MDedge Endocrinology

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

It’s time for my once-a-decade (more or less) list of resolutions. As long as you are pledging to turn over a new leaf at home, why not do it at the office as well?

I can’t presume to know what issues need addressing in your practice, but I do know the ones I get asked about most often, so I can offer some suggestions that might provide inspiration:

1. Keep your website up to date. Check it now, then make a note to check it regularly. Most people find their physicians online these days, and you don’t want them finding a year-old presentation with outdated photos, personnel, services, and rates. Keep your site current, or hire someone to do it for you.

2. Be an authoritative presence on social media. Like it or not, you should be on Facebook, Twitter (at least for now), Instagram, TikTok – wherever your patients congregate. Medical topics are popular search categories, and they are searching for expert advice. You are the expert. There is a ton of medical misinformation online, and it needs to be countered with accurate, factual data from bona fide experts.

8. Back up your data. Now is an excellent time to verify that the information on your office and personal computers is being backed up – locally and online – on a regular schedule. Don’t wait until something crashes.

9. Keep a closer eye on your office finances. Most physicians delegate the bookkeeping, and that’s fine. But ignoring the financial side completely creates an atmosphere that facilitates embezzlement. Set aside a couple of hours each month to review the books personally. And make sure your employees know you’re doing it.

10. Make sure your long-range financial planning is on track. I’ve said this before, but it can’t be repeated too often. Economic conditions change all the time. Once a year, you should sit down with your accountant and lawyer and make sure your investments are well-diversified and all other aspects of your finances – budgets, credit ratings, insurance coverage, tax situations, college savings, estate plans, retirement accounts – are in the best shape possible.

11. Pay down your debt. Another oldie but goodie. Debt can destroy the best laid retirement plans. If you carry significant debt, set up a plan to pay it off as soon as you can.

12. Take more vacations. Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.” If you’ve been working too much, this is the year to start spending more time enjoying your life, your friends and family, and the world. As John Lennon said, “Life is what happens to you while you’re busy making other plans.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Bribery really is the solution to all of life’s problems

Breaking news: The United States has a bit of an obesity epidemic. Okay, maybe not so breaking news. But it’s a problem we’ve been struggling with for a very long time. Part of the issue is that there really is no secret to weight loss. Pretty much anything can work if you’re committed. The millions of diets floating around are testament to this idea.

The problem of losing weight is amplified if you don’t rake in the big bucks. Lower-income individuals often can’t afford healthy superfoods, and they’re often too busy to spend time at classes, exercising, or following programs. A group of researchers at New York University has offered up an alternate solution to encourage weight loss in low-income people: Pay them.

Specifically, pay them for losing weight. A reward, if you will. The researchers recruited several hundred lower-income people and split them into three groups. All participants received a free 1-year membership to a gym and weight-loss program, as well as food journals and fitness devices, but one group received payment (on average, about $300 overall) for attending meetings, exercising a certain amount every week, or weighing themselves twice a week. About 40% of people in this group lost 5% of their body weight after 6 months, twice as many as in the group that did not receive payment for performing these tasks.

The big winners, however, were those in the third group. They also received the free stuff, but the researchers offered them a more simple and direct bribe: Lose 5% of your weight over 6 months and we’ll pay you. The reward? About $450 on average, and it worked very well, with half this group losing the weight after 6 months. That said, after a year something like a fifth of this group put the weight back on, bringing them in line with the group that was paid to perform tasks. Still, both groups outperformed the control group, which received no money.

The takeaway from this research is pretty obvious. Pay people a fair price to do something, and they’ll do it. This is a lesson that has absolutely no relevance in the modern world. Nope, none whatsoever. We all receive completely fair wages. We all have plenty of money to pay for things. Everything is fine.
 

More green space, less medicine

Have you heard of the 3-30-300 rule? Proposed by urban forester Cecil Konijnendijk, it’s become the rule of thumb for urban planners and other foresters into getting more green space in populated areas. A recent study has found that people who lived within this 3-30-300 rule had better mental health and less medication use.

rawpixel

If you’re not an urban forester, however, you may not know what the 3-30-300 rule is. But it’s pretty simple, people should be able to see at least three trees from their home, have 30% tree canopy in their neighborhood, and have 300 Spartans to defend against the Persian army.

We may have made that last one up. It’s actually have a green space or park within 300 meters of your home.

