Journal of Clinical Outcomes Management

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Long-term antidepressant use is tied to an increased risk of adverse outcomes, including cardiovascular disease (CVD), cerebrovascular disease, coronary heart disease (CHD), and all-cause mortality, new research suggests.

The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.

After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.

On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.

The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.

“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.

“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.

The study was published online in the British Journal of Psychiatry Open.
 

Monitoring of CVD risk ‘critical’

Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”

Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”

Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.

The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.

The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.

The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.

Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.

Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
 

Mechanism unclear

By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).

At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).

At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.

On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).

“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.

“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.

Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
 

Strengths, limitations

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.

The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”

A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.

The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”

Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”

The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.

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

Long-term antidepressant use is tied to an increased risk of adverse outcomes, including cardiovascular disease (CVD), cerebrovascular disease, coronary heart disease (CHD), and all-cause mortality, new research suggests.

The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.

After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.

On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.

The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.

“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.

“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.

The study was published online in the British Journal of Psychiatry Open.
 

Monitoring of CVD risk ‘critical’

Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”

Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”

Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.

The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.

The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.

The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.

Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.

Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
 

Mechanism unclear

By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).

At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).

At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.

On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).

“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.

“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.

Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
 

Strengths, limitations

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.

The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”

A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.

The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”

Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”

The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.

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

Long-term antidepressant use is tied to an increased risk of adverse outcomes, including cardiovascular disease (CVD), cerebrovascular disease, coronary heart disease (CHD), and all-cause mortality, new research suggests.

The investigators drew on 10-year data from the UK Biobank on over 220,000 adults and compared the risk of developing adverse health outcomes among those taking antidepressants with the risk among those who were not taking antidepressants.

After adjusting for preexisting risk factors, they found that 10-year antidepressant use was associated with a twofold higher risk of CHD, an almost-twofold higher risk of CVD as well as CVD mortality, a higher risk of cerebrovascular disease, and more than double the risk of all-cause mortality.

On the other hand, at 10 years, antidepressant use was associated with a 23% lower risk of developing hypertension and a 32% lower risk of diabetes.

The main culprits were mirtazapine, venlafaxine, duloxetine, and trazodone, although SSRIs were also tied to increased risk.

“Our message for clinicians is that prescribing of antidepressants in the long term may not be harm free [and] we hope that this study will help doctors and patients have more informed conversations when they weigh up the potential risks and benefits of treatments for depression,” study investigator Narinder Bansal, MD, honorary research fellow, Centre for Academic Health and Centre for Academic Primary Care, University of Bristol (England), said in a news release.

“Regardless of whether the drugs are the underlying cause of these problems, our findings emphasize the importance of proactive cardiovascular monitoring and prevention in patients who have depression and are on antidepressants, given that both have been associated with higher risks,” she added.

The study was published online in the British Journal of Psychiatry Open.
 

Monitoring of CVD risk ‘critical’

Antidepressants are among the most widely prescribed drugs; 70 million prescriptions were dispensed in 2018 alone, representing a doubling of prescriptions for these agents in a decade, the investigators noted. “This striking rise in prescribing is attributed to long-term treatment rather than an increased incidence of depression.”

Most trials that have assessed antidepressant efficacy have been “poorly suited to examining adverse outcomes.” One reason for this is that many of the trials are short-term studies. Since depression is “strongly associated” with CVD risk factors, “careful assessment of the long-term cardiometabolic effects of antidepressant treatment is critical.”

Moreover, information about “a wide range of prospectively measured confounders ... is needed to provide robust estimates of the risks associated with long-term antidepressant use,” the authors noted.

The researchers examined the association between antidepressant use and four cardiometabolic morbidity outcomes – diabetes, hypertension, cerebrovascular disease, and CHD. In addition, they assessed two mortality outcomes – CVD mortality and all-cause mortality. Participants were divided into cohorts on the basis of outcome of interest.

The dataset contains detailed information on socioeconomic status, demographics, anthropometric, behavioral, and biochemical risk factors, disability, and health status and is linked to datasets of primary care records and deaths.

The study included 222,121 participants whose data had been linked to primary care records during 2018 (median age of participants, 56-57 years). About half were women, and 96% were of White ethnicity.

Participants were excluded if they had been prescribed antidepressants 12 months or less before baseline, if they had previously been diagnosed for the outcome of interest, if they had been previously prescribed psychotropic drugs, if they used cardiometabolic drugs at baseline, or if they had undergone treatment with antidepressant polytherapy.

Potential confounders included age, gender, body mass index, waist/hip ratio, smoking and alcohol intake status, physical activity, parental history of outcome, biochemical and hematologic biomarkers, socioeconomic status, and long-term illness, disability, or infirmity.
 

Mechanism unclear

By the end of the 5- and 10-year follow-up periods, an average of 8% and 6% of participants in each cohort, respectively, had been prescribed an antidepressant. SSRIs constituted the most commonly prescribed class (80%-82%), and citalopram was the most commonly prescribed SSRI (46%-47%). Mirtazapine was the most frequently prescribed non-SSRI antidepressant (44%-46%).

At 5 years, any antidepressant use was associated with an increased risk for diabetes, CHD, and all-cause mortality, but the findings were attenuated after further adjustment for confounders. In fact, SSRIs were associated with a reduced risk of diabetes at 5 years (hazard ratio, 0.64; 95% confidence interval, 0.49-0.83).

At 10 years, SSRIs were associated with an increased risk of cerebrovascular disease, CVD mortality, and all-cause mortality; non-SSRIs were associated with an increased risk of CHD, CVD, and all-cause mortality.

On the other hand, SSRIs were associated with a decrease in risk of diabetes and hypertension at 10 years (HR, 0.68; 95% CI, 0.53-0.87; and HR, 0.77; 95% CI, 0.66-0.89, respectively).

“While we have taken into account a wide range of pre-existing risk factors for cardiovascular disease, including those that are linked to depression such as excess weight, smoking, and low physical activity, it is difficult to fully control for the effects of depression in this kind of study, partly because there is considerable variability in the recording of depression severity in primary care,” said Dr. Bansal.

“This is important because many people taking antidepressants such as mirtazapine, venlafaxine, duloxetine and trazodone may have a more severe depression. This makes it difficult to fully separate the effects of the depression from the effects of medication,” she said.

Further research “is needed to assess whether the associations we have seen are genuinely due to the drugs; and, if so, why this might be,” she added.
 

Strengths, limitations

Commenting on the study, Roger McIntyre, MD, professor of psychiatry and pharmacology and head of the mood disorders psychopharmacology unit at the University of Toronto,, discussed the strengths and weaknesses of the study.

The UK Biobank is a “well-described, well-phenotyped dataset of good quality,” said Dr. McIntyre, chairperson and executive director of the Brain and Cognitive Discover Foundation, Toronto, who was not involved with the study. Another strength is the “impressive number of variables the database contains, which enabled the authors to go much deeper into the topics.”

A “significant limitation” is the confounding that is inherent to the disorder itself – “people with depression have a much higher intrinsic risk of CVD, [cerebrovascular disease], and cardiovascular mortality,” Dr. McIntyre noted.

The researchers did not adjust for trauma or childhood maltreatment, “which are the biggest risk factors for both depression and CVD; and drug and alcohol misuse were also not accounted for.”

Additionally, “to determine whether something is an association or potentially causative, it must satisfy the Bradford-Hill criteria,” said Dr. McIntyre. “Since we’re moving more toward using these big databases and because we depend on them to give us long-term perspectives, we would want to see coherent, compelling Bradford-Hill criteria regarding causation. If you don’t have any, that’s fine too, but then it’s important to make clear that there is no clear causative line, just an association.”

The research was funded by the National Institute of Health Research School for Primary Care Research and was supported by the NI Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. Dr. McIntyre has received research grant support from CI/GACD/National Natural Science Foundation of China and the Milken Institute and speaker/consultation fees from numerous companies. Dr. McIntyre is a CEO of Braxia Scientific.

