Journal of Clinical Outcomes Management

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

About 60% of physicians cite documenting information in the electronic health record and other paperwork as major contributors to burnout. Physicians have been working with a variety of ways to reduce their documentation burdens; could one of them be right for you?

Two methods involve human scribes – working either on-site or off-site. Two other methods involve digital solutions: The first is widely used speech-to-text software, which requires the doctors to manually enter the text into the EHR; the second uses artificial intelligence (AI) to not only turn speech into text but to also automatically organize it and enter it into the EHR.

These AI solutions, which are only a few years old, are widely considered to be a work in progress – but many doctors who have used these products are impressed.
 

Other people do the documenting: On-site scribes

“It’s estimated that now one in five to one in eight doctors use scribes,” said Jeffrey A. Gold, MD, an internist who has studied the phenomenon. Utilization is already very high in emergency medicine and has been surging in specialties such as orthopedic surgery; it is also growing in primary care.

Scribes work with the doctor and enter information into the EHR. Their numbers have reportedly been rising in recent years, as more doctors look for ways to cut back on their documentation, according to Dr. Gold, vice chair for quality and safety at the department of medicine at Oregon Health and Science University, Portland.

The price tag of $33,000 a year or more for an on-site scribe is a major barrier. And because the typical scribe only works for 1-1.5 years, they must be constantly hired and trained, which is done by scribing services such as Scrivas in Miami.

However, Scrivas CEO Fernando G. Mendoza, MD, said scribes typically pay for themselves because they allow physicians to see more patients. Scribes can save doctors 2-3 hours of work per day, increase reimbursement by around 20% by producing more detailed notes, and improve satisfaction for both patients and doctors, according to several studies. In one study, physician documentation time significantly decreased, averaging 3 minutes per patient and 36 minutes per session.

Despite these possible savings, many health systems resisted hiring scribes for their employed physicians until the past few years, according to Kevin Brady, president of Physicians Angels, a scribing service based in Toledo, Ohio. “They figured they’d just spent millions on EHRs and didn’t want to spend any more,” he said. “They were also waiting for the EHR vendors to simplify documentation, but that never happened.”

Mr. Brady said what finally convinced many systems to invest in scribes was the need to reduce physician turnover and improve recruitment. Newly minted physicians often look for jobs that don’t interfere with their leisure time.
 

On-site scribes

On-site scribes accompany the doctor into the exam room and type the note during the encounter. Typically, the note is completed when the encounter is over, allowing for orders to be carried out immediately.

The traditional scribe is a premed student who wants to get acquainted with medicine and is thus willing to make a fairly low income. This career trajectory is the reason scribes have a high turnover. As demand surged, the scribe pool was supplemented with students aspiring to other health care professions like nursing, and even with people who want to make a career of scribing.

Since scribes have to set aside time for studying, scribe companies provide each physician-customer with one or two backup scribes. Dr. Mendoza bills his scribes as “personal assistants” who can do some nonclinical tasks beyond filling in the EHR, such as reminding doctors about the need to order a test or check in on another patient briefly before moving on to the next exam room.

Dr. Gold, however, warned against allowing “functional creep,” where scribes are asked to carry out tasks beyond their abilities, such as interpreting medical data. He added that doctors are expected to read through and sign all scribe-generated orders.

Some practices grow their own scribes, cross-training their medical assistants (MAs) to do the work. This addresses the turnover problem and could reduce costs. MAs already know clinical terms and how the doctor works, and they may be able to get special training at a local community college. However, some MAs do not want this extra work, and in any case, the work would take them away from other duties.

How often do physicians use their scribes? “Our doctors generally use them for all of their visits, but surgeons tend to limit use to their clinic days when they’re not in surgery,” said Tony Andrulonis, MD, president of ScribeAmerica in Fort Lauderdale, Fla.
 

Virtual scribes work off-site

Virtual scribes, who operate remotely from the doctor and can cost up to $10 less per hour than on-site scribes, got a boost during the COVID-19 pandemic because they fit well with telemedicine visits. Furthermore, the growing availability of virtual scribes from abroad has made scribes even more affordable.

“When doctors could no longer work on-site due to the pandemic, they replaced their on-site scribes with virtual scribes, and to some extent this trend is still going on,” Dr. Gold said.

One downside with virtual scribes is that they cannot do many of the extra tasks that on-site scribes can do. However, they are often a necessity in rural areas where on-site scribes are not available. In addition to having an audio-video connection, they may also just be on audio in areas where internet reception is poor or the patient wants privacy, Dr. Andrulonis said.

Mr. Brady said Physicians Angels uses offshore scribes from India. The company charges $16-$18 per hour, compared with $26-$28 per hour for U.S.-based virtual scribes. He said well over half of his clients are family physicians, who appreciate the lower cost.

Another advantage of offshore scribes is slower turnover and full-time availability. Mr. Brady said his scribes usually stay with the company for 5-6 years and are always available. “This is their full-time job,” Brady said.

Mr. Brady said when large organizations arrange with his company for scribes, often the goal is that the scribes pay for themselves. “They’ll tell their doctors: ‘We’ll let you have scribes as long as you see one or two more patients a day,’ ” he said. Mr. Brady then helps the organization reach that goal, which he said is easily achievable, except when doctors have no clear incentive to see more patients. He also works with clients on other goals, such as higher quality of life or time saved.
 

Speech-to-text software

For years, doctors have been using speech-to-text software to transform their speech into notes. They speak into the microphone, calling out punctuation and referring to prep-made templates for routine tasks. As they speak, the text appears on a screen. They can correct the text if necessary, and then they must put that information into the EHR.

Speech-to-text systems are used by more physicians than those using human scribes. Nuance’s Dragon Medical One system is the most popular, with more than 1000 large healthcare organizations signed up. Competitors include Dolbey, Entrada, and nVoq.

Prices are just a fraction of the cost of a human scribe. Dolbey’s Fusion Narrate system, for example, costs about $800-$850 a year per user. Doctors should shop around for these systems, because prices can vary by 30%-50%, said Wayne Kaniewski, MD, a retired family and urgent care physician and now owner and CEO of Twin Cities EMR Consulting in Minneapolis.

As a contracted reseller of the nVoq and Dolbey systems, Dr. Kaniewski provides training and support. During 13 years in business, he said machine dictation systems have become faster, more accurate, and, thanks to cloud-based technology, easier to set up.
 

