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How blunt is too blunt for informed consent?
Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.
“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.
In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.
“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”
That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.
“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”
Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.
How long an informed consent discussion takes depends on the procedure.
“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.
Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.
She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.
When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.
“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
Document, document, document!
To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.
“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”
It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.
In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).
“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
What happens when things go wrong?
If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.
“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”
Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.
Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.
“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”
To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.
“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”
For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.
Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.
“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”
In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.
“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”
A version of this article first appeared on Medscape.com.
Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.
“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.
In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.
“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”
That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.
“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”
Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.
How long an informed consent discussion takes depends on the procedure.
“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.
Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.
She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.
When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.
“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
Document, document, document!
To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.
“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”
It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.
In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).
“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
What happens when things go wrong?
If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.
“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”
Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.
Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.
“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”
To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.
“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”
For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.
Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.
“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”
In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.
“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”
A version of this article first appeared on Medscape.com.
Sitting across from a patient explaining a complicated treatment proposal, protocol, or medication may be one of the most complex yet crucial tasks you have as a physician. Although informed consent is at the forefront of shared decisions between you and your patient, there’s a fine line between providing enough information on the risks and benefits of a particular treatment and knowing you’ve explained it well enough to fully educate your patient about their choices.
“It is a bit of a fine line because unless your patient happens to be a health care provider, medicine is complicated for patients to understand,” said David L. Feldman, MD, chief medical officer at The Doctors Company, the nation’s largest medical malpractice insurer in New York.
In addition, documenting the interaction is critical, said James Giordano, PhD, MPhil, professor in the departments of neurology and biochemistry and chief of the neuroethics studies program at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center, Washington.
“As with anything in medicine, the key rule is that if it’s not documented, it’s not done,” he said. “This also means diligent documentation in all aspects of the medical record, including the electronic medical record and the written one.”
That said, it’s important to know what’s enough and what’s too granular when you discuss a procedure with your patients, said Erum N. Ilyas, MD, a board-certified dermatologist at Schweiger Dermatology and a bioethicist near Philadelphia.
“One of the most challenging aspects of informed consent, especially for young physicians, is how to discuss a procedure or a medication in a manner that is both relevant and concise,” Dr. llyas said. “I’ve had residents about to perform a skin biopsy spend several minutes covering every aspect of every potential outcome of a routine skin biopsy. The patient is left traumatized and confused as to whether they should proceed with the small procedure.”
Instead, the goal of informed consent is to ensure that the patient has a general overview of the procedure and is empowered, knowing that the decision to proceed is, indeed, part of their decision-making process.
How long an informed consent discussion takes depends on the procedure.
“When I was in practice as a plastic surgeon, the conversations varied from the straightforward ‘I’m taking this mole off your cheek, and there’s a risk of scarring and bleeding’ to talking about a mastectomy and breast reconstruction, which could take an hour or more to discuss,” Dr. Feldman said.
Ultimately, it’s as essential for doctors to explain the risks associated with a procedure as it is for patients to understand precisely what’s involved, Dr. Ilyas added.
She also recommends creating a flow to the conversation that places the discussion of risks within the context of why the procedure is being performed. This way, clarity about both the risks and the need for the treatment or procedure can be achieved.
When doing so, it’s critical to make sure you’re speaking your patient’s language – literally.
“Have a translator in the room if needed,” Dr. Feldman added. “If your patient is hearing or sight impaired, you need to have every contingency ready to ensure that everyone is in complete communication.”
Document, document, document!
To best protect yourself, the patient must consent to each procedure and intervention via active, informed consent, said Dr. Giordano.
“It’s not enough to hand a patient a piece of paper and say sign it,” he said. “There should be some documented evidence that the patient has not only read the document but that the key parts of the document have been explained and that the patient’s level of comprehension has been assessed and verified.”
It is vital if the patient has a disability, a neurological impairment, or a neurocognitive or psychiatric condition that might impede his or her ability to understand the consent that’s being sought.
In addition, it’s best if a ‘clinical proxy’ handles the consent (for example, a nurse, office worker, or case manager).
“This can be very helpful because it means you’ve had third-party documentation of informed consent,” Dr. Giordano said. “It should then be re-documented with you as the clinician and stated that the patient has affirmatively and actively agreed to treatment.”
What happens when things go wrong?
If you’re sued over informed consent, with the patient claiming that you didn’t fully explain the potential risks, the first thing to consider is why this happened.
“Very often, these situations occur if there was some difficulty or competency of communication,” Dr. Giordano said. “You may have done everything right, but somehow the patient hasn’t gained an understanding of the procedure required.”
Physicians must take a hard look at how they’re explaining risks and possible side effects. For doctors who perform these procedures regularly, the risks may seem small, and they may unconsciously minimize them to the patient. But when something goes wrong, the patient may then feel that they didn’t fully understand the frequency of poor outcomes, or the potential severity.
Next, it’s important to perform a ‘gap analysis’ to assess why something went awry. That means, look at all the potential factors involved to identify which one was the weak link.
“It might be that the patient was on a signing frenzy and signed away but didn’t receive active and informed content,” Dr. Giordano said. “The goal is to learn how to close the gap for this case and for future cases.”
To protect yourself, consider using technology to your advantage, especially since lawsuits over informed consent usually happen several years after the procedure. This is when a patient might argue that you didn’t tell them about possible complications and that they might have opted out of the procedure if they had known about those issues ahead of time.
“Even before the statute of limitations is up for a lawsuit, it could be five years from the time the procedure occurred due to the length of time a lawsuit can take,” Dr. Feldman said. “That’s why it’s important to take a video of your conversation or make a recording of the informed consent conversation. This way if there’s a question of what you said, there’s a video of it.”
For many physicians, this would be a big change – to video record and then store all their informed consent conversations. It could most likely help you if a lawsuit occurs, but some physicians may feel that process to be cumbersome and time-consuming, and they’d rather find another way to ensure that patients understand the risks.
Ultimately, however, if there’s a legal question involved with informed consent, the general thinking is that the effect on the patient must be harmful for it to stand up.