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

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

Unlike for many other professions, there is no age limit for practicing medicine. According to international standards, airplane pilots, for example, who are responsible for the safety of many human lives, must retire by the age of 60 if they work alone, or 65 if they have a copilot. In Brazil, however, this age limit does not exist for pilots or physicians.

The only restriction on professional practice within the medical context is the mandatory retirement imposed on medical professors who teach at public (state and federal) universities, starting at the age of 75. Nevertheless, these professionals can continue practicing administrative and research-related activities. After “expulsion,” as this mandatory retirement is often called, professors who stood out or contributed to the institution and science may receive the title of professor emeritus.

In the private sector, age limits are not formally set, but the hiring of middle-aged professionals is limited.

At the Heart Institute of the University of São Paulo (Brazil) School of Medicine Clinical Hospital (InCor/HCFMUSP), one of the world’s largest teaching and research centers for cardiovascular and pulmonary diseases, several octogenarian specialists lead studies and teams. One of these is Noedir Stolf, MD, an 82-year-old cardiovascular surgeon who operates almost every day and coordinates studies on transplants, mechanical circulatory support, and aortic surgery. There is also Protásio Lemos da Luz, MD, an 82-year-old clinical cardiologist who guides research on subjects including atherosclerosis, the endothelium, microbiota, and diabetes. The protective effect of wine on atherosclerosis is one of his best-known studies.

No longer working is also not in the cards for Angelita Habr-Gama, MD, who, at 89 years old, is one of the oldest physicians in current practice. With a career spanning more than 7 decades, she is a world reference in coloproctology. She was the first woman to become a surgical resident at the HCFMUSP, where she later founded the coloproctology specialty and created the first residency program for the specialty. In April 2022, Dr. Habr-Gama joined the ranks of the 100 most influential scientists in the world, nominated by researchers at Stanford (Calif.) University, and published in PLOS Biology.

In 2020, she was sedated, intubated, and hospitalized in the intensive care unit of the Oswaldo Cruz German Hospital for 54 days because of a SARS-CoV-2 infection. After her discharge, she went back to work in less than 10 days – and added chess classes to her routine. “To get up and go to work makes me very happy. Work is my greatest hobby. No one has ever heard me complain about my life,” Dr. Habr-Gama told this news organization after having rescheduled the interview twice because of emergency surgeries.

“Doctors have a professional longevity that does not exist for other professions in which the person retires and stops practicing their profession or goes on to do something else for entertainment. Doctors can retire from one place of employment or public practice and continue practicing medicine in the office as an administrator or consultant,” Ângelo Vattimo, first secretary of the state of São Paulo Regional Board of Medicine (CREMESP), stated. The board regularly organizes a ceremony to honor professionals who have been practicing for 50 years, awarding them a certificate and engraved medal. “Many of them are around 80 years old, working and teaching. This always makes us very happy. What profession has such exceptional compliance for so long?” said Mr. Vattimo.

In the medical field, the older the age range, the smaller the number of women. According to the 2020 Medical Demographics in Brazil survey, only 2 out of 10 practicing professionals older than 70 are women.

Not everyone over 80 has Dr. Habr-Gama’s vitality, because the impact of aging is not equal. “If you look at a group of 80-year-olds, there will be much more variability than within a group of 40-year-olds,” stated Mark Katlic, MD, chief of surgery at LifeBridge Health System in the United States, who has dedicated his life to studying the subject. Dr. Katlic spoke on the subject in an interview that was published in the article “How Old Is Too Old to Work as a Doctor?” published by this news organization in April of 2022. The article discusses the evaluations of elderly physicians’ skills and competences that U.S. companies conduct. The subject has been leading to profound debate.

Dr. Katlic defends screening programs for elderly physicians, which already are in effect at the company for which he works, LifeBridge Health, and various others in the United States. “We do [screen elderly physicians at LifeBridge Health], and so do a few dozen other [U.S. institutions], but there are hundreds [of health care institutions] that do not conduct this screening,” he pointed out.

Age-related assessment faces great resistance in the United States. One physician who is against the initiative is Frank Stockdale, MD, PhD, an 86-year-old practicing oncologist affiliated with Stanford (Calif.) University Health. “It’s age discrimination ... Physicians [in the United States] receive assessments throughout their careers as part of the accreditation process – there’s no need to change that as physicians reach a certain age,” Dr. Stockdale told this news organization.

The U.S. initiative of instituting physician assessment programs for those of a certain age has even been tested in court. According to an article published in Medscape, “in New Haven, Connecticut, for instance, the U.S. Equal Employment Opportunity Commission (EEOC) filed a suit in 2020 on behalf of the Yale New Haven Hospital staff, alleging a discriminatory late career practitioner policy.”

Also, according to the article, a similar case in Minnesota reached a settlement in 2021, providing monetary relief to staff impacted by out-of-pocket costs for the assessment, in addition to requiring that the hospital in question report to the EEOC any complaints related to age discrimination.

The fact is that increased life expectancy and, subsequently, the number of middle-aged physicians in practice, has raised several questions regarding the impact of aging on professional practice. In Brazil, the subject is of interest to more than 34,571 physicians between 65 and 69 years of age and 34,237 physicians older than 70. In all, this population represents approximately 14.3% of the country’s active workforce, according to the 2020 Medical Demographics in Brazil survey.

The significant participation of health care professionals over age 50 in a survey conducted by this news organization to learn what physicians think about the age limit for practicing their professions is evidence that the subject is a present concern. Of a total of 1,641 participants, 57% were age 60 or older, 17% were between 50 and 59 years, and 12% were between 40 and 49 years. Among all participants, 51% were against these limitations, 17% approved of the idea for all specialties, and 32% believed the restriction was appropriate only for some specialties. Regarding the possibility of older physicians undergoing regular assessments, the opinions were divided: Thirty-one percent thought they should be assessed in all specialties. Furthermore, 31% believed that cognitive abilities should be regularly tested in all specialties, 31% thought this should take place for some specialties, and 38% were against this approach.

Professionals want to know, for example, how (and whether) advanced age can interfere with performance, what are the competences required to practice their activities, and if the criteria vary by specialty. “A psychiatrist doesn’t have to have perfect visual acuity, as required from a dermatologist, but it is important that they have good hearing, for example,” argued Clóvis Constantino, MD, former president of the São Paulo Regional Medical Board (CRM-SP) and former vice president of the Brazilian Federal Medical Board (CFM). “However, a surgeon has to stand for several hours in positions that may be uncomfortable. It’s not easy,” he told this news organization.

In the opinion of 82-year-old Henrique Klajner, MD, the oldest pediatrician in practice at the Albert Einstein Israeli Hospital in São Paulo, the physician cannot be subjected to the types of evaluations that have been applied in the United States. “Physicians should conduct constant self-evaluations to see if they have the competences and skills needed to practice their profession ... Moreover, this is not a matter of age. It is a matter of ethics,” said Dr. Klajner.

The ability to adapt to change and implement innovation is critical to professional longevity, he said. “Nowadays, when I admit patients, I no longer do hospital rounds, which requires a mobility equal to physical abuse for me. Therefore, I work with physicians who take care of my hospitalized patients.”

Dr. Klajner also feels there is a distinction between innovations learned through studies and what can be offered safely to patients. “If I have to care for a hospitalized patient with severe pneumonia, for example, since I am not up to date in this specialty, I am going to call upon a pulmonologist I trust and forgo my honorarium for this admission. But I will remain on the team, monitoring the patient’s progression,” he said.

During the COVID-19 pandemic, Dr. Klajner stopped seeing patients in person under the recommendation of his son, Sidney Klajner, MD, also a physician. The elder Dr. Klajner began exploring telemedicine, which opened a whole new world of possibilities. “I have conducted several online visits to provide educational instruction to mothers returning home post delivery, for example,” he told this news organization. The time to stop is not something that concerns Dr. Klajner. “I’m only going to stop when I have a really important reason to do so. For example, if I can no longer write or study, reading and rereading an article without being able to understand what is being said. At this time, none of that is happening.”