Digital assistants

AI software, also known as digital assistants, takes speech-to-text software to the next logical step – organizing and automatically entering the information into the EHR. Using ambient technology, a smartphone captures the physician-patient conversation in the exam room, extracts the needed information, and distributes it in the EHR.

The cost is about one-sixth that of a human scribe, but higher than the cost for speech-to-text software because the technology still makes errors and requires a human at the software company to guide the process.

Currently about 10 companies sell digital scribes, including Nuance’s Dragon Medical One, NoteSwift, DeepScribe, and ScribeAmerica. These systems can be connected to the major EHR systems, and in some cases EHR systems have agreements with digital scribe vendors so that their systems can be seamlessly connected.

“DAX software can understand nonlinear conversations – the way normal conversations bounce from topic to topic,” said Kenneth Harper, general manager of Nuance’s Ambient Clinical Intelligence Division. “This level of technology was not possible 5 years ago.”

Mr. Harper said DAX saves doctors 6 minutes per patient on average, and 70% of doctors using it reported less burnout and fatigue. Kansas University Medical Center has been testing DAX with physicians there. Many of them no longer need to write up their notes after hours, said Denton Shanks, DO, the medical center’s digital health medical director.

One of the things Dr. Shanks likes about DAX is that it remembers all the details of a visit. As a family physician, “there are something like 15 different problems that come up in one typical visit. Before, I had to carry those problems in my head, and when I wrote up my notes at the end of the day, I might have forgotten a few of them. Not so with DAX.”

Dr. Shanks knows he has to speak clearly and unambiguously when using DAX. “DAX can only document what it hears, so I describe what I am looking at in a physical exam or I might further explain the patient’s account so DAX can pick up on it.”
 

Are digital assistants ready for doctors?

Since a human at the software company is needed to guide the system, it takes a few hours for the digital assistant to complete entries into the EHR, but vendors are looking for ways to eliminate human guidance.

“We’re definitely moving toward digital scribes, but we’re not there yet,” Dr. Gold said, pointing to a 2018 study that found a significantly higher error rate for speech recognition software than for human scribes.

Dr. Kaniewski added that digital scribes pick up a great deal of irrelevant information, making for a bloated note. “Clinicians must then edit the note down, which is more work than just dictating a concise note,” he said.

Many doctors, however, are happy with these new systems. Steven Y. Lin, MD, a family physician who has been testing a digital scribe system with 40 fellow clinicians at Stanford (Calif.) Health Care, said 95% of clinicians who stayed with the trial are continuing to use the system, but he concedes that there was a relatively high dropout rate. “These people felt that they had lost control of the process when using the software.”

Furthermore, Dr. Lin is concerned that using a digital scribe may eliminate doctors’ crucial step of sitting down and writing the clinical note. Here “doctors bring together everything they have heard and then come up with the diagnosis and treatment.” He recognized that doctors could still take this step when reviewing the digital note, but it would be easy to skip.
 

What is the future for documentation aids?

Increasingly more doctors are finding ways to expedite documentation tasks. Speech-to-text software is still the most popular solution, but more physicians are now using human scribes, driven by the decisions of some large organizations to start paying for them.

However, these physicians are often expected to work harder in order for the scribes to pay for themselves, which is a solution that could, ironically, add to burnout rather than alleviate it.

Digital assistants answer these concerns because they are more affordable and are supposed to do all the work of human scribes. This software parses the physician-patient conversation into a clinical note and other data and deposits them directly into the EHR.

Most experts think digital assistants will eventually meet their promise, but it is widely thought that they’re not ready yet. It will be up to vendors like Nuance to convince skeptics that their products are ready for doctors.

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

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

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

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

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

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

CHICAGO – Geno Merli, MD, associate chief medical officer at Thomas Jefferson University Hospital, Philadelphia, and long-time hospital medicine expert, recalled a recent situation at his center, during a panel discussion.

It involved a 70-year-old man who had a history of prostate cancer, obstructive sleep apnea, and hernias. In January, he had a surgery for hernia repair. On the 3rd day after the procedure, he was transferred to the hospital medicine service at about 9 p.m. and was on a patient-controlled pump for pain and had abdominal drains. Because of the extensive surgery and because he had begun to walk shortly after the procedure, he wasn’t on thrombosis prevention medication, Dr. Merli explained at the annual meeting of the American College of Physicians.

The day after his transfer he was walking with a physical therapist when he became short of breath, his oxygen saturation dropped, and his heart rate soared. Bilateral pulmonary emboli were found, along with thrombosis in the right leg.

What was remarkable, Dr. Merli noted, was what the patient’s medical record was lacking.

He added, “I think if we start looking at this at our sites, we may find out that communication needs to be improved, and I believe standardized.”

This situation underscores the continuing need to refine handoffs between surgery and hospital medicine, a point in care that is primed for potential errors, the other panelists noted during the session.

Most important information is often not communicated

A 2010 study in pediatrics that looked at intern-to-intern handoffs found that the most important piece of information wasn’t communicated successfully 60% of the time – in other words, more often than not, the person on the receiving end didn’t really understand that crucial part of the scenario. Since then, the literature has been regularly populated with studies attempting to refine handoff procedures.

 Lily Ackermann, MD, hospitalist and clinical associate professor of medicine at Jefferson, said in the session that hospitalists need to be sure to reach out to surgery at important junctures in care.

 “I would say the No. 1 biggest mistake we make is not calling the surgery attending directly when clinical questions arise,” she said. “I think this is very important – attending [physician in hospital medicine] to attending [physician in surgery].”

 Murray Cohen, MD, director of acute care surgery at Jefferson, said he shared that concern.

“We want to be called, we want to be called for our patients,” he said in the session. “And we’re upset when you don’t call for our patients.”

Hospitalists should discuss blood loss, pain management, management of drains, deep vein thrombosis prevention, nutrition, infectious disease concerns, and timing of vaccines post procedure, Dr. Ackermann said during the presentation,

The panelists also emphasized that understanding the follow-up care that surgery was planning after a procedure is important, and to not just expect surgeons to actively follow a patient. They also reminded hospitalists to look at the wounds and make sure they understand how to handle the wounds going forward. Plus, when transferring a patient to surgery, hospitalists should understand when getting someone to surgery is urgent and not to order unnecessary tests as a formality when time is of the essence, they said.

