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Are Women Better Doctors Than Men?
This transcript has been edited for clarity.
It’s a battle of the sexes today as we dive into a paper that makes you say, “Wow, what an interesting study” and also “Boy, am I glad I didn’t do that study.” That’s because studies like this are always somewhat fraught; they say something about medicine but also something about society — and that makes this a bit precarious. But that’s never stopped us before. So, let’s go ahead and try to answer the question: Do women make better doctors than men?
On the surface, this question seems nearly impossible to answer. It’s too broad; what does it mean to be a “better” doctor? At first blush it seems that there are just too many variables to control for here: the type of doctor, the type of patient, the clinical scenario, and so on.
But this study, “Comparison of hospital mortality and readmission rates by physician and patient sex,” which appears in Annals of Internal Medicine, uses a fairly ingenious method to cut through all the bias by leveraging two simple facts: First, hospital medicine is largely conducted by hospitalists these days; second, due to the shift-based nature of hospitalist work, the hospitalist you get when you are admitted to the hospital is pretty much random.
In other words, if you are admitted to the hospital for an acute illness and get a hospitalist as your attending, you have no control over whether it is a man or a woman. Is this a randomized trial? No, but it’s not bad.
Researchers used Medicare claims data to identify adults over age 65 who had nonelective hospital admissions throughout the United States. The claims revealed the sex of the patient and the name of the attending physician. By linking to a medical provider database, they could determine the sex of the provider.
The goal was to look at outcomes across four dyads:
- Male patient – male doctor
- Male patient – female doctor
- Female patient – male doctor
- Female patient – female doctor
The primary outcome was 30-day mortality.
I told you that focusing on hospitalists produces some pseudorandomization, but let’s look at the data to be sure. Just under a million patients were treated by approximately 50,000 physicians, 30% of whom were female. And, though female patients and male patients differed, they did not differ with respect to the sex of their hospitalist. So, by physician sex, patients were similar in mean age, race, ethnicity, household income, eligibility for Medicaid, and comorbid conditions. The authors even created a “predicted mortality” score which was similar across the groups as well.
Now, the female physicians were a bit different from the male physicians. The female hospitalists were slightly more likely to have an osteopathic degree, had slightly fewer admissions per year, and were a bit younger.
So, we have broadly similar patients regardless of who their hospitalist was, but hospitalists differ by factors other than their sex. Fine.
I’ve graphed the results here. 
This is a relatively small effect, to be sure, but if you multiply it across the millions of hospitalist admissions per year, you can start to put up some real numbers.
So, what is going on here? I see four broad buckets of possibilities.
Let’s start with the obvious explanation: Women, on average, are better doctors than men. I am married to a woman doctor, and based on my personal experience, this explanation is undoubtedly true. But why would that be?
The authors cite data that suggest that female physicians are less likely than male physicians to dismiss patient concerns — and in particular, the concerns of female patients — perhaps leading to fewer missed diagnoses. But this is impossible to measure with administrative data, so this study can no more tell us whether these female hospitalists are more attentive than their male counterparts than it can suggest that the benefit is mediated by the shorter average height of female physicians. Perhaps the key is being closer to the patient?
The second possibility here is that this has nothing to do with the sex of the physician at all; it has to do with those other things that associate with the sex of the physician. We know, for example, that the female physicians saw fewer patients per year than the male physicians, but the study authors adjusted for this in the statistical models. Still, other unmeasured factors (confounders) could be present. By the way, confounders wouldn’t necessarily change the primary finding — you are better off being cared for by female physicians. It’s just not because they are female; it’s a convenient marker for some other quality, such as age.
The third possibility is that the study represents a phenomenon called collider bias. The idea here is that physicians only get into the study if they are hospitalists, and the quality of physicians who choose to become a hospitalist may differ by sex. When deciding on a specialty, a talented resident considering certain lifestyle issues may find hospital medicine particularly attractive — and that draw toward a more lifestyle-friendly specialty may differ by sex, as some prior studies have shown. If true, the pool of women hospitalists may be better than their male counterparts because male physicians of that caliber don’t become hospitalists.
Okay, don’t write in. I’m just trying to cite examples of how to think about collider bias. I can’t prove that this is the case, and in fact the authors do a sensitivity analysis of all physicians, not just hospitalists, and show the same thing. So this is probably not true, but epidemiology is fun, right?
And the fourth possibility: This is nothing but statistical noise. The effect size is incredibly small and just on the border of statistical significance. Especially when you’re working with very large datasets like this, you’ve got to be really careful about overinterpreting statistically significant findings that are nevertheless of small magnitude.
Regardless, it’s an interesting study, one that made me think and, of course, worry a bit about how I would present it. Forgive me if I’ve been indelicate in handling the complex issues of sex, gender, and society here. But I’m not sure what you expect; after all, I’m only a male doctor.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
It’s a battle of the sexes today as we dive into a paper that makes you say, “Wow, what an interesting study” and also “Boy, am I glad I didn’t do that study.” That’s because studies like this are always somewhat fraught; they say something about medicine but also something about society — and that makes this a bit precarious. But that’s never stopped us before. So, let’s go ahead and try to answer the question: Do women make better doctors than men?
On the surface, this question seems nearly impossible to answer. It’s too broad; what does it mean to be a “better” doctor? At first blush it seems that there are just too many variables to control for here: the type of doctor, the type of patient, the clinical scenario, and so on.
But this study, “Comparison of hospital mortality and readmission rates by physician and patient sex,” which appears in Annals of Internal Medicine, uses a fairly ingenious method to cut through all the bias by leveraging two simple facts: First, hospital medicine is largely conducted by hospitalists these days; second, due to the shift-based nature of hospitalist work, the hospitalist you get when you are admitted to the hospital is pretty much random.
In other words, if you are admitted to the hospital for an acute illness and get a hospitalist as your attending, you have no control over whether it is a man or a woman. Is this a randomized trial? No, but it’s not bad.
Researchers used Medicare claims data to identify adults over age 65 who had nonelective hospital admissions throughout the United States. The claims revealed the sex of the patient and the name of the attending physician. By linking to a medical provider database, they could determine the sex of the provider.
The goal was to look at outcomes across four dyads:
- Male patient – male doctor
- Male patient – female doctor
- Female patient – male doctor
- Female patient – female doctor
The primary outcome was 30-day mortality.
I told you that focusing on hospitalists produces some pseudorandomization, but let’s look at the data to be sure. Just under a million patients were treated by approximately 50,000 physicians, 30% of whom were female. And, though female patients and male patients differed, they did not differ with respect to the sex of their hospitalist. So, by physician sex, patients were similar in mean age, race, ethnicity, household income, eligibility for Medicaid, and comorbid conditions. The authors even created a “predicted mortality” score which was similar across the groups as well.
