Clinical Endocrinology News

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

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

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

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 [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

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 [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

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 [email protected].

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

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

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

San Diego – The anabolic osteoporosis treatment abaloparatide (Tymlos, Radius Health) works in men as well as women, new data indicate.  

Findings from the Abaloparatide for the Treatment of Men With Osteoporosis (ATOM) randomized, double-blind, placebo-controlled, phase 3 study were presented last week at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2022.

Abaloparatide, a subcutaneously administered parathyroid-hormone–related protein (PTHrP) analog, resulted in significant increases in bone mineral density by 12 months at the lumbar spine, total hip, and femoral neck, compared with placebo in men with osteoporosis, with no significant adverse effects.

“Osteoporosis is underdiagnosed in men. Abaloparatide is another option for an ignored population,” presenter Neil Binkley, MD, of the University of Wisconsin School of Medicine and Public Health Madison, said in an interview.

Abaloparatide was approved by the U.S. Food and Drug Administration in 2017 for the treatment of postmenopausal women at high risk for fracture due to a history of osteoporotic fracture or multiple fracture risk factors, or who haven’t responded to or are intolerant of other osteoporosis therapies.

While postmenopausal women have mainly been the focus in osteoporosis, men account for approximately 30% of the societal burden of osteoporosis and have greater fracture-related morbidity and mortality than women.

About one in four men over the age of 50 years will have a fragility fracture in their lifetime. Yet, they’re far less likely to be diagnosed or to be included in osteoporosis treatment trials, Dr. Binkley noted.

Asked to comment, session moderator Thanh D. Hoang, DO, told this news organization, “I think it’s a great option to treat osteoporosis, and now we have evidence for treating osteoporosis in men. Mostly the data have come from postmenopausal women.”
 

Screen men with hypogonadism or those taking steroids

“This new medication is an addition to the very limited number of treatments that we have when patients don’t respond to [initial] medications. To have another anabolic bone-forming medication is very, very good,” said Dr. Hoang, who is professor and program director of the Endocrinology Fellowship Program at Walter Reed National Military Medical Center, Bethesda, Maryland.

Radius Health filed a Supplemental New Drug Application with the FDA for abaloparatide (Tymlos) subcutaneous injection in men with osteoporosis at high risk for fracture in February. There is a 10-month review period.

Dr. Binkley advises bone screening for men who have conditions such as hypogonadism or who are taking glucocorticoids or chemotherapeutics.

But, he added, “I think that if we did nothing else good in the osteoporosis field, if we treated people after they fractured that would be a huge step forward. Even with a normal T score, when those people fracture, they [often] don’t have normal bone mineral density ... That’s a group of people we’re ignoring still. They’re not getting diagnosed, and they’re not getting treated.”

ATOM Study: Significant BMD increases at key sites

The approval of abaloparatide in women was based on the phase 3, 18-week ACTIVE trial of more than 2,000 high-risk women, in whom abaloparatide was associated with an 86% reduction in vertebral fracture incidence, compared with placebo, and also significantly greater reductions in nonvertebral fractures, compared with both placebo and teriparatide (Forteo, Eli Lilly).

The ATOM study involved a total of 228 men aged 40-85 years with primary or hypogonadism-associated osteoporosis randomized 2:1 to receive subcutaneous 80 μg abaloparatide or injected placebo daily for 12 months. All had T scores (based on male reference range) of ≤ −2.5 at the lumbar spine or hip, or ≤ −1.5 and with radiologic vertebral fracture or a history of low trauma nonvertebral fracture in the past 5 years, or T score ≤ −2.0 if older than 65 years.

Increases in bone mineral density from baseline were significantly greater with abaloparatide compared with placebo at the lumbar spine, total hip, and femoral neck at 3, 6, and 12 months. Mean percentage changes at 12 months were 8.5%, 2.1%, and 3.0%, for the three locations, respectively, compared with 1.2%, 0.01%, and 0.2% for placebo (all P ≤ .0001).

Three fractures occurred in those receiving placebo and one with abaloparatide.

For markers of bone turnover, median serum procollagen type I N-terminal propeptide (s-PINP) was 111.2 ng/mL after 1 month of abaloparatide treatment and 85.7 ng/mL at month 12. Median serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) was 0.48 ng/mL at month 6 and 0.45 ng/mL at month 12 in the abaloparatide group. Geometric mean relative to baseline s-PINP and s-CTX increased significantly at months 3, 6, and 12 (all P < .001 for relative treatment effect of abaloparatide vs. placebo).

The most commonly reported treatment-emergent adverse events were injection site erythema (12.8% vs. 5.1%), nasopharyngitis (8.7% vs. 7.6%), dizziness (8.7% vs. 1.3%), and arthralgia (6.7% vs. 1.3%), with abaloparatide versus placebo. Serious treatment-emergent adverse event rates were similar in both groups (5.4% vs. 5.1%). There was one death in the abaloparatide group, which was deemed unrelated to the drug.

Dr. Binkley has reported receiving consulting fees from Amgen and research support from Radius. Dr. Hoang has reported disclosures with Acella Pharmaceuticals and Horizon Therapeutics (no financial compensation).

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

According to the latest evidence, the ketogenic diet is emerging as an effective strategy not only to promote weight loss, but also to manage many comorbidities associated with obesity, including COVID-19. This development was revealed during the 8th International Scientific Symposium New Frontiers in Scientific Research, organized by PronoKal Group and held in Barcelona. During this conference, international multidisciplinary experts in the study and management of obesity presented the latest data on the benefits of treatment based on a very-low-calorie ketogenic diet.

“Nutritional ketosis has gained great interest in recent years because it is shown to have beneficial properties for health and promotes healthy aging, increasing longevity,” said Ana Belén Crujeiras, BSc, PhD, principal investigator of the Health Research Institute of Santiago de Compostela-Galician Health Service (IDIS-SERGAS) Group of Epigenomics in Endocrinology and Nutrition and the Biomedical Research Networking Center for Obesity and Nutrition Physiopathology (CIBEROBN). “Furthermore, in the case of obesity, we have more and more evidence that it is an effective treatment, mainly because to achieve this metabolic state (ketosis), routes that require the combustion of fats are activated, and this induces body weight loss.”

The specialist stressed that several strategies are used to induce nutritional ketosis. They are characterized by low carbohydrate consumption (low-carbohydrate and high-fat diet; low-carbohydrate, low-fat diet; and intermittent fasting). But Dr. Crujeiras warned that to use it as a treatment for a disease such as obesity, it must be backed by strong and solid scientific evidence, moving away from the concept of fad diets.

In this sense, since 2010, Dr. Crujeiras’ team has developed several studies focused on analyzing the efficacy and safety of treatment with a very-low-calorie ketogenic diet, the results of which have been published in high-impact journals.

Dr. Crujeiras commented on the main conclusions drawn from these investigations. “Our work has shown that the very-low-calorie ketogenic diet is effective for rapid weight loss and maintenance of lost weight, as well as reducing fat mass, primarily visceral fat mass.

“In this sense, a very interesting result is that despite the strong weight loss it induces, it preserves muscle mass and function and improves resting metabolic rate. These two variables are important, because all therapeutic strategies that exist to lose weight lead to a significant reduction in fat-free mass and also a reduction in energy expenditure at rest. This factor is associated with the risk of regaining lost weight, which is currently the great challenge in the treatment of obesity,” she added.
 

Specific methylation pattern

Dr. Crujeiras indicated that other notable evidence is the favorable impact on an emotional and psychological level. “To determine whether the caloric restriction of this diet and the strong weight loss that it involves were associated with an increased desire to eat, we also carried out an analysis with psychobiological tests. These results led us to conclude that this guideline is accompanied by a reduction of anxiety about food and an improvement in psychobiological parameters, thus increasing the quality of life of these patients.”

The specialist also mentioned that studies currently in progress show that the beneficial effect of this diet could be mediated by epigenetic mechanisms. “In our group, we have identified a specific DNA methylation pattern in people with obesity and we wondered if the very-low-calorie ketogenic diet would be able to reverse that methylome.