IPASS: a formalized handoff process

The panelists all spoke highly of a formalized handoff process known as IPASS. This acronym reminds physicians to ask specific questions.

The I represents illness severity and calls for asking: “Is the patient stable or unstable?

The P stands for patient summary and is meant to prompt physicians to seek details about the procedure.

The A is for action list, which is meant to remind the physician to get the post-op plan for neurological, cardiovascular, gastrointestinal, and other areas.

The first S is for situational awareness, and calls for asking: What is the biggest concern over the next 24 hours?

The final S represents synthesis by the receiver, prompting a physician to summarize the information he or she has received about the patient.

Natalie Margules, MD, a clinical instructor and hospitalist at Jefferson who did not present in the session, reiterated the value of the IPASS system. Before it was used for handoffs, she said, “I was never taught anything formalized – basically, just ‘Tell them what’s important.’

Dr. Margules noted that she considers the framework’s call for the synthesis to be one of it most useful parts.

 Dr. Merli, Dr. Ackermann, and Dr. Cohen reported no relevant financial disclosures.

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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

A South African study based on blood samples found that the BA.4 and BA.5 sublineages of Omicron were more likely to evade antibodies produced by previous Omicron infections than the immunity provided by vaccinations.

Scientists took blood samples from 39 people infected with Omicron, with 24 people not vaccinated and 15 vaccinated with the Pfizer or the Johnson & Johnson vaccines, Reuters reported.

“The vaccinated group showed about a fivefold higher neutralization capacity ... and should be better protected,” the investigators found, according to Reuters.

There was an eightfold decrease in antibody protection in unvaccinated blood samples when exposed to the subvariants compared to a threefold decrease in the blood samples from vaccinated people.

“Based on neutralization escape, BA.4 and BA.5 have potential to result in a new infection wave,” the investigators found.

The finding is important because health authorities say cases caused by the sublineages are increasing in South Africa to a degree that the nation may be entering a fifth wave of COVID, Reuters said.

Health Minister Joe Phaahla said recently that hospitalizations were increasing but that ICU admissions had not greatly gone up yet.

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

People with metabolic dysfunction–associated fatty liver disease (MAFLD) – a newly defined condition – may be more likely to die from COVID-19, researchers say.

A cohort of people hospitalized for COVID-19 in Central Military Hospital, Mexico City, who met the criteria for MAFLD died at a higher rate than a control group without fatty liver disease, said Martín Uriel Vázquez-Medina, MSc, a researcher in the National Polytechnic Institute in Mexico City.

Patients who met only the criteria for the traditional classification, nonalcoholic fatty liver disease (NAFLD), also died of COVID-19 at a higher rate than the control group, but the difference was not statistically significant.

“It is important to screen for MAFLD,” Mr. Vázquez-Medina told this news organization. “It’s a new definition, but it has really helped us to identify which patients are going to get worse by COVID-19.”

The study was published in Hepatology Communications.
 

More evidence for clinical relevance of MAFLD

The finding lends support to an initiative to use MAFLD instead of NAFLD to identify patients whose liver steatosis poses a threat to their health, Mr. Vázquez-Medina said.

NAFLD affects as much as a quarter of the world’s population. No drugs have been approved to treat it. Some researchers have reasoned that the imprecision of the definition of NAFLD could be one reason for the lack of progress in treatment.

“NAFLD is something that doesn’t have positive criteria to be diagnosed,” said Mr. Vázquez-Medina. “You only say NAFLD when you don’t find hepatitis or another disease.”

In an article published in Gastroenterology, an international consensus panel proposed MAFLD as an alternative, arguing that a focus on metabolic dysfunction could more accurately reflect the pathogenesis of the disease and help stratify patients.

Previous research has suggested that patients with MAFLD have a higher risk of atherosclerotic cardiovascular disease and that the prevalence of colorectal adenomas is a higher in these patients, compared with patients with NAFLD.

The high prevalence of MAFLD in Mexico – about 30% – could help explain the country’s high rate of mortality from COVID-19, Mr. Vázquez-Medina said. Almost 6% of people diagnosed with COVID in Mexico have died from it, according to the Johns Hopkins University and Medical Center Coronavirus Resource Center.
 

Sorting COVID outcomes by liver steatosis

To understand the interaction of MAFLD, NAFLD, liver fibrosis, and COVID-19, Mr. Vázquez-Medina and his colleagues analyzed the records of all patients admitted to the Central Military Hospital with COVID-19 from April 4, 2020, to June 24, 2020.

They excluded patients for whom complete data were lacking or for whom a liver function test was not conducted in the first 24 hours of hospitalization. Also excluded were patients with significant consumption of alcohol (> 30 g/day for men and > 20 g/day for women) and those with a history of autoimmune liver disease, liver cancer, decompensated cirrhosis, platelet disorders, or myopathies.

The remaining patients were divided into three groups – 220 who met the criteria for MAFLD, 79 who met the criteria for NAFLD but not MAFLD, and 60 other patients as a control group.

The researchers defined MAFLD as the presence of liver steatosis detected with a noninvasive method and one of the following: overweight (body mass index, 25-29.9 kg/m2), type 2 diabetes, or the presence of two metabolic abnormalities (blood pressure > 140/90 mm Hg, plasma triglycerides > 150 mg/dL, plasma high-density lipoprotein cholesterol < 40 mg/dL in men and < 50 mg/dL in women, and prediabetes).

They defined NAFLD as the presence of liver steatosis without the other criteria for MAFLD.

The patients with MAFLD were the most likely to be intubated and were the most likely to die (intubation, 44.09%; mortality, 55%), followed by those with NAFLD (intubation, 40.51%; mortality, 51.9%) and those in the control group (intubation, 20%; mortality, 38.33%).

The difference in mortality between the MAFLD group and the control group was statistically significant (P = .02). The mortality difference between the NAFLD and the control group fell just short of statistical significance (P = .07).

For intubation, the difference between the MAFLD and the control group was highly statistically significant (P = .001), and the difference between the NAFLD and the control group was also statistically significant (P = .01)

Patients with advanced fibrosis and either MAFLD or NAFLD were also more likely to die than patients in the control group with advanced fibrosis.