“The question becomes whether the outcome rendered that gap in the consenting process forgivable,” Dr. Giordano said. “The hope is that there was nothing harmful to the patient and that the benefit of the procedure was demonstrable despite any gaps in the informed consent process.”
In the end, informed consent should be a matter of good communication before, during, and after any treatment or procedure.
“When you form a relationship with a patient who needs any procedure, small or large, you’re going to be guiding them through a very scary thing,” Dr. Feldman said. “You want to make patients feel like you care about them and that, while neither you nor the system is perfect, you’ll take care of them. That’s the bottom line.”
A version of this article first appeared on Medscape.com.
Analysis of doctors’ EHR email finds infrequent but notable hostility
Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.
But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:
“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”
“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”
About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.
“F***” was the most common expletive used by patients.
Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”
Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”
“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.
“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”
Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.
Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.
Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”
On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.
Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.
Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.
The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”
A version of this article first appeared on Medscape.com.
Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.
But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:
“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”
“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”
About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.
“F***” was the most common expletive used by patients.
Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”
Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”
“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.
“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”
Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.
Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.
Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”
On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.
Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.
Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.
The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”
A version of this article first appeared on Medscape.com.
Among the emails, 43% were from patients; the remainder were mostly from other physicians or clinicians, or automated. The content of the messages wasn’t associated with doctor burnout, as the researchers had hypothesized. And only about 5% of the messages had negative sentiment.
But the researchers were struck by the hostility of that sentiment, displayed in messages like these that surely would be distressing for physicians to read:
“I hope and expect that you will spend eternity in he**. You are an abusive, nasty, cheap person.”
“Your office is full of liars, hypocrites and I will do everything in my power to prevent anyone from going to your bullsh** office again.”
About 5% of emails had an overall negative sentiment, with high-frequency words like “cancel,” “pain,” or “problem.” Among patient messages, 3% were negative and contained words and expletives suggesting hatred, hostility, or violence.
“F***” was the most common expletive used by patients.
Researchers provided examples of profanity-laced messages, including one patient who said, “I am so upset that I was told the blood work would include the gender of the baby. I have been waiting 5 [days] to find it, and it wasn’t even fu**ing tested!!!! What a disappointment in your office and the bullsh** I was told. I will be switching plans because this is sh**!”
Researchers also noted some high-frequency words associated with violence, such as “shoot,” “fight,” and “kill.”
“This is concerning, especially given documentation of patient-inflicted violence against physicians. Health systems should be proactive in ensuring that the in-basket does not become a venue for physician abuse and cyberbullying,” the researchers wrote in JAMA Network Open.
“Posting reminders in EHR patient portals to use kind language when sending messages, applying filters for expletives or threatening words, and creating frameworks for identifying patients who frequently send negative messages are potential strategies for mitigating this risk.”
Using a form of artificial intelligence technology called natural language processing (NLP), researchers at the University of California, San Diego, analyzed the characteristics of more than 1.4 million emails received by the university’s physicians, 43% of them from patients. They specifically looked at the volume of messages, word count, and overall sentiment.
Whereas other studies have examined the growing burden of EHR messaging for doctors, this type of email sentiment analysis could help in creating solutions. Researchers say that one such solution could involve applying filters for expletives or threatening words. It also could help identify fixable health system issues that make patients so angry, the researchers say.
Among the emails from physicians to physicians, just over half reported burnout, which correlated to the following phrases: “I am beginning to burn out and have one or more symptoms of burnout” and “I feel completely burned out [and] am at the point where I may need to seek help.”
On average, physicians who reported burnout received a greater volume of patient messages. The odds of burnout were significantly higher among Hispanic/Latinx physicians and females. Physicians with more than 15 years of clinical practice had markedly lower burnout.
Despite physicians now spending more time on EHR in-basket tasks than they did before the pandemic, the study found no significant associations between message characteristics and burnout.
Data for the cross-sectional study were collected from multiple specialties from April to September 2020. Physicians then completed a survey and assessed their burnout on a 5-point scale. Of the 609 physician responses, approximately 49% of participants were women, 56% were White, and 64% worked in outpatient settings. About 70% of the doctors had been in practice for 15 years or less.
The sentiment score was based on word content as well as the use of negation, punctuation, degree modifiers, all caps, emoticons, emojis, and acronyms. Positive patient messages were more likely to convey gratitude and thanks, along with casual expressions, such as “fyi” and “lol.”
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Single chest x-ray could predict 10-year CVD risk
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
who presented the results of their deep-learning model at the annual meeting of the Radiological Society of North America.
Current American College of Cardiologists and American Heart Association guidelines recommend estimating 10-year risk of major adverse cardiovascular events (MACE) to determine whether a patient should receive statins to help prevent atherosclerotic cardiovascular disease (ASCVD). Statins are recommended for patients with a 10-year risk of 7.5% or higher, the authors noted.
The current ASCVD risk score is determined with nine factors: age, sex, race, systolic blood pressure, hypertension treatment, smoking, type 2 diabetes, and a lipid panel.
Not all data points available in EHR
But not all of those data points may be available through the electronic health record, “which makes novel and easier approaches for population-wide screening desirable,” said lead researcher Jakob Weiss, MD, a radiologist affiliated with the Cardiovascular Imaging Research Center at Massachusetts General Hospital and the AI in medicine program at the Brigham and Women’s Hospital in Boston.
Chest x-ray images, on the other hand, are commonly available. The images carry rich information beyond diagnostic data but have not been used in this type of prediction model because AI models have been lacking, Dr. Weiss said.
The researchers trained a deep-learning model with single chest x-rays only.
They used 147,497 chest x-rays from 40,643 participants in the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) Screening Trial, a multicenter, randomized controlled trial designed and sponsored by the National Cancer Institute.
Dr. Weiss acknowledged that the population used to train the model was heavily White and that should be a consideration in validating the model.
They compared their model’s ability to predict 10-year ASCVD risk with the standard ACC/AHA model.