“We conducted a study in which we collected blood samples from patients on the very-low-calorie ketogenic diet (600 to 800 kcal/day) drawn before treatment, at peak ketosis, and at the end of treatment. After determining the global pattern of DNA in all patients with obesity targeted with this strategy and through bioinformatic analysis, we were able to obtain a methylation pattern. The results showed that after weight loss on the very-low-calorie ketogenic diet, the methylome that obese people initially had [was] reversed and matched that of normal-weight people.

“Continuing with this bioinformatic analysis more comprehensively, we wanted to see what kind of genes were differentially methylated, especially by the action of the ketosis itself. We found that most of the genes that exhibited differential methylation (in total, 292 identified) belonged to pathways that were involved in the regulation of metabolism, adipose tissue function, CNS function, and also carcinogenesis,” she continued.
 

Immunomodulatory effect

Dr. Crujeiras said that her research group also observed the modulatory role of the very-low-calorie ketogenic diet in the functioning of the immune system, “something that was not seen after similar weight loss induced by bariatric surgery. We analyzed this data in the context of the situation created by COVID-19, taking into account the evidence that people with obesity, compared to those with normal weight, have a higher risk of becoming infected and of having a poor evolution of the infection.”

In this regard, Dr. Crujeiras’ team launched an investigation to study the ACE2 gene methylation pattern, comparing obesity with normal weight and the situation after following a very-low-calorie ketogenic diet or undergoing bariatric surgery. “We observed that the methylation pattern of this gene in obese people was increased, compared to normal-weight people,” she explained, “and this increase was observed mainly in visceral adipose tissue. However, we did not see this in subcutaneous adipose tissue, which is in agreement with the hypothesis that visceral adipose tissue is that mostly associated with obesity-related comorbidities.

“Likewise, the very-low-calorie ketogenic diet was associated with decreased ACE2 methylation, along with increased exposure of this gene. However, after bariatric surgery, no significant changes were observed, so we deduce that we are protecting the patient in some way from inflammation and, therefore, from the potential of serious illness if they become infected.

“In light of these results, we wanted to dig deeper into what was happening with the immune system of obese patients and that inflammation after a very-low-calorie ketogenic diet. We conducted a new study, currently under review in the journal Clinical Nutrition, with the same approach, comparing this diet with a standard hypocaloric balanced diet and bariatric surgery, in which we analyzed a wide battery of cytokines (32). We have observed a differential pattern between the very-low-calorie ketogenic diet and bariatric surgery.

“The results confirm our hypothesis that the very-low-calorie ketogenic diet remodels the inflammatory status of obese patients, and we were also able to verify that the increase in ketone bodies has immunomodulatory properties that were previously demonstrated in preclinical and animal models, which is associated with increased immune function in these patients,” added Dr. Crujeiras.
 

Personalization and weight regain

In regard to the next steps to take in the knowledge and clinical application of the benefits of this dietary strategy, Dr. Crujeiras said that despite the fact that this diet is known to be effective, it is currently prescribed in a standard manner to all patients, “but there is some variability in the response and also a high risk of regaining weight, as is the case with any nutritional intervention strategy, with that ‘regain’ of lost weight being the main challenge in the treatment of obesity. In this sense, the epigenomic and epigenetic markers that we have identified could help us optimize treatment.”

She added that the future lies in establishing an algorithm that encompasses the patient’s exposome data, along with their genetic and epigenetic profile, to properly classify patients and prescribe a personalized precision therapeutic strategy.

Luca Busetto, MD, cochair of the Obesity Management Task Force (OMTF) of the European Association for the Study of Obesity (EASO), also insisted on the challenge posed by the individualized application of the very-low-calorie ketogenic diet, emphasizing that this diet should always be prescribed by a doctor after an appropriate assessment of the patient. “Obesity is not a matter of willpower or motivation, and most people with obesity have struggled their entire lives and failed because their biology tends to cause weight regain. Therefore, we should try to offer them the options that we currently have, including the very-low-calorie ketogenic diet, adapting them as much as possible to the profile of each patient.”

During his speech, Dr. Busetto presented the recent European guidelines for the management of obesity in adults with a very-low-calorie ketogenic diet, endorsed by EASO, and analyzed the main strengths of these recommendations.

Dr. Busetto remarked that three important points clearly justify the use of the very-low-calorie ketogenic diet. The first is the speed with which the initial weight loss occurs. Recent studies have looked at the benefits of a significant loss of excess weight early in a weight-loss diet, and although this is an association rather than a cause, the results strongly suggest that rapid initial weight loss increases the chance of the result being maintained in the long term. This clashes with the traditional recommendation of losing weight little by little as a strategy to achieve long-term results, but it must be taken into account that there are many myths in the treatment of obesity that current evidence is dismantling with new data – and this is one of them.

Secondly, the effect of the very-low-calorie ketogenic diet can be added to other treatments. This has been demonstrated by studies carried out with liraglutide that showed that this dietary strategy optimizes results, compared with patients who had been treated only with this drug. The third point that justifies the use of the very-low-calorie ketogenic diet is the management of obesity comorbidities. Several investigations demonstrate the effectiveness of this diet in this regard, especially in the case of type 2 diabetes. Data suggest that the substantial weight reductions achieved with it also favor the remission of these comorbidities in many patients.
 

EASO ‘approval’

Dr. Busetto pointed out that, based on this evidence, the OMTF proposed the development of standards to be included in the EASO guidelines, since there had been no specific recommendation on the very-low-calorie ketogenic diet.

“The main objective of these European guidelines was to provide data referenced by scientific evidence and to suggest a common protocol for the use of this dietary strategy,” he added.

For this, a very exhaustive meta-analysis was carried out, researching all the publications that compared the very-low-calorie ketogenic diet with other diets. The results showed the superiority of the former method for the reduction of body mass index and weight and fat mass, with no difference in lean (muscle) mass, despite significant weight loss in these patients.

This evidence also demonstrates a reduction and an improvement in metabolic markers, specifically glucose metabolism and lipid metabolism.

“The final conclusions of the study corroborate that the very-low-calorie ketogenic diet can be recommended as an effective and safe tool for people with obesity, especially those with severe obesity or comorbidities (joint disease, preoperative period to bariatric surgery, metabolic and cardiovascular diseases) who need immediate, substantial weight loss. In addition, it can be prescribed to specific groups of patients with obesity after considering potential contraindications and under medical follow-up,” said Dr. Busetto.

In Dr. Busetto’s opinion, it would be convenient to refer to this approach as a method, instead of as a diet, “because, in reality, the state of ketosis is limited in time, and if the ketogenic phase is stopped without a continuity plan, obviously weight is regained. In addition, the method approach may increase adherence by patients.”

Finally, Dr. Busetto emphasized the importance of integrating this type of treatment into a long-term lifestyle strategy (including habits, exercise, and nutritional advice). “We must start from the basis that obesity is a chronic and relapsing disease, whose management should also be chronic and probably maintained throughout life.”

Dr. Crujeiras and Dr. Busetto have disclosed no relevant financial relationships. PronoKal Group has recently become part of Nestlé Health Science.

A version of this article appeared on Medscape.com. It was translated from Medscape Spanish Edition.

According to the latest evidence, the ketogenic diet is emerging as an effective strategy not only to promote weight loss, but also to manage many comorbidities associated with obesity, including COVID-19. This development was revealed during the 8th International Scientific Symposium New Frontiers in Scientific Research, organized by PronoKal Group and held in Barcelona. During this conference, international multidisciplinary experts in the study and management of obesity presented the latest data on the benefits of treatment based on a very-low-calorie ketogenic diet.

“Nutritional ketosis has gained great interest in recent years because it is shown to have beneficial properties for health and promotes healthy aging, increasing longevity,” said Ana Belén Crujeiras, BSc, PhD, principal investigator of the Health Research Institute of Santiago de Compostela-Galician Health Service (IDIS-SERGAS) Group of Epigenomics in Endocrinology and Nutrition and the Biomedical Research Networking Center for Obesity and Nutrition Physiopathology (CIBEROBN). “Furthermore, in the case of obesity, we have more and more evidence that it is an effective treatment, mainly because to achieve this metabolic state (ketosis), routes that require the combustion of fats are activated, and this induces body weight loss.”

