MDedge Endocrinology

Clinicians are well aware of the benefits of physical activity and the consequences of inactivity. 

Managing the diseases associated with inactivity – heart disease, type 2 diabetes, hypertension – falls to physicians. So one might assume they routinely prescribe exercise to their patients, just as they would statins, insulin, or beta-blockers. 

But evidence indicates that doctors don’t routinely have those conversations. They may lack confidence in their ability to give effective advice, fear offending patients, or simply not know what to say.

That’s understandable. Many doctors receive little training on how to counsel patients to exercise, according to research over the past decade. Despite efforts to improve this, many medical students still feel unprepared to prescribe physical activity to patients.

But here’s the thing: Doctors are in a unique position to change things.

Only 28% of Americans meet physical activity guidelines, according to the U.S. Centers for Disease Control and Prevention. At the same time, other research suggests that patients want to be more active and would like help from their doctor.

“Patients are motivated to hear about physical activity from physicians and try to make a change,” says Jane Thornton, MD, PhD, an assistant professor in family medicine at Western University, Ont. “Just saying something, even if you don’t have specialized knowledge, makes a difference because of the credibility we have as physicians.”

Conveniently, just like exercise, the best way to get started is to ... get started.

Here’s how to break down the process into steps.
 

1. Ask patients about their physical activity

Think of this as taking any kind of patient history, only for physical activity.

Do they have a regular exercise routine? For how many minutes a day are they active? How many days a week?

“It takes less than a minute to ask and record,” Dr. Thornton says. Once you put it into the patient’s electronic record, you have something you can track.
 

2. Write an actual prescription

By giving the patient a written, printed prescription when they leave your office, “you’re showing it’s an important part of treatment or prevention,” Dr. Thornton explains. It puts physical activity on the level of a vital sign.

Include frequency, intensity, time, and type of exercise. The American College of Sports Medicine’s Exercise is Medicine initiative provides a prescription template you can use.
 

3. Measure what they do

Measurement helps the patient adopt the new behavior, and it helps the physician provide tailored advice going forward, Dr. Thornton says.

With the rise of health-monitoring wearables, tracking activity has never been easier. Of course, not everyone wants to (or can afford to) use a smartwatch or fitness tracker.

For tech-averse patients, ask if they’re willing to write something down, like how many minutes they spent walking, or how many yoga classes they attended. You may never get this from some patients, but it never hurts to ask.
 

4. Refer out when necessary

This brings us to a sticky issue for many physicians: lack of confidence in their ability to speak authoritatively about physical activity. “In most cases, you can absolutely say, ‘Start slow, go gradually,’ that kind of thing,” Dr. Thornton says. “As with anything, confidence will come with practice.”

For specific prescriptive advice, check out the Exercise is Medicine website, which also has handouts you can share with patients and information for specific conditions. If your patient has prediabetes, you can also point them toward the CDC’s diabetes prevention program, which is available in-person or online and may be free or covered by insurance.

If a patient has contraindications, refer out. If you don’t have exercise or rehab professionals in your network, Dr. Thornton recommends reaching out to your regional or national association of sports-medicine professionals. You should be able to find it with a quick Google search.
 

5. Follow up

Ask about physical activity during every contact, either in person or online. 

Dr. Thornton says the second and fifth steps matter most to patients, especially when the prescription and follow-up come from their primary care physician, rather than a nurse or physician assistant to whom you’ve delegated the task.

“The value comes in having a physician emphasize the importance,” Dr. Thornton says. The more time you spend on it, the more that value comes through.
 

What NOT to say to patients about exercise

This might surprise you: 

“I definitely don’t think telling people the official recommendations for physical activity is useful,” says Yoni Freedhoff, MD, an associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute. “If anything, I’d venture it’s counterproductive.”

It’s not that there’s anything wrong with the recommended minimum – 150 minutes of moderate-to-vigorous-intensity physical activity per week. The problem is what it says to a patient who doesn’t come close to those standards. 

“Few real-world people have the interest, time, energy, or privilege to achieve them,” Dr. Freedhoff says. “Many will recognize that instantly and consequently feel [that] less than that is pointless.”

And that, Dr. Thornton says, is categorically not true. “Even minimal physical activity, in some cases, is beneficial.”

You also want to avoid any explicit connection between exercise and weight loss, Dr. Thornton says.

Though many people do connect the two, the link is often negative, notes a 2019 study from the University of Toronto., triggering painful memories that might go all the way back to gym class. 

Try this pivot from Dr. Freedhoff: “Focus on the role of exercise in mitigating the risks of weight,” he says – like decreasing pain, increasing energy, and improving sleep.
 

How to motivate patients to move

New research backs up this more positive approach. In a study published in Annals of Internal Medicine, doctors in the United Kingdom who emphasized benefits and minimized health harms convinced more patients to join a weight management program than negative or neutral docs did. These doctors conveyed optimism and excitement, smiling and avoiding any mention of obesity or body mass index.

Exactly what benefits inspire change will be different for each patient. But in general, the more immediate the benefit, the more motivating it will be. 

As the University of Toronto study noted, patients weren’t motivated by vague, distant goals like “increasing life expectancy or avoiding health problems many years in the future.”

They’re much more likely to take action to avoid surgery, reduce medications, or minimize the risk of falling. 

For an older patient, Dr. Freedhoff says, “focusing on the preservation of functional independence can be extremely motivating.” That’s especially true if the patient has vivid memories of seeing a sedentary loved one decline late in life. 

For patients who may be more focused on appearance, they could respond to the idea of improving their body composition. For that, “we talk about the quality of weight loss,” says Spencer Nadolsky, DO, an obesity and lipid specialist and medical director of WeightWatchers. “Ultimately, exercise helps shape the body instead of just changing the number on the scale.”
 

Reducing resistance to resistance training

A conversation about reshaping the body or avoiding age-related disabilities leads naturally to resistance training.  

“I always frame resistance training as the single most valuable thing a person might do to try to preserve their functional independence,” Dr. Freedhoff says. If the patient is over 65, he won’t wait for them to show an interest. “I’ll absolutely bring it up with them directly.”

Dr. Freedhoff has an on-site training facility where trainers show patients how to work out at home with minimal equipment, like dumbbells and resistance bands. 

Most doctors, however, don’t have those options. That can lead to a tricky conversation. Participants in the University of Toronto study told the authors they disliked the gym, finding it “boring, intimidating, or discouraging.” 

And yet, “a common suggestion ... from health care providers was to join a gym.”

Many patients, Spencer Nadolsky, MD, says, associate strength training with “grunting, groaning, or getting ‘bulky’ vs. ‘toned.’ ” Memories of soreness from overzealous workouts are another barrier.

He recommends “starting small and slow,” with one or two full-body workouts a week. Those initial workouts might include just one to two sets of four to five exercises. “Consider if someone is exercising at home or in a gym to build a routine around equipment that’s available to them,” Dr. Nadolsky says.

Once you determine what you have to work with, help the patient choose exercises that fit their needs, goals, preferences, limitations, and prior injuries.

One more consideration: While Dr. Nadolsky tries to “stay away from telling a patient they need to do specific types of exercise to be successful,” he makes an exception for patients who’re taking a GLP-1 agonist. “There is a concern for muscle mass loss along with fat loss.”
 

Practicing, preaching, and checking privilege

When Dr. Thornton, Dr. Freedhoff, and Dr. Nadolsky discuss exercise, their patients know they practice what they preach. 

Dr. Nadolsky, who was a nationally ranked wrestler at the University of North Carolina, hosts the Docs Who Lift podcast with his brother, Karl Nadolsky, MD. 

Dr. Freedhoff is also a lifter and fitness enthusiast, and Dr. Thornton was a world-class rower whose team came within 0.8 seconds of a silver medal at the Beijing Olympics. (They finished fourth.)

But not all physicians follow their own lifestyle advice, Dr. Freedhoff says. That doesn’t make them bad doctors – it makes them human.

“I’ve done 300 minutes a week of exercise” – the recommended amount for weight maintenance – “to see what’s involved,” Dr. Freedhoff says. “That’s far, far, far from a trivial amount.”

That leads to this advice for his fellow physicians:

“The most important thing to know about exercise is that finding the time and having the health to do so is a privilege,” he says. 

Understanding that is crucial for assessing your patient’s needs and providing the right help.

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

Clinicians are well aware of the benefits of physical activity and the consequences of inactivity. 

Managing the diseases associated with inactivity – heart disease, type 2 diabetes, hypertension – falls to physicians. So one might assume they routinely prescribe exercise to their patients, just as they would statins, insulin, or beta-blockers. 

But evidence indicates that doctors don’t routinely have those conversations. They may lack confidence in their ability to give effective advice, fear offending patients, or simply not know what to say.

That’s understandable. Many doctors receive little training on how to counsel patients to exercise, according to research over the past decade. Despite efforts to improve this, many medical students still feel unprepared to prescribe physical activity to patients.

But here’s the thing: Doctors are in a unique position to change things.

Only 28% of Americans meet physical activity guidelines, according to the U.S. Centers for Disease Control and Prevention. At the same time, other research suggests that patients want to be more active and would like help from their doctor.

“Patients are motivated to hear about physical activity from physicians and try to make a change,” says Jane Thornton, MD, PhD, an assistant professor in family medicine at Western University, Ont. “Just saying something, even if you don’t have specialized knowledge, makes a difference because of the credibility we have as physicians.”

Conveniently, just like exercise, the best way to get started is to ... get started.

Here’s how to break down the process into steps.
 

1. Ask patients about their physical activity

Think of this as taking any kind of patient history, only for physical activity.

Do they have a regular exercise routine? For how many minutes a day are they active? How many days a week?

“It takes less than a minute to ask and record,” Dr. Thornton says. Once you put it into the patient’s electronic record, you have something you can track.
 

2. Write an actual prescription

By giving the patient a written, printed prescription when they leave your office, “you’re showing it’s an important part of treatment or prevention,” Dr. Thornton explains. It puts physical activity on the level of a vital sign.

Include frequency, intensity, time, and type of exercise. The American College of Sports Medicine’s Exercise is Medicine initiative provides a prescription template you can use.
 

3. Measure what they do

Measurement helps the patient adopt the new behavior, and it helps the physician provide tailored advice going forward, Dr. Thornton says.

With the rise of health-monitoring wearables, tracking activity has never been easier. Of course, not everyone wants to (or can afford to) use a smartwatch or fitness tracker.

For tech-averse patients, ask if they’re willing to write something down, like how many minutes they spent walking, or how many yoga classes they attended. You may never get this from some patients, but it never hurts to ask.
 

4. Refer out when necessary

This brings us to a sticky issue for many physicians: lack of confidence in their ability to speak authoritatively about physical activity. “In most cases, you can absolutely say, ‘Start slow, go gradually,’ that kind of thing,” Dr. Thornton says. “As with anything, confidence will come with practice.”

For specific prescriptive advice, check out the Exercise is Medicine website, which also has handouts you can share with patients and information for specific conditions. If your patient has prediabetes, you can also point them toward the CDC’s diabetes prevention program, which is available in-person or online and may be free or covered by insurance.

If a patient has contraindications, refer out. If you don’t have exercise or rehab professionals in your network, Dr. Thornton recommends reaching out to your regional or national association of sports-medicine professionals. You should be able to find it with a quick Google search.
 

5. Follow up

Ask about physical activity during every contact, either in person or online. 

Dr. Thornton says the second and fifth steps matter most to patients, especially when the prescription and follow-up come from their primary care physician, rather than a nurse or physician assistant to whom you’ve delegated the task.

“The value comes in having a physician emphasize the importance,” Dr. Thornton says. The more time you spend on it, the more that value comes through.
 

What NOT to say to patients about exercise

This might surprise you: 

“I definitely don’t think telling people the official recommendations for physical activity is useful,” says Yoni Freedhoff, MD, an associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute. “If anything, I’d venture it’s counterproductive.”