“Based on a single chest radiograph image, deep learning can predict the risk of future cardiovascular events independent of cardiovascular risk factors and with similar performance to the established and guideline-recommended ASCVD risk score,” Dr. Weiss said.
Tested against independent group
They tested the model against an independent group of 11,430 outpatients (average age, 60 years; 42.9% male) who underwent a routine outpatient chest x-ray at Mass General Brigham and were potentially eligible to receive statins.
Of those 11,430 patients, 1,096 (9.6%) had a major adverse cardiac event over the median follow-up of 10.3 years.
There was a significant association of CXR-CVD risk and MACE among patients eligible to receive statins, the researchers found (hazard ratio, 2.03; 95% confidence interval, 1.81-2.30; P < .001), which remained significant after adjusting for cardiovascular risk factors (adjusted HR, 1.63; 95% CI, 1.43-1.86; P < .001).
Some of the variables were missing in the standard model, but in a subgroup of 2,401 patients, all the variables were available.
They calculated ASCVD risk in that subgroup using the standard model and the CXR model and found that the performance was similar (c-statistic, 0.64 vs. 0.65; P = .48) to the ASCVD risk score (aHR, 1.58; 95% CI, 1.20-2.09; P = .001).
Ritu R. Gill MD, MPH, associate professor of radiology at Harvard Medical School in Boston, who was not part of the study, said in an interview that “the predictive algorithm is promising and potentially translatable and could enhance the annual medical checkup in a select population.
“The algorithm was developed using the PLCO cohort with radiographs, which are likely subjects in the lung cancer screening arm,” she said. “This cohort would be at high risk of cardiovascular diseases, as smoking is a known risk factor for atherosclerotic disease, and therefore the results are expected.
“The algorithm needs to be validated in an independent database with inclusion of subjects with younger age groups and adjusted for gender and racial diversity,” Gill said.
David Cho, MD, a cardiologist at the University of California, Los Angeles, who also was not part of the study, said in an interview that “this work is a great example of AI being able to detect clinically relevant outcomes with a widely used and low-cost screening test.
“The volume of data needed to train these models is already out there,” Dr. Cho said. “It just needs to be mined.”
He noted that this tool, if validated in randomized trials, could help determine risk among patients living in places where access to specialized cardiac care is limited.
Dr. Weiss and Dr. Cho disclosed no relevant financial relationships. Dr. Gill has received research support from Cannon Inc and consultant fees from Imbio and WorldCare.
A version of this article first appeared on Medscape.com.
AT RSNA 2022
Covid vax prevents death in children regardless of variant
The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.
However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.
In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.
Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.
The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.
Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).
During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).
Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.
Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.
The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.
“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
Study limitations and strengths
The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.
Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.
The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
Data support value of vaccination, outside experts say
“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted.
The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.
However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.
Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.
“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”
“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”
Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.
The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.
The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.
However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.
In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.
Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.
The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.
Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).
During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).
Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.
Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.
The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.
“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
Study limitations and strengths
The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.
Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.
The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
Data support value of vaccination, outside experts say
“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted.
The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.
However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.
Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.
“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”
“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”
Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.
The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.
The vaccine’s effectiveness against infection in the short term has been established, as has the waning effectiveness of the vaccine over time, wrote Juan Manuel Castelli, MD, of the Ministry of Health of Argentina, Buenos Aires, and colleagues, in the British Medical Journal.
However, data on the impact of vaccine effectiveness on mortality in children and adolescents are limited, especially during periods of omicron variant dominance, the researchers said.
In their new study, the researchers reviewed data from 844,460 children and adolescents aged 3-17 years from the National Surveillance System and the Nominalized Federal Vaccination Registry of Argentina, during a time that included a period of omicron dominance.
Argentina began vaccinating adolescents aged 12-17 years against COVID-19 in August 2021 and added children aged 3-11 years in October 2021. Those aged 12-17 years who were considered fully vaccinated received two doses of either Pfizer-BioNTech and/or Moderna vaccines, and fully-vaccinated 3- to 11-year-olds received two doses of Sinopharm vaccine.
The average time from the second vaccine dose to a COVID-19 test was 66 days for those aged 12-17 years and 54 days for 3- to 11-year-olds. The researchers matched COVID-19 cases with uninfected controls, and a total of 139,321 cases were included in the analysis.
Overall, the estimated vaccine effectiveness against COVID-19 was 64.2% during a period of delta dominance (61.2% in children aged 3-11 years and 66.8% in adolescents aged 12-17 years).
During a period of omicron dominance, estimated vaccine effectiveness was 19.9% across all ages (15.9% and 26.0% for younger and older age groups, respectively).
Effectiveness of the vaccine decreased over time, regardless of the dominant variant, but the decline was greater during the omicron dominant period, the researchers noted. During the omicron period, effectiveness in children aged 3-11 years decreased from 37.6% at 15-30 days postvaccination to 2.0% at 60 days or longer after vaccination. In adolescents aged 12-17 years, vaccine effectiveness during the omicron period decreased from 55.8% at 15-30 days postvaccination to 12.4% at 60 days or longer after vaccination.
Despite the waning protection against infection, the vaccine’s effectiveness against death from COVID-19 was 66.9% in children aged 3-11 years and 97.6% in adolescents aged 12-17 during the period of omicron dominance, the researchers noted.
The results are consistent with similar studies showing a decreased vaccine effectiveness against infection but a persistent effectiveness against deaths over time, the researchers wrote in the discussion section of their paper.
“Our results suggest that the primary vaccination schedule is effective in preventing mortality in children and adolescents with COVID-19 regardless of the circulating SARS-CoV-2 variant,” the researchers said.
Study limitations and strengths
The study was limited by several factors including the incomplete data on symptoms and hospital admissions, the possible impact of unmeasured confounding variables, and the observational design that prevents conclusions of causality, the researchers noted. However, the results were strengthened by the large sample size and access to detailed vaccination records, they said.
