Feature

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

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

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

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

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

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

Be aware of what’s in the contract

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

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

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

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

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

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

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

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

Clarify call coverage

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

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

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

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

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

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

Differences in specialties and settings

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

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

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

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

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

Using scribes to maximize your time

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

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

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

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

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

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

Creating time-efficient strategies

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

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

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

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

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

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

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

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

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

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

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

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

Be aware of what’s in the contract

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

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

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

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

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

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

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

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

Clarify call coverage

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

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

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

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

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

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

Differences in specialties and settings

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

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

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

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

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

Using scribes to maximize your time

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

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

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

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

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

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

Creating time-efficient strategies

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

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

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

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

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

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

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

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

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

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

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

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

Be aware of what’s in the contract

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

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

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

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

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

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

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

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

Clarify call coverage

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

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

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

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

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

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

Differences in specialties and settings

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

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

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

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

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

Using scribes to maximize your time

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

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

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

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

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

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

Creating time-efficient strategies

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

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

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

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

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

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

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

During a fellowship rotation in gynecology, Rebekah D. Fenton, MD, asked the attending physicians what pain management options they could offer patients for insertion of an intrauterine device (IUD). Their answer surprised her: None. 

The research on the effectiveness of pain management techniques during the procedure were not strong enough to warrant providing potential relief. 

But Dr. Fenton knew the attending physician was wrong: She’d received the drug lidocaine during a recent visit to her own ob.gyn. to get an IUD placed. The local anesthetic enabled her to avoid the experiences of many patients who often withstand debilitating cramping and pain during insertion, side effects that can last for hours after the procedure has ended.

By not teaching her how to administer pain treatment options such as lidocaine gel or injection, “they made the decision for me, whether I could give patients this option,” said Dr. Fenton, now an adolescent medicine specialist at Alivio Medical Center in Chicago.

Without clear guidelines, pain management decisions for routine gynecologic procedures are largely left up to individual clinicians. As a result, patients undergoing IUD placements, biopsies, hysteroscopies, and pelvic exams are often subject to pain that could be mitigated. 

Some research suggests simple numbing agents, including lidocaine, may induce less pain without the need for full anesthesia. But clinicians don’t always present these options.

During gynecologic procedures, the amount of pain a patient can expect is often downplayed by clinicians. Because every patient experiences the sensation differently, discussing options for pain management and the range of possible pain is paramount in building patient-clinician trust, and ultimately providing the best care for patients in the long run, according to Megan Wasson, DO, chair of the department of medical and surgical gynecology at Mayo Clinic Arizona in Phoenix. 

“It comes down to shared decision-making so the patient is aware of the pain that should be expected and what avenue they want to go down,” Dr. Wasson said. “It’s not a one-size-fits-all.”
 

Lack of uniform protocols

The American College of Obstetricians and Gynecologists (ACOG) has clear guidelines for pain management during pregnancy and delivery but not for many routine gynecologic procedures. Some experts say not offering options for pain management based on lack of efficacy evidence can undermine a patient’s experience. 

ACOG does have recommendations for reducing dilation pain during a hysteroscopy, including providing intravaginal misoprostol and estrogen. The organization also recommends performing a vaginoscopy instead if possible because the procedure is typically less painful than is a hysteroscopy. 

For an IUD placement, ACOG states that the procedure “may cause temporary discomfort” and recommends that patients take over-the-counter pain relief before a procedure. The most recent clinical bulletin on the topic, published in 2016, states routine misoprostol is not recommended for IUD placement, although it may be considered with difficult insertions for management of pain. 

A clinical inquiry published in 2020 outlined the efficacy of several pain options that practitioners can weigh with patients. The inquiry cited a 2019 meta-analysis of 38 studies that found lidocaine-prilocaine cream to be the most effective option for pain management during IUD placement, reducing insertion pain by nearly 30%. The inquiry concluded that a combination of 600 mcg of misoprostol and 4% lidocaine gel may be effective, while lower dosages of both drugs were not effective. A 2018 clinical trial cited in the analysis found that though a 20-cc 1% lidocaine paracervical block on its own did not reduce pain, the block mixed with sodium bicarbonate reduced pain during IUD insertion by 22%. 

Some doctors make the decision to not use lidocaine without offering it to patients first, according to Dr. Fenton. Instead, clinicians should discuss any potential drawbacks, such as pain from administering the numbing agent with a needle or the procedure taking extra time while the patient waits for the lidocaine to kick in. 

“That always felt unfair, to make that decision for [the patient],” Dr. Fenton said. 

Often clinicians won’t know how a patient will respond to a procedure: A 2014 secondary analysis of a clinical trial compared how patients rated their pain after an IUD procedure to the amount of pain physicians perceived the procedure to cause. They found that the average pain scores patients reported were nearly twice as high as clinician expectations were.

ACOG’s guideline states that the evidence backing paracervical blocks and lidocaine to IUD insertion pain is controversial. The American College of Physicians also cites “low-quality evidence” to support patient reports of pain and discomfort during pelvic exams. Some studies have found up to 60% of women report these negative experiences. 

The varying evidence highlights the need for a personalized approach – one that includes patients – to pain management for routine gynecological procedures.

“Usually patients are pretty good predictors,” said Lisa Bayer, MD, MPH, associate professor of obstetrics and gynecology at Oregon Health & Science University in Portland. “They can anticipate what different things are going to feel like based on previous experiences.”
 

Making patients part of the discussion

Clinicians should have open discussions with patients about their past experiences and current anxieties about a gynecologic procedure, according to Dr. Bayer.

“Part of it is just creating a really safe environment of trust as a medical provider,” she said. 

A study published in 2016 of more than 800 patients undergoing oocyte retrieval, which has clear protocols for pain management, found that previous negative gynecologic experiences were significantly correlated to greater amounts of pain reported during the procedure. 

If pain isn’t properly managed, patients may avoid care in the future, putting them at risk for unplanned pregnancies, skipped cancer screenings, and complications from undiagnosed conditions and infections, Dr. Bayer added. Clinician offices will not always have access to all pain management options, so making referrals to another physician who has access to the appropriate technique may be the best thing for the patient, Dr. Bayer said. 


 

Downplaying the experience

Informing a patient that she will feel only a little discomfort during a procedure – when a clinician doesn’t know how exactly the patient will react – can also result in distrust. 

When a clinician says, “ ’It’s only going to be a little cramp, it’s only going to be a little pinch,’ we know extreme pain is a possibility, we’ve seen it,” Dr. Fenton said. “But if we choose to disregard that [possibility], it feels invalidating for patients.”

Failing to fully explain the possible pain scale can also directly interfere with the procedure at hand. 

“My first concern is if they aren’t anticipating the amount of pain they are going to experience, they may move; For biopsies and IUD insertions, we need them to be still,” Dr. Wasson said. “If they are unable to tolerate the procedure, we’ve put them through pain and not been able to accomplish the primary goal.”

Managing both pain and what patients can expect is even more crucial for adolescent and teenage patients who are often having their first gynecologic experience. 

“We’re framing what these experiences look like,” Dr. Fenton said. “That means there are opportunities for creating a space that builds trust and security for the patients moving forward.”
 

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

Ultraprocessed foods (UPFs) make up nearly three-quarters of the entire U.S. food supply and about 60% of Americans’ daily caloric intake. A significant body of research has tied consumption of these foods – awash in added sugar, salt, fat, artificial colors, or preservatives – to cancer, diabetes, and heart disease.
 

Now, a growing number of studies also link them to poor brain health, including an increased risk of dementia, depression, and anxiety, and some experts are calling for public health policies aimed at reducing UPF consumption.

But what’s the science behind the link between UPFs and brain health and what does it mean for clinicians and their patients?
 

Under srutiny

A mainstay of diets in countries around the world, UPFs have come under increasing scrutiny because of their link to major diseases. The ingredients in UPFs add little or no nutritional value. Their primary function is to increase a product’s shelf life and palatability. Some recent evidence suggests these foods may be as addictive as tobacco. In addition, two pooled analysis studies using the Yale Food Addiction Scale showed that 14% of adults and 12% of children in the United States may have a UPF addiction.

The most widely used measure of what is, and what is not, a UPF was developed in 2009 by researchers in Brazil. The NOVA food classification system assigns food and beverages to one of four groups:

• Unprocessed and minimally processed foods, such as fruits, vegetables, milk, and meat.
• Processed culinary ingredients, including white sugar, butter, and oils derived from seeds, nuts, and fruits.
• Processed foods, such as tomato paste, bacon, canned tuna, and wine.
• Ultraprocessed foods, such as soda, ice cream, breakfast cereal, and prepackaged meals.

Those sounding the alarm about the potential harmful effects of UPFs are particularly concerned about their consumption by young people. The National Health and Nutrition Examination Survey showed that from 1999 to 2018, highly processed foods accounted for the majority of energy intake in those aged 2-19 years.

One of the most commonly used additives in UPFs, the artificial sweetener aspartame, garnered headlines this summer when the World Health Organization classified it as a likely carcinogen in humans. Aspartame is used in thousands of products, from soda to chewing gum to chewable vitamins.

The U.S. Food and Drug Administration strongly disagreed with the WHO’s position and is sticking by its recommended daily limit of 50 mg/kg of body weight – equivalent to 75 packets of the sweetener Equal – as safe for human consumption.

“Aspartame is one of the most studied food additives in the human food supply,” FDA officials said in a statement, adding that the agency found “significant shortcomings” in the studies the WHO used to justify the new classification. “FDA scientists do not have safety concerns when aspartame is used under the approved conditions.”

Increased attention to consumption of UPFs in general and aspartame particularly in recent years has yielded several studies pointing to the foods’ association with compromised brain health.
 

Link to depression, dementia

A recent report on UPF consumption and mental well-being among nearly 300,000 people across 70 countries showed that 53% of those who consumed UPFs several times a day were distressed or were struggling with their mental well-being, compared with 18% of those who rarely or never consumed UPFs.

Part of the Global Mind Project run by the nonprofit Sapien Labs in Arlington, Va., the report also showed that individuals with the highest rates of UPF consumption reported higher levels of confusion, slowed thinking, unwanted or obsessive thoughts, irritability, and feelings of sadness.

“There seems to be a much broader effect than just depression symptoms,” Tara Thiagarajan, PhD, founder and chief scientist of Sapien Labs and coauthor of the report, said in an interview.

The report, which has not been peer reviewed, comes on the heels of several other studies, including one from the Nurses Health Study II that showed that participants who consumed more than eight servings of UPFs daily had about a 50% higher depression risk, compared with those who consumed half that much.

“We found that UPFs in general, and artificial sweeteners and beverages in particular, were associated with increased risk,” said lead investigator Andrew T. Chan, MD, MPH, professor of medicine at Harvard Medical School and chief of the clinical and translational epidemiology unit, Massachusetts General Hospital, both in Boston.

“This was an interesting finding that correlates with data from animal studies that artificial sweeteners may trigger the transmission of particular signaling molecules in the brain that are important for mood,” he told this news organization.

Cognition may also be affected. An analysis of more than 72,000 people in the UK Biobank showed that those who consumed a high levels of UPFs were 50% more likely to develop dementia than those who consumed fewer processed foods. For every 10% increase in UPF consumption, the odds of developing any kind of dementia increased by 25%.

Another study of nearly 11,000 people showed that higher UPF consumption was associated with a significantly faster decline in executive and global cognitive function.
 

Epigenetic changes

While these and other studies suggest a link between UPF consumption and brain health, they are designed to demonstrate correlation. To date, no human study has proven that eating highly processed foods directly causes a decline in mental health or cognition.

Animal studies could provide that causal link. Earlier this year, researchers at Florida State University in Tallahassee reported learning and memory deficits in two groups of male mice that completed a maze test after being fed water mixed with aspartame for about 20% of their adult lives, compared with a group of mice that drank water only. Animals that ingested aspartame could finish the test, but it took them longer, and they needed help.

The amount of aspartame used in the study was just 7% and 15% of the FDA’s recommended maximum intake of aspartame (equivalent to two to four 8-ounce diet sodas daily).

Most intriguing was that offspring of the mice in the aspartame groups demonstrated the same levels of cognitive decline and anxiety as their fathers, even though they had never ingested the artificial sweetener. Researchers theorize that in addition to changes in brain gene expression, aspartame also caused epigenetic changes in germ cells.

