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Early in career, female academic docs earn less than males: study

Article Type
Changed
Wed, 02/23/2022 - 08:24

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

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Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

Researchers point the finger squarely at starting salaries for physicians as the reason women earn less than their male peers in academic medicine, according to a new study. Worse still, the earning potential of women in most specialties is $214,440 (or 10%) less than their male colleagues over the course of the first 10 years of their careers in academic medicine.

Among the vast majority of subspecialties, women’s starting salaries and their salaries 10 years into their careers were lower than their male colleagues in academic medicine, per the study in JAMA Network Open.

Eva Catenaccio, MD, an epilepsy fellow at Children’s Hospital of Philadelphia and the lead author of the study, told this news organization that the gender disparities in earning potential are “pervasive in academic medicine.” These earnings disparities, which occur in nearly all subspecialties and can reach hundreds of thousands of dollars in the first 10 years of an academic physician’s career, “are largely the result of gender differences in annual salary that start immediately after training,” she said.

Changing the timing of academic promotion and equalizing starting salary and salary growth can help close the salary gap, said Dr. Catenaccio.

The study also reveals that women could face a 1-year delay in promotion from assistant to associate professor, compared with men. This delay could reduce female physicians’ earning potential by a 10-year median of $26,042 (or 2%), whereas failure to be promoted at all could decrease the 10-year earning potential by a median of $218,724 (or 13%).

Across medicine more broadly, male physicians continue to earn 35% more than their female colleagues, according to the 2021 Medscape Physician Compensation Report. The biggest differences in take-home pay exist between male and female specialists, per the report. On average, male physicians earn $376,000, while women’s take-home pay is $283,000.
 

Medical schools and hospital leaders have a role to play

The earning potential during the first 10 years of post-training employment by gender was the most dramatic in neurosurgery, orthopedic surgery, and cardiology, per the study. Three subspecialties where women and men have similar earning potential include pediatric nephrology, pediatric neurology, and pediatric rheumatology.

The coauthors note that it’s commonly understood that women don’t negotiate as often or as successfully as their male colleagues. A 2019 study in JAMA Surgery of 606 male and female surgery residents revealed that while residents of both genders shared similar career goals, women had lower future salary expectations and a significantly more negative view of the salary negotiation process.

Dr. Catenaccio and her coauthors acknowledge that negotiation skills and financial literacy should be taught during medical school and postgraduate training. “However, the onus for ensuring salary equity should not fall on the individual candidate alone; rather, departmental and hospital leadership should take responsibility to ensure uniform starting salaries and prevent gender-based inequalities,” they wrote in the study.

“We hope that this study encourages academic medical institutions to increase transparency and equity around compensation, particularly for junior faculty,” Dr. Catenaccio said in an interview. “This will require both ensuring equal starting salaries and providing periodic adjustments throughout individuals’ careers to prevent divergence in earning potential by gender or any other individual characteristics.”

Harold Simon, MD, MBA, vice chair for faculty for the department of pediatrics and professor of pediatrics and emergency medicine at Emory University, Atlanta, told this news organization that “[i]ncreased transparency around compensation can enable women to advocate for equitable pay. However, the burden for ensuring equity should not fall on individuals but instead must be the primary responsibility of academic institutions.”

Specifically, Dr. Simon advocates for hospital leaders to “ensure equity among providers including compensation [as] a crucial part of maintaining a diverse workforce and, ultimately, providing balanced access to health care for patients.”

In addition, the authors call for periodic compensation evaluations and adjustments to help prevent gender-based salary differences among female and male physicians in academia. “This is absolutely necessary, both to develop future compensation plans and to address any pre-existing gender-based salary inequities for those women currently well into their careers,” they wrote in the study.

Data analysis was conducted from March to May 2021. Researchers used models to estimate the impacts of promotion timing and potential interventions, which include equalizing starting salaries and annual salary rates.

The study included compensation data for 24,593 female and 29,886 male academic physicians across 45 subspecialties. It relied on publicly available data from the Association of American Medical Colleges’ annual Medical School Faculty Salary Survey report.

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

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Treatment for BV, trichomoniasis approved for adolescents

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The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

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The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

The Food and Drug Administration has approved secnidazole for the treatment of bacterial vaginosis (BV) and trichomoniasis in patients aged 12 years and older.

The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.

Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.

The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.

The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.

Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.

Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.

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Long COVID is real and consists of these conditions – or does it?

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Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”

That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.

During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.

So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.

Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.

From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

 

 

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

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Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”

That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.

During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.

So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.

Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.

From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

 

 

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?

Statistically, these are the conditions that defined post-acute SARS-CoV-2 (PASC) infection, or long COVID, for 28,118 people who tested positive for SARS-CoV-2 by PCR before the Omicron wave. The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.

Medscape Illustration/Dreamstime/Getty Images

“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”

That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.

During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.

So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.

Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.

From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.

More than 1 in 10

About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.

 

 

“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”

For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.

In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.

And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.

The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.

“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”

Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
 

Ready to define long COVID?

As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.

“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.

“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”

He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.

“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”

Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.

“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”

Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

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

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Obstetrical care for gender diverse patients: A summary from the SMFM annual meeting

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Fri, 02/18/2022 - 11:14

The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.

One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.

Dr. K. Ashley Brandt

We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1

There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.

Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1

Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3

Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.

Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1

While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.

2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.

3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.

4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.

5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).

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The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.

One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.

Dr. K. Ashley Brandt

We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1

There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.

Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1

Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3

Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.

Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1

While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.

2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.

3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.

4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.

5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).

The purpose of this commentary is to provide a brief summary of discussions centering around reproductive health experiences and obstetrical care for gender-diverse patients from the recent Society of Maternal & Fetal Medicine meeting. Two presentations featured patient perspectives combined with physician lectures to provide a comprehensive outlook on unique reproductive care needs for this growing population.