Both heterologous and homologous mRNA vaccine schedules showed similar effectiveness in preventing short-term infection and mortality from COVID-19 during periods of differing dominant variants, they noted.
The study findings support the vaccination of children against COVID-19 as an important public health measure to prevent mortality in children and adolescents, they concluded.
Data support value of vaccination, outside experts say
“COVID vaccines may not be as effective over time as the gene variants in the SARS-CoV-2 virus change,” Adrienne G. Randolph, MD, a pediatrician at Harvard Medical School and Boston Children’s Hospital, said in an interview. “Therefore, it is essential to assess vaccine effectiveness over time to look at effectiveness against variants and duration of effectiveness.” Dr. Randolph, who was not involved in the study, said she was not surprised by the findings, which she described as consistent with data from the United States. “COVID vaccines are very effective against preventing life-threatening disease, but the effectiveness against less severe illness for COVID vaccines is not as effective against Omicron,” she noted.
The take-home message for clinicians is that it’s important to get children vaccinated against COVID to prevent severe and life-threatening illness, said Dr. Randolph. “Although these cases are uncommon in children, it is not possible to predict which children will be the most severely affected by COVID,” she emphasized.
However, “we need more data on the new COVID booster vaccines in children that are designed to be more effective against Omicron’s newer variants,” Dr. Randolph said in an interview. “We also need more data on COVID vaccine effectiveness in the youngest children, under 5 years of age, and data on vaccinating mothers to prevent COVID in infants,” she said.
Tim Joos, MD, a Seattle-based clinician who practices a combination of internal medicine and pediatrics, agreed that future research should continue to assess how the new COVID boosters are faring against new variants, noting that the current study did not include data from children who received the new bivalent vaccine.
“The methodology of this study uses a test negative case control design which is common for estimating vaccine effectiveness post-release of a vaccine, but is subject to biases,” Dr. Joos explained. “These are not the clean effectiveness numbers of the prospective randomized control trials that we are used to hearing about when a vaccine is first being approved.”
“Nevertheless, the study reinforces the initial manufacturers’ studies that the vaccines are effective at preventing infection in the pediatric population,” Dr. Joos said in an interview. The current study also reinforces the effectiveness of vaccines in preventing “the rare but devastating mortality from COVID-19 in the pediatric population.”
Commenting on other research showing an increasing ratio of COVID deaths among vaccinated individuals compared to total COVID deaths, he noted that this finding is “likely reflecting a denominator effect of rapidly declining COVID deaths overall,” partly from the vaccines and partly from immunity after previous natural infection.
The study received no outside funding. The researchers, Dr. Randolph, and Dr. Joos had no financial conflicts to disclose. Dr. Joos serves on the Editorial Advisory Board of Pediatric News.
FROM THE BMJ
Doctor urges compassionate access to specialized radiotherapy for inoperable RCC
An individual patient data meta-analysis of patients undergoing stereotactic ablative body radiotherapy for primary renal cell carcinoma gives support for SABR as a treatment option for patients unwilling or unfit to undergo surgery, shows a study published in The Lancet Oncology.
The analysis, led by Shankar Siva, PhD, of the Peter MacCallum Cancer Centre, Melbourne, also showed that single-fraction SABR might yield less local failure than multifraction SABR.
The incidence of renal cell carcinoma is rising especially in patients older than 70 years, particularly among those with a greater burden of medical comorbidities who face additional risks from anesthesia and major surgery. As alternatives to radical or partial nephrectomy, guidelines recommend nephron-sparing approaches such as thermal ablation and SABR, a noninvasive procedure that avoids anesthesia. While a 2019 meta-analysis revealed promising safety and efficacy for SABR in patients with comorbidities, tumors of stage T1b or higher (that is, ≥ 4 cm) and in solitary kidneys, follow-up was only 28 months and long term outcome data have been awaited.
The current study assessed 5-year outcomes after SABR in primary renal cell carcinoma from the International Radiosurgery Consortium of the Kidney database plus patient data from 12 new contributing institutions in Australia, Canada, Germany, Japan and the United States. The primary endpoint was investigator-assessed local failure. Among 190 patients (median age, 73.6 years), 81 patients (43%) received single-fraction SABR and 109 (57%) received multifraction SABR, with all fractions greater than 5 Gy. Median tumor diameter was 4.0 cm (interquartile range, 2.8-4.9). Among patients with operability details available, referring urologists deemed 75% inoperable; 29% had a solitary kidney.
The cumulative incidence of local failure at 5 years was 5.5% (95% confidence interval, 2.8%–9.5%) overall. Patients receiving single-fraction SABR were observed to have improved local failure and progression-free survival, but not cancer-specific survival, compared with those receiving multifraction SABR.
“We found that multifraction SABR was associated with a 6-times higher risk of local failure after adjustment for baseline characteristics. This data is provocative and needs to be tested in a randomized trial,” Dr. Siva said in a Lancet Oncology podcast interview. There were no grade 3 toxic effects or treatment-related deaths. One patient developed an acute grade 4 duodenal ulcer and late grade 4 gastritis.
Reductions in estimated glomerular filtration rate (eGFR), from a median of 60.0 mL/min per 1.73 m2 at baseline were 10.0 mL/min per 1.73 m2 at 3 years and by 14.2 mL/min per 1.73 m2 at 5 years post SABR. “Most of these patients had severe chronic kidney disease, the median eGFR being only 33 mL/min,” Dr. Siva stated. “So overall the kidney function declines were quite acceptable.”
The results show, Dr. Siva and colleagues stated, that In the audio interview, Dr. Siva said, “I would suggest that we consider SABR for those patients who have larger, inoperable kidney cancers. SABR, in this context, is particularly attractive because these patients don’t have any alternative cure or treatment options. In my opinion, this group should be given compassionate access to SABR. It would be a great place to start.”
The authors acknowledged that because toxicity data were collected retrospectively, low rates of treatment-related toxic effects might be caused by underreporting.
Dr. Siva and colleagues reported no outside funding. Dr. Siva was supported by the Cancer Council Victoria Colebatch Fellowship.