“Epigenetic changes in germ cells due to environmental exposures are both good and bad,” lead investigator Pradeep G. Bhide, PhD, professor of developmental neuroscience and director of the Center for Brain Repair at FSU, told this news organization. “They are bad because the next generation is affected. But they’re good because as long as the exposure no longer occurs, 2 or 3 generations later, that’s gone.”

The mice, which lacked taste receptors for aspartame, were the same age and weight in all three groups. Because the only difference was exposure to the artificial sweetener, Dr. Bhide says it suggests a causal link.

“Extrapolation of data from well-controlled laboratory experiments in mice to humans is always risky,” Dr. Bhide said. “The extrapolations give us insights into what could happen rather than what will happen.”
 

Potential mechanisms

Although scientists can’t say for certain how UPFs affect brain health, there are several theories. UPFs may influence an inflammatory immune response, which has been linked to depression and dementia. Consumption of highly processed foods may also disrupt the gut microbiome, Dr. Chan said, which, in turn, may increase depression risk.

“This is an important potential mechanism linking ultraprocessed food to depression since there is emerging evidence that microbes in the gut have been linked with mood through their role in metabolizing and producing proteins that have activity in the brain,” he said.

In addition, with UPFs that contain aspartame, there could be a more direct link to brain function. In the gastrointestinal track, the sweetener is quickly broken down into methanol, aspartic acid, and phenylalanine. All three enter the bloodstream, cross the blood-brain barrier, and are neuroactive.

“Phenylalanine is a precursor for neurotransmitters in the brain, and aspartic acid activates the glutamate excitatory neurotransmitter receptor,” Dr. Bhide said. “The effects we’ve seen could be due to these metabolites that have a direct effect on the brain function.”
 

Time to act?

Some researchers are building a case for classifying UPFs as addictive substances. Others are calling for additional research on UPF safety that is conducted outside the food industry.

There has also been some discussion of placing warning labels on UPFs. However, there is disagreement about what information should be included and how consumers might interpret it. The question of which food products are UPFs and which are not also isn’t settled. The NOVA system may be widely used, but it still has its detractors who believe it misclassifies some healthy foods as ultraprocessed.

Dr. Chan and other experts say the research conducted thus far requires additional corroboration to inform appropriate public health interventions. That would likely take the form of a large, randomized trial with one group of participants eating a healthy diet and the other consuming large amounts of UPFs.

“This type of study is extremely challenging given the number of people that would have to be willing to participate and be willing to eat a very specific diet over a long period of time,” Dr. Chan said. “I am also not sure it would be ethical to assign people to such a diet, given what we already know about the potential health effects of UPFs.”

Dr. Thiagarajan and others have called on funding agencies to direct more grant monies toward studies of UPFs to better understand their effect on brain health.

“Given the magnitude of the problem and given that there is a fair bit of evidence that points to a potential causal link, then we damn well better put money into this and get to the bottom of it,” she said.

Others are looking to the FDA to increase the agency’s scrutiny of food additives. While some additives such as artificial sweeteners have a place in diets of people with diabetes or obesity, Dr. Bhide suggests it may be wise for healthy individuals to reduce their daily intake of UPFs.

“Our data raise this to a different level because of the transgenerational transmission, which has never been shown before,” he said. “We are saying that the FDA should look in preclinical models at germ cells and maybe transgenerational transmission before approving any food additive.”

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

Ultraprocessed foods (UPFs) make up nearly three-quarters of the entire U.S. food supply and about 60% of Americans’ daily caloric intake. A significant body of research has tied consumption of these foods – awash in added sugar, salt, fat, artificial colors, or preservatives – to cancer, diabetes, and heart disease.
 

Now, a growing number of studies also link them to poor brain health, including an increased risk of dementia, depression, and anxiety, and some experts are calling for public health policies aimed at reducing UPF consumption.

But what’s the science behind the link between UPFs and brain health and what does it mean for clinicians and their patients?
 

Under srutiny

A mainstay of diets in countries around the world, UPFs have come under increasing scrutiny because of their link to major diseases. The ingredients in UPFs add little or no nutritional value. Their primary function is to increase a product’s shelf life and palatability. Some recent evidence suggests these foods may be as addictive as tobacco. In addition, two pooled analysis studies using the Yale Food Addiction Scale showed that 14% of adults and 12% of children in the United States may have a UPF addiction.

The most widely used measure of what is, and what is not, a UPF was developed in 2009 by researchers in Brazil. The NOVA food classification system assigns food and beverages to one of four groups:

• Unprocessed and minimally processed foods, such as fruits, vegetables, milk, and meat.
• Processed culinary ingredients, including white sugar, butter, and oils derived from seeds, nuts, and fruits.
• Processed foods, such as tomato paste, bacon, canned tuna, and wine.
• Ultraprocessed foods, such as soda, ice cream, breakfast cereal, and prepackaged meals.

Those sounding the alarm about the potential harmful effects of UPFs are particularly concerned about their consumption by young people. The National Health and Nutrition Examination Survey showed that from 1999 to 2018, highly processed foods accounted for the majority of energy intake in those aged 2-19 years.

One of the most commonly used additives in UPFs, the artificial sweetener aspartame, garnered headlines this summer when the World Health Organization classified it as a likely carcinogen in humans. Aspartame is used in thousands of products, from soda to chewing gum to chewable vitamins.

The U.S. Food and Drug Administration strongly disagreed with the WHO’s position and is sticking by its recommended daily limit of 50 mg/kg of body weight – equivalent to 75 packets of the sweetener Equal – as safe for human consumption.

“Aspartame is one of the most studied food additives in the human food supply,” FDA officials said in a statement, adding that the agency found “significant shortcomings” in the studies the WHO used to justify the new classification. “FDA scientists do not have safety concerns when aspartame is used under the approved conditions.”

Increased attention to consumption of UPFs in general and aspartame particularly in recent years has yielded several studies pointing to the foods’ association with compromised brain health.
 

Link to depression, dementia

A recent report on UPF consumption and mental well-being among nearly 300,000 people across 70 countries showed that 53% of those who consumed UPFs several times a day were distressed or were struggling with their mental well-being, compared with 18% of those who rarely or never consumed UPFs.

Part of the Global Mind Project run by the nonprofit Sapien Labs in Arlington, Va., the report also showed that individuals with the highest rates of UPF consumption reported higher levels of confusion, slowed thinking, unwanted or obsessive thoughts, irritability, and feelings of sadness.

“There seems to be a much broader effect than just depression symptoms,” Tara Thiagarajan, PhD, founder and chief scientist of Sapien Labs and coauthor of the report, said in an interview.

The report, which has not been peer reviewed, comes on the heels of several other studies, including one from the Nurses Health Study II that showed that participants who consumed more than eight servings of UPFs daily had about a 50% higher depression risk, compared with those who consumed half that much.

“We found that UPFs in general, and artificial sweeteners and beverages in particular, were associated with increased risk,” said lead investigator Andrew T. Chan, MD, MPH, professor of medicine at Harvard Medical School and chief of the clinical and translational epidemiology unit, Massachusetts General Hospital, both in Boston.

“This was an interesting finding that correlates with data from animal studies that artificial sweeteners may trigger the transmission of particular signaling molecules in the brain that are important for mood,” he told this news organization.

Cognition may also be affected. An analysis of more than 72,000 people in the UK Biobank showed that those who consumed a high levels of UPFs were 50% more likely to develop dementia than those who consumed fewer processed foods. For every 10% increase in UPF consumption, the odds of developing any kind of dementia increased by 25%.

Another study of nearly 11,000 people showed that higher UPF consumption was associated with a significantly faster decline in executive and global cognitive function.
 

Epigenetic changes

While these and other studies suggest a link between UPF consumption and brain health, they are designed to demonstrate correlation. To date, no human study has proven that eating highly processed foods directly causes a decline in mental health or cognition.

Animal studies could provide that causal link. Earlier this year, researchers at Florida State University in Tallahassee reported learning and memory deficits in two groups of male mice that completed a maze test after being fed water mixed with aspartame for about 20% of their adult lives, compared with a group of mice that drank water only. Animals that ingested aspartame could finish the test, but it took them longer, and they needed help.

The amount of aspartame used in the study was just 7% and 15% of the FDA’s recommended maximum intake of aspartame (equivalent to two to four 8-ounce diet sodas daily).

Most intriguing was that offspring of the mice in the aspartame groups demonstrated the same levels of cognitive decline and anxiety as their fathers, even though they had never ingested the artificial sweetener. Researchers theorize that in addition to changes in brain gene expression, aspartame also caused epigenetic changes in germ cells.

“Epigenetic changes in germ cells due to environmental exposures are both good and bad,” lead investigator Pradeep G. Bhide, PhD, professor of developmental neuroscience and director of the Center for Brain Repair at FSU, told this news organization. “They are bad because the next generation is affected. But they’re good because as long as the exposure no longer occurs, 2 or 3 generations later, that’s gone.”

The mice, which lacked taste receptors for aspartame, were the same age and weight in all three groups. Because the only difference was exposure to the artificial sweetener, Dr. Bhide says it suggests a causal link.

“Extrapolation of data from well-controlled laboratory experiments in mice to humans is always risky,” Dr. Bhide said. “The extrapolations give us insights into what could happen rather than what will happen.”
 

Potential mechanisms

Although scientists can’t say for certain how UPFs affect brain health, there are several theories. UPFs may influence an inflammatory immune response, which has been linked to depression and dementia. Consumption of highly processed foods may also disrupt the gut microbiome, Dr. Chan said, which, in turn, may increase depression risk.

“This is an important potential mechanism linking ultraprocessed food to depression since there is emerging evidence that microbes in the gut have been linked with mood through their role in metabolizing and producing proteins that have activity in the brain,” he said.

In addition, with UPFs that contain aspartame, there could be a more direct link to brain function. In the gastrointestinal track, the sweetener is quickly broken down into methanol, aspartic acid, and phenylalanine. All three enter the bloodstream, cross the blood-brain barrier, and are neuroactive.

“Phenylalanine is a precursor for neurotransmitters in the brain, and aspartic acid activates the glutamate excitatory neurotransmitter receptor,” Dr. Bhide said. “The effects we’ve seen could be due to these metabolites that have a direct effect on the brain function.”
 

Time to act?

Some researchers are building a case for classifying UPFs as addictive substances. Others are calling for additional research on UPF safety that is conducted outside the food industry.

There has also been some discussion of placing warning labels on UPFs. However, there is disagreement about what information should be included and how consumers might interpret it. The question of which food products are UPFs and which are not also isn’t settled. The NOVA system may be widely used, but it still has its detractors who believe it misclassifies some healthy foods as ultraprocessed.

Dr. Chan and other experts say the research conducted thus far requires additional corroboration to inform appropriate public health interventions. That would likely take the form of a large, randomized trial with one group of participants eating a healthy diet and the other consuming large amounts of UPFs.

“This type of study is extremely challenging given the number of people that would have to be willing to participate and be willing to eat a very specific diet over a long period of time,” Dr. Chan said. “I am also not sure it would be ethical to assign people to such a diet, given what we already know about the potential health effects of UPFs.”

Dr. Thiagarajan and others have called on funding agencies to direct more grant monies toward studies of UPFs to better understand their effect on brain health.

“Given the magnitude of the problem and given that there is a fair bit of evidence that points to a potential causal link, then we damn well better put money into this and get to the bottom of it,” she said.

Others are looking to the FDA to increase the agency’s scrutiny of food additives. While some additives such as artificial sweeteners have a place in diets of people with diabetes or obesity, Dr. Bhide suggests it may be wise for healthy individuals to reduce their daily intake of UPFs.

“Our data raise this to a different level because of the transgenerational transmission, which has never been shown before,” he said. “We are saying that the FDA should look in preclinical models at germ cells and maybe transgenerational transmission before approving any food additive.”

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

Ultraprocessed foods (UPFs) make up nearly three-quarters of the entire U.S. food supply and about 60% of Americans’ daily caloric intake. A significant body of research has tied consumption of these foods – awash in added sugar, salt, fat, artificial colors, or preservatives – to cancer, diabetes, and heart disease.
 

Now, a growing number of studies also link them to poor brain health, including an increased risk of dementia, depression, and anxiety, and some experts are calling for public health policies aimed at reducing UPF consumption.

But what’s the science behind the link between UPFs and brain health and what does it mean for clinicians and their patients?
 