One of the speakers, Trystan Reese, is a transgender activist, educator, and transgender male who chose to carry his own pregnancy and subsequently delivered his son in 2017. During the summit, he described many barriers that he faced during his pregnancy and offered providers suggestions on how to improve the care for members of the gender-diverse community seeking to start a family.

Dr. K. Ashley Brandt

We often think of conception and pregnancy as experiences unique to one gender. This is simply not the case. In discussing preconceptual care and pregnancy, it is paramount for providers to make the distinction between gender identity and natal sex. Gender identity is an internal sense of self in relation to natal sex. Depending on this intrinsic feeling, people may identify as cisgender, transgender, or as a gender outside of the standard binary. Natal sex describes biologic characteristics such as chromosomal makeup, reproductive anatomy, and secondary sexual changes. In keeping these distinctions in mind, pregnancy is therefore exclusive to a person’s natal sex, not gender identity. One of the biggest challenges in caring for transgender patients who desire pregnancy, is the psychological distress related to the gendered notions surrounding this experience.1

There are many ways in which patients encounter unintentional marginalization within the medical system. For example, many electronic medical record systems don’t allow for pronouns or give error messages if the patient’s gender identity is different from their sex assigned at birth. Patients who attend prenatal appointments or birth classes are given documents that center around cisgender women and heterosexual relationships. The labor and delivery wards themselves typically include language such as “maternity,” and birth certificates have distinct “mother” and “father” denotations.1 Insurance coverage for prenatal care and delivery can be problematic if a patient who is assigned female at birth has changed their gender marker to “male” on their insurance card.

Many of these roadblocks can be ameliorated by utilizing more inclusive terminology. Terms such as “maternal” can be replaced with “pregnant patients, parent, or patients giving birth.” Names of maternity wards can be altered to perinatal units, which is more inclusive and more descriptive of the wide variety of patients that may experience childbirth and parenthood.1 Introducing “you-centered” language can also be helpful. Instead of saying “women may find ...” providers can try saying “patients may find ...” or “individuals may find.”1

Most of the medical and obstetrical care of gender-diverse patients is routine. Prenatal labs, aneuploidy screening, ultrasounds, and fetal surveillance do not differ between transgender and cisgender patients. However, the experience of pregnancy itself can significantly heighten feelings of dysphoria as it inherently leads to patients confronting aspects of their biological sex.2 Because of the teratogenic nature of testosterone, patients are required to stop taking testosterone prior to conception and for the duration of pregnancy. This can also heighten dysphoria and lead to increased rates of anxiety and depression.3

Many transgender patients can safely achieve a normal vaginal birth.4 A small survey of 41 people demonstrated that more transgender men who had taken testosterone were delivered by cesarean section (36% vs. 19%).3 Staff training is an important aspect of caring for a transgender patient in labor to ensure that all members of the labor unit are cognizant of appropriate name and pronoun usage. Another interesting, although unsurprising, fact is that many transgender gestational parents chose a community-based (out-of-hospital) birth according to a 2014 study.1 This is predominantly because of the discrimination patients face when delivering within a hospital setting.

Postpartum depression screening should be conducted prior to patients leaving the hospital and individualized during postpartum appointments. Reinitiation of testosterone can occur 4-6 weeks after delivery.1

While pregnancy can pose some unique challenges to gender-diverse individuals, these intricacies are not insurmountable. The result of pregnancy, regardless of one’s gender identity, is the same – parenthood. One patient’s description of his experience was particularly poignant: “Pregnancy and childbirth were very male experiences for me. When I birthed my children, I was born into fatherhood.”1 It is up to all providers to modify clinical settings, as well as our patient interactions and use of language, if we are to provide inclusion in obstetrics.1,5

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Brandt JS et al. “Understanding intersections: Care for transgender and gender diverse patient populations.” SMFM 2022 annual meeting. 2022 Feb 2.

2. Hoffkling A et al. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):332.

3. Light AD et al. Obstet Gynecol. 2014;124:1120-7.

4. Moseson H et al. Int J Transgend Health. 2021 Nov 17;22(1-2):30-41.

5. Brandt JS et al. Obstetrical care for trans*person, in “Trans*gynecology: Managing transgender patients in obstetrics and gynecology practice.” (Cambridge, England: Cambridge University Press, 2022).

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Most Americans unaware alcohol can cause cancer

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The majority of Americans are not aware that alcohol consumption causes a variety of cancers and especially do not consider wine and beer to have a link with cancer, suggest the results from a national survey.

coldsnowstorm/iStock / Getty Images Plus

“Alcohol is a leading modifiable risk factor for cancer, yet most Americans are unaware that alcohol increases cancer risk,” write lead author Andrew Seidenberg, PhD, MPH, National Cancer Institute, Rockville, Md., and colleagues.

“Increasing awareness of the alcohol-cancer link, such as through multimedia campaigns and patient-provider communication, may be an important new strategy for health advocates working to implement preventive alcohol policies,” they add.

The findings were published in the February issue of the American Journal of Preventive Medicine.

“This is the first study to examine the relationship between alcohol control policy support and awareness of the alcohol-cancer link among a national U.S. sample,” the authors write.

The results show that there is some public support for the idea of adding written warnings about the alcohol-cancer risk to alcoholic beverages, which is something that a number of cancer organizations have been petitioning for.

A petition filed by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations, proposes labeling that would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Such labeling has “the potential to save lives by ensuring that consumers have a more accurate understanding of the link between alcohol and cancer, which will empower them to better protect their health,” the groups said in the petition.
 

Public support

The findings come from an analysis of the 2020 Health Information National Trends Survey 5 Cycle 4. A total of 3,865 adults participated in the survey, approximately half of whom were nondrinkers.