An individual patient data meta-analysis of patients undergoing stereotactic ablative body radiotherapy for primary renal cell carcinoma gives support for SABR as a treatment option for patients unwilling or unfit to undergo surgery, shows a study published in The Lancet Oncology.
The analysis, led by Shankar Siva, PhD, of the Peter MacCallum Cancer Centre, Melbourne, also showed that single-fraction SABR might yield less local failure than multifraction SABR.
The incidence of renal cell carcinoma is rising especially in patients older than 70 years, particularly among those with a greater burden of medical comorbidities who face additional risks from anesthesia and major surgery. As alternatives to radical or partial nephrectomy, guidelines recommend nephron-sparing approaches such as thermal ablation and SABR, a noninvasive procedure that avoids anesthesia. While a 2019 meta-analysis revealed promising safety and efficacy for SABR in patients with comorbidities, tumors of stage T1b or higher (that is, ≥ 4 cm) and in solitary kidneys, follow-up was only 28 months and long term outcome data have been awaited.
The current study assessed 5-year outcomes after SABR in primary renal cell carcinoma from the International Radiosurgery Consortium of the Kidney database plus patient data from 12 new contributing institutions in Australia, Canada, Germany, Japan and the United States. The primary endpoint was investigator-assessed local failure. Among 190 patients (median age, 73.6 years), 81 patients (43%) received single-fraction SABR and 109 (57%) received multifraction SABR, with all fractions greater than 5 Gy. Median tumor diameter was 4.0 cm (interquartile range, 2.8-4.9). Among patients with operability details available, referring urologists deemed 75% inoperable; 29% had a solitary kidney.
The cumulative incidence of local failure at 5 years was 5.5% (95% confidence interval, 2.8%–9.5%) overall. Patients receiving single-fraction SABR were observed to have improved local failure and progression-free survival, but not cancer-specific survival, compared with those receiving multifraction SABR.
“We found that multifraction SABR was associated with a 6-times higher risk of local failure after adjustment for baseline characteristics. This data is provocative and needs to be tested in a randomized trial,” Dr. Siva said in a Lancet Oncology podcast interview. There were no grade 3 toxic effects or treatment-related deaths. One patient developed an acute grade 4 duodenal ulcer and late grade 4 gastritis.
Reductions in estimated glomerular filtration rate (eGFR), from a median of 60.0 mL/min per 1.73 m2 at baseline were 10.0 mL/min per 1.73 m2 at 3 years and by 14.2 mL/min per 1.73 m2 at 5 years post SABR. “Most of these patients had severe chronic kidney disease, the median eGFR being only 33 mL/min,” Dr. Siva stated. “So overall the kidney function declines were quite acceptable.”
The results show, Dr. Siva and colleagues stated, that In the audio interview, Dr. Siva said, “I would suggest that we consider SABR for those patients who have larger, inoperable kidney cancers. SABR, in this context, is particularly attractive because these patients don’t have any alternative cure or treatment options. In my opinion, this group should be given compassionate access to SABR. It would be a great place to start.”
The authors acknowledged that because toxicity data were collected retrospectively, low rates of treatment-related toxic effects might be caused by underreporting.
Dr. Siva and colleagues reported no outside funding. Dr. Siva was supported by the Cancer Council Victoria Colebatch Fellowship.
An individual patient data meta-analysis of patients undergoing stereotactic ablative body radiotherapy for primary renal cell carcinoma gives support for SABR as a treatment option for patients unwilling or unfit to undergo surgery, shows a study published in The Lancet Oncology.
The analysis, led by Shankar Siva, PhD, of the Peter MacCallum Cancer Centre, Melbourne, also showed that single-fraction SABR might yield less local failure than multifraction SABR.
The incidence of renal cell carcinoma is rising especially in patients older than 70 years, particularly among those with a greater burden of medical comorbidities who face additional risks from anesthesia and major surgery. As alternatives to radical or partial nephrectomy, guidelines recommend nephron-sparing approaches such as thermal ablation and SABR, a noninvasive procedure that avoids anesthesia. While a 2019 meta-analysis revealed promising safety and efficacy for SABR in patients with comorbidities, tumors of stage T1b or higher (that is, ≥ 4 cm) and in solitary kidneys, follow-up was only 28 months and long term outcome data have been awaited.
The current study assessed 5-year outcomes after SABR in primary renal cell carcinoma from the International Radiosurgery Consortium of the Kidney database plus patient data from 12 new contributing institutions in Australia, Canada, Germany, Japan and the United States. The primary endpoint was investigator-assessed local failure. Among 190 patients (median age, 73.6 years), 81 patients (43%) received single-fraction SABR and 109 (57%) received multifraction SABR, with all fractions greater than 5 Gy. Median tumor diameter was 4.0 cm (interquartile range, 2.8-4.9). Among patients with operability details available, referring urologists deemed 75% inoperable; 29% had a solitary kidney.
The cumulative incidence of local failure at 5 years was 5.5% (95% confidence interval, 2.8%–9.5%) overall. Patients receiving single-fraction SABR were observed to have improved local failure and progression-free survival, but not cancer-specific survival, compared with those receiving multifraction SABR.
“We found that multifraction SABR was associated with a 6-times higher risk of local failure after adjustment for baseline characteristics. This data is provocative and needs to be tested in a randomized trial,” Dr. Siva said in a Lancet Oncology podcast interview. There were no grade 3 toxic effects or treatment-related deaths. One patient developed an acute grade 4 duodenal ulcer and late grade 4 gastritis.
Reductions in estimated glomerular filtration rate (eGFR), from a median of 60.0 mL/min per 1.73 m2 at baseline were 10.0 mL/min per 1.73 m2 at 3 years and by 14.2 mL/min per 1.73 m2 at 5 years post SABR. “Most of these patients had severe chronic kidney disease, the median eGFR being only 33 mL/min,” Dr. Siva stated. “So overall the kidney function declines were quite acceptable.”