Under srutiny

A mainstay of diets in countries around the world, UPFs have come under increasing scrutiny because of their link to major diseases. The ingredients in UPFs add little or no nutritional value. Their primary function is to increase a product’s shelf life and palatability. Some recent evidence suggests these foods may be as addictive as tobacco. In addition, two pooled analysis studies using the Yale Food Addiction Scale showed that 14% of adults and 12% of children in the United States may have a UPF addiction.

The most widely used measure of what is, and what is not, a UPF was developed in 2009 by researchers in Brazil. The NOVA food classification system assigns food and beverages to one of four groups:

• Unprocessed and minimally processed foods, such as fruits, vegetables, milk, and meat.
• Processed culinary ingredients, including white sugar, butter, and oils derived from seeds, nuts, and fruits.
• Processed foods, such as tomato paste, bacon, canned tuna, and wine.
• Ultraprocessed foods, such as soda, ice cream, breakfast cereal, and prepackaged meals.

Those sounding the alarm about the potential harmful effects of UPFs are particularly concerned about their consumption by young people. The National Health and Nutrition Examination Survey showed that from 1999 to 2018, highly processed foods accounted for the majority of energy intake in those aged 2-19 years.

One of the most commonly used additives in UPFs, the artificial sweetener aspartame, garnered headlines this summer when the World Health Organization classified it as a likely carcinogen in humans. Aspartame is used in thousands of products, from soda to chewing gum to chewable vitamins.

The U.S. Food and Drug Administration strongly disagreed with the WHO’s position and is sticking by its recommended daily limit of 50 mg/kg of body weight – equivalent to 75 packets of the sweetener Equal – as safe for human consumption.

“Aspartame is one of the most studied food additives in the human food supply,” FDA officials said in a statement, adding that the agency found “significant shortcomings” in the studies the WHO used to justify the new classification. “FDA scientists do not have safety concerns when aspartame is used under the approved conditions.”

Increased attention to consumption of UPFs in general and aspartame particularly in recent years has yielded several studies pointing to the foods’ association with compromised brain health.
 

Link to depression, dementia

A recent report on UPF consumption and mental well-being among nearly 300,000 people across 70 countries showed that 53% of those who consumed UPFs several times a day were distressed or were struggling with their mental well-being, compared with 18% of those who rarely or never consumed UPFs.

Part of the Global Mind Project run by the nonprofit Sapien Labs in Arlington, Va., the report also showed that individuals with the highest rates of UPF consumption reported higher levels of confusion, slowed thinking, unwanted or obsessive thoughts, irritability, and feelings of sadness.

“There seems to be a much broader effect than just depression symptoms,” Tara Thiagarajan, PhD, founder and chief scientist of Sapien Labs and coauthor of the report, said in an interview.

The report, which has not been peer reviewed, comes on the heels of several other studies, including one from the Nurses Health Study II that showed that participants who consumed more than eight servings of UPFs daily had about a 50% higher depression risk, compared with those who consumed half that much.

“We found that UPFs in general, and artificial sweeteners and beverages in particular, were associated with increased risk,” said lead investigator Andrew T. Chan, MD, MPH, professor of medicine at Harvard Medical School and chief of the clinical and translational epidemiology unit, Massachusetts General Hospital, both in Boston.

“This was an interesting finding that correlates with data from animal studies that artificial sweeteners may trigger the transmission of particular signaling molecules in the brain that are important for mood,” he told this news organization.

Cognition may also be affected. An analysis of more than 72,000 people in the UK Biobank showed that those who consumed a high levels of UPFs were 50% more likely to develop dementia than those who consumed fewer processed foods. For every 10% increase in UPF consumption, the odds of developing any kind of dementia increased by 25%.

Another study of nearly 11,000 people showed that higher UPF consumption was associated with a significantly faster decline in executive and global cognitive function.
 

Epigenetic changes

While these and other studies suggest a link between UPF consumption and brain health, they are designed to demonstrate correlation. To date, no human study has proven that eating highly processed foods directly causes a decline in mental health or cognition.

Animal studies could provide that causal link. Earlier this year, researchers at Florida State University in Tallahassee reported learning and memory deficits in two groups of male mice that completed a maze test after being fed water mixed with aspartame for about 20% of their adult lives, compared with a group of mice that drank water only. Animals that ingested aspartame could finish the test, but it took them longer, and they needed help.

The amount of aspartame used in the study was just 7% and 15% of the FDA’s recommended maximum intake of aspartame (equivalent to two to four 8-ounce diet sodas daily).

Most intriguing was that offspring of the mice in the aspartame groups demonstrated the same levels of cognitive decline and anxiety as their fathers, even though they had never ingested the artificial sweetener. Researchers theorize that in addition to changes in brain gene expression, aspartame also caused epigenetic changes in germ cells.

“Epigenetic changes in germ cells due to environmental exposures are both good and bad,” lead investigator Pradeep G. Bhide, PhD, professor of developmental neuroscience and director of the Center for Brain Repair at FSU, told this news organization. “They are bad because the next generation is affected. But they’re good because as long as the exposure no longer occurs, 2 or 3 generations later, that’s gone.”

The mice, which lacked taste receptors for aspartame, were the same age and weight in all three groups. Because the only difference was exposure to the artificial sweetener, Dr. Bhide says it suggests a causal link.

“Extrapolation of data from well-controlled laboratory experiments in mice to humans is always risky,” Dr. Bhide said. “The extrapolations give us insights into what could happen rather than what will happen.”
 

Potential mechanisms

Although scientists can’t say for certain how UPFs affect brain health, there are several theories. UPFs may influence an inflammatory immune response, which has been linked to depression and dementia. Consumption of highly processed foods may also disrupt the gut microbiome, Dr. Chan said, which, in turn, may increase depression risk.

“This is an important potential mechanism linking ultraprocessed food to depression since there is emerging evidence that microbes in the gut have been linked with mood through their role in metabolizing and producing proteins that have activity in the brain,” he said.

In addition, with UPFs that contain aspartame, there could be a more direct link to brain function. In the gastrointestinal track, the sweetener is quickly broken down into methanol, aspartic acid, and phenylalanine. All three enter the bloodstream, cross the blood-brain barrier, and are neuroactive.

“Phenylalanine is a precursor for neurotransmitters in the brain, and aspartic acid activates the glutamate excitatory neurotransmitter receptor,” Dr. Bhide said. “The effects we’ve seen could be due to these metabolites that have a direct effect on the brain function.”
 

Time to act?

Some researchers are building a case for classifying UPFs as addictive substances. Others are calling for additional research on UPF safety that is conducted outside the food industry.

There has also been some discussion of placing warning labels on UPFs. However, there is disagreement about what information should be included and how consumers might interpret it. The question of which food products are UPFs and which are not also isn’t settled. The NOVA system may be widely used, but it still has its detractors who believe it misclassifies some healthy foods as ultraprocessed.

Dr. Chan and other experts say the research conducted thus far requires additional corroboration to inform appropriate public health interventions. That would likely take the form of a large, randomized trial with one group of participants eating a healthy diet and the other consuming large amounts of UPFs.

“This type of study is extremely challenging given the number of people that would have to be willing to participate and be willing to eat a very specific diet over a long period of time,” Dr. Chan said. “I am also not sure it would be ethical to assign people to such a diet, given what we already know about the potential health effects of UPFs.”

Dr. Thiagarajan and others have called on funding agencies to direct more grant monies toward studies of UPFs to better understand their effect on brain health.

“Given the magnitude of the problem and given that there is a fair bit of evidence that points to a potential causal link, then we damn well better put money into this and get to the bottom of it,” she said.

Others are looking to the FDA to increase the agency’s scrutiny of food additives. While some additives such as artificial sweeteners have a place in diets of people with diabetes or obesity, Dr. Bhide suggests it may be wise for healthy individuals to reduce their daily intake of UPFs.

“Our data raise this to a different level because of the transgenerational transmission, which has never been shown before,” he said. “We are saying that the FDA should look in preclinical models at germ cells and maybe transgenerational transmission before approving any food additive.”

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

Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine Society, The International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine Society, The International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

Your patients may see ads claiming that testosterone replacement therapy (TRT) offers postmenopausal women health benefits beyond restored sex drive: that TRT can improve their mood, energy, and thinking and give them stronger bones and bigger muscles.

How accurate are these claims? According to six experts who talked with this news organization, not very.

“Right now in this country and around the world, testosterone’s only use in postmenopausal women is for libido,” said Adrian Sandra Dobs, MD, MHS, professor of medicine and director of the Johns Hopkins Clinical Research Network at Johns Hopkins Medicine, Baltimore.

“Treating postmenopausal women with testosterone is a rarity. Some physicians and some wellness centers make their money out of prescribing estrogen and testosterone to women in patches, gels, creams, capsules, pellets, and other forms. But when you look at the scientific data, outside of libido, it’s difficult to recommend testosterone therapy,” she added by phone.

“One has to be very careful about using testosterone in women,” Dr. Dobs cautioned. “There’s a lot of hype out there.”

Low testosterone in women has not been well studied, and no testosterone treatments for this condition have been approved by the U.S. Food and Drug Administration. Providers need to adjust male treatment data to their female patients, who require significantly lower doses than males. Contraindications and long-term side effects are poorly understood, said Mary Rosser, MD, PhD, assistant professor of women’s health and director of integrated women’s health at Columbia University Irving Medical Center, New York.

“Despite this preponderance of scientific evidence and recommendations, the myths about testosterone die hard, including that it improves women’s muscle function, endurance, and well-being,” Dr. Rosser said.

“Websites that use compounded products or pellets are not FDA-regulated; therefore, they have no responsibility to prove their claims. They can entice women into using this stuff with all kinds of promises about ‘hormone balancing’ and other meaningless terms. The Endocrine Society statement reviewed the clinical studies on testosterone for various indications surrounding physical endurance, well-being, and mental health – and the studies do not support its use,” Dr. Rosser added.

According to the Australasian Menopause Society, women’s blood testosterone levels tend to peak in their 20s, slowly decline to around 25% of peak levels at menopause, then rise again in later years.

Susan Davis, PhD, and her colleagues at Monash University, Melbourne, found in a study that TRT in postmenopausal women may improve sexual well-being and that side effects include acne and increased hair growth. But they found no benefits for cognition, bone mineral density, body composition, muscle strength, or psychological well-being, and they note that more data are needed on long-term safety.
 

Postmenopausal testosterone recommended for libido only

“Hypoactive sexual desire disorder (HSDD) is really the only indication for postmenopausal testosterone use,” Nanette F. Santoro, MD, professor and chair of obstetrics and gynecology at the University of Colorado School of Medicine, Aurora, noted by email. “In clinical studies using androgen gel containing testosterone, testosterone treatment has resulted in a mean of one more satisfying sexual encounter per month. Consensus statements issued by the Endocrine Society, The International Menopause Society, and the North American Menopause Society have come to similar conclusions: The only indication for androgen therapy for women is HSDD,” added Santoro, an author of the Endocrine Society statement.

“Sexual health and the sense of well-being are very much related,” Sandra Ann Carson, MD, professor of obstetrics and gynecology at Yale Medicine, New Haven, Conn., said by phone. “So we give testosterone to increase sexual desire. Testosterone is not a treatment for decreased sense of well-being alone. Women who lose their sense of well-being due to depression or other factors need to have a mental health evaluation, not testosterone.”

“Because no female product is presently approved by a national regulatory body, male formulations can be judiciously used in female doses and blood testosterone concentrations must be monitored regularly,” Dr. Rosser said. “The recommendation is for considering use of compounded testosterone for hypoactive sexual desire only; it is against use for overall health and wellness.”

“The real mischief occurs when women are exposed to doses that are supraphysiologic,” Dr. Rosser cautioned. “At high doses that approach and sometimes exceed men’s levels of testosterone, women can have deepening of the voice, adverse changes in cholesterol, and even breast atrophy. This can occur with bioidentical compounded testosterone and with testosterone pellets. The National Academies of Science, Engineering, and Medicine recommend unequivocally that such preparations not be used.”

Not all postmenopausal women should take TRT, said Meredith McClure, MD, assistant professor in the department of obstetrics and gynecology of UT Southwestern Medical School, Dallas, because it has only been shown in trials to help with HSDD.

She advised clinicians to avoid prescribing testosterone to patients who “can’t take estrogen, including if [they] have hormone-sensitive cancer, blood clot risk, liver disease, heart attack, stroke, or undiagnosed genital bleeding.”
 