Now, the female physicians were a bit different from the male physicians. The female hospitalists were slightly more likely to have an osteopathic degree, had slightly fewer admissions per year, and were a bit younger.
So, we have broadly similar patients regardless of who their hospitalist was, but hospitalists differ by factors other than their sex. Fine.
I’ve graphed the results here.
This is a relatively small effect, to be sure, but if you multiply it across the millions of hospitalist admissions per year, you can start to put up some real numbers.
So, what is going on here? I see four broad buckets of possibilities.
Let’s start with the obvious explanation: Women, on average, are better doctors than men. I am married to a woman doctor, and based on my personal experience, this explanation is undoubtedly true. But why would that be?
The authors cite data that suggest that female physicians are less likely than male physicians to dismiss patient concerns — and in particular, the concerns of female patients — perhaps leading to fewer missed diagnoses. But this is impossible to measure with administrative data, so this study can no more tell us whether these female hospitalists are more attentive than their male counterparts than it can suggest that the benefit is mediated by the shorter average height of female physicians. Perhaps the key is being closer to the patient?
The second possibility here is that this has nothing to do with the sex of the physician at all; it has to do with those other things that associate with the sex of the physician. We know, for example, that the female physicians saw fewer patients per year than the male physicians, but the study authors adjusted for this in the statistical models. Still, other unmeasured factors (confounders) could be present. By the way, confounders wouldn’t necessarily change the primary finding — you are better off being cared for by female physicians. It’s just not because they are female; it’s a convenient marker for some other quality, such as age.
The third possibility is that the study represents a phenomenon called collider bias. The idea here is that physicians only get into the study if they are hospitalists, and the quality of physicians who choose to become a hospitalist may differ by sex. When deciding on a specialty, a talented resident considering certain lifestyle issues may find hospital medicine particularly attractive — and that draw toward a more lifestyle-friendly specialty may differ by sex, as some prior studies have shown. If true, the pool of women hospitalists may be better than their male counterparts because male physicians of that caliber don’t become hospitalists.
Okay, don’t write in. I’m just trying to cite examples of how to think about collider bias. I can’t prove that this is the case, and in fact the authors do a sensitivity analysis of all physicians, not just hospitalists, and show the same thing. So this is probably not true, but epidemiology is fun, right?
And the fourth possibility: This is nothing but statistical noise. The effect size is incredibly small and just on the border of statistical significance. Especially when you’re working with very large datasets like this, you’ve got to be really careful about overinterpreting statistically significant findings that are nevertheless of small magnitude.
Regardless, it’s an interesting study, one that made me think and, of course, worry a bit about how I would present it. Forgive me if I’ve been indelicate in handling the complex issues of sex, gender, and society here. But I’m not sure what you expect; after all, I’m only a male doctor.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
It’s a battle of the sexes today as we dive into a paper that makes you say, “Wow, what an interesting study” and also “Boy, am I glad I didn’t do that study.” That’s because studies like this are always somewhat fraught; they say something about medicine but also something about society — and that makes this a bit precarious. But that’s never stopped us before. So, let’s go ahead and try to answer the question: Do women make better doctors than men?
On the surface, this question seems nearly impossible to answer. It’s too broad; what does it mean to be a “better” doctor? At first blush it seems that there are just too many variables to control for here: the type of doctor, the type of patient, the clinical scenario, and so on.
But this study, “Comparison of hospital mortality and readmission rates by physician and patient sex,” which appears in Annals of Internal Medicine, uses a fairly ingenious method to cut through all the bias by leveraging two simple facts: First, hospital medicine is largely conducted by hospitalists these days; second, due to the shift-based nature of hospitalist work, the hospitalist you get when you are admitted to the hospital is pretty much random.
In other words, if you are admitted to the hospital for an acute illness and get a hospitalist as your attending, you have no control over whether it is a man or a woman. Is this a randomized trial? No, but it’s not bad.
Researchers used Medicare claims data to identify adults over age 65 who had nonelective hospital admissions throughout the United States. The claims revealed the sex of the patient and the name of the attending physician. By linking to a medical provider database, they could determine the sex of the provider.
The goal was to look at outcomes across four dyads:
- Male patient – male doctor
- Male patient – female doctor
- Female patient – male doctor
- Female patient – female doctor
The primary outcome was 30-day mortality.
I told you that focusing on hospitalists produces some pseudorandomization, but let’s look at the data to be sure. Just under a million patients were treated by approximately 50,000 physicians, 30% of whom were female. And, though female patients and male patients differed, they did not differ with respect to the sex of their hospitalist. So, by physician sex, patients were similar in mean age, race, ethnicity, household income, eligibility for Medicaid, and comorbid conditions. The authors even created a “predicted mortality” score which was similar across the groups as well.
Now, the female physicians were a bit different from the male physicians. The female hospitalists were slightly more likely to have an osteopathic degree, had slightly fewer admissions per year, and were a bit younger.
So, we have broadly similar patients regardless of who their hospitalist was, but hospitalists differ by factors other than their sex. Fine.
I’ve graphed the results here.
This is a relatively small effect, to be sure, but if you multiply it across the millions of hospitalist admissions per year, you can start to put up some real numbers.
So, what is going on here? I see four broad buckets of possibilities.
Let’s start with the obvious explanation: Women, on average, are better doctors than men. I am married to a woman doctor, and based on my personal experience, this explanation is undoubtedly true. But why would that be?
The authors cite data that suggest that female physicians are less likely than male physicians to dismiss patient concerns — and in particular, the concerns of female patients — perhaps leading to fewer missed diagnoses. But this is impossible to measure with administrative data, so this study can no more tell us whether these female hospitalists are more attentive than their male counterparts than it can suggest that the benefit is mediated by the shorter average height of female physicians. Perhaps the key is being closer to the patient?
The second possibility here is that this has nothing to do with the sex of the physician at all; it has to do with those other things that associate with the sex of the physician. We know, for example, that the female physicians saw fewer patients per year than the male physicians, but the study authors adjusted for this in the statistical models. Still, other unmeasured factors (confounders) could be present. By the way, confounders wouldn’t necessarily change the primary finding — you are better off being cared for by female physicians. It’s just not because they are female; it’s a convenient marker for some other quality, such as age.