The specialist stressed that several strategies are used to induce nutritional ketosis. They are characterized by low carbohydrate consumption (low-carbohydrate and high-fat diet; low-carbohydrate, low-fat diet; and intermittent fasting). But Dr. Crujeiras warned that to use it as a treatment for a disease such as obesity, it must be backed by strong and solid scientific evidence, moving away from the concept of fad diets.

In this sense, since 2010, Dr. Crujeiras’ team has developed several studies focused on analyzing the efficacy and safety of treatment with a very-low-calorie ketogenic diet, the results of which have been published in high-impact journals.

Dr. Crujeiras commented on the main conclusions drawn from these investigations. “Our work has shown that the very-low-calorie ketogenic diet is effective for rapid weight loss and maintenance of lost weight, as well as reducing fat mass, primarily visceral fat mass.

“In this sense, a very interesting result is that despite the strong weight loss it induces, it preserves muscle mass and function and improves resting metabolic rate. These two variables are important, because all therapeutic strategies that exist to lose weight lead to a significant reduction in fat-free mass and also a reduction in energy expenditure at rest. This factor is associated with the risk of regaining lost weight, which is currently the great challenge in the treatment of obesity,” she added.
 

Specific methylation pattern

Dr. Crujeiras indicated that other notable evidence is the favorable impact on an emotional and psychological level. “To determine whether the caloric restriction of this diet and the strong weight loss that it involves were associated with an increased desire to eat, we also carried out an analysis with psychobiological tests. These results led us to conclude that this guideline is accompanied by a reduction of anxiety about food and an improvement in psychobiological parameters, thus increasing the quality of life of these patients.”

The specialist also mentioned that studies currently in progress show that the beneficial effect of this diet could be mediated by epigenetic mechanisms. “In our group, we have identified a specific DNA methylation pattern in people with obesity and we wondered if the very-low-calorie ketogenic diet would be able to reverse that methylome.

“We conducted a study in which we collected blood samples from patients on the very-low-calorie ketogenic diet (600 to 800 kcal/day) drawn before treatment, at peak ketosis, and at the end of treatment. After determining the global pattern of DNA in all patients with obesity targeted with this strategy and through bioinformatic analysis, we were able to obtain a methylation pattern. The results showed that after weight loss on the very-low-calorie ketogenic diet, the methylome that obese people initially had [was] reversed and matched that of normal-weight people.

“Continuing with this bioinformatic analysis more comprehensively, we wanted to see what kind of genes were differentially methylated, especially by the action of the ketosis itself. We found that most of the genes that exhibited differential methylation (in total, 292 identified) belonged to pathways that were involved in the regulation of metabolism, adipose tissue function, CNS function, and also carcinogenesis,” she continued.
 

Immunomodulatory effect

Dr. Crujeiras said that her research group also observed the modulatory role of the very-low-calorie ketogenic diet in the functioning of the immune system, “something that was not seen after similar weight loss induced by bariatric surgery. We analyzed this data in the context of the situation created by COVID-19, taking into account the evidence that people with obesity, compared to those with normal weight, have a higher risk of becoming infected and of having a poor evolution of the infection.”

In this regard, Dr. Crujeiras’ team launched an investigation to study the ACE2 gene methylation pattern, comparing obesity with normal weight and the situation after following a very-low-calorie ketogenic diet or undergoing bariatric surgery. “We observed that the methylation pattern of this gene in obese people was increased, compared to normal-weight people,” she explained, “and this increase was observed mainly in visceral adipose tissue. However, we did not see this in subcutaneous adipose tissue, which is in agreement with the hypothesis that visceral adipose tissue is that mostly associated with obesity-related comorbidities.

“Likewise, the very-low-calorie ketogenic diet was associated with decreased ACE2 methylation, along with increased exposure of this gene. However, after bariatric surgery, no significant changes were observed, so we deduce that we are protecting the patient in some way from inflammation and, therefore, from the potential of serious illness if they become infected.

“In light of these results, we wanted to dig deeper into what was happening with the immune system of obese patients and that inflammation after a very-low-calorie ketogenic diet. We conducted a new study, currently under review in the journal Clinical Nutrition, with the same approach, comparing this diet with a standard hypocaloric balanced diet and bariatric surgery, in which we analyzed a wide battery of cytokines (32). We have observed a differential pattern between the very-low-calorie ketogenic diet and bariatric surgery.

“The results confirm our hypothesis that the very-low-calorie ketogenic diet remodels the inflammatory status of obese patients, and we were also able to verify that the increase in ketone bodies has immunomodulatory properties that were previously demonstrated in preclinical and animal models, which is associated with increased immune function in these patients,” added Dr. Crujeiras.
 

Personalization and weight regain

In regard to the next steps to take in the knowledge and clinical application of the benefits of this dietary strategy, Dr. Crujeiras said that despite the fact that this diet is known to be effective, it is currently prescribed in a standard manner to all patients, “but there is some variability in the response and also a high risk of regaining weight, as is the case with any nutritional intervention strategy, with that ‘regain’ of lost weight being the main challenge in the treatment of obesity. In this sense, the epigenomic and epigenetic markers that we have identified could help us optimize treatment.”

She added that the future lies in establishing an algorithm that encompasses the patient’s exposome data, along with their genetic and epigenetic profile, to properly classify patients and prescribe a personalized precision therapeutic strategy.

Luca Busetto, MD, cochair of the Obesity Management Task Force (OMTF) of the European Association for the Study of Obesity (EASO), also insisted on the challenge posed by the individualized application of the very-low-calorie ketogenic diet, emphasizing that this diet should always be prescribed by a doctor after an appropriate assessment of the patient. “Obesity is not a matter of willpower or motivation, and most people with obesity have struggled their entire lives and failed because their biology tends to cause weight regain. Therefore, we should try to offer them the options that we currently have, including the very-low-calorie ketogenic diet, adapting them as much as possible to the profile of each patient.”

During his speech, Dr. Busetto presented the recent European guidelines for the management of obesity in adults with a very-low-calorie ketogenic diet, endorsed by EASO, and analyzed the main strengths of these recommendations.

Dr. Busetto remarked that three important points clearly justify the use of the very-low-calorie ketogenic diet. The first is the speed with which the initial weight loss occurs. Recent studies have looked at the benefits of a significant loss of excess weight early in a weight-loss diet, and although this is an association rather than a cause, the results strongly suggest that rapid initial weight loss increases the chance of the result being maintained in the long term. This clashes with the traditional recommendation of losing weight little by little as a strategy to achieve long-term results, but it must be taken into account that there are many myths in the treatment of obesity that current evidence is dismantling with new data – and this is one of them.

Secondly, the effect of the very-low-calorie ketogenic diet can be added to other treatments. This has been demonstrated by studies carried out with liraglutide that showed that this dietary strategy optimizes results, compared with patients who had been treated only with this drug. The third point that justifies the use of the very-low-calorie ketogenic diet is the management of obesity comorbidities. Several investigations demonstrate the effectiveness of this diet in this regard, especially in the case of type 2 diabetes. Data suggest that the substantial weight reductions achieved with it also favor the remission of these comorbidities in many patients.
 

EASO ‘approval’

Dr. Busetto pointed out that, based on this evidence, the OMTF proposed the development of standards to be included in the EASO guidelines, since there had been no specific recommendation on the very-low-calorie ketogenic diet.

“The main objective of these European guidelines was to provide data referenced by scientific evidence and to suggest a common protocol for the use of this dietary strategy,” he added.

For this, a very exhaustive meta-analysis was carried out, researching all the publications that compared the very-low-calorie ketogenic diet with other diets. The results showed the superiority of the former method for the reduction of body mass index and weight and fat mass, with no difference in lean (muscle) mass, despite significant weight loss in these patients.

This evidence also demonstrates a reduction and an improvement in metabolic markers, specifically glucose metabolism and lipid metabolism.