It’s not that there’s anything wrong with the recommended minimum – 150 minutes of moderate-to-vigorous-intensity physical activity per week. The problem is what it says to a patient who doesn’t come close to those standards. 

“Few real-world people have the interest, time, energy, or privilege to achieve them,” Dr. Freedhoff says. “Many will recognize that instantly and consequently feel [that] less than that is pointless.”

And that, Dr. Thornton says, is categorically not true. “Even minimal physical activity, in some cases, is beneficial.”

You also want to avoid any explicit connection between exercise and weight loss, Dr. Thornton says.

Though many people do connect the two, the link is often negative, notes a 2019 study from the University of Toronto., triggering painful memories that might go all the way back to gym class. 

Try this pivot from Dr. Freedhoff: “Focus on the role of exercise in mitigating the risks of weight,” he says – like decreasing pain, increasing energy, and improving sleep.
 

How to motivate patients to move

New research backs up this more positive approach. In a study published in Annals of Internal Medicine, doctors in the United Kingdom who emphasized benefits and minimized health harms convinced more patients to join a weight management program than negative or neutral docs did. These doctors conveyed optimism and excitement, smiling and avoiding any mention of obesity or body mass index.

Exactly what benefits inspire change will be different for each patient. But in general, the more immediate the benefit, the more motivating it will be. 

As the University of Toronto study noted, patients weren’t motivated by vague, distant goals like “increasing life expectancy or avoiding health problems many years in the future.”

They’re much more likely to take action to avoid surgery, reduce medications, or minimize the risk of falling. 

For an older patient, Dr. Freedhoff says, “focusing on the preservation of functional independence can be extremely motivating.” That’s especially true if the patient has vivid memories of seeing a sedentary loved one decline late in life. 

For patients who may be more focused on appearance, they could respond to the idea of improving their body composition. For that, “we talk about the quality of weight loss,” says Spencer Nadolsky, DO, an obesity and lipid specialist and medical director of WeightWatchers. “Ultimately, exercise helps shape the body instead of just changing the number on the scale.”
 

Reducing resistance to resistance training

A conversation about reshaping the body or avoiding age-related disabilities leads naturally to resistance training.  

“I always frame resistance training as the single most valuable thing a person might do to try to preserve their functional independence,” Dr. Freedhoff says. If the patient is over 65, he won’t wait for them to show an interest. “I’ll absolutely bring it up with them directly.”

Dr. Freedhoff has an on-site training facility where trainers show patients how to work out at home with minimal equipment, like dumbbells and resistance bands. 

Most doctors, however, don’t have those options. That can lead to a tricky conversation. Participants in the University of Toronto study told the authors they disliked the gym, finding it “boring, intimidating, or discouraging.” 

And yet, “a common suggestion ... from health care providers was to join a gym.”

Many patients, Spencer Nadolsky, MD, says, associate strength training with “grunting, groaning, or getting ‘bulky’ vs. ‘toned.’ ” Memories of soreness from overzealous workouts are another barrier.

He recommends “starting small and slow,” with one or two full-body workouts a week. Those initial workouts might include just one to two sets of four to five exercises. “Consider if someone is exercising at home or in a gym to build a routine around equipment that’s available to them,” Dr. Nadolsky says.

Once you determine what you have to work with, help the patient choose exercises that fit their needs, goals, preferences, limitations, and prior injuries.

One more consideration: While Dr. Nadolsky tries to “stay away from telling a patient they need to do specific types of exercise to be successful,” he makes an exception for patients who’re taking a GLP-1 agonist. “There is a concern for muscle mass loss along with fat loss.”
 

Practicing, preaching, and checking privilege

When Dr. Thornton, Dr. Freedhoff, and Dr. Nadolsky discuss exercise, their patients know they practice what they preach. 

Dr. Nadolsky, who was a nationally ranked wrestler at the University of North Carolina, hosts the Docs Who Lift podcast with his brother, Karl Nadolsky, MD. 

Dr. Freedhoff is also a lifter and fitness enthusiast, and Dr. Thornton was a world-class rower whose team came within 0.8 seconds of a silver medal at the Beijing Olympics. (They finished fourth.)

But not all physicians follow their own lifestyle advice, Dr. Freedhoff says. That doesn’t make them bad doctors – it makes them human.

“I’ve done 300 minutes a week of exercise” – the recommended amount for weight maintenance – “to see what’s involved,” Dr. Freedhoff says. “That’s far, far, far from a trivial amount.”

That leads to this advice for his fellow physicians:

“The most important thing to know about exercise is that finding the time and having the health to do so is a privilege,” he says. 

Understanding that is crucial for assessing your patient’s needs and providing the right help.

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

Clinicians are well aware of the benefits of physical activity and the consequences of inactivity. 

Managing the diseases associated with inactivity – heart disease, type 2 diabetes, hypertension – falls to physicians. So one might assume they routinely prescribe exercise to their patients, just as they would statins, insulin, or beta-blockers. 

But evidence indicates that doctors don’t routinely have those conversations. They may lack confidence in their ability to give effective advice, fear offending patients, or simply not know what to say.

That’s understandable. Many doctors receive little training on how to counsel patients to exercise, according to research over the past decade. Despite efforts to improve this, many medical students still feel unprepared to prescribe physical activity to patients.

But here’s the thing: Doctors are in a unique position to change things.

Only 28% of Americans meet physical activity guidelines, according to the U.S. Centers for Disease Control and Prevention. At the same time, other research suggests that patients want to be more active and would like help from their doctor.

“Patients are motivated to hear about physical activity from physicians and try to make a change,” says Jane Thornton, MD, PhD, an assistant professor in family medicine at Western University, Ont. “Just saying something, even if you don’t have specialized knowledge, makes a difference because of the credibility we have as physicians.”

Conveniently, just like exercise, the best way to get started is to ... get started.

Here’s how to break down the process into steps.
 

1. Ask patients about their physical activity

Think of this as taking any kind of patient history, only for physical activity.

Do they have a regular exercise routine? For how many minutes a day are they active? How many days a week?

“It takes less than a minute to ask and record,” Dr. Thornton says. Once you put it into the patient’s electronic record, you have something you can track.
 

2. Write an actual prescription

By giving the patient a written, printed prescription when they leave your office, “you’re showing it’s an important part of treatment or prevention,” Dr. Thornton explains. It puts physical activity on the level of a vital sign.

Include frequency, intensity, time, and type of exercise. The American College of Sports Medicine’s Exercise is Medicine initiative provides a prescription template you can use.
 

3. Measure what they do

Measurement helps the patient adopt the new behavior, and it helps the physician provide tailored advice going forward, Dr. Thornton says.

With the rise of health-monitoring wearables, tracking activity has never been easier. Of course, not everyone wants to (or can afford to) use a smartwatch or fitness tracker.

For tech-averse patients, ask if they’re willing to write something down, like how many minutes they spent walking, or how many yoga classes they attended. You may never get this from some patients, but it never hurts to ask.
 

4. Refer out when necessary

This brings us to a sticky issue for many physicians: lack of confidence in their ability to speak authoritatively about physical activity. “In most cases, you can absolutely say, ‘Start slow, go gradually,’ that kind of thing,” Dr. Thornton says. “As with anything, confidence will come with practice.”

For specific prescriptive advice, check out the Exercise is Medicine website, which also has handouts you can share with patients and information for specific conditions. If your patient has prediabetes, you can also point them toward the CDC’s diabetes prevention program, which is available in-person or online and may be free or covered by insurance.

If a patient has contraindications, refer out. If you don’t have exercise or rehab professionals in your network, Dr. Thornton recommends reaching out to your regional or national association of sports-medicine professionals. You should be able to find it with a quick Google search.
 

5. Follow up

Ask about physical activity during every contact, either in person or online. 

Dr. Thornton says the second and fifth steps matter most to patients, especially when the prescription and follow-up come from their primary care physician, rather than a nurse or physician assistant to whom you’ve delegated the task.

“The value comes in having a physician emphasize the importance,” Dr. Thornton says. The more time you spend on it, the more that value comes through.
 

What NOT to say to patients about exercise

This might surprise you: 

“I definitely don’t think telling people the official recommendations for physical activity is useful,” says Yoni Freedhoff, MD, an associate professor of family medicine at the University of Ottawa and medical director of the Bariatric Medical Institute. “If anything, I’d venture it’s counterproductive.”

It’s not that there’s anything wrong with the recommended minimum – 150 minutes of moderate-to-vigorous-intensity physical activity per week. The problem is what it says to a patient who doesn’t come close to those standards. 

“Few real-world people have the interest, time, energy, or privilege to achieve them,” Dr. Freedhoff says. “Many will recognize that instantly and consequently feel [that] less than that is pointless.”

And that, Dr. Thornton says, is categorically not true. “Even minimal physical activity, in some cases, is beneficial.”

You also want to avoid any explicit connection between exercise and weight loss, Dr. Thornton says.

Though many people do connect the two, the link is often negative, notes a 2019 study from the University of Toronto., triggering painful memories that might go all the way back to gym class. 

Try this pivot from Dr. Freedhoff: “Focus on the role of exercise in mitigating the risks of weight,” he says – like decreasing pain, increasing energy, and improving sleep.
 

How to motivate patients to move

New research backs up this more positive approach. In a study published in Annals of Internal Medicine, doctors in the United Kingdom who emphasized benefits and minimized health harms convinced more patients to join a weight management program than negative or neutral docs did. These doctors conveyed optimism and excitement, smiling and avoiding any mention of obesity or body mass index.

Exactly what benefits inspire change will be different for each patient. But in general, the more immediate the benefit, the more motivating it will be. 

As the University of Toronto study noted, patients weren’t motivated by vague, distant goals like “increasing life expectancy or avoiding health problems many years in the future.”

They’re much more likely to take action to avoid surgery, reduce medications, or minimize the risk of falling. 

For an older patient, Dr. Freedhoff says, “focusing on the preservation of functional independence can be extremely motivating.” That’s especially true if the patient has vivid memories of seeing a sedentary loved one decline late in life. 

For patients who may be more focused on appearance, they could respond to the idea of improving their body composition. For that, “we talk about the quality of weight loss,” says Spencer Nadolsky, DO, an obesity and lipid specialist and medical director of WeightWatchers. “Ultimately, exercise helps shape the body instead of just changing the number on the scale.”
 

Reducing resistance to resistance training

A conversation about reshaping the body or avoiding age-related disabilities leads naturally to resistance training.  

“I always frame resistance training as the single most valuable thing a person might do to try to preserve their functional independence,” Dr. Freedhoff says. If the patient is over 65, he won’t wait for them to show an interest. “I’ll absolutely bring it up with them directly.”

Dr. Freedhoff has an on-site training facility where trainers show patients how to work out at home with minimal equipment, like dumbbells and resistance bands. 

Most doctors, however, don’t have those options. That can lead to a tricky conversation. Participants in the University of Toronto study told the authors they disliked the gym, finding it “boring, intimidating, or discouraging.” 

And yet, “a common suggestion ... from health care providers was to join a gym.”

Many patients, Spencer Nadolsky, MD, says, associate strength training with “grunting, groaning, or getting ‘bulky’ vs. ‘toned.’ ” Memories of soreness from overzealous workouts are another barrier.

He recommends “starting small and slow,” with one or two full-body workouts a week. Those initial workouts might include just one to two sets of four to five exercises. “Consider if someone is exercising at home or in a gym to build a routine around equipment that’s available to them,” Dr. Nadolsky says.

Once you determine what you have to work with, help the patient choose exercises that fit their needs, goals, preferences, limitations, and prior injuries.

One more consideration: While Dr. Nadolsky tries to “stay away from telling a patient they need to do specific types of exercise to be successful,” he makes an exception for patients who’re taking a GLP-1 agonist. “There is a concern for muscle mass loss along with fat loss.”
 

Practicing, preaching, and checking privilege

When Dr. Thornton, Dr. Freedhoff, and Dr. Nadolsky discuss exercise, their patients know they practice what they preach. 