TRT for non-libido issues may sometimes be appropriate

“Perhaps women with hip fracture or cancer cachexia could benefit from testosterone to build muscle mass,” said Dr. Dobbs, who is involved in an ongoing study of testosterone treatment in women with hip fracture. “But as yet, we have no proof that testosterone helps.”

In rare cases, Stanley G. Korenman, MD, a reproductive endocrinologist and associate dean for ethics at UCLA Health, treats postmenopausal patients with TRT for reasons other than low libido. “I have a very specialized practice in reproductive endocrinology and internal medicine and am one of very few people in the country who do this kind of management,” he said in an interview. “If my postmenopausal patients have low testosterone and lack energy, I’m willing to give them low doses. If they feel more energetic, we continue, but if they don’t, we stop. I don’t think there’s any risk whatsoever at the low level I prescribe.

“I prescribe standard gel that comes in a squirt bottle, and I suggest they take half a squirt every other day – about one-eighth of a male dose – on the sole of the foot, where hair does not grow.

“I would not prescribe testosterone for bone health. We have bisphosphonates and other much better treatments for that. And I would not prescribe it to someone who is seriously emotionally disturbed or seriously depressed. This is not a treatment for depression.”

“Postmenopausal testosterone is not ‘the latest greatest thing,’ but being very low risk, it’s worth trying once in a while, in the appropriate patient, at the right dose,” Dr. Korenman advised. He cautioned people to “avoid the longevity salespeople who sell all sorts of things in all sorts of doses to try to keep us alive forever.”

All contributors report no relevant financial relationships.

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

David Felson, MD, MPH, often steps out of his physician’s role to help patients with osteoarthritis (OA). “I have one now who needed me to write to her landlord to get her to a ground floor apartment because she’s unable to navigate the stairs,” said Dr. Felson, a professor of medicine and epidemiology at Boston University.

Rheumatologists don’t have a lot of options to treat patients with OA, Dr. Felson said. The most effective treatments are NSAIDs. While reasonably effective, they have a lot of side effects and are not always safe to use, he said.

Exercise also works, but people don’t adhere to it after a while. “Another useful strategy is getting cortisone injections into the affected joint, but that doesn’t last for very long, and I think we’re all reluctant to do it over and over again,” Dr. Felson said.

Some might say, “Well, why can’t they just get a knee replacement?” Many patients don’t want the surgery, and others are too frail to qualify. They’re also not 100% successful. Patients after the surgery sometimes say that they’re still in pain.

There’s an urgent need for more effective therapies, said Dr. Felson, who’s been working on a unique approach to target patients at high risk for OA by studying two specific populations who sustain knee injury.
 

Previous clinical trials have failed

Clinical trials to test OA treatments have run into some roadblocks. The market for this is enormous, with the potential to benefit millions of patients, Dr. Felson continued.

However, very few large pharmaceutical companies or even biotech companies are pursuing treatment development in osteoarthritis because there have been a lot of expensive failures. “It’s made them gun shy,” Dr. Felson noted.

One issue is OA has a long disease course, taking decades to progress and see changes, said Jason Kim, PhD, vice president for osteoarthritis research at the Arthritis Foundation in Atlanta.

Ron Hester

The typical clinical trial window runs just 2-5 years, which is insufficient to see adequate results in a disease like OA. Longer trials are prohibitively costly, especially for corporations with near-term pressures, Dr. Kim said.

Many of these trials also apply disease-modifying drugs to participants with OA who are “too far gone” and beyond repair. By the time older people present with OA to the doctor, their disease is far advanced, and it may not be reversible or even stoppable, Dr. Felson said.
 

Finding patients with ACL reconstruction with ‘bad outcomes’

Dr. Kim and Dr. Felson have joined other researchers to test a new approach, using people with anterior cruciate ligament (ACL) reconstruction as a starting block to sleuth out OA tendencies years before it even begins.

When someone gets an ACL or meniscal tear, the knee in many cases begins the process of developing OA. However, that process can take 10-20 years, or sometimes even longer.

“We can’t do trials that last that long,” Dr. Felson said. But there are a few people who do quickly develop OA when they sustain those injuries. “If we can grab those people and get them involved in a study where we test treatments, we could probably figure out what kinds of treatments would be effective,” Dr. Felson explained.

The challenge is finding enough patients with ACL reconstruction with bad outcomes to effectively study OA prevention and treatment. While that sounds unfortunate, “it’s what we needed,” Dr. Felson said.

A longitudinal study known as the MOON trial that tracked 2,340 ACL reconstruction cases offered some initial clues, providing a foundation for future research. Dr. Felson and Dr. Kim joined lead researcher Kurt Spindler, MD, to create the “MOON” cohort for people who underwent surgery after an ACL tear, following them for a decade.

Through the MOON trial, Spindler et al. were able to assess how many people developed OA over 2, 6, and 10 years of follow-up, and how many experienced pain.

“It allowed us to guesstimate whether we were going to have enough numbers of people getting bad outcomes to see if we could get enough numbers to treat,” Dr. Felson said.
 

Clinical trial to test FastOA criteria

The Arthritis Foundation, which funded the MOON trial along with the National Institutes of Health and The American Orthopaedic Society for Sports Medicine, launched the FastOA initiative, based on its findings.

FastOA is defined as “the rapid development of OA in those who have sustained a major joint injury.” One criterion for FastOA is older age. Eighteen- to 25-year-olds generally don’t have high risk for injury or OA. “It’s only when you get to your late 20s and 30s where your risk really starts to increase substantially, just like the risk of osteoarthritis does,” Dr. Felson said.

The other major risk factor for FastOA is pain. Pain after ACL reconstruction usually takes a long time to surface. Many people never experience pain. However, for a subgroup of people who get ACL reconstruction, their pain never goes away. “What the MOON data told us was that those are the people who continue to have pain later and who get osteoarthritis quicker,” he added.

The MOON results also informed researchers on the types of patients they should seek out for a future trial. “We wouldn’t just take everybody with ACL reconstructions. We’d take selected people who we knew based on the MOON data were at really high likelihood of developing FastOA,” Dr. Felson said .

Armed with these risk factors, Dr. Felson and colleagues plan to apply FastOA to a new clinical trial, Post-Injury Knee Arthritis Severity Outcomes (PIKASO), that will test the use of metformin, a well-known diabetes drug, in 500 patients at high risk of developing post-traumatic OA in the knee following ACL reconstruction.

Two groups will participate in the PIKASO trial, an initiative of the Arthritis Foundation’s Osteoarthritis Clinical Trials Network (OA-CTN).

“If you have pain at the time of ACL reconstruction, we are interested in you. And if even you don’t have pain, if you’re among older people who need ACL reconstruction, we’re also interested in you,” Dr. Felson said.

People aged 25-40 are eligible for the older category and those 18-40 are eligible for the pain group. It’s important to include younger people in the study, Dr. Felson said. One of his colleagues, a physical therapist, was disabled by a sports injury in her late teens. Now in her 30s, she’s disabled by OA and will have to wait up to 15 years to qualify for a knee replacement.

“It’s a good idea for us to focus in on the younger folks who develop osteoarthritis at a very early age where there’s nothing we can do for them in terms of surgical options for a few years,” he said.

Targeting specific groups means fewer patients will need to be followed over the period of the study, which will lower costs, Dr. Kim said.

Metformin, a popular diabetes drug with a good safety profile, is an ideal treatment for this trial, Dr. Felson said. It’s been tested in multiple animal models and has been shown to protect against OA in all those models.

Researchers will employ imaging and biomechanics measurements to assess changes in joint structure. Eight institutions will participate, including Mass General Brigham, the trial’s clinical coordinating center, and the Cleveland Clinic and University of North Carolina at Chapel Hill, which will coordinate the collection and analysis of MRI data and biomechanical and function assessments, respectively.

“Positive results from this trial would have the potential to enable surgeons to immediately prescribe the drug before a patient undergoes surgery to slow the disease progression, or even fully prevent” post-traumatic OA, according to a statement from the Arthritis Foundation.
 

‘We’re taking a leap’

PIKASO doesn’t come without its challenges. “There’s a lot of dangers here,” Dr. Felson acknowledged.

Even with the application of the FastOA risk factors, not enough people may end up getting OA. “We could do an expensive study with 500 people and not get enough people with OA to be able to test a treatment,” he said.

Another risk is metformin might not work in these participants to prevent disease. “We’re taking a leap and we’re hoping that leap works out,” Dr. Felson added.

Physicians outside of this project are hopeful that FastOA will facilitate the development of new OA therapeutic strategies.

“We all intuitively understand that a joint injury will increase our risk of arthritis in 5, 10 years, even 20 years if we’re lucky,” said Dominik R. Haudenschild, PhD, professor and director of translational orthopaedic research at Houston Methodist Academic Institute.

Most patients with a painful joint can recall when an injury took place. Focusing on treatments closer to the time of injury before irreversible disease sets in makes sense, he added.

The MOON researchers found that pain is not uncommon in patients with ACL reconstruction, making them an excellent choice for analysis, Dr. Haudenschild continued.

PIKASO could face some limitations, specifically with respect to the effect size – how big of a difference a treatment can make the moment a measurement is taken.

“If we’re looking at earlier disease, the intensity of pain is likely lower, or pain isn’t felt as frequently, or the extent of structural damage in the joint is smaller,” he explained. Even a perfect treatment would only make a smaller difference at the moment measurements are taken, which can be harder to measure.

“But I expect that many of the limitations can likely be overcome by making sure the appropriate outcomes are chosen,” he said.

Nancy E. Lane, MD, professor of medicine and rheumatology at UC Davis Health System, is hoping the research will better inform physicians and patients about ACL tears. They should be aware “that within a few months of an ACL injury, the bone structure around the joint changes and there are cartilage changes,” Dr. Lane said.

While early changes may not necessarily lead to OA, patients who develop joint pain with activity or joint swelling would benefit from education, additional imaging, and modifying their activities to prevent progression, she said.

“Hopefully, within a few years we will have effective treatments to slow or reverse the development of knee OA,” Dr. Lane said.

The PIKASO trial is scheduled to begin enrollment at the end of this year or in early 2024.

Dr. Felson is a board member and past and current awardee of the Arthritis Foundation. Dr. Kim is a staff member of the Arthritis Foundation. Dr. Haudenschild received a grant from the Arthritis Foundation and participates in local, regional, and national activities with the Arthritis Foundation. Dr. Lane had no disclosures.
 

David Felson, MD, MPH, often steps out of his physician’s role to help patients with osteoarthritis (OA). “I have one now who needed me to write to her landlord to get her to a ground floor apartment because she’s unable to navigate the stairs,” said Dr. Felson, a professor of medicine and epidemiology at Boston University.

Rheumatologists don’t have a lot of options to treat patients with OA, Dr. Felson said. The most effective treatments are NSAIDs. While reasonably effective, they have a lot of side effects and are not always safe to use, he said.

Exercise also works, but people don’t adhere to it after a while. “Another useful strategy is getting cortisone injections into the affected joint, but that doesn’t last for very long, and I think we’re all reluctant to do it over and over again,” Dr. Felson said.

Some might say, “Well, why can’t they just get a knee replacement?” Many patients don’t want the surgery, and others are too frail to qualify. They’re also not 100% successful. Patients after the surgery sometimes say that they’re still in pain.

There’s an urgent need for more effective therapies, said Dr. Felson, who’s been working on a unique approach to target patients at high risk for OA by studying two specific populations who sustain knee injury.
 

Previous clinical trials have failed

Clinical trials to test OA treatments have run into some roadblocks. The market for this is enormous, with the potential to benefit millions of patients, Dr. Felson continued.

However, very few large pharmaceutical companies or even biotech companies are pursuing treatment development in osteoarthritis because there have been a lot of expensive failures. “It’s made them gun shy,” Dr. Felson noted.

One issue is OA has a long disease course, taking decades to progress and see changes, said Jason Kim, PhD, vice president for osteoarthritis research at the Arthritis Foundation in Atlanta.

Ron Hester

The typical clinical trial window runs just 2-5 years, which is insufficient to see adequate results in a disease like OA. Longer trials are prohibitively costly, especially for corporations with near-term pressures, Dr. Kim said.

Many of these trials also apply disease-modifying drugs to participants with OA who are “too far gone” and beyond repair. By the time older people present with OA to the doctor, their disease is far advanced, and it may not be reversible or even stoppable, Dr. Felson said.
 

Finding patients with ACL reconstruction with ‘bad outcomes’

Dr. Kim and Dr. Felson have joined other researchers to test a new approach, using people with anterior cruciate ligament (ACL) reconstruction as a starting block to sleuth out OA tendencies years before it even begins.

