Giving the Smallest GI Transplant Patients a New Lease On Life

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Changed
Wed, 11/27/2024 - 04:14

The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.

As medical director of intestinal transplant at Stanford Children’s Health, Dr. Zhang sees children with critical illnesses like intestinal failure or chronic liver disease. Everyday life for them is a challenge.

 

Stanford Medicine
Dr. Ke-You (Yoyo) Zhang

Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.

Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.

In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.

She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
 

Q: Why did you choose this subspecialty of pediatric GI? 

I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.

And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills. 
 

Q: How did you become interested in the field of pediatric intestinal and liver transplantation? 

I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.

Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
 

Q: What challenges are unique to this type of transplant work? 

Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.

Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014. 
 

Q: Are these transplants hard to acquire?

Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant. 

Q: Is there a success story you’d like to share? 

One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming. 

He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal. 

He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him. 
 

Q: What advancements lie ahead for this field of work? Have you work on any notable research? 

I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.

I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting. 
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons? 

My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.

 

 

Lightning Round

Texting or talking?

Huge texter

Favorite junk food?

French fries



Cat or dog person?

Dog

Favorite ice cream?

Strawberry

If you weren’t a gastroenterologist, what would you be?Florist

Best place you’ve traveled to?

Thailand

Number of cups of coffee you drink per day?

Too many

Favorite city in the US besides the one you live in?

New York City

Favorite sport?

Tennis

Optimist or pessimist?

Optimist

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Topics
Sections

The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.

As medical director of intestinal transplant at Stanford Children’s Health, Dr. Zhang sees children with critical illnesses like intestinal failure or chronic liver disease. Everyday life for them is a challenge.

 

Stanford Medicine
Dr. Ke-You (Yoyo) Zhang

Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.

Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.

In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.

She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
 

Q: Why did you choose this subspecialty of pediatric GI? 

I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.

And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills. 
 

Q: How did you become interested in the field of pediatric intestinal and liver transplantation? 

I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.

Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
 

Q: What challenges are unique to this type of transplant work? 

Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.

Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014. 
 

Q: Are these transplants hard to acquire?

Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant. 

Q: Is there a success story you’d like to share? 

One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming. 

He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal. 

He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him. 
 

Q: What advancements lie ahead for this field of work? Have you work on any notable research? 

I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.

I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting. 
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons? 

My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.

 

 

Lightning Round

Texting or talking?

Huge texter

Favorite junk food?

French fries



Cat or dog person?

Dog

Favorite ice cream?

Strawberry

If you weren’t a gastroenterologist, what would you be?Florist

Best place you’ve traveled to?

Thailand

Number of cups of coffee you drink per day?

Too many

Favorite city in the US besides the one you live in?

New York City

Favorite sport?

Tennis

Optimist or pessimist?

Optimist

The best part about working with kids is that “I get to laugh every day,” said Ke-You (Yoyo) Zhang, MD, clinical assistant professor for pediatrics–gastroenterology and hepatology at Stanford Medicine in California.

As medical director of intestinal transplant at Stanford Children’s Health, Dr. Zhang sees children with critical illnesses like intestinal failure or chronic liver disease. Everyday life for them is a challenge.

 

Stanford Medicine
Dr. Ke-You (Yoyo) Zhang

Dealing with sick children is difficult. “But I think the difference between pediatrics and adults is despite how hard things get, children are the single most resilient people you’re ever going to meet,” she said.

Kids don’t always know they’re sick and they don’t act sick, even when they are. “Every day, I literally get on the floor, I get to play, I get to run around. And truly, I have fun every single day. I get excited to go to work. And I think that’s what makes work not feel like work,” said Dr. Zhang.

In an interview, she discussed the satisfaction of following patients throughout their care continuum and her research to reduce the likelihood of transplant rejection.

She also shared an inspirational story of one young patient who spent his life tied to an IV, and how a transplant exposed him to the normal joys of life, like swimming, going to camp and getting on a plane for the first time.
 

Q: Why did you choose this subspecialty of pediatric GI? 

I think it’s the best subspecialty because I think it combines a lot of the things that I enjoy, which is long-term continuity of care. It’s about growing up with your patients and seeing them through all the various stages of their life, often meeting patients when they’re babies. I get pictures of high school graduations and life milestones and even see some of my patients have families of their own. Becoming a part of their family is very meaningful to me. I also like complexity and acuity, and gastroenterology and hepatology provide those things.

And then lastly, it’s great to be able to exercise procedural skills and constantly learn new procedural skills. 
 

Q: How did you become interested in the field of pediatric intestinal and liver transplantation? 

I did all my training here at Stanford. We have one of the largest pediatric transplant centers and we also have a very large intestinal rehabilitation population.

Coming through residency and fellowship, I had a lot of exposure to transplant and intestinal failure, intestinal rehabilitation. I really liked the longitudinal relationship I got to form with my patients. Sometimes they’re in the neonatal ICU, where you’re meeting them in their very first days of life. You follow them through their chronic illness, through transplant and after transplant for many years. You become not just their GI, but the center of their care.
 

Q: What challenges are unique to this type of transplant work? 

Pediatric intestinal failure and intestinal transplant represents an incredibly small subset of children. Oftentimes, they do not get the resources and recognition on a national policy level or even at the hospital level that other gastrointestinal diseases receive. What’s difficult is they are such a small subset but their complexity and their needs are probably in the highest percentile. So that’s a really challenging combination to start with. And there’s only a few centers that specialize in doing intestinal rehabilitation and intestinal transplantation for children in the country.

Developing expertise has been slow. But I think in the last decade or so, our understanding and success with intestinal rehabilitation and intestinal transplantation has really improved, especially at large centers like Stanford. We’ve had a lot of success stories and have not had any graft loss since 2014. 
 

Q: Are these transplants hard to acquire?

Yes, especially when you’re transplanting not just the intestines but the liver as well. You’re waiting for two organs, not just one organ. And on top of that, you’re waiting for an appropriately sized donor; usually a child who’s around the same size or same age who’s passed away. Those organs would have to be a good match. Children can wait multiple years for a transplant. 

Q: Is there a success story you’d like to share? 

One patient I met in the neonatal ICU had congenital short bowel syndrome. He was born with hardly any intestines. He developed complications of being on long-term intravenous nutrition, which included recurrent central line infections and liver disease. He was never able to eat because he really didn’t have a digestive system that could adequately absorb anything. He had a central line in one of his large veins, so he couldn’t go swimming. 

He had to have special adaptive wear to even shower or bathe and couldn’t travel. It’s these types of patients that benefit so much from transplant. Putting any kid through transplant is a massive undertaking and it certainly has risks. But he underwent a successful transplant at the age of 8—not just an intestinal transplant, but a multi-visceral transplant of the liver, intestine, and pancreas. He’s 9 years old now, and no longer needs intravenous nutrition. He ate by mouth for the very first time after transplant. He’s trying all sorts of new foods and he was able to go to a special transplant camp for children. Getting on a plane to Los Angeles, which is where our transplant camp is, was a huge deal. 

He was able to swim in the lake. He’s never been able to do that. And he wants to start doing sports this fall. This was really a life-changing story for him. 
 

Q: What advancements lie ahead for this field of work? Have you work on any notable research? 

I think our understanding of transplant immunology has really progressed, especially recently. That’s what part of my research is about—using novel therapies to modulate the immune system of pediatric transplant recipients. The No. 1 complication that occurs after intestinal transplant is rejection because obviously you’re implanting somebody else’s organs into a patient.

I am involved in a clinical trial that’s looking at the use of extracellular vesicles that are isolated from hematopoietic stem cells. These vesicles contain various growth factors, anti-inflammatory proteins and tissue repair factors that we are infusing into intestinal transplant patients with the aim to repair the intestinal tissue patients are rejecting. 
 

Q: When you’re not being a GI, how do you spend your free weekend afternoons? 

My husband and I have an almost 2-year-old little girl. She keeps us busy and I spend my afternoons chasing after a crazy toddler.

 

 

Lightning Round

Texting or talking?

Huge texter

Favorite junk food?

French fries



Cat or dog person?

Dog

Favorite ice cream?

Strawberry

If you weren’t a gastroenterologist, what would you be?Florist

Best place you’ve traveled to?

Thailand

Number of cups of coffee you drink per day?

Too many

Favorite city in the US besides the one you live in?

New York City

Favorite sport?

Tennis

Optimist or pessimist?

Optimist

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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes

Article Type
Changed
Tue, 09/24/2024 - 13:12

 

In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

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Topics
Sections

 

In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

 

In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.

The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.

A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.

 

Thyme Care
Dr. Samyukta Mullangi

“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.

Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.

The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.

The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.

CMS expects the new navigators may:

  • Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
  • Provide support to accomplish the clinician’s treatment plan.
  • Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.

Peers as Navigators

The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.

“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.

The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.

But those without a definitive diagnosis may also qualify to receive navigator services.

In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.

“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.

Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.

The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.

The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



Gaining a special Medicare payment for these kinds of services will elevate this work, she said.

Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.

Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.

“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
 

 

 

Potential Challenges

Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.

“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.

In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.

While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.

“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.

Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.

Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.

A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.

Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.

The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.

Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
 

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

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As PAC expands, hospital medicine’s role – and leadership – will be key.

 

The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.

PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.

Manoj K. Mathew
Dr. Manoj K. Mathew
“Previously, physicians considered post-acute care only within the limited scope of what’s in their own care universe – such as skilled nursing facilities [SNFs], inpatient rehabilitation facilities [IRFs], long-term acute-care hospitals [LTACHs], and home health visits,” Dr. Mathew says. “But in today’s world, PAC goes well beyond these types of facilities to include other types: postdischarge clinics, palliative care programs, chronic-care/high-risk clinics, home care, and telehealth.”

Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.

“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”

Dr. Sean Muldoon
Another reason for increased Medicare spending on PAC stems from the fact that patients no longer need to be hospitalized before going to a PAC setting.

“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
 

Hospitalists can fill a need

More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.

“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”

Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.

“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.

PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.

“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”

Transitioning Care

Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.

“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”

If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.

“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”

Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.

“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”

Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.

Dr. Robert Harrington
“We’re headed down a path that will mandate and incentivize all of us to provide more-coordinated, more-efficient, higher-quality care,” he says. “We need to meet patients at the level of care that they need and provide continuity through the entire episode of care from hospital to home.”
 

 

 

How PAC settings differ from hospitals

Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.

“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”

According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.

“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”

Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”

Despite some frustrations cited by others, James D. Tollman, MD, FHM, president of Boxford, Mass.–based Essex Inpatient Physicians, believes working in a PAC setting can be a less-demanding environment for a hospitalist than an inpatient facility. “They have much more flexibility with their schedule,” he says. “In the hospital, hospitalists have longer, more physically demanding shifts. At SNFs, the level of decision making is often easier; usually they house lower-acuity patients. However, there might be more challenges with disposition, family issues, and follow-ups. Plus, you have to do more to coordinate care.”
 

What’s ahead?

Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.

And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.

“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.

Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.

“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
 

The cost of care, and other PAC facts and figures

The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2

 

 

It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3

What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2

References

1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.

2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.

3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.

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As PAC expands, hospital medicine’s role – and leadership – will be key.
As PAC expands, hospital medicine’s role – and leadership – will be key.

 

The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.

PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.

Manoj K. Mathew
Dr. Manoj K. Mathew
“Previously, physicians considered post-acute care only within the limited scope of what’s in their own care universe – such as skilled nursing facilities [SNFs], inpatient rehabilitation facilities [IRFs], long-term acute-care hospitals [LTACHs], and home health visits,” Dr. Mathew says. “But in today’s world, PAC goes well beyond these types of facilities to include other types: postdischarge clinics, palliative care programs, chronic-care/high-risk clinics, home care, and telehealth.”

Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.

“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”

Dr. Sean Muldoon
Another reason for increased Medicare spending on PAC stems from the fact that patients no longer need to be hospitalized before going to a PAC setting.

“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
 

Hospitalists can fill a need

More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.

“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”

Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.

“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.

PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.

“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”

Transitioning Care

Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.

“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”

If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.

“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”

Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.

“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”

Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.

Dr. Robert Harrington
“We’re headed down a path that will mandate and incentivize all of us to provide more-coordinated, more-efficient, higher-quality care,” he says. “We need to meet patients at the level of care that they need and provide continuity through the entire episode of care from hospital to home.”
 

 

 

How PAC settings differ from hospitals

Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.

“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”

According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.

“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”

Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”

Despite some frustrations cited by others, James D. Tollman, MD, FHM, president of Boxford, Mass.–based Essex Inpatient Physicians, believes working in a PAC setting can be a less-demanding environment for a hospitalist than an inpatient facility. “They have much more flexibility with their schedule,” he says. “In the hospital, hospitalists have longer, more physically demanding shifts. At SNFs, the level of decision making is often easier; usually they house lower-acuity patients. However, there might be more challenges with disposition, family issues, and follow-ups. Plus, you have to do more to coordinate care.”
 

What’s ahead?

Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.

And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.

“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.

Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.

“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
 

The cost of care, and other PAC facts and figures

The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2

 

 

It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3

What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2

References

1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.

2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.

3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.

 

The definition of “hospitalist,” according to the SHM website, is a clinician “dedicated to delivering comprehensive medical care to hospitalized patients.” For years, the hospital setting was the specialties’ identifier. But as hospitalists’ scope has expanded, and post-acute care (PAC) in the United States has grown, more hospitalists are extending their roles into this space.

PAC today is more than the traditional nursing home, according to Manoj K. Mathew, MD, SFHM, national medical director of Agilon Health in Los Angeles.

Manoj K. Mathew
Dr. Manoj K. Mathew
“Previously, physicians considered post-acute care only within the limited scope of what’s in their own care universe – such as skilled nursing facilities [SNFs], inpatient rehabilitation facilities [IRFs], long-term acute-care hospitals [LTACHs], and home health visits,” Dr. Mathew says. “But in today’s world, PAC goes well beyond these types of facilities to include other types: postdischarge clinics, palliative care programs, chronic-care/high-risk clinics, home care, and telehealth.”

Many of those expanded settings Dr. Mathew describes emerged as a result of the Affordable Care Act. Since its enactment in 2010, the ACA has heightened providers’ focus on the “Triple Aim” of improving the patient experience (including quality and satisfaction), improving the health of populations, and reducing the per capita cost of healthcare.Vishal Kuchaculla, MD, New England regional post-acute medical director of Knoxville,Tenn.-based TeamHealth, says new service lines also developed as Medicare clamped down on long-term inpatient hospital stays by giving financial impetus to discharge patients as soon as possible.

“Over the last few years, there’s been a major shift from fee-for-service to risk-based payment models,” Dr. Kuchaculla says. “The government’s financial incentives are driving outcomes to improve performance initiatives.”

Dr. Sean Muldoon
Another reason for increased Medicare spending on PAC stems from the fact that patients no longer need to be hospitalized before going to a PAC setting.

“Today, LTACHs can be used as substitutes for short-term acute care,” says Sean R. Muldoon, MD, MPH, FCCP, chief medical officer of Kindred Healthcare in Louisville, Ky., and former chair of SHM’s Post-Acute Care Committee. “This means that a patient can be directly admitted from their home to an LTACH. In fact, many hospice and home-care patients are referred from physicians’ offices without a preceding hospitalization.”
 

Hospitalists can fill a need

More hospitalists are working in PACs for a number of reasons. Dr. Mathew says PAC facilities and services have “typically lacked the clinical structure and processes to obtain the results that patients and payors expect.

“These deficits needed to be quickly remedied as patients discharged from hospitals have increased acuity and higher disease burdens,” he adds. “Hospitalists were the natural choice to fill roles requiring their expertise and experience.”

Dr. Muldoon considers the expanded scope of practice into PACs an additional layer to hospital medicine’s value proposition to the healthcare system.

“As experts in the management of inpatient populations, it’s natural for hospitalists to expand to other facilities with inpatient-like populations,” he says, noting SNFs are the most popular choice, with IRFs and LTACHs also being common places to work. Few hospitalists work in home care or hospice.

PAC settings are designed to help patients who are transitioning from an inpatient setting back to their home or other setting.

“Many patients go home after a SNF stay, while others will move to a nursing home or other longer-term care setting for the first time,” says Tiffany Radcliff, PhD, a health economist in the department of health policy and management at Texas A&M University School of Public Health in College Station. “With this in mind, hospitalists working in PAC have the opportunity to address each patient’s ongoing care needs and prepare them for their next setting. Hospitalists can manage medication or other care regimen changes that resulted from an inpatient stay, reinforce discharge instructions to the patient and their caregivers, and identify any other issues with continuing care that need to be addressed before discharge to the next care setting.”

Transitioning Care

Even if a hospitalist is not employed at a PAC, it’s important that they know something about them.

“As patients are moved downstream earlier, hospitalists are being asked to help make a judgment regarding when and where an inpatient is transitioned,” Dr. Muldoon says. As organizations move toward becoming fully risk capable, it is necessary to develop referral networks of high-quality PAC providers to achieve the best clinical outcomes, reduce readmissions, and lower costs.2“Therefore, hospitalists should have a working knowledge of the different sites of service as well as some opinion on the suitability of available options in their community,” Dr. Muldoon says. “The hospitalist can also help to educate the hospitalized patient on what to expect at a PAC.”

If a patient is inappropriately prepared for the PAC setting, it could lead to incomplete management of their condition, which ultimately could lead to readmission.

“When hospitalists know how care is provided in a PAC setting, they are better able to ensure a smoother transition of care between settings,” says Tochi Iroku-Malize, MD, MPH, MBA, FAAFP, SFHM, chair of family medicine at Northwell Health in Long Island, N.Y. “This will ultimately prevent unnecessary readmissions.”

Further, the quality metrics that hospitals and thereby hospitalists are judged by no longer end at the hospital’s exit.

“The ownership of acute-care outcomes requires extending the accountability to outside of the institution’s four walls,” Dr. Mathew says. “The inpatient team needs to place great importance on the transition of care and the subsequent quality of that care when the patient is discharged.”

Robert W. Harrington Jr., MD, SFHM, chief medical officer of Plano, Texas–based Reliant Post-Acute Care Solutions and former SHM president, says the health system landscapes are pushing HM beyond the hospitals’ walls.

Dr. Robert Harrington
“We’re headed down a path that will mandate and incentivize all of us to provide more-coordinated, more-efficient, higher-quality care,” he says. “We need to meet patients at the level of care that they need and provide continuity through the entire episode of care from hospital to home.”
 

 

 

How PAC settings differ from hospitals

Practicing in PAC has some important nuances that hospitalists from short-term acute care need to get accustomed to, Dr. Muldoon says. Primarily, the diagnostic capabilities are much more limited, as is the presence of high-level staffing. Further, patients are less resilient to medication changes and interventions, so changes need to be done gradually.

“Hospitalists who try to practice acute-care medicine in a PAC setting may become frustrated by the length of time it takes to do a work-up, get a consultation, and respond to a patient’s change of condition,” Dr. Muldoon says. “Nonetheless, hospitalists can overcome this once recognizing this mind shift.”

According to Dr. Harrington, another challenge hospitalists may face is the inability of the hospital’s and PAC facility’s IT platforms to exchange electronic information.

