropriate behavior is and don’t need to add yet another CME course, ugh.”

Roughly equal shares of doctors surveyed felt some obligation to take at least some Medicaid patients or felt no societal obligation. The remaining 18% were willing to treat Medicaid patients once states streamlined the rules and improved reimbursements.

And finally, nearly all the survey respondents said physicians should advise patients on the risks of marijuana, notwithstanding the number of states and localities that recently have legalized pot or cannabis products.
 

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

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Both low and high levels of maternal 25-hydroxy [25(OH)] vitamin D are linked to an increased risk for adverse pregnancy outcomes in women with systemic lupus erythematosus (SLE), with levels of 40-59 ng/mL being associated with the lowest risk.

METHODOLOGY:

• Researchers analyzed 260 pregnancies in the Hopkins Lupus Cohort to examine the association between 25(OH) vitamin D levels and adverse pregnancy outcomes in women with SLE.
• The participants were required to have serum vitamin D levels measured during pregnancy and pregnancy-related outcomes data.
• The 25(OH) vitamin D levels were measured at visits every 6 weeks, and the participants were divided into six subgroups on the basis of the mean 25(OH) vitamin D levels: < 20 ng/dL, 20-29 ng/dL, 30-39 ng/dL, 40-49 ng/dL, 50-59 ng/dL, and ≥ 60 ng/dL.
• The adverse pregnancy outcomes included miscarriage, preterm delivery, and restricted intrauterine growth of the fetus.
• This study used a time-to-event analysis to assess the association between time-varying 25(OH) vitamin D levels and adverse pregnancy outcomes.

TAKEAWAY:

• Adverse pregnancy outcomes were observed in 45.3% of pregnancies; the risks for miscarriage and preterm delivery were significantly different across the six subgroups with varying vitamin D levels (P = .0045 and P = .0007, respectively).
• A U-shaped curve association was observed between vitamin D levels and adverse pregnancy outcomes, with the highest risk seen in patients with the lowest or highest levels of vitamin D during pregnancy, while the lowest risk was seen in those with vitamin D levels between 40 and 59 ng/mL.
• Low 25(OH) vitamin D levels during the second trimester resulted in premature delivery in 9 out of 10 pregnancies; however, a relationship between vitamin D levels in the first trimester and pregnancy outcomes was not observed.
• The time-to-event analysis showed that the U-shaped association between vitamin D levels and adverse pregnancy outcomes was still observed even after accounting for lupus disease activity; however, the elevated risk seen in individuals with the highest levels of vitamin D was no longer statistically significant.

IN PRACTICE:

“We recommend monitoring of maternal serum 25(OH) vitamin D levels throughout SLE pregnancies and supplementing patients with vitamin D insufficiency or deficiency, aiming for 25(OH) vitamin D range of 40-59 ng/mL. Over supplementation should be avoided,” the authors wrote.

SOURCE:

The study was led by Nima Madanchi, MD, Johns Hopkins University, Baltimore, and was published online on September 23, 2024, in Arthritis Care & Research.

LIMITATIONS:

This study could not prove a cause-and-effect relationship between vitamin D levels and adverse pregnancy outcomes. This study included only clinically identified pregnancies, potentially missing very early miscarriages. It also could not adjust for parity due to the unknown parity of the index pregnancy.

DISCLOSURES:

This Hopkins Lupus Cohort was supported by grants from the National Institutes of Health. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

More evidence suggests there is little risk in administering the live rotavirus vaccine to the babies of mothers on biologics during pregnancy for inflammatory bowel disease (IBD).

No adverse events or impairment of the immune system emerged in babies at 7 days, 1 month, and 9 months post vaccination, in findings from a small Canadian study published in Clinical Gastroenterology and Hepatology.

University of Calgary

The study found normal extended immune function testing in infants despite third-trimester maternal biologic therapy and regardless of circulating drug levels. The data provide reassurance about live rotavirus vaccination in this population and may also offer insights into the safety of other live vaccines in biologic-exposed individuals, wrote investigators led by gastroenterologist Cynthia H. Seow, MD, a professor in the Cumming School of Medicine at the University of Calgary in Alberta, Canada.