When someone gets an ACL or meniscal tear, the knee in many cases begins the process of developing OA. However, that process can take 10-20 years, or sometimes even longer.

“We can’t do trials that last that long,” Dr. Felson said. But there are a few people who do quickly develop OA when they sustain those injuries. “If we can grab those people and get them involved in a study where we test treatments, we could probably figure out what kinds of treatments would be effective,” Dr. Felson explained.

The challenge is finding enough patients with ACL reconstruction with bad outcomes to effectively study OA prevention and treatment. While that sounds unfortunate, “it’s what we needed,” Dr. Felson said.

A longitudinal study known as the MOON trial that tracked 2,340 ACL reconstruction cases offered some initial clues, providing a foundation for future research. Dr. Felson and Dr. Kim joined lead researcher Kurt Spindler, MD, to create the “MOON” cohort for people who underwent surgery after an ACL tear, following them for a decade.

Through the MOON trial, Spindler et al. were able to assess how many people developed OA over 2, 6, and 10 years of follow-up, and how many experienced pain.

“It allowed us to guesstimate whether we were going to have enough numbers of people getting bad outcomes to see if we could get enough numbers to treat,” Dr. Felson said.
 

Clinical trial to test FastOA criteria

The Arthritis Foundation, which funded the MOON trial along with the National Institutes of Health and The American Orthopaedic Society for Sports Medicine, launched the FastOA initiative, based on its findings.

FastOA is defined as “the rapid development of OA in those who have sustained a major joint injury.” One criterion for FastOA is older age. Eighteen- to 25-year-olds generally don’t have high risk for injury or OA. “It’s only when you get to your late 20s and 30s where your risk really starts to increase substantially, just like the risk of osteoarthritis does,” Dr. Felson said.

The other major risk factor for FastOA is pain. Pain after ACL reconstruction usually takes a long time to surface. Many people never experience pain. However, for a subgroup of people who get ACL reconstruction, their pain never goes away. “What the MOON data told us was that those are the people who continue to have pain later and who get osteoarthritis quicker,” he added.

The MOON results also informed researchers on the types of patients they should seek out for a future trial. “We wouldn’t just take everybody with ACL reconstructions. We’d take selected people who we knew based on the MOON data were at really high likelihood of developing FastOA,” Dr. Felson said .

Armed with these risk factors, Dr. Felson and colleagues plan to apply FastOA to a new clinical trial, Post-Injury Knee Arthritis Severity Outcomes (PIKASO), that will test the use of metformin, a well-known diabetes drug, in 500 patients at high risk of developing post-traumatic OA in the knee following ACL reconstruction.

Two groups will participate in the PIKASO trial, an initiative of the Arthritis Foundation’s Osteoarthritis Clinical Trials Network (OA-CTN).

“If you have pain at the time of ACL reconstruction, we are interested in you. And if even you don’t have pain, if you’re among older people who need ACL reconstruction, we’re also interested in you,” Dr. Felson said.

People aged 25-40 are eligible for the older category and those 18-40 are eligible for the pain group. It’s important to include younger people in the study, Dr. Felson said. One of his colleagues, a physical therapist, was disabled by a sports injury in her late teens. Now in her 30s, she’s disabled by OA and will have to wait up to 15 years to qualify for a knee replacement.

“It’s a good idea for us to focus in on the younger folks who develop osteoarthritis at a very early age where there’s nothing we can do for them in terms of surgical options for a few years,” he said.

Targeting specific groups means fewer patients will need to be followed over the period of the study, which will lower costs, Dr. Kim said.

Metformin, a popular diabetes drug with a good safety profile, is an ideal treatment for this trial, Dr. Felson said. It’s been tested in multiple animal models and has been shown to protect against OA in all those models.

Researchers will employ imaging and biomechanics measurements to assess changes in joint structure. Eight institutions will participate, including Mass General Brigham, the trial’s clinical coordinating center, and the Cleveland Clinic and University of North Carolina at Chapel Hill, which will coordinate the collection and analysis of MRI data and biomechanical and function assessments, respectively.

“Positive results from this trial would have the potential to enable surgeons to immediately prescribe the drug before a patient undergoes surgery to slow the disease progression, or even fully prevent” post-traumatic OA, according to a statement from the Arthritis Foundation.
 

‘We’re taking a leap’

PIKASO doesn’t come without its challenges. “There’s a lot of dangers here,” Dr. Felson acknowledged.

Even with the application of the FastOA risk factors, not enough people may end up getting OA. “We could do an expensive study with 500 people and not get enough people with OA to be able to test a treatment,” he said.

Another risk is metformin might not work in these participants to prevent disease. “We’re taking a leap and we’re hoping that leap works out,” Dr. Felson added.

Physicians outside of this project are hopeful that FastOA will facilitate the development of new OA therapeutic strategies.

“We all intuitively understand that a joint injury will increase our risk of arthritis in 5, 10 years, even 20 years if we’re lucky,” said Dominik R. Haudenschild, PhD, professor and director of translational orthopaedic research at Houston Methodist Academic Institute.

Most patients with a painful joint can recall when an injury took place. Focusing on treatments closer to the time of injury before irreversible disease sets in makes sense, he added.

The MOON researchers found that pain is not uncommon in patients with ACL reconstruction, making them an excellent choice for analysis, Dr. Haudenschild continued.

PIKASO could face some limitations, specifically with respect to the effect size – how big of a difference a treatment can make the moment a measurement is taken.

“If we’re looking at earlier disease, the intensity of pain is likely lower, or pain isn’t felt as frequently, or the extent of structural damage in the joint is smaller,” he explained. Even a perfect treatment would only make a smaller difference at the moment measurements are taken, which can be harder to measure.

“But I expect that many of the limitations can likely be overcome by making sure the appropriate outcomes are chosen,” he said.

Nancy E. Lane, MD, professor of medicine and rheumatology at UC Davis Health System, is hoping the research will better inform physicians and patients about ACL tears. They should be aware “that within a few months of an ACL injury, the bone structure around the joint changes and there are cartilage changes,” Dr. Lane said.

While early changes may not necessarily lead to OA, patients who develop joint pain with activity or joint swelling would benefit from education, additional imaging, and modifying their activities to prevent progression, she said.

“Hopefully, within a few years we will have effective treatments to slow or reverse the development of knee OA,” Dr. Lane said.

The PIKASO trial is scheduled to begin enrollment at the end of this year or in early 2024.

Dr. Felson is a board member and past and current awardee of the Arthritis Foundation. Dr. Kim is a staff member of the Arthritis Foundation. Dr. Haudenschild received a grant from the Arthritis Foundation and participates in local, regional, and national activities with the Arthritis Foundation. Dr. Lane had no disclosures.
 

David Felson, MD, MPH, often steps out of his physician’s role to help patients with osteoarthritis (OA). “I have one now who needed me to write to her landlord to get her to a ground floor apartment because she’s unable to navigate the stairs,” said Dr. Felson, a professor of medicine and epidemiology at Boston University.

Rheumatologists don’t have a lot of options to treat patients with OA, Dr. Felson said. The most effective treatments are NSAIDs. While reasonably effective, they have a lot of side effects and are not always safe to use, he said.

Exercise also works, but people don’t adhere to it after a while. “Another useful strategy is getting cortisone injections into the affected joint, but that doesn’t last for very long, and I think we’re all reluctant to do it over and over again,” Dr. Felson said.

Some might say, “Well, why can’t they just get a knee replacement?” Many patients don’t want the surgery, and others are too frail to qualify. They’re also not 100% successful. Patients after the surgery sometimes say that they’re still in pain.

There’s an urgent need for more effective therapies, said Dr. Felson, who’s been working on a unique approach to target patients at high risk for OA by studying two specific populations who sustain knee injury.
 

Previous clinical trials have failed

Clinical trials to test OA treatments have run into some roadblocks. The market for this is enormous, with the potential to benefit millions of patients, Dr. Felson continued.

However, very few large pharmaceutical companies or even biotech companies are pursuing treatment development in osteoarthritis because there have been a lot of expensive failures. “It’s made them gun shy,” Dr. Felson noted.

One issue is OA has a long disease course, taking decades to progress and see changes, said Jason Kim, PhD, vice president for osteoarthritis research at the Arthritis Foundation in Atlanta.

Ron Hester

The typical clinical trial window runs just 2-5 years, which is insufficient to see adequate results in a disease like OA. Longer trials are prohibitively costly, especially for corporations with near-term pressures, Dr. Kim said.

Many of these trials also apply disease-modifying drugs to participants with OA who are “too far gone” and beyond repair. By the time older people present with OA to the doctor, their disease is far advanced, and it may not be reversible or even stoppable, Dr. Felson said.
 

Finding patients with ACL reconstruction with ‘bad outcomes’

Dr. Kim and Dr. Felson have joined other researchers to test a new approach, using people with anterior cruciate ligament (ACL) reconstruction as a starting block to sleuth out OA tendencies years before it even begins.

When someone gets an ACL or meniscal tear, the knee in many cases begins the process of developing OA. However, that process can take 10-20 years, or sometimes even longer.

“We can’t do trials that last that long,” Dr. Felson said. But there are a few people who do quickly develop OA when they sustain those injuries. “If we can grab those people and get them involved in a study where we test treatments, we could probably figure out what kinds of treatments would be effective,” Dr. Felson explained.

The challenge is finding enough patients with ACL reconstruction with bad outcomes to effectively study OA prevention and treatment. While that sounds unfortunate, “it’s what we needed,” Dr. Felson said.

A longitudinal study known as the MOON trial that tracked 2,340 ACL reconstruction cases offered some initial clues, providing a foundation for future research. Dr. Felson and Dr. Kim joined lead researcher Kurt Spindler, MD, to create the “MOON” cohort for people who underwent surgery after an ACL tear, following them for a decade.

Through the MOON trial, Spindler et al. were able to assess how many people developed OA over 2, 6, and 10 years of follow-up, and how many experienced pain.

“It allowed us to guesstimate whether we were going to have enough numbers of people getting bad outcomes to see if we could get enough numbers to treat,” Dr. Felson said.
 

Clinical trial to test FastOA criteria

The Arthritis Foundation, which funded the MOON trial along with the National Institutes of Health and The American Orthopaedic Society for Sports Medicine, launched the FastOA initiative, based on its findings.

FastOA is defined as “the rapid development of OA in those who have sustained a major joint injury.” One criterion for FastOA is older age. Eighteen- to 25-year-olds generally don’t have high risk for injury or OA. “It’s only when you get to your late 20s and 30s where your risk really starts to increase substantially, just like the risk of osteoarthritis does,” Dr. Felson said.

The other major risk factor for FastOA is pain. Pain after ACL reconstruction usually takes a long time to surface. Many people never experience pain. However, for a subgroup of people who get ACL reconstruction, their pain never goes away. “What the MOON data told us was that those are the people who continue to have pain later and who get osteoarthritis quicker,” he added.

The MOON results also informed researchers on the types of patients they should seek out for a future trial. “We wouldn’t just take everybody with ACL reconstructions. We’d take selected people who we knew based on the MOON data were at really high likelihood of developing FastOA,” Dr. Felson said .

Armed with these risk factors, Dr. Felson and colleagues plan to apply FastOA to a new clinical trial, Post-Injury Knee Arthritis Severity Outcomes (PIKASO), that will test the use of metformin, a well-known diabetes drug, in 500 patients at high risk of developing post-traumatic OA in the knee following ACL reconstruction.

Two groups will participate in the PIKASO trial, an initiative of the Arthritis Foundation’s Osteoarthritis Clinical Trials Network (OA-CTN).

“If you have pain at the time of ACL reconstruction, we are interested in you. And if even you don’t have pain, if you’re among older people who need ACL reconstruction, we’re also interested in you,” Dr. Felson said.

People aged 25-40 are eligible for the older category and those 18-40 are eligible for the pain group. It’s important to include younger people in the study, Dr. Felson said. One of his colleagues, a physical therapist, was disabled by a sports injury in her late teens. Now in her 30s, she’s disabled by OA and will have to wait up to 15 years to qualify for a knee replacement.

“It’s a good idea for us to focus in on the younger folks who develop osteoarthritis at a very early age where there’s nothing we can do for them in terms of surgical options for a few years,” he said.

Targeting specific groups means fewer patients will need to be followed over the period of the study, which will lower costs, Dr. Kim said.