As well as investigating how aware people were of the alcohol-cancer link, the investigators looked at how prevalent public support might be for the following three communication-focused alcohol policies:

  • Banning outdoor alcohol-related advertising
  • Requiring health warnings on alcohol beverage containers
  • Requiring recommended drinking guidelines on alcoholic beverage containers

“Awareness of the alcohol-cancer link was measured separately for wine, beer, and liquor by asking: In your opinion, how much does drinking the following types of alcohol affect the risk of getting cancer?” the authors explain.

“Awareness of the alcohol-cancer link was low,” the investigators comment; only about one-third (31.8%) of participants were aware that alcohol increases the risk of cancer. The figures were even lower for individual beverage type, at 20.3% for wine, 24.9% for beer, and 31.2% for liquor. Furthermore, approximately half of participants responded with “don’t know” to the three awareness items, investigators noted.

On the other hand, more than half of the Americans surveyed supported adding both health warning labels (65.1%) and information on recommended drinking guidelines (63.9%) to alcoholic beverage containers. Support was lower (34.4% of respondents) for banning outdoor alcohol advertising.

Among Americans who were aware that alcohol increased cancer risk, support was also higher for all three policies.

For example, about 75% of respondents who were aware that alcohol increases cancer risk supported adding health warnings and drinking guidelines to beverage containers, compared with about half of Americans who felt that alcohol consumption had either no effect on or decreased cancer risk.

Even among those who were aware of the alcohol-cancer link, public support for outdoor advertising was not high (37.8%), but it was even lower (23.6%) among respondents who felt alcohol had no effect on or decreased the risk of cancer.

“Policy support was highest among nondrinkers, followed by drinkers, and was lowest among heavier drinkers,” the authors report.

For example, almost 43% of nondrinkers supported restrictions on outdoor alcohol advertising, compared with only about 28.6% of drinkers and 22% of heavier drinkers. More respondents supported adding health warning labels on alcoholic beverages – 70% of nondrinkers, 65% of drinkers, and 57% of heavier drinkers, investigators observe.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

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The majority of Americans are not aware that alcohol consumption causes a variety of cancers and especially do not consider wine and beer to have a link with cancer, suggest the results from a national survey.

coldsnowstorm/iStock / Getty Images Plus

“Alcohol is a leading modifiable risk factor for cancer, yet most Americans are unaware that alcohol increases cancer risk,” write lead author Andrew Seidenberg, PhD, MPH, National Cancer Institute, Rockville, Md., and colleagues.

“Increasing awareness of the alcohol-cancer link, such as through multimedia campaigns and patient-provider communication, may be an important new strategy for health advocates working to implement preventive alcohol policies,” they add.

The findings were published in the February issue of the American Journal of Preventive Medicine.

“This is the first study to examine the relationship between alcohol control policy support and awareness of the alcohol-cancer link among a national U.S. sample,” the authors write.

The results show that there is some public support for the idea of adding written warnings about the alcohol-cancer risk to alcoholic beverages, which is something that a number of cancer organizations have been petitioning for.

A petition filed by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations, proposes labeling that would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Such labeling has “the potential to save lives by ensuring that consumers have a more accurate understanding of the link between alcohol and cancer, which will empower them to better protect their health,” the groups said in the petition.
 

Public support

The findings come from an analysis of the 2020 Health Information National Trends Survey 5 Cycle 4. A total of 3,865 adults participated in the survey, approximately half of whom were nondrinkers.

As well as investigating how aware people were of the alcohol-cancer link, the investigators looked at how prevalent public support might be for the following three communication-focused alcohol policies:

  • Banning outdoor alcohol-related advertising
  • Requiring health warnings on alcohol beverage containers
  • Requiring recommended drinking guidelines on alcoholic beverage containers

“Awareness of the alcohol-cancer link was measured separately for wine, beer, and liquor by asking: In your opinion, how much does drinking the following types of alcohol affect the risk of getting cancer?” the authors explain.

“Awareness of the alcohol-cancer link was low,” the investigators comment; only about one-third (31.8%) of participants were aware that alcohol increases the risk of cancer. The figures were even lower for individual beverage type, at 20.3% for wine, 24.9% for beer, and 31.2% for liquor. Furthermore, approximately half of participants responded with “don’t know” to the three awareness items, investigators noted.

On the other hand, more than half of the Americans surveyed supported adding both health warning labels (65.1%) and information on recommended drinking guidelines (63.9%) to alcoholic beverage containers. Support was lower (34.4% of respondents) for banning outdoor alcohol advertising.

Among Americans who were aware that alcohol increased cancer risk, support was also higher for all three policies.

For example, about 75% of respondents who were aware that alcohol increases cancer risk supported adding health warnings and drinking guidelines to beverage containers, compared with about half of Americans who felt that alcohol consumption had either no effect on or decreased cancer risk.

Even among those who were aware of the alcohol-cancer link, public support for outdoor advertising was not high (37.8%), but it was even lower (23.6%) among respondents who felt alcohol had no effect on or decreased the risk of cancer.

“Policy support was highest among nondrinkers, followed by drinkers, and was lowest among heavier drinkers,” the authors report.

For example, almost 43% of nondrinkers supported restrictions on outdoor alcohol advertising, compared with only about 28.6% of drinkers and 22% of heavier drinkers. More respondents supported adding health warning labels on alcoholic beverages – 70% of nondrinkers, 65% of drinkers, and 57% of heavier drinkers, investigators observe.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

The majority of Americans are not aware that alcohol consumption causes a variety of cancers and especially do not consider wine and beer to have a link with cancer, suggest the results from a national survey.

coldsnowstorm/iStock / Getty Images Plus

“Alcohol is a leading modifiable risk factor for cancer, yet most Americans are unaware that alcohol increases cancer risk,” write lead author Andrew Seidenberg, PhD, MPH, National Cancer Institute, Rockville, Md., and colleagues.

