MDedge Emergency Medicine

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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

The more boosters the better? Data from Israel show that immune protection in elderly people is strengthened even further after a fourth dose. Karl Lauterbach, MD, German minister of health, recently pleaded for a second booster for those aged 18 years and older, and he pushed for a European Union–wide recommendation. He has not been able to implement this yet.

Just as before, Germany’s Standing Committee on Vaccination (STIKO) is only recommending the second booster for people aged 70 years and older, the European Medicines Agency (EMA) is recommending the fourth vaccination for everyone aged 80 years and older, and the United States has set the general age limit at 50 years.

Specialists remain skeptical about expanding the availability of the second booster. “From an immunologic perspective, people under the age of 70 with a healthy immune system do not need this fourth vaccination,” said Christiane Falk, PhD, head of the Institute for Transplantation Immunology of the Hannover Medical School (Germany) and member of the German Federal Government COVID Expert Panel, at a Science Media Center press briefing.

After the second vaccination, young healthy people are sufficiently protected against a severe course of the disease. Dr. Falk sees the STIKO recommendation as feasible, since it can be worked with. People in nursing facilities or those with additional underlying conditions would be considered for a fourth vaccination, explained Dr. Falk.
 

Complete protection unrealistic

Achieving complete protection against infection through multiple boosters is not realistic, said Christoph Neumann-Haefelin, MD, head of the Working Group for Translational Virus Immunology at the Clinic for Internal Medicine II, University Hospital Freiburg, Germany. Therefore, this should not be pursued when discussing boosters. “The aim of the booster vaccination should be to protect different groups of people against severe courses of the disease,” said Dr. Neumann-Haefelin.

Neutralizing antibodies that are only present in high concentrations for a few weeks after infection or vaccination are sometimes able to prevent the infection on their own. The immunologic memory of B cells and T cells, which ensures long-lasting protection against severe courses of the disease, is at a high level after two doses, and a third dose increases the protection more.

While people with a weak immune system need significantly more vaccinations in a shorter period to receive the same protection, too many booster vaccinations against SARS-CoV-2 are not sensible for young healthy people.
 

Immune saturation effect

A recent study in macaques showed that an adjusted Omicron booster did not lead to higher antibody titers, compared with a usual booster. In January 2022, the EMA warned against frequent consecutive boosters that may no longer produce the desired immune response.

If someone receives a booster too early, a saturation effect can occur, warned Andreas Radbruch, PhD, scientific director of the German Rheumatism Research Center Berlin. “We know this from lots of experimental studies but also from lots of other vaccinations. For example, you cannot be vaccinated against tetanus twice at 3- or 4-week intervals. Nothing at all will happen the second time,” explained Dr. Radbruch.

If the same antigen is applied again and again at the same dose, the immune system is made so active that the antigen is directly intercepted and cannot have any new effect on the immune system. This mechanism has been known for a long time, said Dr. Radbruch.
 

‘Original antigenic sin’

Premature boosting could even be a handicap in the competition between immune response and virus, said Dr. Radbruch. This is due to the principle of “original antigenic sin.” If the immune system has already come into contact with a virus, contact with a new virus variant will cause it to form antibodies predominantly against those epitopes that were already present in the original virus. As a result of this, too many boosters can weaken protection against different variants.

“We have not actually observed this with SARS-CoV-2, however,” said Dr. Radbruch. “Immunity is always extremely broad. With a double or triple vaccination, all previously existing variants are covered by an affinity-matured immune system.”

Dr. Neumann-Haefelin confirmed this and added that all virus mutations, including Omicron, have different epitopes that affect the antibody response, but the T-cell response does not differ.

Dr. Radbruch said that the vaccine protection probably lasts for decades. Following an infection or vaccination, the antibody concentration in the bone marrow is similar to that achieved after a measles or tetanus vaccination. “The vaccination is already extremely efficient. You have protection at the same magnitude as for other infectious diseases or vaccinations, which is expected to last decades,” said Dr. Radbruch.