In the United States, as well as in Brazil, physicians rarely provide information to human resources departments on colleagues showing signs of cognitive or motor decline affecting their professional performance. “The expectation is that health care professionals will report colleagues with cognitive impairments, but that often does not happen,” Dr. Katlic said.

It is also not common for professionals to report their own deficits to their institutions. In large part, this is caused by a lack of well-defined policies for dealing with this issue. This news organization sought out several public and private hospitals in Brazil to see if there is any guidance on professional longevity: Most said that there is not. Only the A. C. Camargo Cancer Center reported, through its public relations team, that a committee is discussing the subject but that it is still in the early stages.

Brazilian specialist associations do not offer guidelines or instructions on the various aspects of professional longevity. Dr. Constantino tried to put the subject on the agenda during the years in which he was an administrator with the CFM. “We tried to open up discussions regarding truly elderly physicians, but the subject was not well received. I believe that it is precisely because there is a tradition of physicians working until they are no longer able that this is more difficult in Brazil ... No one exactly knows what to do in this respect.” Dr. Constantino is against the use of age as a criterion for quitting practice.

“Of course, this is a point that has to be considered, but I always defended the need for regular assessment of physicians, regardless of age range. And, although assessments are always welcome, in any profession, I also believe this would not be well received in Brazil.” He endorses an assessment of one’s knowledge and not of physical abilities, which are generally assessed through investigation when needed.

The absence of guidelines increases individual responsibility, as well as vulnerability. “Consciously, physicians will not put patients at risk if they do not have the competence to care for them or to perform a surgical procedure,” said Clystenes Odyr Soares Silva, MD, PhD, adjunct professor of pulmonology of the Federal University of São Paulo (Brazil) School of Medicine (UNIFESP). “Your peers will tell you if you are no longer able,” he added. The problem is that physicians rarely admit to or talk about their colleagues’ deficits, especially if they are in the spotlight because of advanced age. In this situation, the observation and opinion of family members regarding the health care professional’s competences and skills will hold more weight.

In case of health-related physical impairment, such as partial loss of hand movement, for example, “it is expected that this will set off an ethical warning in the person,” said Dr. Constantino. When this warning does not occur naturally, patients or colleagues can report the professional, and this may lead to the opening of an administrative investigation. If the report is found to be true, this investigation is used to suspend physicians who do not have the physical or mental ability to continue practicing medicine.

“If it’s something very serious, the physician’s license can be temporarily suspended while [the physician] is treated by a psychiatrist, with follow-up by the professional board. When discharged, the physician will get his or her [professional] license back and can go back to work,” Dr. Constantino explained. If an expert evaluation is needed, the physician will then be assessed by a forensic psychiatrist. One of the most in-demand forensic psychiatrists in Brazil is Guido Arturo Palomba, MD, 73 years old. “I have assessed some physicians for actions reported to see if they were normal people or not, but never for circumstances related to age,” Dr. Palomba said.

In practice, Brazilian medical entities do not have policies or programs to guide physicians who wish to grow old while they work or those who have started to notice they are not performing as they used to. “We have never lived as long; therefore, the quality of life in old age, as well as the concept of aging, are some of the most relevant questions of our time. These are subjects requiring additional discussion, broadening understanding and awareness in this regard,” observed Mr. Vattimo.

Dr. Constantino and Dr. Silva, who are completely against age-based assessments, believe that recertification of the specialist license every 5 years is the best path to confirming whether the physician is still able to practice. “A knowledge-based test every 5 years to recertify the specialist license has often been a topic of conversation. I think it’s an excellent idea. The person would provide a dossier of all they have done in terms of courses, conferences, and other activities, present it, and receive a score,” said Dr. Silva.

In practice, recertification of the specialist license is a topic of discussion that has been raised for years, and it is an idea that the Brazilian Medical Association (AMB) defends. In conjunction with the CFM, the association is studying a way to best implement this assessment. “It’s important to emphasize that this measure would not be retroactive at first. Instead, it would only be in effect for professionals licensed after the recertification requirement is established,” the AMB pointed out in a note sent to this news organization. Even so, the measure has faced significant resistance from a faction of the profession, and its enactment does not seem to be imminent.

The debate regarding professional longevity is taking place in various countries. In 2021, the American Medical Association Council on Medical Education released a report with a set of guidelines for the screening and assessment of physicians. The document is the product of a committee created in 2015 to study the subject. The AMA recommends that the assessment of elderly physicians be based on evidence and ethical, relevant, fair, equitable, transparent, verifiable, nonexhaustive principles, contemplating support and protecting against legal proceedings. In April of this year, a new AMA document highlighted the same principles.

Also in the United States, one of oldest initiatives created to support physicians in the process of recycling, the University of California San Diego Physician Assessment and Clinical Education Program (PACE), has a section focusing on the extended practice of medicine (Practicing Medicine Longer). For those wanting to learn more about discussions on this subject, there are online presentations on experiences in Quebec and Ontario with assessing aging physicians, neuropsychological perspectives on the aging medical population, and what to expect of healthy aging, among other subjects.

Created in 1996, PACE mostly provides services to physicians who need to address requirements of the state medical boards. Few physicians enroll on their own.

The first part of the program assesses knowledge and skills over approximately 2 days. In the second phase, the physician participates in a series of activities in a corresponding residency program. Depending on the results, the physician may have to go through a remedial program with varying activities to deal with performance deficiencies to clinical experiences at the residency level.

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

New research suggests there may be better times during the day for eating and fasting. 

Eating earlier in the day may help you lose weight, and eating meals within a 10-hour window could improve blood sugar and cholesterol levels, according to two new studies published in Cell Metabolism.

“You have this internal biological clock that makes you better at doing different things at different times of the day,” Courtney Peterson, PhD, an associate professor of nutrition sciences at the University of Alabama at Birmingham, told NBC News. Dr. Peterson wasn’t involved with the studies.

“It seems like the best time for your metabolism, in most people, is the mid to late morning,” she said.

In one study, researchers found that eating later in the day made people hungrier during a 24-hour period, as compared with eating the same meals earlier in the day. Late eating also burned calories at a slower rate and led to fat tissue that stored more calories. Combined, the changes may increase the risk for obesity, the study authors found.

In another study, among firefighters as shift workers, researchers found that eating meals within a 10-hour window decreased the size of bad cholesterol particles, which could reduce risk factors for heart disease. The 10-hour eating window also improved blood pressure and blood sugar levels among those with health conditions such as diabetes, high blood pressure, and high cholesterol.

The two new studies confirm findings from previous studies that indicate humans may have an ideal eating window based on the body’s circadian rhythms, which regulate sleep and wake cycles and can affect appetite, metabolism, and blood sugar levels.

In the firefighter study, for instance, the 10-hour window appears to be a “sweet spot” for the body, the authors found. More severe restrictions, as found with many intermittent fasting diets, could be difficult for the body to maintain.

“When we think about 6 or 8 hours, you might see a benefit, but people might not stick to it for a long time,” Satchidananda Panda, PhD, one of the study authors and a professor at the Salk Institute, La Jolla, Calif., told NBC News.

The new studies had small sample sizes, though they offer insight for future research. In the first study, 16 people who were overweight or obese tried two eating plans for 24-hour periods. Some of them began eating an hour after their natural wake-up time, and others waited to begin eating until about 5 hours after waking up. They ate the same meals with the same calories and nutrients.

The researchers measured their hormone levels and found that eating later decreased the levels of leptin, which helps people to feel full. Eating later also doubled the odds that people felt hungry throughout the day. Those in the study who ate later in the day also had more cravings for starchy or salty foods, as well as meat and dairy, which are energy-dense foods.

The research team also found changes in fat tissue, which could lead to a higher chance of building up new fat cells and a lower chance of burning fat. Late eaters burned about 60 fewer calories than early eaters during the day.

“Your body processes calories differently when you eat late in the day. It tips the scale in favor of weight gain and fat gain,” Dr. Peterson said. “From this study, we can get pretty clear recommendations that people shouldn’t skip breakfast.”