That’s why screening for MAFLD is important, Mr. Vázquez-Medina said.
 

Next steps and new questions

Future research should examine whether patients with MAFLD have elevated levels of biomarkers for inflammation, such as interleukin 6, Mr. Vázquez-Medina said. A “chronic low proinflammatory state” may be the key to understanding the vulnerability of patients to MAFLD to COVID-19, he speculated.

The metabolic traits associated with MAFLD could explain the higher mortality and intubation rates with COVID, said Rohit Loomba, MD, MHSc, a professor of medicine in the division of gastroenterology at the University of California, San Diego, who was not involved in the study.

“Hypertension, diabetes, and obesity increase the risk of complications from COVID in all patients, whether they have been diagnosed with NAFLD or not,” he told this news organization in an email.

Mr. Vasquez-Medina pointed out that the patients with MAFLD had a higher risk of mortality even after adjusting for age, sex, type 2 diabetes, hypertension, overweight, and obesity (BMI ≥ 30 kg/m2). MAFLD also was more strongly associated with a poor outcome than either hypertension alone or obesity alone. Only age emerged as a significant independent covariate in the study.

Dr. Loomba also questioned whether the regression model used in this study for liver steatosis was “fully reflective of NAFLD.”

The researchers identified liver steatosis with a diagnostic formula that used noninvasive clinical BMI and laboratory tests (alanine aminotransferase), citing a study that found the regression formula was better at diagnosing NAFLD than FibroScan.

Mr. Vázquez-Medina reported no relevant financial relationships. Dr. Loomba serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen, Madrigal, Metacrine, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals, and Viking Therapeutics. He is co-founder of LipoNexus.

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

People with metabolic dysfunction–associated fatty liver disease (MAFLD) – a newly defined condition – may be more likely to die from COVID-19, researchers say.

A cohort of people hospitalized for COVID-19 in Central Military Hospital, Mexico City, who met the criteria for MAFLD died at a higher rate than a control group without fatty liver disease, said Martín Uriel Vázquez-Medina, MSc, a researcher in the National Polytechnic Institute in Mexico City.

Patients who met only the criteria for the traditional classification, nonalcoholic fatty liver disease (NAFLD), also died of COVID-19 at a higher rate than the control group, but the difference was not statistically significant.

“It is important to screen for MAFLD,” Mr. Vázquez-Medina told this news organization. “It’s a new definition, but it has really helped us to identify which patients are going to get worse by COVID-19.”

The study was published in Hepatology Communications.
 

More evidence for clinical relevance of MAFLD

The finding lends support to an initiative to use MAFLD instead of NAFLD to identify patients whose liver steatosis poses a threat to their health, Mr. Vázquez-Medina said.

NAFLD affects as much as a quarter of the world’s population. No drugs have been approved to treat it. Some researchers have reasoned that the imprecision of the definition of NAFLD could be one reason for the lack of progress in treatment.

“NAFLD is something that doesn’t have positive criteria to be diagnosed,” said Mr. Vázquez-Medina. “You only say NAFLD when you don’t find hepatitis or another disease.”

In an article published in Gastroenterology, an international consensus panel proposed MAFLD as an alternative, arguing that a focus on metabolic dysfunction could more accurately reflect the pathogenesis of the disease and help stratify patients.

Previous research has suggested that patients with MAFLD have a higher risk of atherosclerotic cardiovascular disease and that the prevalence of colorectal adenomas is a higher in these patients, compared with patients with NAFLD.

The high prevalence of MAFLD in Mexico – about 30% – could help explain the country’s high rate of mortality from COVID-19, Mr. Vázquez-Medina said. Almost 6% of people diagnosed with COVID in Mexico have died from it, according to the Johns Hopkins University and Medical Center Coronavirus Resource Center.
 

Sorting COVID outcomes by liver steatosis

To understand the interaction of MAFLD, NAFLD, liver fibrosis, and COVID-19, Mr. Vázquez-Medina and his colleagues analyzed the records of all patients admitted to the Central Military Hospital with COVID-19 from April 4, 2020, to June 24, 2020.

They excluded patients for whom complete data were lacking or for whom a liver function test was not conducted in the first 24 hours of hospitalization. Also excluded were patients with significant consumption of alcohol (> 30 g/day for men and > 20 g/day for women) and those with a history of autoimmune liver disease, liver cancer, decompensated cirrhosis, platelet disorders, or myopathies.

The remaining patients were divided into three groups – 220 who met the criteria for MAFLD, 79 who met the criteria for NAFLD but not MAFLD, and 60 other patients as a control group.

The researchers defined MAFLD as the presence of liver steatosis detected with a noninvasive method and one of the following: overweight (body mass index, 25-29.9 kg/m2), type 2 diabetes, or the presence of two metabolic abnormalities (blood pressure > 140/90 mm Hg, plasma triglycerides > 150 mg/dL, plasma high-density lipoprotein cholesterol < 40 mg/dL in men and < 50 mg/dL in women, and prediabetes).

They defined NAFLD as the presence of liver steatosis without the other criteria for MAFLD.

The patients with MAFLD were the most likely to be intubated and were the most likely to die (intubation, 44.09%; mortality, 55%), followed by those with NAFLD (intubation, 40.51%; mortality, 51.9%) and those in the control group (intubation, 20%; mortality, 38.33%).

The difference in mortality between the MAFLD group and the control group was statistically significant (P = .02). The mortality difference between the NAFLD and the control group fell just short of statistical significance (P = .07).

For intubation, the difference between the MAFLD and the control group was highly statistically significant (P = .001), and the difference between the NAFLD and the control group was also statistically significant (P = .01)

Patients with advanced fibrosis and either MAFLD or NAFLD were also more likely to die than patients in the control group with advanced fibrosis.

That’s why screening for MAFLD is important, Mr. Vázquez-Medina said.
 

Next steps and new questions

Future research should examine whether patients with MAFLD have elevated levels of biomarkers for inflammation, such as interleukin 6, Mr. Vázquez-Medina said. A “chronic low proinflammatory state” may be the key to understanding the vulnerability of patients to MAFLD to COVID-19, he speculated.

The metabolic traits associated with MAFLD could explain the higher mortality and intubation rates with COVID, said Rohit Loomba, MD, MHSc, a professor of medicine in the division of gastroenterology at the University of California, San Diego, who was not involved in the study.