Metformin, a popular diabetes drug with a good safety profile, is an ideal treatment for this trial, Dr. Felson said. It’s been tested in multiple animal models and has been shown to protect against OA in all those models.

Researchers will employ imaging and biomechanics measurements to assess changes in joint structure. Eight institutions will participate, including Mass General Brigham, the trial’s clinical coordinating center, and the Cleveland Clinic and University of North Carolina at Chapel Hill, which will coordinate the collection and analysis of MRI data and biomechanical and function assessments, respectively.

“Positive results from this trial would have the potential to enable surgeons to immediately prescribe the drug before a patient undergoes surgery to slow the disease progression, or even fully prevent” post-traumatic OA, according to a statement from the Arthritis Foundation.
 

‘We’re taking a leap’

PIKASO doesn’t come without its challenges. “There’s a lot of dangers here,” Dr. Felson acknowledged.

Even with the application of the FastOA risk factors, not enough people may end up getting OA. “We could do an expensive study with 500 people and not get enough people with OA to be able to test a treatment,” he said.

Another risk is metformin might not work in these participants to prevent disease. “We’re taking a leap and we’re hoping that leap works out,” Dr. Felson added.

Physicians outside of this project are hopeful that FastOA will facilitate the development of new OA therapeutic strategies.

“We all intuitively understand that a joint injury will increase our risk of arthritis in 5, 10 years, even 20 years if we’re lucky,” said Dominik R. Haudenschild, PhD, professor and director of translational orthopaedic research at Houston Methodist Academic Institute.

Most patients with a painful joint can recall when an injury took place. Focusing on treatments closer to the time of injury before irreversible disease sets in makes sense, he added.

The MOON researchers found that pain is not uncommon in patients with ACL reconstruction, making them an excellent choice for analysis, Dr. Haudenschild continued.

PIKASO could face some limitations, specifically with respect to the effect size – how big of a difference a treatment can make the moment a measurement is taken.

“If we’re looking at earlier disease, the intensity of pain is likely lower, or pain isn’t felt as frequently, or the extent of structural damage in the joint is smaller,” he explained. Even a perfect treatment would only make a smaller difference at the moment measurements are taken, which can be harder to measure.

“But I expect that many of the limitations can likely be overcome by making sure the appropriate outcomes are chosen,” he said.

Nancy E. Lane, MD, professor of medicine and rheumatology at UC Davis Health System, is hoping the research will better inform physicians and patients about ACL tears. They should be aware “that within a few months of an ACL injury, the bone structure around the joint changes and there are cartilage changes,” Dr. Lane said.

While early changes may not necessarily lead to OA, patients who develop joint pain with activity or joint swelling would benefit from education, additional imaging, and modifying their activities to prevent progression, she said.

“Hopefully, within a few years we will have effective treatments to slow or reverse the development of knee OA,” Dr. Lane said.

The PIKASO trial is scheduled to begin enrollment at the end of this year or in early 2024.

Dr. Felson is a board member and past and current awardee of the Arthritis Foundation. Dr. Kim is a staff member of the Arthritis Foundation. Dr. Haudenschild received a grant from the Arthritis Foundation and participates in local, regional, and national activities with the Arthritis Foundation. Dr. Lane had no disclosures.
 

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Which conditions are caused by infection? Though it may seem like an amateur concern in the era of advanced microscopy, some culprits evade conventional methods of detection. Large medical databases hold the power to unlock answers. 

A recent study from Sweden and Denmark meticulously traced the lives and medical histories of nearly one million men and women in those countries who had received blood transfusions over nearly five decades. Some of these patients later experienced brain bleeds. The inescapable question: Could a virus found in some donor blood have caused the hemorrhages?

Traditionally, brain bleeds have been thought to strike at random. But the new study, published in JAMA, points toward an infection that causes or, at the very least, is linked to the condition. The researchers used a large databank to make the discovery. 

“As health data becomes more available and easier to analyze, we’ll see all kinds of cases like this,” said Jingcheng Zhao, MD, of the clinical epidemiology division of Sweden’s Karolinska Institutet in Solna and lead author of the study.

Scientists say the field of medical research is on the cusp of a revolution as immense health databases guide discovery and improve clinical care. 

“If you can aggregate data, you have the statistical power to identify associations,” said David R. Crosslin, PhD, professor in the division of biomedical informatics and genomics at Tulane University in New Orleans. “It opens up the world for understanding diseases.”

With access to the large database, Dr. Zhao and his team found that some blood donors later experienced brain bleeds. And it turned out that the recipients of blood from those same donors carried the highest risk of experiencing a brain bleed later in life. Meanwhile, patients whose donors remained bleed-free had the lowest risk.
 

Not so fast in the United States

In Nordic countries, all hospitals, clinics, and pharmacies report data on diagnoses and health care visits to the government, tracking that began with paper and pen in the 1960s. But the United States health care system is too fragmented to replicate such efforts, with several brands of electronic medical records operating across different systems. Data sharing across institutions is minimal. 

Most comparable health data in the United States comes from reimbursement information collected by the Centers for Medicare & Medicaid Services on government-sponsored insurance programs.

“We would need all the health care systems in the country to operate within the same IT system or use the same data model,” said Euan Ashley, MD, PhD, professor of genomics at Stanford (Calif.) University. “It’s an exciting prospect. But I think [the United States] is one of the last countries where it’ll happen.”

States, meanwhile, collect health data on specific areas like sexually transmitted infection cases and rates. Other states have registries, like the Connecticut Tumor Registry, which was established in 1941 and is the oldest population-based cancer registry in the world.

But all of these efforts are ad hoc, and no equivalent exists for heart disease and other conditions.

Health data companies have recently entered the U.S. data industry mainly through partnerships with health systems and insurance companies, using deidentified information from patient charts.

The large databases have yielded important findings that randomized clinical trials simply cannot, according to Dr. Ashley.

For instance, a study found that a heavily-lauded immunotherapy treatment did not provide meaningful outcomes for patients aged 75 years or older, but it did for younger patients.

This sort of analysis might enable clinicians to administer treatments based on how effective they are for patients with particular demographics, according to Cary Gross, MD, professor at Yale University in New Haven, Conn.

“From a bedside standpoint, these large databases can identify who benefits from what,” Dr. Gross said. “Precision medicine is not just about genetic tailoring.” These large datasets also provide insight into genetic and environmental variables that contribute to disease. 

For instance, the UK Biobank has more than 500,000 participants paired with their medical records and scans of their body and brain. Researchers perform cognitive tests on participants and extract DNA from blood samples over their lifetime, allowing examination of interactions between risk factors. 

A similar but much smaller-scale effort underway in the United States, called the All of Us Research Program, has enrolled more than 650,000 people, less than one-third the size of the UK Biobank by relative populations. The goal of the program is to provide insights into prevention and treatment of chronic disease among a diverse set of at least one million participants. The database includes information on sexual orientation, which is a fairly new datapoint collected by researchers in an effort to study health outcomes and inequities among the LGBTQ+ community.

Dr. Crosslin and his colleagues are writing a grant proposal to use the All of Us database to identify genetic risks for preeclampsia. People with certain genetic profiles may be predisposed to the life-threatening condition, and researchers may discover that lifestyle changes could decrease risk, Dr. Crosslin said. 
 

Changes in the United States

The COVID-19 pandemic exposed the lack of centralized data in the United States because a majority of research on the virus has been conducted abroad in countries with national health care systems and these large databases. 

The U.S. gap spurred a group of researchers to create the National Institutes of Health–funded National COVID Cohort Collaborative (N3C), a project that gathers medical records from millions of patients across health systems and provides access to research teams investigating a wide spectrum of topics, such as optimal timing for ventilator use.

But until government or private health systems develop a way to share and regulate health data ethically and efficiently, significant limits will persist on what large-scale databases can do, Dr. Gross said. 

“At the federal level, we need to ensure this health information is made available for public health researchers so we don’t create these private fiefdoms of data,” Dr. Gross said. “Things have to be transparent. I think our country needs to take a step back and think about what we’re doing with our health data and how we can make sure it’s being managed ethically.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Black Americans attempt to quit smoking more often than their White counterparts but are less likely to succeed, and they pay the health consequences.

This knowledge has driven Kevin Choi, MD, acting scientific director of the National Institute on Minority Health and Health Disparities in Bethesda, Md., to dedicate his career to studying the patterns and disparities of smoking among these patients.

Dr. Choi wants primary care clinicians to know not just that they have the potential to educate patients on the harms of smoking – most patients already know smoking is unhealthy – but that aiding them will likely necessitate more assertive follow-up.

To do so, “we need to understand the bigger backdrop of racial and sociological stress experienced by the Black population, which stems from both interpersonal and structural racism,” Dr. Choi said.

Not only are Black smokers more likely to try to quit, but they also tend to smoke fewer cigarettes per day than other racial groups. Yet they experience higher rates of smoking-related mortality.
 

The reasons behind the attempts

Multiple factors play into Black smokers’ lower rates of successful quitting attempts than Asian, Hispanic, White, and Native American individuals.

One reason: An estimated 85% of Black smokers smoke highly addictive menthol cigarettes. According to Dr. Choi and other experts, the tobacco industry engages in targeted marketing of menthols by sponsoring community events in predominantly Black neighborhoods and colleges with historically Black populations and by using Black culture in advertising.

“The built environment really drives a change in behavior, and we have seen that chronically in the African American population being overly targeted and now being overly addicted to nicotine,” said Daniel Kortsch, MD, a family medicine physician and chair of the Tobacco Cessation Workgroup at Denver Health.

Menthol cigarettes are more addictive than traditional cigarettes, in part because they provide a less harsh feeling in the respiratory system, owing to anti-tussive, anti-irritant, and cooling properties that act as a cough suppressant and mask irritation and pain.

“You do not feel like you’re smoking that much or that it’s dangerous, and that’s exactly the reason why it’s harder to quit,” said Julia Adamian, MD, section chief of general internal medicine and clinical innovation at NYU Langone Tisch Hospital.

In addition, menthol cigarettes interact with the body in complex ways that make quitting harder, according to a study published in Nicotine & Tobacco Research. Menthol increases the amount of nicotine that the body absorbs and thus increases the risk of dependence on the drug.

According to Dr. Choi, rates of cigar and cigarillo use are higher among Black Americans, compared with other races, and these products are often left out of cessation programs. Smokers, regardless of race, may have a misguided belief that cigars and cigarillos are less harmful than cigarettes.

Research published in 2021 found that Black cigar smokers who were interested in cessation had not been asked by their health care provider if they smoked cigars, and those who were asked reported a lack of support for cessation.

Primary care providers should work to remove any misconceptions a patient has regarding the safety of cigarillos and cigars, Dr. Choi said.

These smokers are also at a disadvantage regarding cessation success because of the neighborhoods they may live in, according to Dr. Choi. Black Americans are more likely to earn less and to live in neighborhoods with lower housing values than other racial groups. Areas with more low-income households tend to have a higher density of tobacco outlets.

“If you’re trying to quit smoking, but you walk by three, four, or five gas stations, convenience stores, and other tobacco outlets with signs that advertise sales, it’s not going to make quitting easy,” Dr. Choi said.
 

Tailoring treatment to Black smokers

Considering the unique challenges Black patients may face in quitting, clinicians should provide more follow-up and consistent support, according to Dr. Adamian. The higher risk of tobacco-related death among Black smokers means clinicians need to be more aggressive in recommending every treatment possible if one treatment fails.

Pharmacotherapy, nicotine replacement therapy, and counseling are evidence-based options to help patients stop smoking.

Dr. Kortsch considers pharmacotherapy to be the most effective and evidence-based treatment for nicotine addiction. However, Black Americans are less likely than White smokers to try smoking cessation medications, and they express more suspicion about efficacy and potential addiction to the tools.

“African American populations simply do not use pharmacotherapy to the extent that other populations do to help them quit smoking; this is a problem,” Dr. Kortsch said.

Dr. Kortsch recommends the use of varenicline for all patients with nicotine addiction. He recommends varenicline in combination with tobacco replacement products such as lozenges, patches, gums, or inhalers if the patient is a heavy smoker as opposed to someone who has a few cigarettes on the weekends.

If a patient has anxiety or depression, Dr. Adamian advises initiating a pharmacologic treatment such as bupropion or varenicline more quickly, because mood disorders can hinder cessation.