“Despite the well-established safety and effectiveness of non–live vaccination in individuals with IBD, including those on immunomodulators and biologic therapy, vaccine uptake in pregnant women with IBD and their infants remains suboptimal,” Seow said in an interview. This largely arises from maternal and physician concerns regarding transplacental transfer of IBD therapies and their impact on the safety of vaccination.

“These concerns were heightened after reports emerged of five fatal outcomes following the administration of the live Bacille Calmette-Guérin [BCG] vaccine in biologic-exposed infants. However, it had already been reported that inadvertent administration of the live oral rotavirus vaccine, a very different vaccine in terms of target and mechanism of action, in biologic-exposed individuals had not been associated with significant adverse effects,” she said.

They undertook their analysis with the hypothesis that vaccination would carry low risk, although the live oral vaccine is not currently recommended in biologic-exposed infants. “Yet rotavirus is a leading cause of severe, dehydrating diarrhea in children under the age of 5 years globally, and vaccination has led to significant reductions in hospitalizations and mortality,” Seow added.

Provision of the vaccine to anti–tumor necrosis factor (TNF)–exposed infants has been incorporated into the Canadian Public Health and Immunization guidelines, as the majority of the biologic-exposed infants were exposed to anti-TNF agents. “And with collection of further data, we expect that this will be extended to other biologic agent exposure. These data are important to pregnant women with IBD as they help to normalize their care. Pregnancy is difficult enough without having to remember exceptions to care,” Seow said.

“Before some of the studies came out, broad guidelines recommended that live vaccines should not be used in biologic-exposed infants, but this had been thought to be overly zealous and too conservative, and the risk was thought to be low,” said Elizabeth Spencer, MD, an assistant professor of pediatrics in the Division of Pediatric Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York City, in an interview. Spencer was not involved in the Canadian study.

“At our center, we had some moms on biologics during pregnancy who forgot and had their babies vaccinated for rotavirus, and the babies were all fine,” she said.

The safety of this vaccine has been confirmed by several small studies and recently the PIANO Helmsley Global Consensus on Pregnancy and Inflammatory Bowel Disease, which was presented at Digestive Disease Week 2024. The consensus encompasses preconception counseling and the safety of IBD medications during pregnancy and lactation.

Icahn School of Medicine at Mount Sinai

“Another concern, however, was that giving a live GI bug like rotavirus to babies might overstimulate their immune systems and provoke IBD,” Spencer added. “While a number of population-based studies in the US and Europe showed that was not the case, at least in the general population, there was a suggestion that, down the road, vaccination might be mildly protective against IBD in some cases.”

She added the caveat that these studies were not done in mothers and their babies with IBD, who might be inherently at greater risk for IBD. “So, a question for future research would be, ‘Is immune stimulation of the gut in IBD moms and their babies a good or a bad thing for their gut?’ ”

Spencer conceded that “the data present a bit of a blurry picture, but I think it’s always better just to vaccinate according to the regular schedule. The current data say there is no added risk, but it would be nice to look specifically at risk in moms with IBD and their children.”
 

The Study

The prospective cohort study is a substudy of a larger 2023 one that included biologic use in a range of maternal illnesses, not just IBD.

For the current study, Seow and colleagues identified 57 infants born to 52 mothers with IBD attending a pregnancy clinic at the University of Calgary in the period 2019-2023. Almost 81% of the mothers had Crohn’s disease, and the median duration of IBD was 10 years. The median gestational age at delivery was 39 weeks, and almost 60% of deliveries were vaginal. The infants had been exposed in utero to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester.

The 57 biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing. The live oral rotavirus vaccine series was provided to 50 infants, with the first dose at a median of 13 weeks of age. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 μg/mL (range, 0.4-28.8 μg/mL), adalimumab concentrations of 1.7 μg/mL (range, 0.7-7.9 μg/mL), ustekinumab concentrations of 0.6 μg/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks of age.

As anticipated, infant immune function was normal regardless of circulating drug levels.

The overall message, said Seow, is “healthy mum equals healthy baby. Be more concerned regarding active inflammation than active medications. In almost all circumstances, treat to target in pregnancy as you would in the nonpregnant state.” She added, however, that further studies are needed to determine the safety and optimal timing of other live vaccines, such as the BCG, in the presence of biologic therapy.