Dr. Nadolsky, who was a nationally ranked wrestler at the University of North Carolina, hosts the Docs Who Lift podcast with his brother, Karl Nadolsky, MD. 

Dr. Freedhoff is also a lifter and fitness enthusiast, and Dr. Thornton was a world-class rower whose team came within 0.8 seconds of a silver medal at the Beijing Olympics. (They finished fourth.)

But not all physicians follow their own lifestyle advice, Dr. Freedhoff says. That doesn’t make them bad doctors – it makes them human.

“I’ve done 300 minutes a week of exercise” – the recommended amount for weight maintenance – “to see what’s involved,” Dr. Freedhoff says. “That’s far, far, far from a trivial amount.”

That leads to this advice for his fellow physicians:

“The most important thing to know about exercise is that finding the time and having the health to do so is a privilege,” he says. 

Understanding that is crucial for assessing your patient’s needs and providing the right help.

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

New evidence points to an association between exposure to “forever chemicals” and an increased risk for thyroid cancer.

The study suggests that higher exposure to per- and polyfluoroalkyl substances (PFAS), specifically perfluorooctanesulfonic acid (n-PFOS), may increase a person’s risk for thyroid cancer by 56%.

Several news outlets played up the findings, published online in eBioMedicine. “Dangerous ‘Forever Chemicals’ in Your Everyday Items Are Causing Cancer,” Newsweek reported.

But Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong (Australia), voiced his skepticism.

“While it’s possible that PFAS might be causing thyroid cancer, the evidence thus far is unconvincing and probably not worth worrying about,” said Dr. Meyerowitz-Katz, who was not involved in the research.
 

PFAS and thyroid cancer

PFAS are a class of widely used synthetic chemicals found in many consumer and industrial products, including nonstick cookware, stain-repellent carpets, waterproof rain gear, microwave popcorn bags, and firefighting foam.

These substances have been dubbed “forever chemicals” because they do not degrade and are ubiquitous in the environment.

Exposure to endocrine-disrupting chemicals, including PFAS, has been identified as a potential risk factor for thyroid cancer, with some research linking PFAS exposure to thyroid dysfunction and carcinogenesis.

To investigate further, the researchers performed a nested case-control study of 86 patients with thyroid cancer using plasma samples collected at or before diagnosis and 86 controls without cancer who were matched on age, sex, race/ethnicity, body weight, smoking status, and year of sample collection. 

Eighteen individual PFAS were measured in plasma samples; 10 were undetectable and were therefore excluded from the analysis. Of the remaining eight PFAS, only one showed a statistically significant correlation with thyroid cancer. 

Specifically, the researchers found that exposure to n-PFOS was associated with a 56% increased risk for thyroid cancer among people who had a high level of the chemical in their blood (adjusted odds ratio, 1.56; P = .004). The results were similar when patients with papillary thyroid cancer only were included (aOR, 1.56; P = .009).

A separate longitudinal analysis of 31 patients diagnosed with thyroid cancer 1 year or more after plasma sample collection and 31 controls confirmed the positive association between n-PFOS and thyroid cancer (aOR, 2.67; P < .001). The longitudinal analysis also suggested correlations for a few other PFAS.

“This study supports the hypothesis that PFAS exposure may be associated with increased risk of thyroid cancer,” the authors concluded.

But in a Substack post, Dr. Meyerowitz-Katz said that it’s important to put the findings into “proper context before getting terrified about this all-new cancer risk.”

First, this study was “genuinely tiny,” with data on just 88 people with thyroid cancer and 88 controls, a limitation the researchers also acknowledged.

“That’s really not enough to do any sort of robust epidemiological analysis – you can generate interesting correlations, but what those correlations mean is anyone’s guess,” Dr. Meyerowitz-Katz said.

Even more importantly, one could easily argue that the results of this study show that most PFAS aren’t associated with thyroid cancer, given that there was no strong association for seven of the eight PFAS measured, he explained.

“There are no serious methodological concerns here, but equally there’s just not much you can reasonably gather from finding a single correlation among a vast ocean of possibilities,” Dr. Meyerowitz-Katz wrote. “Maybe there’s a correlation there, but you’d need to investigate this in much bigger samples, with more controls, and better data, to understand what that correlation means.”

Bottom line, Dr. Meyerowitz-Katz explained, is that “the link between PFAS and thyroid cancer is, at best, incredibly weak.”

Funding for the study was provided by the National Institutes of Health and The Andrea and Charles Bronfman Philanthropies. One coauthor is cofounder of Linus Biotechnology and is owner of a license agreement with NIES (Japan); received honoraria and travel compensation for lectures for the Bio-Echo and Brin foundations; and has 22 patents at various stages. Dr. Meyerowitz-Katz has no relevant disclosures.

A version of this article appeared on Medscape.com.

New evidence points to an association between exposure to “forever chemicals” and an increased risk for thyroid cancer.

The study suggests that higher exposure to per- and polyfluoroalkyl substances (PFAS), specifically perfluorooctanesulfonic acid (n-PFOS), may increase a person’s risk for thyroid cancer by 56%.

Several news outlets played up the findings, published online in eBioMedicine. “Dangerous ‘Forever Chemicals’ in Your Everyday Items Are Causing Cancer,” Newsweek reported.

But Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong (Australia), voiced his skepticism.

“While it’s possible that PFAS might be causing thyroid cancer, the evidence thus far is unconvincing and probably not worth worrying about,” said Dr. Meyerowitz-Katz, who was not involved in the research.
 

PFAS and thyroid cancer

PFAS are a class of widely used synthetic chemicals found in many consumer and industrial products, including nonstick cookware, stain-repellent carpets, waterproof rain gear, microwave popcorn bags, and firefighting foam.

These substances have been dubbed “forever chemicals” because they do not degrade and are ubiquitous in the environment.

Exposure to endocrine-disrupting chemicals, including PFAS, has been identified as a potential risk factor for thyroid cancer, with some research linking PFAS exposure to thyroid dysfunction and carcinogenesis.

To investigate further, the researchers performed a nested case-control study of 86 patients with thyroid cancer using plasma samples collected at or before diagnosis and 86 controls without cancer who were matched on age, sex, race/ethnicity, body weight, smoking status, and year of sample collection. 

Eighteen individual PFAS were measured in plasma samples; 10 were undetectable and were therefore excluded from the analysis. Of the remaining eight PFAS, only one showed a statistically significant correlation with thyroid cancer. 

Specifically, the researchers found that exposure to n-PFOS was associated with a 56% increased risk for thyroid cancer among people who had a high level of the chemical in their blood (adjusted odds ratio, 1.56; P = .004). The results were similar when patients with papillary thyroid cancer only were included (aOR, 1.56; P = .009).

A separate longitudinal analysis of 31 patients diagnosed with thyroid cancer 1 year or more after plasma sample collection and 31 controls confirmed the positive association between n-PFOS and thyroid cancer (aOR, 2.67; P < .001). The longitudinal analysis also suggested correlations for a few other PFAS.

“This study supports the hypothesis that PFAS exposure may be associated with increased risk of thyroid cancer,” the authors concluded.

But in a Substack post, Dr. Meyerowitz-Katz said that it’s important to put the findings into “proper context before getting terrified about this all-new cancer risk.”

First, this study was “genuinely tiny,” with data on just 88 people with thyroid cancer and 88 controls, a limitation the researchers also acknowledged.

“That’s really not enough to do any sort of robust epidemiological analysis – you can generate interesting correlations, but what those correlations mean is anyone’s guess,” Dr. Meyerowitz-Katz said.

Even more importantly, one could easily argue that the results of this study show that most PFAS aren’t associated with thyroid cancer, given that there was no strong association for seven of the eight PFAS measured, he explained.

“There are no serious methodological concerns here, but equally there’s just not much you can reasonably gather from finding a single correlation among a vast ocean of possibilities,” Dr. Meyerowitz-Katz wrote. “Maybe there’s a correlation there, but you’d need to investigate this in much bigger samples, with more controls, and better data, to understand what that correlation means.”

Bottom line, Dr. Meyerowitz-Katz explained, is that “the link between PFAS and thyroid cancer is, at best, incredibly weak.”

Funding for the study was provided by the National Institutes of Health and The Andrea and Charles Bronfman Philanthropies. One coauthor is cofounder of Linus Biotechnology and is owner of a license agreement with NIES (Japan); received honoraria and travel compensation for lectures for the Bio-Echo and Brin foundations; and has 22 patents at various stages. Dr. Meyerowitz-Katz has no relevant disclosures.

A version of this article appeared on Medscape.com.

New evidence points to an association between exposure to “forever chemicals” and an increased risk for thyroid cancer.

The study suggests that higher exposure to per- and polyfluoroalkyl substances (PFAS), specifically perfluorooctanesulfonic acid (n-PFOS), may increase a person’s risk for thyroid cancer by 56%.

Several news outlets played up the findings, published online in eBioMedicine. “Dangerous ‘Forever Chemicals’ in Your Everyday Items Are Causing Cancer,” Newsweek reported.

But Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong (Australia), voiced his skepticism.

“While it’s possible that PFAS might be causing thyroid cancer, the evidence thus far is unconvincing and probably not worth worrying about,” said Dr. Meyerowitz-Katz, who was not involved in the research.
 

PFAS and thyroid cancer

PFAS are a class of widely used synthetic chemicals found in many consumer and industrial products, including nonstick cookware, stain-repellent carpets, waterproof rain gear, microwave popcorn bags, and firefighting foam.

These substances have been dubbed “forever chemicals” because they do not degrade and are ubiquitous in the environment.

Exposure to endocrine-disrupting chemicals, including PFAS, has been identified as a potential risk factor for thyroid cancer, with some research linking PFAS exposure to thyroid dysfunction and carcinogenesis.

To investigate further, the researchers performed a nested case-control study of 86 patients with thyroid cancer using plasma samples collected at or before diagnosis and 86 controls without cancer who were matched on age, sex, race/ethnicity, body weight, smoking status, and year of sample collection. 

Eighteen individual PFAS were measured in plasma samples; 10 were undetectable and were therefore excluded from the analysis. Of the remaining eight PFAS, only one showed a statistically significant correlation with thyroid cancer. 

Specifically, the researchers found that exposure to n-PFOS was associated with a 56% increased risk for thyroid cancer among people who had a high level of the chemical in their blood (adjusted odds ratio, 1.56; P = .004). The results were similar when patients with papillary thyroid cancer only were included (aOR, 1.56; P = .009).

A separate longitudinal analysis of 31 patients diagnosed with thyroid cancer 1 year or more after plasma sample collection and 31 controls confirmed the positive association between n-PFOS and thyroid cancer (aOR, 2.67; P < .001). The longitudinal analysis also suggested correlations for a few other PFAS.

“This study supports the hypothesis that PFAS exposure may be associated with increased risk of thyroid cancer,” the authors concluded.

But in a Substack post, Dr. Meyerowitz-Katz said that it’s important to put the findings into “proper context before getting terrified about this all-new cancer risk.”

First, this study was “genuinely tiny,” with data on just 88 people with thyroid cancer and 88 controls, a limitation the researchers also acknowledged.

“That’s really not enough to do any sort of robust epidemiological analysis – you can generate interesting correlations, but what those correlations mean is anyone’s guess,” Dr. Meyerowitz-Katz said.

Even more importantly, one could easily argue that the results of this study show that most PFAS aren’t associated with thyroid cancer, given that there was no strong association for seven of the eight PFAS measured, he explained.

“There are no serious methodological concerns here, but equally there’s just not much you can reasonably gather from finding a single correlation among a vast ocean of possibilities,” Dr. Meyerowitz-Katz wrote. “Maybe there’s a correlation there, but you’d need to investigate this in much bigger samples, with more controls, and better data, to understand what that correlation means.”

Bottom line, Dr. Meyerowitz-Katz explained, is that “the link between PFAS and thyroid cancer is, at best, incredibly weak.”