Cessation counseling is another option, but clinicians may need to more thoroughly explain what it entails. According to Dr. Choi, Black patients may be more reluctant to try cessation counseling because of the negative stigma associated with the term “counseling.” But this treatment is not therapy – it involves identifying and coming up with strategies to manage smoking triggers and providing encouragement. Clinicians can eliminate any confusion patients may have between psychological therapy and cessation counseling.

“ ‘Counseling’ tends to have a somewhat negative connotation among racial minority populations, like you go to counseling because you’re crazy,” Dr. Choi said. “That needs to change.”

Clinicians also must clarify how each cessation tool works. For example, some patients may not realize that the nicotine patch isn’t an instant fix for a craving and that hours may pass before the user feels its effects, according to Dr. Choi.
 

Move past the ‘advise’ stage

While recommending to patients various forms of cessation, clinicians should be mindful of the U.S. Preventive Services Task Force’s guidelines for providers who treat patients who smoke. Those guidelines include a five-step process: Ask, Advise, Assess, Assist, and Arrange.

Dr. Choi said most providers stop at the “Advise” stage. In steps one and two, providers ask patients whether they smoke, then advise them to quit. Stage three involves asking whether or not a patient is ready to quit and where they are in their journey.

Clinicians shouldn’t give up when patients say they do not currently plan to quit. Instead, they can use the conversation to create an ongoing dialogue about the patient’s readiness to quit in future visits. Follow-up phone calls or text messages should be made 2-4 weeks after a patient makes an attempt to quit and at the same interval thereafter, Dr. Adamian advised.

“It takes a concerted effort on behalf of all people to be successful, and it is really uncommon for someone to be successful with only one attempt,” Dr. Kortsch said.

In a recent study published in the Journal of the American Medical Association, researchers identified three key factors that influence a Black smoker’s ability to stop smoking in early attempts. These factors have been shown to increase the chances of long-term cessation: fewer cigarettes per day, nonuse of other tobacco products, and lower levels of cotinine (a nicotine metabolite) at baseline.

“Using these predictors of early treatment response could allow providers to anticipate which smokers may benefit from a minimal, low-cost intervention and who may benefit from more intensive treatment,” said Eleanor Leavens, PhD, assistant professor in the department of population health at the University of Kansas School of Medicine, Kansas City, who led the study.

Dr. Leavens’ research also confirmed that early abstinence predicts long-term cessation success. Smokers who were able to forgo cigarettes within 2 weeks of their quit date were almost four times more likely to remain abstinent over the long term.

A quick phone call or message from the clinician or a staff member can help patients achieve early progress, enable changes in approach to quitting, and build a relationship with the patient, Dr. Adamian said.

“Have more empathy for what Black patients are going through,” Dr. Choi said. “Continue to cheer them on and to be a supporter of their smoking cessation journey.”

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

Yevgenia Pashinsky, MD, has seen her share of patients who have bounced from one gastroenterologist to the next after becoming frustrated when food elimination, supplements, or medications don’t alleviate their gastrointestinal symptoms.

In most cases, their decision to switch gastroenterologists comes down to a simple fact: No one dissected their diets.

The situation underscores how essential it is for gastroenterologists to be comfortable with nutrition concepts, said Dr. Pashinsky, a gastroenterologist with New York Gastroenterology Associates and affiliated with Mount Sinai Hospital in New York.

“There should be a focus in recognizing patterns that will help the physician pinpoint triggers, thereby helping identify the underlying disorder and guide further diagnostic and treatment options,” she said.

Although many common digestive diseases and their corresponding outcomes are linked to dietary quality and are complicated by poor nutrition and/or obesity, nutrition often gets pushed to the wayside in GI education, write Carolyn Newberry, MD, Brandon Sprung, MD, and Octavia Pickett-Blakely, MD, MHS, in a recent analysis.

“Gastroenterology fellows report limited exposure to nutrition topics leading to knowledge deficit on assessment,” they add.

As a result, not enough gastroenterologists are giving this topic the attention it needs, some in the industry contend.

One 2022 studybased on a survey of 279 GI clinicians treating patients with irritable bowel syndrome (IBS) reported that only 56% felt that they were trained to provide nutrition education, and 46% said that they sometimes, rarely, or never offered to help patients with their menu planning, label reading, or grocery shopping. And 77% said that they spent 10 minutes or less counseling patients on nutrition. Though almost all respondents (91%) said that having access to a dietitian would help them better manage patients with IBS, 42% said that they lack access to one.

But some gastroenterology professors are working to incorporate nutrition into GI training and integrating dietitians in their work with fellows as well as collaborating with dietitians to improve care in their own practices.
 

Nutrition overlooked in procedure-heavy specialty

In 1985, the National Academies of Sciences, Engineering, and Medicine made recommendations to upgrade nutrition education programs in U.S. medical schools.

Still, medical schools often don’t have the faculty or infrastructure to integrate and teach foundational nutrition concepts. These topics include clinical concepts, such as protein, carbohydrate and fat digestion/absorption, weight loss/gain, and symptoms related to food intake, as well as physical examination, which can help identify nutritional risks, said Dr. Pickett-Blakely, an associate professor of clinical medicine at the University of Pennsylvania and director of the Penn Center for GI Nutrition, both in Philadelphia.

Standardized medical exams include only about five questions on nutrition, and they’re all geared toward pathology, Dr. Pashinsky noted.

GI training, which includes 3 years of internal medicine residency and 3 years of GI fellowship, typically doesn’t focus on nutrition beyond total and peripheral parenteral nutrition and nutritional deficiencies, Dr. Pashinsky said. Instead, it focuses on the recognition, diagnosis, and medical management of GI diseases.

The Accreditation Council for Graduate Medical Education requires that fellows demonstrate core competency in nutrition and in the prevention, evaluation, and management of disorders of nutrient assimilation. The council also has incorporated the opportunity to interact with and learn from dietitians in its requirements for GI fellowship programs. Fellows in the dual GI/transplant hepatology pathway, created in 2021, must show competency in nutritional support for patients with chronic liver disease and in the factors involved in nutrition and malnutrition and their management.

Despite these requirements, the education that fellows receive often falls short for several reasons, said Dr. Sprung, an associate professor of medicine at the University of Rochester Medical Center’s gastroenterology and hepatology division in New York.

Gastroenterology faculties have generally shown a lack of interest in nutrition, translating into fewer faculty members able to train the future generations of physicians, he said. Training institutions have limited nutrition and obesity resources, staff, and support.

Gastroenterology is also a very procedure-focused specialty, and many students and trainees come to fellowships for procedural training, Dr. Sprung noted. Nutrition and obesity training don’t fit as well into what is traditionally an organ- or disease-specific style of education and training and, as a result, are superseded, he added.

It is possible that some fellowships are just not teaching these core concepts, Dr. Pickett-Blakely said. “The depth and breath of coverage of these concepts varies from program to program,” she added.

Exacerbating the problem is the growth of numerous subspecialties, including inflammatory bowel diseases, hepatobiliary disease, neurogastroenterology, and gastrointestinal motility, Dr. Pickett-Blakely said. Emphasis has dwindled over time on an in-depth understanding of core gastrointestinal functions, like digestion and absorption, and how these functions can be supported for optimal wellness and are affected by diseases.

“With the loss of those with the ability to educate trainees, nutrition sort of falls out of curricula, and trainees aren’t able to be exposed to those educational concepts,” she said.

It would be ideal if foundational concepts of nutrition were integrated into the subspecialty GI fellowships, which are 1-year fellowships that take place before or after the 3-year traditional fellowship, Dr. Pickett-Blakely said.

GI fellows interested in incorporating nutrition and obesity in their clinical practice on a routine basis could investigate getting board certified in nutrition, Dr. Sprung said. The National Board of Physician Nutrition Specialists, the National Board for Nutrition Support, and several other organizations offer certifications in nutrition.

If more physicians became board certified in nutritional or obesity specialties, teaching faculty numbers would increase, and that could help training grow, he noted.
 

Weaving more nutrition into training

To further increase knowledge, Dr. Sprung and Dr. Newberry, who is an assistant professor and director of GI nutrition at Weill Cornell Medicine’s Innovative Center for Health and Nutrition in Gastroenterology in New York, have created a free online resource covering core nutrition and obesity concepts that is available to GI fellowship programs.

Key components of the curriculum include online pre- and postlearning tests, self-directed reading materials, virtual recorded lectures, and case-based learning modules. It also provides a section on care coordination with a GI dietitian.

“Because the curriculum spans all facets of gastroenterology practice, the information can enhance clinical care experiences on general rotations,” write Dr. Newberry and colleagues in their recent analysis in Gastroenterology.

GI fellows can look at the content at their own pace and complete the curriculum as part of a formal elective.

The developers can see who’s taken the tests, and test participation indicates that several GI programs across the country are already using the program, Dr. Sprung said.

But it hasn’t been as widely adopted as hoped, he said.

“We’re trying to put some spotlight on it through articles, presentations during Digestive Disease Week, and emails to program directors, things like that,” Dr. Sprung said. “So it’s great to spread the word and get the message out there.”
 

Collaboration in practice

Ultimately, helping a patient with functional GI problems takes a village, and many practices are now including multidisciplinary teams.

Having these dietitians available to them, as well as seeing the benefit to their patients first-hand, has helped encourage the attending gastroenterologists’ interest, said Nancee Jaffe, RD, MS, who is senior supervisor for the GI nutrition program at UCLA Health’s Vatche & Tamar Manoukian Division of Digestive Diseases in Beverly Hills, Calif.

“We all subspecialize, which allows both doctors and patients access to the best nutrition information for a myriad of GI conditions,” Ms. Jaffe said.

In the spirit of teamwork, the university also has an integrative digestive health and wellness program, which is inclusive of doctors, dietitians, and psychologists. These teams meet monthly to discuss cases involving disorders of gut-brain interaction using a multicentered approach, she said.

In New York, one of the first things Dr. Newberry, who is also a clinical gastroenterologist with advanced training in nutrition and obesity sciences, did when she accepted her job at Weill Cornell was to advocate for a multidisciplinary team. At the Innovative Center for Health and Nutrition in Gastroenterology, she works with a group of dietitians, a hepatologist, an endocrinologist, and a team of surgeons to take care of patients. The focus is on treating patients’ GI issues while helping them lose weight.

The clinic sees a lot of patients with reflux disease and fatty liver disease. When patients come in, they’ll see the gastroenterologist, the dietitian, the endocrinologist, and possibly the bariatric surgeon. The team approach, which calls for constant communication among the physicians, improves outcomes, Dr. Newberry said.

It has been shown in the literature that multidisciplinary teams are effective for chronic diseases like nonalcoholic fatty liver disease (now known as metabolic dysfunction-associated steatotic liver disease) and inflammatory bowel disease, she added.

At the University of Rochester, Dr. Sprung and his fellow gastroenterologists coordinate with dietitians and nutrition experts for nutrition support services, as well as liver and transplant nutritional services.

We have nurse practitioners and physician assistants who run our nutritional support services for people who need such specialized care, such as total parenteral nutrition or tube feeds, or for those who need advanced therapies, like for short-gut syndrome, he said.

At NYGA, Dr. Pashinsky works with a team of registered dietitians who have specialized in gastroenterology. The dietitians help with identifying which foods in a patient’s diet are problematic and making recommendations to replace them with nutritionally equivalent staples to avoid dietary gaps, she said.

Dietitians inform patient care because they’re trained in food compounds and how foods pass through the GI tract, said Tamara Duker Freuman, RD, MS, CDN, who leads the group of registered dietitians at NYGA. Ms. Freuman comanages many patients with Dr. Pashinsky.

Oftentimes, the patient provides insights they never tell the doctor, and the dietitian gets a better idea of the patient’s life and eating habits, she said. “We’re able to spend more time with patients than physicians are, and we ask different questions.”

“Any detective work I do informs any future diagnostics [Dr. Pashinsky] does. It’s a team sport,” Ms. Freuman said.Dr. Pickett-Blakely has been a consultant for Novo Nordisk and WebMD. Dr. Newberry has received a speaking honorarium for Baxter and InBody. Dr. Sprung, Dr. Pashinsky, Ms. Freuman, and Ms. Jaffe reported no disclosures.

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

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

WASHINGTON – In psoriatic disease, psoriatic arthritis (PsA) remains one of the greatest unmet needs, with the transition from cutaneous psoriasis poorly understood, diagnosis challenging, and therapeutic accomplishments trailing far behind advances for skin disease. However, leading researchers in rheumatology and dermatology believe that they’re turning the corner toward a day when therapies are phenotype-targeted and diagnosis can be made early and treatment begun well before inflammation worsens and pain and joint damage ensue.