“The major vendors on both sides need to figure out an interoperability strategy,” he says. “Currently, it often takes 1-3 days to receive a new patient’s discharge summary. The summary may consist of a stack of paper that takes significant time to sort through and requires the PAC facility to perform duplicate data entry. It’s a very highly inefficient process that opens up the doors to mistakes and errors of omission and commission that can result in bad patient outcomes.”

Arif Nazir, MD, CMD, FACP, AGSF, chief medical officer of Signature HealthCARE and president of SHC Medical Partners, both in Louisville, Ky., cites additional reasons the lack of seamless communication between a hospital and PAC facility is problematic. “I see physicians order laboratory tests and investigations that were already done in the hospital because they didn’t know they were already performed or never received the results,” he says. “Similarly, I see patients continue to take medications prescribed in the hospital long term even though they were only supposed to take them short term. I’ve also seen patients come to a PAC setting from a hospital without any formal understanding of their rehabilitative period and expectations for recovery.”

Despite some frustrations cited by others, James D. Tollman, MD, FHM, president of Boxford, Mass.–based Essex Inpatient Physicians, believes working in a PAC setting can be a less-demanding environment for a hospitalist than an inpatient facility. “They have much more flexibility with their schedule,” he says. “In the hospital, hospitalists have longer, more physically demanding shifts. At SNFs, the level of decision making is often easier; usually they house lower-acuity patients. However, there might be more challenges with disposition, family issues, and follow-ups. Plus, you have to do more to coordinate care.”
 

What’s ahead?

Looking to the future, Surafel Tsega, MD, clinical instructor at Mount Sinai Hospital in New York, says he thinks there will be a move toward greater collaboration among inpatient and PAC facilities, particularly in the discharge process, given that hospitals have an added incentive to ensure safe transitions because reimbursement from the Centers for Medicare & Medicaid Services is tied to readmissions and there are penalties for readmission. This involves more comprehensive planning regarding “warm handoffs” (e.g., real-time discussions with PAC providers about a patient’s hospital course and plan of care upon discharge), transferring of information, and so forth.

And while it can still be challenging to identify high-risk patients or determine the intensity and duration of their care, Dr. Mathew says risk-stratification tools and care pathways are continually being refined to maximize value with the limited resources available. In addition, with an increased emphasis on employing a team approach to care, there will be better integration of non-medical services to address the social determinants of health, which play significant roles in overall health and healing.

“Working with community-based organizations for this purpose will be a valuable tool for any of the population health–based initiatives,” he says.

Dr. Muldoon says he believes healthcare reform will increasingly view an inpatient admission as something to be avoided.

“If hospitalization can’t be avoided, then it should be shortened as much as possible,” he says. “This will shift inpatient care into LTACHs, SNFs, and IRFs. Hospitalists would be wise to follow patients into those settings as traditional inpatient census is reduced. This will take a few years, so hospitalists should start now in preparing for that downstream transition of individuals who were previously inpatients.”
 

The cost of care, and other PAC facts and figures

The amount of money that Medicare spends on post-acute care (PAC) has been increasing. In 2012, 12.6% of Medicare beneficiaries used some form of PAC, costing $62 billion.2 That amounts to the Centers for Medicare & Medicaid Services spending close to 25% of Medicare beneficiary expenses on PAC, a 133% increase from 2001 to 2012. Among the different types, $30.4 billion was spent on skilled nursing facilities (SNFs), $18.6 billion on home health, and $13.1 billion on long-term acute care (LTAC) and acute-care rehabilitation.2

 

 

It’s also been reported that after short-term acute-care hospitalization, about one in five Medicare beneficiaries requires continued specialized treatment in one of the three typical Medicare PAC settings: inpatient rehabilitation facilities (IRFs), LTAC hospitals, and SNFs.3

What’s more, hospital readmission nearly doubles the cost of an episode, so the financial implications for organizations operating in risk-bearing arrangements are significant. In 2013, 2,213 hospitals were charged $280 million in readmission penalties.2

References

1. The role of post-acute care in new care delivery models. American Hospital Association website. Available at: http://www.aha.org/research/reports/tw/15dec-tw-postacute.pdf. Accessed Nov. 7, 2016.

2. Post-acute care integration: Today and in the future. DHG Healthcare website. Available at: http://www2.dhgllp.com/res_pubs/HCG-Post-Acute-Care-Integration.pdf. Accessed Nov. 7, 2016.

3. Overview: Post-acute care transitions toolkit. Society for Hospital Medicine website. Available at: http://www.hospitalmedicine.org/Web/Quality___Innovation/Implementation_Toolkit/pact/Overview_PACT.aspx?hkey=dea3da3c-8620-46db-a00f-89f07f021958. Accessed Nov. 10, 2016.

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Transplantation palliative care: The time is ripe

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Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

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Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

 

Over 10 years ago, a challenge was made in a surgical publication for increased collaboration between the fields of transplantation and palliative care.1

Since that time not much progress has been made bringing these fields together in a consistent way that would mutually benefit patients and the specialties. However, other progress has been made, particularly in the field of palliative care, which could brighten the prospects and broaden the opportunities to accomplish collaboration between palliative care and transplantation.

Growth of palliative services

During the past decade there has been a robust proliferation of hospital-based palliative care programs in the United States. In all, 67% of U.S. hospitals with 50 or more beds report palliative care teams, up from 63% in 2011 and 53% in 2008.

Dr. Daniel Azoulay
In addition, the number of hospice and palliative medicine fellowship programs and certified physicians, including surgeons, has increased across the country. There are approximately 120 training fellowships in hospice and palliative medicine and more than 7,000 physicians certified in hospice and palliative medicine through the American Board of Medical Specialties and American Osteopathic Association.

Only a decade ago, critical care and palliative care were generally considered mutually exclusive. Evidence is trickling in to suggest that this is no longer the case. Although palliative care was not an integral part of critical care at that time, patients, families, and even practitioners began to demand these services. Cook and Rocker have eloquently advocated the rightful place of palliative care in the ICU.2

Studies in recent years have shown that the integration of palliative care into critical care decreases in length of ICU and hospital stay, decreases costs, enhances patient/family satisfaction, and promotes a more rapid consensus about goals of care, without increasing mortality. The ICU experience to date could be considered a reassuring precedent for transplantation palliative care.

Integration of palliative care with transplantation

Early palliative care intervention has been shown to improve symptom burden and depression scores in end-stage liver disease patients awaiting transplant. In addition, early palliative care consultation in conjunction with cancer treatment has been associated with increased survival in non–small-cell lung cancer patients. It has been demonstrated that early integration of palliative care in the surgical ICU alongside disease-directed curative care can be accomplished without change in mortality, while improving end-of-life practice in liver transplant patients.3

Dr. Geoffrey P. Dunn
Transplantation palliative care is a species of surgical palliative care, which is defined as the treatment of suffering and the promotion of quality of life for seriously or terminally ill patients under surgical care. Despite the dearth of information about palliative care for patients under the care of transplant surgeons, clearly there are few specialties with so many patients need of palliative care support. There is no “Stage I” disease in the world of transplantation. Any patient awaiting transplantation, any patient’s family considering organ donation from a critically ill loved one, and any transplant patient with chronic organ rejection or other significant morbidity is appropriate for palliative care consultation. Palliative care support addresses two needs critically important for successful transplantation outcomes: improved medical compliance that comes with diligent symptom control and psychosocial support.

What palliative care can do for transplant patients

What does palliative care mean for the person (and family) awaiting transplantation? For the cirrhotic patient with cachexia, ascites, and encephalopathy, it means access to the services of a team trained in the management of these symptoms. Palliative care teams can also provide psychosocial and spiritual support for patients and families who are intimidated by the complex navigation of the health care system and the existential threat that end-stage organ failure presents to them. Skilled palliative care and services can be the difference between failing and extended life with a higher quality of life for these very sick patients

Resuscitation of a patient, whether through restoration of organ function or interdicting the progression of disease, begins with resuscitation of hope. Nothing achieves this more quickly than amelioration of burdensome symptoms for the patient and family.

The barriers for transplant surgeons and teams referring and incorporating palliative care services in their practices are multiple and profound. The unique dilemma facing the transplant team is to balance the treatment of the failing organ, the treatment of the patient (and family and friends), and the best use of the graft, a precious gift of society.

Palliative surgery has been defined as any invasive procedure in which the main intention is to mitigate physical symptoms in patients with noncurable disease without causing premature death. The very success of transplantation over the past 3 decades has obscured our memory of transplantation as a type of palliative surgery. It is a well-known axiom of reconstructive surgery that the reconstructed site should be compared to what was there, not to “normal.” Even in the current era of improved immunosuppression and posttransplant support services, one could hardly describe even a successful transplant patient’s experience as “normal.” These patients’ lives may be extended and/or enhanced but they need palliative care before, during, and after transplantation. The growing availability of trained palliative care clinicians and teams, the increased familiarity of palliative and end-of-life care to surgical residents and fellows, and quality metrics measuring palliative care outcomes will provide reassurance and guidance to address reservations about the convergence of the two seemingly opposite realities.
 

 

 

A modest proposal

We propose that palliative care be presented to the entire spectrum of transplantation care: on the ward, in the ICU, and after transplantation. More specific “triggers” for palliative care for referral of transplant patients should be identified. Wentlandt et al.4 have described a promising model for an ambulatory clinic, which provides early, integrated palliative care to patients awaiting and receiving organ transplantation. In addition, we propose an application for grant funding for a conference and eventual formation of a work group of transplant surgeons and team members, palliative care clinicians, and patient/families who have experienced one of the aspects of the transplant spectrum. We await the subspecialty certification in hospice and palliative medicine of a transplant surgeon. Outside of transplantation, every other surgical specialty in the United States has diplomates certified in hospice and palliative medicine. We await the benefits that will accrue from research about the merging of these fields.