He clarified that the decrease in antibodies after vaccination and infection is normal and does not indicate a drop in protection. “Quantity and quality must not be confused here. There is simply less mass, but the grade of remaining antibody increases.”

In the competition around the virus antigens (referred to as affinity maturation), antibodies develop that bind 10 to 100 times better and are particularly protective against the virus. The immune system is thereby sustainably effective.
 

For whom and when?

Since the immune response is age dependent, it makes more sense to administer an additional booster to elderly people than to young people. Also included in this group, however, are people whose immune system still does not provide the same level of protection after the second or even third vaccination as that of younger, healthy people.

Dr. Radbruch noted that 4% of people older than 70 years exhibited autoantibodies against interferons. The effects are huge. “That is 20% of patients in an intensive care unit – and they all have a very poor prognosis,” said Dr. Radbruch. These people are extremely threatened by the virus. Multiple vaccinations are sensible for them.

Even people with a weak immune response benefit from multiple vaccinations, confirmed Dr. Neumann-Haefelin. “We are not seeing the antibody responses here that we see in young people with healthy immune systems until the third or fourth vaccination sometimes.”

Although for young healthy people, it is particularly important to ensure a sufficient period between vaccinations so that the affinity maturation is not impaired, those with a weak immune response can be vaccinated again as soon as after 3 months.

The “optimum minimum period of time” for people with healthy immune systems is 6 months, according to Dr. Neumann-Haefelin. “This is true for everyone in whom a proper response is expected.” The vaccine protection probably lasts significantly longer, and therefore, frequent boosting may not be necessary in the future, he said. The time separation also applies for medical personnel, for whom the Robert Koch Institute also recommends a second booster.

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.

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.

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

Topline results from the phase 3 DELIVER trial show dapagliflozin (Farxiga) significantly reduced the primary endpoint of cardiovascular death or worsening heart failure in patients with mildly reduced or preserved ejection fraction, AstraZeneca announced today.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor is not approved in this setting but is already approved for treatment of type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction.

“The results of DELIVER extend the benefit of dapagliflozin to the full spectrum of patients with heart failure,” principal investigator of the trial, Scott Solomon, MD, Harvard Medical School and Brigham and Women’s Hospital, Boston, said in the news release.

The safety and tolerability of dapagliflozin in the trial were consistent with its established safety profile, the company says.

The full trial results will be submitted for presentation at a forthcoming medical meeting, and regulatory submissions will be made in the coming months, it notes.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

From stubborn high blood pressure to diverticulitis, two deputy editors of the Annals of Internal Medicine reviewed eight recently published articles they feel will influence practice.

1. Adding a New Medication Versus Maximizing Dose to Intensify Hypertension Treatment in Older Adults: A Retrospective Observational Study

Roughly one in three adults with hypertension have inadequate blood pressure control, and clinicians have two options for intensifying treatment: “The dose of the current drug regimen can be maximized, or a new drug can be added,” said deputy editor Christina C. Wee, MD, MPH, at the annual meeting of the American College of Physicians.

Data from randomized controlled trials suggest treatment with lower doses of combination therapy may be more effective, with fewer side effects – although the best strategy in older adults remains unclear.

To answer that question, researchers conducted a large-scale, population-based, retrospective cohort study, and observational data were used to emulate a target trial with two groups: new medication and maximizing dose.

The cohort comprised people aged 65 years or older with hypertension and was limited to those with a systolic blood pressure of 130 mm Hg or higher. Two intensification approaches were used: adding a new medication, defined as a total dose increase with a new medication; and maximizing dose, defined as a total dose increase without new medication.

A total of 178,562 patients were included in the study, and 45,575 (25.5%) had intensification by adding a new medication and 132,987 (74.5%) by maximizing dose.