This study was funded by the Alberta Children’s Hospital Research Institute. Seow reported advisory/speaker’s fees for Janssen, AbbVie, Takeda, Pfizer, Fresenius Kabi, Bristol-Myers Squibb, Pharmascience, and Lilly, as well as funding from Alberta Children’s Hospital Research Institute, Crohn’s and Colitis Canada, the Canadian Institutes of Health Research, and Calgary Health Trust, and data safety monitoring from New South Wales Government Health, Australia. Multiple coauthors disclosed similar consulting or speaker relationships with private industry. Spencer had no competing interests with regard to her comments.

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

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Brazilian researchers have identified a previously unrecognized function of sperm that is unrelated to reproduction. A study of 13 patients admitted to the Hospital das Clínicas da Universidade de São Paulo with moderate to severe COVID-19 showed that male gametes released extracellular traps (in a process called ETosis) in response to the infection. This immune response, which is common to macrophages and neutrophils, had never been observed in mammalian reproductive cells.

“It opens up a new line of research,” said Jorge Hallak, a professor at the University of São Paulo School of Medicine, São Paulo, Brazil, and first author of the article published in Andrology. “This may be an innovative mechanism, or it may have always existed, and no one knew.”

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in cells more than 3 months after infection in 11 participants, although polymerase chain reaction tests were negative. These findings suggest the potential for drafting a protocol or guidance on when to attempt a pregnancy. “My concern is with assisted reproduction, in which, in general, only one basic spermogram is done, without diagnostic investigation or serology for coronavirus,” said Hallak.

Symptomatic infections hinder the reproductive process because symptoms such as high fever impair cell function by triggering increased DNA fragmentation, reduced mitochondrial activity, decreased acrosome reaction, and cell death, thus affecting sperm count and gamete mobility.

The new findings indicate that the impact of SARS-CoV-2 infection can continue for as long as 90 days after symptoms and signs disappear and affect sperm count and gamete quality for even longer. “With the sperm selection technique, you are at risk of taking a cell with viruses and injecting it into the egg. It is not known what changes this may cause to the embryo,” said Hallak.

The expert emphasized that the finding contributes to the understanding of reproductive difficulties that previously had no plausible explanation. It serves as a warning against negligence in the evaluation of men in assisted reproductive treatments.

Daniel Zylberstein, urologist and member of the Brazilian Association of Assisted Reproduction, who did not participate in the research, noted that the result comes from a small study that should be expanded to try to develop guidance for doctors.

“There is still no protocol for these cases. The ideal approach would be to wait for complete spermatogenesis, which takes about 3 months, before putting patients on treatment. This often does not happen, and treatment begins shortly after clinical recovery. In the case of moderate to severe COVID-19, this period should be longer than 90 days,” he said.

The study suggests establishing a quarantine period for reproduction until the sperm are free of the virus, said Zylberstein. “With infected sperm, it makes no sense to start reproductive treatment. This sperm is spending energy to fight the pathogen. Assisted reproduction is expensive and exhaustive and may not have the expected outcome because of SARS-CoV-2 infectivity.”

This story was translated from the Medscape Portuguese edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Eating more eggs is linked to weight gain in postmenopausal women, especially those with a high intake of Western foods such as processed and red meat, French fries, sweets, and deserts. Genetic predisposition for a high body mass index (BMI) also influences weight gain with higher egg intake.

METHODOLOGY:

• Egg consumption and elevated body weight are each linked to an increased risk for serious chronic diseases; however, whether elevated body weight mediates the association between egg intake and an elevated risk for serious chronic diseases needs further assessment.
• To investigate the association between eating eggs and weight gain, as well as the role of genetic susceptibility to an elevated BMI, researchers conducted a prospective study including 4439 postmenopausal women of European descent from the Women’s Health Initiative (WHI).
• They measured the participants’ consumption of egg and egg nutrients using a self-administered food frequency questionnaire.
• Changes in the consumption of eggs and egg nutrients such as cholesterol, choline, and betaine were assessed between baseline and follow-up visits at 1, 3, 6, and 9 years.
• The primary outcome was the change in body weight between baseline and each follow-up visit. Furthermore, an exploratory analysis evaluated how eating Western foods and genetic predisposition for a high BMI (assessed through a polygenic score) influenced weight change.