“The final conclusions of the study corroborate that the very-low-calorie ketogenic diet can be recommended as an effective and safe tool for people with obesity, especially those with severe obesity or comorbidities (joint disease, preoperative period to bariatric surgery, metabolic and cardiovascular diseases) who need immediate, substantial weight loss. In addition, it can be prescribed to specific groups of patients with obesity after considering potential contraindications and under medical follow-up,” said Dr. Busetto.

In Dr. Busetto’s opinion, it would be convenient to refer to this approach as a method, instead of as a diet, “because, in reality, the state of ketosis is limited in time, and if the ketogenic phase is stopped without a continuity plan, obviously weight is regained. In addition, the method approach may increase adherence by patients.”

Finally, Dr. Busetto emphasized the importance of integrating this type of treatment into a long-term lifestyle strategy (including habits, exercise, and nutritional advice). “We must start from the basis that obesity is a chronic and relapsing disease, whose management should also be chronic and probably maintained throughout life.”

Dr. Crujeiras and Dr. Busetto have disclosed no relevant financial relationships. PronoKal Group has recently become part of Nestlé Health Science.

A version of this article appeared on Medscape.com. It was translated from Medscape Spanish Edition.

According to the latest evidence, the ketogenic diet is emerging as an effective strategy not only to promote weight loss, but also to manage many comorbidities associated with obesity, including COVID-19. This development was revealed during the 8th International Scientific Symposium New Frontiers in Scientific Research, organized by PronoKal Group and held in Barcelona. During this conference, international multidisciplinary experts in the study and management of obesity presented the latest data on the benefits of treatment based on a very-low-calorie ketogenic diet.

“Nutritional ketosis has gained great interest in recent years because it is shown to have beneficial properties for health and promotes healthy aging, increasing longevity,” said Ana Belén Crujeiras, BSc, PhD, principal investigator of the Health Research Institute of Santiago de Compostela-Galician Health Service (IDIS-SERGAS) Group of Epigenomics in Endocrinology and Nutrition and the Biomedical Research Networking Center for Obesity and Nutrition Physiopathology (CIBEROBN). “Furthermore, in the case of obesity, we have more and more evidence that it is an effective treatment, mainly because to achieve this metabolic state (ketosis), routes that require the combustion of fats are activated, and this induces body weight loss.”

The specialist stressed that several strategies are used to induce nutritional ketosis. They are characterized by low carbohydrate consumption (low-carbohydrate and high-fat diet; low-carbohydrate, low-fat diet; and intermittent fasting). But Dr. Crujeiras warned that to use it as a treatment for a disease such as obesity, it must be backed by strong and solid scientific evidence, moving away from the concept of fad diets.

In this sense, since 2010, Dr. Crujeiras’ team has developed several studies focused on analyzing the efficacy and safety of treatment with a very-low-calorie ketogenic diet, the results of which have been published in high-impact journals.

Dr. Crujeiras commented on the main conclusions drawn from these investigations. “Our work has shown that the very-low-calorie ketogenic diet is effective for rapid weight loss and maintenance of lost weight, as well as reducing fat mass, primarily visceral fat mass.

“In this sense, a very interesting result is that despite the strong weight loss it induces, it preserves muscle mass and function and improves resting metabolic rate. These two variables are important, because all therapeutic strategies that exist to lose weight lead to a significant reduction in fat-free mass and also a reduction in energy expenditure at rest. This factor is associated with the risk of regaining lost weight, which is currently the great challenge in the treatment of obesity,” she added.
 

Specific methylation pattern

Dr. Crujeiras indicated that other notable evidence is the favorable impact on an emotional and psychological level. “To determine whether the caloric restriction of this diet and the strong weight loss that it involves were associated with an increased desire to eat, we also carried out an analysis with psychobiological tests. These results led us to conclude that this guideline is accompanied by a reduction of anxiety about food and an improvement in psychobiological parameters, thus increasing the quality of life of these patients.”

The specialist also mentioned that studies currently in progress show that the beneficial effect of this diet could be mediated by epigenetic mechanisms. “In our group, we have identified a specific DNA methylation pattern in people with obesity and we wondered if the very-low-calorie ketogenic diet would be able to reverse that methylome.

“We conducted a study in which we collected blood samples from patients on the very-low-calorie ketogenic diet (600 to 800 kcal/day) drawn before treatment, at peak ketosis, and at the end of treatment. After determining the global pattern of DNA in all patients with obesity targeted with this strategy and through bioinformatic analysis, we were able to obtain a methylation pattern. The results showed that after weight loss on the very-low-calorie ketogenic diet, the methylome that obese people initially had [was] reversed and matched that of normal-weight people.

“Continuing with this bioinformatic analysis more comprehensively, we wanted to see what kind of genes were differentially methylated, especially by the action of the ketosis itself. We found that most of the genes that exhibited differential methylation (in total, 292 identified) belonged to pathways that were involved in the regulation of metabolism, adipose tissue function, CNS function, and also carcinogenesis,” she continued.
 

Immunomodulatory effect

Dr. Crujeiras said that her research group also observed the modulatory role of the very-low-calorie ketogenic diet in the functioning of the immune system, “something that was not seen after similar weight loss induced by bariatric surgery. We analyzed this data in the context of the situation created by COVID-19, taking into account the evidence that people with obesity, compared to those with normal weight, have a higher risk of becoming infected and of having a poor evolution of the infection.”

In this regard, Dr. Crujeiras’ team launched an investigation to study the ACE2 gene methylation pattern, comparing obesity with normal weight and the situation after following a very-low-calorie ketogenic diet or undergoing bariatric surgery. “We observed that the methylation pattern of this gene in obese people was increased, compared to normal-weight people,” she explained, “and this increase was observed mainly in visceral adipose tissue. However, we did not see this in subcutaneous adipose tissue, which is in agreement with the hypothesis that visceral adipose tissue is that mostly associated with obesity-related comorbidities.

“Likewise, the very-low-calorie ketogenic diet was associated with decreased ACE2 methylation, along with increased exposure of this gene. However, after bariatric surgery, no significant changes were observed, so we deduce that we are protecting the patient in some way from inflammation and, therefore, from the potential of serious illness if they become infected.

“In light of these results, we wanted to dig deeper into what was happening with the immune system of obese patients and that inflammation after a very-low-calorie ketogenic diet. We conducted a new study, currently under review in the journal Clinical Nutrition, with the same approach, comparing this diet with a standard hypocaloric balanced diet and bariatric surgery, in which we analyzed a wide battery of cytokines (32). We have observed a differential pattern between the very-low-calorie ketogenic diet and bariatric surgery.

“The results confirm our hypothesis that the very-low-calorie ketogenic diet remodels the inflammatory status of obese patients, and we were also able to verify that the increase in ketone bodies has immunomodulatory properties that were previously demonstrated in preclinical and animal models, which is associated with increased immune function in these patients,” added Dr. Crujeiras.
 

Personalization and weight regain

In regard to the next steps to take in the knowledge and clinical application of the benefits of this dietary strategy, Dr. Crujeiras said that despite the fact that this diet is known to be effective, it is currently prescribed in a standard manner to all patients, “but there is some variability in the response and also a high risk of regaining weight, as is the case with any nutritional intervention strategy, with that ‘regain’ of lost weight being the main challenge in the treatment of obesity. In this sense, the epigenomic and epigenetic markers that we have identified could help us optimize treatment.”

She added that the future lies in establishing an algorithm that encompasses the patient’s exposome data, along with their genetic and epigenetic profile, to properly classify patients and prescribe a personalized precision therapeutic strategy.

Luca Busetto, MD, cochair of the Obesity Management Task Force (OMTF) of the European Association for the Study of Obesity (EASO), also insisted on the challenge posed by the individualized application of the very-low-calorie ketogenic diet, emphasizing that this diet should always be prescribed by a doctor after an appropriate assessment of the patient. “Obesity is not a matter of willpower or motivation, and most people with obesity have struggled their entire lives and failed because their biology tends to cause weight regain. Therefore, we should try to offer them the options that we currently have, including the very-low-calorie ketogenic diet, adapting them as much as possible to the profile of each patient.”

During his speech, Dr. Busetto presented the recent European guidelines for the management of obesity in adults with a very-low-calorie ketogenic diet, endorsed by EASO, and analyzed the main strengths of these recommendations.