“Both produced systolic blood pressure reduction with a slight advantage in the ‘add a new medication’ group,” Dr. Wee said. “That group reduced their systolic blood pressure by over 4.5 points as compared to 3.8 points in the maximized [dose] group.”

At 12 months the results were similar, but only 50% of patients in the new medication group were able to sustain that strategy, compared with two-thirds of patients who had their dose increased.

“This suggests that, in older adults, adding a new antihypertensive medication versus maximizing dosing of existing regimen is less common, only minimally more effective, and less sustainable,” Dr. Wee said. “Maximizing dose of antihypertensive medication is a reasonable approach [and] may be easier to sustain.”
 

2. Cost-Effectiveness of Screening Mammography Beyond Age 75 Years: A Cost-Effectiveness Analysis

The U.S. Preventive Services Task Force recommends biennial screening mammograms through the age of 74 years, and a meta-analysis of randomized controlled trials suggests mortality is reduced among women with at least a 10-year life expectancy, Dr. Wee said.

However, whether screening beyond age 75 years is cost effective, especially among women with comorbidities, is unclear.

To address that question, researchers estimated benefits, harms, and cost-effectiveness of extending mammography to age 80, 85, or 90 years according to comorbidity burden, using data from the Surveillance, Epidemiology, and End Results program and the Breast Cancer Surveillance Consortium.

The results showed that extending annual mammography beyond age 75 years was not cost effective, but biennial mammography was. “It was cost effective to age 80 regardless of baseline comorbidity score, but it averted only small, absolute numbers of breast cancer deaths – especially for women with comorbidities,” Dr. Wee said. “It was not cost effective beyond age 80.”
 

3. Prediction of End-Stage Kidney Disease Using Estimated Glomerular Filtration Rate With and Without Race: A Prospective Cohort Study

Estimated glomerular filtration rate (eGFR) is associated with end-stage kidney disease (ESKD) and is used to make dialysis and transplant decisions. “However, the accuracy of using eGFR alone has been questioned and, previously, some eGFR equations included a correction for race and this has been quite controversial,” Dr. Wee said. “And just last year, the Chronic Kidney Disease Epidemiology Collaboration released their new equations, removing the adjustment for race.”

The study authors posed two questions:

• How well does eGFR alone predict risk of ESKD, compared with Kidney Function Risk Equation (KFRE)?  
• Does using different eGFR equations affect performance of either eGFR alone or KFRE in predicting the risk of ESKD?

During a maximum 16 years of follow-up, 856 participants (n = 3,873) developed ESKD. Across all eGFR equations, the KFRE score was superior for predicting 2-year incidence of end-stage kidney disease, compared with eGFR alone.

“KFRE score better predicted 2-year risk of ESKD than eGFR alone regardless of eGFR equations used,” Dr. Wee said. “Correcting eGFR equations for race did not improve performance and validates recent guidelines.”
 

4. Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy: A Propensity Score-Matched Cohort Study

The study looked at the comparative risks of drug holidays after long-term (≥ 3 years) risedronate versus alendronate therapy in a cohort of individuals aged 66 years or older. The primary outcome was hip fracture within 3 years after a 120-day ascertainment period.

The cohort included 25,077 propensity score–matched pairs (81% female) with a mean age of 81 years. Hip fracture rates were higher among risedronate than alendronate drug holidays, although this association was attenuated when any fracture was included as the outcome.

Overall, risedronate treatment before a drug holiday was associated with an 18% greater risk of hip fractures than alendronate, and this relative increase translated to a small absolute increase of 0.6%.

“These differences primarily manifested after 24 months, but given these small differences, I’m not sure if we need to change our current management strategy,” Dr. Wee said. “But further study is warranted.”
 

5. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults: A Response-Adaptive, Randomized Clinical Trial

This study assessed the effects of four doses of vitamin D₃ supplements on the risk of falls.