“Hypertension, diabetes, and obesity increase the risk of complications from COVID in all patients, whether they have been diagnosed with NAFLD or not,” he told this news organization in an email.

Mr. Vasquez-Medina pointed out that the patients with MAFLD had a higher risk of mortality even after adjusting for age, sex, type 2 diabetes, hypertension, overweight, and obesity (BMI ≥ 30 kg/m2). MAFLD also was more strongly associated with a poor outcome than either hypertension alone or obesity alone. Only age emerged as a significant independent covariate in the study.

Dr. Loomba also questioned whether the regression model used in this study for liver steatosis was “fully reflective of NAFLD.”

The researchers identified liver steatosis with a diagnostic formula that used noninvasive clinical BMI and laboratory tests (alanine aminotransferase), citing a study that found the regression formula was better at diagnosing NAFLD than FibroScan.

Mr. Vázquez-Medina reported no relevant financial relationships. Dr. Loomba serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen, Madrigal, Metacrine, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals, and Viking Therapeutics. He is co-founder of LipoNexus.

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

People with metabolic dysfunction–associated fatty liver disease (MAFLD) – a newly defined condition – may be more likely to die from COVID-19, researchers say.

A cohort of people hospitalized for COVID-19 in Central Military Hospital, Mexico City, who met the criteria for MAFLD died at a higher rate than a control group without fatty liver disease, said Martín Uriel Vázquez-Medina, MSc, a researcher in the National Polytechnic Institute in Mexico City.

Patients who met only the criteria for the traditional classification, nonalcoholic fatty liver disease (NAFLD), also died of COVID-19 at a higher rate than the control group, but the difference was not statistically significant.

“It is important to screen for MAFLD,” Mr. Vázquez-Medina told this news organization. “It’s a new definition, but it has really helped us to identify which patients are going to get worse by COVID-19.”

The study was published in Hepatology Communications.
 

More evidence for clinical relevance of MAFLD

The finding lends support to an initiative to use MAFLD instead of NAFLD to identify patients whose liver steatosis poses a threat to their health, Mr. Vázquez-Medina said.

NAFLD affects as much as a quarter of the world’s population. No drugs have been approved to treat it. Some researchers have reasoned that the imprecision of the definition of NAFLD could be one reason for the lack of progress in treatment.

“NAFLD is something that doesn’t have positive criteria to be diagnosed,” said Mr. Vázquez-Medina. “You only say NAFLD when you don’t find hepatitis or another disease.”

In an article published in Gastroenterology, an international consensus panel proposed MAFLD as an alternative, arguing that a focus on metabolic dysfunction could more accurately reflect the pathogenesis of the disease and help stratify patients.

Previous research has suggested that patients with MAFLD have a higher risk of atherosclerotic cardiovascular disease and that the prevalence of colorectal adenomas is a higher in these patients, compared with patients with NAFLD.

The high prevalence of MAFLD in Mexico – about 30% – could help explain the country’s high rate of mortality from COVID-19, Mr. Vázquez-Medina said. Almost 6% of people diagnosed with COVID in Mexico have died from it, according to the Johns Hopkins University and Medical Center Coronavirus Resource Center.
 

Sorting COVID outcomes by liver steatosis

To understand the interaction of MAFLD, NAFLD, liver fibrosis, and COVID-19, Mr. Vázquez-Medina and his colleagues analyzed the records of all patients admitted to the Central Military Hospital with COVID-19 from April 4, 2020, to June 24, 2020.

They excluded patients for whom complete data were lacking or for whom a liver function test was not conducted in the first 24 hours of hospitalization. Also excluded were patients with significant consumption of alcohol (> 30 g/day for men and > 20 g/day for women) and those with a history of autoimmune liver disease, liver cancer, decompensated cirrhosis, platelet disorders, or myopathies.

The remaining patients were divided into three groups – 220 who met the criteria for MAFLD, 79 who met the criteria for NAFLD but not MAFLD, and 60 other patients as a control group.

The researchers defined MAFLD as the presence of liver steatosis detected with a noninvasive method and one of the following: overweight (body mass index, 25-29.9 kg/m2), type 2 diabetes, or the presence of two metabolic abnormalities (blood pressure > 140/90 mm Hg, plasma triglycerides > 150 mg/dL, plasma high-density lipoprotein cholesterol < 40 mg/dL in men and < 50 mg/dL in women, and prediabetes).

They defined NAFLD as the presence of liver steatosis without the other criteria for MAFLD.

The patients with MAFLD were the most likely to be intubated and were the most likely to die (intubation, 44.09%; mortality, 55%), followed by those with NAFLD (intubation, 40.51%; mortality, 51.9%) and those in the control group (intubation, 20%; mortality, 38.33%).

The difference in mortality between the MAFLD group and the control group was statistically significant (P = .02). The mortality difference between the NAFLD and the control group fell just short of statistical significance (P = .07).

For intubation, the difference between the MAFLD and the control group was highly statistically significant (P = .001), and the difference between the NAFLD and the control group was also statistically significant (P = .01)

Patients with advanced fibrosis and either MAFLD or NAFLD were also more likely to die than patients in the control group with advanced fibrosis.

That’s why screening for MAFLD is important, Mr. Vázquez-Medina said.
 

Next steps and new questions

Future research should examine whether patients with MAFLD have elevated levels of biomarkers for inflammation, such as interleukin 6, Mr. Vázquez-Medina said. A “chronic low proinflammatory state” may be the key to understanding the vulnerability of patients to MAFLD to COVID-19, he speculated.

The metabolic traits associated with MAFLD could explain the higher mortality and intubation rates with COVID, said Rohit Loomba, MD, MHSc, a professor of medicine in the division of gastroenterology at the University of California, San Diego, who was not involved in the study.

“Hypertension, diabetes, and obesity increase the risk of complications from COVID in all patients, whether they have been diagnosed with NAFLD or not,” he told this news organization in an email.

Mr. Vasquez-Medina pointed out that the patients with MAFLD had a higher risk of mortality even after adjusting for age, sex, type 2 diabetes, hypertension, overweight, and obesity (BMI ≥ 30 kg/m2). MAFLD also was more strongly associated with a poor outcome than either hypertension alone or obesity alone. Only age emerged as a significant independent covariate in the study.