TAKEAWAY:

• An increased consumption of eggs was associated with weight gain, showing a positive linear trend at 1, 2, 3, and 6 years. By the third year, women whose egg consumption had increased by two eggs per week gained 0.70 kg more weight (P = .0002) than women whose egg consumption was reduced by 2.4 eggs per week (P-linear < .0001).
• An increase in the consumption of nutrients obtained from eggs, including cholesterol (P-linear < .0001) and choline (P-linear < .02), was positively associated with weight gain.
• Women with a higher consumption of Western foods showed significant associations between changes in egg, cholesterol, and choline intake and weight gain.
• A significant association was found between the BMI polygenic score and changes in body weight, with women most genetically predisposed to a higher BMI showing greater weight gain when their egg consumption increased by an average of 3.5 eggs per week.

IN PRACTICE:

“These results suggest that even relatively small increases or decreases in egg consumption could cause increases or decreases, respectively, in body weight among postmenopausal women, unless there are adequate compensating changes in factors such as dietary energy intake or physical activity,” the authors wrote. “Our results require confirmation,” they added.

SOURCE:

This study, led by James A. Greenberg, Department of Health and Nutrition Sciences, Brooklyn College, The City University of New York, was published online in Clinical Nutrition.

LIMITATIONS: 

This observational study was susceptible to residual confounding, which suggests that the observed associations may not have established causality. Additionally, the results were according to data from a group of postmenopausal American women of European descent, which limited the generalizability to other populations.

DISCLOSURES:

The WHI program was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health & Human Services. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Eating more eggs is linked to weight gain in postmenopausal women, especially those with a high intake of Western foods such as processed and red meat, French fries, sweets, and deserts. Genetic predisposition for a high body mass index (BMI) also influences weight gain with higher egg intake.

METHODOLOGY:

• Egg consumption and elevated body weight are each linked to an increased risk for serious chronic diseases; however, whether elevated body weight mediates the association between egg intake and an elevated risk for serious chronic diseases needs further assessment.
• To investigate the association between eating eggs and weight gain, as well as the role of genetic susceptibility to an elevated BMI, researchers conducted a prospective study including 4439 postmenopausal women of European descent from the Women’s Health Initiative (WHI).
• They measured the participants’ consumption of egg and egg nutrients using a self-administered food frequency questionnaire.
• Changes in the consumption of eggs and egg nutrients such as cholesterol, choline, and betaine were assessed between baseline and follow-up visits at 1, 3, 6, and 9 years.
• The primary outcome was the change in body weight between baseline and each follow-up visit. Furthermore, an exploratory analysis evaluated how eating Western foods and genetic predisposition for a high BMI (assessed through a polygenic score) influenced weight change.

TAKEAWAY:

• An increased consumption of eggs was associated with weight gain, showing a positive linear trend at 1, 2, 3, and 6 years. By the third year, women whose egg consumption had increased by two eggs per week gained 0.70 kg more weight (P = .0002) than women whose egg consumption was reduced by 2.4 eggs per week (P-linear < .0001).
• An increase in the consumption of nutrients obtained from eggs, including cholesterol (P-linear < .0001) and choline (P-linear < .02), was positively associated with weight gain.
• Women with a higher consumption of Western foods showed significant associations between changes in egg, cholesterol, and choline intake and weight gain.
• A significant association was found between the BMI polygenic score and changes in body weight, with women most genetically predisposed to a higher BMI showing greater weight gain when their egg consumption increased by an average of 3.5 eggs per week.

IN PRACTICE:

“These results suggest that even relatively small increases or decreases in egg consumption could cause increases or decreases, respectively, in body weight among postmenopausal women, unless there are adequate compensating changes in factors such as dietary energy intake or physical activity,” the authors wrote. “Our results require confirmation,” they added.

SOURCE:

This study, led by James A. Greenberg, Department of Health and Nutrition Sciences, Brooklyn College, The City University of New York, was published online in Clinical Nutrition.