In the new study, only 4.7% of people surveyed lived in an area that followed all three rules. About 62% of the surveyed lived with a green space at least 300 meters away, 43% had at least three trees within 15 meters from their home, and a rather pitiful 9% had adequate tree canopy coverage in their neighborhood.

Greater adherence to the 3-30-300 rule was associated with fewer visits to the psychologist, with 8.3% of the participants reporting a psychologist visit in the last year. The data come from a sample of a little over 3,000 Barcelona residents aged 15-97 who were randomly selected to participate in the Barcelona Public Health Agency Survey.

“There is an urgent need to provide citizens with more green space,” said Mark Nieuwenhuijsen, lead author of the study. “We may need to tear out asphalt and plant more trees, which would not only improve health, but also reduce heat island effects and contribute to carbon capture.”

The main goal and message is that more green space is good for everyone. So if you’re feeling a little overwhelmed, take a breather and sit somewhere green. Or call those 300 Spartans and get them to start knocking some buildings down.
 

Said the toilet to the engineer: Do you hear what I hear?

A mythical hero’s journey took Dorothy along the yellow brick road to find the Wizard of Oz. Huckleberry Finn used a raft to float down the Mississippi River. Luke Skywalker did most of his traveling between planets. For the rest of us, the journey may be just a bit shorter.

Maia Gatlin

Also a bit less heroic. Unless, of course, you’re prepping for a colonoscopy. Yup, we’re headed to the toilet, but not just any toilet. This toilet was the subject of a presentation at the annual meeting of the Acoustical Society of America, titled “The feces thesis: Using machine learning to detect diarrhea,” and that presentation was the hero’s journey of Maia Gatlin, PhD, a research engineer at the Georgia Institute of Technology.

She and her team attached a noninvasive microphone sensor to a toilet, and now they can identify bowel diseases without collecting any identifiable information.

The audio sample of an excretion event is “transformed into a spectrogram, which essentially captures the sound in an image. Different events produce different features in the audio and the spectrogram. For example, urination creates a consistent tone, while defecation may have a singular tone. In contrast, diarrhea is more random,” they explained in the written statement.

They used a machine learning algorithm to classify each spectrogram based on its features. “The algorithm’s performance was tested against data with and without background noises to make sure it was learning the right sound features, regardless of the sensor’s environment,” Dr. Gatlin and associates wrote.

Their goal is to use the toilet sensor in areas where cholera is common to prevent the spread of disease. After that, who knows? “Perhaps someday, our algorithm can be used with existing in-home smart devices to monitor one’s own bowel movements and health!” she suggested.

That would be a heroic toilet indeed.

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

Automated alerts to aid clinical decision-making are designed with the best of intentions but can be easy to ignore or overlook. But a randomized trial testing such electronic alerts or “nudges” for promoting statin prescribing may have identified a few design features that help their success, researchers say.

In the trial’s primary finding, for example, reminders displayed to primary care physicians in the electronic health record worked best when the system also reached out to the patient.

Ariel Skelley/DigitalVision/Getty Images

Reminders sent only to the clinician also boosted statin prescribing, but not as well, and nudging only the patient didn’t work at all, compared to a nudge-free usual care approach. The patient-only nudges consisted of text messages explaining why a statin prescription may figure in their upcoming appointment.
 

Nudge trustworthiness

Importantly, the clinician nudges were more than simply reminders to consider a statin prescription, Mitesh S. Patel, MD, MBA, Ascension Health, St. Louis, told this news organization. They also displayed the patient’s atherosclerotic cardiovascular disease (ASCVD) 10-year risk score and explained why a statin may be appropriate. He thinks that information, often left out of such clinical decision support alerts, increases physician trust in them.

In another key feature, Dr. Patel said, the EHR nudges themselves were actionable – that is, they were functional in ways that streamlined the prescribing process. In particular, they include checkbox shortcuts to prescribing statins at appropriate patient-specific dosages, making the entire process “faster and easier,” said Dr. Patel, who is senior author on the study published in JAMA Cardiology with lead author Srinath Adusumalli, MD, University of Pennsylvania, Philadelphia.

The timing may matter as well, he observed. In previous iterations of the study’s EHR nudge system, the nudge would appear “when you open the chart,” he said. “Now, it’s when you go to the orders section, which is when you’re going to be in the mindset of ordering prescriptions and tests.”

Prescription rates were higher with the doctor-patient nudges than with the doctor-only approach, Dr. Patel speculates, largely because the decision process for initiating statins is shared. “The most effective intervention is going to recognize that and try to bring the two groups together.”
 