Dr. Loomba also questioned whether the regression model used in this study for liver steatosis was “fully reflective of NAFLD.”

The researchers identified liver steatosis with a diagnostic formula that used noninvasive clinical BMI and laboratory tests (alanine aminotransferase), citing a study that found the regression formula was better at diagnosing NAFLD than FibroScan.

Mr. Vázquez-Medina reported no relevant financial relationships. Dr. Loomba serves as a consultant to Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Bristol-Myers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen, Madrigal, Metacrine, NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals, and Viking Therapeutics. He is co-founder of LipoNexus.

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

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

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

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

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

Is fear of missing an infection – call it “FOMI” – leading you to overprescribe antibiotics to your patients?   

Inappropriate use of antibiotics can result in adverse events and toxicity, superinfections such as Clostridioides difficile and Methicillin-resistant Staphylococcus aureus, excess mortality and costs, and resistance to the drugs.   

All that has been well-known for years, and antibiotic resistance has become a leading public health concern. So why are physicians continuing to overprescribe the drugs?

Speaking at the 2022 annual Internal Medicine Meeting of the American College of Physicians, James “Brad” Cutrell, MD, medical director of antimicrobial stewardship, University of Texas Southwestern Medical Center, Dallas, said clinicians in the United States and elsewhere appear to be falling into a three-part fallacy when it comes to using the drugs: fear of “missing an infection,” coupled with patient expectations that they will leave the office with a prescription and combined with an overemphasis on the potential benefit to the individual at the expense of the risk to society of antibiotic resistance.

Antibiotics are the only drugs that lose their efficacy for all patients over time the more they are used. “For example, if I give a beta blocker to a patient, it’s not going to affect other patients down the road,” Dr. Cutrell said. “It’s not going to lose its efficacy.”

“What we need in medicine is a new culture around antibiotic use,” Dr. Cutrell added. “We need more respect for the dangers of antibiotic misuse and to have confidence in [their] benefits and when they can be used wisely.”
 

Rampant misuse

Outpatient prescriptions account for at least 60% of antibiotic use in the United States. The rate is even higher in other countries, Dr. Cutrell said during a presentation at the 2022 annual Internal Medicine Meeting of the American College of Physicians.

“About 10% of adult visits and 20% of pediatric visits will result in an antibiotic prescription,” said Dr. Cutrell, noting that prescribing patterns vary widely across the country, with as much as a three-fold difference in some locations. But at least 30% of outpatient antibiotic prescriptions are inappropriately ordered, he said.

“When we look at acute respiratory infections, upwards of 50% are not indicated at all,” he said. Imagine, he added, if the same error rate applied to other medical practices: “What if surgeons were only right 50% of the time, or if the oncologist was only giving the right treatment 50% of the time?”

The most recent Antibiotic Threats Report from the U.S. Centers for Disease Control and Prevention estimated that antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and about 36,000 deaths annually in the United States alone.
 

How to be a better steward

The core elements for antimicrobial stewardship in the outpatient setting, according to Dr. Cutrell, include making a commitment to optimize prescribing, implementing at least one policy or practice to improve prescribing, monitoring prescribing practices and offering feedback to clinicians, and educating both patients and clinicians.

All that is similar to in-patient stewardship, he said, but outpatient clinicians face a few unique challenges. “Patients are lower acuity, and there is less diagnostic data, and program resources and time are more limited,” he said. Patient satisfaction is also a major driver, and it is also more difficult to measure and track ambulatory antibiotic use.

Interventions have been identified, however, that can help improve stewardship. One is auditing and feedback with peers. “Another [is] commitment posters, which can be placed around the clinic, and that helps set the culture,” he said. “Clinical education and practice guidelines are also important.”

Clinicians should also:

• Observe antibiotic best practices
• Optimize antibiotic selection and dosing
• Practice effective diagnostic stewardship
• Use the shortest duration of therapy necessary
• Avoid antibiotics for inappropriate indications
• Educate patients on when antibiotics are needed
• Follow and become good antibiotic stewardship mentors

“Multiple antibiotic stewardship interventions are effective, particularly those focused on behavioral interventions,” Dr. Cutrell said. “Every provider should follow antibiotic ‘best practices’ and other simple steps to prescribe antibiotics more wisely and to improve patient care.”

Dr. Cutrell reported financial relationships with Gilead Sciences and Regeneron Pharmaceuticals.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) - a class of widely used synthetic chemicals dubbed “forever chemicals” - can lead to liver damage and may be a culprit in rising rates of nonalcoholic fatty liver disease (NAFLD), say the authors of a comprehensive evidence review.

They found “consistent” evidence for PFAS hepatotoxicity from rodent studies. In addition, exposure to PFAS was found to be associated with markers of liver function in observational studies in people.

The review, published online in Environmental Health Perspectives, may be the first systematic analysis of PFAS exposure and liver damage.

Possible contributor to growing NAFLD epidemic

In their analysis, the authors included 85 rodent studies and 24 epidemiologic studies, primarily involving people from the United States and largely focusing on four “legacy” PFAS: perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS).

Meta-analyses of human studies found that higher levels of alanine aminotransferase were significantly associated with exposure to three of the older chemicals – PFOA, PFOS, and PFNA.

The “positive” and “convincing” associations between exposure to these synthetic chemicals and higher ALT levels suggest that exposure may contribute to the growing NAFLD epidemic, the researchers write.

Exposure to one of the chemicals, PFOA, was also associated with higher aspartate aminotransferase and gamma-glutamyl transferase levels in people.

In rodents, exposure to these synthetic chemicals consistently resulted in higher ALT levels and steatosis.

“The mechanism is not well understood yet, but there are a few proposed theories,” first author Elizabeth Costello, MPH, PhD student, department of population and public health sciences, University of Southern California, Los Angeles, told this news organization.

“PFAS are similar to fatty acids in chemical structure, so it’s possible that they activate some of the same receptors or otherwise interfere with fat metabolism. This might lead to inflammation or fat accumulation in the liver,” Ms. Costello explained.

People widely exposed

PFAS are ubiquitous in the environment. They have been detected in the blood of most people and have been linked to a variety of health concerns. Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.

“We are exposed to PFAS in so many ways – through water, food, and products we use. It can be very difficult for individuals to control their own exposure,” Ms. Costello commented.