“Increasing awareness of the alcohol-cancer link, such as through multimedia campaigns and patient-provider communication, may be an important new strategy for health advocates working to implement preventive alcohol policies,” they add.

The findings were published in the February issue of the American Journal of Preventive Medicine.

“This is the first study to examine the relationship between alcohol control policy support and awareness of the alcohol-cancer link among a national U.S. sample,” the authors write.

The results show that there is some public support for the idea of adding written warnings about the alcohol-cancer risk to alcoholic beverages, which is something that a number of cancer organizations have been petitioning for.

A petition filed by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations, proposes labeling that would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

Such labeling has “the potential to save lives by ensuring that consumers have a more accurate understanding of the link between alcohol and cancer, which will empower them to better protect their health,” the groups said in the petition.
 

Public support

The findings come from an analysis of the 2020 Health Information National Trends Survey 5 Cycle 4. A total of 3,865 adults participated in the survey, approximately half of whom were nondrinkers.

As well as investigating how aware people were of the alcohol-cancer link, the investigators looked at how prevalent public support might be for the following three communication-focused alcohol policies:

  • Banning outdoor alcohol-related advertising
  • Requiring health warnings on alcohol beverage containers
  • Requiring recommended drinking guidelines on alcoholic beverage containers

“Awareness of the alcohol-cancer link was measured separately for wine, beer, and liquor by asking: In your opinion, how much does drinking the following types of alcohol affect the risk of getting cancer?” the authors explain.

“Awareness of the alcohol-cancer link was low,” the investigators comment; only about one-third (31.8%) of participants were aware that alcohol increases the risk of cancer. The figures were even lower for individual beverage type, at 20.3% for wine, 24.9% for beer, and 31.2% for liquor. Furthermore, approximately half of participants responded with “don’t know” to the three awareness items, investigators noted.

On the other hand, more than half of the Americans surveyed supported adding both health warning labels (65.1%) and information on recommended drinking guidelines (63.9%) to alcoholic beverage containers. Support was lower (34.4% of respondents) for banning outdoor alcohol advertising.

Among Americans who were aware that alcohol increased cancer risk, support was also higher for all three policies.

For example, about 75% of respondents who were aware that alcohol increases cancer risk supported adding health warnings and drinking guidelines to beverage containers, compared with about half of Americans who felt that alcohol consumption had either no effect on or decreased cancer risk.

Even among those who were aware of the alcohol-cancer link, public support for outdoor advertising was not high (37.8%), but it was even lower (23.6%) among respondents who felt alcohol had no effect on or decreased the risk of cancer.

“Policy support was highest among nondrinkers, followed by drinkers, and was lowest among heavier drinkers,” the authors report.

For example, almost 43% of nondrinkers supported restrictions on outdoor alcohol advertising, compared with only about 28.6% of drinkers and 22% of heavier drinkers. More respondents supported adding health warning labels on alcoholic beverages – 70% of nondrinkers, 65% of drinkers, and 57% of heavier drinkers, investigators observe.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

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FROM THE AMERICAN JOURNAL OF PREVENTIVE MEDICINE

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Group prenatal care had mixed effect on preterm birth disparities

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Fri, 02/18/2022 - 10:23

Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

Dr. Ilina Pluym

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

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Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

Dr. Ilina Pluym

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

Group prenatal care did not reduce preterm birth among low-income patients compared to patients receiving individual prenatal care, but the different care models did shrink racial disparities in low-birth-weight and preterm births, according to a study presented Feb. 3 at the annual meeting sponsored by the Society for Maternal-Fetal Medicine. Patients who attended more group prenatal care visits also had better outcomes, reported Amy Crockett, MD, professor of ob.gyn. and director of the Maternal-Fetal Medicine Fellowship Program at the University of South Carolina in Greenville.

Though the results did not show group prenatal care to be the “silver bullet” they might have hoped for in reducing preterm birth and low birth weight among Black women, the study did show group prenatal care to have some clinical effect, Dr. Crockett suggested.

Ilina Pluym, MD, assistant professor of maternal-fetal medicine at the University of California Los Angeles, said that preterm birth and low birth weight are complex problems that cannot be solved by a single fix.

Dr. Ilina Pluym

“In terms of the racial disparities, it is difficult to prove that 9 months of good access to prenatal care will undo the years of limited health care and life stressors that, as a whole, possibly contribute more to the overall risk profile of the patient,” Dr. Pluym said. “But as providers, we want to intervene and help in the portion that we can, and optimizing prenatal care is one tangible thing we can try.”

The racial disparities that exist in preterm birth, low birth weight, and infant and maternal mortality are not caused by biologic or genetic factors, Dr. Crockett told attendees.

”Rather, they are the result of long-standing systemic racism and discrimination deeply embedded in the culture of the United States,” she said. “To achieve racial equity, we need reform at the societal level.” But she noted that it might be possible for individual practices to play a role as well, which led her to design a study comparing outcomes from group versus individual prenatal care.

The group care model used for the study is called Centering Pregnancy, in which 8-10 pregnant patients who are due in the same month attend 10 two-hour prenatal care sessions together. Dr. Crockett noted that other research has identified potential reductions in preterm birth with group care models, but some are underpowered while others are observational and limited by confounding, selection bias, or small sample sizes.

The researchers aimed to recruit 3,160 patients to ensure an adequately powered study after estimated losses to follow-up, but they were able to recruit only 2,350 patients, resulting in potentially underpowered results. All the patients were receiving care at a single obstetric practice for a medically low-risk singleton pregnancy of 20 or fewer weeks gestation. A total of 1,176 patients were randomly assigned to attend group prenatal care appointments, and 1,174 patients were assigned to individual prenatal care.