LIMITATIONS: 

This observational study was susceptible to residual confounding, which suggests that the observed associations may not have established causality. Additionally, the results were according to data from a group of postmenopausal American women of European descent, which limited the generalizability to other populations.

DISCLOSURES:

The WHI program was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health & Human Services. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Eating more eggs is linked to weight gain in postmenopausal women, especially those with a high intake of Western foods such as processed and red meat, French fries, sweets, and deserts. Genetic predisposition for a high body mass index (BMI) also influences weight gain with higher egg intake.

METHODOLOGY:

• Egg consumption and elevated body weight are each linked to an increased risk for serious chronic diseases; however, whether elevated body weight mediates the association between egg intake and an elevated risk for serious chronic diseases needs further assessment.
• To investigate the association between eating eggs and weight gain, as well as the role of genetic susceptibility to an elevated BMI, researchers conducted a prospective study including 4439 postmenopausal women of European descent from the Women’s Health Initiative (WHI).
• They measured the participants’ consumption of egg and egg nutrients using a self-administered food frequency questionnaire.
• Changes in the consumption of eggs and egg nutrients such as cholesterol, choline, and betaine were assessed between baseline and follow-up visits at 1, 3, 6, and 9 years.
• The primary outcome was the change in body weight between baseline and each follow-up visit. Furthermore, an exploratory analysis evaluated how eating Western foods and genetic predisposition for a high BMI (assessed through a polygenic score) influenced weight change.

TAKEAWAY:

• An increased consumption of eggs was associated with weight gain, showing a positive linear trend at 1, 2, 3, and 6 years. By the third year, women whose egg consumption had increased by two eggs per week gained 0.70 kg more weight (P = .0002) than women whose egg consumption was reduced by 2.4 eggs per week (P-linear < .0001).
• An increase in the consumption of nutrients obtained from eggs, including cholesterol (P-linear < .0001) and choline (P-linear < .02), was positively associated with weight gain.
• Women with a higher consumption of Western foods showed significant associations between changes in egg, cholesterol, and choline intake and weight gain.
• A significant association was found between the BMI polygenic score and changes in body weight, with women most genetically predisposed to a higher BMI showing greater weight gain when their egg consumption increased by an average of 3.5 eggs per week.

IN PRACTICE:

“These results suggest that even relatively small increases or decreases in egg consumption could cause increases or decreases, respectively, in body weight among postmenopausal women, unless there are adequate compensating changes in factors such as dietary energy intake or physical activity,” the authors wrote. “Our results require confirmation,” they added.

SOURCE:

This study, led by James A. Greenberg, Department of Health and Nutrition Sciences, Brooklyn College, The City University of New York, was published online in Clinical Nutrition.

LIMITATIONS: 

This observational study was susceptible to residual confounding, which suggests that the observed associations may not have established causality. Additionally, the results were according to data from a group of postmenopausal American women of European descent, which limited the generalizability to other populations.

DISCLOSURES:

The WHI program was funded by the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health & Human Services. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Maternal serum folate levels during early to midpregnancy show a U-shaped association with congenital heart disease (CHD) risk in offspring. Both low and high folate levels are linked to an increased risk, with vitamin B12 deficiency and elevated homocysteine levels further exacerbating this risk.

METHODOLOGY:

• Researchers conducted a case-control study with 129 participants with CHD and 516 matched control participants from Guangdong Provincial People’s Hospital in China between 2015 and 2018.
• Maternal serum levels of folate, vitamin B12, and homocysteine were measured at around 16 weeks of gestation using a chemiluminescence microparticle immunoassay.
• CHD was confirmed using echocardiography, and the participants were matched by maternal age at a ratio of 1:4.
• Covariates included periconceptional folic acid supplementation, maternal education, occupation, parity, abortion history, pregnancy complications, and genetic polymorphisms related to folate metabolism.
• Conditional logistic regression was used to assess the associations, with adjustments for various covariates and sensitivity analyses excluding participants with missing genetic data.