1. Molmenti EP, Dunn GP: Transplantation and palliative care: The convergence of two seemingly opposite realities. Surg Clin North Am. 2005;85:373-82.

2. Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med. 2014;370:2506-14.

3. Lamba S, Murphy P, McVicker S, Smith JH, and Mosenthal AC. Changing end-of-life care practice for liver transplant patients: structured palliative care intervention in the surgical intensive care unit. J Pain Symptom Manage. 2012; 44(4):508-19.

4. Wentlandt, K., Dall’Osto, A., Freeman, N., Le, L. W., Kaya, E., Ross, H., Singer, L. G., Abbey, S., Clarke, H. and Zimmermann, C. (2016), The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program. Clin Transplant. 2016 Nov 4; doi: 10.1111/ctr.12838.

Dr. Azoulay is a transplantation specialist of Assistance Publique – Hôpitaux de Paris, and the University of Paris. Dr. Dunn is medical director of the Palliative Care Consultation Service at the University of Pittsburgh Medical Center Hamot, and vice-chair of the ACS Committee on Surgical Palliative Care.

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Blood Buddies: Can Mentorship Revive Classical Hematology?

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Wed, 11/27/2024 - 02:49

For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

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For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

For some medical students and trainees who go on to become hematologists, attraction to the field happens the first time they’re engrossed in figuring out what a blood smear is telling them. Others get drawn to hematology during a rotation in residency, when they encounter patients with hemophilia or sickle cell disease.

But when it comes to turning people on to the idea of a career in classical hematology (CH), there may be no more powerful influence than a mentor who loves their job. That’s why the field is focusing so much on supporting mentors and mentees amid a stark shortage of classical hematologists.

“Mentorship is key for maintaining trainee interest in the field and for providing role models for career growth,” said Rakhi P. Naik, MD, MHS, associate professor of medicine and director of the Hematology Fellowship Track at Johns Hopkins University, Baltimore, Maryland, in an interview. “This collaboration is especially critical because there are so few trainees and so few mentors currently in the field.”

Now there’s new research backing up the power of mentorship, even when it’s only provided virtually, and a brand-new program aims to unite more mentors and mentees.

Here’s a closer look at mentor-focused efforts to attract medical students to CH.

 

How Severe Is the Shortage in CH?

Patients with conditions treated by classical hematologists are waiting months for appointments at many outpatient centers, with some being forced to wait 6 months or more, said Srikanth Nagalla, MD, chief of benign hematology at Miami Cancer Institute, Florida, in an interview.

The shortage is creating dire problems in the inpatient setting too, Nagalla said. “Serious blood disorders like heparin-induced thrombocytopenia, acute chest syndrome [a complication of sickle cell disease], and thrombotic thrombocytopenic purpura have to be diagnosed and treated in a timely manner. If not, the morbidity and mortality are really high.”

If classical hematologists aren’t available, he said, oncologists and others not trained in hematology will need to cover these patients. 

Hematologist Ariela Marshall, MD, associate professor of medicine at the University of Minnesota in Minneapolis, noted in an interview that the CH shortage comes at a time when medical advances and an aging population are boosting the number of patients with noncancerous blood disorders. Older people are at greater risk for blood clots, she said. And lifespans for patients with bleeding and clotting disorders are rising thanks to effective new treatments.

“Because of our larger patient population in CH, we are going to need more classical hematologists to follow them for longer and longer periods of time,” she said. 

There’s no sign yet that newly minted physicians will take up the slack in CH. A 2019 study found that just 4.6% of 626 of hematology/oncology fellows said they planned to go into CH, also known as benign hematology, vs 67.1% who expected to treat patients with solid tumors, blood cancer, or both. The rest, 24.6%, planned to work in CH plus the two oncology fields.

 

Why Does a Shortage Exist?

“The reasons are complex, but one of the most important factors was the combining of the adult hematology and medical oncology training programs by the Accreditation Council for Graduate Medical Education in 1995,” Naik said. “After that time, the majority of fellowship training programs went from having separate programs for hematology and medical oncology to combining the training for the two specialties into one. Because most of these combined training programs resided within Cancer Centers, classical hematology training slowly became de-emphasized.”

As a result, fewer fellows ended up specializing in CH, she said. 

The field of CH also appears to suffer from a less than enticing reputation. According to a 2019 study coauthored by Marshall, surveys of thousands of hematology/oncology fellows found that “hematology, particularly benign hematology, was viewed as having poorer income potential, research funding, job availability, and job security than oncology.”

Regarding pay, Marshall said the good news is that many classical hematologists work in academia, where it’s common for pay to be “equitable across hematology/oncology divisions and based more on academic rank and other factors rather than subspecialty within hematology oncology.”

However, she noted, “this may differ at institutions where hematology and oncology are different departments. For example, centers where oncology is its own department, and hematology is part of the department of medicine.” 

As for job availability, Naik said that there’s plenty of demand. “In academics, it is clear that there are jobs available everywhere, but trainees are often worried about job prospects in private practice. While classical hematology jobs in private practice are not widely advertised, I can attest that there is no shortage of need,” she said. “Many private practices do not specifically advertise for classical hematologists because they assume that classical hematology experts are not available. But I assure you that every private practice my trainees have ever approached is always ecstatic to hire a classical hematologist.”

 

Why Are Mentors Important?

Mentorship is crucial to promoting the value of CH as a great career choice in a competitive environment, classical hematologists say. “We can motivate trainees by showing how the disease states themselves are so fascinating and how the treatments are showing great outcomes,” Nagalla said. “We can show positive results, how patient lives can be changed, and how well-respected across the system [we] are.”

As a selling point, classical hematologists like to emphasize that their field requires intensive detective work. “Let’s say a patient comes with anemia, which might have 15 different causes. You get some labs, and then you systemically rule in or rule out most of these on the differential diagnosis,” Nagalla said. “Then once you narrow it down, you get more labs. You keep going to the next step and next step, and so finally you come to a conclusion.”

As for therapy, Marshall said that “while for many cancers there are specific treatment recommendations for patients with a specific cancer type at a specific stage, there is not always a specific treatment recommendation (or a ‘right answer’) for our CH patients. Treatment planning depends strongly on a patient’s preferences, other medical conditions, and a discussion about risks [and] benefits of different treatment options such that two patients with the same condition may choose two different treatment options.”

Marshall also emphasizes to trainees that “CH is a broad field. Physicians and trainees are able to interact and collaborate with physicians in other specialties such as gastroenterology, cardiology, ob/gyn, and surgical specialties.” 

 

Does Research Support Mentorship in CH?

The 2019 study that revealed just 4.6% of fellows planned to go into CH found that “fellows who planned to enter hematology-only careers were significantly more likely to report having clinical training and mentorship experiences in hematology throughout their training relative to fellows with oncology-only or combined hematology/oncology career plans.”

Now there are more data to support mentorships. For a study published in Blood Advances in September 2024, Zoya Qureshy, MD, an internal medicine chief resident at the University of California at San Diego, and colleagues evaluated a year-long external membership program implemented by the American Society of Hematology (ASH) Medical Educators Institute. 

The program linked 35 US hematology/oncology fellows (80% female, 46% White, 35% Asian) who were interested in CH to 34 North American faculty members. The pairs were told to meet virtually once a month. 

Of 30 mentees and 23 mentors surveyed, 94% and 85%, respectively, said their pairings were good matches. Two thirds of the mentees accepted faculty positions in CH after their mentorships.

“Our study showed that external mentorship in a virtual format is feasible,” Qureshy said in an interview. “Additionally, external mentorship provided benefits such as different perspectives and the opportunity for mentorship for those who may not have it in their field of interest at their home institution.”

Qureshy added that “one strength of our mentorship program was that mentoring pairs were meticulously assigned based on shared interests and background. Many participants cited this common ground as a reason why they thought their mentoring pair was a good match.” 

There’s an important caveat: Most of the mentees weren’t new to CH. About 70% had previously worked with a mentor in the CH field, and 86% had previously conducted research in the field. 

 

What’s Next for Mentorship in CH?

The ASH Hematology-Focused Fellowship Training Program Consortium aims to mint 50 new academic hematologists by 2030 through programs at 12 institutions. “Mentorship is an exciting aspect of the program since it allows classical hematology trainees to form a network of peers nationally and also provides access to mentors across institutions,” Naik said. “And as the workforce grows, there will be more and more role models for future trainees to look up to.”

Moving forward, she said, “we hope to inspire even more institutions to adopt hematology training tracks throughout the country.”

Meanwhile, ASH’s new Classical Hematology Advancement Mentorship is taking applications for its debut 2025 program through January 9, 2025. Trainees will meet monthly with mentors both virtually and in person. Applicants must have been in their first or second year of hematology/oncology fellowship training at accredited programs in the United States as of July 15, 2024.

Naik, Marshall, Nagalla, and Qureshy have no relevant disclosures.

A version of this article appeared on Medscape.com.

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Winter Depression: How to Make the ‘SAD’ Diagnosis

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’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

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’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

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

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Trump Nominations for US Health Agencies Spark Controversy, Criticism, Praise

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

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

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Europe’s Lifeline: Science Weighs in on Suicide Prevention

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Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

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Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

Suicide and self-harm continue to be serious concerns in Europe, despite decreasing rates over the past two decades. In 2021 alone, 47,346 people died by suicide in the European Union, close to 1% of all deaths reported that year. Measures have been taken at population, subpopulation, and individual levels to prevent suicide and suicide attempts. But can more be done? Yes, according to experts.