The patients in both groups were an average age of 25 with a prepregnancy body mass index of 29. A similar proportion in both the group and individual care were married (24%) patients and had a government payer (96%-97%). Approximately 41%were Black patients, 37% were White patients, and 21% were Hispanic patients in both groups. Rates of chronic hypertension, smoking, vaginal infection in pregnancy, parity, cervix length, and use of cerclage were similar in both groups.

Gestational age outcomes were available for 1,099 group care patients (94%) and 1,120 individual care patients (95%), and birth weight outcomes were available for 1,028 group care patients (87%) and 1,044 individual care patients (89%).

In the individual care group, 8.7% of the patients had a preterm birth, compared to 10.4% who attended group prenatal care, but the findings did not reach significance (odds ratio [OR], 1.22; 95% confidence interval [CI]: 0.92-1.63). The difference between the 9.6% of group care patients and 8.9% of individual care patients who had babies with low birth weights were not significantly different.

While no significant difference in preterm birth occurred between the groups, the secondary outcome looking at racial disparities yielded one statistically significant result. Black women receiving individual prenatal care were twice as likely as were White women to have an infant with a low birth weight (OR, 2.1; 95% CI: 1.29-3.5). Among those receiving group care, however, the 12.5% of Black women and 8.9% of White women whose infants had a low birth weight were not significantly different.

There was a trend toward narrower disparities in preterm birth in the group versus individual care groups. Among those receiving group care, 11.4% of Black women and 10.8% of White women had a preterm birth, compared to 10.2% of Black women and 7.7% of White women in the individual care group.

Then the researchers compared the groups with regard to compliance while adjusting for baseline differences. “We saw decreasing rates of preterm birth for Black patients relative to White patients, particularly after attending five or more sessions in the group care arm with the rates of preterm birth narrowing and the disparity becoming nonsignificant with more exposure to group care,” Dr. Crockett said. “In individual care, the rate of preterm birth remained the highest for Black women regardless of the number of visits attended.”

The idea of trying group prenatal care is appealing, Dr. Pluym said in an interview, though both models have their advantages.

”The strength of individual care is the focus on the patient exam and individual patient questions,” Dr. Pluym said. “The strengths of group prenatal care are the consolidation of the patient education aspect of prenatal care that is uniform for all patients, the sense of community patients feel, and the opportunity to hear other patients questions that you may not have thought of. It sounds like, anecdotally, patients and providers really found the group sessions valuable and they helped dampen implicit bias and build relationships.”

One potential limitation of this randomized controlled trial is that the providers were the same for both group and individual care, potentially causing some confounding, Dr. Pluym noted. But the study does have one clear clinical message, she said.

“My take away is more prenatal care is better – individual or group,” Dr. Pluym said. “Every clinic should evaluate their own structure and see if group care would be feasible for their patient population. There may be a benefit globally, but is it is not the ‘silver bullet,’ as they said, for lowering preterm birth or growth restriction.”

The research was funded by the Institute of Child Health and Development. The study researchers and Dr. Pluym reported no disclosures.

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About 73% of U.S. estimated to be immune to Omicron variant

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Tue, 02/22/2022 - 10:48

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

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About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

About 73% of Americans are now immune to the Omicron variant, which could increase to 80% by mid-March, a university health institute says.

About half of eligible Americans have received booster shots, and about 80 million confirmed COVID-19 infections have been reported. Many more infections have occurred but haven’t been officially recorded, The Associated Press reported.

The high percentage of immunity from vaccination and previous infection tends to prevent or shorten new illnesses and reduce the amount of virus circulating overall. Health experts are now discussing whether the number is high enough to stop new waves or reduce the burden on hospitals.

“I am optimistic even if we have a surge in summer, cases will go up, but hospitalizations and deaths will not,” Ali Mokdad, PhD, a professor of health metrics sciences at the University of Washington in Seattle, told the AP.

Dr. Mokdad works on COVID-19 forecasting for the university’s Institute for Health Metrics and Evaluation, which has been a reliable model during the pandemic. Dr. Mokdad calculated the 73% number for the AP.

“We have changed,” he said. “We have been exposed to this virus and we know how to deal with it.”

The United States is now reporting about 125,000 new cases per day, according to the data tracker from the New York Times, marking a 68% decrease from the past 2 weeks. Hospitalizations are also down 39%, and about 2,300 new deaths are being reported daily, marking a 13% decline.

There will be more outbreaks as new variants emerge, immunity wanes, and some people remain unvaccinated, Dr. Mokdad said. But the coronavirus is no longer new, and the entire population is no longer “immunologically naive.” Scientists are now trying to understand how long booster protection will last against Omicron and how many people have been infected who had mild or no symptoms that were never reported.

By the end of the Omicron surge, about three out of four people in the United States will have been infected, Shaun Truelove, PhD, an epidemiologist and disease modeler at Johns Hopkins University, told the AP.

“We know it’s a huge proportion of the population,” he said. “This varies a lot by location, and in some areas, we expect the number infected to be closer to one in two.”

That means different regions and groups of people have different levels of protection and risk. In Virginia, for instance, disease modelers estimate that about 45% of residents have the highest level of immunity by being vaccinated and boosted or vaccinated with a recent Omicron infection. Another 47% have immunity that has waned somewhat.

“That’s going to be a nice shield of armor for our population as a whole,” Bryan Lewis, PhD, an epidemiologist who leads the University of Virginia’s COVID-19 modeling team, told the outlet. “If we do get to very low case rates, we certainly can ease back on some of these restrictions.”

About 7% of Virginians are considered the most vulnerable because they were never vaccinated or infected, he noted. Nationwide, about 80 million Americans are still vulnerable, the AP reported.

“The 26% who could still get Omicron right now have to be very careful,” Dr. Mokdad said.