Funding for the study was provided by the National Institutes of Health and The Andrea and Charles Bronfman Philanthropies. One coauthor is cofounder of Linus Biotechnology and is owner of a license agreement with NIES (Japan); received honoraria and travel compensation for lectures for the Bio-Echo and Brin foundations; and has 22 patents at various stages. Dr. Meyerowitz-Katz has no relevant disclosures.

A version of this article appeared on Medscape.com.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – Treatment with aprocitentan, a novel agent currently under Food and Drug Administration review for lowering blood pressure in people with treatment-resistant hypertension, showed efficacy and safety in people with stage 3 or 4 chronic kidney disease (CKD). The results come from a prespecified subgroup analysis of data collected in the drug’s pivotal trial, PRECISION.

The findings provide support for potentially using aprocitentan, if approved for U.S. marketing in 2024, in patients with blood pressure that remains elevated despite treatment with three established antihypertensive drug classes and with stage 3 CKD with an estimated glomerular filtration rate of 30-59 mL/min per 1.73 m². This is a key group of patients because “chronic kidney disease is the most common comorbidity in patients with resistant hypertension,” said George Bakris, MD, who presented the subgroup analysis at Kidney Week 2023, organized by the American Society of Nephrology.

Mtchel L. Zoler/MDedge News

The CKD subgroup analysis showed “good evidence for safety and evidence in stage 3 CKD,” a subgroup of 141 patients among the total 730 enrolled in PRECISION, said Dr. Bakris. Professor and director of the Comprehensive Hypertension Center at the University of Chicago, he acknowledged that while the results also showed a signal for safety and efficacy in the 21 enrolled patients with stage 4 hypertension, 15-29 mL/min per 1.73m², this number of stage 4 patients was too small to allow definitive conclusions.

Nephrologist Nishigandha Pradhan, MD, who cochaired the session with this report, agreed. “Resistant hypertension is a particularly intractable problem in patients with CKD, and the risk is greatest with stage 4 CKD. If studies could show that aprocitentan is safe in people with stage 4 CKD, that would be a big plus, but we need more data,” commented Dr. Pradhan in an interview.
 

Incremental blood pressure reductions

The parallel-group, phase 3 PRECISION trial investigated the safety and short-term antihypertensive effect of aprocitentan in patients with resistant hypertension. The study’s primary efficacy endpoint was blood pressure reduction from baseline in 730 randomized people with persistent systolic hypertension despite treatment with three established antihypertensive agents including a diuretic. The study ran during June 2018–April 2022 at 191 sites in 22 countries.

The primary outcome after 4 weeks on treatment was a least-square mean reduction in office-measured systolic blood pressure, compared with placebo, of 3.8 mm Hg with a 12.5-mg daily oral dose of aprocitentan and 3.7 mm Hg with a 25-mg daily oral dose. Both significant differences were first reported in 2022. Twenty-four–hour ambulatory systolic blood pressures after 4 weeks of treatment fell by an average of 4.2 mm Hg on the lower dose compared with placebo and by an average of 5.9 mm Hg on the higher daily dose, compared with placebo.

Consistent blood pressure reductions occurred in the CKD subgroups. Among people with stage 3 CKD, daytime ambulatory blood pressure at 4 weeks fell by about 10 mm Hg on both the 12.5-mg daily and 25-mg daily doses, compared with placebo.

Among the small number of people with stage 4 CKD, the incremental nighttime systolic blood pressure on aprocitentan, compared with placebo, was even greater, with about a 15–mm Hg incremental reduction on 12.5 mg daily and about a 17–mm Hg incremental reduction on the higher dose.

“This is the first evidence for a change in nocturnal blood pressure in people with stage 4 CKD [and treatment-resistant hypertension], but it was just 21 patients so not yet a big deal,” Dr. Bakris noted.
 

Increased rates of fluid retention

Although aprocitentan was generally well tolerated, the most common adverse effect was edema or fluid retention, mainly during the first 4 weeks of treatment. In the full PRECISION cohort, this adverse event occurred in 2.1% of people treated with placebo, 9.1% of those on the 12.5-mg daily dose, and in 18.4% of those on the higher dose during the initial 4-week phase of treatment.

Among all stage 3 and 4 CKD patients on aprocitentan, edema or fluid retention occurred in 21% during the first 4 weeks, and in 27% during an additional 32 weeks of treatment with 25 mg aprocitentan daily. A majority of these patients started a diuretic to address their excess fluid, with only two discontinuing aprocitentan treatment.

“Fluid retention is an issue with aprocitentan,” Dr. Bakris acknowledged. But he also highlighted than only 6 of the 162 patients with CKD required hospitalization for heart failure during the study, and one of these cases had placebo treatment. Among the five with acute heart failure while on aprocitentan, none had to stop their treatment, and two had a clear prior history of heart failure.

The companies developing aprocitentan, Janssen and Idorsia, used the PRECISION results as the centerpiece in filing for a new drug approval to the FDA, with a March 2024 goal for the FDA‘s decision. Dr. Bakris called the application “a solid case for approval.” But he added that approval will likely require that all treatment candidates first undergo testing of their heart function or fluid volume, such as a measure of their blood level of N-terminal pro-B-type natriuretic peptide, with treatment withheld when the level is too high.

The upside of aprocitentan compared with current drug options for treating resistant hypertension is that it has not appeared to cause any increase in blood potassium levels, which is an issue with the current top agent for resistant hypertension, spironolactone.

“The problem with spironolactone is the risk for hyperkalemia, which keeps us looking for something with lower risk,” commented Dr. Pradhan, a nephrologist with University Hospitals in Cleveland. Hyperkalemia is an even greater risk for people with CKD. Although the PRECISION trial identified the issue of fluid retention with aprocitentan, titrating an effective dose of a loop diuretic for treated patients may effectively blunt the edema risk, Dr. Pradhan said.

Endothelin has a potent vasoconstrictive effect and is “implicated in the pathogenesis of hypertension,” Dr. Bakris explained. Aprocitentan antagonizes both the endothelin A and B receptors. The subgroup analyses also showed that in people with CKD, treatment with aprocitentan led to roughly a halving of the baseline level of urine albumin-to-creatinine ratio, a small and stable decrease in estimated glomerular filtration rate, and a modest and stable increase in blood levels of N-terminal pro-B-type natriuretic hormone.

The PRECISION trial was sponsored by Janssen Pharmaceuticals and Idorsia Pharmaceuticals, the companies jointly developing aprocitentan. Dr. Bakris has been a consultant to Janssen, and also a consultant to or honoraria recipient of Alnylam, AstraZeneca, Bayer, Dia Medica Therapeutics, Ionis, inREGEN, KBP Biosciences, Merck, Novo Nordisk, and Quantum Genomics. Dr. Pradhan had no disclosures.

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.

PHILADELPHIA – An electronic medical record alert to primary care physicians that their adult patients with type 2 diabetes were due for an albuminuria and renal-function check boosted screening for chronic kidney disease (CKD) by roughly half compared with the preintervention rate in a single U.S. academic health system.

“Screening rates for CKD more rapidly improved after implementation” of the EMR alert, said Maggy M. Spolnik, MD, at Kidney Week 2023, organized by the American Society of Nephrology.

“There was an immediate and ongoing effect over a year,” said Dr. Spolnik, a nephrologist at Indiana University in Indianapolis.

Mitchel L. Zoler/MDedge News

However, CKD screening rates in the primary care setting remain a challenge. In the study, the EMR alert produced a urine albumin-to-creatinine ratio (UACR) screening rate of about 26% of patient encounters, she reported. While this was significantly above the roughly 17% rate that had persisted for months before the intervention, it still fell short of the universal annual screening for adults with type 2 diabetes not previously diagnosed with CKD recommended by medical groups such as the American Diabetes Association and the Kidney Disease: Improving Global Outcomes organization. The U.S. Preventive Services Task Force’s assessment in 2012 concluded inadequate information existed at that time to make recommendations about CKD screening, but the group is now revisiting the issue.
 

‘Albuminuria is an earlier marker’ than eGFR

“Primary care physicians need to regularly monitor albuminuria in adults with type 2 diabetes,” commented Karen A. Griffin, MD, a nephrologist and professor at Loyola University in Maywood, Ill. “By the time you diagnose CKD based on reduced estimated glomerular filtration rate (eGFR), a patient has already lost more than half their renal function. Albuminuria is an earlier marker of a problem,” Dr. Griffin said in an interview.

Mitchel L. Zoler/MDedge News

Primary care physicians have been slow to adopt at least annual checks on both eGFR and the urinary albumin-to-creatinine ratio (UACR) in their adult patients with type 2 diabetes. Dr. Spolnik cited reasons such as the brief 15-minute consultation that primary care physicians have when seeing a patient, and an often confusing ordering menu that gives a UACR test various other names such as tests for microalbuminuria or macroalbuminuria.

To simplify ordering, the EMR prompt assessed in Dr. Spolnik’s study called the test “kidney screening” that automatically bundled an order for both eGFR calculation with UACR measurement. Another limitation is that UACR measurement requires a urine sample, which patients often find inconvenient to provide at the time of their examination.

The study run by Dr. Spolnik involved 10,744 adults with type 2 diabetes without an existing diagnosis of CKD seen in an outpatient, primary care visit to the UVA Health system centered in Charlottesville, Va. during April 2021–April 2022. A total of 23,419 encounters served as usual-care controls. The intervention period with active EMR alerts for kidney screening included 10,204 similar patients seen during April 2022–April 2023 in a total of 20,358 encounters. The patients averaged about 61-62 years old, and about 45% were men.
 

Bundling alerts into a single pop-up

The primary care clinicians who received the prompts were generally receptive to them, but they asked the researchers to bundle the UACR and eGFR measurement prompts along with any other alerts they received in the EMR into a single on-screen pop-up.

Dr. Spolnik acknowledged the need for further research and refinement to the prompt. For example, she wants to assess prompts for patients identified as having CKD that would promote best-practice management, including lifestyle and medical interventions. She also envisions expanding the prompts to also include other, related disorders such as hypertension.

But she and her colleagues were convinced enough by the results that they have not only continued the program at UVA Health but they also expanded it, starting in October 2023, to the academic primary care practice at Indiana University.

If the Indiana University trial confirms the efficacy seen in Virginia, the next step might be inclusion by Epic of the CKD screening alert as a routine option in the EMR software it distributes to its U.S. clients, Dr. Spolnik said in an interview.

Dr. Spolnik and Dr. Griffin had no disclosures.

Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.

The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.

The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.

The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.

“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”

The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.

Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.

A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.

“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.

Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
 

E/M add-on payment

“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.

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

Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.

The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.

The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.

The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.

“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”

The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.

Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.

A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.

“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.

Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
 

E/M add-on payment

“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.

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

Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.

The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.

The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.

The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.

“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”

The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.

Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.

A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.

“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.

Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
 

E/M add-on payment

“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.

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

What’s in a day’s work? For doctors, it’s typically a mix of seeing patients and completing paperwork and follow-up. Often it extends well past the standard workday.

Dennis Hursh, JD, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, describes one overwhelmed ob.gyn. who recently consulted him for this problem.

“My client had accepted a position in a group practice where his contract stated he would be working during normal office hours, Monday through Friday, from 8 a.m. to 5 p.m. – in other words, a 40-hour workweek,” Mr. Hursh said.

But the distressed physician discovered that actually, he was working almost twice as many hours. “He’d get to work early to do charting, then see patients during the 40 hours, perhaps grabbing a quick sandwich for a few minutes – and then stay after 5 [p.m.] for a few more hours when he’d work on charts or other administrative tasks. Then he’d get something to eat, work on more charts, then go to bed, get up in the morning, and repeat.”

Mr. Hursh summarized the client’s life: “Eating, sleeping, practicing clinical medicine, and doing nonclinical tasks.”

It turned out that the 40-hour workweek included in the contract referred to patient-facing hours, not to all of the ancillary tasks that are part of practicing medicine in this day and age. “Unfortunately, this is far from an isolated story,” said Mr. Hursh.
 

