A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

A 35-year-old Brazilian man who participated in a trial in which he received an intensified antiretroviral regimen plus supplemental vitamin B₃ for 48 weeks has joined the short list of patients who have experienced a period of remission from HIV in the absence of effective treatment.

Along with the Mississippi baby, a San Francisco man, a 24-year-old Thai man, a 9-year-old South African child, and the London and Berlin patients, the Brazilian man has an undetectable viral load and, more than a year after stopping treatment, his HIV antibody test is negative.

But as with the Berlin and London patients, it seems unlikely that – even if the man remains HIV free into the future – the circumstances of his remission will be broadly applicable to other people with HIV, said Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

“I don’t think it’s replicable,” Dieffenbach told Medscape Medical News. Researchers should still try to confirm the finding, but they will probably learn more by studying the man’s unique genetic characteristics and immune system “than to go out and treat another 200 people with the same protocol.”
 

‘Shock-and-kill strategy’

The man had been on treatment since his HIV diagnosis in 2012, and was one of 30 people to enroll in a Brazilian study – the Multi Interventional Study Exploring HIV-1 Residual Replication: A Step Toward HIV Eradication and Sterilizing Cure – in 2016. At that point, his regimen consisted of the combination of efavirenz, lamivudine, and tenofovir disoproxil fumarate (Symfi, Mylan Pharmaceuticals) and his viral load was undetectable.

He was one of five people in the study to be randomized to receive the integrase inhibitor dolutegravir (Tivicay, ViiV Healthcare), the CCR5 receptor inhibitor maraviroc (Selzentry, ViiV Healthcare), and twice-daily nicotinamide 500 mg, a form of vitamin B₃, in addition to his regular regimen for 48 weeks.

Nicotinamide has been used for decades because of its anti-infective properties, particularly in tuberculosis. In vitro, it also works to reverse HIV latency, said study investigator Ricardo Diaz, MD, from the Federal University of São Paulo, who presented the data at a press conference for the International AIDS Conference (AIDS) 2020.

“This is a shock-and-kill strategy,” said Leila Giron, PhD, from the Wistar Institute in Philadelphia, who was one of the study investigators. “We did in vitro studies to make sure nicotinamide took HIV out of the cells.”

“The cell machinery changed a lot,” she told Medscape Medical News. “And because it’s a B vitamin, all five participants didn’t have any side effects.”

But the patient was the only person in his treatment group to experience viral load “blips” during treatment – at weeks 16 and 24. And viral DNA was present at low levels in his peripheral blood spots and rectal tissue at baseline and at 48 weeks, and his HIV antibodies dropped from 91.8 RLU at baseline to 58.0 RLU at week 48.

“He had a decline in cell activation, inflammation, and a very deep decline in antibody titers,” Diaz reported.

After 48 weeks of the intensified treatment, the patient returned to his usual regimen for 3 years. Then, in March 2019, he agreed to try an analytical treatment interruption and discontinued all HIV treatment.

“What’s interesting is right before the analytical treatment interruption, the HIV DNA sequences were completely negative,” said Diaz.

Every 3 weeks for the next 64.7 weeks, his viral load came back undetectable, and so did HIV DNA in blood spots. One thing did change, though: in February 2020, the man’s HIV antibody test came back negative.

The team checked that he wasn’t still taking his antiretroviral medication, which might have explained the undetectable viral load, and he wasn’t.
 

Surprise, skepticism, and hope

The results have prompted surprise, skepticism, and questions from clinicians and researchers.

The remission is notable because it occurred without the invasive process of a stem cell transplant that both the London and Berlin patients underwent, said Anton Pozniak, MD, from Chelsea and Westminster Hospital in London, who is cochair of AIDS 2020.

“They need a bigger study to see whether or not [the participant] is one of these guys who stopped treatment and might take a year or two, or four, to rebound,” he said. But if other studies replicate the results, the control of HIV in “one in five people would still be huge.”

The rationale behind treatment intensification for HIV remission is that “the three-drug ART regimen was perhaps insufficient to completely block HIV replication” in the reservoirs, even though that replication could be happening below levels detectable with current tests, said Laura Persaud, MD, from the Johns Hopkins University School of Medicine in Baltimore, who is chair of the International Maternal Pediatric Adolescent AIDS Clinical Trial Network (IMPAACT) HIV Cure Committee and was not involved in the study.

“The idea was to see if you could accelerate the decay of the reservoir” if you added medications that targeted different parts of the HIV lifecycle. Symfi, for instance, targets just one step in the viral replication process: the point where HIV RNA reverse transcribes itself into DNA so it can integrate into immune cells. But CCR5 inhibitors block entry of HIV into the cell in the first place, and integrase inhibitors, like raltegravir (Isentress, Merck) and dolutegravir, prevent HIV DNA from integrating into the host chromosome after it has reverse transcribed itself.

Still, recent data suggest that treatment intensification might not be as effective as hypothesized, she said. And the nicotinamide study was in vitro. To what extent this is a direct result of this treatment strategy is unclear.

“It’s hard to believe, in this small study, that this agent [nicotinamide] would have such a striking effect on DNA proviral levels,” she said. “We learn from each of these cases. But this is a single case, with multiple mechanisms that may have contributed to the outcome here. To what extent this is a direct result of this treatment strategy is unclear.”

Only time will tell, and Persaud knows this first hand. Back in 2014, she presented data at another HIV conference on the Mississippi baby who, after 21 months of no treatment, still didn›t have an HIV viral load.

At the time, the baby was hailed as “functionally cured,” but just 6 months later, the virus returned.

Dieffenbach agrees. “There are 10,000 genetic variations that need to be considered, and it all adds up to a unique individual,” he said of the Brazilian patient. “This one is one person, and it’s still early days.”
 

Counseling patients on niacin supplementation

Some clinicians are already bracing for the flood of people with HIV now wanting to take, or who are already taking, a niacin supplement because of this case, said Laura Waters, MD, from Mortimer Market Centre in London, who is chair of the British HIV Association.

But nicotinamide is different than nicotinic acid, which is what many people mean when they talk about niacin supplementation, according to data from the Office of Dietary Supplements (ODS) at the National Institutes of Health. Nicotinic acid has been used as a supplement for people with high cholesterol for years. Most Americans get more than the recommended daily intake of both types of niacin – 16 mg for adult men and 14 mg for adult women – in their regular diet, according to the 2015/16 National Health and Nutrition Examination Survey.

The Brazilian patient received a total daily dose of nicotinamide of 1000 mg, which is not associated with any adverse effects. Doses above 3000 mg daily can lead to diarrhea and a decrease in platelet count, according to the ODS.

Although Diaz said he doesn’t think people with HIV should run out and start taking a supplement right away, Waters said she sees it as inevitable.

The good news is that if people really are taking nicotinamide – not nicotinic acid – it seems “fairly well tolerated without many side effects,” she said, but added: “I expect shortages of nicotinamide from tomorrow.”

This story first appeared on Medscape.com.

After practicing clinical care for 4 years, hospitalist Suneel Dhand, MD, was ready for a change and eager for the chance to help improve the broader health care system.

phototechno/Thinkstock

So when the opportunity arose to direct an internal medicine program at a large hospital, Dr. Dhand gladly accepted the role. He aimed to enhance frontline staffing, expand his hospital medicine team’s influence, and raise the standard of care for patients.

Almost immediately, however, Dr. Dhand knew the administrative route was the wrong path for him.

“I realized very quickly that initiating change and being a positive force, while working with multiple competing interests, is far from easy,” said Dr. Dhand. “I didn’t particularly feel well supported by the high-level administrators. Without resources, it’s extra difficult to make things happen.”

A year and half into the role, Dr. Dhand left the position and returned to purely clinical work. He now practices as a Boston-area hospitalist while writing, filming, and podcasting about medicine on the side.

“I have no intention of leaving clinical medicine,” he said. “If somebody gave me a very highly compensated offer right now to come and be a hospital leader, I wouldn’t do it. It’s not me, and I wouldn’t enjoy it.”

Taking on an administrative or executive role can sound appealing to many clinicians. The Medscape Physician Compensation Report 2018 found that 42% of employed physicians were aiming for a promotion. Another physician survey by The Physicians Foundation found that 46% planned to change career paths in 2018 and that more than 12% planned to seek a nonclinical job in the next 1-3 years.

Interest in executive and leadership roles has also increased because of the COVID-19 pandemic, particularly as more physicians struggle financially and search for alternative compensation, said Peter B. Angood, MD, CEO and president for the American Association for Physician Leadership.

“Because of the COVID-19 impacts on health care and our country as a whole, the strengths of physician leadership have been better recognized at multiple levels,” Dr. Angood said. “As a result, there is definitely early interest as the ongoing impacts of COVID-19 are appreciated in how to further integrate physicians as leaders within the health care industry as a whole.”
 

Administration: Not for everyone

But as Dr. Dhand’s experience highlights, administration is not the right direction for every physician. Take the case of prominent surgeon and Harvard University professor Atul Gawande, MD, who in May stepped down as chief executive for Haven, the health care venture backed by Amazon, after just 2 years. In a statement, Dr. Gawande indicated he would be taking a less operational role with the company to devote more time to policy and activities associated with COVID-19.

Although the details of Dr. Gawande’s departure are unclear, his abrupt exit raises questions. Are physicians prepared for executive positions before making the move? Who makes the best fit for an administrative job?

“It’s certainly something most folks should not just jump into,” said Dr. Angood. “In the same way that physicians spend an awful lot of time developing their expertise to become an expert clinician, the same philosophy for becoming an expert administrative leader should be applied. You need to put in the same amount of energy and effort to truly be effective.”