The percentages will continue to change as immunity wanes and new variants circulate in the country. For now, the Institute for Health Metrics and Evaluation model estimates that about 63% to 81% of Americans are protected.

“We’ve reached a much better position for the coming months, but with waning immunity, we shouldn’t take it for granted,” Dr. Mokdad said.

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

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Breast cancer trials enrolling now: Could your patient benefit?

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Thu, 12/15/2022 - 17:23

A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

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A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

A number of clinical trials in breast cancer have opened in recent months. Maybe one of your patients could benefit from being enrolled.

Menopausal women at moderate risk of developing breast cancer. A phase 2 study sponsored by the National Cancer Institute is seeking women aged 45-60 in late menopause or post menopause who are at “moderate” risk of developing breast cancer. Examples of criteria for moderate risk include prior proliferative disease on breast biopsy or having a first- or second-degree relative who developed breast cancer at aged 60 or younger. Researchers are looking for a signal that bazedoxifene plus conjugated estrogens (Duavee), a hot-flash therapy, could prevent breast cancer in at-risk people. Participants in the active-therapy group will receive once-daily oral medication for 6 months. The control patients will have the option of taking the medication after 6 months. The trial aims to enroll 120 participants. It began recruiting on Dec. 2, 2021, at the University of Kansas Medical Center; sites in California, Illinois, and Massachusetts are planned. The primary outcome is the change in fibroglandular volume. Overall survival (OS) and quality of life (QOL) will not be measured. More details at clinicaltrials.gov.

Early high-risk nonmetastatic HER2+ breast cancer with no prior treatment. Adults with this type of breast cancer are invited to join a phase 3 trial of trastuzumab deruxtecan (T-DXd; Enhertu) as neoadjuvant therapy. T-DXd is currently approved for patients with advanced disease, so this study could lead to a new indication. Participants will receive standard intravenous regimens of either T-DXd monotherapy; T-DXd followed by paclitaxel (Taxol), trastuzumab (Herceptin), and pertuzumab (Perjeta), referred to as the THP regime; or doxorubicin plus cyclophosphamide followed by THP. The primary outcome is rate of pathologic complete response, and a secondary outcome is OS over approximately 5 years. QOL won’t be measured. The study opened on Oct. 25, 2021, and eventually hopes to recruit 624 participants in 19 countries and 15 U.S. states. More details at clinicaltrials.gov.

“[This is an] important early trial to move trastuzumab deruxtecan to early disease. If successful as monotherapy, this would be a big win for patients,” commented Kathy Miller, MD, professor of oncology and medicine at Indiana University, Indianapolis, a contributor to this news organization. She cautioned that monitoring rates of pneumonitis will be important in this curable setting.

Locally advanced unresectable or metastatic HER2+ breast cancer with no prior tyrosine-kinase inhibitor therapy. Adult patients with these clinical features are eligible for a phase 3 study that is also testing a drug in an earlier setting than its current label – tucatinib (Tukysa) as first-line anti-HER2 therapy in advanced disease. Tucatinib was approved in April 2020 by the U.S. Food and Drug Administration as second-line therapy in such patients, so this study could also lead to a new indication. Participants in the experimental arm will receive tucatinib tablets twice daily and a combination of trastuzumab and pertuzumab intravenously or subcutaneously every 3 weeks for up to approximately 3 years. Patients in the control arm will take a placebo instead of tucatinib. Seven sites across Florida, Kentucky, Maryland, and South Carolina aim to start recruiting 650 participants on Feb. 28, 2022. The primary outcome is progression-free survival (PFS). OS and QoL will be tracked. More details at clinicaltrials.gov.

“Tucatinib has real activity,” commented Dr. Miller, adding that “we haven’t [yet] found the best way to exploit that activity for our patients.”

Inoperable or metastatic HR+ HER2– breast cancer after one or two lines of systemic chemotherapy. Adults with this type of breast cancer are being recruited for a phase 3 study to compare datopotamab deruxtecan (Dato-DXd), an experimental antibody-drug conjugate (ADC), against a range of standard single-agent chemotherapies. Participants will receive either intravenous Dato-DXd or investigator’s choice of one of four chemotherapies: oral capecitabine (Xeloda), IV gemcitabine (Gemzar), IV eribulin (Halaven), or IV vinorelbine (Navelbine). The trial began recruiting for 700 participants at sites worldwide on Oct. 18, 2021. U.S. sites are in Michigan and California; trial centers in 15 other states are planned. Primary outcomes are OS over approximately 3.5 years and PFS over approximately 2 years. QOL is tracked. More details at clinicaltrials.gov.

Commenting on this trial, Dr. Miller said: “ADCs will play an expanded role in our management. This may be one of the first to move into the ER+ population.”

Advanced ER+, HER2– breast cancer. Adult patients with this type of cancer can join a phase 3 trial testing oral imlunestrant, an experimental selective estrogen-receptor degrader (SERD), against standard endocrine therapy. For up to 3 years, people in the study will take either daily tablets of imlunestrant or once-daily pills of imlunestrant and another SERD, abemaciclib (Verzenio). A third group of participants will receive their investigator’s choice of either daily tablets of exemestane (Aromasin) or monthly intramuscular injections of fulvestrant (Faslodex). The study opened to 800 participants on Oct. 4, 2021, at sites in 11 U.S. states and worldwide. The primary outcome is PFS over approximately 3 years; 5-year OS is a secondary outcome. QOL is not assessed. More details at clinicaltrials.gov

Dr. Miller predicted that “oral SERDs will replace fulvestrant in the future: We already have positive phase 3 data with elacestrant.”

Dr. Miller has a regular column with this news organization, Miller on Oncology. She has disclosed no relevant financial relationships. A version of this article first appeared on Medscape.com.