TAKEAWAY:

• A U-shaped association was found between maternal serum folate levels and CHD risk in offspring, with both low and high levels linked to increased risk (P < .001).
• Low maternal folate levels were associated with an adjusted odds ratio (aOR) of 3.09 (95% CI, 1.88-5.08) for CHD risk, whereas high levels had an aOR of 1.81 (95% CI, 1.07-3.06).
• Using World Health Organization criteria, folate deficiency (< 5.9 ng/mL) had an aOR of 18.97 (95% CI, 3.87-93.11) and elevated levels (> 20 ng/mL) had an aOR of 5.71 (95% CI, 2.72-11.98) for CHD risk.
• Vitamin B12 deficiency and elevated homocysteine levels further increased the risk associated with both low and high maternal folate levels.

IN PRACTICE:

“Insufficient folate and vitamin B12 can lead to increased homocysteine levels, which is harmful to the cardiovascular system. Thus, homocysteine might act as a central mediator in the relationships between deficiencies in folate and vitamin B12 and the risk of CHD. Additionally, the role of folate extends beyond homocysteine mediation, contributing independently to placental implantation and vascular remodeling, irrespective of vitamin B12 and homocysteine levels,” the authors wrote.

SOURCE:

The study was led by Yanji Qu, PhD, and Jie Li, PhD, Global Health Research Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China. It was published online in JAMA Network Open.

LIMITATIONS:

The study’s limitations included the measurement of maternal serum folate levels at a single time point, which may not reflect preconception and early postconception periods. The study’s findings may not be generalizable to other populations as participants were recruited from a single cardiac referral center in Southern China. Additionally, the lack of dietary intake data limited the ability to account for related biases. The sample size, while relatively large for CHD research, may lack sufficient power for stratified analyses.

DISCLOSURES:

One coauthor reported receiving personal fees from Guangdong Cardiovascular Institute outside the submitted work. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Fluconazole resistance in yeast isolates from women with recurrent vulvovaginal candidiasis in Leeds, England, increased from 3.5% to 9.6% over 3 years. Non–Candida albicans yeasts also rose from 6.0% to 12.6% during the same period.

METHODOLOGY:

• Researchers conducted a retrospective data search of vaginal cultures from adult women in Leeds, England, between April 2018 and March 2021.
• A total of 5461 vaginal samples from women with clinical information indicating complicated/recurrent vulvovaginal candidiasis were included.
• Samples were processed on the WASPLAB automated platform, and species identification and antifungal susceptibility testing were performed in the Mycology Reference Centre by Matrix-assisted laser desorption ionization–time-of-flight mass spectrometry.
• Susceptibility to fluconazole was determined using disc diffusion and the Sensititre YeastOne microbroth dilution assay.
•  

TAKEAWAY:

According to the authors, the prevalence of non–C albicans yeasts increased from 6.0% in 2018-2019 to 12.6% in 2020-2021 (P = .0003).

Fluconazole-sensitive (dose-dependent) and fluconazole-resistant isolates increased from 3.5% in 2018-2019 to 9.6% in 2020-2021 (P = .0001).

Most fluconazole resistance was observed in C albicans, with other species such as Nakaseomyces glabrata and Pichia kudriavzevii also showing resistance.

The authors state that the increase in fluconazole resistance and non–C albicans yeasts may be linked to a policy change encouraging empirical treatment of vulvovaginal candidiasis in primary care.

IN PRACTICE:

“This study shows that the rates of non–Candida albicans and fluconazole-resistant C albicans have increased year on year in the 3 years studied. The exact reasons for this increase remain unclear, but it follows the introduction of restricted access to fungal cultures for the diagnosis of vulvovaginal candidiasis by those working in primary care. A clinical diagnosis, followed by empirical treatment, has been recommended instead. Consequently, we believe this policy of encouraging empirical vaginitis treatment based on nonspecific symptoms and signs needs revisiting,” the authors wrote.

SOURCE:

The study was led by Jennifer C. Ratner, Leeds Teaching Hospitals NHS Trust, England. It was published online in Sexually Transmitted Infections.

LIMITATIONS:

The study’s limitations included a potential bias introduced by the reduced number of samples received from specialist sexual health clinics during the COVID-19 pandemic. Additionally, the study could not distinguish between cases of recurrent vulvovaginal candidiasis with complete resolution of symptoms and those with persistent symptoms despite treatment.