Two text messages

The trial, with 158 participating physicians in 28 primary care practices, randomly assigned 4,131 patients to three intervention groups and one control group. Nudges were sent only to the physician, only to the patient, or to both physician and patient; and there was a no-nudge usual-care group.

Patient nudges consisted of two text messages, one 4 days and another 15 minutes before the appointment, announcing that prescription of a statin “to reduce the chance of a heart attack” would be discussed with the physician, the report states.

Statins are grossly underprescribed nationally, it notes, and that was reflected in prescription rates seen during the study’s initial 12-month, no-intervention period of observation. Rates ranged from only 4.7% up to 6% of patients across the four assignment groups.

During the subsequent 6-month intervention period, however, the rates climbed in the doctor-only and doctor-plus-patient nudge groups compared with usual care, by 5.5 (P = .01) and 7.2 (P = .001) absolute percentage points, respectively.

The overall cohort’s mean age was 65.5. About half were male, 29% were Black, 66% were White, and 22.6% already had a cardiovascular disease diagnosis. The analysis was adjusted for calendar month and preintervention statin prescribing rates. Further adjustment for demographics, insurance type, household income, and comorbidities yielded results similar to the primary analysis, the report states.
 

The results in context

“Although the differences in the combined clinician and patient and clinician-only arms were small, this outcome needs to be interpreted in the context of the population in which the study was performed,” an editorial accompanying the published report states.

For example, “the majority of untreated patients were candidates for primary, not secondary, prevention, making this group of patients particularly challenging for seeing large effect sizes of interventions.”

Moreover, “There was a high baseline prescription rate of statins in the statin-eligible population (approximately 70%) and a high rate of already established patients,” write Faraz S. Ahmad, MD, and Stephen D. Persell, MD, of Northwestern University, Chicago.

Among the approximately 30% of patients who had not previously been prescribed statins, the true target of the nudge interventions, the published trial report states, about 98% were not seeing the physician for the first time.

So “this may not have been the first opportunity to discuss statins,” they write. “It is possible that many of these patients were resistant to statins in the past, which could have created a ceiling effect for prescribing rates.”

Dr. Patel reports owning and receiving personal fees from Catalyst Health and serving on an advisory board for and receiving personal fees from Humana. Dr. Adusumalli reports having been employed by CVS Health. Dr. Ahmad reports receiving consulting fees from Teladoc Livongo and Pfizer. Dr. Persell discloses receiving grants from Omron Healthcare.

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

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”

For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin D, zinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”

For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin D, zinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

A systematic review of nutritional supplements for hair loss finds that a wide range of the products have potential but that the studies could not provide definitive evidence of safety and effectiveness because of small sample sizes, heterogeneity of hair loss types in study subjects, or other limitations.

The review, published online in JAMA Dermatology, notes that “Twelve of the 20 nutritional interventions had high-quality studies suggesting objectively evaluated effectiveness.”

It is “ground breaking,” in part because of its breadth and depth, said Eva Simmons-O’Brien, MD, a dermatologist in Towson, Md., who often recommends supplements for her patients with hair loss. “It basically kind of vindicates what some of us have been doing for a number of years in terms of treating hair loss,” she told this news organization. “It should hopefully make it more commonplace for dermatologists to consider using nutritional supplements as an adjuvant to treating hair loss,” added Dr. Simmons-O’Brien.

The review “is very helpful,” agreed Lynne J. Goldberg, MD, professor of dermatology and pathology and laboratory medicine at Boston University. Dr. Goldberg noted that many patients are already taking supplements and want to know whether they are safe and effective. The review “points out what the problems are; it talks about what the individual ingredients are and what they do, what the problems are; and it concluded that some people may find these helpful. Which is exactly what I tell my patients,” said Dr. Goldberg, who is also director of the Hair Clinic at Boston Medical Center.

“For patients who are highly motivated and eager to try this, we’re hoping that this systematic review serves as a foundation to have a conversation,” study coauthor Arash Mostaghimi, MD, MPA, MPH, of the department of dermatology at Harvard Medical School, told this news organization. “When there’s medical uncertainty and the question is how much risk is one willing to take, the most important thing to do is to present the data and engage in shared decision-making with the patient,” noted Dr. Mostaghimi, who is also director of the inpatient dermatology consult service at Brigham and Women’s Hospital, Boston.
 