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When your medical error harmed a patient and you’re wracked with guilt

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Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

 

 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

 

 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

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Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

 

 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

 

 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

Peter Schwartz, MD, was chair of the department of obstetrics and gynecology at a hospital in Reading, Pa., in the mid-1990s when a young physician sought him out. The doctor, whom Dr. Schwartz regarded as talented and empathetic, was visibly shaken. The expectant mother they were caring for had just lost her unborn child.

“The doctor came into my office within an hour of the event and asked me to look at the case,” Dr. Schwartz recalled. “I could see that they had failed to recognize ominous changes in the fetal heart rate, and I faced the pain of having to tell them, ‘I think this could have been handled much better.’” Dr. Schwartz delivered the news as compassionately as he could, but a subsequent review confirmed his suspicion: The doctor had made a serious error.

“The doctor was devastated,” he said. “She got counseling and took time off, but in the end, she quit practicing medicine. She said, ‘If I keep practicing, something like that could happen again, and I don’t think I could handle it.’”

To err may be human, but in a health care setting, the harm can be catastrophic. While patients and their families are the ones who suffer most, doctors can be so traumatized by their medical mistakes that their feelings of guilt, shame, and self-doubt can lead to depression, anxiety, post-traumatic stress disorder, and even suicidal ideation. The trauma can be so profound that, in a now famous 2000 editorial in the British Medical Journal, Albert Wu, MD, gave the phenomenon a name: “second victim syndrome.”

Today, as quality improvement organizations and health systems work to address medical errors in a just and transparent way, they’re realizing that finding ways to help traumatized clinicians is integral to their efforts.
 

Are doctors really ‘second victims?’

Although the medical field is moving away from the term “second victim,” which patient advocates argue lacks a ring of accountability, the emotional trauma doctors and other clinicians endure is garnering increased attention. In the 2 decades since Dr. Wu wrote his editorial, research has shown that many types of adverse health care events can evoke traumatic responses. In fact, studies indicate that from 10.4% to 43.3% of health care workers may experience negative symptoms following an adverse event.

But for doctors – who have sworn an oath to do no harm – the emotional toll of having committed a serious medical error can be particularly burdensome and lingering. In a Dutch study involving more than 4,300 doctors and nurses, respondents who were involved in a patient safety incident that resulted in harm were nine times more likely to have negative symptoms lasting longer than 6 months than those who were involved in a near-miss experience.

“There’s a feeling of wanting to erase yourself,” says Danielle Ofri, MD, a New York internist and author of “When We Do Harm: A Doctor Confronts Medical Error.”

That emotional response can have a profound impact on the way medical errors are disclosed, investigated, and ultimately resolved, said Thomas Gallagher, MD, an internist and executive director of the Collaborative for Accountability and Improvement, a patient safety program at the University of Washington.

“When something goes wrong, as physicians, we don’t know what to do,” Dr. Gallagher says. “We feel awful, and often our human reflexes lead us astray. The doctor’s own emotions become barriers to addressing the situation.” For example, guilt and shame may lead doctors to try to hide or diminish their mistakes. Some doctors might try to shift blame, while others may feel so guilty they assume they were responsible for an outcome that was beyond their control.

Recognizing that clinicians’ responses to medical errors are inextricably tangled with how those events are addressed, a growing number of health systems are making clinician support a key element when dealing with medical errors.
 

 

 

Emotional first aid

Although it’s typical for physicians to feel isolated in the wake of errors, these experiences are far from unique. Research conducted by University of Missouri Health Care nurse scientist Susan Scott, RN, PhD, shows that just as most individuals experiencing grief pass through several distinct emotional stages, health care professionals who make errors go through emotional stages that may occur sequentially or concurrently.

An initial period of chaos is often followed by intrusive reflections, haunting re-enactments, and feelings of inadequacy. The doctor’s thinking moves from “How did that happen?” to “What did I miss?” to “What will people think about me?” As the error comes under scrutiny by quality improvement organizations, licensing boards, and/or lawyers, the doctor feels besieged. The doctor may want to reach out but is afraid to. According to Dr. Scott, only 15% of care providers ask for help.

Recognizing that physicians and other care providers rarely ask for support – or may not realize they need it – a growing number of health systems are implementing Communication and Resolution Programs (CRPs). Rather than respond to medical errors with a deny-and-defend mentality, CRPs emphasize transparency and accountability.

This approach, which the Agency for Healthcare Research and Quality has embraced and codified with its Communication and Optimal Resolution (CANDOR) toolkit, focuses on prompt incident reporting; communication with and support for patients, family members, and caregivers affected by the event; event analysis; quality improvement; and just resolution of the event, including apologies and financial compensation where appropriate.

The CANDOR toolkit, which includes a module entitled Care for the Caregiver, directs health systems to identify individuals and establish teams, led by representatives from patient safety and/or risk management, who can respond promptly to an event. After ensuring the patient is clinically stable and safe, the CANDOR process provides for immediate and ongoing emotional support to the patient, the family, and the caregiver.

“A lot of what CRPs are about is creating structures and processes that normalize an open and compassionate response to harm events in medicine,” says Dr. Gallagher, who estimates that between 400 and 500 health systems now have CRPs in place.
 

Wisdom through adversity

While clinicians experience many difficult and negative emotions in the wake of medical errors, how they move forward after the event varies markedly. Some, unable to come to terms with the trauma, may move to another institution or leave medicine entirely. Others, while occasionally reliving the trauma, learn to cope. For the most fortunate, enduring the trauma of a medical error can lead to growth, insight, and wisdom.

In an article published in the journal Academic Medicine, researchers asked 61 physicians who had made serious medical errors, “What helped you to cope positively?” Some of the most common responses – talking about their feelings with a peer, disclosing and apologizing for a mistake, and developing system changes to prevent additional errors – are baked into some health systems’ CRP programs. Other respondents said they dedicated themselves to learning from the mistake, becoming experts in a given field, or sharing what they learned from the experience through teaching.