The motivations behind moving to an administrative role vary among physicians, said Carson F. Dye, fellow and faculty member at the American College of Healthcare Executives and a leadership consultant. Some doctors make the shift because they have a natural proclivity for leading, whereas others want to make a greater impact on patient care and quality, Mr. Dye said. Still other physicians simply want a greater say in the everyday areas that affect them.

At the same time, there are more physician leadership opportunities than before. Positions such as chief quality officer, chief medical information officer, president of the employed medical group, and chief population health officer rarely existed 20 or 30 years ago, Mr. Dye noted.

“Moreover, nonclinical executives have begun to see the great value in having more physician leaders involved because it enhances physician engagement and provides valuable input for strategic change,” Mr. Dye said. “As a result, more physicians are coaxed into considering leadership roles.”

North Carolina internist Michael Lalor, MD, says leadership responsibilities landed in his lap early in his career and led to his ultimate post as a full-time administrator. Dr. Lalor was a couple years out of residency and working for a small private practice when the owner decided to retire early and asked him to take over the group, he explained.

After accepting, Dr. Lalor hired another physician, expanded the group, and later merged with a larger network.

“I loved it from the perspective of the intersection of business and medicine,” he said. “It really gave me experience you don’t get in training, such as the actual operations of running a medical group, contract negotiations, expansion plans, payroll, accounting. It was an entirely new experience that I really enjoyed.”

Dr. Lalor also served as a medical director for a small, nonprofit hospice in the area, which spurred him to become board certified in hospice and palliative medicine. He now acts as chief medical officer for a large hospice and palliative care organization based in North Carolina.

Chicago-area family physician John Jurica, MD, made his way up the executive ladder through a series of steps. Dr. Jurica said he felt drawn to committees and projects that addressed population health and quality issues. Tapping into this interest, he became medical director for Riverside Medical Center in Kankakee, Ill., followed by vice president of medical affairs and then chief medical officer for the hospital.

Along the way, Dr. Jurica volunteered with nonprofit organizations, served on hospital boards, and completed a master’s degree in public health.

“The more I got into it, the more I liked it,” he said. “I was wanting to be involved in helping larger numbers of patients in a different way, work on big problems, affect the community, and work on multidisciplinary teams.”

Today, Dr. Jurica is medical director and part owner of two urgent care centers. His career journey inspired him to create the VITAL Physician Executive blog, which offers advice about becoming a physician executive. He also hosts a podcast devoted to nonclinical careers for physicians.

Dr. Jurica said he hears a range of reasons for seeking a change from clinical care, including disillusionment with medicine; high debt; outside interests; and burnout.

“A number of physicians have said, ‘I really don’t enjoy medicine anymore,’ ” Dr. Jurica said. “ ‘The paperwork is onerous, I’m working long hours, I have to see more patients, and I’m getting paid the same or less. It’s just not what I thought it would be.’ ”

Although burnout prompts some physicians to pursue administrative roles, Dr. Angood cautions that this is like entering a rebound relationship after leaving a bad relationship. Making the move merely because of dissatisfaction with your current position can set you up for disappointment, he said.

“Too often, physicians who are frustrated with the complexities of clinical care will view administrative roles as a parachute for themselves out of that situation,” he said. “If they don’t understand the nuances of administrative work, they run the risk of moving into a role that will ultimately provide them a different level of dissatisfaction, rather than the higher level of satisfaction they were seeking. It is all about trying to ensure a good match in terms of expectations in order to obtain optimal outcomes.”
 

Who’s right for an administrative job?

Nearly any type of personality can make a good fit for an administrative post, said Dr. Jurica.

“If you look at most leadership teams, they usually have a team of people that have different personality types that complement one another,” he said. “You can be an extrovert, an introvert, Whatever kind of breakdown in personality you have can be successful.”

Certain attributes, however, are more helpful for executive positions, according to Mr. Dye, including comfort in dealing with ambiguity, a willingness to make difficult decisions, an aptitude for interpreting nonverbal cues, and the ability to demonstrate confidence, but not arrogance.

“Someone who is collaborative and cooperative, a good listener, and has a compelling vision for change in health care also makes a great leader,” he said.

The ability to balance and manage the needs of different groups is also key, said Heidi Moawad, MD, a neurologist, career consultant, and author of “Careers Beyond Clinical Medicine” (New York: Oxford University Press, 2013).

“Sometimes the needs of one group steps on the toes of the needs of another group,” said Dr. Moawad, who provides career resources for physicians at nonclinicaldoctors.com. “You have to be someone who isn’t so overwhelmed by pleasing everyone. You have to think fairly about the needs of all the groups involved, not just the loudest group.”

Is there a specialty best suited to an administrative role? Executive recruiters typically encounter more primary care physician candidates when conducting physician executive searches, according to Mr. Dye. This is likely because primary care doctors are usually the lowest paid of all specialties, and their pay scale may better fit with that of hiring organizations, he said. Higher-paid specialists, on the other hand, may be deterred from pursuing executive roles because of the possibility of lower pay. In addition, primary care physicians typically have traits that align well with administrative/executive functions.

“The nature of their clinical practice means that they are able to see the broad spectrum of the continuum of care and understand the system better,” he said.

Dr. Jurica stressed, however, that strong leaders can come from any specialty and that many medical backgrounds can fit an administrative or executive position.

“It’s more related to interests, desires, personality, and experiences over time as to whether they fit that role or mature into that role,” he said.

Just because you’re a great clinician doesn’t mean you’ll make a good administrative leader, Dr. Lalor said. Physicians can often fall into executive or leadership positions because they’re considered the best or most productive clinician in a group, he explained.

“The skill set is not 100% the same,” he said. “Not everybody is necessarily suited for it. They kind of fall into it and then have great missteps in their earliest experiences.”
 

Will you miss your former responsibilities?

Some physicians who enter the administrative realm really miss the clinical world and the satisfaction of helping patients directly, added Mr. Dye. He hears from many physicians who miss the “short-term nature” of clinical practice, meaning encountering a patient, determining an intervention, and moving on to another patient.

“Decisions are made, and the physician gets to see the result of those decisions,” he said. “One physician remarked to me that she lived her clinical life in ‘15-minute segments’ and that her executive world had many issues that went on for years, making it very frustrating to her that she was not really making progress.”

For physicians such as family physician Krista Skorupa, MD, who straddle both the clinical and administrative spheres, obstacles can arise in the form of time and balance. Dr. Skorupa splits her time between practicing family medicine and acting as vice president of medical practice for the M Health Fairview Primary Care Service Line in St. Paul, Minn.

“Most people will tell you it’s the balance that’s one of the hardest things,” she said. “You always feel like you’re doing one job not as well as you could because you’re trying to do two jobs at 100%.”

Dr. Skorupa said she has been fortunate to work for organizations that have provided the time and compensation for both jobs. But she warns that some institutions expect physicians to excel at dual clinical and administrative roles, yet fail to allot enough time or compensation for both.

Doctors going the executive route should also prepare for their work relationships to change – some for the worse.

Some peers may perceive a physician’s trek into administration as going to “the dark side,” Dr. Angood said. Attitudes from colleagues may change, and not everyone may be accepting of your new role, he advised.

And as Dr. Dhand experienced, conflict can stem from having to act as an intermediary between staff physicians and administrators. In his director position, Dr. Dhand had to relay administrative policies to his physician colleagues. The task was challenging because Dr. Dhand did not necessarily agree with the policies and felt they burdened already overworked physicians.

“I believe almost all physician leaders feel this way,” he said. “They walk in the same shoes as clinicians and know what a tough job it is. Yet, we are part of the system and have to follow rules and protocols. When you are the one giving bad news, you frequently become the fall guy.”
 

Is administration right for me?

To decide whether administration is right for you, start by talking to other physicians in the industry and asking questions, said Dr. Skorupa.

“I strongly encourage mentorship and network,” she said. “I learned a lot by just asking physicians who were in different leadership roles, to ‘Tell me your story. How did you get to where you’re at?’ It’s been hearing those stories that helped me craft my own.”

Consider joining committees within your local hospital or among your national specialty organization to evaluate whether the work interests you, Dr. Moawad advises.

“Getting some experience is important to see if it’s right for you,” she said.

Another way to measure your interest is by taking on a part-time job in physician leadership, Mr. Dye said. This allows physicians to try out leadership without leaving clinical practice behind.

“Dyad roles where physicians are paired with a nonphysician partner can also be helpful to physicians who are wanting to move slowly into leadership,” he said. “Typically, the physician partner in a dyad model also continues to practice clinically part time and thus does not lose that connection with medicine.”

In addition to getting some leadership experience, you may want to consider formal training in executive leadership. Many specialty societies offer formal coursework related to leadership, as do some hospital organizations.

The Society of Hospital Medicine offers a 3-course Leadership Academy that prepares clinical and academic leaders with skills traditionally not taught in medical school or typical residency programs. The society also offers a Leadership Capstone program for hospitalists with 3 or more years of experience, who are already leading or preparing to lead an academic, business, or clinical change initiative at their institution.

Physicians can find numerous courses and programs through AAPL, including the organization’s certified physician executive credential. The ACHE has a spectrum of career resources for health care professionals, including courses, competency assessments, and executive career coaches. Medscape’s Physician Business Academy also offers a course in leadership called “How to Become an Effective Leader,” which covers the attributes needed to become an effective leader and how to learn and develop relevant skills and traits.

Some physicians heading down the administrative road pursue more formal degrees, such as an MBA, MHA, or MMM, added Dr. Jurica. A business degree is not required, but degrees do have advantages, he said.