Researchers are investigating factors that contribute to suicide at the individual level, as well as environmental and societal pressures that may increase risk. New predictive tools show promise in identifying individuals at high risk, and ongoing programs offer hope for early and ongoing interventions. Successful preventive strategies are multimodal, emphasizing the need for trained primary care and mental health professionals to work together to identify and support individuals at risk at every age and in all settings.

 

‘Radical Change’ Needed

The medical community’s approach to suicide prevention is all wrong, according to Igor Galynker, MD, PhD, clinical professor of psychiatry and director of the Mount Sinai Suicide Prevention Research Lab in New York City. 

Galynker is collaborating with colleagues in various parts of the world, including Europe, to validate the use of suicide crisis syndrome (SCS) as a diagnosis to help imminent suicide risk evaluation and treatment.

SCS is a negative cognitive-affective state associated with imminent suicidal behavior in those who are already at high risk for suicide. Galynker and his colleagues want to see SCS recognized and accepted as a suicide-specific diagnosis in the Diagnostic and Statistical Manual of Mental Disorders and the World Health Organization’s International Classification of Diseases. 

Currently, he explained to this news organization, clinicians depend on a person at risk for suicide telling them that this is what they are feeling. This is “absurd,” he said, because people in this situation are in acute pain and distress and cannot answer accurately.

“It is the most lethal psychiatric condition, because people die from it ... yet we rely on people at the worst moment of their lives to tell us accurately when and how they are going to kill themselves. We don’t ask people with serious mental illness to diagnose their own mental illness and rely on that diagnosis.”

Data show that most people who attempt or die by suicide deny suicidal thoughts when assessed by healthcare providers using current questionnaires and scales. Thus, there needs to be “a radical change” in how patients at acute risk are assessed and treated to help “prevent suicides and avoid lost opportunities to intervene,” he said.

Galynker explained that SCS is the final and most acute stage of the “ narrative crisis model” of suicide, which reflects the progression of suicidal risk from chronic risk factors to imminent suicidal risk. “The narrative crisis model has four distinct and successive stages, with specific guidance and applicable interventions that enable patients to receive a stage-specific treatment.”

“Suicide crisis syndrome is a very treatable syndrome that rapidly resolves” with appropriate interventions, he said. “Once it is treated, the patient can engage with psychotherapy and other treatments.”

Galynker said he and his colleagues have had encouraging results with their studies so far on the subjective and objective views of clinicians using the risk assessment tools they are developing to assess suicidal ideation. Further studies are ongoing. 

 

Improving Prediction

There is definitely room for improvement in current approaches to suicide prevention, said Raffaella Calati, PhD, assistant professor of clinical psychology at the University of Milano-Bicocca, Italy, who has had research collaborations with Galynker.

Calati advocates for a more integrated approach across disciplines, institutions, and the community to provide an effective support network for those at risk. 

Accurately predicting suicide risk is challenging, she told this news organization. She and colleagues are working to develop more precise predictive tools for identifying individuals at risk, often by leveraging artificial intelligence and data analytics. They have designed and implemented app-based interventions for psychiatric patients at risk for suicide and university students with psychological distress. The interventions are personalized and based on multiple approaches, such as cognitive-behavioral therapy (CBT) and third-wave CBT. 

The results of current studies are preliminary, she acknowledged, “but even if apps are extremely complex, our projects received high interest from participants and the scientific community,” she said. The aim now is to integrate these tools into healthcare systems so that monitoring high-risk patients becomes part of regular care. 

Another area of focus is the identification of specific subtypes of individuals at risk for suicide, particularly by examining factors such as pain, dissociation, and interoception — the ability to sense and interpret internal signals from the body. 

“By understanding how these experiences intersect and contribute to suicide risk, I aim to identify distinct profiles within at-risk populations, which could ultimately enable more tailored and effective prevention efforts,” she said.

Her work also involves meta-research to build large, comprehensive datasets that increase statistical power for exploring suicide risk factors, such as physical health conditions and symptoms associated with borderline personality disorder. By creating these datasets, she aims to “improve understanding of how various factors contribute to suicide risk, ultimately supporting more effective prevention strategies.”

 

Country-Level Efforts

Preventive work is underway in other countries as well. In Nordic countries such as Denmark, Finland, and Sweden, large-scale national registries that track people’s medical histories, prescriptions, and demographic information are being used to develop predictive algorithms that identify those at high risk for suicide. The predictions are based on known risk factors like previous mental health diagnoses, substance abuse, and social determinants of health.

A recent Norwegian study found that a novel assessment tool used at admission to an acute inpatient unit was a powerful predictor of suicide within 3 years post-discharge.

Researchers in the Netherlands have also recently co-designed a digital integrated suicide prevention program, which has led to a significant reduction in suicide mortality. 

SUPREMOCOL (suicide prevention by monitoring and collaborative care) was implemented in Noord-Brabant, a province in the Netherlands that historically had high suicide rates. It combines technology and personal care, allowing healthcare providers to track a person’s mental health, including by phone calls, text messages, and mobile apps that help people express their feelings and report any changes in their mental state. By staying connected, the program aims to identify warning signs early and provide timely interventions.

The results from the 5-year project showed that rates dropped by 21.5%, from 14.4 per 100,000 to 11.8 per 100,000, and remained low, with a rate of 11.3 per 100,000 by 2021.

Finland used to have one of the highest suicide rates in the world. Now it is implementing its suicide prevention program for 2020-2030, with 36 proposed measures to prevent suicide mortality. 

The program includes measures such as increasing public awareness, early intervention, supporting at-risk groups, developing new treatment options, and enhancing research efforts. Earlier successful interventions included limiting access to firearms and poison, and increasing use of antidepressants and other targeted interventions.

“A key is to ensure that the individuals at risk of suicide have access to adequate, timely, and evidence-based care,” said Timo Partonen, MD, research professor at the Finnish Institute for Health and Welfare and associate professor of psychiatry at the University of Helsinki.

“Emergency and frontline professionals, as well as general practitioners and occupational health physicians, have a key role in identifying people at risk of suicide,” he noted. “High-quality competencies will be developed for healthcare professionals, including access to evidence-based suicide prevention models for addressing and assessing suicide risk.” 

 

Global Strategies

Policymakers across Europe are increasingly recognizing the importance of enhanced public health approaches to suicide prevention. 

The recently adopted EU Action Plan on Mental Health emphasizes the need for comprehensive suicide prevention strategies across Europe, including the promotion of mental health literacy and the provision of accessible mental health services.

The plan was informed by initiatives such as the European Alliance Against Depression (EAAD)-Best project, which ran from 2021 until March 2024. The collaborative project brought together researchers, healthcare providers, and community organizations to improve care for patients with depression and to prevent suicidal behavior in Europe. 

The multimodal approach included community engagement and training for healthcare professionals, as well as promoting the international uptake of the iFightDepression tool, an internet-based self-management approach for patients with depression. It has shown promise in reducing suicide rates in participating regions, including Europe, Australia, South America, and Africa.

“What we now know is that multiple interventions produce a synergic effect with a tendency to reduce suicidal behavior,” said EAAD founding member Ricardo Gusmão, MD, PhD, professor of public mental health at the University of Porto, Portugal. Current approaches to suicide prevention globally vary widely, with “many, fragmentary, atomized interventions, and we know that none of them, in isolation, produces spectacular results.” 

Gusmão explained that promising national suicide prevention strategies are based on multicomponent community interventions. On the clinical side, they encompass training primary health and specialized mental health professionals, and have a guaranteed chain of care and functioning pathways for access. They also involve educational programs in schools, universities, prisons, work settings, and geriatric care centers. Additionally, they have well-developed good standards for media communication and health marketing campaigns on well-being and mental health literacy.

Relevant and cohesive themes for successful strategies include the promotion of positive mental health, the identification and available treatments for depression and common mental disorders, and the management of suicidal crisis stigma. 

“We are now focusing on workplace settings and vulnerable groups such as youth, the elderly, unemployed, migrants and, of course, people affected by mental disorders,” he said. “Suicide prevention is like a web that must be weaved by long-lasting efforts and intersectoral collaboration.”

“Even one suicide is one too many,” Brendan Kelly, MD, PhD, professor of psychiatry, Trinity College Dublin, and author of The Modern Psychiatrist’s Guide to Contemporary Practice, told this news organization. “Nobody is born wanting to die by suicide. And every suicide is an individual tragedy, not a statistic. We need to work ever more intensively to reduce rates of suicide. All contributions to research and fresh thinking are welcome.”

Galynker, Calati, Partonen, and Kelly have disclosed no relevant financial relationships.  Gusmão has been involved in organizing Janssen-funded trainings for registrars on suicidal crisis management. 

 

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

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Food as Medicine: Diet’s Role in Parkinson’s Disease

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Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Interest is growing in the role of nutrition as means of slowing, or even preventing, neurodegeneration in patients with Parkinson’s disease.

For 15 years, John Duda, MD, national director of the VA Parkinson’s Disease Research, Education and Clinical Centers, has urged his patients to “keep waiting” for effective treatments to manage both motor and nonmotor symptoms of Parkinson’s disease.

However, Duda, who also serves as director of the Brain Wellness Clinic at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania, recognized the persistent lack of effective drugs to address these symptoms. This prompted him to consider what other evidence-based strategies he could use to support his patients. 

“I recognized that nutritional approaches within a broader program that includes medication review, stress management, social connections, adequate sleep, and physical exercise could make a real difference,” he said.