Dr. Ofri said that after she made an error decades ago while managing a patient with diabetic ketoacidosis, her senior resident publicly berated her for it. The incident taught her a clinical lesson: Never remove an insulin drip without administering long-acting insulin. More importantly, the resident’s verbal thumping taught her about the corrosive effects of shame. Today, Dr. Ofri, who works in a teaching hospital, says that when meeting a new medical team, she begins by recounting her five biggest medical errors.

“I want them to come to me if they make a mistake,” she says. “I want to first make sure the patient is okay. But then I want to make sure the doctor is okay. I also want to know: What was it about the system that contributed to the error, and what can we do to prevent similar errors in the future?”
 

 

 

Acceptance and compassion

Time, experience, supportive peers, an understanding partner or spouse: all of these can help a doctor recover from the trauma of a mistake. “But they’re not an eraser,” Dr. Schwartz said.

Sometimes, doctors say, the path forward starts with acceptance.

Jan Bonhoeffer, MD, author of “Dare to Care: How to Survive and Thrive in Today’s Medical World,” tells a story about a mistake that transformed his life. In 2004, he was working in a busy London emergency department when an adolescent girl arrived complaining of breathing trouble. Dr. Bonhoeffer diagnosed her with asthma and discharged her with an inhaler. The next day, the girl was back in the hospital – this time in the ICU, intubated, and on a ventilator. Because he had failed to take an x-ray, Dr. Bonhoeffer missed the tumor growing in the girl’s chest.

Dr. Bonhoeffer was shattered by his error. “After that experience, I knew I wanted to make learning from my mistakes part of my daily practice,” he says. Now, at the end of each workday, Dr. Bonhoeffer takes an inventory of the day and reflects on all his actions, large and small, clinical and not. “I take a few minutes and think about everything I did and what I should have done differently,” he said. The daily practice can be humbling because it forces him to confront his errors, but it is also empowering, he said, “because the next day I get to make a different choice.”

Dr. Bonhoeffer added, “Doctors are fallible, and you have to be compassionate with yourself. Compassion isn’t sweet. It’s not motherhood and honey pies. It’s coming to terms with reality. It’s not a cure, but it’s healing.”

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

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Experimental breast cancer immunotherapy treatment passes important hurdle in pilot study

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Fri, 12/16/2022 - 10:07

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

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A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

A new pilot study has shown that refractory, hormone-positive metastatic breast cancer can respond to treatment with autologous tumor-infiltrating lymphocytes (TILs) that recognize specific tumor antigens. Three of 6 patients treated had a response, including one that lasted more than five years. TILs were expanded ex vivo, and patients treated with lymphodepleting chemotherapy before the infusion, along with the checkpoint inhibitor pembrolizumab (Keytruda, Merck).

The results pave the way for recruitment of more patients as researchers at the National Cancer Institute ramp up the experimental treatment. They also help to overturn the long-held dogma that breast cancer is not immunogenic, according to lead researcher Steven A. Rosenberg, MD, PhD, who is chief of the surgery branch of the National Cancer Institute.

Although common hormone positive breast cancer doesn’t respond to immunotherapy, the study found that two-thirds of patients with metastatic breast cancer have mutations recognized by TILs. “We can identify the antigens [that] T cells recognize,” said Dr. Rosenberg, who is the lead author on a paper describing the pilot study, published online Feb. 1 in the Journal of Clinical Oncology.

There has been wide speculation that some solid tumors, including common hormone-positive breast cancers, are not immunogenic, because they don’t respond to cancer vaccines or checkpoint inhibitors. However, newer research has unearthed an explanation: Patients with these solid tumors produce immunogenic antigens, but they differ from patient to patient. There was not a single shared antigen among the 42 patients in the study. “Every patient reacts with a unique antigen, so the treatments have to be highly personalized,” said Dr. Rosenberg.

In the phase 2 study, the researchers recruited 42 participants, who underwent screening for novel tumor antigens. Sixty percent were hormone-receptor positive and HER2 negative, 26% were triple negative, and 14% were HER2 enriched.

Of 42 patients, 28 (67%) had at least one detectable, immunogenic tumor antigen, including 46% of HR+/Her2– patients, 32% of triple-negative patients, and 21% of HER2-enriched patients. Thirteen patients had a positive TIL screen, making them candidates for treatment.

Six patients underwent the procedure. Researchers selected TIL culture fragments that responded when stimulated with mutant peptides. They expanded those cells externally over 24 days and then administered lymphodepleting chemotherapy 1 week before the infusion of the expanded TILs. Patients received aldesleukin (Proleukin, Prometheus Laboratories) every 8 hours after TIL infusion, as tolerated. Patients also received pembrolizumab 2 days before the TIL infusion and up to three more doses at 3-week intervals.

Three patients experienced objective tumor regression, including a complete response that has lasted for 5.5 years. Two had partial responses that lasted 6 and 10 months. One patient with a partial response had a limited recurrence that could be excised, followed by further regression of other lesions, and was disease free 2 years after treatment.

The National Cancer Institute has just constructed a new building on the National Institutes of Health campus to pursue this research, and Dr. Rosenberg is actively recruiting patients to further study the treatment protocol. “We’re prepared to start treating large numbers of breast cancer patients with this. It’s highly experimental, it needs to be improved, it’s not ready for primetime. But we have now a signal that it can work,” said Dr. Rosenberg.

The study was funded by the National Cancer Institute. Dr. Rosenberg has received research funding from Kite, Iovance Biotherapeutics, and ZIOPHARM Oncology.

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FROM JOURNAL OF CLINICAL ONCOLOGY

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