Dr. Busetto remarked that three important points clearly justify the use of the very-low-calorie ketogenic diet. The first is the speed with which the initial weight loss occurs. Recent studies have looked at the benefits of a significant loss of excess weight early in a weight-loss diet, and although this is an association rather than a cause, the results strongly suggest that rapid initial weight loss increases the chance of the result being maintained in the long term. This clashes with the traditional recommendation of losing weight little by little as a strategy to achieve long-term results, but it must be taken into account that there are many myths in the treatment of obesity that current evidence is dismantling with new data – and this is one of them.

Secondly, the effect of the very-low-calorie ketogenic diet can be added to other treatments. This has been demonstrated by studies carried out with liraglutide that showed that this dietary strategy optimizes results, compared with patients who had been treated only with this drug. The third point that justifies the use of the very-low-calorie ketogenic diet is the management of obesity comorbidities. Several investigations demonstrate the effectiveness of this diet in this regard, especially in the case of type 2 diabetes. Data suggest that the substantial weight reductions achieved with it also favor the remission of these comorbidities in many patients.
 

EASO ‘approval’

Dr. Busetto pointed out that, based on this evidence, the OMTF proposed the development of standards to be included in the EASO guidelines, since there had been no specific recommendation on the very-low-calorie ketogenic diet.

“The main objective of these European guidelines was to provide data referenced by scientific evidence and to suggest a common protocol for the use of this dietary strategy,” he added.

For this, a very exhaustive meta-analysis was carried out, researching all the publications that compared the very-low-calorie ketogenic diet with other diets. The results showed the superiority of the former method for the reduction of body mass index and weight and fat mass, with no difference in lean (muscle) mass, despite significant weight loss in these patients.

This evidence also demonstrates a reduction and an improvement in metabolic markers, specifically glucose metabolism and lipid metabolism.

“The final conclusions of the study corroborate that the very-low-calorie ketogenic diet can be recommended as an effective and safe tool for people with obesity, especially those with severe obesity or comorbidities (joint disease, preoperative period to bariatric surgery, metabolic and cardiovascular diseases) who need immediate, substantial weight loss. In addition, it can be prescribed to specific groups of patients with obesity after considering potential contraindications and under medical follow-up,” said Dr. Busetto.

In Dr. Busetto’s opinion, it would be convenient to refer to this approach as a method, instead of as a diet, “because, in reality, the state of ketosis is limited in time, and if the ketogenic phase is stopped without a continuity plan, obviously weight is regained. In addition, the method approach may increase adherence by patients.”

Finally, Dr. Busetto emphasized the importance of integrating this type of treatment into a long-term lifestyle strategy (including habits, exercise, and nutritional advice). “We must start from the basis that obesity is a chronic and relapsing disease, whose management should also be chronic and probably maintained throughout life.”

Dr. Crujeiras and Dr. Busetto have disclosed no relevant financial relationships. PronoKal Group has recently become part of Nestlé Health Science.

A version of this article appeared on Medscape.com. It was translated from Medscape Spanish Edition.

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

The “twincretin” era for treating patients with type 2 diabetes has begun, with the Food and Drug Administration’s approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins.

Tirzepatide represents “an important advance in the treatment of type 2 diabetes,” the FDA’s Patrick Archdeacon, MD, associate director of the division of diabetes, lipid disorders, and obesity, said in a statement released by the agency.

That advance is based on tirzepatide’s engineering, which gives it agonist properties for both the glucagonlike peptide–1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP). Several agents are already approved for U.S. use from the class with single-agonist activity on the GLP-1 receptor, including semaglutide (Ozempic for treating patients with type 2 diabetes; Wegovy for weight loss).

The FDA’s approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5-mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.

Tirzepatide, which will be marketed by Lilly as Mounjaro, will hit the U.S. market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug’s unprecedented efficacy for reducing hemoglobin A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.
 

‘Impressive’ effects

The effects from tirzepatide on A1c and weight seen in these studies was “impressive, and will likely drive use of this agent,” commented Carol H. Wysham, MD, an endocrinologist at the MultiCare Rockwood Clinic in Spokane, Wash.

Tirzepatide received good notices in several editorials that accompanied the published reports of the pivotal trials. The first of these, a commentary from two U.K.-based endocrinologists, said that “tirzepatide appears to represent an advancement over current GLP-1 analogues, providing enhanced glycemic and weight benefits without an added penalty in terms of gastrointestinal adverse effects.”

The pivotal trials included head-to-head comparisons between tirzepatide and a 1.0-mg/week dose of semaglutide, as well as comparisons with each of two long-acting insulin analogs, insulin glargine (Lantus) and insulin degludec (Tresiba).

“These are the most important comparators,” Dr. Wysham said.

“Tirzepatide was appropriately compared with the best-in-class and most effective glucose-lowering agents currently available,” said Ildiko Lingvay, MD, an endocrinologist and professor at the University of Texas Southwestern Medical Center in Dallas.

“Given its outstanding efficacy at both lowering glucose and weight, I expect tirzepatide to have quick uptake among patients with diabetes,” Dr. Lingvay said. “The only limiting factor will be cost,” she added in an interview, highlighting the major stumbling block that could limit tirzepatide’s uptake.

“As with any new medication, access will be the biggest barrier to uptake,” agreed Alice Y.Y. Cheng, MD, an endocrinologist at the University of Toronto.
 

Lingering uncertainties

The timing of the comparison with semaglutide leaves some unanswered questions. The SURPASS-2 trial compared the three primary tirzepatide regimens (5 mg, 10 mg, and 15 mg/week) with a 1.0-mg/week dose of semaglutide, which was at the time the only approved dosage of semaglutide for patients with type 2 diabetes. Since then, a 2.0-mg/week dosage of semaglutide (Ozempic) received U.S. approval for treating patients with type 2 diabetes, and a 2.4-mg/week dosage (Wegovy) received an FDA nod for treating people with obesity.

The lack of head-to-head data for tirzepatide against the 2.0-mg/week dose of semaglutide “leaves a clinical gap,” said Dr. Cheng. Tirzepatide “represents an advance over semaglutide at the 1-mg/week dose, but we do not know for sure compared to the higher dose.”

Another important limitation for tirzepatide right now is that the agent’s obligatory cardiovascular outcome trial, SURPASS CVOT, with about 12,500 enrolled patients, will not have findings out until about 2025, leaving uncertainty until then about tirzepatide’s cardiovascular effects.

“We are missing the cardiovascular outcome data – very important data will come” from that trial, noted Dr. Wysham. “There will be some reluctance to use the agent in high-risk patients until we see the results.”

Given tirzepatide’s proven efficacy so far, the missing cardiovascular results “are not a limitation for most patients, but for patients with preexisting cardiovascular disease I will continue to use agents with proven benefits until the SURPASS CVOT results come out,” Dr. Lingvay said.

And then there is the cost issue, something that Lilly had not yet publicly addressed at the time that the FDA announced its decision.

An analysis of cost effectiveness published by the U.S. Institute for Clinical and Economic Review in February 2022 concluded that tirzepatide had a better impact on patient quality of life, compared with 1.0 mg/week semaglutide for treating patients with type 2 diabetes, which gave it a modest pricing cushion, compared with semaglutide of about $5,500 per quality-adjusted life-year gained. But the researchers who prepared the report admitted that tirzepatide’s cost-effectiveness was hard to estimate without knowing the drug’s actual price.  

Dr. Wysham has financial ties to AstraZeneca, Abbott, Boehringer Ingelheim, Intercept, Janssen, Mylan, Novo Nordisk, and Sanofi. Dr. Lingvay has dies to Lilly, Novo Nordisk, Sanofi, Boehringer Ingelheim, Merck, Pfizer, and Mylan, Intarcia, MannKind, Valeritas, and several other drug and device makers.

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

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

People with nonalcoholic fatty liver disease (NAFLD) and a lean or healthy body mass index are at increased risk for peripheral vascular disease, stroke, and cardiovascular disease, a surprise finding from a new study reveals.