“The most important factor in preparing a physician for this career shift is taking on progressively more challenging duties managing people, running important projects, working with budgets, and honing your leadership skills,” he said. “However, there are benefits to having a degree. It provides formal education in these areas. Pursuing such a degree demonstrates a commitment to your leadership career and can be helpful when competing with other physician leaders for an attractive position.”

The reality is that more hospitals and health systems are recognizing the value of having physicians in leadership and executive functions, Dr. Angood said. Data show that health systems and hospitals with physician leaders perform better.

“This is because physicians not only have strong leadership and administrative capabilities, but they already have a strong sense of the clinical environment and how best to deliver good clinical care. It’s a double benefit nonclinical administrators are unable to match.”

As for Dr. Dhand, he doesn’t regret his stint in administration, despite finding out the path was not his calling.

“My experience was an eye-opener; I’m glad I did it,” he said. “I would change certain things looking back, like having lower expectations and understanding that change takes time. It’s also okay to be unpopular. I’m much happier now, though, only doing clinical medicine, and have found fulfillment through other nonclinical ventures.”

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

After practicing clinical care for 4 years, hospitalist Suneel Dhand, MD, was ready for a change and eager for the chance to help improve the broader health care system.

phototechno/Thinkstock

So when the opportunity arose to direct an internal medicine program at a large hospital, Dr. Dhand gladly accepted the role. He aimed to enhance frontline staffing, expand his hospital medicine team’s influence, and raise the standard of care for patients.

Almost immediately, however, Dr. Dhand knew the administrative route was the wrong path for him.

“I realized very quickly that initiating change and being a positive force, while working with multiple competing interests, is far from easy,” said Dr. Dhand. “I didn’t particularly feel well supported by the high-level administrators. Without resources, it’s extra difficult to make things happen.”

A year and half into the role, Dr. Dhand left the position and returned to purely clinical work. He now practices as a Boston-area hospitalist while writing, filming, and podcasting about medicine on the side.

“I have no intention of leaving clinical medicine,” he said. “If somebody gave me a very highly compensated offer right now to come and be a hospital leader, I wouldn’t do it. It’s not me, and I wouldn’t enjoy it.”

Taking on an administrative or executive role can sound appealing to many clinicians. The Medscape Physician Compensation Report 2018 found that 42% of employed physicians were aiming for a promotion. Another physician survey by The Physicians Foundation found that 46% planned to change career paths in 2018 and that more than 12% planned to seek a nonclinical job in the next 1-3 years.

Interest in executive and leadership roles has also increased because of the COVID-19 pandemic, particularly as more physicians struggle financially and search for alternative compensation, said Peter B. Angood, MD, CEO and president for the American Association for Physician Leadership.

“Because of the COVID-19 impacts on health care and our country as a whole, the strengths of physician leadership have been better recognized at multiple levels,” Dr. Angood said. “As a result, there is definitely early interest as the ongoing impacts of COVID-19 are appreciated in how to further integrate physicians as leaders within the health care industry as a whole.”
 

Administration: Not for everyone

But as Dr. Dhand’s experience highlights, administration is not the right direction for every physician. Take the case of prominent surgeon and Harvard University professor Atul Gawande, MD, who in May stepped down as chief executive for Haven, the health care venture backed by Amazon, after just 2 years. In a statement, Dr. Gawande indicated he would be taking a less operational role with the company to devote more time to policy and activities associated with COVID-19.

Although the details of Dr. Gawande’s departure are unclear, his abrupt exit raises questions. Are physicians prepared for executive positions before making the move? Who makes the best fit for an administrative job?

“It’s certainly something most folks should not just jump into,” said Dr. Angood. “In the same way that physicians spend an awful lot of time developing their expertise to become an expert clinician, the same philosophy for becoming an expert administrative leader should be applied. You need to put in the same amount of energy and effort to truly be effective.”

The motivations behind moving to an administrative role vary among physicians, said Carson F. Dye, fellow and faculty member at the American College of Healthcare Executives and a leadership consultant. Some doctors make the shift because they have a natural proclivity for leading, whereas others want to make a greater impact on patient care and quality, Mr. Dye said. Still other physicians simply want a greater say in the everyday areas that affect them.

At the same time, there are more physician leadership opportunities than before. Positions such as chief quality officer, chief medical information officer, president of the employed medical group, and chief population health officer rarely existed 20 or 30 years ago, Mr. Dye noted.

“Moreover, nonclinical executives have begun to see the great value in having more physician leaders involved because it enhances physician engagement and provides valuable input for strategic change,” Mr. Dye said. “As a result, more physicians are coaxed into considering leadership roles.”

North Carolina internist Michael Lalor, MD, says leadership responsibilities landed in his lap early in his career and led to his ultimate post as a full-time administrator. Dr. Lalor was a couple years out of residency and working for a small private practice when the owner decided to retire early and asked him to take over the group, he explained.

After accepting, Dr. Lalor hired another physician, expanded the group, and later merged with a larger network.

“I loved it from the perspective of the intersection of business and medicine,” he said. “It really gave me experience you don’t get in training, such as the actual operations of running a medical group, contract negotiations, expansion plans, payroll, accounting. It was an entirely new experience that I really enjoyed.”

Dr. Lalor also served as a medical director for a small, nonprofit hospice in the area, which spurred him to become board certified in hospice and palliative medicine. He now acts as chief medical officer for a large hospice and palliative care organization based in North Carolina.

Chicago-area family physician John Jurica, MD, made his way up the executive ladder through a series of steps. Dr. Jurica said he felt drawn to committees and projects that addressed population health and quality issues. Tapping into this interest, he became medical director for Riverside Medical Center in Kankakee, Ill., followed by vice president of medical affairs and then chief medical officer for the hospital.

Along the way, Dr. Jurica volunteered with nonprofit organizations, served on hospital boards, and completed a master’s degree in public health.

“The more I got into it, the more I liked it,” he said. “I was wanting to be involved in helping larger numbers of patients in a different way, work on big problems, affect the community, and work on multidisciplinary teams.”

Today, Dr. Jurica is medical director and part owner of two urgent care centers. His career journey inspired him to create the VITAL Physician Executive blog, which offers advice about becoming a physician executive. He also hosts a podcast devoted to nonclinical careers for physicians.

Dr. Jurica said he hears a range of reasons for seeking a change from clinical care, including disillusionment with medicine; high debt; outside interests; and burnout.

“A number of physicians have said, ‘I really don’t enjoy medicine anymore,’ ” Dr. Jurica said. “ ‘The paperwork is onerous, I’m working long hours, I have to see more patients, and I’m getting paid the same or less. It’s just not what I thought it would be.’ ”

Although burnout prompts some physicians to pursue administrative roles, Dr. Angood cautions that this is like entering a rebound relationship after leaving a bad relationship. Making the move merely because of dissatisfaction with your current position can set you up for disappointment, he said.

“Too often, physicians who are frustrated with the complexities of clinical care will view administrative roles as a parachute for themselves out of that situation,” he said. “If they don’t understand the nuances of administrative work, they run the risk of moving into a role that will ultimately provide them a different level of dissatisfaction, rather than the higher level of satisfaction they were seeking. It is all about trying to ensure a good match in terms of expectations in order to obtain optimal outcomes.”
 

Who’s right for an administrative job?

Nearly any type of personality can make a good fit for an administrative post, said Dr. Jurica.

“If you look at most leadership teams, they usually have a team of people that have different personality types that complement one another,” he said. “You can be an extrovert, an introvert, Whatever kind of breakdown in personality you have can be successful.”

Certain attributes, however, are more helpful for executive positions, according to Mr. Dye, including comfort in dealing with ambiguity, a willingness to make difficult decisions, an aptitude for interpreting nonverbal cues, and the ability to demonstrate confidence, but not arrogance.

“Someone who is collaborative and cooperative, a good listener, and has a compelling vision for change in health care also makes a great leader,” he said.

The ability to balance and manage the needs of different groups is also key, said Heidi Moawad, MD, a neurologist, career consultant, and author of “Careers Beyond Clinical Medicine” (New York: Oxford University Press, 2013).

“Sometimes the needs of one group steps on the toes of the needs of another group,” said Dr. Moawad, who provides career resources for physicians at nonclinicaldoctors.com. “You have to be someone who isn’t so overwhelmed by pleasing everyone. You have to think fairly about the needs of all the groups involved, not just the loudest group.”

Is there a specialty best suited to an administrative role? Executive recruiters typically encounter more primary care physician candidates when conducting physician executive searches, according to Mr. Dye. This is likely because primary care doctors are usually the lowest paid of all specialties, and their pay scale may better fit with that of hiring organizations, he said. Higher-paid specialists, on the other hand, may be deterred from pursuing executive roles because of the possibility of lower pay. In addition, primary care physicians typically have traits that align well with administrative/executive functions.

“The nature of their clinical practice means that they are able to see the broad spectrum of the continuum of care and understand the system better,” he said.

Dr. Jurica stressed, however, that strong leaders can come from any specialty and that many medical backgrounds can fit an administrative or executive position.

“It’s more related to interests, desires, personality, and experiences over time as to whether they fit that role or mature into that role,” he said.

Just because you’re a great clinician doesn’t mean you’ll make a good administrative leader, Dr. Lalor said. Physicians can often fall into executive or leadership positions because they’re considered the best or most productive clinician in a group, he explained.

“The skill set is not 100% the same,” he said. “Not everybody is necessarily suited for it. They kind of fall into it and then have great missteps in their earliest experiences.”
 