The third possibility is that the study represents a phenomenon called collider bias. The idea here is that physicians only get into the study if they are hospitalists, and the quality of physicians who choose to become a hospitalist may differ by sex. When deciding on a specialty, a talented resident considering certain lifestyle issues may find hospital medicine particularly attractive — and that draw toward a more lifestyle-friendly specialty may differ by sex, as some prior studies have shown. If true, the pool of women hospitalists may be better than their male counterparts because male physicians of that caliber don’t become hospitalists.
Okay, don’t write in. I’m just trying to cite examples of how to think about collider bias. I can’t prove that this is the case, and in fact the authors do a sensitivity analysis of all physicians, not just hospitalists, and show the same thing. So this is probably not true, but epidemiology is fun, right?
And the fourth possibility: This is nothing but statistical noise. The effect size is incredibly small and just on the border of statistical significance. Especially when you’re working with very large datasets like this, you’ve got to be really careful about overinterpreting statistically significant findings that are nevertheless of small magnitude.
Regardless, it’s an interesting study, one that made me think and, of course, worry a bit about how I would present it. Forgive me if I’ve been indelicate in handling the complex issues of sex, gender, and society here. But I’m not sure what you expect; after all, I’m only a male doctor.
Dr. Wilson is associate professor of medicine and public health and director of the Clinical and Translational Research Accelerator at Yale University, New Haven, Conn. He has disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Menopause, RSV, and More: 4 New Meds to Know
BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date.
A New First-Line for GERD?
Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD).
GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.
“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees.
Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.
Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.
Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
Nonhormonal Drug for Menopause
Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.
“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.
Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia.
Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.
“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
RSV Vaccine for Everyone
Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention.
The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.
Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.
Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.
“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.
As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
New Antidepressants
A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.
Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression.
Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.
“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.”
Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said.
Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said.
Gepirone will be available to prescribe to patients in fall 2024.
Dr. Smetana reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date.
A New First-Line for GERD?
Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD).
GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.
“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees.
Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.
Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.
Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
Nonhormonal Drug for Menopause
Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.
“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.
Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia.
Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.
“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
RSV Vaccine for Everyone
Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention.
The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.
Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.
Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.
“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.
As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
New Antidepressants
A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.
Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression.
Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.
“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.”
Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said.
Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said.
Gepirone will be available to prescribe to patients in fall 2024.
Dr. Smetana reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date.
A New First-Line for GERD?
Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD).
GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.
“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees.
Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.
The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.
Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.
Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
Nonhormonal Drug for Menopause
Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.
“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.
Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia.
Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.
“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
RSV Vaccine for Everyone
Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention.
The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.
Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.
Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.
“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.
As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
New Antidepressants
A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.
Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression.
Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.
“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.”
Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said.
Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said.
Gepirone will be available to prescribe to patients in fall 2024.
Dr. Smetana reported no relevant financial conflicts of interest.
A version of this article appeared on Medscape.com.
Weighing the Benefits of Integrating AI-based Clinical Notes Into Your Practice
Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?”
This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.
The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
Transformative Evolution of Clinical Documentation
The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.
How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:
Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.
Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.
Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.
Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.
Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.
Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
Broad-Spectrum Benefits of AI in Documentation
- Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
- Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
- Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
- Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.
The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.
In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.
I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.
Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.
A version of this article appeared on Medscape.com.
Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?”
This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.
The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
Transformative Evolution of Clinical Documentation
The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.
How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:
Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.
Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.
Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.
Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.
Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.
Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
Broad-Spectrum Benefits of AI in Documentation
- Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
- Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
- Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
- Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.
The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.
In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.
I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.
Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.
A version of this article appeared on Medscape.com.
Picture a healthcare system where physicians aren’t bogged down by excessive charting but are instead fully present with their patients, offering undivided attention and personalized care. In a recent X post, Stuart Blitz, COO and co-founder of Hone Health, sparked a thought-provoking conversation. “The problem with US healthcare is physicians are burned out since they spend way too much time charting, not enough with patients,” he wrote. “If you created a health system that did zero charting, you’d attract the best physicians and all patients would go there. Who is working on this?”
This resonates with many in the medical community, myself included, because the strain of extensive documentation detracts from patient care. Having worked in both large and small healthcare systems, I know the burden of extensive charting is a palpable challenge, often detracting from the time we can devote to our patients.
The first part of this two-part series examines the overarching benefits of artificial intelligence (AI)–based clinical documentation in modern healthcare, a field witnessing a paradigm shift thanks to advancements in AI.
Transformative Evolution of Clinical Documentation
The transition from manual documentation to AI-driven solutions marks a significant shift in the field, with a number of products in development including Nuance, Abridge, Ambience, ScribeAmerica, 3M, and DeepScribe. These tools use ambient clinical intelligence (ACI) to automate documentation, capturing patient conversations and translating them into structured clinical summaries. This innovation aligns with the vision of reducing charting burdens and enhancing patient-physician interactions.
How does it work? ACI refers to a sophisticated form of AI applied in healthcare settings, particularly focusing on enhancing the clinical documentation process without disrupting the natural flow of the consultation. Here’s a technical yet practical breakdown of ACI and the algorithms it typically employs:
Data capture and processing: ACI systems employ various sensors and processing units, typically integrated into clinical settings. These sensors, like microphones and cameras, gather diverse data such as audio from patient-doctor dialogues and visual cues. This information is then processed in real-time or near–real-time.
Natural language processing (NLP): A core component of ACI is advanced NLP algorithms. These algorithms analyze the captured audio data, transcribing spoken words into text. NLP goes beyond mere transcription; it involves understanding context, extracting relevant medical information (like symptoms, diagnoses, and treatment plans), and interpreting the nuances of human language.
Deep learning: Machine learning, particularly deep-learning techniques, are employed to improve the accuracy of ACI systems continually. These algorithms can learn from vast datasets of clinical interactions, enhancing their ability to transcribe and interpret future conversations accurately. As they learn, they become better at understanding different accents, complex medical terms, and variations in speech patterns.
Integration with electronic health records (EHRs): ACI systems are often designed to integrate seamlessly with existing EHR systems. They can automatically populate patient records with information from patient-clinician interactions, reducing manual entry and potential errors.
Customization and personalization: Many ACI systems offer customizable templates or allow clinicians to tailor documentation workflows. This flexibility ensures that the output aligns with the specific needs and preferences of healthcare providers.
Ethical and privacy considerations: ACI systems must navigate significant ethical and privacy concerns, especially related to patient consent and data security. These systems need to comply with healthcare privacy regulations such as HIPAA. They need to securely manage sensitive patient data and restrict access to authorized personnel only.
Broad-Spectrum Benefits of AI in Documentation
- Reducing clinician burnout: By automating the documentation process, AI tools like DAX Copilot alleviate a significant contributor to physician burnout, enabling clinicians to focus more on patient care.