The second study followed 137 firefighters in San Diego who ate a Mediterranean diet with fish, vegetables, fruit, and olive oil for 12 weeks. Among those, 70 firefighters ate during a 10-hour window, and the rest ate during a longer window, generally about 13 hours. They logged their meals in an app and wore devices to track blood sugar levels.

In the 10-hour group, most firefighters ate between 8 a.m. or 9 a.m. and 6 p.m. or 7 p.m. The time-restricted eating appeared to be linked with health benefits, such as less harmful cholesterol buildup and reduced heart disease. 

Among firefighters with risk factors for heart disease, such as high blood pressure and high blood sugar, the time-restricted eating decreased their blood pressure and blood sugar levels. 

The restricted window appears to allow the body to break down toxins and get rid of sodium and other things that can drive up blood pressure and blood sugar, the authors wrote.

During periods of fasting, “organs get some rest from digesting food so they can divert their energy toward repairing cells,” Dr. Panda said.

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

New research suggests there may be better times during the day for eating and fasting. 

Eating earlier in the day may help you lose weight, and eating meals within a 10-hour window could improve blood sugar and cholesterol levels, according to two new studies published in Cell Metabolism.

“You have this internal biological clock that makes you better at doing different things at different times of the day,” Courtney Peterson, PhD, an associate professor of nutrition sciences at the University of Alabama at Birmingham, told NBC News. Dr. Peterson wasn’t involved with the studies.

“It seems like the best time for your metabolism, in most people, is the mid to late morning,” she said.

In one study, researchers found that eating later in the day made people hungrier during a 24-hour period, as compared with eating the same meals earlier in the day. Late eating also burned calories at a slower rate and led to fat tissue that stored more calories. Combined, the changes may increase the risk for obesity, the study authors found.

In another study, among firefighters as shift workers, researchers found that eating meals within a 10-hour window decreased the size of bad cholesterol particles, which could reduce risk factors for heart disease. The 10-hour eating window also improved blood pressure and blood sugar levels among those with health conditions such as diabetes, high blood pressure, and high cholesterol.

The two new studies confirm findings from previous studies that indicate humans may have an ideal eating window based on the body’s circadian rhythms, which regulate sleep and wake cycles and can affect appetite, metabolism, and blood sugar levels.

In the firefighter study, for instance, the 10-hour window appears to be a “sweet spot” for the body, the authors found. More severe restrictions, as found with many intermittent fasting diets, could be difficult for the body to maintain.

“When we think about 6 or 8 hours, you might see a benefit, but people might not stick to it for a long time,” Satchidananda Panda, PhD, one of the study authors and a professor at the Salk Institute, La Jolla, Calif., told NBC News.

The new studies had small sample sizes, though they offer insight for future research. In the first study, 16 people who were overweight or obese tried two eating plans for 24-hour periods. Some of them began eating an hour after their natural wake-up time, and others waited to begin eating until about 5 hours after waking up. They ate the same meals with the same calories and nutrients.

The researchers measured their hormone levels and found that eating later decreased the levels of leptin, which helps people to feel full. Eating later also doubled the odds that people felt hungry throughout the day. Those in the study who ate later in the day also had more cravings for starchy or salty foods, as well as meat and dairy, which are energy-dense foods.

The research team also found changes in fat tissue, which could lead to a higher chance of building up new fat cells and a lower chance of burning fat. Late eaters burned about 60 fewer calories than early eaters during the day.

“Your body processes calories differently when you eat late in the day. It tips the scale in favor of weight gain and fat gain,” Dr. Peterson said. “From this study, we can get pretty clear recommendations that people shouldn’t skip breakfast.”

The second study followed 137 firefighters in San Diego who ate a Mediterranean diet with fish, vegetables, fruit, and olive oil for 12 weeks. Among those, 70 firefighters ate during a 10-hour window, and the rest ate during a longer window, generally about 13 hours. They logged their meals in an app and wore devices to track blood sugar levels.

In the 10-hour group, most firefighters ate between 8 a.m. or 9 a.m. and 6 p.m. or 7 p.m. The time-restricted eating appeared to be linked with health benefits, such as less harmful cholesterol buildup and reduced heart disease. 

Among firefighters with risk factors for heart disease, such as high blood pressure and high blood sugar, the time-restricted eating decreased their blood pressure and blood sugar levels. 

The restricted window appears to allow the body to break down toxins and get rid of sodium and other things that can drive up blood pressure and blood sugar, the authors wrote.

During periods of fasting, “organs get some rest from digesting food so they can divert their energy toward repairing cells,” Dr. Panda said.

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

New research suggests there may be better times during the day for eating and fasting. 

Eating earlier in the day may help you lose weight, and eating meals within a 10-hour window could improve blood sugar and cholesterol levels, according to two new studies published in Cell Metabolism.

“You have this internal biological clock that makes you better at doing different things at different times of the day,” Courtney Peterson, PhD, an associate professor of nutrition sciences at the University of Alabama at Birmingham, told NBC News. Dr. Peterson wasn’t involved with the studies.

“It seems like the best time for your metabolism, in most people, is the mid to late morning,” she said.

In one study, researchers found that eating later in the day made people hungrier during a 24-hour period, as compared with eating the same meals earlier in the day. Late eating also burned calories at a slower rate and led to fat tissue that stored more calories. Combined, the changes may increase the risk for obesity, the study authors found.

In another study, among firefighters as shift workers, researchers found that eating meals within a 10-hour window decreased the size of bad cholesterol particles, which could reduce risk factors for heart disease. The 10-hour eating window also improved blood pressure and blood sugar levels among those with health conditions such as diabetes, high blood pressure, and high cholesterol.

The two new studies confirm findings from previous studies that indicate humans may have an ideal eating window based on the body’s circadian rhythms, which regulate sleep and wake cycles and can affect appetite, metabolism, and blood sugar levels.

In the firefighter study, for instance, the 10-hour window appears to be a “sweet spot” for the body, the authors found. More severe restrictions, as found with many intermittent fasting diets, could be difficult for the body to maintain.

“When we think about 6 or 8 hours, you might see a benefit, but people might not stick to it for a long time,” Satchidananda Panda, PhD, one of the study authors and a professor at the Salk Institute, La Jolla, Calif., told NBC News.

The new studies had small sample sizes, though they offer insight for future research. In the first study, 16 people who were overweight or obese tried two eating plans for 24-hour periods. Some of them began eating an hour after their natural wake-up time, and others waited to begin eating until about 5 hours after waking up. They ate the same meals with the same calories and nutrients.

The researchers measured their hormone levels and found that eating later decreased the levels of leptin, which helps people to feel full. Eating later also doubled the odds that people felt hungry throughout the day. Those in the study who ate later in the day also had more cravings for starchy or salty foods, as well as meat and dairy, which are energy-dense foods.

The research team also found changes in fat tissue, which could lead to a higher chance of building up new fat cells and a lower chance of burning fat. Late eaters burned about 60 fewer calories than early eaters during the day.

“Your body processes calories differently when you eat late in the day. It tips the scale in favor of weight gain and fat gain,” Dr. Peterson said. “From this study, we can get pretty clear recommendations that people shouldn’t skip breakfast.”

The second study followed 137 firefighters in San Diego who ate a Mediterranean diet with fish, vegetables, fruit, and olive oil for 12 weeks. Among those, 70 firefighters ate during a 10-hour window, and the rest ate during a longer window, generally about 13 hours. They logged their meals in an app and wore devices to track blood sugar levels.

In the 10-hour group, most firefighters ate between 8 a.m. or 9 a.m. and 6 p.m. or 7 p.m. The time-restricted eating appeared to be linked with health benefits, such as less harmful cholesterol buildup and reduced heart disease. 

Among firefighters with risk factors for heart disease, such as high blood pressure and high blood sugar, the time-restricted eating decreased their blood pressure and blood sugar levels. 

The restricted window appears to allow the body to break down toxins and get rid of sodium and other things that can drive up blood pressure and blood sugar, the authors wrote.

During periods of fasting, “organs get some rest from digesting food so they can divert their energy toward repairing cells,” Dr. Panda said.