Observational studies have shown an inverse association between dietary patterns and Parkinson’s disease risk, age of onset, symptom severity, and mortality rates — particularly with the Mediterranean diet (MeDi) and the MIND diet, which combines elements of MeDi and the Dietary Approaches to Stop Hypertension (DASH) diet. Although randomized controlled trials are still limited, the epidemiologic evidence supporting dietary interventions is “compelling,” said Duda. 

For example, a cross-sectional study comparing 167 participants with Parkinson’s disease vs 119 controls showed that later age of Parkinson’s disease onset correlated with adherence to the MIND diet in women, with a difference of up to 17.4 years (P < .001) between low and high dietary tertiles. 

The MeDi was correlated with later onset in men, with differences of up to 8.4 years (P = .002). As previously reported, a healthy diet emphasizing vegetables, fruits, nuts, and grains was inversely associated with prodromal features of Parkinson’s disease, including constipation, excessive daytime sleepiness, and depression. In addition, lower rates of Parkinson’s disease have been shown in populations following vegetarian and vegan dietary patterns. 

 

Does Parkinson’s disease Start in the Gut?

Parkinson’s disease is characterized by decreased short-chain fatty acid–producing bacteria and increased pro-inflammatory species linked to intestinal inflammation and alpha-synuclein aggregation. “There are reasons to believe that a-synuclein accumulation may start in the gut,” Duda noted.

Numerous studies implicate gut microbiome dysbiosis as a pathogenic mechanism in Parkinson’s disease, with gastrointestinal symptoms often predating motor symptoms. Dysbiosis might result in a pro-inflammatory state potentially linked to the recurrent gastrointestinal symptoms. Fecal microbiota transplant may restore a healthier gut environment and beneficially affect Parkinson’s disease symptoms, he said.

Some of the benefits conferred by the MeDi and other healthy diets may be mediated by improving the gut microbiome. Duda cited a study that showed that a 14-day ovo-lacto vegetarian diet intervention and a daily fecal enema for 8 days improved not only the microbiome but also Movement Disorder Society Unified Parkinson’s Disease Rating Scale—part III scores. 

Duda also reviewed the role of dietary interventions in addressing common Parkinson’s disease symptoms, such as orthostatic hypotension. He recommended that Parkinson’s disease patients with this condition should avoid eating large meals, increase dietary salt intake, increase fluid intake, and decrease alcohol intake.

Malnutrition affects close to 25% of those with Parkinson’s disease, which is partially attributable to diminished olfaction. Because the experience of taste is largely driven by a sense of smell, patients may be less interested in eating. Duda recommended increasing herbs, spices, and other flavors in food. High caloric–density foods, including nuts, nut butters, and seeds, can boost weight, he said. However, he added, any patient with significant weight loss should consult a nutritionist.

Constipation is one of the most debilitating symptoms of Parkinson’s disease, affecting up to 66% of patients. Duda advised increasing fluid intake, exercise, and dietary fiber and use of stool softeners and laxatives. The MeDi may reduce symptoms of constipation and have a beneficial effect on gut microbiota. 

Coffee may be helpful for sleepiness in Parkinson’s disease and may also confer neuroprotective, motor, and cognitive benefits. As an adjuvant treatment, caffeine may alter levodopa pharmacokinetics, reduce dyskinesia, improve gait in patients with freezing and may even reduce the risk of developing Parkinson’s disease, with a maximum benefit reached at approximately three cups of coffee daily.

 

Problematic Foods

There is also a growing body of evidence regarding the deleterious effects of ultraprocessed foods (UPFs), Duda said. He noted that a recent systematic review and meta-analysis of 28 studies showed that higher UPF intake was significantly associated with an enhanced risk for Parkinson’s disease (relative risk, 1.56; 95% CI, 1.21-2.02). As previously reported, UPFs have been tied to a host of adverse neurologic outcomes, including cognitive decline and stroke. 

Although protein is a necessary nutrient, incorporating it into the diet of Parkinson’s disease patients taking levodopa is complicated. Levodopa, a large neutral amino acid (LNAA), competes with other LNAAs for transport to the brain from the small intestine, Duda explained. 

“Some people notice that carbidopa-levodopa doesn’t work as well if taken with a high-protein meal.” He recommended taking carbidopa-levodopa 30 minutes before or 60 minutes after meals.

Rebecca Gilbert, MD, PhD, chief mission officer of the American Parkinson’s Disease Association, said that patients with Parkinson’s disease might want to avoid eating protein during the day, concentrating instead on carbohydrates and vegetables and saving the protein for the evening, which is closer to bedtime. Some evidence also supports the use of protein redistribution diets to enhance the clinical response to levodopa and reduce motor fluctuations. 

 

What About Supplements? 

It’s “hard to prove that one specific supplement can be protective against Parkinson’s disease because diet consists of many different components and the whole diet may be worth more than the sum of its parts,” Gilbert said. The evidence for individual supplements “isn’t robust enough to say they prevent or treat Parkinson’s disease.”

Research on the role of specific nutrients in Parkinson’s disease is conflicting, with no clear evidence supporting or refuting their benefits. For example, a study that followed participants for about 30 years showed no link between reduced Parkinson’s disease risk and vitamin B or folate intake. 

On the other hand, there is research suggesting that certain vitamins may help reduce Parkinson’s disease risk, although these nutrients do not operate in isolation. For instance, one recent study showed a connection between vitamins C and E and reduced Parkinson’s disease risk, but factors such as body mass index and coffee consumption appeared to influence the strength of this association.

Consuming polyunsaturated fatty acids along with reducing saturated fatty acid intake has been tied to a reduced risk for Parkinson’s disease. 

Additionally, certain foods may offer protective effects, including green and black tea, with consumption of three or more cups per day associated with a delay in motor symptom onset by 7.7 years. Foods high in nicotine content, such as those from the Solanaceae family — including peppers, tomatoes, tomato juice, and potatoes — have also been linked to potential protective benefits.

Diets rich in antioxidants, including carotenoids, lutein, and vitamins E and C, have been robustly linked to a reduced risk for parkinsonism and progression of parkinsonian symptoms in older adults.

Increasing the intake of dietary flavonoids, particularly tea, berry fruits, apples, red wine, and oranges or orange juice, can reduce Parkinson’s disease risk. One study showed that male participants in the highest quintile of total flavonoid consumption had a 40% lower Parkinson’s disease risk compared with those in the lowest quintile. Another study showed that flavonoid-rich foods were also associated with a lower risk for death in patients with Parkinson’s disease. 

 

Food as Medicine 

Although recent research shows that the drug development pipeline for Parkinson’s disease is robust, with a wide variety of approaches being developed and evaluated in phase 1 and 2, investigators note that only a limited number of disease-modifying treatments are transitioning to phase 3.

Duda noted that phytochemicals incorporated into the diet might target some of the same mechanisms that are targets of these drugs in development. 

“Flavonoids have been shown to stabilize alpha-synuclein in vitro,” he said. “Caffeine, curcumin, resveratrol, and eliminating meat and dairy inhibit mTOR [mammalian target of rapamycin], and mTOR inhibition results in increased autophagy that may help clear alpha-synuclein. Genestein, an isoflavone in soybeans, protects dopaminergic neurons by inhibiting microglia activation. Flavonoids inhibit inflammation by inhibiting release of NO [nitric oxide] and pro-inflammatory cytokines,” he noted. 

Ongoing studies of dietary interventions for Parkinson’s disease are exploring various areas, including the potential role of the ketogenic diet in protecting the gut microbiome, optimizing protein intake for muscle preservation and sleep, the effects of psyllium and wheat bran on weight and constipation, and the impact of a gluten-free diet.

 

Practical Tips for Healthy Eating 

Gilbert emphasized that there are no medications or interventions currently available that can delay a Parkinson’s disease diagnosis by up to 17 years, as some dietary patterns have been shown to do, and she noted that it’s not possible to replicate the MeDi diet in a pill. However, she recommended a practical approach to eating that includes a diet low in ultraprocessed foods and high in beneficial nutrients. She encouraged people to shop for “real food” and enjoy a variety of colorful fruits and vegetables.

Duda acknowledged that motivating patients to follow a healthy diet can be difficult. As a result, the focus often shifts to making small adjustments and modifications. For example, he suggested that instead of pairing meat with French fries, people could opt for vegetables or add greens to their meals. Similarly, instead of having eggs and bacon for breakfast, they might choose oatmeal.

Preparing whole-food, plant-based meals may take more time than patients are accustomed to, so Duda suggests that, if possible, patients involve loved ones in both the meal preparation and the meal itself. He explained that a healthy meal can become an opportunity for bonding and that the key is educating them about new meal-related concepts. 

Duda reported no relevant financial relationships with the pharmaceutical or food industries. He has received compensation from the Physicians Committee for Responsible Medicine for his lecture delivered at the conference and research grant support from the VA, the National Institutes of Health, the Michael J. Fox Foundation, and the Department of Defense unrelated to this topic. Gilbert reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Side Effects of GLP-1 Drugs: What Doctors Should Know

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Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.

But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).

“It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

“But that’s not really happening now,” she added.

Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.

Here’s what the latest research shows about GLP-1s’ side effects.

 

Most Common: Gastrointestinal Issues

Depending on the symptom and the specific drug, anywhere from one third to one half of patients will experience some kind of stomach trouble.

  • In that clinical review, which looked at studies of three GLP-1 medications — semaglutide (Ozempic, Wegovy, Rybelsus), liraglutide (Saxenda, Victoza), and tirzepatide (Mounjaro, Zepbound) — semaglutide users fared comparatively worse.
  • Nausea was reported most frequently — 44.2% of semaglutide users dealt with it, compared with 40.2% for liraglutide and 31% for tirzepatide. Diarrhea, constipation, and vomiting also struck one quarter to one third of semaglutide patients, and slightly fewer for the other two medications.