“Our team had expected to see that those with a normal BMI would have a lower prevalence of any metabolic or cardiovascular conditions,” lead researcher Karn Wijarnpreecha, MD, MPH, said during a media briefing that previewed select research for Digestive Disease Week^® (DDW) 2022. “So, we were very surprised to find this link to cardiovascular disease.”

The investigators saw this increased risk of cardiovascular disease despite this group having a lower prevalence of atherosclerotic risk factors and metabolic disease.

This first study of its kind suggests physicians should consider the risk of cardiovascular disease in all patients with NAFLD, not just in those who are overweight or living with obesity – groups traditionally thought to carry more risk.

NAFLD in lean individuals is not a benign disease.

“NAFLD patients with a normal BMI are often overlooked because we assume that the risk for more serious conditions is lower than for those who are overweight or obese. But this way of thinking may be putting these patients at risk,” added Dr. Wijarnpreecha, who is a transplant hepatology fellow at the University of Michigan, Ann Arbor.

Key findings

Approximately 25% of U.S. adults live with NAFLD, an umbrella term for liver conditions in people who drink little to no alcohol. It is characterized by too much fat stored in the liver. Although most people have no symptoms, the condition can lead to other dangerous conditions, such as diabetes, cardiovascular disease, and cirrhosis of the liver, Dr. Wijarnpreecha said.

The investigators retrospectively studied a cohort of 18,793 adults diagnosed with NAFLD at the University of Michigan Hospital from 2012-2021. One aim was to compare the prevalence of cirrhosis, cardiovascular disease, metabolic diseases, and chronic kidney disease in relation to BMI.

They also classified people into four BMI categories: lean, overweight, obesity class 1, and obesity class 2-3.

Compared with non-lean patients, lean patients had a higher prevalence of peripheral arterial disease and stroke and a similar rate of cardiovascular disease based on identification of ICD codes.

Almost 6% of lean patients had peripheral arterial disease, compared with rates of approximately 4%-5% in overweight people and people with obesity. Similarly, more than 6% of the lean group experienced a stroke compared with 5% or less of the other BMI groups.

“We found that lean patients with NAFLD also had a significant higher prevalence of cardiovascular disease, independent of age, sex, race, smoking status, diabetes, hypertension, and dyslipidemia,” Dr. Wijarnpreecha said.

At the same time, compared with non-lean patients, lean patients had a lower prevalence of cirrhosis, diabetes mellitus, hypertension, dyslipidemia, and chronic kidney disease in an analysis that adjusted for confounders.
 

Exploring the unknown

Researchers now have a mystery on their hands: What is causing this unexpected higher risk of cardiovascular disease in lean people with NAFLD?

Loren Laine, MD, chief of the section of digestive diseases at Yale University School of Medicine, New Haven, Conn., and moderator of the media briefing, asked Wijarnpreecha for his leading theory behind this connection.

“We think that could be from a difference in lifestyle, diet, exercise, genetics, or even gut microbiota,” Dr. Wijarnpreecha replied. “But these are factors that we did not capture from this current study.”

“We are preparing to conduct additional research with longitudinal data to better understand NAFLD in lean patients,” Dr. Wijarnpreecha added.

“It’s an interesting finding, but there are some questions from this retrospective study,” said Arun J. Sanyal, MD, when asked to comment on the study.

Identifying and quantifying any alcohol use, smoking, or hypertension that could also have contributed to increased cardiovascular risk would be useful. Another question relates to how the population with NAFLD was identified. Was NAFLD an incidental finding in their diagnosis, asked Dr. Sanyal, director of the Stravitz-Sanyal Institute for Liver Disease & Metabolic Health at Virginia Commonwealth University, Richmond.

“I’m not dissing the study,” he said, “But like all the observations like this, I think we have to kick the tires.”

It’s an “important new observation” that requires further study to fully understand what it means and what the therapeutic implications might be. It is also important to assess any possible confounders and any causal relationship among these factors, Dr. Sanyal added.

“There’s no question it is important to continue to do these types of studies,” he added. “Through this kind of research we find new things that lead to the science that can then significantly change how we approach these issues.”

A version of this article first appeared on Medscape.com. This article was updated on May 18, 2022.

New clinical practice guidelines for the diagnosis and management of nonalcoholic fatty liver disease (NAFLD) are the first to be targeted specifically to primary care and endocrinology clinical settings.

They include 34 evidence-based clinical practice recommendations for screening, diagnosis, management, and referral, presented in a table and an algorithm flow chart as well as detailed text.

The new guidelines are by the American Association of Clinical Endocrinology and cosponsored by the American Association for the Study of Liver Diseases. They were presented at the annual scientific & clinical congress of the AACE and simultaneously published in Endocrine Practice.

These are “the first of this type for this field of medicine. The vast majority of patients with NAFLD are being seen in the primary care and endocrinology settings. Only when they get to the more advanced disease are they being referred to the liver specialists. So, we need to be the ones who are diagnosing and managing these patients because there just aren’t enough liver specialists to do that,” Scott Isaacs, MD, cochair of the writing panel for the guidelines, said in an interview.

80 million Americans have NAFLD, but very few are aware

The spectrum of NAFLD ranges from nonprogressive steatosis to the progressive conditions nonalcoholic steatohepatitis, fibrotic NASH, and end-stage NASH cirrhosis. And NASH, in turn, is a major cause of liver cancer. NAFLD is also strongly associated with insulin resistance, type 2 diabetes, atherogenesis, and myocardial dysfunction.

The global prevalence of NAFLD is about 25% and NASH, about 12%-14%. However, a recent study found that, among patients in endocrine and primary care clinics, more than 70% of patients with type 2 diabetes and more than 90% with type 2 diabetes who had a body mass index above 35 kg/m2 also had NAFLD, and more than 20% of those patients had significant liver fibrosis.

Problematically, very few people are aware they have either. “It’s so common. At least 80 million Americans have this but only about 6% know they have it. We talk about it a lot, but it’s not talked about enough,” said Dr. Isaacs, an endocrinologist who practices in Atlanta.

In fact, most cases of NAFLD are diagnosed incidentally when people undergo an ultrasound or a CT scan for another reason. And, in about 70% of cases the liver enzymes are normal, and those patients rarely undergo liver workups, Dr. Isaacs noted.

In an accompanying editorial, Suthat Liangpunsakul, MD, wrote: “In my perspective, as a hepatologist, this AACE guideline is very practical and easy to incorporate into routine practice in primary care and endocrinology settings. ... Early identification and risk stratification of patients with NAFLD, especially the degree of hepatic fibrosis, are required to reduce downstream health care costs and triage unwarranted specialty care referrals.”

And “an effective screening strategy may also identify those in primary care and endocrinology settings who may benefit from an appropriate referral to hepatologists before the development of portal hypertension complications, decompensated liver disease, and hepatocellular carcinoma,” added Dr. Liangpunsakul, professor of medicine in the division of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Screening advised using new FIB-4 test

The guideline calls for screening all patients at high risk for NAFLD, including those with prediabetes, type 2 diabetes, obesity, and/or two or more cardiometabolic risk factors, or those with hepatic steatosis found on imaging, and/or persistently elevated plasma aminotransferase levels (that is, for more than 6 months).

The recommended screening test is the Fibrosis-4 (FIB-4) index, calculated using the patient’s age, AST level, platelet count, and ALT level: FIB-4 score = age (years) x AST (U/L)/PLT (10⁹/L) x ALT ½ (U/L).

Recently approved by the Food and Drug Administration, the FIB-4 has been demonstrated to help identify liver disease in primary care settings.

“We really want to encourage clinicians to do the screening. The first step is the FIB-4 test. It’s a mathematical calculation using blood tests that we do anyway,” Dr. Isaacs said in an interview.

The FIB-4 stratifies patients as being low, intermediate, or high risk for liver fibrosis. Those at low risk can be managed in primary care or endocrinology settings with a focus on obesity management and cardiovascular disease prevention. “Those at low risk on FIB-4 still have a high cardiovascular disease risk. They still need to be managed,” Dr. Isaacs observed.

For those at intermediate risk, a second noninvasive test – either a liver stiffness measurement by elastography or an enhanced liver fibrosis test – is advised. If the patient is found to be at high risk or is still indeterminant after two noninvasive tests, referral to a liver specialist for further testing, including possible biopsy, is advised.