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

Restriction of dietary salt to alleviate or prevent volume overload in patients with acute decompensated heart failure (ADHF) is common hospital practice, but without a solid evidence base. A trial testing whether taking salt pills might have benefits for patients with ADHF undergoing intensive diuresis, therefore, may seem a bit counterintuitive.

In just such a randomized, placebo-controlled trial, the approach made no difference to weight loss on diuresis, a proxy for volume reduction, or to serum creatinine levels in ADHF patients receiving high-dose intravenous diuretic therapy.

Georges Lievre / Fotolia.com

The patients consumed the extra salt during their intravenous therapy in the form of tablets providing 6 g sodium chloride daily on top of their hospital-provided, low-sodium meals.

During that time, serum sodium levels remained stable for the 34 patients assigned to the salt tablets but dropped significantly in the 31 given placebo pills.

They lost about the same weight, averages of 4 kg and 4.6 kg (8.8-10 lb), respectively, and their urine output was also similar. Patients who took the salt tablets showed less of an increase in blood urea nitrogen (BUN) at both 96 hours and at discharge.

The findings “challenge the routine practice of sodium chloride restriction in acute heart failure, something done thousands of times a day, millions of times a year,” Robert A. Montgomery, MD, Cleveland Clinic, said when presenting the study at the annual scientific meeting of the Heart Failure Society of America.

The trial, called OSPREY-AHF (Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure), also may encourage a shift in ADHF management from a preoccupation with salt restriction to focus more on fighting fluid retention.

OSPREY-HF took on “an established practice that doesn’t have much high-quality evidentiary support,” one guided primarily by consensus and observational data, Montgomery said in an interview.

There are also potential downsides to dietary sodium restriction, including some that may complicate or block ADHF therapies.

“Low-sodium diets can be associated with decreased caloric intake and nutritional quality,” Dr. Montgomery observed. And observational studies suggest that “patients who are on a low sodium diet can develop increased neurohormonal activation. The kidney is not sensing salt, and so starts ramping up the hormones,” which promotes diuretic resistance.

But emerging evidence also suggests “that giving sodium chloride in the form of hypertonic saline can help patients who are diuretic resistant.” The intervention, which appears to attenuate the neurohormonal activation associated with high-dose intravenous diuretics, Dr. Montgomery noted, helped inspire the design of OSPREY-AHF.

Edema consists of “a gallon of water and a pinch of salt, so we really should stop being so salt-centric and think much more about water as the problem in decompensated heart failure,” said John G.F. Cleland, MD, PhD, during the question-and-answer period after Montgomery’s presentation. Dr. Cleland, of the University of Glasgow Institute of Health and Wellbeing, is not connected to OSPREY-AHF.

“I think that maybe we overinterpret how important salt is” as a focus of volume management in ADHF, offered David Lanfear, MD, Henry Ford Health System, Detroit, who is also not part of the study.

OSPREY-AHF was well conducted but applies to a “very specific” clinical setting, Dr. Lanfear said in an interview. “These people are getting aggressive diuresis, a big dose and continuous infusion. It’s not everybody that has heart failure.”

Although the study was small, “I think it will fuel interest in this area and, probably, further investigation,” he said. The trial on its own won’t change practice, “but it will raise some eyebrows.”

The trial included patients with ADHF who have been “admitted to a cardiovascular medicine floor, not the intensive care unit” and were receiving at least 10 mg per hour of furosemide. It excluded any who were “hypernatremic or severely hyponatremic,” said Dr. Montgomery when presenting the study. They were required to have an initial estimated glomerular filtration rate (eGFR) of at least 15 mL/min per 1.73 m².

The patients were randomly assigned double blind at a single center to receive tablets providing 2 g sodium chloride or placebo pills – 34 and 31 patients, respectively – three times daily during intravenous diuresis.

At 96 hours, the two groups showed no difference in change in creatinine levels or change in weight, both primary endpoints. Nor did they differ in urine output or change in eGFR. But serum sodium levels fell further, and BUN levels went up more in those given placebo.

The two groups showed no differences in hospital length of stay, use of renal replacement therapy at 90 days, ICU time during the index hospitalization, 30-day readmission, or 90-day mortality – although the trial wasn’t powered for clinical outcomes, Dr. Montgomery reported.

"We have patients who complain about their sodium-restricted diet, we have patients that have cachexia, who have a lot of complaints about provider-ordered meals and recommendations,” Dr. Montgomery explained in an interview.

Clinicians provide education and invest a lot of effort into getting patients with heart failure to start and maintain a low-sodium diet, he said. “But a low-sodium diet, in prior studies – and our study adds to this – is not a lever that actually seems to positively or adversely affect patients.”

Dr. Montgomery pointed to the recently published SODIUM-HF trial comparing low-sodium and unrestricted-sodium diets in outpatients with heart failure. It saw no clinical benefit from the low-sodium intervention.

Until studies show, potentially, that sodium restriction in hospitalized patients with heart failure makes a clinical difference, Dr. Montgomery said, “I’d say we should invest our time in things that we know are the most helpful, like getting them on guideline-directed medical therapy, when instead we spend an enormous amount of time counseling on and enforcing dietary restriction.”

Support for this study was provided by Cleveland Clinic Heart Vascular and Thoracic Institute’s Wilson Grant and Kaufman Center for Heart Failure Treatment and Recovery Grant. Dr. Lanfear disclosed research support from SomaLogic and Lilly; consulting for Abbott Laboratories, AstraZeneca, Janssen, Martin Pharmaceuticals, and Amgen; and serving on advisory panels for Illumina and Cytokinetics. Dr. Montgomery and Dr. Cleland disclosed no relevant financial relationships.

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

Restriction of dietary salt to alleviate or prevent volume overload in patients with acute decompensated heart failure (ADHF) is common hospital practice, but without a solid evidence base. A trial testing whether taking salt pills might have benefits for patients with ADHF undergoing intensive diuresis, therefore, may seem a bit counterintuitive.

In just such a randomized, placebo-controlled trial, the approach made no difference to weight loss on diuresis, a proxy for volume reduction, or to serum creatinine levels in ADHF patients receiving high-dose intravenous diuretic therapy.

Georges Lievre / Fotolia.com

The patients consumed the extra salt during their intravenous therapy in the form of tablets providing 6 g sodium chloride daily on top of their hospital-provided, low-sodium meals.

During that time, serum sodium levels remained stable for the 34 patients assigned to the salt tablets but dropped significantly in the 31 given placebo pills.

They lost about the same weight, averages of 4 kg and 4.6 kg (8.8-10 lb), respectively, and their urine output was also similar. Patients who took the salt tablets showed less of an increase in blood urea nitrogen (BUN) at both 96 hours and at discharge.

The findings “challenge the routine practice of sodium chloride restriction in acute heart failure, something done thousands of times a day, millions of times a year,” Robert A. Montgomery, MD, Cleveland Clinic, said when presenting the study at the annual scientific meeting of the Heart Failure Society of America.

The trial, called OSPREY-AHF (Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure), also may encourage a shift in ADHF management from a preoccupation with salt restriction to focus more on fighting fluid retention.

OSPREY-HF took on “an established practice that doesn’t have much high-quality evidentiary support,” one guided primarily by consensus and observational data, Montgomery said in an interview.

There are also potential downsides to dietary sodium restriction, including some that may complicate or block ADHF therapies.

“Low-sodium diets can be associated with decreased caloric intake and nutritional quality,” Dr. Montgomery observed. And observational studies suggest that “patients who are on a low sodium diet can develop increased neurohormonal activation. The kidney is not sensing salt, and so starts ramping up the hormones,” which promotes diuretic resistance.

But emerging evidence also suggests “that giving sodium chloride in the form of hypertonic saline can help patients who are diuretic resistant.” The intervention, which appears to attenuate the neurohormonal activation associated with high-dose intravenous diuretics, Dr. Montgomery noted, helped inspire the design of OSPREY-AHF.