Be aware of what’s in the contract

“The first draft of many standard physician employment contracts often omits mention of patient contact hour requirements and rather uses vague verbiage such as ‘full-time’ employment or ‘1.0 FTE’ – or full-time equivalent – without defining that term,” said Mr. Hursh. Typically, the 40 hours exclude call coverage, but most physicians understand that and, at least at first glance, it all sounds very reasonable.

But once charting, hours on the phone, arguing with managed care companies, sending in prescriptions, administrative meetings, and other tasks are thrown in, the work hours expand dramatically. Moreover, if your employer doesn’t utilize hospitalists, you may be expected to “round” outside of the 40 hours, which can be particularly burdensome if the employer admits patients to multiple hospitals.

Amanda Hill, JD, owner of Hill Health Law based in Austin, Texas, told this news organization that this predicament isn’t unique to physicians. Exempt employees who don’t clock in and out are often expected to work overtime – that is, to “work as long as it takes to get the job done.” It can affect NPs, PAs, and many others in the health care space. But the number of tasks that fall upon a doctor’s shoulders and the fact that patients’ health and lives are at stake up the ante and make the situation far more difficult for doctors than for employees in other industries.

So it’s important to nail down precise terms in the contract and, if possible, negotiate for a more humane schedule by specifying how the working hours will be used.

“It’s true that a 1.0 FTE definition is too vague,” Ms. Hill said. “I’ve negotiated a lot of contracts where we nail down in writing that the in-office schedule equals 34 hours per week, so the physician is guaranteed an additional 6 hours for administrative time.”

Mr. Hursh usually asks for 32 hours of patient contact per week, which leaves 1 full day per week to catch up on basic administrative tasks. “It’s important for employers to recognize that seeing patients isn’t the only thing a doctor does and there’s a lot of work in addition to face-to-face time,” he said.

But he hasn’t always been successful. One physician client was seeking a workweek consisting of 36 patient contact hours, “which is 90% of the usual FTE of a 40-hour week,” said Mr. Hursh. “But the employer called it ‘part-time,’ as if the doctor were planning to be lying in the sun for the other 4 hours.”

The client decided to accept a 10% pay cut and 10% less vacation to guarantee that she had those extra hours for administrative tasks. “She’s probably working way more than 36 hours a week, but maybe closer to 50 or 60 instead of 70 or more,” he said.
 

Clarify call coverage

Call coverage is typically not included in the hours a physician is contracted to work on a weekly basis. “Most contracts have call, and it’s usually evenly distributed among parties in a practice, but call can expand if another doctor is out sick, for example,” said Ms. Hill.

Sometimes the language in the contract is vague regarding call coverage. “I ask, how many shifts per year is the doctor is expected to work? Then, I try to negotiate extra pay if more shifts arise,” she said. “The hospital or practice may not demand extra call because they don’t want to pay extra money to the physician.”

On the other hand, some physicians may be eager to take extra call if it means extra income.

Ms. Hill stated that one of her clients was being paid as a “part-time, 2-day-a-week provider” but was asked to be on call and take night and weekend work. When you added it all up, she was putting in almost 30 hours a week.

“This is abusive to a provider that works so hard for patients,” Ms. Hill said. “We have to protect them through the contract language, so they have something hard and fast to point to when their administrator pushes them too hard. Doctors should get value for their time.”

Ms. Hill and her client pushed for more money, and the employer gave in. “All we had to do was to point out how many hours she was actually working. She didn’t mind all the extra call, but she wanted to be compensated.” The doctor’s salary was hiked by $25,000.
 

Differences in specialties and settings

There are some specialties where it might be easier to have more defined hours, while other specialties are more challenging. Anu Murthy, Esq., an attorney and associate contract review specialist at Contract Diagnostics (a national firm that reviews physician contracts) told this news organization that the work of hospitalists, intensivists, and emergency department physicians, for example, is done in shifts, which tend to be fixed hours.

“They need to get their charting completed so that whoever takes over on the next shift has access to the most recent notes about the patient,” she said. By contrast, surgeons can’t always account for how long a given surgery will take. “It could be as long as 9 hours,” she said. Notes need to be written immediately for the sake of the patient’s postsurgical care.

Dermatologists tend to deal with fewer emergencies, compared with other specialists, and it’s easier for their patients to be slotted into an organized schedule. On the other hand, primary care doctors – internists, family practice physicians, and pediatricians – may be seeing 40-50 patients a day, one every 15 minutes.

Practice setting also makes a difference, said Ms. Murthy. Veterans Administration (VA) hospitals or government-run clinics tend to have more rigidly defined hours, compared with other settings, so if you’re in a VA hospital or government-run clinic, work-life balance tends to be better.

Physicians who work remotely via telehealth also tend to have a better work-life balance, compared with those who see patients in person, Ms. Murthy said. But the difference may be in not having to spend extra time commuting to work or interacting with others in the work environment, since some research has suggested that telehealth physicians may actually spend more time engaged in charting after hours, compared with their in-person counterparts.
 

Using scribes to maximize your time

Elliott Trotter, MD, is an emergency medicine physician, associate clinical professor of emergency medicine at Texas Christian University Medical Schools, and founder of the ScribeNest, a Texas-based company that trains health care scribes. He told this news organization that there are ways to maximize one’s time during shifts so that much of the charting can be accomplished during working hours.

“About 28 years ago, I realized that the documentation load for physicians was enormous and at that time I developed the Modern Scribe, using premed students for ‘elbow support’ to help with the workload by documenting the ED encounters in real time during the encounter so I wouldn’t have to do so later.”

Over the years, as EHRs have become more ubiquitous and onerous, the role of the scribe has “evolved from a luxury to a necessity,” said Dr. Trotter. The scribes can actually record the encounter directly into the EHR so that the physician doesn’t have to do so later and doesn’t have to look at a computer screen but can look at the patient during the encounter.

“This enhances communication and has been shown to improve patient care,” he said.

Dr. Trotter said he rarely, if ever, needs to do documentation after hours. “But one of my physician colleagues had over 500 charts in his in-basket on a regular basis, which was overwhelming and untenable.”

The use of AI in health care is rapidly growing. Tools to help hasten the process of taking notes through use of AI-generated summaries is something appealing to many doctors. Ms. Hill warned physicians to “be careful not to rely so heavily on AI that you trust it over your own words.” She noted that it can make mistakes, and the liability always remains with the clinician.
 

Creating time-efficient strategies

Wilfrid Noel Raby, PhD, MD, a psychiatrist in private practice in Teaneck, N.J., was formerly a psychiatrist in the substance abuse unit at Montefiore Hospital, New York. He told this news organization that he developed a system whereby he rarely had to take work home with him. “I was working only 20 hours a week, but I was usually able to do my charting during those hours, as well as seeing patients,” he said. “I scheduled my appointments and structured a little ‘buffer time’ between them so that I had time to document the first appointment before moving on to the next one.”

There were days when this wasn’t possible because there were too many patients who needed to be seen back-to-back. “So I developed my own template where I could take rapid, very standardized notes that fit into the format of the EHR and met those expectations.” Then, when he had finished seeing patients, he could quickly enter the content of his notes into the EHR. If necessary, he completed his charting on a different day.

Viwek Bisen, DO, assistant professor of psychiatry, Hackensack (N.J.) University Medical Center, is a psychiatrist in the emergency department. “My contract is based on a traditional 40-hour workweek, with 80% of my time allotted to seeing patients and 20% of my time allotted to administration.”

But the way his time actually plays out is that he’s seeing patients during about half of the 32 hours. “The rest of the time, I’m charting, speaking to family members of patients, writing notes, engaging in team meetings, and dealing with insurance companies.” Dr. Bisen has developed his own system of completing his notes while still in the hospital. “I’ve learned to be efficient and manage my time better, so I no longer have to take work home with me.”

“At the end of the day, doctors are people,” Ms. Hill said. “They are not machines. Maybe in residency and fellowship they may grind out impossible shifts with little sleep, but this pace isn’t tenable for an entire career.”

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

What’s in a day’s work? For doctors, it’s typically a mix of seeing patients and completing paperwork and follow-up. Often it extends well past the standard workday.

Dennis Hursh, JD, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, describes one overwhelmed ob.gyn. who recently consulted him for this problem.

“My client had accepted a position in a group practice where his contract stated he would be working during normal office hours, Monday through Friday, from 8 a.m. to 5 p.m. – in other words, a 40-hour workweek,” Mr. Hursh said.

But the distressed physician discovered that actually, he was working almost twice as many hours. “He’d get to work early to do charting, then see patients during the 40 hours, perhaps grabbing a quick sandwich for a few minutes – and then stay after 5 [p.m.] for a few more hours when he’d work on charts or other administrative tasks. Then he’d get something to eat, work on more charts, then go to bed, get up in the morning, and repeat.”

Mr. Hursh summarized the client’s life: “Eating, sleeping, practicing clinical medicine, and doing nonclinical tasks.”

It turned out that the 40-hour workweek included in the contract referred to patient-facing hours, not to all of the ancillary tasks that are part of practicing medicine in this day and age. “Unfortunately, this is far from an isolated story,” said Mr. Hursh.
 

Be aware of what’s in the contract

“The first draft of many standard physician employment contracts often omits mention of patient contact hour requirements and rather uses vague verbiage such as ‘full-time’ employment or ‘1.0 FTE’ – or full-time equivalent – without defining that term,” said Mr. Hursh. Typically, the 40 hours exclude call coverage, but most physicians understand that and, at least at first glance, it all sounds very reasonable.

But once charting, hours on the phone, arguing with managed care companies, sending in prescriptions, administrative meetings, and other tasks are thrown in, the work hours expand dramatically. Moreover, if your employer doesn’t utilize hospitalists, you may be expected to “round” outside of the 40 hours, which can be particularly burdensome if the employer admits patients to multiple hospitals.

Amanda Hill, JD, owner of Hill Health Law based in Austin, Texas, told this news organization that this predicament isn’t unique to physicians. Exempt employees who don’t clock in and out are often expected to work overtime – that is, to “work as long as it takes to get the job done.” It can affect NPs, PAs, and many others in the health care space. But the number of tasks that fall upon a doctor’s shoulders and the fact that patients’ health and lives are at stake up the ante and make the situation far more difficult for doctors than for employees in other industries.

So it’s important to nail down precise terms in the contract and, if possible, negotiate for a more humane schedule by specifying how the working hours will be used.

“It’s true that a 1.0 FTE definition is too vague,” Ms. Hill said. “I’ve negotiated a lot of contracts where we nail down in writing that the in-office schedule equals 34 hours per week, so the physician is guaranteed an additional 6 hours for administrative time.”

Mr. Hursh usually asks for 32 hours of patient contact per week, which leaves 1 full day per week to catch up on basic administrative tasks. “It’s important for employers to recognize that seeing patients isn’t the only thing a doctor does and there’s a lot of work in addition to face-to-face time,” he said.

But he hasn’t always been successful. One physician client was seeking a workweek consisting of 36 patient contact hours, “which is 90% of the usual FTE of a 40-hour week,” said Mr. Hursh. “But the employer called it ‘part-time,’ as if the doctor were planning to be lying in the sun for the other 4 hours.”

The client decided to accept a 10% pay cut and 10% less vacation to guarantee that she had those extra hours for administrative tasks. “She’s probably working way more than 36 hours a week, but maybe closer to 50 or 60 instead of 70 or more,” he said.
 

Clarify call coverage

Call coverage is typically not included in the hours a physician is contracted to work on a weekly basis. “Most contracts have call, and it’s usually evenly distributed among parties in a practice, but call can expand if another doctor is out sick, for example,” said Ms. Hill.

Sometimes the language in the contract is vague regarding call coverage. “I ask, how many shifts per year is the doctor is expected to work? Then, I try to negotiate extra pay if more shifts arise,” she said. “The hospital or practice may not demand extra call because they don’t want to pay extra money to the physician.”

On the other hand, some physicians may be eager to take extra call if it means extra income.