Those found to be at high risk with the FIB-4 should also be referred to hepatology. In both the intermediate- and high-risk groups, management should be multidisciplinary, including a hepatologist, endocrinologist, and other professionals to prevent both cardiovascular disease and progression to cirrhosis, the guidelines say.

“The diagnosis isn’t about diagnosing liver fat. It’s about diagnosing fibrosis, or the risk for clinically significant fibrosis. That’s really where the challenge lies,” Dr. Isaacs commented.
 

NAFLD treatment in endocrinology and primary care: CVD prevention

During the presentation at the AACE meeting, guideline panel cochair Kenneth Cusi, MD, chief of endocrinology, diabetes, and metabolism at the University of Florida, Gainesville, summarized current and future treatments for NAFLD.

Lifestyle intervention, cardiovascular risk reduction, and weight loss for those who are overweight or obese are recommended for all patients with NAFLD, including structured weight-loss programs, antiobesity medications, and bariatric surgery if indicated.

There are currently no FDA-approved medications specifically for NASH, but pioglitazone, approved for type 2 diabetes, and glucagonlike peptide–1 agonists, approved for type 2 diabetes and weight loss, have been shown to be effective in treating the condition and preventing progression. Other treatments are in development, Dr. Cusi said.  

The guideline also includes a section on diagnosis and management of NAFLD in children and adolescents. Here, the FIB-4 is not recommended because it isn’t accurate due to the age part of the equation, so liver enzyme tests are used in pediatric patients considered at high risk because of clinical factors. Management is similar to adults, except not all medications used in adults are approved for use in children.

In the editorial, Dr. Liangpunsakul cautioned that “the level of uptake and usage of the guideline may be an obstacle.”

To remedy that, he advised that “the next effort should gear toward distributing this guideline to the targeted providers and developing the ‘feedback platforms’ on its execution in the real-world. ... The successful implementation of this AACE guideline by the primary care providers and endocrinologists, hopefully, will deescalate the future burden of NAFLD-related morbidity and mortality.”

Dr. Isaacs and Dr. Liangpunsakul have reported no relevant financial relationships. Dr. Cusi has reported receiving research support towards the University of Florida as principal investigator from the National Institute of Health, Echosens, Inventiva, Nordic Bioscience, Novo Nordisk, Poxel, Labcorp, and Zydus, and is a consultant for Altimmune, Akero, Arrowhead, AstraZeneca, 89Bio, Bristol-Myers Squibb, Coherus, Intercept, Lilly, Madrigal, Merck, Novo Nordisk, Quest, Sagimet, Sonic Incytes, Terns, and Thera Technologies.

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

New clinical practice guidelines for the diagnosis and management of nonalcoholic fatty liver disease (NAFLD) are the first to be targeted specifically to primary care and endocrinology clinical settings.

They include 34 evidence-based clinical practice recommendations for screening, diagnosis, management, and referral, presented in a table and an algorithm flow chart as well as detailed text.

The new guidelines are by the American Association of Clinical Endocrinology and cosponsored by the American Association for the Study of Liver Diseases. They were presented at the annual scientific & clinical congress of the AACE and simultaneously published in Endocrine Practice.

These are “the first of this type for this field of medicine. The vast majority of patients with NAFLD are being seen in the primary care and endocrinology settings. Only when they get to the more advanced disease are they being referred to the liver specialists. So, we need to be the ones who are diagnosing and managing these patients because there just aren’t enough liver specialists to do that,” Scott Isaacs, MD, cochair of the writing panel for the guidelines, said in an interview.

80 million Americans have NAFLD, but very few are aware

The spectrum of NAFLD ranges from nonprogressive steatosis to the progressive conditions nonalcoholic steatohepatitis, fibrotic NASH, and end-stage NASH cirrhosis. And NASH, in turn, is a major cause of liver cancer. NAFLD is also strongly associated with insulin resistance, type 2 diabetes, atherogenesis, and myocardial dysfunction.

The global prevalence of NAFLD is about 25% and NASH, about 12%-14%. However, a recent study found that, among patients in endocrine and primary care clinics, more than 70% of patients with type 2 diabetes and more than 90% with type 2 diabetes who had a body mass index above 35 kg/m2 also had NAFLD, and more than 20% of those patients had significant liver fibrosis.

Problematically, very few people are aware they have either. “It’s so common. At least 80 million Americans have this but only about 6% know they have it. We talk about it a lot, but it’s not talked about enough,” said Dr. Isaacs, an endocrinologist who practices in Atlanta.

In fact, most cases of NAFLD are diagnosed incidentally when people undergo an ultrasound or a CT scan for another reason. And, in about 70% of cases the liver enzymes are normal, and those patients rarely undergo liver workups, Dr. Isaacs noted.

In an accompanying editorial, Suthat Liangpunsakul, MD, wrote: “In my perspective, as a hepatologist, this AACE guideline is very practical and easy to incorporate into routine practice in primary care and endocrinology settings. ... Early identification and risk stratification of patients with NAFLD, especially the degree of hepatic fibrosis, are required to reduce downstream health care costs and triage unwarranted specialty care referrals.”

And “an effective screening strategy may also identify those in primary care and endocrinology settings who may benefit from an appropriate referral to hepatologists before the development of portal hypertension complications, decompensated liver disease, and hepatocellular carcinoma,” added Dr. Liangpunsakul, professor of medicine in the division of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Screening advised using new FIB-4 test

The guideline calls for screening all patients at high risk for NAFLD, including those with prediabetes, type 2 diabetes, obesity, and/or two or more cardiometabolic risk factors, or those with hepatic steatosis found on imaging, and/or persistently elevated plasma aminotransferase levels (that is, for more than 6 months).

The recommended screening test is the Fibrosis-4 (FIB-4) index, calculated using the patient’s age, AST level, platelet count, and ALT level: FIB-4 score = age (years) x AST (U/L)/PLT (10⁹/L) x ALT ½ (U/L).

Recently approved by the Food and Drug Administration, the FIB-4 has been demonstrated to help identify liver disease in primary care settings.

“We really want to encourage clinicians to do the screening. The first step is the FIB-4 test. It’s a mathematical calculation using blood tests that we do anyway,” Dr. Isaacs said in an interview.

The FIB-4 stratifies patients as being low, intermediate, or high risk for liver fibrosis. Those at low risk can be managed in primary care or endocrinology settings with a focus on obesity management and cardiovascular disease prevention. “Those at low risk on FIB-4 still have a high cardiovascular disease risk. They still need to be managed,” Dr. Isaacs observed.

For those at intermediate risk, a second noninvasive test – either a liver stiffness measurement by elastography or an enhanced liver fibrosis test – is advised. If the patient is found to be at high risk or is still indeterminant after two noninvasive tests, referral to a liver specialist for further testing, including possible biopsy, is advised.

Those found to be at high risk with the FIB-4 should also be referred to hepatology. In both the intermediate- and high-risk groups, management should be multidisciplinary, including a hepatologist, endocrinologist, and other professionals to prevent both cardiovascular disease and progression to cirrhosis, the guidelines say.

“The diagnosis isn’t about diagnosing liver fat. It’s about diagnosing fibrosis, or the risk for clinically significant fibrosis. That’s really where the challenge lies,” Dr. Isaacs commented.
 

NAFLD treatment in endocrinology and primary care: CVD prevention

During the presentation at the AACE meeting, guideline panel cochair Kenneth Cusi, MD, chief of endocrinology, diabetes, and metabolism at the University of Florida, Gainesville, summarized current and future treatments for NAFLD.

Lifestyle intervention, cardiovascular risk reduction, and weight loss for those who are overweight or obese are recommended for all patients with NAFLD, including structured weight-loss programs, antiobesity medications, and bariatric surgery if indicated.

There are currently no FDA-approved medications specifically for NASH, but pioglitazone, approved for type 2 diabetes, and glucagonlike peptide–1 agonists, approved for type 2 diabetes and weight loss, have been shown to be effective in treating the condition and preventing progression. Other treatments are in development, Dr. Cusi said.  