Edema consists of “a gallon of water and a pinch of salt, so we really should stop being so salt-centric and think much more about water as the problem in decompensated heart failure,” said John G.F. Cleland, MD, PhD, during the question-and-answer period after Montgomery’s presentation. Dr. Cleland, of the University of Glasgow Institute of Health and Wellbeing, is not connected to OSPREY-AHF.

“I think that maybe we overinterpret how important salt is” as a focus of volume management in ADHF, offered David Lanfear, MD, Henry Ford Health System, Detroit, who is also not part of the study.

OSPREY-AHF was well conducted but applies to a “very specific” clinical setting, Dr. Lanfear said in an interview. “These people are getting aggressive diuresis, a big dose and continuous infusion. It’s not everybody that has heart failure.”

Although the study was small, “I think it will fuel interest in this area and, probably, further investigation,” he said. The trial on its own won’t change practice, “but it will raise some eyebrows.”

The trial included patients with ADHF who have been “admitted to a cardiovascular medicine floor, not the intensive care unit” and were receiving at least 10 mg per hour of furosemide. It excluded any who were “hypernatremic or severely hyponatremic,” said Dr. Montgomery when presenting the study. They were required to have an initial estimated glomerular filtration rate (eGFR) of at least 15 mL/min per 1.73 m².

The patients were randomly assigned double blind at a single center to receive tablets providing 2 g sodium chloride or placebo pills – 34 and 31 patients, respectively – three times daily during intravenous diuresis.

At 96 hours, the two groups showed no difference in change in creatinine levels or change in weight, both primary endpoints. Nor did they differ in urine output or change in eGFR. But serum sodium levels fell further, and BUN levels went up more in those given placebo.

The two groups showed no differences in hospital length of stay, use of renal replacement therapy at 90 days, ICU time during the index hospitalization, 30-day readmission, or 90-day mortality – although the trial wasn’t powered for clinical outcomes, Dr. Montgomery reported.

"We have patients who complain about their sodium-restricted diet, we have patients that have cachexia, who have a lot of complaints about provider-ordered meals and recommendations,” Dr. Montgomery explained in an interview.

Clinicians provide education and invest a lot of effort into getting patients with heart failure to start and maintain a low-sodium diet, he said. “But a low-sodium diet, in prior studies – and our study adds to this – is not a lever that actually seems to positively or adversely affect patients.”

Dr. Montgomery pointed to the recently published SODIUM-HF trial comparing low-sodium and unrestricted-sodium diets in outpatients with heart failure. It saw no clinical benefit from the low-sodium intervention.

Until studies show, potentially, that sodium restriction in hospitalized patients with heart failure makes a clinical difference, Dr. Montgomery said, “I’d say we should invest our time in things that we know are the most helpful, like getting them on guideline-directed medical therapy, when instead we spend an enormous amount of time counseling on and enforcing dietary restriction.”

Support for this study was provided by Cleveland Clinic Heart Vascular and Thoracic Institute’s Wilson Grant and Kaufman Center for Heart Failure Treatment and Recovery Grant. Dr. Lanfear disclosed research support from SomaLogic and Lilly; consulting for Abbott Laboratories, AstraZeneca, Janssen, Martin Pharmaceuticals, and Amgen; and serving on advisory panels for Illumina and Cytokinetics. Dr. Montgomery and Dr. Cleland disclosed no relevant financial relationships.

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

Restriction of dietary salt to alleviate or prevent volume overload in patients with acute decompensated heart failure (ADHF) is common hospital practice, but without a solid evidence base. A trial testing whether taking salt pills might have benefits for patients with ADHF undergoing intensive diuresis, therefore, may seem a bit counterintuitive.

In just such a randomized, placebo-controlled trial, the approach made no difference to weight loss on diuresis, a proxy for volume reduction, or to serum creatinine levels in ADHF patients receiving high-dose intravenous diuretic therapy.

Georges Lievre / Fotolia.com

The patients consumed the extra salt during their intravenous therapy in the form of tablets providing 6 g sodium chloride daily on top of their hospital-provided, low-sodium meals.

During that time, serum sodium levels remained stable for the 34 patients assigned to the salt tablets but dropped significantly in the 31 given placebo pills.

They lost about the same weight, averages of 4 kg and 4.6 kg (8.8-10 lb), respectively, and their urine output was also similar. Patients who took the salt tablets showed less of an increase in blood urea nitrogen (BUN) at both 96 hours and at discharge.

The findings “challenge the routine practice of sodium chloride restriction in acute heart failure, something done thousands of times a day, millions of times a year,” Robert A. Montgomery, MD, Cleveland Clinic, said when presenting the study at the annual scientific meeting of the Heart Failure Society of America.

The trial, called OSPREY-AHF (Oral Sodium to Preserve Renal Efficiency in Acute Heart Failure), also may encourage a shift in ADHF management from a preoccupation with salt restriction to focus more on fighting fluid retention.

OSPREY-HF took on “an established practice that doesn’t have much high-quality evidentiary support,” one guided primarily by consensus and observational data, Montgomery said in an interview.

There are also potential downsides to dietary sodium restriction, including some that may complicate or block ADHF therapies.

“Low-sodium diets can be associated with decreased caloric intake and nutritional quality,” Dr. Montgomery observed. And observational studies suggest that “patients who are on a low sodium diet can develop increased neurohormonal activation. The kidney is not sensing salt, and so starts ramping up the hormones,” which promotes diuretic resistance.

But emerging evidence also suggests “that giving sodium chloride in the form of hypertonic saline can help patients who are diuretic resistant.” The intervention, which appears to attenuate the neurohormonal activation associated with high-dose intravenous diuretics, Dr. Montgomery noted, helped inspire the design of OSPREY-AHF.

Edema consists of “a gallon of water and a pinch of salt, so we really should stop being so salt-centric and think much more about water as the problem in decompensated heart failure,” said John G.F. Cleland, MD, PhD, during the question-and-answer period after Montgomery’s presentation. Dr. Cleland, of the University of Glasgow Institute of Health and Wellbeing, is not connected to OSPREY-AHF.

“I think that maybe we overinterpret how important salt is” as a focus of volume management in ADHF, offered David Lanfear, MD, Henry Ford Health System, Detroit, who is also not part of the study.

OSPREY-AHF was well conducted but applies to a “very specific” clinical setting, Dr. Lanfear said in an interview. “These people are getting aggressive diuresis, a big dose and continuous infusion. It’s not everybody that has heart failure.”

Although the study was small, “I think it will fuel interest in this area and, probably, further investigation,” he said. The trial on its own won’t change practice, “but it will raise some eyebrows.”

The trial included patients with ADHF who have been “admitted to a cardiovascular medicine floor, not the intensive care unit” and were receiving at least 10 mg per hour of furosemide. It excluded any who were “hypernatremic or severely hyponatremic,” said Dr. Montgomery when presenting the study. They were required to have an initial estimated glomerular filtration rate (eGFR) of at least 15 mL/min per 1.73 m².

The patients were randomly assigned double blind at a single center to receive tablets providing 2 g sodium chloride or placebo pills – 34 and 31 patients, respectively – three times daily during intravenous diuresis.

At 96 hours, the two groups showed no difference in change in creatinine levels or change in weight, both primary endpoints. Nor did they differ in urine output or change in eGFR. But serum sodium levels fell further, and BUN levels went up more in those given placebo.

The two groups showed no differences in hospital length of stay, use of renal replacement therapy at 90 days, ICU time during the index hospitalization, 30-day readmission, or 90-day mortality – although the trial wasn’t powered for clinical outcomes, Dr. Montgomery reported.

"We have patients who complain about their sodium-restricted diet, we have patients that have cachexia, who have a lot of complaints about provider-ordered meals and recommendations,” Dr. Montgomery explained in an interview.

Clinicians provide education and invest a lot of effort into getting patients with heart failure to start and maintain a low-sodium diet, he said. “But a low-sodium diet, in prior studies – and our study adds to this – is not a lever that actually seems to positively or adversely affect patients.”

Dr. Montgomery pointed to the recently published SODIUM-HF trial comparing low-sodium and unrestricted-sodium diets in outpatients with heart failure. It saw no clinical benefit from the low-sodium intervention.