Surprising effectiveness

Going into the study, “we felt it would be likely that majority of nutritional supplements would either not be effective or not studied,” he said.

Dr. Mostaghimi and his coauthors conducted the study because so many patients take nutritional supplements to address hair loss, he said. An initial literature survey yielded more than 6,300 citations, but after screening and reviews, the authors included 30 articles for evaluation.

The review begins with a look at studies of saw palmetto (Serenoa repens), a botanical compound thought to inhibit the enzyme 5-alpha reductase (5AR), which converts testosterone to dihydroxytestosterone (DHT). DHT is a mediator of androgenic alopecia (AGA). The studies suggest that the compound might stabilize hair loss, “although its effect is likely less than that of finasteride,” write the authors. They also note that side effects associated with finasteride, such as sexual dysfunction, were also observed with saw palmetto “but to a lesser extent.”

For AGA, pumpkin seed oil may also be effective and a “potential alternative” to finasteride for AGA, and Forti5, a nutritional supplement that includes botanical 5AR inhibitors and other ingredients, had favorable effects in one study, the authors write. But neither has been compared to finasteride, and the Forti5 study lacked a control group.

The review also examines the micronutrients vitamin D, zinc, B vitamins, and antioxidants. Low levels of vitamin D have been associated with alopecia areata (AA), AGA, and telogen effluvium (TE) in some studies, and zinc deficiencies have been associated with TE, hair breakage, and thinning, according to the review. A single-arm vitamin D study showed improved results at 6 months for women with TE, but there was no control group and TE is self-resolving, the authors add. Studies in patients with normal zinc levels at baseline who had AA or hair loss showed significant hair regrowth and increased hair thickness and density, but the trials were a mishmash of controls and no controls and relied on self-perceived hair-loss data.

Larger more rigorous studies should be done to evaluate zinc’s effectiveness with AA, the authors comment.

Many patients take vitamin B7 (biotin) for hair loss. It has not been studied on its own but was an ingredient in some supplements in the review. Dr. Simmons-O’Brien said that biotin won’t result in new hair growth but that it can help strengthen the new hairs that grow as a result of other therapies. Both she and the study authors note that the Food and Drug Administration has warned against biotin supplementation because it can interfere with troponin and other test results.

The review also finds that immunomodulators –such as Chinese herbal extracts from paeony and glycyrrhizin – were effective in severe AA. Growth hormone modulators targeting deficiencies in insulin growth factor 1 or growth hormone are also promising. Studies of the modulators capsaicin and isoflavones – used topically – spurred hair growth, the authors write.

Products containing marine protein supplements, including Viviscal and Nourkrin, appeared effective in increasing hair counts in men and women, but the studies were funded by the manufacturer and were not well controlled. Side effects with Viviscal included bloating, according to the review.

The multi-ingredient supplements Nutrafol, Omni-Three, Apple Nutraceutical, and Lambdapil were also included in the review. Only Omni-Three showed no effectiveness, but studies of the other supplements had various limitations, including lack of controls and small sample sizes.
 

Complicated problem, multiple solutions

Given the many reasons for hair loss, multiple solutions are needed, the dermatologists note.

Dr. Mostaghimi said that he’s still a bit skeptical that supplements work as consistently as described or as well as described, given that he and his coauthors were unable to find any negative studies. In talking with patients who are taking supplements, he said that his first aim is to make sure they are safe. At least the supplements in the review have been studied for safety, he added.

He will encourage replacement of vitamin D or zinc or other vitamins or minerals if patients are deficient but said that he does not “actively encourage supplementation.”

Dr. Simmons-O’Brien said that, when evaluating patients with hair loss, she orders lab tests to determine whether the patient has anemia or a thyroid issue or deficiencies in vitamins or minerals or other nutritional deficiencies, asks about diet and styling practices, and takes a scalp biopsy. It is not uncommon to recommend supplementation on the basis of those findings, she added.

“As a hair-loss specialist, my job is to treat the patient at their level, in their framework, in their comfort zone,” said Dr. Goldberg. Some patients don’t want to take medications for hair loss, so she might recommend supplements in those cases but tells patients that they aren’t well studied.

She added that it can be hard to tell whether a supplement is working, particularly if it has multiple ingredients.