Ms. Hill stated that one of her clients was being paid as a “part-time, 2-day-a-week provider” but was asked to be on call and take night and weekend work. When you added it all up, she was putting in almost 30 hours a week.

“This is abusive to a provider that works so hard for patients,” Ms. Hill said. “We have to protect them through the contract language, so they have something hard and fast to point to when their administrator pushes them too hard. Doctors should get value for their time.”

Ms. Hill and her client pushed for more money, and the employer gave in. “All we had to do was to point out how many hours she was actually working. She didn’t mind all the extra call, but she wanted to be compensated.” The doctor’s salary was hiked by $25,000.
 

Differences in specialties and settings

There are some specialties where it might be easier to have more defined hours, while other specialties are more challenging. Anu Murthy, Esq., an attorney and associate contract review specialist at Contract Diagnostics (a national firm that reviews physician contracts) told this news organization that the work of hospitalists, intensivists, and emergency department physicians, for example, is done in shifts, which tend to be fixed hours.

“They need to get their charting completed so that whoever takes over on the next shift has access to the most recent notes about the patient,” she said. By contrast, surgeons can’t always account for how long a given surgery will take. “It could be as long as 9 hours,” she said. Notes need to be written immediately for the sake of the patient’s postsurgical care.

Dermatologists tend to deal with fewer emergencies, compared with other specialists, and it’s easier for their patients to be slotted into an organized schedule. On the other hand, primary care doctors – internists, family practice physicians, and pediatricians – may be seeing 40-50 patients a day, one every 15 minutes.

Practice setting also makes a difference, said Ms. Murthy. Veterans Administration (VA) hospitals or government-run clinics tend to have more rigidly defined hours, compared with other settings, so if you’re in a VA hospital or government-run clinic, work-life balance tends to be better.

Physicians who work remotely via telehealth also tend to have a better work-life balance, compared with those who see patients in person, Ms. Murthy said. But the difference may be in not having to spend extra time commuting to work or interacting with others in the work environment, since some research has suggested that telehealth physicians may actually spend more time engaged in charting after hours, compared with their in-person counterparts.
 

Using scribes to maximize your time

Elliott Trotter, MD, is an emergency medicine physician, associate clinical professor of emergency medicine at Texas Christian University Medical Schools, and founder of the ScribeNest, a Texas-based company that trains health care scribes. He told this news organization that there are ways to maximize one’s time during shifts so that much of the charting can be accomplished during working hours.

“About 28 years ago, I realized that the documentation load for physicians was enormous and at that time I developed the Modern Scribe, using premed students for ‘elbow support’ to help with the workload by documenting the ED encounters in real time during the encounter so I wouldn’t have to do so later.”

Over the years, as EHRs have become more ubiquitous and onerous, the role of the scribe has “evolved from a luxury to a necessity,” said Dr. Trotter. The scribes can actually record the encounter directly into the EHR so that the physician doesn’t have to do so later and doesn’t have to look at a computer screen but can look at the patient during the encounter.

“This enhances communication and has been shown to improve patient care,” he said.

Dr. Trotter said he rarely, if ever, needs to do documentation after hours. “But one of my physician colleagues had over 500 charts in his in-basket on a regular basis, which was overwhelming and untenable.”

The use of AI in health care is rapidly growing. Tools to help hasten the process of taking notes through use of AI-generated summaries is something appealing to many doctors. Ms. Hill warned physicians to “be careful not to rely so heavily on AI that you trust it over your own words.” She noted that it can make mistakes, and the liability always remains with the clinician.
 

Creating time-efficient strategies

Wilfrid Noel Raby, PhD, MD, a psychiatrist in private practice in Teaneck, N.J., was formerly a psychiatrist in the substance abuse unit at Montefiore Hospital, New York. He told this news organization that he developed a system whereby he rarely had to take work home with him. “I was working only 20 hours a week, but I was usually able to do my charting during those hours, as well as seeing patients,” he said. “I scheduled my appointments and structured a little ‘buffer time’ between them so that I had time to document the first appointment before moving on to the next one.”

There were days when this wasn’t possible because there were too many patients who needed to be seen back-to-back. “So I developed my own template where I could take rapid, very standardized notes that fit into the format of the EHR and met those expectations.” Then, when he had finished seeing patients, he could quickly enter the content of his notes into the EHR. If necessary, he completed his charting on a different day.

Viwek Bisen, DO, assistant professor of psychiatry, Hackensack (N.J.) University Medical Center, is a psychiatrist in the emergency department. “My contract is based on a traditional 40-hour workweek, with 80% of my time allotted to seeing patients and 20% of my time allotted to administration.”

But the way his time actually plays out is that he’s seeing patients during about half of the 32 hours. “The rest of the time, I’m charting, speaking to family members of patients, writing notes, engaging in team meetings, and dealing with insurance companies.” Dr. Bisen has developed his own system of completing his notes while still in the hospital. “I’ve learned to be efficient and manage my time better, so I no longer have to take work home with me.”

“At the end of the day, doctors are people,” Ms. Hill said. “They are not machines. Maybe in residency and fellowship they may grind out impossible shifts with little sleep, but this pace isn’t tenable for an entire career.”

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

What’s in a day’s work? For doctors, it’s typically a mix of seeing patients and completing paperwork and follow-up. Often it extends well past the standard workday.

Dennis Hursh, JD, managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, describes one overwhelmed ob.gyn. who recently consulted him for this problem.

“My client had accepted a position in a group practice where his contract stated he would be working during normal office hours, Monday through Friday, from 8 a.m. to 5 p.m. – in other words, a 40-hour workweek,” Mr. Hursh said.

But the distressed physician discovered that actually, he was working almost twice as many hours. “He’d get to work early to do charting, then see patients during the 40 hours, perhaps grabbing a quick sandwich for a few minutes – and then stay after 5 [p.m.] for a few more hours when he’d work on charts or other administrative tasks. Then he’d get something to eat, work on more charts, then go to bed, get up in the morning, and repeat.”

Mr. Hursh summarized the client’s life: “Eating, sleeping, practicing clinical medicine, and doing nonclinical tasks.”

It turned out that the 40-hour workweek included in the contract referred to patient-facing hours, not to all of the ancillary tasks that are part of practicing medicine in this day and age. “Unfortunately, this is far from an isolated story,” said Mr. Hursh.
 

Be aware of what’s in the contract

“The first draft of many standard physician employment contracts often omits mention of patient contact hour requirements and rather uses vague verbiage such as ‘full-time’ employment or ‘1.0 FTE’ – or full-time equivalent – without defining that term,” said Mr. Hursh. Typically, the 40 hours exclude call coverage, but most physicians understand that and, at least at first glance, it all sounds very reasonable.

But once charting, hours on the phone, arguing with managed care companies, sending in prescriptions, administrative meetings, and other tasks are thrown in, the work hours expand dramatically. Moreover, if your employer doesn’t utilize hospitalists, you may be expected to “round” outside of the 40 hours, which can be particularly burdensome if the employer admits patients to multiple hospitals.

Amanda Hill, JD, owner of Hill Health Law based in Austin, Texas, told this news organization that this predicament isn’t unique to physicians. Exempt employees who don’t clock in and out are often expected to work overtime – that is, to “work as long as it takes to get the job done.” It can affect NPs, PAs, and many others in the health care space. But the number of tasks that fall upon a doctor’s shoulders and the fact that patients’ health and lives are at stake up the ante and make the situation far more difficult for doctors than for employees in other industries.

So it’s important to nail down precise terms in the contract and, if possible, negotiate for a more humane schedule by specifying how the working hours will be used.

“It’s true that a 1.0 FTE definition is too vague,” Ms. Hill said. “I’ve negotiated a lot of contracts where we nail down in writing that the in-office schedule equals 34 hours per week, so the physician is guaranteed an additional 6 hours for administrative time.”

Mr. Hursh usually asks for 32 hours of patient contact per week, which leaves 1 full day per week to catch up on basic administrative tasks. “It’s important for employers to recognize that seeing patients isn’t the only thing a doctor does and there’s a lot of work in addition to face-to-face time,” he said.

But he hasn’t always been successful. One physician client was seeking a workweek consisting of 36 patient contact hours, “which is 90% of the usual FTE of a 40-hour week,” said Mr. Hursh. “But the employer called it ‘part-time,’ as if the doctor were planning to be lying in the sun for the other 4 hours.”

The client decided to accept a 10% pay cut and 10% less vacation to guarantee that she had those extra hours for administrative tasks. “She’s probably working way more than 36 hours a week, but maybe closer to 50 or 60 instead of 70 or more,” he said.
 

Clarify call coverage

Call coverage is typically not included in the hours a physician is contracted to work on a weekly basis. “Most contracts have call, and it’s usually evenly distributed among parties in a practice, but call can expand if another doctor is out sick, for example,” said Ms. Hill.

Sometimes the language in the contract is vague regarding call coverage. “I ask, how many shifts per year is the doctor is expected to work? Then, I try to negotiate extra pay if more shifts arise,” she said. “The hospital or practice may not demand extra call because they don’t want to pay extra money to the physician.”

On the other hand, some physicians may be eager to take extra call if it means extra income.

Ms. Hill stated that one of her clients was being paid as a “part-time, 2-day-a-week provider” but was asked to be on call and take night and weekend work. When you added it all up, she was putting in almost 30 hours a week.

“This is abusive to a provider that works so hard for patients,” Ms. Hill said. “We have to protect them through the contract language, so they have something hard and fast to point to when their administrator pushes them too hard. Doctors should get value for their time.”

Ms. Hill and her client pushed for more money, and the employer gave in. “All we had to do was to point out how many hours she was actually working. She didn’t mind all the extra call, but she wanted to be compensated.” The doctor’s salary was hiked by $25,000.
 

Differences in specialties and settings

There are some specialties where it might be easier to have more defined hours, while other specialties are more challenging. Anu Murthy, Esq., an attorney and associate contract review specialist at Contract Diagnostics (a national firm that reviews physician contracts) told this news organization that the work of hospitalists, intensivists, and emergency department physicians, for example, is done in shifts, which tend to be fixed hours.

“They need to get their charting completed so that whoever takes over on the next shift has access to the most recent notes about the patient,” she said. By contrast, surgeons can’t always account for how long a given surgery will take. “It could be as long as 9 hours,” she said. Notes need to be written immediately for the sake of the patient’s postsurgical care.

Dermatologists tend to deal with fewer emergencies, compared with other specialists, and it’s easier for their patients to be slotted into an organized schedule. On the other hand, primary care doctors – internists, family practice physicians, and pediatricians – may be seeing 40-50 patients a day, one every 15 minutes.

Practice setting also makes a difference, said Ms. Murthy. Veterans Administration (VA) hospitals or government-run clinics tend to have more rigidly defined hours, compared with other settings, so if you’re in a VA hospital or government-run clinic, work-life balance tends to be better.

Physicians who work remotely via telehealth also tend to have a better work-life balance, compared with those who see patients in person, Ms. Murthy said. But the difference may be in not having to spend extra time commuting to work or interacting with others in the work environment, since some research has suggested that telehealth physicians may actually spend more time engaged in charting after hours, compared with their in-person counterparts.
 

Using scribes to maximize your time

Elliott Trotter, MD, is an emergency medicine physician, associate clinical professor of emergency medicine at Texas Christian University Medical Schools, and founder of the ScribeNest, a Texas-based company that trains health care scribes. He told this news organization that there are ways to maximize one’s time during shifts so that much of the charting can be accomplished during working hours.

“About 28 years ago, I realized that the documentation load for physicians was enormous and at that time I developed the Modern Scribe, using premed students for ‘elbow support’ to help with the workload by documenting the ED encounters in real time during the encounter so I wouldn’t have to do so later.”

Over the years, as EHRs have become more ubiquitous and onerous, the role of the scribe has “evolved from a luxury to a necessity,” said Dr. Trotter. The scribes can actually record the encounter directly into the EHR so that the physician doesn’t have to do so later and doesn’t have to look at a computer screen but can look at the patient during the encounter.