- Enhanced patient care: With AI handling documentation, clinicians can engage more with their patients, leading to improved care quality and patient satisfaction.
- Data accuracy and quality: AI-driven documentation captures detailed patient encounters accurately, ensuring high-quality and comprehensive medical records.
- Response to the growing need for efficient healthcare: AI-based documentation is a direct response to the growing call for more efficient healthcare practices, where clinicians spend less time on paperwork and more with patients.
The shift toward AI-based clinical documentation represents a critical step in addressing the inefficiencies in healthcare systems. It’s a move towards a more patient-centered approach, where clinicians can focus more on patient care by reducing the time spent on excessive charting. Hopefully, we can integrate these solutions into our clinics at a large enough scale to make such an impact.
In the next column, we will explore in-depth insights from Kenneth Harper at Nuance on the technical implementation of these tools, with DAX as an example.
I would love to read your comments on AI in clinical trials as well as other AI-related topics. Write me at [email protected] or find me on X @DrBonillaOnc.
Dr. Loaiza-Bonilla is the co-founder and chief medical officer at Massive Bio, a company connecting patients to clinical trials using artificial intelligence. His research and professional interests focus on precision medicine, clinical trial design, digital health, entrepreneurship, and patient advocacy. Dr Loaiza-Bonilla serves as medical director of oncology research at Capital Health in New Jersey, where he maintains a connection to patient care by attending to patients 2 days a week. He has served as a consultant for Verify, PSI CRO, Bayer, AstraZeneca, Cardinal Health, BrightInsight, The Lynx Group, Fresenius, Pfizer, Ipsen, and Guardant; served as a speaker or a member of a speakers bureau for Amgen, Guardant, Eisai, Ipsen, Natera, Merck, Bristol-Myers Squibb, and AstraZeneca. He holds a 5% or greater equity interest in Massive Bio.
A version of this article appeared on Medscape.com.
New Federal Rule Delivers Workplace Support, Time Off for Pregnant Docs
Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum.
The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”
Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship.
Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population.
Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations.
Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career.
She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”
Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014.
Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”
After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause.
The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
Increasing Support for Doctor-Moms
The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.
FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks.
Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said.
Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery.
Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave.
“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments.
This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6.
“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors.
Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause.
“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein.
A version of this article appeared on Medscape.com.
Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum.
The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”
Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship.
Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population.
Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations.
Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career.
She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”
Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014.
Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”
After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause.
The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
Increasing Support for Doctor-Moms
The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.
FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks.
Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said.
Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery.
Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave.
“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments.
This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6.
“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors.
Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause.
“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein.
A version of this article appeared on Medscape.com.
Pregnant physicians may receive more workplace accommodations and protection against discrimination thanks to an updated rule from the US Equal Employment Opportunity Commission (EEOC). The guidelines could prevent women from losing critical career momentum.
The Pregnant Workers Fairness Act (PWFA) aims to help workers balance professional demands with healthy pregnancies. It requires employers to provide reasonable accommodations for a “worker’s known limitations,” including physical or mental conditions associated with “pregnancy, childbirth, or related medical conditions.”
Reasonable accommodations vary but may involve time off to attend healthcare appointments or recover from childbirth, extra breaks during a shift, shorter work hours, or the ability to sit instead of stand. Private and public sector employers, including state and local governments, federal agencies, and employment agencies, must abide by the new guidelines unless they can provide evidence that doing so will cause undue hardship.
Female doctors have historically encountered significant barriers to family planning. Years of training cause them to delay having children, often leading to higher rates of infertility, miscarriage, and pregnancy complications than in the general population.
Some specialties, like surgeons, are particularly at risk, with 42% reporting at least one pregnancy loss. Most surgeons work their regular schedules until delivery despite desiring workload reductions, commonly citing unsupportive workplaces as a reason for not seeking accommodations.
Trauma surgeon Qaali Hussein, MD, became pregnant with her first child during her intern year in 2008. She told this news organization that her residency program didn’t even have a maternity policy at the time, and her male supervisor was certain that motherhood would end her surgical career.
She shared how “women usually waited until the end of their training to get pregnant. No one had ever gotten pregnant during the program and returned from maternity leave. I was the first to do so, so there wasn’t a policy or any program support to say, ‘What can we do to help?’ ”
Dr. Hussein used her vacation and sick time, returning to work 4 weeks after delivery. She had five more children, including twins her chief year and another baby during fellowship training in 2014.
Each subsequent pregnancy was met with the same response from program leadership, she recalled. “They’d say, ‘This is it. You may have been able to do the first and second child, but this one will be impossible.’ ”
After the PWFA regulations first became enforceable in June, the EEOC accepted public feedback. The guidelines received nearly 100,000 comments, spurred mainly by the inclusion of abortion care as a qualifying condition for which an employee could receive accommodations. About 54,000 comments called for abortion to be excluded from the final rule, and 40,000 supported keeping the clause.
The EEOC issued the final rule on April 15. It includes abortion care. However, the updated rule “does not require any employee to have — or not to have — an abortion, does not require taxpayers to pay for any abortions, and does not compel health care providers to provide any abortions,” the unpublished version of the final rule said. It is scheduled to take effect 60 days after its publication in the Federal Register on April 19.
Increasing Support for Doctor-Moms
The PWFA supplements other EEOC protections, such as pregnancy discrimination under Title VII of the Civil Rights Act of 1964 and access to reasonable accommodations under the Americans with Disabilities Act. In addition, it builds upon Department of Labor regulations, like the PUMP Act for breastfeeding employees and the Family and Medical Leave Act, which provides 12 weeks of unpaid, job-protected leave for the arrival of a child or certain medical conditions.
FMLA applies only to employees who have worked full-time for at least 12 months for an employer with 50 or more employees. Meanwhile, the unpaid, job-protected leave under the PWFA has no waiting period, lowers the required number of employees to 15, and permits accommodations for up to 40 weeks.
Employers are encouraged to honor “common and simple” requests, like using a closer parking space or pumping or nursing at work, without requiring a doctor’s note, the rule said.
Efforts to improve family leave policies for physicians and residents have been gaining traction. In 2021, the American Board of Medical Specialties began requiring its member boards with training programs lasting 2 or more years to allow at least 6 weeks off for parental, caregiver, and medical leave. This time can be taken without exhausting vacation or sick leave or requiring an extension in training. Over half of the 24 member boards permit leave beyond 6 weeks, including the American Boards of Allergy and Immunology, Emergency Medicine, Family Medicine, Radiology, and Surgery.