The guideline also includes a section on diagnosis and management of NAFLD in children and adolescents. Here, the FIB-4 is not recommended because it isn’t accurate due to the age part of the equation, so liver enzyme tests are used in pediatric patients considered at high risk because of clinical factors. Management is similar to adults, except not all medications used in adults are approved for use in children.

In the editorial, Dr. Liangpunsakul cautioned that “the level of uptake and usage of the guideline may be an obstacle.”

To remedy that, he advised that “the next effort should gear toward distributing this guideline to the targeted providers and developing the ‘feedback platforms’ on its execution in the real-world. ... The successful implementation of this AACE guideline by the primary care providers and endocrinologists, hopefully, will deescalate the future burden of NAFLD-related morbidity and mortality.”

Dr. Isaacs and Dr. Liangpunsakul have reported no relevant financial relationships. Dr. Cusi has reported receiving research support towards the University of Florida as principal investigator from the National Institute of Health, Echosens, Inventiva, Nordic Bioscience, Novo Nordisk, Poxel, Labcorp, and Zydus, and is a consultant for Altimmune, Akero, Arrowhead, AstraZeneca, 89Bio, Bristol-Myers Squibb, Coherus, Intercept, Lilly, Madrigal, Merck, Novo Nordisk, Quest, Sagimet, Sonic Incytes, Terns, and Thera Technologies.

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

New clinical practice guidelines for the diagnosis and management of nonalcoholic fatty liver disease (NAFLD) are the first to be targeted specifically to primary care and endocrinology clinical settings.

They include 34 evidence-based clinical practice recommendations for screening, diagnosis, management, and referral, presented in a table and an algorithm flow chart as well as detailed text.

The new guidelines are by the American Association of Clinical Endocrinology and cosponsored by the American Association for the Study of Liver Diseases. They were presented at the annual scientific & clinical congress of the AACE and simultaneously published in Endocrine Practice.

These are “the first of this type for this field of medicine. The vast majority of patients with NAFLD are being seen in the primary care and endocrinology settings. Only when they get to the more advanced disease are they being referred to the liver specialists. So, we need to be the ones who are diagnosing and managing these patients because there just aren’t enough liver specialists to do that,” Scott Isaacs, MD, cochair of the writing panel for the guidelines, said in an interview.

80 million Americans have NAFLD, but very few are aware

The spectrum of NAFLD ranges from nonprogressive steatosis to the progressive conditions nonalcoholic steatohepatitis, fibrotic NASH, and end-stage NASH cirrhosis. And NASH, in turn, is a major cause of liver cancer. NAFLD is also strongly associated with insulin resistance, type 2 diabetes, atherogenesis, and myocardial dysfunction.

The global prevalence of NAFLD is about 25% and NASH, about 12%-14%. However, a recent study found that, among patients in endocrine and primary care clinics, more than 70% of patients with type 2 diabetes and more than 90% with type 2 diabetes who had a body mass index above 35 kg/m2 also had NAFLD, and more than 20% of those patients had significant liver fibrosis.

Problematically, very few people are aware they have either. “It’s so common. At least 80 million Americans have this but only about 6% know they have it. We talk about it a lot, but it’s not talked about enough,” said Dr. Isaacs, an endocrinologist who practices in Atlanta.

In fact, most cases of NAFLD are diagnosed incidentally when people undergo an ultrasound or a CT scan for another reason. And, in about 70% of cases the liver enzymes are normal, and those patients rarely undergo liver workups, Dr. Isaacs noted.

In an accompanying editorial, Suthat Liangpunsakul, MD, wrote: “In my perspective, as a hepatologist, this AACE guideline is very practical and easy to incorporate into routine practice in primary care and endocrinology settings. ... Early identification and risk stratification of patients with NAFLD, especially the degree of hepatic fibrosis, are required to reduce downstream health care costs and triage unwarranted specialty care referrals.”

And “an effective screening strategy may also identify those in primary care and endocrinology settings who may benefit from an appropriate referral to hepatologists before the development of portal hypertension complications, decompensated liver disease, and hepatocellular carcinoma,” added Dr. Liangpunsakul, professor of medicine in the division of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Screening advised using new FIB-4 test

The guideline calls for screening all patients at high risk for NAFLD, including those with prediabetes, type 2 diabetes, obesity, and/or two or more cardiometabolic risk factors, or those with hepatic steatosis found on imaging, and/or persistently elevated plasma aminotransferase levels (that is, for more than 6 months).

The recommended screening test is the Fibrosis-4 (FIB-4) index, calculated using the patient’s age, AST level, platelet count, and ALT level: FIB-4 score = age (years) x AST (U/L)/PLT (10⁹/L) x ALT ½ (U/L).

Recently approved by the Food and Drug Administration, the FIB-4 has been demonstrated to help identify liver disease in primary care settings.

“We really want to encourage clinicians to do the screening. The first step is the FIB-4 test. It’s a mathematical calculation using blood tests that we do anyway,” Dr. Isaacs said in an interview.

The FIB-4 stratifies patients as being low, intermediate, or high risk for liver fibrosis. Those at low risk can be managed in primary care or endocrinology settings with a focus on obesity management and cardiovascular disease prevention. “Those at low risk on FIB-4 still have a high cardiovascular disease risk. They still need to be managed,” Dr. Isaacs observed.

For those at intermediate risk, a second noninvasive test – either a liver stiffness measurement by elastography or an enhanced liver fibrosis test – is advised. If the patient is found to be at high risk or is still indeterminant after two noninvasive tests, referral to a liver specialist for further testing, including possible biopsy, is advised.

Those found to be at high risk with the FIB-4 should also be referred to hepatology. In both the intermediate- and high-risk groups, management should be multidisciplinary, including a hepatologist, endocrinologist, and other professionals to prevent both cardiovascular disease and progression to cirrhosis, the guidelines say.

“The diagnosis isn’t about diagnosing liver fat. It’s about diagnosing fibrosis, or the risk for clinically significant fibrosis. That’s really where the challenge lies,” Dr. Isaacs commented.
 

NAFLD treatment in endocrinology and primary care: CVD prevention

During the presentation at the AACE meeting, guideline panel cochair Kenneth Cusi, MD, chief of endocrinology, diabetes, and metabolism at the University of Florida, Gainesville, summarized current and future treatments for NAFLD.

Lifestyle intervention, cardiovascular risk reduction, and weight loss for those who are overweight or obese are recommended for all patients with NAFLD, including structured weight-loss programs, antiobesity medications, and bariatric surgery if indicated.

There are currently no FDA-approved medications specifically for NASH, but pioglitazone, approved for type 2 diabetes, and glucagonlike peptide–1 agonists, approved for type 2 diabetes and weight loss, have been shown to be effective in treating the condition and preventing progression. Other treatments are in development, Dr. Cusi said.  

The guideline also includes a section on diagnosis and management of NAFLD in children and adolescents. Here, the FIB-4 is not recommended because it isn’t accurate due to the age part of the equation, so liver enzyme tests are used in pediatric patients considered at high risk because of clinical factors. Management is similar to adults, except not all medications used in adults are approved for use in children.

In the editorial, Dr. Liangpunsakul cautioned that “the level of uptake and usage of the guideline may be an obstacle.”

To remedy that, he advised that “the next effort should gear toward distributing this guideline to the targeted providers and developing the ‘feedback platforms’ on its execution in the real-world. ... The successful implementation of this AACE guideline by the primary care providers and endocrinologists, hopefully, will deescalate the future burden of NAFLD-related morbidity and mortality.”

Dr. Isaacs and Dr. Liangpunsakul have reported no relevant financial relationships. Dr. Cusi has reported receiving research support towards the University of Florida as principal investigator from the National Institute of Health, Echosens, Inventiva, Nordic Bioscience, Novo Nordisk, Poxel, Labcorp, and Zydus, and is a consultant for Altimmune, Akero, Arrowhead, AstraZeneca, 89Bio, Bristol-Myers Squibb, Coherus, Intercept, Lilly, Madrigal, Merck, Novo Nordisk, Quest, Sagimet, Sonic Incytes, Terns, and Thera Technologies.

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