Apovian finds that careful dosage helps her patients avoid the worst effects.

“We don’t know who’s going to do well and who’s not,” she said. “We start slowly, and usually things go OK.”

If a patient does react poorly, she’ll hold off on increasing the dosage until they acclimate and advise using over-the-counter meds like MiraLAX to address the symptoms.

Few documented severe adverse gastro events appeared in the data, affecting less than 1% of liraglutide and tirzepatide patients and 2.6% of semaglutide users. The majority of these events were gallbladder-related.

 

Questions About Causation: Depression and Suicidality

About a year ago, a study used 18 years’ worth of data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to examine how often patients reported suicidal ideation and/or depression while using GLP-1 medications. Compared with metformin and insulin, researchers found disproportionate reporting by patients using semaglutide and liraglutide. Other GLP-1 medications didn’t show this effect. The researchers pointed out: These statistics don’t show causation — there’s no clear reason why those two medications were linked to more reports.

Further research has been more reassuring:

  • Another study also used FAERS but looked only at data from 2018 to 2022, when usage of these drugs was ramping up, and found no link between suicidal or self-injurious behaviors and GLP-1.
  • A recent cohort study, which looked at data from nearly 300,000 people, found that GLP-1 users aren’t at increased risk for death by suicide.
  • Both the FDA and the European Medicines Agency have issued statements that the evidence doesn’t support a causal association.

There are several factors at play here. People with obesity and diabetes are more likely to have depression to begin with. And more importantly, even if there is a link, causality remains unclear. For instance, patients who lose weight via bariatric surgery are at increased risk for depression, substance abuse, and self-harm. These symptoms may be related to the weight loss itself, not the medications.

“Some people use food as something other than nutrition. They use food to soothe other psychological issues,” Apovian said. “When that’s taken away, the psychological issues are still there.”

In her practice, she’s seen the risk for mental health issues rise with more substantial weight loss — 50-100 pounds.

This lack of clarity regarding causation means it’s important to perform a detailed patient history before prescribing, so you can monitor more closely with preexisting psychiatric disorders.

 

Possible Link: Ocular Symptoms

Here, too, the research isn’t definitive but leans toward no clear association. Several studies have looked for a link between GLP-1 and vision-related issues:

  • One examined FAERS data and network pharmacology and found semaglutide and lixisenatide were significantly associated with adverse events like blurred vision, visual impairment, and diabetic retinopathy.
  • This summer, a cohort study of almost 17,000 people with diabetes or overweight/obesity suggested a link between semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION), a common cause of blindness due to optic nerve damage. The study found “a substantially increased risk of NAION among individuals prescribed semaglutide relative to those prescribed other medications to treat type 2 diabetes and obesity or overweight.”
  • But this month, another cohort study with 135,000 participants looked at NAION in people with type 2 diabetes, obesity, or both. It compared results with common non-GLP-1 medications and found just the opposite: No increased risk for NAION.

One drawback with all these studies is that they’re based on large databases rather than randomized controlled trials (RCTs). When researchers focused on RCTs in a 2023 meta-analysis, they found a significant association with only one form of GLP-1, albiglutide — which was withdrawn from the market in 2017. The other six FDA-approved drugs didn’t show a statistically significant link.

 

Possible Trouble: Pulmonary Aspiration Under Sedation

Earlier this month, the FDA updated labeling for semaglutide, liraglutide, and tirzepatide to include a warning about the risk for aspiration during surgery. While there are no published studies, several case reports have appeared.

GLP-1 medications delay gastric emptying, so even though a patient may have fasted before surgery as usual, some food or liquid may remain. In response to this possibility, a group of professional medical societies issued guidelines for using these medications during the perioperative period. They include:

  • Consideration of dosage, symptoms, and other medical conditions: The risk is higher during the escalation phase, and in general, higher doses mean higher risk.
  • Potential discontinuation of GLP-1 usage when assessment shows an elevated risk.
  • Assessment on the day of the procedure for possible delayed gastric emptying.
  • Preoperative dietary modifications, which might include switching to a liquid diet.

Rare: Serious Effects

And then there are the outliers, the frightening issues that make headlines. On their own, none of these are common enough to affect consideration of GLP-1 use:

  • Studies in rats suggested an increased risk for thyroid cancer, but subsequent research has found no evidence.
  • Colonic ischemia in association with tirzepatide.
  • Acute pancreatitis leading to death in association with semaglutide.
  • Speaking of pancreatitis, that clinical review of studies did find that both liraglutide and semaglutide led to an elevated risk for pancreatitis, bowel obstruction, and gastroparesis. But the numbers were so small as to be insignificant — for instance, just 0.2% of patients experienced pancreatitis.

Benefits Outweigh Risks

When you lay out these side effects against the countless known benefits of weight loss and blood sugar management — the lower risk for high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver disease, several cancers, and more — the advantages of GLP-1 drugs seem clear. Ultimately, of course, it’s the patient’s decision whether to begin and continue taking any medication for a chronic disease.

Apovian recommends having in-depth conversations before you write that first prescription – she compares the situation to using an antihypertensive drug. If your patient understands potential side effects, they’re more likely to maintain long-term compliance.

“We educate our patients how to use these drugs, indefinitely, if you want to maintain a lower, healthier body weight,” she said. “I don’t see patients who stop using them, but they’re out there. These are people desperate to lose weight, who aren’t given the education to understand we’re treating a disease. It’s not a matter of willpower.”

And once a patient starts taking a GLP-1, monitor them closely, with in-person visits rather than telehealth, while increasing the dosage. If they experience side effects, stay at that level until they ease. And if the patient has a good weight-loss response at a lower dose, stay there. Just because you can go higher, it doesn’t mean you should.

 

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

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Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.

But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).

“It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

“But that’s not really happening now,” she added.

Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.

Here’s what the latest research shows about GLP-1s’ side effects.

 

Most Common: Gastrointestinal Issues

Depending on the symptom and the specific drug, anywhere from one third to one half of patients will experience some kind of stomach trouble.

  • In that clinical review, which looked at studies of three GLP-1 medications — semaglutide (Ozempic, Wegovy, Rybelsus), liraglutide (Saxenda, Victoza), and tirzepatide (Mounjaro, Zepbound) — semaglutide users fared comparatively worse.
  • Nausea was reported most frequently — 44.2% of semaglutide users dealt with it, compared with 40.2% for liraglutide and 31% for tirzepatide. Diarrhea, constipation, and vomiting also struck one quarter to one third of semaglutide patients, and slightly fewer for the other two medications.

Apovian finds that careful dosage helps her patients avoid the worst effects.

“We don’t know who’s going to do well and who’s not,” she said. “We start slowly, and usually things go OK.”

If a patient does react poorly, she’ll hold off on increasing the dosage until they acclimate and advise using over-the-counter meds like MiraLAX to address the symptoms.

Few documented severe adverse gastro events appeared in the data, affecting less than 1% of liraglutide and tirzepatide patients and 2.6% of semaglutide users. The majority of these events were gallbladder-related.

 

Questions About Causation: Depression and Suicidality

About a year ago, a study used 18 years’ worth of data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to examine how often patients reported suicidal ideation and/or depression while using GLP-1 medications. Compared with metformin and insulin, researchers found disproportionate reporting by patients using semaglutide and liraglutide. Other GLP-1 medications didn’t show this effect. The researchers pointed out: These statistics don’t show causation — there’s no clear reason why those two medications were linked to more reports.

Further research has been more reassuring:

  • Another study also used FAERS but looked only at data from 2018 to 2022, when usage of these drugs was ramping up, and found no link between suicidal or self-injurious behaviors and GLP-1.
  • A recent cohort study, which looked at data from nearly 300,000 people, found that GLP-1 users aren’t at increased risk for death by suicide.
  • Both the FDA and the European Medicines Agency have issued statements that the evidence doesn’t support a causal association.

There are several factors at play here. People with obesity and diabetes are more likely to have depression to begin with. And more importantly, even if there is a link, causality remains unclear. For instance, patients who lose weight via bariatric surgery are at increased risk for depression, substance abuse, and self-harm. These symptoms may be related to the weight loss itself, not the medications.

“Some people use food as something other than nutrition. They use food to soothe other psychological issues,” Apovian said. “When that’s taken away, the psychological issues are still there.”

In her practice, she’s seen the risk for mental health issues rise with more substantial weight loss — 50-100 pounds.

This lack of clarity regarding causation means it’s important to perform a detailed patient history before prescribing, so you can monitor more closely with preexisting psychiatric disorders.

 

Possible Link: Ocular Symptoms

Here, too, the research isn’t definitive but leans toward no clear association. Several studies have looked for a link between GLP-1 and vision-related issues:

  • One examined FAERS data and network pharmacology and found semaglutide and lixisenatide were significantly associated with adverse events like blurred vision, visual impairment, and diabetic retinopathy.
  • This summer, a cohort study of almost 17,000 people with diabetes or overweight/obesity suggested a link between semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION), a common cause of blindness due to optic nerve damage. The study found “a substantially increased risk of NAION among individuals prescribed semaglutide relative to those prescribed other medications to treat type 2 diabetes and obesity or overweight.”
  • But this month, another cohort study with 135,000 participants looked at NAION in people with type 2 diabetes, obesity, or both. It compared results with common non-GLP-1 medications and found just the opposite: No increased risk for NAION.

One drawback with all these studies is that they’re based on large databases rather than randomized controlled trials (RCTs). When researchers focused on RCTs in a 2023 meta-analysis, they found a significant association with only one form of GLP-1, albiglutide — which was withdrawn from the market in 2017. The other six FDA-approved drugs didn’t show a statistically significant link.