Estefania Oliveros, MD, MSc, cardiologist and assistant professor at the Lewis Katz School of Medicine at Temple University, Philadelphia, told this news organization that the Accreditation Council for Graduate Medical Education also requires that residents and fellows receive 6 weeks of paid leave.
“We add to that vacation time, so it gives them at least 8 weeks,” she said. The school has created spaces for nursing mothers — something neither she nor Dr. Hussein had access to when breastfeeding — and encourages the attendings to be proactive in excusing pregnant fellows for appointments.
This differs significantly from her fellowship training experience 6 years ago at another institution, where she worked without accommodations until the day before her cesarean delivery. Dr. Oliveros had to use all her vacation time for recovery, returning to the program after 4 weeks instead of the recommended 6.
“And that’s the story you hear all the time. Not because people are ill-intended; I just don’t think the system is designed to accommodate women, so we lose a lot of talent that way,” said Dr. Oliveros, whose 2019 survey in the Journal of the American College of Cardiology called for more support and protections for pregnant doctors.
Both doctors believe the PWFA will be beneficial but only if leadership in the field takes up the cause.
“The cultures of these institutions determine whether women feel safe or even confident enough to have children in medical school or residency,” said Dr. Hussein.
A version of this article appeared on Medscape.com.
AI Surpasses Harvard Docs on Clinical Reasoning Test
TOPLINE:
The AI had more instances of incorrect reasoning than the doctors did but scored better overall.
METHODOLOGY:
- The study involved 39 physicians from two academic medical centers in Boston and the generative AI model GPT-4.
- Participants were presented with 20 simulated clinical cases involving common problems such as pharyngitis, headache, abdominal pain, cough, and chest pain. Each case included sections describing the triage presentation, review of systems, physical examination, and diagnostic testing.
- The primary outcome was the Revised-IDEA (R-IDEA) score, a 10-point scale evaluating clinical reasoning documentation across four domains: Interpretive summary, differential diagnosis, explanation of the lead diagnosis, and alternative diagnoses.
TAKEAWAY:
- AI achieved a median R-IDEA score of 10, higher than attending physicians (median score, 9) and residents (8).
- The chatbot had a significantly higher estimated probability of achieving a high R-IDEA score of 8-10 (0.99) compared with attendings (0.76) and residents (0.56).
- AI provided more responses that contained instances of incorrect clinical reasoning (13.8%) than residents (2.8%) and attending physicians (12.5%). It performed similarly to physicians in diagnostic accuracy and inclusion of cannot-miss diagnoses.
IN PRACTICE:
“Future research should assess clinical reasoning of the LLM-physician interaction, as LLMs will more likely augment, not replace, the human reasoning process,” the authors of the study wrote.
SOURCE:
Adam Rodman, MD, MPH, with Beth Israel Deaconess Medical Center, Boston, was the corresponding author on the paper. The research was published online in JAMA Internal Medicine.
LIMITATIONS:
Simulated clinical cases may not replicate performance in real-world scenarios. Further training could enhance the performance of the AI, so the study may underestimate its capabilities, the researchers noted.
DISCLOSURES:
The study was supported by the Harvard Clinical and Translational Science Center and Harvard University. Authors disclosed financial ties to publishing companies and Solera Health. Dr. Rodman received funding from the Gordon and Betty Moore Foundation.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
The AI had more instances of incorrect reasoning than the doctors did but scored better overall.
METHODOLOGY:
- The study involved 39 physicians from two academic medical centers in Boston and the generative AI model GPT-4.
- Participants were presented with 20 simulated clinical cases involving common problems such as pharyngitis, headache, abdominal pain, cough, and chest pain. Each case included sections describing the triage presentation, review of systems, physical examination, and diagnostic testing.
- The primary outcome was the Revised-IDEA (R-IDEA) score, a 10-point scale evaluating clinical reasoning documentation across four domains: Interpretive summary, differential diagnosis, explanation of the lead diagnosis, and alternative diagnoses.
TAKEAWAY:
- AI achieved a median R-IDEA score of 10, higher than attending physicians (median score, 9) and residents (8).
- The chatbot had a significantly higher estimated probability of achieving a high R-IDEA score of 8-10 (0.99) compared with attendings (0.76) and residents (0.56).
- AI provided more responses that contained instances of incorrect clinical reasoning (13.8%) than residents (2.8%) and attending physicians (12.5%). It performed similarly to physicians in diagnostic accuracy and inclusion of cannot-miss diagnoses.
IN PRACTICE:
“Future research should assess clinical reasoning of the LLM-physician interaction, as LLMs will more likely augment, not replace, the human reasoning process,” the authors of the study wrote.
SOURCE:
Adam Rodman, MD, MPH, with Beth Israel Deaconess Medical Center, Boston, was the corresponding author on the paper. The research was published online in JAMA Internal Medicine.
LIMITATIONS:
Simulated clinical cases may not replicate performance in real-world scenarios. Further training could enhance the performance of the AI, so the study may underestimate its capabilities, the researchers noted.
DISCLOSURES:
The study was supported by the Harvard Clinical and Translational Science Center and Harvard University. Authors disclosed financial ties to publishing companies and Solera Health. Dr. Rodman received funding from the Gordon and Betty Moore Foundation.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
The AI had more instances of incorrect reasoning than the doctors did but scored better overall.
METHODOLOGY:
- The study involved 39 physicians from two academic medical centers in Boston and the generative AI model GPT-4.
- Participants were presented with 20 simulated clinical cases involving common problems such as pharyngitis, headache, abdominal pain, cough, and chest pain. Each case included sections describing the triage presentation, review of systems, physical examination, and diagnostic testing.
- The primary outcome was the Revised-IDEA (R-IDEA) score, a 10-point scale evaluating clinical reasoning documentation across four domains: Interpretive summary, differential diagnosis, explanation of the lead diagnosis, and alternative diagnoses.
TAKEAWAY:
- AI achieved a median R-IDEA score of 10, higher than attending physicians (median score, 9) and residents (8).
- The chatbot had a significantly higher estimated probability of achieving a high R-IDEA score of 8-10 (0.99) compared with attendings (0.76) and residents (0.56).
- AI provided more responses that contained instances of incorrect clinical reasoning (13.8%) than residents (2.8%) and attending physicians (12.5%). It performed similarly to physicians in diagnostic accuracy and inclusion of cannot-miss diagnoses.
IN PRACTICE:
“Future research should assess clinical reasoning of the LLM-physician interaction, as LLMs will more likely augment, not replace, the human reasoning process,” the authors of the study wrote.
SOURCE:
Adam Rodman, MD, MPH, with Beth Israel Deaconess Medical Center, Boston, was the corresponding author on the paper. The research was published online in JAMA Internal Medicine.