DISCLOSURES:

One coauthor disclosed receiving fees from Pfizer for contributing to webinar presentations in 2023. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Fluconazole resistance in yeast isolates from women with recurrent vulvovaginal candidiasis in Leeds, England, increased from 3.5% to 9.6% over 3 years. Non–Candida albicans yeasts also rose from 6.0% to 12.6% during the same period.

METHODOLOGY:

• Researchers conducted a retrospective data search of vaginal cultures from adult women in Leeds, England, between April 2018 and March 2021.
• A total of 5461 vaginal samples from women with clinical information indicating complicated/recurrent vulvovaginal candidiasis were included.
• Samples were processed on the WASPLAB automated platform, and species identification and antifungal susceptibility testing were performed in the Mycology Reference Centre by Matrix-assisted laser desorption ionization–time-of-flight mass spectrometry.
• Susceptibility to fluconazole was determined using disc diffusion and the Sensititre YeastOne microbroth dilution assay.
•  

TAKEAWAY:

According to the authors, the prevalence of non–C albicans yeasts increased from 6.0% in 2018-2019 to 12.6% in 2020-2021 (P = .0003).

Fluconazole-sensitive (dose-dependent) and fluconazole-resistant isolates increased from 3.5% in 2018-2019 to 9.6% in 2020-2021 (P = .0001).

Most fluconazole resistance was observed in C albicans, with other species such as Nakaseomyces glabrata and Pichia kudriavzevii also showing resistance.

The authors state that the increase in fluconazole resistance and non–C albicans yeasts may be linked to a policy change encouraging empirical treatment of vulvovaginal candidiasis in primary care.

IN PRACTICE:

“This study shows that the rates of non–Candida albicans and fluconazole-resistant C albicans have increased year on year in the 3 years studied. The exact reasons for this increase remain unclear, but it follows the introduction of restricted access to fungal cultures for the diagnosis of vulvovaginal candidiasis by those working in primary care. A clinical diagnosis, followed by empirical treatment, has been recommended instead. Consequently, we believe this policy of encouraging empirical vaginitis treatment based on nonspecific symptoms and signs needs revisiting,” the authors wrote.

SOURCE:

The study was led by Jennifer C. Ratner, Leeds Teaching Hospitals NHS Trust, England. It was published online in Sexually Transmitted Infections.

LIMITATIONS:

The study’s limitations included a potential bias introduced by the reduced number of samples received from specialist sexual health clinics during the COVID-19 pandemic. Additionally, the study could not distinguish between cases of recurrent vulvovaginal candidiasis with complete resolution of symptoms and those with persistent symptoms despite treatment.

DISCLOSURES:

One coauthor disclosed receiving fees from Pfizer for contributing to webinar presentations in 2023. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Fluconazole resistance in yeast isolates from women with recurrent vulvovaginal candidiasis in Leeds, England, increased from 3.5% to 9.6% over 3 years. Non–Candida albicans yeasts also rose from 6.0% to 12.6% during the same period.

METHODOLOGY:

• Researchers conducted a retrospective data search of vaginal cultures from adult women in Leeds, England, between April 2018 and March 2021.
• A total of 5461 vaginal samples from women with clinical information indicating complicated/recurrent vulvovaginal candidiasis were included.
• Samples were processed on the WASPLAB automated platform, and species identification and antifungal susceptibility testing were performed in the Mycology Reference Centre by Matrix-assisted laser desorption ionization–time-of-flight mass spectrometry.
• Susceptibility to fluconazole was determined using disc diffusion and the Sensititre YeastOne microbroth dilution assay.
•  

TAKEAWAY:

According to the authors, the prevalence of non–C albicans yeasts increased from 6.0% in 2018-2019 to 12.6% in 2020-2021 (P = .0003).

Fluconazole-sensitive (dose-dependent) and fluconazole-resistant isolates increased from 3.5% in 2018-2019 to 9.6% in 2020-2021 (P = .0001).

Most fluconazole resistance was observed in C albicans, with other species such as Nakaseomyces glabrata and Pichia kudriavzevii also showing resistance.