Dr. Mostaghimi reported consulting fees from Pfizer, Concert, Lilly, Hims and Hers, Equillium, AbbVie, Digital Diagnostics, and Bioniz and grants from Pfizer, all outside the submitted work. In addition, Dr. Mostaghimi disclosed that he is an associate editor of JAMA Dermatology but was not involved in any of the decisions regarding the review of the manuscript or its acceptance. No other disclosures were reported by the other study authors. Dr. Goldberg reported no disclosures. Dr. Simmons-O›Brien is a medical consultant for Isdin, but not for hair products.

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

Patients with intermediate-risk papillary thyroid cancer and lymph node metastasis show no significant increase in tumor recurrence when undergoing lobectomy compared with a total thyroidectomy, new research shows.

“Results of this cohort study suggest that patients with ipsilateral clinical lateral neck metastasis (cN1b) papillary thyroid cancer who underwent lobectomy exhibited recurrence-free survival rates similar to those who underwent total thyroidectomy after controlling for major prognostic factors,” the authors conclude in the study published online in JAMA Surgery.

“These findings suggest that cN1b alone should not be an absolute indication for total thyroidectomy,” they note.

The study, involving the largest cohort to date to compare patients with intermediate-risk papillary thyroid cancer treated with lobectomy versus total thyroidectomy, “challenged the current guidelines and pushed the boundary of limited surgical treatment even further,” say Michelle B. Mulder, MD, and Quan-Yang Duh, MD, of the department of surgery, University of California, San Francisco, in an accompanying editorial.

“It can be a game changer if confirmed by future prospective and multicenter studies,” they add.
 

Guidelines still recommend total thyroidectomy with subsequent RAI

While lower-intensity treatment options, with a lower risk of complications, have gained favor in the treatment of low-risk papillary thyroid cancer, guidelines still recommend the consideration of total thyroidectomy and subsequent radioactive iodine ablation (RAI) for intermediate-risk cancers because of the higher chance of recurrence, particularly among those with clinically positive nodes.

However, data on the superiority of a total thyroidectomy, with or without RAI, versus lobectomy is inconsistent, prompting first author Siyuan Xu, MD, of the department of head and neck surgical oncology, National Cancer Center, Beijing, and colleagues to compare the risk of recurrence with the two approaches.

For the study, patients with intermediate-risk papillary thyroid cancer treated at the Chinese Academy of Medical Sciences Cancer Hospital in Beijing between January 2000 and December 2017, who had a lobectomy or total thyroidectomy, were paired 1:1 in a propensity score matching analysis.

Other than treatment type, the 265 pairs of patients were matched based on all other potential prognostic factors, including age, sex, primary tumor size, minor extrathyroidal extension, multifocality, number of lymph node metastases, and lymph node ratio.

Participants were a mean age of 37 years and 66% were female.

With a median follow-up of 60 months in the lobectomy group and 58 months in the total thyroidectomy group, structural recurrences occurred in 7.9% (21) and 6.4% (17) of patients, respectively, which was not significantly different.

The primary endpoint, 5-year rate of recurrence-free survival, was also not significantly different between the lobectomy (92.3%) and total thyroidectomy groups (93.7%) (adjusted hazard ratio, 1.10; P = .77).

In a further stratified analysis of patients treated with total thyroidectomy along with RAI (n = 75), the lack of a significant difference in recurrence-free survival versus lobectomy remained (aHR, 0.59; P = .46).

The results were similar in unadjusted as well as adjusted analyses, and a power analysis indicated that the study had a 90% power to detect a more than 4.9% difference in recurrence-free survival.

“Given the lower complication rate of lobectomy, a maximal 4.9% recurrence-free survival difference is acceptable, which enhances the reliability of the study results,” the authors say.

They conclude that “our findings call into question whether cN1b alone [ipsilateral clinical lateral neck metastasis papillary thyroid cancer] should be an absolute determinant for deciding the optimal extent of thyroid surgery for papillary thyroid cancer.”
 

With total thyroidectomy, RAI can be given

An important argument in favor of total thyroidectomy is that with the complete resection of thyroid tissue, RAI ablation can then be used for postoperative detection of residual or metastatic disease, as well as for treatment, the authors note.

Indeed, a study using the Surveillance, Epidemiology, and End Results (SEER) database showed RAI ablation is associated with a 29% reduction in the risk of death in patients with intermediate-risk papillary thyroid cancer, with a hazard risk of 0.71.

However, conflicting data from Memorial Sloan-Kettering Cancer Center, New York, suggests no significant benefit with total thyroidectomy and RAI ablation.