The cohort included 688 participants, aged 70 years and older, with an elevated fall risk and a serum 25-hydroxyvitamin D level of 25-72.5 nmol/L. The intervention was 200 (control), 1,000, 2,000, or 4,000 IU of vitamin D3 per day.

“Their results showed that supplementation at doses of 1,000 IU/day or higher did not prevent falls compared with 200 IU/day,” said deputy editor Stephanie Chang, MD, MPH. “Several analyses raised safety concerns about vitamin D3 doses of 1,000 IU/day or higher.”
 

6. Postdiagnosis Smoking Cessation and Reduced Risk for Lung Cancer Progression and Mortality: A Prospective Cohort Study

This study sought to determine if quitting smoking after a diagnosis of lung cancer reduced the risk for disease progression and mortality. Researchers prospectively analyzed patients with non–small cell lung cancer (NSCLC) who were recruited between 2007 and 2016 and followed annually through 2020. The cohort comprised 517 current smokers who were diagnosed with early-stage (IA-IIIA) NSCLC.

The adjusted median overall survival time was 21.6 months higher among patients who quit smoking versus those who continued smoking, and a higher 5-year overall and progression-free survival were observed among patients who quit than those who continued smoking. After adjusting for confounders, smoking cessation remained associated with a lower risk for all-cause mortality, cancer-specific mortality, and disease progression.
 

7. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events

This study sought to determine if alcohol consumption heightened the risk for an episode of atrial fibrillation (AFib). The cohort included 100 individuals with paroxysmal AFib who were fitted with a continuous electrocardiogram monitor and an ankle-worn transdermal ethanol sensor for 4 weeks. Real-time documentation of each alcoholic drink consumed was self-recorded and finger-stick blood tests for phosphatidylethanol were used to corroborate ascertainments of drinking events.

Phosphatidylethanol testing correlated with the number of real-time recorded drinks and with the transdermal alcohol sensor. Consuming one alcoholic drink was associated with a twofold increased risk of AFib over the next 4 hours. The risk rose threefold with the consumption of two drinks.

“There is evidence of dose-response relationship with higher risk with more drinks,” Dr. Chang said. “Even one drink may predispose to an acute episode of AF[ib] in those so predisposed.”
 

8. Evaluation and Management After Acute Left-Sided Colonic Diverticulitis: A Systematic Review

Management of uncomplicated diverticulitis is usually conservative and includes bowel rest and fluids. However, uncertainty remains about the role of hospitalization and antibiotics, Dr. Chang said. The new review included 51 studies looking at colonoscopy, nonsurgical treatments, and elective surgery for patients with diverticulitis.

It was unclear if patients with recent acute diverticulitis are at increased risk for colorectal cancer, although those with complicated diverticulitis do appear to be at a higher risk of the disease. Treatment with mesalamine was shown to be ineffective in preventing recurrence, and other nonsurgical treatments lacked adequate evidence.

As for surgery, elective procedures reduce recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most.

“The ACP recommends initial management without antibiotics,” said Dr. Chang, adding that other questions need to be addressed, such as inpatient versus outpatient management and elective surgery after an acute episode.

Dr. Wee and Dr. Chang disclosed no relevant financial relationships.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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.

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

Fecal matter may be in the fountain of youth

Yes, you read that headline correctly. New research by scientists at Quadram Institute and the University of East Anglia, both in Norwich, England, supports the claim that transferring fecal microbes might actually have some positive effects on reversing the aging process in the eyes, brain, and gut.

How do they know? Mice, of course. In the study, scientists took the gut microbes from older mice and transferred them into the younger mince. The young mice displayed inflamed signs of aging in their guts, brains, and eyes, which, we all know, decline in function as we age. What happens is a chronic inflammation of cells as we get older that can be found in the brain or gut that leads to a degenerative state over time.

Albrecht Fietz/Pixabay

When the older mice received the gut microbes from younger mice, the investigators saw the reverse: Gut, brain, and eye functionality improved. In a way, minimizing the inflammation.