Will you miss your former responsibilities?

Some physicians who enter the administrative realm really miss the clinical world and the satisfaction of helping patients directly, added Mr. Dye. He hears from many physicians who miss the “short-term nature” of clinical practice, meaning encountering a patient, determining an intervention, and moving on to another patient.

“Decisions are made, and the physician gets to see the result of those decisions,” he said. “One physician remarked to me that she lived her clinical life in ‘15-minute segments’ and that her executive world had many issues that went on for years, making it very frustrating to her that she was not really making progress.”

For physicians such as family physician Krista Skorupa, MD, who straddle both the clinical and administrative spheres, obstacles can arise in the form of time and balance. Dr. Skorupa splits her time between practicing family medicine and acting as vice president of medical practice for the M Health Fairview Primary Care Service Line in St. Paul, Minn.

“Most people will tell you it’s the balance that’s one of the hardest things,” she said. “You always feel like you’re doing one job not as well as you could because you’re trying to do two jobs at 100%.”

Dr. Skorupa said she has been fortunate to work for organizations that have provided the time and compensation for both jobs. But she warns that some institutions expect physicians to excel at dual clinical and administrative roles, yet fail to allot enough time or compensation for both.

Doctors going the executive route should also prepare for their work relationships to change – some for the worse.

Some peers may perceive a physician’s trek into administration as going to “the dark side,” Dr. Angood said. Attitudes from colleagues may change, and not everyone may be accepting of your new role, he advised.

And as Dr. Dhand experienced, conflict can stem from having to act as an intermediary between staff physicians and administrators. In his director position, Dr. Dhand had to relay administrative policies to his physician colleagues. The task was challenging because Dr. Dhand did not necessarily agree with the policies and felt they burdened already overworked physicians.

“I believe almost all physician leaders feel this way,” he said. “They walk in the same shoes as clinicians and know what a tough job it is. Yet, we are part of the system and have to follow rules and protocols. When you are the one giving bad news, you frequently become the fall guy.”
 

Is administration right for me?

To decide whether administration is right for you, start by talking to other physicians in the industry and asking questions, said Dr. Skorupa.

“I strongly encourage mentorship and network,” she said. “I learned a lot by just asking physicians who were in different leadership roles, to ‘Tell me your story. How did you get to where you’re at?’ It’s been hearing those stories that helped me craft my own.”

Consider joining committees within your local hospital or among your national specialty organization to evaluate whether the work interests you, Dr. Moawad advises.

“Getting some experience is important to see if it’s right for you,” she said.

Another way to measure your interest is by taking on a part-time job in physician leadership, Mr. Dye said. This allows physicians to try out leadership without leaving clinical practice behind.

“Dyad roles where physicians are paired with a nonphysician partner can also be helpful to physicians who are wanting to move slowly into leadership,” he said. “Typically, the physician partner in a dyad model also continues to practice clinically part time and thus does not lose that connection with medicine.”

In addition to getting some leadership experience, you may want to consider formal training in executive leadership. Many specialty societies offer formal coursework related to leadership, as do some hospital organizations.

The Society of Hospital Medicine offers a 3-course Leadership Academy that prepares clinical and academic leaders with skills traditionally not taught in medical school or typical residency programs. The society also offers a Leadership Capstone program for hospitalists with 3 or more years of experience, who are already leading or preparing to lead an academic, business, or clinical change initiative at their institution.

Physicians can find numerous courses and programs through AAPL, including the organization’s certified physician executive credential. The ACHE has a spectrum of career resources for health care professionals, including courses, competency assessments, and executive career coaches. Medscape’s Physician Business Academy also offers a course in leadership called “How to Become an Effective Leader,” which covers the attributes needed to become an effective leader and how to learn and develop relevant skills and traits.

Some physicians heading down the administrative road pursue more formal degrees, such as an MBA, MHA, or MMM, added Dr. Jurica. A business degree is not required, but degrees do have advantages, he said.

“The most important factor in preparing a physician for this career shift is taking on progressively more challenging duties managing people, running important projects, working with budgets, and honing your leadership skills,” he said. “However, there are benefits to having a degree. It provides formal education in these areas. Pursuing such a degree demonstrates a commitment to your leadership career and can be helpful when competing with other physician leaders for an attractive position.”

The reality is that more hospitals and health systems are recognizing the value of having physicians in leadership and executive functions, Dr. Angood said. Data show that health systems and hospitals with physician leaders perform better.

“This is because physicians not only have strong leadership and administrative capabilities, but they already have a strong sense of the clinical environment and how best to deliver good clinical care. It’s a double benefit nonclinical administrators are unable to match.”

As for Dr. Dhand, he doesn’t regret his stint in administration, despite finding out the path was not his calling.

“My experience was an eye-opener; I’m glad I did it,” he said. “I would change certain things looking back, like having lower expectations and understanding that change takes time. It’s also okay to be unpopular. I’m much happier now, though, only doing clinical medicine, and have found fulfillment through other nonclinical ventures.”

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

After practicing clinical care for 4 years, hospitalist Suneel Dhand, MD, was ready for a change and eager for the chance to help improve the broader health care system.

phototechno/Thinkstock

So when the opportunity arose to direct an internal medicine program at a large hospital, Dr. Dhand gladly accepted the role. He aimed to enhance frontline staffing, expand his hospital medicine team’s influence, and raise the standard of care for patients.

Almost immediately, however, Dr. Dhand knew the administrative route was the wrong path for him.

“I realized very quickly that initiating change and being a positive force, while working with multiple competing interests, is far from easy,” said Dr. Dhand. “I didn’t particularly feel well supported by the high-level administrators. Without resources, it’s extra difficult to make things happen.”

A year and half into the role, Dr. Dhand left the position and returned to purely clinical work. He now practices as a Boston-area hospitalist while writing, filming, and podcasting about medicine on the side.

“I have no intention of leaving clinical medicine,” he said. “If somebody gave me a very highly compensated offer right now to come and be a hospital leader, I wouldn’t do it. It’s not me, and I wouldn’t enjoy it.”

Taking on an administrative or executive role can sound appealing to many clinicians. The Medscape Physician Compensation Report 2018 found that 42% of employed physicians were aiming for a promotion. Another physician survey by The Physicians Foundation found that 46% planned to change career paths in 2018 and that more than 12% planned to seek a nonclinical job in the next 1-3 years.

Interest in executive and leadership roles has also increased because of the COVID-19 pandemic, particularly as more physicians struggle financially and search for alternative compensation, said Peter B. Angood, MD, CEO and president for the American Association for Physician Leadership.

“Because of the COVID-19 impacts on health care and our country as a whole, the strengths of physician leadership have been better recognized at multiple levels,” Dr. Angood said. “As a result, there is definitely early interest as the ongoing impacts of COVID-19 are appreciated in how to further integrate physicians as leaders within the health care industry as a whole.”
 

Administration: Not for everyone

But as Dr. Dhand’s experience highlights, administration is not the right direction for every physician. Take the case of prominent surgeon and Harvard University professor Atul Gawande, MD, who in May stepped down as chief executive for Haven, the health care venture backed by Amazon, after just 2 years. In a statement, Dr. Gawande indicated he would be taking a less operational role with the company to devote more time to policy and activities associated with COVID-19.

Although the details of Dr. Gawande’s departure are unclear, his abrupt exit raises questions. Are physicians prepared for executive positions before making the move? Who makes the best fit for an administrative job?

“It’s certainly something most folks should not just jump into,” said Dr. Angood. “In the same way that physicians spend an awful lot of time developing their expertise to become an expert clinician, the same philosophy for becoming an expert administrative leader should be applied. You need to put in the same amount of energy and effort to truly be effective.”

The motivations behind moving to an administrative role vary among physicians, said Carson F. Dye, fellow and faculty member at the American College of Healthcare Executives and a leadership consultant. Some doctors make the shift because they have a natural proclivity for leading, whereas others want to make a greater impact on patient care and quality, Mr. Dye said. Still other physicians simply want a greater say in the everyday areas that affect them.

At the same time, there are more physician leadership opportunities than before. Positions such as chief quality officer, chief medical information officer, president of the employed medical group, and chief population health officer rarely existed 20 or 30 years ago, Mr. Dye noted.

“Moreover, nonclinical executives have begun to see the great value in having more physician leaders involved because it enhances physician engagement and provides valuable input for strategic change,” Mr. Dye said. “As a result, more physicians are coaxed into considering leadership roles.”

North Carolina internist Michael Lalor, MD, says leadership responsibilities landed in his lap early in his career and led to his ultimate post as a full-time administrator. Dr. Lalor was a couple years out of residency and working for a small private practice when the owner decided to retire early and asked him to take over the group, he explained.

After accepting, Dr. Lalor hired another physician, expanded the group, and later merged with a larger network.

“I loved it from the perspective of the intersection of business and medicine,” he said. “It really gave me experience you don’t get in training, such as the actual operations of running a medical group, contract negotiations, expansion plans, payroll, accounting. It was an entirely new experience that I really enjoyed.”

Dr. Lalor also served as a medical director for a small, nonprofit hospice in the area, which spurred him to become board certified in hospice and palliative medicine. He now acts as chief medical officer for a large hospice and palliative care organization based in North Carolina.

Chicago-area family physician John Jurica, MD, made his way up the executive ladder through a series of steps. Dr. Jurica said he felt drawn to committees and projects that addressed population health and quality issues. Tapping into this interest, he became medical director for Riverside Medical Center in Kankakee, Ill., followed by vice president of medical affairs and then chief medical officer for the hospital.