“This enhances communication and has been shown to improve patient care,” he said.

Dr. Trotter said he rarely, if ever, needs to do documentation after hours. “But one of my physician colleagues had over 500 charts in his in-basket on a regular basis, which was overwhelming and untenable.”

The use of AI in health care is rapidly growing. Tools to help hasten the process of taking notes through use of AI-generated summaries is something appealing to many doctors. Ms. Hill warned physicians to “be careful not to rely so heavily on AI that you trust it over your own words.” She noted that it can make mistakes, and the liability always remains with the clinician.
 

Creating time-efficient strategies

Wilfrid Noel Raby, PhD, MD, a psychiatrist in private practice in Teaneck, N.J., was formerly a psychiatrist in the substance abuse unit at Montefiore Hospital, New York. He told this news organization that he developed a system whereby he rarely had to take work home with him. “I was working only 20 hours a week, but I was usually able to do my charting during those hours, as well as seeing patients,” he said. “I scheduled my appointments and structured a little ‘buffer time’ between them so that I had time to document the first appointment before moving on to the next one.”

There were days when this wasn’t possible because there were too many patients who needed to be seen back-to-back. “So I developed my own template where I could take rapid, very standardized notes that fit into the format of the EHR and met those expectations.” Then, when he had finished seeing patients, he could quickly enter the content of his notes into the EHR. If necessary, he completed his charting on a different day.

Viwek Bisen, DO, assistant professor of psychiatry, Hackensack (N.J.) University Medical Center, is a psychiatrist in the emergency department. “My contract is based on a traditional 40-hour workweek, with 80% of my time allotted to seeing patients and 20% of my time allotted to administration.”

But the way his time actually plays out is that he’s seeing patients during about half of the 32 hours. “The rest of the time, I’m charting, speaking to family members of patients, writing notes, engaging in team meetings, and dealing with insurance companies.” Dr. Bisen has developed his own system of completing his notes while still in the hospital. “I’ve learned to be efficient and manage my time better, so I no longer have to take work home with me.”

“At the end of the day, doctors are people,” Ms. Hill said. “They are not machines. Maybe in residency and fellowship they may grind out impossible shifts with little sleep, but this pace isn’t tenable for an entire career.”

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

TOPLINE:

The prevalence of elevated LDL cholesterol (LDL-C) has declined over the past 2 decades, but 1 in 17 Americans still have a level of 160-189 mg/dL, and 1 in 48 have a level of at least 190 mg/dL, new research shows. Among people with the higher LDL-C level, one in four are both unaware and untreated, the authors report.

METHODOLOGY:

• Using data on 23,667 adult participants in the National Health and Nutrition Examination Survey conducted from 1999 to 2020, researchers identified 1,851 (7.8%) with an LDL-C level of 160-189 mg/dL and 669 (2.8%) with an LDL-C level of at least 190 mg/dL.
• Individuals were classified as “unaware” if they had never had their LDL-C measured or had never been informed of having elevated LDL-C and as “untreated” if their medications didn’t include a statin, ezetimibe, a bile acid sequestrant, or a proprotein convertase subtilisin/kexin type 9 inhibitor.
• The authors compared the prevalence of “unaware” and “untreated” by age, sex, race and ethnicity, educational attainment, poverty index, and insurance status.

TAKEAWAY:

• During the study period, the age-adjusted prevalence of an LDL-C level of 160-189 mg/dL declined from 12.4% (95% confidence interval, 10.0%-15.3%), representing 21.5 million U.S. adults, to 6.1% (95% CI, 4.8%-7.6%), representing 14.0 million adults (P < .001).
• The age-adjusted prevalence of an LDL-C level of at least 190 mg/dL declined from 3.8% (95% CI, 2.8%-5.2%), representing 6.6 million adults, to 2.1% (95% CI, 1.4%-3.0%), representing 4.8 million adults (P = .001).
• Among those with an LDL-C level of 160-189 mg/dL, the proportion of who were unaware and untreated declined from 52.1% to 42.7%, and among those with an LDL-C level of at least 190 mg/dL, it declined from 40.8% to 26.8%.
• Being unaware and untreated was more common in younger adults, men, racial and ethnic minority groups, those with lower educational attainment, those with lower income, and those without health insurance.

IN PRACTICE:

The lack of awareness and treatment of high LDL-C uncovered by the study “may be due to difficulties accessing primary care, low rates of screening in primary care, lack of consensus on screening recommendations, insufficient emphasis on LDL-C as a quality measure, and hesitance to treat asymptomatic individuals,” the authors concluded.

SOURCE:

The research was led by Ahmed Sayed, MBBS, faculty of medicine, Ain Shams University, Cairo, Egypt. It was published online in JAMA Cardiology.

LIMITATIONS:

The analysis was limited by a small number of participants with LDL-C levels of at least 190 mg/dL, possible nonresponse bias, and dependency on participant recall of whether LDL-C was previously measured. The inclusion of pregnant women may have influenced LDL-C levels.

DISCLOSURES:

Dr. Sayed has no relevant conflict of interest. The disclosures of the other authors are listed in the original publication.

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

TOPLINE:

The prevalence of elevated LDL cholesterol (LDL-C) has declined over the past 2 decades, but 1 in 17 Americans still have a level of 160-189 mg/dL, and 1 in 48 have a level of at least 190 mg/dL, new research shows. Among people with the higher LDL-C level, one in four are both unaware and untreated, the authors report.

METHODOLOGY:

• Using data on 23,667 adult participants in the National Health and Nutrition Examination Survey conducted from 1999 to 2020, researchers identified 1,851 (7.8%) with an LDL-C level of 160-189 mg/dL and 669 (2.8%) with an LDL-C level of at least 190 mg/dL.
• Individuals were classified as “unaware” if they had never had their LDL-C measured or had never been informed of having elevated LDL-C and as “untreated” if their medications didn’t include a statin, ezetimibe, a bile acid sequestrant, or a proprotein convertase subtilisin/kexin type 9 inhibitor.
• The authors compared the prevalence of “unaware” and “untreated” by age, sex, race and ethnicity, educational attainment, poverty index, and insurance status.

TAKEAWAY:

• During the study period, the age-adjusted prevalence of an LDL-C level of 160-189 mg/dL declined from 12.4% (95% confidence interval, 10.0%-15.3%), representing 21.5 million U.S. adults, to 6.1% (95% CI, 4.8%-7.6%), representing 14.0 million adults (P < .001).
• The age-adjusted prevalence of an LDL-C level of at least 190 mg/dL declined from 3.8% (95% CI, 2.8%-5.2%), representing 6.6 million adults, to 2.1% (95% CI, 1.4%-3.0%), representing 4.8 million adults (P = .001).
• Among those with an LDL-C level of 160-189 mg/dL, the proportion of who were unaware and untreated declined from 52.1% to 42.7%, and among those with an LDL-C level of at least 190 mg/dL, it declined from 40.8% to 26.8%.
• Being unaware and untreated was more common in younger adults, men, racial and ethnic minority groups, those with lower educational attainment, those with lower income, and those without health insurance.

IN PRACTICE:

The lack of awareness and treatment of high LDL-C uncovered by the study “may be due to difficulties accessing primary care, low rates of screening in primary care, lack of consensus on screening recommendations, insufficient emphasis on LDL-C as a quality measure, and hesitance to treat asymptomatic individuals,” the authors concluded.

SOURCE:

The research was led by Ahmed Sayed, MBBS, faculty of medicine, Ain Shams University, Cairo, Egypt. It was published online in JAMA Cardiology.

LIMITATIONS:

The analysis was limited by a small number of participants with LDL-C levels of at least 190 mg/dL, possible nonresponse bias, and dependency on participant recall of whether LDL-C was previously measured. The inclusion of pregnant women may have influenced LDL-C levels.

DISCLOSURES:

Dr. Sayed has no relevant conflict of interest. The disclosures of the other authors are listed in the original publication.

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

TOPLINE:

The prevalence of elevated LDL cholesterol (LDL-C) has declined over the past 2 decades, but 1 in 17 Americans still have a level of 160-189 mg/dL, and 1 in 48 have a level of at least 190 mg/dL, new research shows. Among people with the higher LDL-C level, one in four are both unaware and untreated, the authors report.

METHODOLOGY:

• Using data on 23,667 adult participants in the National Health and Nutrition Examination Survey conducted from 1999 to 2020, researchers identified 1,851 (7.8%) with an LDL-C level of 160-189 mg/dL and 669 (2.8%) with an LDL-C level of at least 190 mg/dL.
• Individuals were classified as “unaware” if they had never had their LDL-C measured or had never been informed of having elevated LDL-C and as “untreated” if their medications didn’t include a statin, ezetimibe, a bile acid sequestrant, or a proprotein convertase subtilisin/kexin type 9 inhibitor.
• The authors compared the prevalence of “unaware” and “untreated” by age, sex, race and ethnicity, educational attainment, poverty index, and insurance status.

TAKEAWAY:

• During the study period, the age-adjusted prevalence of an LDL-C level of 160-189 mg/dL declined from 12.4% (95% confidence interval, 10.0%-15.3%), representing 21.5 million U.S. adults, to 6.1% (95% CI, 4.8%-7.6%), representing 14.0 million adults (P < .001).
• The age-adjusted prevalence of an LDL-C level of at least 190 mg/dL declined from 3.8% (95% CI, 2.8%-5.2%), representing 6.6 million adults, to 2.1% (95% CI, 1.4%-3.0%), representing 4.8 million adults (P = .001).
• Among those with an LDL-C level of 160-189 mg/dL, the proportion of who were unaware and untreated declined from 52.1% to 42.7%, and among those with an LDL-C level of at least 190 mg/dL, it declined from 40.8% to 26.8%.
• Being unaware and untreated was more common in younger adults, men, racial and ethnic minority groups, those with lower educational attainment, those with lower income, and those without health insurance.

IN PRACTICE:

The lack of awareness and treatment of high LDL-C uncovered by the study “may be due to difficulties accessing primary care, low rates of screening in primary care, lack of consensus on screening recommendations, insufficient emphasis on LDL-C as a quality measure, and hesitance to treat asymptomatic individuals,” the authors concluded.

SOURCE:

The research was led by Ahmed Sayed, MBBS, faculty of medicine, Ain Shams University, Cairo, Egypt. It was published online in JAMA Cardiology.

LIMITATIONS:

The analysis was limited by a small number of participants with LDL-C levels of at least 190 mg/dL, possible nonresponse bias, and dependency on participant recall of whether LDL-C was previously measured. The inclusion of pregnant women may have influenced LDL-C levels.

DISCLOSURES:

Dr. Sayed has no relevant conflict of interest. The disclosures of the other authors are listed in the original publication.

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

GLASGOW – An interactive digital decision tool that individualizes menopause care received praise from primary care clinicians in the United Kingdom, who said it could improve patient care and streamline office visits.

The tool, called Wellspring, helps clarify menopause guidelines from the U.K.’s National Institute for Health and Care Excellence while fostering shared decision-making with evidence-based data.  

“Access to hormone replacement therapy [HRT], as well as decision-making around treatment for menopausal symptoms, is often complicated by concerns around its safety, and there is still a knowledge and a confidence gap among health care professionals causing reluctance to prescribe HRT,”  said Aini Kamal, MSc, from University College London. Ms. Kamal presented results of a survey about the tool at the annual meeting of the Royal College of General Practitioners.

For the study, Ms. Kamal, Daniel Reisel, MBBS, PhD, a gynecologist at UCL, and colleagues evaluated Wellspring with doctors, nurses, and pharmacists.

“Ensuring that women receive education around symptoms, so that they are empowered, is a key part of optimizing their care and sharing decision-making,” Dr. Reisel said in an interview. He added that U.K. primary care had seen an increase in cases of women presenting with symptoms associated with the perimenopause and menopause at a time when U.K. Members of Parliament are debating whether to make it mandatory for all women to have menopause check-up in their early 40s.