There’s tons of research out there that suggests gut health is the key to a healthy life, but this study points directly to an improvement in brain and vision functionality as a result of the transfer.

Now, we’re not insinuating you get a poo transfer as you reach old age. And the shift to human studies on microbiota replacement therapy is still in the works. But this definitely is a topic to watch and could be a game changer in the age-old quest to bottle youth or at least improve quality of life as we age.

For now, the scientists did find some connections between the beneficial bacteria in the transplants and the human diet that could have similar effects, like changes in the metabolism of certain fats and vitamin that could have effects on the inflammatory cells in the eye and brain.

The more you know!
 

It’s not lying, it’s preemptive truth

Lying is bad. Bold statement, we know, but a true one. After all, God spent an entire commandment telling people not to do the whole bearing false witness thing, and God is generally known for not joking around. He’s a pretty serious dude.

In case you’ve been wandering around the desert for a while and haven’t had wifi, we have a bit of a misinformation problem these days. People lie all the time about a lot of things, and a lot of people believe the lies. According to new research, however, there are also a lot of people who recognize the lies but accept them anyway because they believe that the lies will become true in the future.

Peter Timmerhues/Pixabay

Imagine the following scenario: A friend gets a job he’s not qualified for because he listed a skill he doesn’t have. That’s bad, right? And the people the researchers interviewed agreed, at least initially. But when informed that our friend is planning on obtaining the skill in summer classes in the near future, the study participants became far more willing to excuse the initial lie.

A friend jumping the gun on training he doesn’t have yet is fairly innocuous as far as lying goes, but as the researchers found, this willingness to forgive lies because they could become true extends far further. For example, millions of people do not vote illegally in U.S. elections, nor do White people get approved for mortgages at rates 300% higher than minorities, but when asked to imagine scenarios in which those statements could be true, study participants were less likely to condemn the lie and prevent it from spreading further, especially if their political viewpoints aligned with the respective falsehood.

It seems, then, that while we may aspire to not tell lies, we take after another guy with magic powers who spent too much time in the desert: “What I told you was true, from a certain point of view.”
 

It tastes like feng shui, but it’s not

You know about biomes. You’ve read about various microbiomes. Allow us to introduce you to the envirome,

The envirome “includes all the natural and man-made elements of our environment throughout the lifespan, notably the built environment,” said Robert Schneider, dean of the College of Integrative Medicine at Maharishi International University. Located in – you guessed it – Fairfield, Iowa, and home of the Fighting Transcendentalists. MAHARISHI RULES!

Free-Photos/Pixabay

• The headboard of a bed should be oriented to the east or south when you sleep. This will improve mental health.
• While sitting at a desk or work area, a person should face east or north to improve brain coherence.
• The main entrance of a house should face east because morning light is superior to afternoon light.

And you were worried about feng shui. Well, forget feng shui. Feng shui is for amateurs. MVA is the way to go. MVA is the GOAT. MAHARISHI RULES!

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.

Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
 

Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.
 

Consistently sleeping 7 hours per night was associated with optimal cognitive function and mental health for middle-aged adults, a new study found.

Sleep disturbances are common in older age, and previous studies have shown associations between too much or too little sleep and increased risk of cognitive decline, but the ideal amount of sleep for preserving mental health has not been well described, according to the authors of the new paper.

In the study published in Nature Aging, the team of researchers from China and the United Kingdom reviewed data from the UK Biobank, a national database of individuals in the United Kingdom that includes cognitive assessments, mental health questionnaires, and brain imaging data, as well as genetic information.

Sleep is important for physical and psychological health, and also serves a neuroprotective function by clearing waste products from the brain, lead author Yuzhu Li of Fudan University, Shanghai, China, and colleagues wrote.

The study population included 498,277 participants, aged 38-73 years, who completed touchscreen questionnaires about sleep duration between 2006 and 2010. The average age at baseline was 56.5 years, 54% were female, and the mean sleep duration was 7.15 hours.