Along the way, Dr. Jurica volunteered with nonprofit organizations, served on hospital boards, and completed a master’s degree in public health.

“The more I got into it, the more I liked it,” he said. “I was wanting to be involved in helping larger numbers of patients in a different way, work on big problems, affect the community, and work on multidisciplinary teams.”

Today, Dr. Jurica is medical director and part owner of two urgent care centers. His career journey inspired him to create the VITAL Physician Executive blog, which offers advice about becoming a physician executive. He also hosts a podcast devoted to nonclinical careers for physicians.

Dr. Jurica said he hears a range of reasons for seeking a change from clinical care, including disillusionment with medicine; high debt; outside interests; and burnout.

“A number of physicians have said, ‘I really don’t enjoy medicine anymore,’ ” Dr. Jurica said. “ ‘The paperwork is onerous, I’m working long hours, I have to see more patients, and I’m getting paid the same or less. It’s just not what I thought it would be.’ ”

Although burnout prompts some physicians to pursue administrative roles, Dr. Angood cautions that this is like entering a rebound relationship after leaving a bad relationship. Making the move merely because of dissatisfaction with your current position can set you up for disappointment, he said.

“Too often, physicians who are frustrated with the complexities of clinical care will view administrative roles as a parachute for themselves out of that situation,” he said. “If they don’t understand the nuances of administrative work, they run the risk of moving into a role that will ultimately provide them a different level of dissatisfaction, rather than the higher level of satisfaction they were seeking. It is all about trying to ensure a good match in terms of expectations in order to obtain optimal outcomes.”
 

Who’s right for an administrative job?

Nearly any type of personality can make a good fit for an administrative post, said Dr. Jurica.

“If you look at most leadership teams, they usually have a team of people that have different personality types that complement one another,” he said. “You can be an extrovert, an introvert, Whatever kind of breakdown in personality you have can be successful.”

Certain attributes, however, are more helpful for executive positions, according to Mr. Dye, including comfort in dealing with ambiguity, a willingness to make difficult decisions, an aptitude for interpreting nonverbal cues, and the ability to demonstrate confidence, but not arrogance.

“Someone who is collaborative and cooperative, a good listener, and has a compelling vision for change in health care also makes a great leader,” he said.

The ability to balance and manage the needs of different groups is also key, said Heidi Moawad, MD, a neurologist, career consultant, and author of “Careers Beyond Clinical Medicine” (New York: Oxford University Press, 2013).

“Sometimes the needs of one group steps on the toes of the needs of another group,” said Dr. Moawad, who provides career resources for physicians at nonclinicaldoctors.com. “You have to be someone who isn’t so overwhelmed by pleasing everyone. You have to think fairly about the needs of all the groups involved, not just the loudest group.”

Is there a specialty best suited to an administrative role? Executive recruiters typically encounter more primary care physician candidates when conducting physician executive searches, according to Mr. Dye. This is likely because primary care doctors are usually the lowest paid of all specialties, and their pay scale may better fit with that of hiring organizations, he said. Higher-paid specialists, on the other hand, may be deterred from pursuing executive roles because of the possibility of lower pay. In addition, primary care physicians typically have traits that align well with administrative/executive functions.

“The nature of their clinical practice means that they are able to see the broad spectrum of the continuum of care and understand the system better,” he said.

Dr. Jurica stressed, however, that strong leaders can come from any specialty and that many medical backgrounds can fit an administrative or executive position.

“It’s more related to interests, desires, personality, and experiences over time as to whether they fit that role or mature into that role,” he said.

Just because you’re a great clinician doesn’t mean you’ll make a good administrative leader, Dr. Lalor said. Physicians can often fall into executive or leadership positions because they’re considered the best or most productive clinician in a group, he explained.

“The skill set is not 100% the same,” he said. “Not everybody is necessarily suited for it. They kind of fall into it and then have great missteps in their earliest experiences.”
 

Will you miss your former responsibilities?

Some physicians who enter the administrative realm really miss the clinical world and the satisfaction of helping patients directly, added Mr. Dye. He hears from many physicians who miss the “short-term nature” of clinical practice, meaning encountering a patient, determining an intervention, and moving on to another patient.

“Decisions are made, and the physician gets to see the result of those decisions,” he said. “One physician remarked to me that she lived her clinical life in ‘15-minute segments’ and that her executive world had many issues that went on for years, making it very frustrating to her that she was not really making progress.”

For physicians such as family physician Krista Skorupa, MD, who straddle both the clinical and administrative spheres, obstacles can arise in the form of time and balance. Dr. Skorupa splits her time between practicing family medicine and acting as vice president of medical practice for the M Health Fairview Primary Care Service Line in St. Paul, Minn.

“Most people will tell you it’s the balance that’s one of the hardest things,” she said. “You always feel like you’re doing one job not as well as you could because you’re trying to do two jobs at 100%.”

Dr. Skorupa said she has been fortunate to work for organizations that have provided the time and compensation for both jobs. But she warns that some institutions expect physicians to excel at dual clinical and administrative roles, yet fail to allot enough time or compensation for both.

Doctors going the executive route should also prepare for their work relationships to change – some for the worse.

Some peers may perceive a physician’s trek into administration as going to “the dark side,” Dr. Angood said. Attitudes from colleagues may change, and not everyone may be accepting of your new role, he advised.

And as Dr. Dhand experienced, conflict can stem from having to act as an intermediary between staff physicians and administrators. In his director position, Dr. Dhand had to relay administrative policies to his physician colleagues. The task was challenging because Dr. Dhand did not necessarily agree with the policies and felt they burdened already overworked physicians.

“I believe almost all physician leaders feel this way,” he said. “They walk in the same shoes as clinicians and know what a tough job it is. Yet, we are part of the system and have to follow rules and protocols. When you are the one giving bad news, you frequently become the fall guy.”
 

Is administration right for me?

To decide whether administration is right for you, start by talking to other physicians in the industry and asking questions, said Dr. Skorupa.

“I strongly encourage mentorship and network,” she said. “I learned a lot by just asking physicians who were in different leadership roles, to ‘Tell me your story. How did you get to where you’re at?’ It’s been hearing those stories that helped me craft my own.”

Consider joining committees within your local hospital or among your national specialty organization to evaluate whether the work interests you, Dr. Moawad advises.

“Getting some experience is important to see if it’s right for you,” she said.

Another way to measure your interest is by taking on a part-time job in physician leadership, Mr. Dye said. This allows physicians to try out leadership without leaving clinical practice behind.

“Dyad roles where physicians are paired with a nonphysician partner can also be helpful to physicians who are wanting to move slowly into leadership,” he said. “Typically, the physician partner in a dyad model also continues to practice clinically part time and thus does not lose that connection with medicine.”

In addition to getting some leadership experience, you may want to consider formal training in executive leadership. Many specialty societies offer formal coursework related to leadership, as do some hospital organizations.

The Society of Hospital Medicine offers a 3-course Leadership Academy that prepares clinical and academic leaders with skills traditionally not taught in medical school or typical residency programs. The society also offers a Leadership Capstone program for hospitalists with 3 or more years of experience, who are already leading or preparing to lead an academic, business, or clinical change initiative at their institution.

Physicians can find numerous courses and programs through AAPL, including the organization’s certified physician executive credential. The ACHE has a spectrum of career resources for health care professionals, including courses, competency assessments, and executive career coaches. Medscape’s Physician Business Academy also offers a course in leadership called “How to Become an Effective Leader,” which covers the attributes needed to become an effective leader and how to learn and develop relevant skills and traits.

Some physicians heading down the administrative road pursue more formal degrees, such as an MBA, MHA, or MMM, added Dr. Jurica. A business degree is not required, but degrees do have advantages, he said.

“The most important factor in preparing a physician for this career shift is taking on progressively more challenging duties managing people, running important projects, working with budgets, and honing your leadership skills,” he said. “However, there are benefits to having a degree. It provides formal education in these areas. Pursuing such a degree demonstrates a commitment to your leadership career and can be helpful when competing with other physician leaders for an attractive position.”

The reality is that more hospitals and health systems are recognizing the value of having physicians in leadership and executive functions, Dr. Angood said. Data show that health systems and hospitals with physician leaders perform better.

“This is because physicians not only have strong leadership and administrative capabilities, but they already have a strong sense of the clinical environment and how best to deliver good clinical care. It’s a double benefit nonclinical administrators are unable to match.”

As for Dr. Dhand, he doesn’t regret his stint in administration, despite finding out the path was not his calling.

“My experience was an eye-opener; I’m glad I did it,” he said. “I would change certain things looking back, like having lower expectations and understanding that change takes time. It’s also okay to be unpopular. I’m much happier now, though, only doing clinical medicine, and have found fulfillment through other nonclinical ventures.”

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

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The World Health Organization is preparing a scientific brief to address the continually emerging evidence on transmission of COVID-19 and plans to release its guidance “in the coming days.”

WHO will likely address airborne transmission of the virus after a commentary from almost 240 multidisciplinary scientists raised the alarm that virus particles could remain airborne longer that previously appreciated, particularly in poorly ventilated indoor spaces.

“Airborne route of infection transmission is significant, but so far completely undermined, and not recognized by the decision makers and bodies responsible for infection control,” lead commentary author Lidia Morawska, PhD, told Medscape Medical News.

“This means that no control measures are taken to mitigate airborne transmission and, as a consequence, people are infected and can die,” said Morawska, director of the International Laboratory for Air Quality and Health at Queensland University of Technology in Brisbane, Australia. “We wanted to bring this to the attention of the world to prevent this from happening.”