The current study’s analysis of patients treated with RAI, though limited in size, supports the latter study’s findings, the authors note.

“When we performed further stratified analyses in patients treated with total thyroidectomy plus RAI ablation and their counterparts, no significant difference was found, which conformed with [the] result from the whole cohort.”

“Certainly, the stratified comparison did not have enough power to examine the effect of RAI ablation on tumor recurrence subject to the limitation of sample size and case selection [and] further study is needed on this topic,” they write.
 

Some limitations warrant cautious interpretation

In their editorial, Dr. Mulder and Dr. Duh note that while some previous studies have shown similar outcomes relating to tumor size, thyroid hormone suppression therapy, and multifocality, “few have addressed lateral neck involvement.”

They suggest cautious interpretation, however, due to limitations, acknowledged by the authors, including the single-center nature of the study.

“Appropriate propensity matching may mitigate selection bias but cannot eliminate it entirely and their findings may not be replicated in other institutions by other surgeons,” they note.

Other limitations include that changes in clinical practice and patient selection were likely over the course of the study because of significant changes in American Thyroid Association (ATA) guidelines between 2009 and 2017, and characteristics including molecular genetic testing, which could have influenced final results, were not taken into consideration.

Furthermore, for patients with intermediate-risk cancer, modifications in postoperative follow-up are necessary following lobectomy versus total thyroidectomy; “the role of radioiodine is limited and the levels of thyroglobulin more complicated to interpret,” they note.

The study and editorial authors had no disclosures to report.

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

Patients with intermediate-risk papillary thyroid cancer and lymph node metastasis show no significant increase in tumor recurrence when undergoing lobectomy compared with a total thyroidectomy, new research shows.

“Results of this cohort study suggest that patients with ipsilateral clinical lateral neck metastasis (cN1b) papillary thyroid cancer who underwent lobectomy exhibited recurrence-free survival rates similar to those who underwent total thyroidectomy after controlling for major prognostic factors,” the authors conclude in the study published online in JAMA Surgery.

“These findings suggest that cN1b alone should not be an absolute indication for total thyroidectomy,” they note.

The study, involving the largest cohort to date to compare patients with intermediate-risk papillary thyroid cancer treated with lobectomy versus total thyroidectomy, “challenged the current guidelines and pushed the boundary of limited surgical treatment even further,” say Michelle B. Mulder, MD, and Quan-Yang Duh, MD, of the department of surgery, University of California, San Francisco, in an accompanying editorial.

“It can be a game changer if confirmed by future prospective and multicenter studies,” they add.
 

Guidelines still recommend total thyroidectomy with subsequent RAI

While lower-intensity treatment options, with a lower risk of complications, have gained favor in the treatment of low-risk papillary thyroid cancer, guidelines still recommend the consideration of total thyroidectomy and subsequent radioactive iodine ablation (RAI) for intermediate-risk cancers because of the higher chance of recurrence, particularly among those with clinically positive nodes.

However, data on the superiority of a total thyroidectomy, with or without RAI, versus lobectomy is inconsistent, prompting first author Siyuan Xu, MD, of the department of head and neck surgical oncology, National Cancer Center, Beijing, and colleagues to compare the risk of recurrence with the two approaches.

For the study, patients with intermediate-risk papillary thyroid cancer treated at the Chinese Academy of Medical Sciences Cancer Hospital in Beijing between January 2000 and December 2017, who had a lobectomy or total thyroidectomy, were paired 1:1 in a propensity score matching analysis.

Other than treatment type, the 265 pairs of patients were matched based on all other potential prognostic factors, including age, sex, primary tumor size, minor extrathyroidal extension, multifocality, number of lymph node metastases, and lymph node ratio.

Participants were a mean age of 37 years and 66% were female.

With a median follow-up of 60 months in the lobectomy group and 58 months in the total thyroidectomy group, structural recurrences occurred in 7.9% (21) and 6.4% (17) of patients, respectively, which was not significantly different.

The primary endpoint, 5-year rate of recurrence-free survival, was also not significantly different between the lobectomy (92.3%) and total thyroidectomy groups (93.7%) (adjusted hazard ratio, 1.10; P = .77).

In a further stratified analysis of patients treated with total thyroidectomy along with RAI (n = 75), the lack of a significant difference in recurrence-free survival versus lobectomy remained (aHR, 0.59; P = .46).