The researchers also reviewed brain imaging data and genetic data from 39,692 participants in 2014 to examine the relationships between sleep duration and brain structure and between sleep duration and genetic risk. In addition, 156,884 participants completed an online follow-up mental health questionnaire in 2016-2017 to assess the longitudinal impact of sleep on mental health.

Both excessive and insufficient sleep was associated with impaired cognitive performance, evidenced by the U-shaped curve found by the researchers in their data analysis, which used quadratic associations.

Specific cognitive functions including pair matching, trail making, prospective memory, and reaction time were significantly impaired with too much or too little sleep, the researchers said. “This demonstrated the positive association of both insufficient and excessive sleep duration with inferior performance on cognitive tasks.”

When the researchers analyzed the association between sleep duration and mental health, sleep duration also showed a U-shaped association with symptoms of anxiety, depression, mental distress, mania, and self-harm, while well-being showed an inverted U-shape. All associations between sleep duration and mental health were statistically significant after controlling for confounding variables (P < .001).

On further analysis (using two-line tests), the researchers determined that consistent sleep duration of approximately 7 hours per night was optimal for cognitive performance and for good mental health.

The researchers also used neuroimaging data to examine the relationship between sleep duration and brain structure. Overall, greater changes were seen in the regions of the brain involved in cognitive processing and memory.

“The most significant cortical volumes nonlinearly associated with sleep duration included the precentral cortex, the superior frontal gyrus, the lateral orbitofrontal cortex, the pars orbitalis, the frontal pole, and the middle temporal cortex,” the researchers wrote (P < .05 for all).

The association between sleep duration and cognitive function diminished among individuals older than 65 years, compared with those aged approximately 40 years, which suggests that optimal sleep duration may be more beneficial in middle age, the researchers noted. However, no similar impact of age was seen for mental health. For brain structure, the nonlinear relationship between sleep duration and cortical volumes was greatest in those aged 44-59 years, and gradually flattened with older age.
 

Research supports sleep discussions with patients

“Primary care physicians can use this study in their discussions with middle-aged and older patients to recommend optimal sleep duration and measures to achieve this sleep target,” Noel Deep, MD, a general internist in group practice in Antigo, Wisc., who was not involved in the study, said in an interview.

“This study is important because it demonstrated that both inadequate and excessive sleep patterns were associated with cognitive and mental health changes,” said Dr. Deep. “It supported previous observations of cognitive decline and mental health disorders being linked to disturbed sleep. But this study was unique because it provides data supporting an optimal sleep duration of 7 hours and the ill effects of both insufficient and excessive sleep duration.

“The usual thought process has been to assume that older individuals may not require as much sleep as the younger individuals, but this study supports an optimal time duration of sleep of 7 hours that benefits the older individuals. It was also interesting to note the mental health effects caused by the inadequate and excessive sleep durations,” he added.

As for additional research, “I would like to look into the quality of the sleep, in addition to the duration of sleep,” said Dr. Deep. For example, whether the excessive sleep was caused by poor quality sleep or fragmented sleep leading to the structural and subsequent cognitive decline.
 

Study limitations

“The current study relied on self-reporting of the sleep duration and was not observed and recorded data,” Dr. Deep noted. “It would also be beneficial to not only rely on healthy volunteers reporting the sleep duration, but also obtain sleep data from individuals with known brain disorders.”

The study findings were limited by several other factors, including the use of total sleep duration only, without other measures of sleep hygiene, the researchers noted. More research is needed to investigate the mechanisms driving the association between too much and not enough sleep and poor mental health and cognitive function.

The study was supported by the National Key R&D Program of China, the Shanghai Municipal Science and Technology Major Project, the Shanghai Center for Brain Science and Brain-Inspired Technology, the 111 Project, the National Natural Sciences Foundation of China and the Shanghai Rising Star Program.

The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the editorial advisory board of Internal Medicine News.