The commentary was published July 6 in Clinical Infectious Diseases.

WHO leaders defended their progress in announcing any changes regarding how COVID-19 can be transmitted during a virtual press briefing today. They have collaborated since April with some of the scientists who coauthored the commentary, for example, said Maria Van Kerkhove, PhD, WHO technical lead on COVID-19.

“We have been working on a scientific brief ... to consolidate knowledge around transmission,” she added.

One focus will be on how masks protect healthcare workers. “We are also looking at the possible role of airborne transmission in other settings,” Van Kerkhove said. “We will be releasing our brief in the coming days.”

“We acknowledge there is emerging evidence in this field,” Benedetta Allegranzi, MD, WHO technical lead on COVID-19, said during the briefing from Geneva. “Therefore, we believe we have to be open to this evidence and its implications.”

WHO participated in an international research meeting last week that addressed means for controlling modes of COVID-19 transmission, Allegranzi said. “Our group and others really highlighted importance of research on different modes of transmission, including droplets of different sizes and their relative importance,” she said. Another aim was determining the dose of the virus required for airborne transmission.

“These fields of research are really growing but not definitive. More evidence needs to be gathered and evaluated,” she explained.

In the meantime, Allegranzi said, “the possibility of airborne transmission in public settings – especially closed, poorly ventilated settings – cannot be ruled out.”

Morawska said the evidence already exists. “A continuous surprise is that it takes the world such a long time to accept this, while this has such solid scientific foundation.” As an example, she cited an April report she coauthored in the journal Environment International. She and colleagues call for “national authorities to acknowledge the reality that the virus spreads through air and recommend that adequate control measures be implemented to prevent further spread of the SARS-CoV-2 virus, in particularly removal of the virus-laden droplets from indoor air by ventilation.”

The take-home message from the commentary, Morawska said, is a call to action. The authors state there is a need “to provide sufficient and effective ventilation (supply clean outdoor air, minimize recirculating air) particularly in public buildings, workplace environments, schools, hospitals, and aged care homes.”

WHO Chief Scientist Soumya Swaminathan, MD, explained why the organization remains cautious about making premature pronouncements regarding airborne transmission. “Any guidance we put out has implications for billions of people around the world, so we want to be as careful as possible,” she said during the press briefing. “We have to consider the weight of the evidence.”

“We are constantly looking for information on how we can do better,” Swaminathan added. WHO officials are reviewing hundreds of scientific reports every day, she said, and not all are of good quality. For this reason, she and other scientists at WHO perform a “living systematic review” – updating the consensus of evidence on a weekly basis.  

“This process on COVID-19 will, I am sure, continue for the weeks and months to come,” she added.

This article first appeared on Medscape.com.

The Food and Drug Administration has approved collagenase clostridium histolyticum–aaes (Qwo, Endo International) for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In cellulite, fibrous septae are a primary contributing factor. The septae make up the fibrous connective tissue that connects the skin perpendicularly to the fascia below and tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.” When injected into the treatment area, Qwo is thought to release the fibrous septae enzymatically by specifically targeting types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.

The most common side effects of Qwo include injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling, and warmth in the treatment area.

Qwo is expected to be available throughout the United States at aesthetic health care practitioner’s offices starting in Spring 2021.

“Qwo could be a game-changer for many women with cellulite,” Anne Chapas, MD, a board-certified dermatologist at Union Square Laser Dermatology in New York, said in a press release. “I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about Qwo is that it is a cutting-edge cellulite treatment, without the cutting,” Dr. Chapas, said.

lfranki@mdedge.com

The Food and Drug Administration has approved collagenase clostridium histolyticum–aaes (Qwo, Endo International) for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In cellulite, fibrous septae are a primary contributing factor. The septae make up the fibrous connective tissue that connects the skin perpendicularly to the fascia below and tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.” When injected into the treatment area, Qwo is thought to release the fibrous septae enzymatically by specifically targeting types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.

The most common side effects of Qwo include injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling, and warmth in the treatment area.

Qwo is expected to be available throughout the United States at aesthetic health care practitioner’s offices starting in Spring 2021.

“Qwo could be a game-changer for many women with cellulite,” Anne Chapas, MD, a board-certified dermatologist at Union Square Laser Dermatology in New York, said in a press release. “I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about Qwo is that it is a cutting-edge cellulite treatment, without the cutting,” Dr. Chapas, said.

lfranki@mdedge.com

The Food and Drug Administration has approved collagenase clostridium histolyticum–aaes (Qwo, Endo International) for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In cellulite, fibrous septae are a primary contributing factor. The septae make up the fibrous connective tissue that connects the skin perpendicularly to the fascia below and tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.” When injected into the treatment area, Qwo is thought to release the fibrous septae enzymatically by specifically targeting types 1 and 3 collagen, which may result in smoothing of the skin and an improved appearance of cellulite.

The most common side effects of Qwo include injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling, and warmth in the treatment area.

Qwo is expected to be available throughout the United States at aesthetic health care practitioner’s offices starting in Spring 2021.

“Qwo could be a game-changer for many women with cellulite,” Anne Chapas, MD, a board-certified dermatologist at Union Square Laser Dermatology in New York, said in a press release. “I am thrilled there will now be an FDA-approved injectable treatment option proven to address a root cause of cellulite. What is exciting about Qwo is that it is a cutting-edge cellulite treatment, without the cutting,” Dr. Chapas, said.

lfranki@mdedge.com

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

dbrunk@mdedge.com

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

dbrunk@mdedge.com

Of the many psoriasis mimicker clinicians are likely to encounter, atopic dermatitis is likely the most common one, especially the nummular eczema variant form.

“It has an earlier age of onset, usually in infancy, and can occur with the atopic triad that presents with asthma and seasonal allergies as well,” Israel David “Izzy” Andrews, MD, said at the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “There is typically a very strong family history, as this is an autosomal dominant condition, and it’s far more common than psoriasis. The annual incidence is estimated to be 10%-15% of pediatric patients. It has classic areas of involvement depending on the age of the patient, and lesions are intensely pruritic at all times. There is induration and crust, but it’s important to distinguish crust from scale. Whereas crust is dried exudate, and scale is usually secondary to a hyperproliferation of the skin. Initially, treatments (especially topical) are similar and may also delay the formalized diagnosis of either of the two.”

Another psoriasis mimicker, pityriasis rosea, is thought to be secondary to human herpes virus 6 or 7 infection, said Dr. Andrews, of the department of dermatology at Phoenix Children’s Hospital. It typically appears in the teens and tweens and usually presents as a large herald patch or plaque on the trunk. As the herald patch resolves, smaller lesions will develop on the trunk following skin folds. “It’s rarely symptomatic and it’s very short lived, and clears within 6-12 weeks,” Dr. Andrews noted. “It can present with an inverse pattern involving the face, neck, and groin, but sparing the trunk. This variant, termed inverse pityriasis rosea, can be confused with inverse psoriasis, which has a similar distribution. However, the inverse pattern of pityriasis rosea will still resolve in a similar time frame to its more classic variant.”

Pityriasis lichenoides can also be mistaken for psoriasis. The acute form can present with erythematous, scaly papules and plaques, but lesions are often found in different phases of resolution or healing. “This benign lymphoproliferative skin disorder can be very difficult to distinguish from psoriasis and may require a biopsy to rule in or out,” Dr. Andrews said. “It can last months to years and there are few treatments that are effective. It is typically nonresponsive to topical steroids and other treatments that would be more effective for psoriasis, helping to distinguish the two. It is thought to exist in the spectrum with other lymphoproliferative diseases including cutaneous T-cell lymphoma [CTCL]. However, there are only a few cases in the literature that support a transformation from pityriasis lichenoides to CTCL.”

Seborrheic dermatitis is more common than atopic dermatitis and psoriasis, but it can be mistaken for psoriasis. It is caused by an inflammatory response secondary to overgrowth of Malassezia yeast and has a bimodal age distribution. “Seborrheic dermatitis affects babies, teens, and tweens, and can persist into adulthood,” he said. “Infants with cradle cap usually resolve with moisturization, gentle brushing, and occasional antifungal shampoos.” Petaloid seborrheic dermatitis can predominately involve the face with psoriatic-appearing induration, plaques, and varying degrees of scales. “In skin of color, this can be confused with discoid lupus, sarcoidosis, and psoriasis, occasionally requiring a biopsy to distinguish,” said Dr. Andrews, who is also an assistant professor of pediatrics at the Mayo Clinic College of Medicine and Science in Scottsdale, Ariz.

Another psoriasis mimicker, pityriasis amiantacea, is thought to be a more severe form of seborrheic dermatitis. It presents with concretions of scale around hair follicles that are highly adherent and are sometimes called sebopsoriasis. “It may be associated with cutaneous findings of psoriasis elsewhere, but may also be found with secondarily infected atopic dermatitis and tinea capitis; however, in my clinical experience, it is most often found in isolation,” he said. “There may be a seasonal association with exacerbation in warm temperatures, and treatment often consists of humectants like salicylic acid for loosening scale, topical steroids for inflammation, and gentle combing out of scale.”

Infections can also mimic psoriasis. For example, tinea infections are often misdiagnosed as eczema or psoriasis and treated with topical steroids. “This can lead to tinea incognito, making it harder to diagnose either condition without attention to detail,” Dr. Andrews said. “On the body, look for expanding lesions with more raised peripheral edges, and central flattening, giving a classic annular appearance. It’s also important to inquire about family history and contacts including pets, contact sports/mat sports (think yoga, gymnastics, martial arts), or other contacts with similar rashes.” Work-up typically includes a fungal culture and starting empiric oral antifungal medications. “It is important to be able to distinguish scalp psoriasis from tinea capitis to prevent the more inflammatory form of tinea capitis, kerion (a deeper more symptomatic, painful and purulent dermatitis), which can lead to permanent scarring alopecia,” he said.