LIMITATIONS:
Simulated clinical cases may not replicate performance in real-world scenarios. Further training could enhance the performance of the AI, so the study may underestimate its capabilities, the researchers noted.
DISCLOSURES:
The study was supported by the Harvard Clinical and Translational Science Center and Harvard University. Authors disclosed financial ties to publishing companies and Solera Health. Dr. Rodman received funding from the Gordon and Betty Moore Foundation.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Integrating Telemedicine for HCV With Opioid Use Disorder Treatment Works
People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.
In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.
The study was published online in JAMA.
HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.
In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.
They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).
Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.
In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.
Participants in the telemedicine group were also seen sooner and started treatment faster.
The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).
Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).
Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.
In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.
“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.
The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.
Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.
A version of this article appeared on Medscape.com .
People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.
In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.
The study was published online in JAMA.
HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.
In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.
They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).
Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.
In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.
Participants in the telemedicine group were also seen sooner and started treatment faster.
The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).
Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).
Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.
In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.
“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.
The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.
Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.
A version of this article appeared on Medscape.com .
People with opioid use disorder (OUD) who have hepatitis C virus (HCV) were twice as likely to be treated and cured of HCV if they received facilitated telemedicine treatment within their opioid treatment program than if they were referred for off-site treatment, the results of a new study showed.
In addition, among cured patients, illicit drug use fell significantly, and there were few reinfections, reported the researchers, led by Andrew Talal, MD, MPH, with the University at Buffalo, State University of New York, Buffalo.
The study was published online in JAMA.
HCV is a major public health concern, especially among people with OUD. Geographic and logistical barriers often prevent this underserved population from accessing treatment; however, telemedicine has the potential to overcome these obstacles.
In a prospective cluster randomized clinical trial, Dr. Talal and colleagues assessed the impact of embedding facilitated telemedicine for HCV care into 12 opioid treatment programs in New York State.
They studied 602 HCV-infected adults (61% male; 51% White) with OUD. Of these, 290 (mean age, 47.1 years) were enrolled in facilitated telemedicine programs onsite, and 312 (mean age, 48.9 years) received an off-site referral (usual care).
Telemedicine participants had an initial telemedicine encounter facilitated by study case managers onsite who also administered a blood test. The telemedicine clinician subsequently evaluated participants and ordered direct-acting antiviral (DAA) medication that was delivered to the opioid treatment program monthly (as refills required) and dispensed along with methadone.
In the telemedicine group, 268 of 290 individuals (92.4%) initiated HCV treatment compared with 126 of 312 (40.4%) in the referral group.
Participants in the telemedicine group were also seen sooner and started treatment faster.
The interval between screening and initial appointments was 14 days with telemedicine vs 18 days with a referral (P = .04). The time between the initial visit and DAA initiation was 49.9 days with telemedicine vs 123.5 days with a referral (P < .001).
Intention-to-treat analysis showed significantly higher HCV cure rates with telemedicine than with referral (90.3% vs 39.4%, respectively). Similarly, the observed cure rates were also higher in the telemedicine group (84.8% vs 34.0%).
Sustained virologic response was durable, with only 13 reinfections (incidence, 2.5 per 100 person-years) occurring during the 2-year follow-up period, the researchers reported.
In addition, illicit drug use decreased significantly among cured patients in both the telemedicine group (P < .001) and the referral group (P = .001). Adults in both groups rated healthcare delivery satisfaction as high or very high.
“Our study demonstrates how telemedicine successfully integrates medical and behavioral treatment,” Dr. Talal said in a statement.
The intervention “builds patient-clinician trust across the screen, and significant decreases in substance use were observed in cured participants with minimal HCV reinfections,” the study team wrote.
Support for this research was provided by the Patient-Centered Outcomes Research Institute and by the Troup Fund of the Kaleida Health Foundation.
A version of this article appeared on Medscape.com .
FROM JAMA
Vaccine ‘Will Not Curb’ Dengue Epidemic, Says PAHO
The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.
The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023.
“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.
“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.
The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.
A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.
PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”
“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.
The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.
“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.
Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.
In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.
Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .
The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.
The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023.
“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.
“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.
The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.
A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.
PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”
“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.
The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.
“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.
Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.
In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.
Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .
The current tetravalent dengue vaccine TAK-003, from the Japanese laboratory Takeda, is not likely to control the ongoing epidemic, according to the Pan American Health Organization (PAHO). The organization emphasized the need to better understand the vaccine’s effectiveness against different serotypes and its safety under real-world clinical conditions.
The Americas are experiencing a record increase in dengue cases. Three times as many cases have been identified during 2024 (3.5 million) than were reported for the same period in 2023.
“The vaccine we have available will not curb the dengue epidemic; it should be used complementarily with other actions. The most important actions are field operations, vector control, prevention, and education,” said Daniel Salas, MD, executive manager of the PAHO Comprehensive Immunization Program, during a press conference on March 28.
“The vaccines we currently have are not the best response to reduce transmission and prevent deaths,” added Jarbas Barbosa, MD, PhD, PAHO’s director. The fatality rate remains below 0.05%, but this figure could be hard to maintain if the situation becomes more uncontrolled.
The TAK-003 regimen consists of two doses with a 3-month interval between applications, so “it is not a tool to control transmission at this moment. Studies have shown that only 8 years of [population-level] vaccination would have a significant impact on dengue transmission,” said Dr. Barbosa.
A new vaccine developed in Brazil in partnership with the company MSD, Butantan-DV, is in phase 3 trials and has the advantage of being a single-dose application, which could facilitate its use in situations with accelerated transmission. “But this vaccine will likely only be available in 2025,” said Dr. Barbosa.
PAHO officials also highlighted the need to better characterize the vaccine’s effectiveness and safety in the real world. They observed, for example, that when TAK-003 was investigated, the circulation of dengue serotype 3 was almost nonexistent, so the efficacy data against that serotype “are very limited.”
“The producer, Takeda, has very limited production capacity. Brazil is the country that uses this vaccine the most, followed by Argentina. Given that these countries have a good epidemiological surveillance system and adverse effect registration, they can conduct studies on how the vaccine performs in real life, which will greatly increase our knowledge about it. For example, we will see its effectiveness against serotype 3,” said Dr. Barbosa.
The PAHO Technical Advisory Group (TAG) on vaccine-preventable diseases recommended that any country using these vaccines have surveillance systems in place because it is important to promptly report and investigate any adverse events, said Dr. Salas. The organization also suggested that vaccination should ideally be administered in a “more controlled environment,” a phase 4 study, “to complete the safety and efficacy profile, especially in those who have not had dengue before and for dengue 3 and 4,” said Dr. Salas in response to a question from this news organization.