The authors state that the increase in fluconazole resistance and non–C albicans yeasts may be linked to a policy change encouraging empirical treatment of vulvovaginal candidiasis in primary care.

IN PRACTICE:

“This study shows that the rates of non–Candida albicans and fluconazole-resistant C albicans have increased year on year in the 3 years studied. The exact reasons for this increase remain unclear, but it follows the introduction of restricted access to fungal cultures for the diagnosis of vulvovaginal candidiasis by those working in primary care. A clinical diagnosis, followed by empirical treatment, has been recommended instead. Consequently, we believe this policy of encouraging empirical vaginitis treatment based on nonspecific symptoms and signs needs revisiting,” the authors wrote.

SOURCE:

The study was led by Jennifer C. Ratner, Leeds Teaching Hospitals NHS Trust, England. It was published online in Sexually Transmitted Infections.

LIMITATIONS:

The study’s limitations included a potential bias introduced by the reduced number of samples received from specialist sexual health clinics during the COVID-19 pandemic. Additionally, the study could not distinguish between cases of recurrent vulvovaginal candidiasis with complete resolution of symptoms and those with persistent symptoms despite treatment.

DISCLOSURES:

One coauthor disclosed receiving fees from Pfizer for contributing to webinar presentations in 2023. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mifepristone plus misoprostol reduces the need for subsequent uterine aspiration and emergency department visits in the management of early pregnancy loss. Despite its effectiveness, mifepristone remains underutilized, with 8.6% of patients receiving it in 2022.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using national insurance claims data of US patients with commercial insurance.
• More than 31,000 pregnant women (mean age, 32.7 years) with a diagnosis of early pregnancy loss between 2015 and 2022 were included.
• The diagnosis of patients included having a missed abortion (72.3%), spontaneous abortion (26.9%), or both (0.8%).
• Researchers compared the outcomes of individuals who received a combination of mifepristone and misoprostol vs those who received misoprostol alone. The outcome measures included the need for subsequent procedural management (uterine aspiration), return visits to the emergency department or an outpatient clinic, hospitalizations, and complications within 6 weeks of initial diagnosis.

TAKEAWAY:

• The use of mifepristone was more common in outpatient clinics than in emergency departments (3.4% vs 0.9%; P < .001).
• The use of mifepristone plus misoprostol vs misoprostol alone was linked to a lower incidence of subsequent procedural management (10.5% vs 14.0%; P = .002) and fewer emergency department visits (3.5% vs 7.9%; P < .001).
• The multivariable analysis showed that the use of mifepristone was linked to decreased odds of subsequent procedural management (adjusted odds ratio, 0.71; 95% CI, 0.57-0.87).
• Despite its effectiveness, mifepristone was used in only 8.6% of those receiving medication management for early pregnancy loss in 2022.

IN PRACTICE:

“Continued efforts are needed to reduce barriers to mifepristone use for medication management of EPL,” the authors wrote.

“Any practitioner who cares for patients experiencing early pregnancy loss should consider mifepristone pretreatment to misoprostol to be the standard of care for medication management. Provision of the evidence-based standard of care with the use of mifepristone for early pregnancy loss is an opportunity to advocate for an essential strategy in improving sexual and reproductive health in the US,” wrote Sarita Sonalkar, MD, MPH, and Rachel McKean, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, in an invited commentary.
 

SOURCE:

The study was led by Lyndsey S. Benson, MD, MS, of the University of Washington School of Medicine, Seattle, and was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by the accuracy of the diagnosis of early pregnancy loss and procedure codes because claims data are intended for billing purposes and may be incomplete or inaccurate. The use of de-identified data meant that specific gestational durations, exact dosing, or routes of misoprostol administration could not be determined. The findings may not be generalizable to those with public insurance or no insurance.

DISCLOSURES:

The study was supported in part by a grant from a Women’s Reproductive Health Research grant from the National Institutes of Health Eunice Kennedy Shriver National Institute for Child Health and Human Development. One author reported serving as an adviser and investigator, while another reported receiving personal fees and serving as an expert witness, contributing editor, and course instructor outside the submitted work.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.