Until studies show, potentially, that sodium restriction in hospitalized patients with heart failure makes a clinical difference, Dr. Montgomery said, “I’d say we should invest our time in things that we know are the most helpful, like getting them on guideline-directed medical therapy, when instead we spend an enormous amount of time counseling on and enforcing dietary restriction.”

Support for this study was provided by Cleveland Clinic Heart Vascular and Thoracic Institute’s Wilson Grant and Kaufman Center for Heart Failure Treatment and Recovery Grant. Dr. Lanfear disclosed research support from SomaLogic and Lilly; consulting for Abbott Laboratories, AstraZeneca, Janssen, Martin Pharmaceuticals, and Amgen; and serving on advisory panels for Illumina and Cytokinetics. Dr. Montgomery and Dr. Cleland disclosed no relevant financial relationships.

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

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

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

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

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

To be cost effective, compared with metformin, for initial therapy for type 2 diabetes, prices for a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) agonist would have to fall by at least 70% and at least 90%, respectively, according to estimates.

Thinkstock Photos

The study, modeled on U.S. patients, by Jin G. Choi, MD, and colleagues, was published online Oct. 3 in the Annals of Internal Medicine.

The researchers simulated the lifetime incidence, prevalence, mortality, and costs associated with three different first-line treatment strategies – metformin, an SGLT2 inhibitor, or a GLP-1 agonist – in U.S. patients with untreated type 2 diabetes.

Compared with patients who received initial treatment with metformin, those who received one of the newer drugs had 4.4% to 5.2% lower lifetime rates of congestive heart failure, ischemic heart disease, myocardial infarction, and stroke.

However, to be cost-effective at under $150,000 per quality-adjusted life-years (QALY), SGLT2 inhibitors would need to cost less than $5 a day ($1,800 a year), and GLP-1 agonists would have to cost less than $6 a day ($2,100 a year), a lot less than now.

Knowing how expensive these drugs are, “I am not surprised” that the model predicts that the price would have to drop so much to make them cost-effective, compared with first-line treatment with metformin, senior author Neda Laiteerapong, MD, said in an interview.

“But I am disappointed,” she said, because these drugs are very effective, and if the prices were lower, more people could benefit.

“In the interest of improving access to high-quality care in the United States, our study results indicate the need to reduce SGLT2 inhibitor and GLP-1 receptor agonist medication costs substantially for patients with type 2 [diabetes] to improve health outcomes and prevent exacerbating diabetes health disparities,” the researchers conclude.

One way that the newer drugs might be more widely affordable is if the government became involved, possibly by passing a law similar to the Affordable Insulin Now Act, speculated Dr. Laiteerapong, who is associate director at the Center for Chronic Disease Research and Policy, University of Chicago.
 

‘Current prices too high to encourage first-line adoption’

Guidelines recommend the use of SGLT2 inhibitors and GLP-1 agonists as second-line therapies for patients with type 2 diabetes, but it has not been clear if clinical benefits would outweigh costs for use as first-line therapies.

“Although clinical trials have demonstrated the clinical effectiveness of these newer drugs, they are hundreds of times more expensive than other ... diabetes drugs,” the researchers note.

On the other hand, costs may fall in the coming years when these new drugs come off-patent.

The current study was designed to help inform future clinical guidelines.

The researchers created a population simulation model based on the United Kingdom Prospective Diabetes Study, Outcomes Model version 2 (UKPDS OM2) for diabetes-related complications and mortality, with added information about hypoglycemic events, quality of life, and U.S. costs. 

The researchers also identified a nationally representative sample of people who would be eligible to start first-line diabetes therapy when their A1c reached 7% for the model. 

Using National Health and Nutrition Examination Survey (NHANES) data (2013-2016), the researchers identified about 7.3 million U.S. adults aged 18 and older with self-reported diabetes or an A1c greater than 6.5% with no reported use of diabetes medications.

Patients were an average age of 55, and 55% were women. They had had diabetes for an average of 4.2 years, and 36% had a history of diabetes complications.

The model projected that patients would have an improved life expectancy of 3.0 and 3.4 months from first-line SGLT2 inhibitors and GLP-1 agonists, respectively, compared with initial therapy with metformin due to reduced rates of macrovascular disease.  

“However, the current drug costs would be too high to encourage their adoption as first-line for usual clinical practice,” the researchers report.
 

‘Disparities could remain for decades’

Generic SGLT2 inhibitors could enter the marketplace shortly, because one of two dapagliflozin patents expired in October 2020 and approval for generic alternatives has been sought from the U.S. Food and Drug Administration, Dr. Choi and colleagues note.

However, it could still take decades for medication prices to drop low enough to become affordable, the group cautions. For example, a generic GLP-1 agonist became available in 2017, but costs remain high.

“Without external incentives,” the group writes, “limited access to these drug classes will likely persist (for example, due to higher copays or requirements for prior authorizations), as will further diabetes disparities – for decades into the future – because of differential access to care due to insurance (for example, private vs. public), which often tracks race and ethnicity.”

The study was supported by the American Diabetes Association. Dr. Choi was supported by a National Institutes of Health, National Institute on Aging grant. Dr. Laiteerapong and other co-authors are members of the National Institute of Diabetes and Digestive and Kidney Diseases Chicago Center for Diabetes Translation Research at the University of Chicago. Dr. Choi and Dr. Laiteerapong have reported no relevant financial relationships.

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

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

The last full week of September brought a 4th straight week of declines in the number of new COVID-19 cases reported among children, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case total of 39,200 for the week of Sept. 23-29 was down by almost 28% from the previous week, with the month of September bringing a decline of about 57% in reported cases for the 45 states and territories that are still releasing pediatric COVID data on their health department websites, the AAP and CHA said in their joint weekly report.

New cases dropped in all four regions after the Northeast and West had seen increases the previous week, and the distribution of cases for the latest week was fairly even, with the Midwest and Northeast right around 10,000, the South slightly over 10,000, and the West under 10,000 by about the same amount. At the state level, the largest increases – around 1.5% – over the last 2 weeks occurred in Kentucky and Nevada, the AAP/CHA data show.

The cumulative number of COVID-19 cases in children was almost 14.8 million as of Sept. 29, with children representing 18.4% of all cases since the pandemic began, the AAP and CHA said. The Centers for Disease Control and Prevention, which is able to use a uniform age range of 0-17 years, puts total cases at 15.2 million and the proportion of child cases at 17.4%. Total deaths in children from COVID as of Oct. 3 were 1,745, the CDC reported.

New vaccinations, in the meantime, are being added in numbers only slightly higher than new cases. Initial COVID vaccinations for the week of Sept. 22-28 were about 44,000 for children under 5 years of age (down from 51,000 the week before), 24,000 for children aged 5-11 years (down from 28,000), and 17,000 for those aged 12-17 (down from 18,000), the AAP said in its weekly vaccination report.

To look at it another way, the total proportion of children under 5 years of age who had received at least one dose of COVID vaccine as of Sept. 28 was 6.5%, compared with 6.4% on Sept. 21, while the corresponding rates for children aged 5-11 and 12-17 were unchanged at 38.5% and 70.9%. The 12- to 17-year-olds, in fact, have been stuck at 70.9% since Sept. 13, according to data from the CDC.

In a recent study published in Vaccine, investigators attributed the discrepancies between age groups at least partly to the acceptance of misinformation about vaccine safety in general and the COVID-19 vaccines in particular.

“All of the misconceptions we studied focused in one way or another on the safety of vaccination, and that explains why people’s misbeliefs about vaccinating kids are so highly related to their concerns about vaccines in general. Unfortunately, those concerns weigh even more heavily when adults consider vaccinating children,” lead author Dan Romer, PhD, of the University of Pennsylvania, Philadelphia, said in a written statement.

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.

A higher percentage of family physicians quit during the early months of the pandemic than the average yearly percentage that did in the prior decade, according to data from Canada.