“People cannot expect that just because they were vaccinated, they will not get dengue. The vaccine has limited reach,” he emphasized.
Other research strategies for vector control, such as the use of the Wolbachia bacteria and mosquito sterilization, are future strategies and “not tools to control this outbreak,” noted Sylvain Aldighieri, MD, director of the Department of Prevention, Control, and Elimination of Transmissible Diseases at PAHO.
In his opening remarks, Dr. Barbosa urged the intensification of efforts with tools that are already available. These approaches include eliminating mosquito breeding sites (“80% are in or near homes”) and protecting against mosquito bites, preparing health services for early diagnosis and timely clinical management, and educating the population about dengue symptoms so they seek medical attention immediately.
Although dengue is increasing throughout Latin America and the Caribbean, the most affected countries are Brazil (83%), Paraguay (5.3%), and Argentina (3.7%), which account for 92% of the cases and 87% of the deaths, PAHO reported.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com .
FDA Approves AI Diagnostic Tool for Early Sepsis Detection
The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.
Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.
Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.
It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.
This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.
Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.
Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.
It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.
This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and prediction of sepsis. The authorization was granted through the FDA’s De Novo pathway.
Sepsis is a complex condition, so diagnosing it early is difficult and has been a decades-long challenge for the US healthcare system.
Using both biomarkers and clinical data with the assistance of AI, the Sepsis ImmunoScore helps assess the risk for the presence of or progression to sepsis within 24 hours of patient evaluation in the emergency department or hospital. By considering 22 diverse parameters, the AI-powered tool provides a comprehensive evaluation of the patient’s biological condition, resulting in a risk score and categorization into four distinct risk levels.
It’s important to note that this system is not an alert mechanism. These risk categories are correlated with the risk for patient deterioration, including length of hospital stay, in-hospital mortality, and the need for escalated care within 24 hours (such as intensive care unit admission, mechanical ventilation, or vasopressor use). The diagnostic software is integrated directly into hospital electronic medical records.
This is the first AI diagnostic tool for sepsis to receive marketing authorization from the FDA.
A version of this article appeared on Medscape.com.
COVID Vaccinations Less Prevalent in Marginalized Patients
Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.
A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.
“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.
The findings were published in CMAJ.
Need vs Resources
Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.
“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.
The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.
The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.
Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).
The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.
“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.
The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.
“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
Helping Primary Care Physicians
Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”
Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.
“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”
The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.
A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.
“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.
The findings were published in CMAJ.
Need vs Resources
Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.
“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.
The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.
The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.
Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).
The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.
“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.
The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.
“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
Helping Primary Care Physicians
Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”
Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.
“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”
The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care physicians who served marginalized communities had the highest proportion of patients who were unvaccinated against COVID-19, Canadian data suggested.
A study of more than 9000 family physicians in Ontario also found that the physicians with the largest proportion of unvaccinated patients were more likely to be male, to have trained outside Canada, to be older, and to work in an enhanced fee-for-service model than their counterparts who had lower proportions of unvaccinated patients.
“The family physicians with the most unvaccinated patients were also more likely to be solo practitioners and less likely to practice in team-based models, meaning they may have fewer support staff in their clinics,” lead author Jennifer Shuldiner, PhD, a scientist at Women’s College Hospital in Toronto, Ontario, Canada, told this news organization.
The findings were published in CMAJ.
Need vs Resources
Dr. Shuldiner and her team had been working on a project to provide additional support to family physicians with large numbers of patients who had not received their COVID-19 vaccinations. Their goal was to encourage family physicians to support these patients in getting vaccinated.
“As we were designing this project, we wondered how these physicians and their patients might differ. What characteristics might they have that would enable us to design and implement an intervention with high uptake and impact?” she said.
The researchers conducted a cross-sectional, population-based cohort study using linked administrative datasets in Ontario. They calculated the percentage of patients unvaccinated against SARS-CoV-2 who were enrolled with each comprehensive care family physician, ranked physicians according to the proportion of unvaccinated patients, and identified 906 physicians in the top 10% of unvaccinated patients. These physicians were compared with the remaining 90% of family physicians.
The physicians with the highest proportion of unvaccinated patients cared for 259,130 unvaccinated patients as of November 1, 2021. The proportion of patients who received two or more doses of the SARS-CoV-2 vaccine in this group was 74.2%. In comparison, the proportion of patients who received two or more doses of the vaccine was 87.0% in the remaining 90% of physicians.
Physicians with the largest proportion of unvaccinated patients were more likely to be male (64.6% vs 48.1%), to have trained outside Canada (46.9% vs 29.3%), to be older (mean age, 56 years vs 49 years), and to work in an enhanced fee-for-service model (49% vs 28%).
The study also found that patients enrolled with physicians in the most unvaccinated group tended to live in places with more ethnic diversity, higher material deprivation, and lower incomes. The proportion of recent immigrants was higher in this group.
“Clinics or practices with a large number of unvaccinated patients could be viable targets for efforts to coordinate public health and primary care,” said Dr. Shuldiner.
The findings indicate “the ongoing inverse relationship between the need for care and its accessibility and utilization. In other words, the practices with the highest need receive the fewest resources,” she noted.
“We know that relationships with trusted family physicians can positively influence patients’ decisions. Our study highlights the need to create equitable systems and processes that create opportunities for primary care teams to play a crucial role in influencing general and COVID-19-specific vaccine-related decision-making.”
Helping Primary Care Physicians
Commenting on the study for this news organization, Sabrina Wong, RN, PhD, professor of nursing at the University of British Columbia in Vancouver, British Columbia, Canada, said, “They did quite a nice analysis to show this using administrative data, and I think the information they’ve uncovered will be helpful in trying to fill the gaps and provide these practitioners with more support.”
Dr. Wong did not participate in the study. “The information they provide will be useful in helping us to move forward working with underserved, underresourced communities and also hopefully provide the clinicians, family physicians, and nurse practitioners working in these areas with more resources,” she said.
“The authors also point out that there needs to be more collaboration between public health and primary care to support these communities in their efforts to get the vaccines to the people in these communities who need them.”
The study was supported by a Canadian Institutes of Health Research grant. Dr. Shuldiner and Dr. Wong reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CMAJ
4 Years In, a Sobering Look at Long COVID Progress
Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)
What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.
Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.
Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.
While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.
Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.
Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.
Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.
Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.
Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
Promising Treatments Have Emerged
Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.
Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.
“This is something tangible that we can offer to patients,” she said.
Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.
For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.
“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.
Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.
Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.
It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
Clinical Trials Exploring New Therapies
Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.
Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.
Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.
Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.
She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
Lack of Urgency Holds Back Progress
Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.
“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.
Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.
He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.
“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”
A version of this article first appeared on Medscape.com.
Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)
What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.
Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.
Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.
While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.
Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.
Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.
Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.
Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.
Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
Promising Treatments Have Emerged
Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.
Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.
“This is something tangible that we can offer to patients,” she said.
Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.
For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.
“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.
Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.
Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.
It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
Clinical Trials Exploring New Therapies
Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.
Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.
Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.
Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.
She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
Lack of Urgency Holds Back Progress
Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.
“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.
Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.
He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.
“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”
A version of this article first appeared on Medscape.com.
Four years ago in the spring of 2020, physicians and patients coined the term “long COVID” to describe a form of the viral infection from which recovery seemed impossible. (And the old nickname “long-haulers” seems so quaint now.)
What started as a pandemic that killed nearly 3 million people globally in 2020 alone would turn into a chronic disease causing a long list of symptoms — from extreme fatigue, to brain fog, tremors, nausea, headaches, rapid heartbeat, and more.
Today, 6.4% of Americans report symptoms of long COVID, and many have never recovered.
Still, we’ve come a long way, although there’s much we don’t understand about the condition. At the very least, physicians have a greater understanding that long COVID exists and can cause serious long-term symptoms.
While physicians may not have a blanket diagnostic tool that works for all patients with long COVID, they have refined existing tests for more accurate results, said Nisha Viswanathan, MD, director of the University of California Los Angeles Long COVID Program at UCLA Health.
Also, a range of new treatments, now undergoing clinical trials, have emerged that have proved effective in managing long COVID symptoms.
Catecholamine testing, for example, is now commonly used to diagnose long COVID, particularly in those who have dysautonomia, a condition caused by dysfunction of the autonomic nervous system and marked by dizziness, low blood pressure, nausea, and brain fog.
Very high levels of the neurotransmitter, for example, were shown to indicate long COVID in a January 2021 study published in the journal Clinical Medicine.
Certain biomarkers have also been shown indicative of the condition, including low serotonin levels. A study published this year in Cell found lower serotonin levels in patients with long COVID driven by low levels of circulating SARS-CoV-2, the virus that causes the condition.
Still, said Dr. Viswanathan, long COVID is a disease diagnosed by figuring out what a patient does not have — by ruling out other causes — rather than what they do. “It’s still a moving target,” she said, meaning that the disease is always changing based on the variant of acute COVID.
Promising Treatments Have Emerged
Dysautonomia, and especially the associated brain fog, fatigue, and dizziness, are now common conditions. As a result, physicians have gotten better at treating them. The vagus nerve is the main nerve of the parasympathetic nervous system that controls everything from digestion to mental health. A February 2022 pilot study suggested a link between vagus nerve dysfunction and some long COVID symptoms.
Vagus nerve stimulation is one form of treatment which involves using a device to stimulate the vagus nerve with electrical impulses. Dr. Viswanathan has been using the treatment in patients with fatigue, brain fog, anxiety, and depression — results, she contends, have been positive.
“This is something tangible that we can offer to patients,” she said.
Curative treatments for long COVID remain elusive, but doctors have many more tools for symptom management than before, said Ziyad Al-Aly, MD, a global expert on long COVID and chief of research and development at the Veterans Affairs St. Louis Health Care System.
For example, physicians are using beta-blockers to treat postural tachycardia syndrome (POTS), a symptom of long COVID that happens when the heart rate increases rapidly after someone stands up or lies down. Beta-blockers, such as the off-label medication ivabradine, have been used clinically to control heart rate, according to a March 2022 study published in the journal HeartRhythm Case Reports.
“It’s not a cure, but beta-blockers can help patients manage their symptoms,” said Dr. Al-Aly.
Additionally, some patients respond well to low-dose naltrexone for the treatment of extreme fatigue associated with long COVID. A January 2024 article in the journal Clinical Therapeutics found that fatigue symptoms improved in patients taking the medication.
Dr. Al-Aly said doctors treating patients with long COVID are getting better at pinpointing the phenotype or manifestation of the condition and diagnosing a treatment accordingly. Treating long COVID fatigue is not the same as treating POTS or symptoms of headache and joint pain.
It’s still all about the management of symptoms and doctors lack any US Food and Drug Administration–approved medications specifically for the condition.
Clinical Trials Exploring New Therapies
Still, a number of large clinical trials currently underway may change that, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.
Two clinical trials headed by Dr. Putrino’s lab are looking into repurposing two HIV antivirals to see whether they affect the levels of circulating SARS-CoV-2 virus in the body that may cause long COVID. The hope is that the antivirals Truvada and maraviroc can reduce the «reactivation of latent virus» that, said Dr. Putrino, causes lingering long COVID symptoms.
Ongoing trials are looking into the promise of SARS-CoV-2 monoclonal antibodies, produced from cells made by cloning a unique white blood cell, as a treatment option. The trials are investigating whether these antibodies may similarly target viral reservoirs that are causing persistence of symptoms in some patients.
Other trials are underway through the National Institutes of Health (NIH) RECOVER initiative in which more than 17,000 patients are enrolled, the largest study of its kind, said Grace McComsey, MD.
Dr. McComsey, who leads the study at University Hospitals Health System in Cleveland, said that after following patients for up to 4 years researchers have gathered “a massive repository of information” they hope will help scientists crack the code of this very complex disease.
She and other RECOVER researchers have recently published studies on a variety of findings, reporting in February, for example, that COVID infections may trigger other autoimmune diseases such as rheumatoid arthritis and type 2 diabetes. Another recent finding showed that people with HIV are at a higher risk for complications due to acute COVID-19.
Lack of Urgency Holds Back Progress
Still, others like Dr. Al-Aly and Dr. Putrino felt that the initiative isn’t moving fast enough. Dr. Al-Aly said that the NIH needs to “get its act together” and do more for long COVID. In the future, he said that we need to double down on our efforts to expand funding and increase urgency to better understand the mechanism of disease, risk factors, and treatments, as well as societal and economic implications.
“We did trials for COVID-19 vaccines at warp speed, but we’re doing trials for long COVID at a snail’s pace,” he said.
Dr. Al-Aly is concerned about the chronic nature of the disease and how it affects patients down the line. His large-scale study published last month in the journal Science looked specifically at chronic fatigue syndrome triggered by the infection and its long-term impact on patients.
He’s concerned about the practical implications for people who are weighted down with symptoms for multiple years.
“Being fatigued and ill for a few months is one thing, but being at home for 5 years is a totally different ballgame.”
A version of this article first appeared on Medscape.com.