Bacterial infections can also mimic psoriasis, specifically nonbullous impetigo and ecthyma, the more ulcerative form of impetigo. The most frequent associations are group A Streptococcus, methicillin-susceptible Staphylococcus aureus and methicillin-resistant S. aureus.

Dr. Andrews closed his presentation by noting that tumor necrosis factor–alpha inhibitor–induced psoriasiform drug eruptions can occur in psoriasis-naive patients or unmask a predilection for psoriasis in patients with Crohn’s disease, juvenile idiopathic arthritis, or other autoinflammatory or autoimmune conditions. “They may improve with continued treatment and resolve with switching treatments,” he said. “Early biopsy in psoriasiform drug eruptions can appear like atopic dermatitis on pathology. When suspecting psoriasis in a pediatric patient, it is important to consider the history and physical exam as well as family history and associated comorbidities. While a biopsy may aide in the work-up, diagnosis can be made clinically.”

Dr. Andrews reported having no financial disclosures.

dbrunk@mdedge.com

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.

The American Gastroenterological Association has released a new guideline for consultative management of patients with COVID-19.

The recommendations, which were written by Shahnaz Sultan, MD, AGAF, chair of the AGA Clinical Guidelines Committee, of the University of Minnesota, Minneapolis, and colleagues, were based on a meta-analysis of data from 47 studies involving 10,890 unique patients.

“We seek to summarize international data on the GI and liver manifestations of COVID-19 infection and treatment,” the panelists wrote in Gastroenterology. “Additionally, this document provides evidence-based clinical guidance on clinical questions that gastroenterologists may be consulted for.”

The guideline includes seven best practice statements.

The first three statements relate to COVID-19–related GI symptoms, which are estimated to occur in less than 10% of patients, and rarely in the absence of other COVID-19–related symptoms, according to Dr. Sultan and her copanelists.

“The overall prevalence of GI symptoms in the context of COVID-19, including nausea, vomiting, abdominal pain, and diarrhea, is lower than estimated previously,” the panelists wrote, referencing a previous meta-analysis by Ka Shing Cheung, MBBS, and colleagues that showed a prevalence of 17.6%.

“It is important to note that the majority of studies were focused on hospitalized patients with COVID-19, and the prevalence of diarrhea in patients with mild symptoms who were not hospitalized is not known.”

Since GI issues may precede other symptoms of COVID-19, the guideline recommends questioning outpatients with new-onset GI symptoms about other symptoms of COVID-19, with viral testing recommended in areas of high prevalence. Conversely, the panelists recommended that patients with suspected or known COVID-19 should undergo thorough history taking for GI symptoms, “including onset, characteristics, duration, and severity.”

The fourth practice statement advises against COVID-19 stool testing in routine clinical practice, either for diagnostic or monitoring purposes.

Although Dr. Cheung and colleagues reported that 48.1% of fecal specimens from patients with COVID-19 contained viral RNA, the panelists concluded that the practical relevance of this finding remains unknown.

“Stool infectivity and transmission have not been confirmed,” the panelists wrote, citing a lack of evidence and conflicting findings.

The final three practice statements address liver concerns.

First, any patient with suspected or confirmed COVID-19 who has elevated liver function tests should be evaluated for alternative etiologies. Second, hospitalized patients with suspected or confirmed COVID-19 should undergo baseline liver function testing, followed by liver monitoring throughout their stay, “particularly in the context of drug treatment for COVID-19.” And third, any patient receiving drugs to treat COVID-19 should be monitored for treatment-related hepatic and GI adverse effects.

Dr. Sultan and colleagues found that approximately 15% of patients with COVID-19 included in their meta-analysis had abnormal liver function tests, more often because of secondary effects rather than virally induced liver injury.

Although liver function test abnormalities were inconsistently reported across studies, and when available, often lacked relevant contextual data, such as information about underlying liver disease, published data suggest that abnormal liver values could predict more severe COVID-19, supporting baseline and serial liver testing, the panelists wrote.

Following these recommendations, the guideline includes a discussion of GI and hepatic adverse effects related to specific COVID-19 treatments.

According to the panelists, chloroquine and hydroxychloroquine may infrequently lead to GI disturbances, and rarely, liver injury, with the latter thought to be a sequela of a hypersensitivity reaction; among antiviral medications, lopinavir/ritonavir and favipiravir may cause GI adverse effects in approximately 5%-15% of patients, with potentially higher rates in children and those receiving higher doses.

“In particular, GI adverse events are poorly understood for both favipiravir and remdesivir,” the panelists wrote.

Hepatic adverse effects, ranging from mild elevations in aminotransferases to acute liver failure, have been documented, albeit rarely, among patients receiving lopinavir/ritonavir, according to the panelists. For remdesivir, liver injury has also been reported, although frequency is unknown, and for favipiravir, hepatic adverse events may be seen in 3% of patients, although, again, the panelists noted a scarcity of relevant findings.

In their concluding remarks, Dr. Sultan and colleagues called for more high-quality data, and encouraged clinicians to contribute to international registries, as these could help guide COVID-19 recommendations for patient subgroups.

The article was funded by the American Gastroenterological Association Institute.

SOURCE: Sultan S et al. Gastroenterology. 2020 May 11. doi: 10.1053/j.gastro.2020.05.001.

Background: Previous studies suggest that clinicians and surrogates rarely discuss patient values in ICU family conferences about goals of care despite recommendations from international critical care societies.

Moreover, there was no deliberation about how to apply patient values and preferences to clinical decisions in 55.7% of the conferences. Surrogates were more likely to bring up these elements of shared decision making than were physicians.

Bottom line: Care providers and surrogates of critically ill ICU patients often fail to discuss patient preferences, values, and how they apply to care decisions in goals of care conferences.

Citation: Scheunemann LP et al. Clinician-family communication about patients’ values and preferences in intensive care units. JAMA Intern Med. 2019;179(5):676-84.

Dr. Mastalerz is a hospitalist and medical director of 9A Accountable Care Unit at the Colorado Health Foundation.

Background: Previous studies suggest that clinicians and surrogates rarely discuss patient values in ICU family conferences about goals of care despite recommendations from international critical care societies.

Moreover, there was no deliberation about how to apply patient values and preferences to clinical decisions in 55.7% of the conferences. Surrogates were more likely to bring up these elements of shared decision making than were physicians.

Bottom line: Care providers and surrogates of critically ill ICU patients often fail to discuss patient preferences, values, and how they apply to care decisions in goals of care conferences.

Citation: Scheunemann LP et al. Clinician-family communication about patients’ values and preferences in intensive care units. JAMA Intern Med. 2019;179(5):676-84.

Dr. Mastalerz is a hospitalist and medical director of 9A Accountable Care Unit at the Colorado Health Foundation.

Background: Previous studies suggest that clinicians and surrogates rarely discuss patient values in ICU family conferences about goals of care despite recommendations from international critical care societies.

Moreover, there was no deliberation about how to apply patient values and preferences to clinical decisions in 55.7% of the conferences. Surrogates were more likely to bring up these elements of shared decision making than were physicians.

Bottom line: Care providers and surrogates of critically ill ICU patients often fail to discuss patient preferences, values, and how they apply to care decisions in goals of care conferences.

Citation: Scheunemann LP et al. Clinician-family communication about patients’ values and preferences in intensive care units. JAMA Intern Med. 2019;179(5):676-84.

Dr. Mastalerz is a hospitalist and medical director of 9A Accountable Care Unit at the Colorado Health Foundation.

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

Although fusions in the neurotrophic receptor tyrosine kinase (NTRK) gene are rare in gastrointestinal carcinomas (found in fewer than 5% of cases), they should be looked for, inasmuch as treatment with the TRK inhibitor entrectinib (Rozlytrek, Genentech/Roche) can achieve robust and durable responses, say researchers.

This point was made during several presentations at the virtual World Conference on Gastrointestinal Cancer (WCGC) 2020 on July 1.

Entrectinib and similar agents that act on NTRK fusion genes are described as tumor agnostic, in that they are biomarkers that define the cancer rather than the organ of origin.

The Food and Drug Administration last year granted accelerated approval of entrectinib for patients with locally advanced or metastatic NTRK-expressing solid tumors that have progressed following prior therapies. The drug can also be used as a first-line treatment when there are no effective therapies.

At the meeting, Manish R. Patel, MD, Department of Medicine, University of Minnesota, Minneapolis, and colleagues presented combined results from the ALKA-372-001, STARTRK-1, and STARTRK-2 studies of entrectinib.

They identified 12 gastrointestinal carcinoma patients among 74 adults with locally advanced/metastatic NTRK fusion positive, TRK inhibitor-naive solid tumors who had undergone at least 6 months of follow-up.

Many of these 12 patients had colorectal cancer (58%) or pancreatic cancer (24%).

Treatment with entrectinib elicited an overall response rate of 50%, which consisted entirely of partial responses.

The median duration of response was 12.9 months, which was largely driven by a median duration of response of 15.1 months among colorectal cancer patients, vs 10.0 months among pancreatic cancer patients and 9.3 months in the patient with cholangiocarcinoma.

The median progression-free survival was 7.1 months across the whole cohort. It was 8.0 months for pancreatic cancer patients and 12.0 months for the patient with cholangiocarcinoma.

The median overall survival was 16 months.