The online survey was completed by 280 participants, and respondents were primarily GPs with several years of relevant prescribing practice. Of those, 93% found information from national guidelines to be accurately presented in the tool, and 97% said they would recommend this decision aid to other health care professionals, Ms. Kamal reported.

Nearly all participants said they could see themselves using the tool with patients in the clinic or as an adjunct to virtual sessions. “This [finding] was particularly important because it demonstrates the clinical potential this tool has,” she said.

 

One consult, too many problems

Louise Newson, MBChB, who runs the U.K.’s largest menopause clinic, said primary care appointments are often time-pressured and follow a “’one problem-one consultation’” policy. As such, women are often thinking ‘Do I go with my joint pains, or my palpitations, tinnitus, or what?’ If a patient presents with tinnitus, a doctor might focus on the potential of an inner ear problem rather than a hormone deficiency, but I do know that if the woman is perimenopausal or menopausal, we often look to replace the missing hormones, and then if the tinnitus doesn’t improve we can revisit the ear problem.” 

Dr. Newson noted that 17% of women in her clinics have had more than six GP visits in the year before she sees them, but in the year following, this figure drops to 1%. Acknowledging that a menopause consultation for a GP is time-consuming, Dr. Newson pointed out that taking time initially with the patient “means it will reduce the number of future consultations quickly, but more importantly, we also know that taking HRT reduces long-term risk of serious diseases, including heart disease and osteoporosis.”

The digital tool can be used by both doctors and patients to help women work through their symptoms and equip them with knowledge so their GP visits are more productive.

“When we see women who are empowered with knowledge [about menopause symptoms], then the consultations are quicker and essentially place the patient central to the discussion,” Dr. Newson said.

Ed Russell-Smith, MBChB, a GP in Scotland who moderated the session, said the tool “lays out a nicely structured approach and provides modern treatment options and resources for patients.”

However, he added “we also need to remember there are potential harms to be done from HRT too. It’s vitally important that while patients might see HRT as a panacea, doctors need to balance this with the risks involved for each individual. As a tool, I think Wellspring can help us in this respect to apply general principles to that patient and individualize treatment.”

Dr. Reisel, Dr. Newson, Ms. Kamal, and Dr. Russell-Smith disclosed no relevant financial relationships. The Wellspring Decision Aid was supported by UCL’s Institute for Women’s Health. The Newson Health clinic is fully private, but research is done via the nonprofit arm, which is supported by the clinic. There is no pharma involvement.

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

Human insulin can be left unrefrigerated for much longer than previously thought, findings from a new Cochrane review suggest.

The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.

Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.

This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.

The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.

The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.   

“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.

In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.

Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.   

“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review. 

While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.

The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”

Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”

Dr. Richter and Dr. Scapozza report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Human insulin can be left unrefrigerated for much longer than previously thought, findings from a new Cochrane review suggest.

The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.

Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.

This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.

The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.

The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.   

“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.

In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.

Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.   

“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review. 

While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.

The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”

Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”

Dr. Richter and Dr. Scapozza report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Human insulin can be left unrefrigerated for much longer than previously thought, findings from a new Cochrane review suggest.

The review included 17 studies in 22 published articles and additional unpublished information from major insulin manufacturers. The data suggest it is possible to store unopened short- and intermediate-acting human insulin vials, pens/cartridges or prefilled plastic syringes at temperatures up to 25 °C (77 °F) for a maximum of 6 months and up to 37 °C (98.6 °F) for a maximum of 2 months without a clinically relevant loss of insulin potency.

Two studies found small decrements in potency at higher temperatures and/or longer durations unrefrigerated, but the rest did not.

This contrasts with current guidance and labeling that advises storing unopened human insulin at temperatures between 2 °C (35.6 °F) and 8°C (46.4 °F), necessitating refrigeration. Once the vial or pen cartridge is opened, the guidance is to store at “room temperature” and use within about 4-6 weeks.

The recommendations vary, however, and there is no clear consensus on how human insulin should be stored in settings where reliable refrigeration can’t be guaranteed, such as low-income countries, those affected by extreme heat, or areas of conflict or natural disasters. Such areas are home to growing numbers of people with diabetes, according to the Cochrane Database of Systematic Reviews report, published online.

The review also found that oscillating temperatures between 25 °C (77 °F) and 37 °C (98.6 °F), typical of daytime and nighttime fluctuations in tropical countries, for up to 3 months do not result in clinically relevant loss of insulin activity for short-acting, intermediate-acting, or mixed human insulin.   

“Our study opens up new possibilities for individuals living in challenging environments, where access to refrigeration is limited. By understanding the thermal stability of insulin and exploring innovative storage solutions, we can make a significant impact on the lives of those who depend on insulin for their well-being,” the study’s lead author, Bernd Richter, MD, of the Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Düsseldorf, Germany, said in a statement.

In addition, one small pilot clinical study showed that human insulin stored for 6 weeks in an unglazed clay pot with temperatures ranging between 25 °C (77 °F) and 27°C (80.6 °F) did not result in differences in plasma glucose–lowering in eight healthy volunteers, compared with refrigerator-stored insulin. “With the help of simple cooling devices for insulin storage such as clay pots, it is possible to effectively reduce high outside temperatures in many high-temperature regions of the world,” wrote Dr. Richter and colleagues Brenda Bongaerts, PhD, and Maria-Inti Metzendorf, also from Heinrich-Heine-University.

Asked to comment, Leonardo Scapozza, PhD, of the School of Pharmaceutical Sciences at the University of Geneva, Switzerland, said that these findings align with a study he published in 2021.   

“Indeed ... we have done a small-scale study by analyzing the insulin coming back from the field and showing that insulin potency and stability was conserved. An extended clinical study where the insulin is submitted to varying controlled condition is not possible and ethically debatable. But an extended study where patients are given a log tag to monitor their real storage condition and the remaining samples are collected back and sent back for analysis in a specialized lab would be very good to further confirm the [conclusions],” said Dr. Scapozza, who was not part of Dr. Richter’s team on this review. 

While the issue of insulin refrigeration is less urgent in higher-income countries, it does arise, as in situations where people accidentally leave their unopened insulin out of the refrigerator or when they carry backup insulin while traveling.

The Cochrane Review excluded studies of insulin analogs, used in most developed countries, but Dr. Scapozza’s study had included them. “We observed the same stability as the ones used in low-income countries.” He added that his data combined with those in the new report provide evidence that would make it “possible to better and optimally use the available insulin that is becoming more and more costly.”

Dr. Scapozza also told this news organization that after he presented his data to Médecins Sans Frontières (Doctors Without Borders), he heard from a collaborator with that group who has diabetes. “He always used his insulin for his own treatment when he was in the field working and his insulin pen was in his backpack or pocket and his treatment was working. After hearing the data, he was very happy because he got a scientific explanation why his treatment was working, whether he was in Switzerland or during his mission in the camps submitted to the same condition of storage as any other patient in low income countries.”

Dr. Richter and Dr. Scapozza report no relevant financial relationships.

A version of this article appeared on Medscape.com.

Patients age 65 and older who receive thyroid hormone therapy and experience low thyrotropin are at increased risk for dementia and other cognitive problems, according to new research published in JAMA Internal Medicine.

The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).

The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.

Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.

“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”

In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.

More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).

During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.

Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.

“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”

Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.

“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”

Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.

In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.

“There’s so much gray zone here,” Dr. Chen said.

The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

Patients age 65 and older who receive thyroid hormone therapy and experience low thyrotropin are at increased risk for dementia and other cognitive problems, according to new research published in JAMA Internal Medicine.

The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).

The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.

Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.

“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”

In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.

More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).

During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.

Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.

“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”

Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.

“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”

Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.

In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.

“There’s so much gray zone here,” Dr. Chen said.

The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.

Patients age 65 and older who receive thyroid hormone therapy and experience low thyrotropin are at increased risk for dementia and other cognitive problems, according to new research published in JAMA Internal Medicine.

The study found that these patients with thyrotoxicosis had a higher likelihood of incident cognitive disorder (adjusted hazard ratio, 1.39; 95% confidence interval, 1.18-1.64; P < .001). Broken down between internal and external causes of thyrotoxicosis, exogenous thyrotoxicosis continued to be a significant risk factor (aHR, 1.34: 95% CI, 1.10-1.63; P = .003), while endogenous thyrotoxicosis did not show a statistically significant risk estimates (aHR, 1.38; 95% CI, 0.96-1.98; P = .08).

The study also found that women were more likely to have low levels of thyrotropin (thyroid-stimulating hormone/TSH) than men and were more likely to be overtreated.

Previous studies looking at the correlation between hyperthyroidism and cognitive disorders often did not include participants who were already taking thyroid hormones, according to Jennifer S. Mammen, MD, PhD, assistant professor of medicine at the Asthma and Allergy Center at John Hopkins University, Baltimore, and the senior author of the study.

“The fact that we see the signal both in people who are being overtreated with thyroid hormone and in people who have endogenous hyperthyroidism is one way that we think that this supports the fact that it’s not just confounding, it’s not just bias,” Dr. Mammen said. “There’s two different sources of hyperthyroidism, and they’re both showing the same relationship.”

In the study, Dr. Mammen and colleagues analyzed electronic health records for patients aged 65 years and older who received primary care in the Johns Hopkins Community Physicians Network over a 10-year period starting in 2014. Patients had to have a minimum of two visits 30 days apart. None had a history of low TSH levels or cognitive disorder diagnoses within 6 months of their first doctor visit.

More than 65,000 patients were included in the study. Slightly more than half (56%) were female, almost 70% were White, 19.3% were Black, 4.6% were Asian, and 0.4% were American Indian. Almost 25,000 low TSH measurements among 2,710 patients were recorded during the study period. The majority of low TSH measurements were exogenous (14,875), followed by origins of unknown cause (5,833), and endogenous (4,159).

During the follow-up period, 7.2% (4,779) patients received a new cognitive disorder diagnosis, which was dementia in 77% of cases.

Dr. Mammen said primary care physicians should carefully consider whether thyroid hormone therapy is necessary for older patients, and, if so, great care should be taken to avoid overtreatment.

“This is yet another reason for us to be vigilant about not overtreating people with thyroid hormone, especially in older adults,” Dr. Mammen said. “We already know that atrial fibrillation rates are increased in people who are hyperthyroid. We know that fracture and osteoporosis is affected by hyperthyroidism. And now we also have an association with higher rates of cognitive disorders.”

Taking a cautious approach to prescribing thyroid hormone therapy for older patients is paramount, according to Jean Chen, MD, partner at Texas Diabetes & Endocrinology, who was not affiliated with the study.

“All medical providers need to be aware that the 65 and older population does not need to be treated as aggressively with their thyroid hormone,” Dr. Chen said. “We are finding more and more complications from overtreatment rather than benefit in this population.”

Often, older patients may complain of symptoms such as constipation, feeling cold, or tiredness, which can be symptoms of hypothyroidism. But these symptoms could also be from anemia, vitamin deficiencies, depression, perimenopause, menopause, insulin resistance, and sleep apnea. If necessary, Dr. Chen recommended primary care physicians consult with an endocrinologist regarding a possible treatment plan and making a differential diagnosis.

In addition, Dr. Chen said other studies have shown that treating patients with thyroid hormone either did not resolve the condition or negatively impacted anxiety, muscle strength, and bone density, or it increased the risk for arrhythmia. Therefore, it’s important to weight the risks versus the benefits.

“There’s so much gray zone here,” Dr. Chen said.

The study was supported by the Richman Family Precision Medicine Center of Excellence in Alzheimer’s Disease, the Richman Family Foundation, the Rick Sharp Alzheimer’s Foundation, the Sharp Family Foundation, among others. The work was also supported by grants from the National Institutes of Health. One coauthor reported personal fees from Karuna, MapLight Therapeutics, Axsome Therapeutics, GIA, GW Research Limited, Merck, EXCIVA, Otsuka, IntraCellular Therapies, and Medesis Pharma for consulting for treatment development in Alzheimer’s disease outside the submitted work. No other disclosures were reported.

A version of this article appeared on Medscape.com.