The results show, Dr. Siva and colleagues stated, that In the audio interview, Dr. Siva said, “I would suggest that we consider SABR for those patients who have larger, inoperable kidney cancers. SABR, in this context, is particularly attractive because these patients don’t have any alternative cure or treatment options. In my opinion, this group should be given compassionate access to SABR. It would be a great place to start.”
The authors acknowledged that because toxicity data were collected retrospectively, low rates of treatment-related toxic effects might be caused by underreporting.
Dr. Siva and colleagues reported no outside funding. Dr. Siva was supported by the Cancer Council Victoria Colebatch Fellowship.
FROM THE LANCET ONCOLOGY
U.S. biosimilar competition, use, and availability still lags behind European countries
The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.
Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.
As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.
“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.
To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.
They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.
Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.
On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.
The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.
However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.
Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.
The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.
The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.
Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.
As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.
“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.
To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.
They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.
Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.
On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.
The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.
However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.
Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.
The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.
The uptake and treatment costs of biosimilar drugs in the United States from 2011 to 2020 were significantly higher than in both Germany and Switzerland, based on data from a cohort study of publicly available commercial databases.
Biologics remain the fastest growing segment of drug research and development, but their costs remain high, David L. Carl, MSc, of the University of Zurich, and colleagues wrote in their study, published online in JAMA Network Open.
As patents and regulatory exclusivity periods expire, biologics face competition from biosimilars, which may drive competition and lower prices, they said.
“However, studies have shown that there are varying policies and biosimilar uptake in European countries and that the observed levels of competition and uptake have not reached the expected levels in the U.S.,” the researchers said.
To assist the discussions of policy makers in the United States and Europe as they consider legislative and regulatory reforms that are intended to promote the competition of biosimilars, the researchers reviewed data from 15 biosimilars and 6 biologics in the United States, 52 biosimilars and 15 biologics in Germany, and 28 biosimilars and 13 biologics in Switzerland.
They analyzed temporal trends in the uptake of biosimilars and their relative prices, compared with the prices of biologics in each country, by obtaining wholesale acquisition costs from online drug pricing databases. They extracted quarterly sales volume data for 2011-2020 from the IQVIA database. In the case of confidential rebates in Switzerland, the researchers obtained list prices.
Overall, the uptake of biosimilars increased in all three countries during the study period. However, the prices of biosimilars and the reference products were significantly higher in the United States, compared with Germany and Switzerland, both of which have national mechanisms for drug price negotiation. The monthly treatment cost of biosimilars was a median of 1.94 and 2.74 times higher in the United States than in Germany and Switzerland, respectively.
On average, the biosimilar market share at launch was highest in Germany; however, it increased at the fastest rate in the United States.
The findings were limited by several factors, including the sample size and the inclusion only of sales data provided by IQVIA, and by the use of list prices only without accounting for drug rebates, the researchers noted. Other limitations were the inability to compare conclusions from the United States and European Union directly because the drugs entered markets at different times, and not all the same drugs have been approved or designated as biosimilars, they said.
However, the results illustrate a difference in uptake of biosimilars in the United States with a reduced impact on drug costs, they said.
Looking ahead, “Policies for drug pricing negotiations in the U.S. against anticompetitive practices of exclusionary contracts could allow biosimilars to enter the market sooner and at lower costs, which could result in lower health care costs and improved patient access,” they concluded.
The study was partially funded by the Swiss National Science Foundation. Lead author Mr. Carl had no financial conflicts to disclose; several coauthors disclosed funding from organizations including The Health Foundation, the U.K. National Institute for Health Research, and the Pharmaceutical Group of the European Union; all were unrelated to the current study.
FROM JAMA NETWORK OPEN
Gestational hypertension-diabetes combo signals CVD risk
Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.
In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.
When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).
Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.
“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.
“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”
It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.
“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
Study rationale and design
GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.
For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.
The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).
After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
Pregnancy is a stress test for the heart
“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.
“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”
That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.
“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”
Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”
The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.
“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.
Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”
The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.
“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.
“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.
She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”
The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.
Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.
In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.
When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).
Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.
“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.
“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”
It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.
“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
Study rationale and design
GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.
For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.
The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).
After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
Pregnancy is a stress test for the heart
“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.
“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”
That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.
“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”
Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”
The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.
“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.
Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”
The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.
“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.
“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.
She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”
The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.
Women who develop transient hypertensive disorders during their pregnancy are at risk for developing subsequent cardiovascular disease (CVD), particularly if this experienced at the same time as gestational diabetes.
In a large population-based study, the adjusted hazard ratios for developing CVD following a gestational hypertensive disorder (GHTD) alone were 1.90 (95% confidence interval, 1.151-2.25) within 5 years and 1.41 (95% CI, 1.12-1.76) after 5 years or more.
When gestational diabetes was added into the mix, however, the risk for CVD after 5 years more than doubled (aHR, 2.43; 95% CI, 1.60-3.67). Risk in the earlier postpartum period was also raised by the combination, but this was not significant (aHR, 1.42; 95% CI, 0.78-2.58).
Having gestational diabetes by itself did not seem to increase the risk for later CVD in the analysis, despite being linked to higher heart disease risk in other studies.
“These are women coming out of a pregnancy – young women of reproductive age – so this is not a group that typically has cardiovascular events,” said Ravi Retnakaran, MD, in an interview, an investigator in the new study, which is published in JAMA Network Open.
“If they are somebody who has both disorders concurrently in their pregnancy, they may be at even greater risk than a woman with one or the other disorder,” added Dr. Retnakaran, who is professor of medicine at the University of Toronto and an endocrinologist at the Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, also in Toronto. “In other words, amongst already high-risk patients. This is identifying a subset at maybe an even higher risk.”
It doesn’t mean that there is a huge absolute risk, Dr. Retnakaran said, but it is showing that there is a heightened risk such that women and their clinicians need to be aware of and potentially the need for greater preventative care in the future.
“It is allowing you to identify future lifetime risk of cardiovascular disease,” he said.