“At this point, it’s important to look for ways to remove PFAS from the environment and phase them out of our products and carefully consider the safety of any replacement chemicals,” she said.

Although most of the research to date has been limited to the four older PFAS (PFOA, PFOS, PFNA, and PFHxS), there are thousands of different PFAS chemicals.

“We don’t know very much about the effects of exposure to multiple PFAS at the same time or how newer replacement PFAS might affect liver disease or other health conditions,” Ms. Costello said.

Reached for comment, Lisa B. VanWagner, MD, with Northwestern University, Chicago, said this analysis is “very interesting,” but she is also “left wondering how we could do anything since it seems from my reading that these chemicals are ubiquitous and used regularly in the environment.”

Dr. VanWagner, who was not involved in the study, said the major limitation is the small number of human studies and the high heterogeneity between studies, “meaning it is hard to come to a firm conclusion about whether what has been observed in the animal studies does truly apply to humans.

“Overall, this study provides important proof of concept for future work to look more specifically at PFAS exposure, and more specific markers of fatty liver disease and liver damage, like liver biopsy, are needed in humans,” Dr. VanWagner said.

“If data accumulate showing that these chemicals do in fact contribute to fatty liver and worsening inflammation or liver damage as a result of exposure, then public health interventions to remove or reduce use of these chemicals could have wide-ranging public health effects,” Dr. VanWagner added.

Further research needed

The authors of an invited perspective published with the study say it underscores the “urgent need for further research and for immediate and reasonable public health action.”

“This work firmly puts PFAS exposure on the list of persistent pollutants, such as polychlorinated biphenyls, that cause hepatotoxicity and whose mechanism is linked to steatosis,” write Alan Ducatman, MD. MSc, with West Virginia University School of Public Health, Morgantown, and Suzanne Fenton, PhD, MS, with the National Institute of Environmental Health Sciences, Research Triangle Park, N.C.

They say other important questions raised by this review include whether individuals who are overweight or obese and those with diabetes are more susceptible to PFAS hepatoxicity, which “replacement” or emerging PFAS can cause liver damage, and whether high doses cause different kinds of liver toxicity than low doses.

“GenX, a current replacement [chemical] for PFOA, has shown significant hepatotoxicity in several recent experimental studies, suggesting it may not be a safe replacement,” they point out.

“A significant challenge will be deciding which of the multiple metabolic pathways altered by PFAS are most important and predictive for induction of liver damage and for progression of liver disease, so that emerging PFAS may be screened for hepatotoxicity prior to entering the market,” Dr. Ducatman and Dr. Fenton conclude.

Support for this research was provided by the National Institute of Environmental Health Science, part of the National Institutes of Health, and the U.S. Department of Agriculture National Institute of Food and Agriculture. Dr. Costello, Dr. VanWagner, Dr. Ducatman, and Dr. Fenton report no relevant financial relationships.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) - a class of widely used synthetic chemicals dubbed “forever chemicals” - can lead to liver damage and may be a culprit in rising rates of nonalcoholic fatty liver disease (NAFLD), say the authors of a comprehensive evidence review.

They found “consistent” evidence for PFAS hepatotoxicity from rodent studies. In addition, exposure to PFAS was found to be associated with markers of liver function in observational studies in people.

The review, published online in Environmental Health Perspectives, may be the first systematic analysis of PFAS exposure and liver damage.

Possible contributor to growing NAFLD epidemic

In their analysis, the authors included 85 rodent studies and 24 epidemiologic studies, primarily involving people from the United States and largely focusing on four “legacy” PFAS: perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS).

Meta-analyses of human studies found that higher levels of alanine aminotransferase were significantly associated with exposure to three of the older chemicals – PFOA, PFOS, and PFNA.

The “positive” and “convincing” associations between exposure to these synthetic chemicals and higher ALT levels suggest that exposure may contribute to the growing NAFLD epidemic, the researchers write.

Exposure to one of the chemicals, PFOA, was also associated with higher aspartate aminotransferase and gamma-glutamyl transferase levels in people.

In rodents, exposure to these synthetic chemicals consistently resulted in higher ALT levels and steatosis.

“The mechanism is not well understood yet, but there are a few proposed theories,” first author Elizabeth Costello, MPH, PhD student, department of population and public health sciences, University of Southern California, Los Angeles, told this news organization.

“PFAS are similar to fatty acids in chemical structure, so it’s possible that they activate some of the same receptors or otherwise interfere with fat metabolism. This might lead to inflammation or fat accumulation in the liver,” Ms. Costello explained.

People widely exposed

PFAS are ubiquitous in the environment. They have been detected in the blood of most people and have been linked to a variety of health concerns. Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.

“We are exposed to PFAS in so many ways – through water, food, and products we use. It can be very difficult for individuals to control their own exposure,” Ms. Costello commented.

“At this point, it’s important to look for ways to remove PFAS from the environment and phase them out of our products and carefully consider the safety of any replacement chemicals,” she said.

Although most of the research to date has been limited to the four older PFAS (PFOA, PFOS, PFNA, and PFHxS), there are thousands of different PFAS chemicals.

“We don’t know very much about the effects of exposure to multiple PFAS at the same time or how newer replacement PFAS might affect liver disease or other health conditions,” Ms. Costello said.

Reached for comment, Lisa B. VanWagner, MD, with Northwestern University, Chicago, said this analysis is “very interesting,” but she is also “left wondering how we could do anything since it seems from my reading that these chemicals are ubiquitous and used regularly in the environment.”

Dr. VanWagner, who was not involved in the study, said the major limitation is the small number of human studies and the high heterogeneity between studies, “meaning it is hard to come to a firm conclusion about whether what has been observed in the animal studies does truly apply to humans.

“Overall, this study provides important proof of concept for future work to look more specifically at PFAS exposure, and more specific markers of fatty liver disease and liver damage, like liver biopsy, are needed in humans,” Dr. VanWagner said.

“If data accumulate showing that these chemicals do in fact contribute to fatty liver and worsening inflammation or liver damage as a result of exposure, then public health interventions to remove or reduce use of these chemicals could have wide-ranging public health effects,” Dr. VanWagner added.

Further research needed

The authors of an invited perspective published with the study say it underscores the “urgent need for further research and for immediate and reasonable public health action.”