 

Possible Trouble: Pulmonary Aspiration Under Sedation

Earlier this month, the FDA updated labeling for semaglutide, liraglutide, and tirzepatide to include a warning about the risk for aspiration during surgery. While there are no published studies, several case reports have appeared.

GLP-1 medications delay gastric emptying, so even though a patient may have fasted before surgery as usual, some food or liquid may remain. In response to this possibility, a group of professional medical societies issued guidelines for using these medications during the perioperative period. They include:

  • Consideration of dosage, symptoms, and other medical conditions: The risk is higher during the escalation phase, and in general, higher doses mean higher risk.
  • Potential discontinuation of GLP-1 usage when assessment shows an elevated risk.
  • Assessment on the day of the procedure for possible delayed gastric emptying.
  • Preoperative dietary modifications, which might include switching to a liquid diet.

Rare: Serious Effects

And then there are the outliers, the frightening issues that make headlines. On their own, none of these are common enough to affect consideration of GLP-1 use:

  • Studies in rats suggested an increased risk for thyroid cancer, but subsequent research has found no evidence.
  • Colonic ischemia in association with tirzepatide.
  • Acute pancreatitis leading to death in association with semaglutide.
  • Speaking of pancreatitis, that clinical review of studies did find that both liraglutide and semaglutide led to an elevated risk for pancreatitis, bowel obstruction, and gastroparesis. But the numbers were so small as to be insignificant — for instance, just 0.2% of patients experienced pancreatitis.

Benefits Outweigh Risks

When you lay out these side effects against the countless known benefits of weight loss and blood sugar management — the lower risk for high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver disease, several cancers, and more — the advantages of GLP-1 drugs seem clear. Ultimately, of course, it’s the patient’s decision whether to begin and continue taking any medication for a chronic disease.

Apovian recommends having in-depth conversations before you write that first prescription – she compares the situation to using an antihypertensive drug. If your patient understands potential side effects, they’re more likely to maintain long-term compliance.

“We educate our patients how to use these drugs, indefinitely, if you want to maintain a lower, healthier body weight,” she said. “I don’t see patients who stop using them, but they’re out there. These are people desperate to lose weight, who aren’t given the education to understand we’re treating a disease. It’s not a matter of willpower.”

And once a patient starts taking a GLP-1, monitor them closely, with in-person visits rather than telehealth, while increasing the dosage. If they experience side effects, stay at that level until they ease. And if the patient has a good weight-loss response at a lower dose, stay there. Just because you can go higher, it doesn’t mean you should.

 

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

Just a few years after some TikTok videos spiked the demand, one in eight US adults has tried Ozempic (semaglutide) or another drug in its class. Glucagon-like peptide 1 (GLP-1) receptor agonist medications have revolutionized obesity medicine.

But they’re not without problems. In the early days of the social media craze, news reports often featured patients whose gastrointestinal side effects sent them to the emergency room (ER).

“It happened a lot then. Patients didn’t want to complain because they were losing weight, and they wound up in the ER with extreme constipation or a small bowel obstruction,” said Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

“But that’s not really happening now,” she added.

Research backs up her assertion: A recent clinical review of studies found that many patients still experience side effects, but only at a mild to moderate level, while the dosage increases — and the unpleasantness tapers with time. Roughly 7% of patients discontinue the medications due to these symptoms.

Here’s what the latest research shows about GLP-1s’ side effects.

 

Most Common: Gastrointestinal Issues

Depending on the symptom and the specific drug, anywhere from one third to one half of patients will experience some kind of stomach trouble.

  • In that clinical review, which looked at studies of three GLP-1 medications — semaglutide (Ozempic, Wegovy, Rybelsus), liraglutide (Saxenda, Victoza), and tirzepatide (Mounjaro, Zepbound) — semaglutide users fared comparatively worse.
  • Nausea was reported most frequently — 44.2% of semaglutide users dealt with it, compared with 40.2% for liraglutide and 31% for tirzepatide. Diarrhea, constipation, and vomiting also struck one quarter to one third of semaglutide patients, and slightly fewer for the other two medications.

Apovian finds that careful dosage helps her patients avoid the worst effects.

“We don’t know who’s going to do well and who’s not,” she said. “We start slowly, and usually things go OK.”

If a patient does react poorly, she’ll hold off on increasing the dosage until they acclimate and advise using over-the-counter meds like MiraLAX to address the symptoms.

Few documented severe adverse gastro events appeared in the data, affecting less than 1% of liraglutide and tirzepatide patients and 2.6% of semaglutide users. The majority of these events were gallbladder-related.

 

Questions About Causation: Depression and Suicidality

About a year ago, a study used 18 years’ worth of data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to examine how often patients reported suicidal ideation and/or depression while using GLP-1 medications. Compared with metformin and insulin, researchers found disproportionate reporting by patients using semaglutide and liraglutide. Other GLP-1 medications didn’t show this effect. The researchers pointed out: These statistics don’t show causation — there’s no clear reason why those two medications were linked to more reports.

Further research has been more reassuring:

  • Another study also used FAERS but looked only at data from 2018 to 2022, when usage of these drugs was ramping up, and found no link between suicidal or self-injurious behaviors and GLP-1.
  • A recent cohort study, which looked at data from nearly 300,000 people, found that GLP-1 users aren’t at increased risk for death by suicide.
  • Both the FDA and the European Medicines Agency have issued statements that the evidence doesn’t support a causal association.

There are several factors at play here. People with obesity and diabetes are more likely to have depression to begin with. And more importantly, even if there is a link, causality remains unclear. For instance, patients who lose weight via bariatric surgery are at increased risk for depression, substance abuse, and self-harm. These symptoms may be related to the weight loss itself, not the medications.

“Some people use food as something other than nutrition. They use food to soothe other psychological issues,” Apovian said. “When that’s taken away, the psychological issues are still there.”

In her practice, she’s seen the risk for mental health issues rise with more substantial weight loss — 50-100 pounds.

This lack of clarity regarding causation means it’s important to perform a detailed patient history before prescribing, so you can monitor more closely with preexisting psychiatric disorders.

 

Possible Link: Ocular Symptoms

Here, too, the research isn’t definitive but leans toward no clear association. Several studies have looked for a link between GLP-1 and vision-related issues:

  • One examined FAERS data and network pharmacology and found semaglutide and lixisenatide were significantly associated with adverse events like blurred vision, visual impairment, and diabetic retinopathy.
  • This summer, a cohort study of almost 17,000 people with diabetes or overweight/obesity suggested a link between semaglutide and nonarteritic anterior ischemic optic neuropathy (NAION), a common cause of blindness due to optic nerve damage. The study found “a substantially increased risk of NAION among individuals prescribed semaglutide relative to those prescribed other medications to treat type 2 diabetes and obesity or overweight.”
  • But this month, another cohort study with 135,000 participants looked at NAION in people with type 2 diabetes, obesity, or both. It compared results with common non-GLP-1 medications and found just the opposite: No increased risk for NAION.

One drawback with all these studies is that they’re based on large databases rather than randomized controlled trials (RCTs). When researchers focused on RCTs in a 2023 meta-analysis, they found a significant association with only one form of GLP-1, albiglutide — which was withdrawn from the market in 2017. The other six FDA-approved drugs didn’t show a statistically significant link.

 

Possible Trouble: Pulmonary Aspiration Under Sedation

Earlier this month, the FDA updated labeling for semaglutide, liraglutide, and tirzepatide to include a warning about the risk for aspiration during surgery. While there are no published studies, several case reports have appeared.

GLP-1 medications delay gastric emptying, so even though a patient may have fasted before surgery as usual, some food or liquid may remain. In response to this possibility, a group of professional medical societies issued guidelines for using these medications during the perioperative period. They include:

  • Consideration of dosage, symptoms, and other medical conditions: The risk is higher during the escalation phase, and in general, higher doses mean higher risk.
  • Potential discontinuation of GLP-1 usage when assessment shows an elevated risk.
  • Assessment on the day of the procedure for possible delayed gastric emptying.
  • Preoperative dietary modifications, which might include switching to a liquid diet.

Rare: Serious Effects

And then there are the outliers, the frightening issues that make headlines. On their own, none of these are common enough to affect consideration of GLP-1 use:

  • Studies in rats suggested an increased risk for thyroid cancer, but subsequent research has found no evidence.
  • Colonic ischemia in association with tirzepatide.
  • Acute pancreatitis leading to death in association with semaglutide.
  • Speaking of pancreatitis, that clinical review of studies did find that both liraglutide and semaglutide led to an elevated risk for pancreatitis, bowel obstruction, and gastroparesis. But the numbers were so small as to be insignificant — for instance, just 0.2% of patients experienced pancreatitis.

Benefits Outweigh Risks

When you lay out these side effects against the countless known benefits of weight loss and blood sugar management — the lower risk for high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver disease, several cancers, and more — the advantages of GLP-1 drugs seem clear. Ultimately, of course, it’s the patient’s decision whether to begin and continue taking any medication for a chronic disease.

Apovian recommends having in-depth conversations before you write that first prescription – she compares the situation to using an antihypertensive drug. If your patient understands potential side effects, they’re more likely to maintain long-term compliance.

“We educate our patients how to use these drugs, indefinitely, if you want to maintain a lower, healthier body weight,” she said. “I don’t see patients who stop using them, but they’re out there. These are people desperate to lose weight, who aren’t given the education to understand we’re treating a disease. It’s not a matter of willpower.”

And once a patient starts taking a GLP-1, monitor them closely, with in-person visits rather than telehealth, while increasing the dosage. If they experience side effects, stay at that level until they ease. And if the patient has a good weight-loss response at a lower dose, stay there. Just because you can go higher, it doesn’t mean you should.

 

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

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