Study rationale and design
GHTD is “a forerunner of hypertension,” and gestational diabetes is “a precursor of diabetes” – each associated with a high risk of developing CVD in the years after pregnancy, the investigators said. While studies have looked at their individual contributions to future CVD risk, not many had looked to see what risks having both may confer in the postpregnancy years.
For the analysis, data on 886,295 women with GHTD (43,861), gestational diabetes (54,061), both (4,975), or neither (783,398) were obtained from several Canadian administrative health databases.
The mean age was around 30 years across the groups, with those with both conditions or gestational diabetes alone more likely to be older than those with GTHD alone or neither condition (32 vs. 29 years, respectively, P < .001).
After a total follow-up period of 12 years, 1,999 CVD events were recorded, most of them (1,162) 5 years after the pregnancy.
Pregnancy is a stress test for the heart
“We know that what we call adverse pregnancy outcomes – things like gestational hypertension, and gestational diabetes, and preeclampsia – are on the rise globally,” Natalie A. Bello, MD, director of hypertension research at the Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, commented in an interview.
“People who are younger and of childbearing age who are going into pregnancy now are less healthy than they perhaps were in the past,” Dr. Bello suggested, with more hypertension, more obesity, and people being less physically active. “We think that’s translating into some of the pregnancy complications.”
That’s concerning for a number of reasons, said Dr. Bello, who is also the cochair of the American College of Cardiology’s Cardio-Obstetrics Workgroup, and the biggest one perhaps is the stress that these may conditions may be placing on the heart.
“We know that when individuals have an adverse pregnancy outcome like gestational hypertension, or gestational diabetes, their risk for heart disease is increased in the future compared to someone who has an uncomplicated pregnancy,” she said. “So, we sort of say pregnancy is like a stress test for your heart.”
Dr. Bello added that “these situations, these adverse pregnancy outcomes are an indicator for us as physicians, but also they should be for patients as well, to sort of make sure they’re talking to their doctor about their risk factors and modifying them whenever possible.”
The population studied came from quite a racially, ethnically, and economically diverse area of Canada, Dr. Bello pointed out, although because of the nature of an administrative database there wasn’t information on individual level risk factors.
“We don’t know things like smoking, or if individuals were obese when they were pregnant. So, there are some limitations that should be noted,” she said.
Also, the results don’t mean that isolated gestational diabetes “isn’t something we need to be concerned about,” Dr. Bello observed, adding that the study may have been underpowered to look at this association. “It may just be that it will take a longer time for individuals who have gestational diabetes who don’t make lifestyle changes to develop diabetes, and then develop heart disease.”
The main message is that the women who have a co-occurrence of gestational hypertension and gestational diabetes are at particularly high risk of cardiovascular disease in the future,” said Dr. Retnakaran.
“The way to look at it from a patient standpoint is that we are all on different tracks in terms of our cardiometabolic destiny,” and that these data give “some understanding of what kind of tracks they are on for future risk,” Dr. Retnakaran said.
“A history of either gestational hypertension, and/or gestational diabetes should be really a warning sign for physicians and for patients that they have a higher risk of heart disease,” said Dr. Bello.
She added that this is a signal “that we need to do things to modify their risk, because we know that about 80% of heart disease is modifiable and preventable with proper risk factor management.”
The study was funded by the Ontario Ministry of Health and Long-Term Care. Dr. Retnakaran has received grants and personal fees from Novo Nordisk and Merck, grants from Boehringer Ingelheim, and personal fees from Eli Lily Takeda, and Sanofi. Dr. Bello had no conflicts of interest to disclose.
FROM JAMA NETWORK OPEN
What the election results mean for GI
In the Senate, Democrats clinched the majority with 50 seats. Only one race, Georgia, is still undecided where a December runoff is planned. This race will not flip the majority since Vice President Kamala Harris casts tie-breaking votes as the President of the Senate.
Republicans recaptured control of the House after reaching 218 seats – enough to take control but the sweeping flip “red wave” did not occur as predicted. Republicans currently hold 220 seats to 213 Democratic seats, while two seats remain undecided. Margins in both chambers are slim, reflecting the division in the country.
What does this mean?
The majorities in both chambers are razor thin and compromises will need to be made to pass funding bills and other priorities.
AGA will continue to prioritize our bipartisan efforts with congressional champions on both sides of the aisle, including Rep. Ami Bera (D-Calif.), Rep. Larry Bucshon (R-Ind.), Sen. Sherrod Brown (D-Ohio), and Sen. Bill Cassidy (R-La.). For the remainder of this Congress, we will fight to:
- Encourage the Senate to take a vote on the House-passed prior authorization reform bill.
- Support robust federal research funding for gastroenterology.
- Reduce dangerous cuts in the Medicare Physician Fee Schedule, effective Jan. 1, 2023.
In the Senate, Democrats clinched the majority with 50 seats. Only one race, Georgia, is still undecided where a December runoff is planned. This race will not flip the majority since Vice President Kamala Harris casts tie-breaking votes as the President of the Senate.
Republicans recaptured control of the House after reaching 218 seats – enough to take control but the sweeping flip “red wave” did not occur as predicted. Republicans currently hold 220 seats to 213 Democratic seats, while two seats remain undecided. Margins in both chambers are slim, reflecting the division in the country.
What does this mean?
The majorities in both chambers are razor thin and compromises will need to be made to pass funding bills and other priorities.
AGA will continue to prioritize our bipartisan efforts with congressional champions on both sides of the aisle, including Rep. Ami Bera (D-Calif.), Rep. Larry Bucshon (R-Ind.), Sen. Sherrod Brown (D-Ohio), and Sen. Bill Cassidy (R-La.). For the remainder of this Congress, we will fight to:
- Encourage the Senate to take a vote on the House-passed prior authorization reform bill.
- Support robust federal research funding for gastroenterology.
- Reduce dangerous cuts in the Medicare Physician Fee Schedule, effective Jan. 1, 2023.