The researchers conducted two analyses of billing claims data for family physicians practicing in Ontario. They examined data for a period from 2010 to 2019 – before the onset of the pandemic – and from 2019 through 2020. The findings were published in Annals of Family Medicine.

Overall, the proportion of family physicians who stopped working rose from an average of 1.6% each year for the period between 2010 and 2019 to 3% in the period from 2019 to 2020. The pandemic data set included 12,247 physicians in Ontario. Of these, 385 (3.1%) reported no billings in the first 6 months of the pandemic.

Compared with family physicians billing for work during the pandemic, those reporting no billings were significantly more likely to be 75 years or older (13.0% vs. 3.4%), to have patient panels of less than 500 patients (40.0% vs. 25.8%), and to be eligible for fee-for-service reimbursement (37.7% vs. 24.9%; P less than .001 for all). The family physicians who reported no billing early in the pandemic also had fewer billing days in the previous year (mean of 73 days vs. 101 days, P less than .001).

In a regression analysis, the absolute increase in the percentage of family physicians who stopped working was 0.3% per year from 2010 to 2019, but rose to 1.2% between 2019 and 2020.

Challenges to family physicians in Ontario in the early months of the COVID-19 pandemic included reduced revenue, inability to keep offices fully staffed, and problems obtaining enough personal protective equipment. Such challenges may have prompted some family physicians to stop working prematurely, but more research is needed in other settings, wrote study author Tara Kiran, MD, of the University of Toronto, and colleagues.

“There were a lot of stories and suggestions that more family physicians were choosing to retire due to COVID,” Michael Green, MD, a coauthor of the paper, said in an interview. “Given the preexisting shortages we thought it would be important to see if this was true, and how big of an issue it was,” he said.

Although the absolute number of primary care physicians who stopped working is small, the implications are large given the ongoing shortage of family physicians in Canada, the researchers wrote.

The characteristics of physicians stopping work, such as older age and smaller practice size, were consistent with that of physicians preparing for retirement, the researchers noted. In addition, 56% of the family physicians who stopped working during the pandemic practiced in a patient enrollment model, in which patients are enrolled and between 15% and 70% of payment is based on age and sex. In this study, approximately 80% of physicians worked in this model. The remaining 20% operated in independent, fee-for-service practices.

“Although we cannot directly attribute causation, we hypothesize that some family physicians accelerated their retirement plans because of the pandemic,” the researchers noted. They proposed that possible reasons include health concerns, increased costs of infection prevention and control, reduced revenue from office visits, and burnout. The current study did not examine these issues.

Additional studies are needed to understand the impact on population health, the researchers concluded, but they estimated that the number of family physicians who stopped work during the pandemic would have provided care for approximately 170,000 patients.

The study findings reflect a genuine turnover by family physicians, vs. a departure from family practice to a fellowship and practice in another specialty, Dr. Green said. “We looked at physician billings to determine who stopped practicing, so we report only on those who stopped billing the Ontario Health Insurance Program altogether,” he explained.

The ongoing pandemic accelerated the issue of an upcoming wave of physician retirements and added to an already large number of people without a family physician, Dr. Green noted.

“We know there will be significant shortages of family physicians if we don’t modernize our ways of delivering primary care,” said Dr. Green. More research is needed on how to support family doctors with teams and administrative supports to allow them to provide high quality care to more patients, he said. Better models to estimate health workforce needs in primary care are needed as well, he added.

In the United States, a physician shortage has been growing since before the pandemic, according to a report published in 2021 by the Association of American Medical Colleges. In this report, “The Complexities of Physician Supply and Demand: Projections from 2019 to 2034,” the authors specifically projected a primary care physician shortage of 17,800 to 48,000 by 2034. This projection is in part based on an increase in the percentage of the U.S. population aged 65 years and older, which will increase the demand for care, according to the authors. The report also confirmed that many U.S. physicians are approaching retirement age and that more than two of five active physicians will be 65 years or older within the next 10 years.

However, the authors of this U.S. report acknowledged that the impact of the pandemic on existing primary care shortages remains unclear.

“There are still many unknowns about the direct short-term and long-term impacts of COVID-19 on the physician workforce, and it may be several years before those impacts are clearly understood,” they said in the executive summary of their report.

Alison N. Huffstetler, MD, a coauthor of a recent report that tried to identify the active primary care workforce in Virginia, said, “We know from other research that there are not enough primary care doctors, right now, to do the work that needs to be done – some citations have noted it would take a primary care doc over 20 hours a day just to provide preventive care.

“As our population continues to age, live longer, and need more complex care management, we must ensure we have an accountable, accessible, and knowledgeable primary care network to care for our communities,” she said.
 

Current state of primary care in Virginia

The study by Dr. Huffstetler, of Virginia Commonwealth University, Richmond, and colleagues was published in Annals of Family Medicine. It used a novel strategy involving the analysis of state all-payer claims data to determine how many physicians were practicing primary care in Virginia.

The researchers used the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD) and identified all Virginia physicians and their specialties through the NPPES between 2015 and 2019. Active physicians were defined as those with at least one claim in the VA-APCD during the study period. They identified 20,976 active physicians in Virginia, 28.1% of whom were classified as primary care. Of these, 52% were family medicine physicians, 18.5% were internal medicine physicians, 16.8% were pediatricians, 11.8% were ob.gyns., and 0.5% were other specialists.

Clinician specialties were identified via specialty codes from the NPPES. Physicians were identified as primary care providers in two ways. The first way was by identifying those who had a National Uniform Claim Committee (NUCC) taxonomy of family medicine. The NUCC identifies a provider’s specialty using several levels of classification based on board certification and subspecialty certification data. The second identifier was having been a physician who had billed for at least 10 wellness visit codes from Jan. 1, 2019, through Dec. 31, 2019.

Over the 5-year study period (2015-2019), the counts and percentages of primary care physicians in the workforce remained stable, and the overall number of physicians in the state increased by 3.5%, the researchers noted. A total of 60.45% of all physicians and 60.87% of primary care physicians remained active, and 11.66% of all physicians had a claim in only 1 of the 5 years.
 

How distribution and access impact patients

In an interview, Dr. Huffstetler said the study she and colleagues authored “offers a transparent and reproducible process for identifying primary care physicians in a state, where they practice, and what changes in staffing occur over time.”

“In Virginia, this is particularly important, as we recently expanded Medicaid, making primary care more affordable for over 500,000 people,” she said. “We also saw the importance of distribution and accessibility to primary care over the past 3 years of COVID. In order to adequately prepare for community needs in the coming years, we must know who is providing primary care, and where they are.”

However, the model used in this study has its limitations, Dr. Huffstetler said, including the lack of a definitive definition of primary care using claims data.

“We used a data-informed wellness visit threshold, but it is likely that primary care is delivered in some locations without claims that are reflected by a wellness visit, and we hope to look at scope in the future to help refine these results,” she said.
 

Canadian study shows pandemic’s impact on patient care

“The pandemic’s impact on primary care remains palpable, and Dr. Kiran’s team has done an excellent analysis on the practice trends during the past several years,” Dr. Huffstetler said.

“The Canadian analysis uses claims in a similar manner to our study; however, it appears that they already knew who the FPs were in Ontario,” Dr. Huffstetler noted. “Their claims threshold of 50 for active practice was higher than ours, at only 1. Should those FPs have moved to a different specialty, the physicians would still have claims for the patients seen in other subspecialties. As such, I don’t suspect that their analysis miscalculated those that transitioned, rather than stopped practice,” she explained.

The Ontario study was supported by the Initial Credential Evaluation Service, which is funded by the Ontario Ministry of Health and the Ministry of Long-Term Care, as well as by the Canadian Institutes of Health Research. Additional support came from the INSPIRE Primary Health Care Research Program, which is also funded by the Ontario Ministry of Health and Long-Term Care. The researchers had no financial conflicts to disclose.

The Virginia study was supported by the Department of Medical Assistance Services and the National Center for Advancing Translational Sciences. The researchers had no financial conflicts to disclose.

The supply and demand report was conducted for the AAMC by IHS Markit, a global information company.