“This work firmly puts PFAS exposure on the list of persistent pollutants, such as polychlorinated biphenyls, that cause hepatotoxicity and whose mechanism is linked to steatosis,” write Alan Ducatman, MD. MSc, with West Virginia University School of Public Health, Morgantown, and Suzanne Fenton, PhD, MS, with the National Institute of Environmental Health Sciences, Research Triangle Park, N.C.

They say other important questions raised by this review include whether individuals who are overweight or obese and those with diabetes are more susceptible to PFAS hepatoxicity, which “replacement” or emerging PFAS can cause liver damage, and whether high doses cause different kinds of liver toxicity than low doses.

“GenX, a current replacement [chemical] for PFOA, has shown significant hepatotoxicity in several recent experimental studies, suggesting it may not be a safe replacement,” they point out.

“A significant challenge will be deciding which of the multiple metabolic pathways altered by PFAS are most important and predictive for induction of liver damage and for progression of liver disease, so that emerging PFAS may be screened for hepatotoxicity prior to entering the market,” Dr. Ducatman and Dr. Fenton conclude.

Support for this research was provided by the National Institute of Environmental Health Science, part of the National Institutes of Health, and the U.S. Department of Agriculture National Institute of Food and Agriculture. Dr. Costello, Dr. VanWagner, Dr. Ducatman, and Dr. Fenton report no relevant financial relationships.

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

Exposure to per- and polyfluoroalkyl substances (PFAS) - a class of widely used synthetic chemicals dubbed “forever chemicals” - can lead to liver damage and may be a culprit in rising rates of nonalcoholic fatty liver disease (NAFLD), say the authors of a comprehensive evidence review.

They found “consistent” evidence for PFAS hepatotoxicity from rodent studies. In addition, exposure to PFAS was found to be associated with markers of liver function in observational studies in people.

The review, published online in Environmental Health Perspectives, may be the first systematic analysis of PFAS exposure and liver damage.

Possible contributor to growing NAFLD epidemic

In their analysis, the authors included 85 rodent studies and 24 epidemiologic studies, primarily involving people from the United States and largely focusing on four “legacy” PFAS: perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS).

Meta-analyses of human studies found that higher levels of alanine aminotransferase were significantly associated with exposure to three of the older chemicals – PFOA, PFOS, and PFNA.

The “positive” and “convincing” associations between exposure to these synthetic chemicals and higher ALT levels suggest that exposure may contribute to the growing NAFLD epidemic, the researchers write.

Exposure to one of the chemicals, PFOA, was also associated with higher aspartate aminotransferase and gamma-glutamyl transferase levels in people.

In rodents, exposure to these synthetic chemicals consistently resulted in higher ALT levels and steatosis.

“The mechanism is not well understood yet, but there are a few proposed theories,” first author Elizabeth Costello, MPH, PhD student, department of population and public health sciences, University of Southern California, Los Angeles, told this news organization.

“PFAS are similar to fatty acids in chemical structure, so it’s possible that they activate some of the same receptors or otherwise interfere with fat metabolism. This might lead to inflammation or fat accumulation in the liver,” Ms. Costello explained.

People widely exposed

PFAS are ubiquitous in the environment. They have been detected in the blood of most people and have been linked to a variety of health concerns. Possible sources of PFAS exposure run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.

“We are exposed to PFAS in so many ways – through water, food, and products we use. It can be very difficult for individuals to control their own exposure,” Ms. Costello commented.

“At this point, it’s important to look for ways to remove PFAS from the environment and phase them out of our products and carefully consider the safety of any replacement chemicals,” she said.

Although most of the research to date has been limited to the four older PFAS (PFOA, PFOS, PFNA, and PFHxS), there are thousands of different PFAS chemicals.

“We don’t know very much about the effects of exposure to multiple PFAS at the same time or how newer replacement PFAS might affect liver disease or other health conditions,” Ms. Costello said.

Reached for comment, Lisa B. VanWagner, MD, with Northwestern University, Chicago, said this analysis is “very interesting,” but she is also “left wondering how we could do anything since it seems from my reading that these chemicals are ubiquitous and used regularly in the environment.”

Dr. VanWagner, who was not involved in the study, said the major limitation is the small number of human studies and the high heterogeneity between studies, “meaning it is hard to come to a firm conclusion about whether what has been observed in the animal studies does truly apply to humans.

“Overall, this study provides important proof of concept for future work to look more specifically at PFAS exposure, and more specific markers of fatty liver disease and liver damage, like liver biopsy, are needed in humans,” Dr. VanWagner said.

“If data accumulate showing that these chemicals do in fact contribute to fatty liver and worsening inflammation or liver damage as a result of exposure, then public health interventions to remove or reduce use of these chemicals could have wide-ranging public health effects,” Dr. VanWagner added.

Further research needed

The authors of an invited perspective published with the study say it underscores the “urgent need for further research and for immediate and reasonable public health action.”

“This work firmly puts PFAS exposure on the list of persistent pollutants, such as polychlorinated biphenyls, that cause hepatotoxicity and whose mechanism is linked to steatosis,” write Alan Ducatman, MD. MSc, with West Virginia University School of Public Health, Morgantown, and Suzanne Fenton, PhD, MS, with the National Institute of Environmental Health Sciences, Research Triangle Park, N.C.

They say other important questions raised by this review include whether individuals who are overweight or obese and those with diabetes are more susceptible to PFAS hepatoxicity, which “replacement” or emerging PFAS can cause liver damage, and whether high doses cause different kinds of liver toxicity than low doses.

“GenX, a current replacement [chemical] for PFOA, has shown significant hepatotoxicity in several recent experimental studies, suggesting it may not be a safe replacement,” they point out.

“A significant challenge will be deciding which of the multiple metabolic pathways altered by PFAS are most important and predictive for induction of liver damage and for progression of liver disease, so that emerging PFAS may be screened for hepatotoxicity prior to entering the market,” Dr. Ducatman and Dr. Fenton conclude.

Support for this research was provided by the National Institute of Environmental Health Science, part of the National Institutes of Health, and the U.S. Department of Agriculture National Institute of Food and Agriculture. Dr. Costello, Dr. VanWagner, Dr. Ducatman, and Dr. Fenton report no relevant financial relationships.

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