The results were similar in unadjusted as well as adjusted analyses, and a power analysis indicated that the study had a 90% power to detect a more than 4.9% difference in recurrence-free survival.

“Given the lower complication rate of lobectomy, a maximal 4.9% recurrence-free survival difference is acceptable, which enhances the reliability of the study results,” the authors say.

They conclude that “our findings call into question whether cN1b alone [ipsilateral clinical lateral neck metastasis papillary thyroid cancer] should be an absolute determinant for deciding the optimal extent of thyroid surgery for papillary thyroid cancer.”
 

With total thyroidectomy, RAI can be given

An important argument in favor of total thyroidectomy is that with the complete resection of thyroid tissue, RAI ablation can then be used for postoperative detection of residual or metastatic disease, as well as for treatment, the authors note.

Indeed, a study using the Surveillance, Epidemiology, and End Results (SEER) database showed RAI ablation is associated with a 29% reduction in the risk of death in patients with intermediate-risk papillary thyroid cancer, with a hazard risk of 0.71.

However, conflicting data from Memorial Sloan-Kettering Cancer Center, New York, suggests no significant benefit with total thyroidectomy and RAI ablation.

The current study’s analysis of patients treated with RAI, though limited in size, supports the latter study’s findings, the authors note.

“When we performed further stratified analyses in patients treated with total thyroidectomy plus RAI ablation and their counterparts, no significant difference was found, which conformed with [the] result from the whole cohort.”

“Certainly, the stratified comparison did not have enough power to examine the effect of RAI ablation on tumor recurrence subject to the limitation of sample size and case selection [and] further study is needed on this topic,” they write.
 

Some limitations warrant cautious interpretation

In their editorial, Dr. Mulder and Dr. Duh note that while some previous studies have shown similar outcomes relating to tumor size, thyroid hormone suppression therapy, and multifocality, “few have addressed lateral neck involvement.”

They suggest cautious interpretation, however, due to limitations, acknowledged by the authors, including the single-center nature of the study.

“Appropriate propensity matching may mitigate selection bias but cannot eliminate it entirely and their findings may not be replicated in other institutions by other surgeons,” they note.

Other limitations include that changes in clinical practice and patient selection were likely over the course of the study because of significant changes in American Thyroid Association (ATA) guidelines between 2009 and 2017, and characteristics including molecular genetic testing, which could have influenced final results, were not taken into consideration.

Furthermore, for patients with intermediate-risk cancer, modifications in postoperative follow-up are necessary following lobectomy versus total thyroidectomy; “the role of radioiodine is limited and the levels of thyroglobulin more complicated to interpret,” they note.

The study and editorial authors had no disclosures to report.

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

Patients with intermediate-risk papillary thyroid cancer and lymph node metastasis show no significant increase in tumor recurrence when undergoing lobectomy compared with a total thyroidectomy, new research shows.

“Results of this cohort study suggest that patients with ipsilateral clinical lateral neck metastasis (cN1b) papillary thyroid cancer who underwent lobectomy exhibited recurrence-free survival rates similar to those who underwent total thyroidectomy after controlling for major prognostic factors,” the authors conclude in the study published online in JAMA Surgery.

“These findings suggest that cN1b alone should not be an absolute indication for total thyroidectomy,” they note.

The study, involving the largest cohort to date to compare patients with intermediate-risk papillary thyroid cancer treated with lobectomy versus total thyroidectomy, “challenged the current guidelines and pushed the boundary of limited surgical treatment even further,” say Michelle B. Mulder, MD, and Quan-Yang Duh, MD, of the department of surgery, University of California, San Francisco, in an accompanying editorial.

“It can be a game changer if confirmed by future prospective and multicenter studies,” they add.
 

Guidelines still recommend total thyroidectomy with subsequent RAI

While lower-intensity treatment options, with a lower risk of complications, have gained favor in the treatment of low-risk papillary thyroid cancer, guidelines still recommend the consideration of total thyroidectomy and subsequent radioactive iodine ablation (RAI) for intermediate-risk cancers because of the higher chance of recurrence, particularly among those with clinically positive nodes.

However, data on the superiority of a total thyroidectomy, with or without RAI, versus lobectomy is inconsistent, prompting first author Siyuan Xu, MD, of the department of head and neck surgical oncology, National Cancer Center, Beijing, and colleagues to compare the risk of recurrence with the two approaches.