In the Senate, Democrats clinched the majority with 50 seats. Only one race, Georgia, is still undecided where a December runoff is planned. This race will not flip the majority since Vice President Kamala Harris casts tie-breaking votes as the President of the Senate.
Republicans recaptured control of the House after reaching 218 seats – enough to take control but the sweeping flip “red wave” did not occur as predicted. Republicans currently hold 220 seats to 213 Democratic seats, while two seats remain undecided. Margins in both chambers are slim, reflecting the division in the country.
What does this mean?
The majorities in both chambers are razor thin and compromises will need to be made to pass funding bills and other priorities.
AGA will continue to prioritize our bipartisan efforts with congressional champions on both sides of the aisle, including Rep. Ami Bera (D-Calif.), Rep. Larry Bucshon (R-Ind.), Sen. Sherrod Brown (D-Ohio), and Sen. Bill Cassidy (R-La.). For the remainder of this Congress, we will fight to:
- Encourage the Senate to take a vote on the House-passed prior authorization reform bill.
- Support robust federal research funding for gastroenterology.
- Reduce dangerous cuts in the Medicare Physician Fee Schedule, effective Jan. 1, 2023.
AGA makes its first investment through new GI innovation fund
Virgo provides gastroenterologists, clinical trial sponsors, and trial site investigators with artificial intelligence–fueled, always-on endoscopic procedure recording and patient recruitment tools for clinical trials in gastroenterology, starting with inflammatory bowel disease clinical trials.
Virgo provides gastroenterologists, clinical trial sponsors, and trial site investigators with artificial intelligence–fueled, always-on endoscopic procedure recording and patient recruitment tools for clinical trials in gastroenterology, starting with inflammatory bowel disease clinical trials.
Virgo provides gastroenterologists, clinical trial sponsors, and trial site investigators with artificial intelligence–fueled, always-on endoscopic procedure recording and patient recruitment tools for clinical trials in gastroenterology, starting with inflammatory bowel disease clinical trials.
Highlights in Breast Cancer From SITC 2022
Jennifer Guerriero, PhD, from Brigham and Women's Hospital in Boston, Massachusetts, shares highlights in breast cancer from the 37th Annual Meeting of the Society for Immunotherapy of Cancer.
She begins with a study of the tumor microenvironment that found a range of MHC-1 expression across breast cancer subtypes. Crucially, expression appears to affect the local immune landscape and response to immunotherapy.
Next, she looks at a study that showed that the tyrosine kinase Ron affects T-cell recruitment into sites of metastatic breast cancer, offering a potential therapeutic target via Ron kinase inhibitors.
Dr Guerriero moves on to a study exploring tumor antigen-specific antibody responses in patients with metastatic triple-negative breast cancer patients and their association with immunotherapy outcomes.
This is followed by a phase 1/2 trial in which an in situ anti-cancer vaccine was created with a combination of four treatments, achieving responses in heavily pretreated patients.
Dr Guerriero ends with a series of posters on CT-0508, a novel anti-HER2 chimeric antigen receptor macrophage therapy, that showed encouraging activity in targeting HER2 overexpressing tumors.
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Assistant Professor, Department of Surgery, Division of Breast Surgery, Brigham and Women's Hospital, Boston, Massachusetts
Jennifer L. Guerriero, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Mersana; Duke St Bio; AstraZeneca; OncoOne
Received research grant from: Merck
Jennifer Guerriero, PhD, from Brigham and Women's Hospital in Boston, Massachusetts, shares highlights in breast cancer from the 37th Annual Meeting of the Society for Immunotherapy of Cancer.
She begins with a study of the tumor microenvironment that found a range of MHC-1 expression across breast cancer subtypes. Crucially, expression appears to affect the local immune landscape and response to immunotherapy.
Next, she looks at a study that showed that the tyrosine kinase Ron affects T-cell recruitment into sites of metastatic breast cancer, offering a potential therapeutic target via Ron kinase inhibitors.
Dr Guerriero moves on to a study exploring tumor antigen-specific antibody responses in patients with metastatic triple-negative breast cancer patients and their association with immunotherapy outcomes.
This is followed by a phase 1/2 trial in which an in situ anti-cancer vaccine was created with a combination of four treatments, achieving responses in heavily pretreated patients.
Dr Guerriero ends with a series of posters on CT-0508, a novel anti-HER2 chimeric antigen receptor macrophage therapy, that showed encouraging activity in targeting HER2 overexpressing tumors.
--
Assistant Professor, Department of Surgery, Division of Breast Surgery, Brigham and Women's Hospital, Boston, Massachusetts
Jennifer L. Guerriero, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Mersana; Duke St Bio; AstraZeneca; OncoOne
Received research grant from: Merck
Jennifer Guerriero, PhD, from Brigham and Women's Hospital in Boston, Massachusetts, shares highlights in breast cancer from the 37th Annual Meeting of the Society for Immunotherapy of Cancer.
She begins with a study of the tumor microenvironment that found a range of MHC-1 expression across breast cancer subtypes. Crucially, expression appears to affect the local immune landscape and response to immunotherapy.
Next, she looks at a study that showed that the tyrosine kinase Ron affects T-cell recruitment into sites of metastatic breast cancer, offering a potential therapeutic target via Ron kinase inhibitors.
Dr Guerriero moves on to a study exploring tumor antigen-specific antibody responses in patients with metastatic triple-negative breast cancer patients and their association with immunotherapy outcomes.
This is followed by a phase 1/2 trial in which an in situ anti-cancer vaccine was created with a combination of four treatments, achieving responses in heavily pretreated patients.
Dr Guerriero ends with a series of posters on CT-0508, a novel anti-HER2 chimeric antigen receptor macrophage therapy, that showed encouraging activity in targeting HER2 overexpressing tumors.
--
Assistant Professor, Department of Surgery, Division of Breast Surgery, Brigham and Women's Hospital, Boston, Massachusetts
Jennifer L. Guerriero, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Mersana; Duke St Bio; AstraZeneca; OncoOne
Received research grant from: Merck