“The challenge right now is that we don’t understand the discrete and overlapping endotypes that underlie the phenotypes or domains” of PsA, said Christopher Ritchlin, MD, MPH, professor of medicine in the division of allergy/immunology and rheumatology and the Center of Musculoskeletal Research at the University of Rochester (N.Y.), who spoke about PsA at the annual research symposium of the National Psoriasis Foundation.

A deep dive into the tissue

Dr. Ritchlin is among those rheumatology clinician-researchers who advocated early on for a “domain” approach to the diagnosis and management of PsA – that is, consideration of the key domains of peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis.

The approach is an especially important part of treatment recommendations from the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. But while interventions can be tailored to some extent to these domains, or phenotypes, there are limitations without an understanding of the different pathophysiology and mechanisms driving the heterogeneity in tissue involvement.

Dr. Ritchlin draws inspiration from pulmonology, which subtyped asthma into various phenotypes (for example, eosinophilic, allergic, intrinsic, exercise-induced) and “drilled down” on understanding underlying mechanisms to guide more specific treatment. Similar phenotype-endotype research has been done for chronic obstructive pulmonary disease, he said at the meeting, pointing to a phase 3 randomized controlled trial, published in the New England Journal of Medicine, that found dupilimab (Dupixent) was effective for patients with COPD who had type 2 inflammation as indicated by elevated eosinophil counts.

“It’s a beautiful example of how to define an endotype from a phenotypic biomarker and then use a specific intervention to improve outcomes,” Dr. Ritchlin said. “We need to do this for psoriasis and PsA.”

The ELLIPSS project will utilize the host of -omics tools and technologies (for proteomics, metabolomics, and genomics, for instance) that are making it increasingly possible to dissect the heterogeneity of single diseases and achieve more precision with treatments.

Researchers will collect blood samples and skin and/or synovial tissue biopsies from cohorts of patients with psoriasis and PsA who are treatment naïve as well as patients who are treated with a biologic or DMARD (looking at responders and non-responders). They’ll also study a cohort of psoriasis patients who may be “on a transition pathway” for PsA based on risk factors such as family history, nail psoriasis, scalp psoriasis, and body surface area greater than 5%.

Patients in all cohorts will represent distinct synovio-entheseal domains of PsA and the heterogeneity of psoriasis (for example, plaque, general, pustular, palmoplantar) and will be followed longitudinally.

With regards to PsA, one goal is to “find new pathways in the joint, then find surrogate markers in the blood that we can use to help mark particular subphenotypes [that will be identified through deep phenotyping],” Dr. Ritchlin said in an interview after the meeting. “This will lead us hopefully to a more precision-based approach.”

The ELLIPSS team joins other researchers who have been studying rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) in an earlier iteration of the AIM program, and that will continue this work. Research on RA has thus far elucidated T-cell subsets in the rheumatoid synovium, as well as interactions of mesenchymal cells with the endothelium, for instance, and led to the identification of key molecules such as granzyme A that weren’t previously known to be involved in RA pathogenesis, Dr. Ritchin said in the interview. The current AIM work also includes Sjögren’s disease.
 

Finding biomarkers, diagnostic signatures

The psoriasis-PsA team has the advantage today of being able to utilize a new technology called spatial transcriptomics, which takes transcriptomics (RNA) from the single-cell level to the tissue level, enabling a look at how disease is affecting cellular organization/tissue architecture, gene activity, and cellular signaling within tissues. “It’s a huge advance in technology,” said Dr. Ritchlin. “We can actually see how the cells are interacting in the synovium [and other tissues].”

A paper published in Science Immunology and discussed at the NPF meeting demonstrates the power of special transcriptomics for learning about the skin. Dr. Scher, Dr. Ritchlin, first authors Rochelle L. Castillo, MD, and Ikjot Sidhu, MS, and other co-investigators reported a “dynamic re-organization of the immune milieu and fibroblasts in PsO lesional and non-lesional skin,” the presence of B cells in lesioned skin, and cellular organization/ecosystems that vary occurring according to clinical severity, among other findings.

Dr. Scher is using the tool for his NPF-funded diagnostic test research and as part of his work at NYU Langone for the ELLIPPS project. Among his goals: To “discover new cell populations in the microenvironment and study how they interact with each other, then compare those cells between psoriasis and PsA patients to first understand if they’re any different,” he explained after the meeting. Researchers can then investigate the synovial tissue, comparing cell populations and interactions in both compartments and looking for any shared markers/cytokines/proteins, he said.

Multiomics research, meanwhile, is showing that a test for early PsA detection could potentially combine clinical parameters with integrated multi-omic markers into a “diagnostic signature” of sorts.

At the meeting, Vinod Chandran, MD, PhD, a rheumatologist at the University of Toronto who also has an NPF PsA diagnostic test grant, said that his multi-omics analysis of blood samples from patients with psoriasis and PsA has identified signatures with a “high discriminatory value” and that certain metabolic pathways appear to play “a central role in the development and differentiation of PsA.” (Validation in other cohorts and economic analyses are ongoing, Dr. Chandran said. Low-cost alternatives that can be applied broadly in the clinic will need to be pursued, Dr. Scher said.)

Eyes on combination therapy

“The likelihood that all patients will respond to one biologic is very low in PsA, so we’ve been thinking about combination therapy for some time,” Dr. Ritchlin said at the meeting. “I think [dual inhibition] is coming.”

Safety has been the concern, but a phase 2 trial published this year compared a combination of IL-23 and TNF inhibition (guselkumab [Tremfya] plus golimumab [Simponi]) with monotherapy of both biologics in patients with ulcerative colitis and showed that the combination safely drove synergistic restoration of a normal epithelium and mucosal healing, he said.

A phase 2 trial in PsA, designed by Dr. Ritchlin and Dr. Scher and named AFFINITY, will study the safety and efficacy of the same combination of IL-23 and TNF blockade, compared with guselkumab (IL-23 inhibition) alone. The trial is currently completing enrollment of patients who have failed one or two anti-TNF agents.

In the meantime, combination therapy is being employed in clinics for “PsA patients who’ve been channeled through multiple biologics and are still not responding ... when [physicians] feel they’re forced to, not right away,” Dr. Ritchlin said in an interview after the meeting. “As we get a better understanding [through clinical trials], it might be something you’ll see earlier in the treatment process.”

It is wise, Dr. Ritchlin said, to devote more time to addressing “extra-articular traits” (for example, obesity, diabetes, uveitis, colitis, centralized pain) and treatable lifestyle/behavioral risk factors (for example, smoking, exercise, nutrition, adherence to therapy, social support) that can contribute to PsA and treatment nonresponse. He calls this the “treatable traits” strategy.

In practice, “there’s a big focus on inflammation and immune dysfunction, but the problem is, there are other factors involved in nonresponse, and I think ‘treatable traits’ gets to those,” Dr. Ritchlin said after the meeting. Rheumatologists and dermatologists lack time and alliances to address these issues, but “if we can find ways to do it, I think we’ll have improved outcomes.”

Dr. Ritchlin, Dr. Chandran, and Dr. Liao reported no relevant disclosures. Dr. Scher reported ties to Janssen, Pfizer, Sanofi, UCB, and Bristol-Myers Squibb.

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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

Alexandra Kharazi, MD, a California-based cardiothoracic surgeon, previously worked as an employed physician and is now in private practice. Though she appreciates that there are some trade-offs to working with her small group of three surgeons, Dr. Kharazi has no qualms about her choice.

“For me, it’s an issue of autonomy,” she said. “While I have to work a lot of hours, I don’t have to adhere to a strict schedule. I also don’t have to follow specific policies and rules.”

In contrast, Cassandra Boduch, MD, an employed psychiatrist with PsychPlus in Houston, is very satisfied with working as an employee. “I looked into private practice, but no one really prepares you for the complications that come with it,” she said. “There’s a lot more that goes into it than people realize.”

By hanging up her own shingle, Dr. Kharazi may be living a rapidly shrinking dream. According to the American Medical Association, between 2012 and 2022, the share of physicians working in private practice fell from 60% to 47%. The share of physicians working in hospitals as direct employees or contractors increased from about 6% to about 10% during the same time period.

Many factors contribute to these shifting trends, a major factor being economic stress stemming from payment cuts in Medicare. Add in rising practice costs and administrative burdens, and more doctors than ever are seeking employment, according to the AMA.

Though the traditional dream of owning your own practice may be slipping away, are employed physicians less happy than are their self-employed peers? By many measures, the answer is no.

In Medscape’s Employed Physicians Report 2023, doctors weighed in on the pros and cons of their jobs.

When asked what they like most about their jobs, employed physician respondents reported “not having to run a business” as their number-one benefit, followed closely by a stable income. The fact that employers pay for malpractice insurance ranked third, followed by work-life balance.

“We get no business classes in medical school or residency,” said one employed physician. “Having a good salary feels good,” said another. Yet another respondent chimed in: “Running a practice as a small business has become undoable over the past 10-12 years.”

And 50% of employed physicians said that they were “very satisfied/satisfied” with their degree of autonomy.

Still, employed physicians also had plenty to say about the downsides of their jobs.

Many pointed to “feeling like a cog in the machine,” and one doctor pointed to the hassle of dealing with bureaucracy. Others complained about the fact that nonphysicians ran the business and lacked an understanding of what physicians really need from their jobs. When asked whether administrative rules made sense, 63% of physician respondents said that yes, the rules make sense for the business; but, only 52% said that the rules make sense for the doctors themselves.

Other complaints included the requirement to reach high productivity targets and too low an income potential. In the 9 years since Medscape’s 2104 Employed Physicians Report, the share of employed doctors paid on a straight salary has declined from 46% to 31%. Those compensated on a base salary plus productivity targets and other performance metrics rose from 13% in 2014 to 32% now.

“Many doctors go into private practice because of the freedom it brings and the potential financial incentives,” added Dr. Boduch. “I know that many doctors have a dream of working for themselves, and in many cases, that works out great for them.”

Dr. Boduch noted that in her job as chief medical officer at PsychPlus, she still has flexibility plus the perks of working with a bigger practice. In this scenario, Dr. Boduch said, the company can negotiate with insurance companies, allowing her the financial rewards of private practice.
 

What’s right for you?

“I think it might be somewhat generational,” said Cody Futch, senior recruiting executive at AMN Healthcare. “It used to be that fewer hospitals offered employment, so private practice was the way to go. Now, there are fewer privates because hospitals and corporations are buying them up.”

This reality has potentially shaped the way younger generations approach their workplace. Also, Gen Z tends to have less intention to stay with a current employer for the long term than did their parents. “Older physicians were trained to expect they’d run their own business and build it over the years,” said Mr. Futch. “The younger generations look at it as a job, something they may want to switch in a few years. It’s a combination of candidates wanting more options, and also the fact that there are more options to be employed.”

Along those lines, younger generations in general tend to place work-life balance as a higher priority than do older generations, and employed physicians place this equation high on the list as well. In the Employed Physicians Report 2023, 54% said that they are satisfied or better with their work-life balance, up from 51% in the 2022 report.

With that in mind, Dr. Kharazi noted that flexibility is one of the chief reasons why she likes private practice. “If my kid has an event I want to attend, I don’t have to adhere to a strict schedule,” she said.

Satisfaction as an employee vs. employed doctor sometimes changes based on the type of medicine you practice too. With specialties that tend to be primarily outpatient, such as dermatology and allergy, private practice may be the best option regardless. “Hospitals don’t seek out those specialists as much and the specialists can operate successfully without a hospital,” said Mr. Futch.

Hospitals try to incentivize doctors with perks like hefty sign-on bonuses, student loan forgiveness, plenty of vacation time, and more. They also put money into marketing their doctors, a time-consuming and expensive aspect that is tough to shoulder in private practice, especially in the early years. Mr. Futch adds that many doctors view employment as a more stable option. “As the government changes reimbursement policies, the income from private practice fluctuates,” he said. “So many doctors worry that if they buy into a private practice, it is a risky endeavor.”

Hospitals aren’t always a sure bet in that regard, either: They go through tough financial times, lay off staff, or make salary cuts. Historically, however, employment tends to be the safer route, which can make it an attractive option.

Ultimately, the pros and cons of each scenario are individual. It’s up to physicians to do their own math and balance sheet before making a decision.

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