For the study, patients with intermediate-risk papillary thyroid cancer treated at the Chinese Academy of Medical Sciences Cancer Hospital in Beijing between January 2000 and December 2017, who had a lobectomy or total thyroidectomy, were paired 1:1 in a propensity score matching analysis.

Other than treatment type, the 265 pairs of patients were matched based on all other potential prognostic factors, including age, sex, primary tumor size, minor extrathyroidal extension, multifocality, number of lymph node metastases, and lymph node ratio.

Participants were a mean age of 37 years and 66% were female.

With a median follow-up of 60 months in the lobectomy group and 58 months in the total thyroidectomy group, structural recurrences occurred in 7.9% (21) and 6.4% (17) of patients, respectively, which was not significantly different.

The primary endpoint, 5-year rate of recurrence-free survival, was also not significantly different between the lobectomy (92.3%) and total thyroidectomy groups (93.7%) (adjusted hazard ratio, 1.10; P = .77).

In a further stratified analysis of patients treated with total thyroidectomy along with RAI (n = 75), the lack of a significant difference in recurrence-free survival versus lobectomy remained (aHR, 0.59; P = .46).

The results were similar in unadjusted as well as adjusted analyses, and a power analysis indicated that the study had a 90% power to detect a more than 4.9% difference in recurrence-free survival.

“Given the lower complication rate of lobectomy, a maximal 4.9% recurrence-free survival difference is acceptable, which enhances the reliability of the study results,” the authors say.

They conclude that “our findings call into question whether cN1b alone [ipsilateral clinical lateral neck metastasis papillary thyroid cancer] should be an absolute determinant for deciding the optimal extent of thyroid surgery for papillary thyroid cancer.”
 

With total thyroidectomy, RAI can be given

An important argument in favor of total thyroidectomy is that with the complete resection of thyroid tissue, RAI ablation can then be used for postoperative detection of residual or metastatic disease, as well as for treatment, the authors note.

Indeed, a study using the Surveillance, Epidemiology, and End Results (SEER) database showed RAI ablation is associated with a 29% reduction in the risk of death in patients with intermediate-risk papillary thyroid cancer, with a hazard risk of 0.71.

However, conflicting data from Memorial Sloan-Kettering Cancer Center, New York, suggests no significant benefit with total thyroidectomy and RAI ablation.

The current study’s analysis of patients treated with RAI, though limited in size, supports the latter study’s findings, the authors note.

“When we performed further stratified analyses in patients treated with total thyroidectomy plus RAI ablation and their counterparts, no significant difference was found, which conformed with [the] result from the whole cohort.”

“Certainly, the stratified comparison did not have enough power to examine the effect of RAI ablation on tumor recurrence subject to the limitation of sample size and case selection [and] further study is needed on this topic,” they write.
 

Some limitations warrant cautious interpretation

In their editorial, Dr. Mulder and Dr. Duh note that while some previous studies have shown similar outcomes relating to tumor size, thyroid hormone suppression therapy, and multifocality, “few have addressed lateral neck involvement.”

They suggest cautious interpretation, however, due to limitations, acknowledged by the authors, including the single-center nature of the study.

“Appropriate propensity matching may mitigate selection bias but cannot eliminate it entirely and their findings may not be replicated in other institutions by other surgeons,” they note.

Other limitations include that changes in clinical practice and patient selection were likely over the course of the study because of significant changes in American Thyroid Association (ATA) guidelines between 2009 and 2017, and characteristics including molecular genetic testing, which could have influenced final results, were not taken into consideration.

Furthermore, for patients with intermediate-risk cancer, modifications in postoperative follow-up are necessary following lobectomy versus total thyroidectomy; “the role of radioiodine is limited and the levels of thyroglobulin more complicated to interpret,” they note.

The study and editorial authors had no disclosures to report.

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

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Mrs. Sutton, of Woodinville, Wash. She added that “every single [Food and Drug Administration]–approved medication for juvenile arthritis” was on the list of nonessential benefits.

Mrs. Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance – which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs – often called “specialty” drugs because of their high prices or the way they are made – are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs.

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort. Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, N.Y.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Ill., a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed – and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tenn., whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mr. Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts.

None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Mrs. Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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

Eric Andrew Salata, MD, a 54-year-old internist based in Naples, Florida, made headlines 2 weeks ago when he was arrested by local police and charged with sexual battery on two of his patients, according to a police statement.

A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.

Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.

Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.

Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.

The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.

At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.

“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”

Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.

Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”

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