Dr. Patel said that this “demonstrates that entrectinib induces durable and clinically meaningful systemic responses in patients with gastrointestinal carcinomas harboring NTRK fusions.”

He noted that entrectinib is “overall very well tolerated, with very few dose interruptions or reductions, and the discontinuation rate was very low.” The majority of adverse events were of grade 1/2. The most common event was change in taste, which occurred in 37.3% of patients. There were no treatment-related deaths.

“The main take-away point from this abstract is that, though they are rare, if we identify patients with NTRK fusions during the course of the disease, we can offer them benefit from entrectinib, and I would argue that ... we should be screening patients for NTRK fusions much more frequently,” Dr. Patel added.

In the second study, a Belgian team performed immunohistochemistry (IHC) analysis followed by next-generation sequencing on archived samples of biliopancreatic cancers to determine the prevalence of NTRK fusions.

They found just one fusion among almost 150 biliary tract cancers and none in nearly 300 pancreatic adenocarcinomas.

Lead author Anne Demols, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, CUB Hôpital Erasme, Brussels, Belgium, said the results show that, “consistent” with their low frequency in solid tumors, NTRK gene fusions are “also rare” in biliopancreatic cancers.

“Given this low frequency, testing and identification are of high clinical importance, due to possible treatment with pan-TRK inhibitors,” she said.

She added that a two-step diagnosis is recommended, in that it is both “time saving” and economical, and that next-generation sequencing is “mandatory” to confirm a positive result on IHC.

For discussant Juan W. Valle, MD, professor of medical oncology at the University of Manchester, United Kingdom, the results of the second study reinforce the take-home message of the first.

He said that “two-step diagnosis can preselect patients suitable for next-generation sequencing assay, and what we saw from the previous [study] is that the therapeutic implications make this an important diagnosis.”

Valle noted that there is an “immortal time bias” in the trial analysis, because patients had to be well enough to undergo at least 6 months of follow-up, and that “future work will focus on the best platform to use for known, as well as the identification of new, fusion partners.”

He highlighted the “improved response rate and progression-free survival” achieved with entrectinib among patients with gastrointestinal cancers harboring NTRK fusions, which will benefit patient outcomes.

Pashtoon Kasi, MD, a gastrointestinal oncologist at the University of Iowa Holden Comprehensive Cancer Center, Iowa City, commented on Twitter that, for him, the results were more than just about the impressive response rate but how “brisk, robust, and durable these tend to be.”

In his experience, even patients with stage IV disease who have responded to entrectinib have been able to undergo “secondary ‘curative’ resections.”

The ALKA-372-001, STARTRK-1 and STARTRK-2 studies were sponsored by F. Hoffmann-La Roche. The study by Demols and colleagues was funded by a research grant from Bayer Health. Dr. Patel reports relationships with Nektar Therapeutic, MSD, and Fate Therapeutics. Demols reports relationships with Bayer, Ipsen, Vifor, Servier and Roche. Dr. Valle reports relationships with numerous companies.

This article first appeared on Medscape.com.

Although fusions in the neurotrophic receptor tyrosine kinase (NTRK) gene are rare in gastrointestinal carcinomas (found in fewer than 5% of cases), they should be looked for, inasmuch as treatment with the TRK inhibitor entrectinib (Rozlytrek, Genentech/Roche) can achieve robust and durable responses, say researchers.

This point was made during several presentations at the virtual World Conference on Gastrointestinal Cancer (WCGC) 2020 on July 1.

Entrectinib and similar agents that act on NTRK fusion genes are described as tumor agnostic, in that they are biomarkers that define the cancer rather than the organ of origin.

The Food and Drug Administration last year granted accelerated approval of entrectinib for patients with locally advanced or metastatic NTRK-expressing solid tumors that have progressed following prior therapies. The drug can also be used as a first-line treatment when there are no effective therapies.

At the meeting, Manish R. Patel, MD, Department of Medicine, University of Minnesota, Minneapolis, and colleagues presented combined results from the ALKA-372-001, STARTRK-1, and STARTRK-2 studies of entrectinib.

They identified 12 gastrointestinal carcinoma patients among 74 adults with locally advanced/metastatic NTRK fusion positive, TRK inhibitor-naive solid tumors who had undergone at least 6 months of follow-up.

Many of these 12 patients had colorectal cancer (58%) or pancreatic cancer (24%).

Treatment with entrectinib elicited an overall response rate of 50%, which consisted entirely of partial responses.

The median duration of response was 12.9 months, which was largely driven by a median duration of response of 15.1 months among colorectal cancer patients, vs 10.0 months among pancreatic cancer patients and 9.3 months in the patient with cholangiocarcinoma.

The median progression-free survival was 7.1 months across the whole cohort. It was 8.0 months for pancreatic cancer patients and 12.0 months for the patient with cholangiocarcinoma.

The median overall survival was 16 months.

Dr. Patel said that this “demonstrates that entrectinib induces durable and clinically meaningful systemic responses in patients with gastrointestinal carcinomas harboring NTRK fusions.”

He noted that entrectinib is “overall very well tolerated, with very few dose interruptions or reductions, and the discontinuation rate was very low.” The majority of adverse events were of grade 1/2. The most common event was change in taste, which occurred in 37.3% of patients. There were no treatment-related deaths.

“The main take-away point from this abstract is that, though they are rare, if we identify patients with NTRK fusions during the course of the disease, we can offer them benefit from entrectinib, and I would argue that ... we should be screening patients for NTRK fusions much more frequently,” Dr. Patel added.

In the second study, a Belgian team performed immunohistochemistry (IHC) analysis followed by next-generation sequencing on archived samples of biliopancreatic cancers to determine the prevalence of NTRK fusions.

They found just one fusion among almost 150 biliary tract cancers and none in nearly 300 pancreatic adenocarcinomas.

Lead author Anne Demols, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, CUB Hôpital Erasme, Brussels, Belgium, said the results show that, “consistent” with their low frequency in solid tumors, NTRK gene fusions are “also rare” in biliopancreatic cancers.

“Given this low frequency, testing and identification are of high clinical importance, due to possible treatment with pan-TRK inhibitors,” she said.

She added that a two-step diagnosis is recommended, in that it is both “time saving” and economical, and that next-generation sequencing is “mandatory” to confirm a positive result on IHC.

For discussant Juan W. Valle, MD, professor of medical oncology at the University of Manchester, United Kingdom, the results of the second study reinforce the take-home message of the first.

He said that “two-step diagnosis can preselect patients suitable for next-generation sequencing assay, and what we saw from the previous [study] is that the therapeutic implications make this an important diagnosis.”

Valle noted that there is an “immortal time bias” in the trial analysis, because patients had to be well enough to undergo at least 6 months of follow-up, and that “future work will focus on the best platform to use for known, as well as the identification of new, fusion partners.”

He highlighted the “improved response rate and progression-free survival” achieved with entrectinib among patients with gastrointestinal cancers harboring NTRK fusions, which will benefit patient outcomes.

Pashtoon Kasi, MD, a gastrointestinal oncologist at the University of Iowa Holden Comprehensive Cancer Center, Iowa City, commented on Twitter that, for him, the results were more than just about the impressive response rate but how “brisk, robust, and durable these tend to be.”

In his experience, even patients with stage IV disease who have responded to entrectinib have been able to undergo “secondary ‘curative’ resections.”

The ALKA-372-001, STARTRK-1 and STARTRK-2 studies were sponsored by F. Hoffmann-La Roche. The study by Demols and colleagues was funded by a research grant from Bayer Health. Dr. Patel reports relationships with Nektar Therapeutic, MSD, and Fate Therapeutics. Demols reports relationships with Bayer, Ipsen, Vifor, Servier and Roche. Dr. Valle reports relationships with numerous companies.

This article first appeared on Medscape.com.

Although fusions in the neurotrophic receptor tyrosine kinase (NTRK) gene are rare in gastrointestinal carcinomas (found in fewer than 5% of cases), they should be looked for, inasmuch as treatment with the TRK inhibitor entrectinib (Rozlytrek, Genentech/Roche) can achieve robust and durable responses, say researchers.

This point was made during several presentations at the virtual World Conference on Gastrointestinal Cancer (WCGC) 2020 on July 1.

Entrectinib and similar agents that act on NTRK fusion genes are described as tumor agnostic, in that they are biomarkers that define the cancer rather than the organ of origin.

The Food and Drug Administration last year granted accelerated approval of entrectinib for patients with locally advanced or metastatic NTRK-expressing solid tumors that have progressed following prior therapies. The drug can also be used as a first-line treatment when there are no effective therapies.

At the meeting, Manish R. Patel, MD, Department of Medicine, University of Minnesota, Minneapolis, and colleagues presented combined results from the ALKA-372-001, STARTRK-1, and STARTRK-2 studies of entrectinib.

They identified 12 gastrointestinal carcinoma patients among 74 adults with locally advanced/metastatic NTRK fusion positive, TRK inhibitor-naive solid tumors who had undergone at least 6 months of follow-up.

Many of these 12 patients had colorectal cancer (58%) or pancreatic cancer (24%).

Treatment with entrectinib elicited an overall response rate of 50%, which consisted entirely of partial responses.

The median duration of response was 12.9 months, which was largely driven by a median duration of response of 15.1 months among colorectal cancer patients, vs 10.0 months among pancreatic cancer patients and 9.3 months in the patient with cholangiocarcinoma.

The median progression-free survival was 7.1 months across the whole cohort. It was 8.0 months for pancreatic cancer patients and 12.0 months for the patient with cholangiocarcinoma.

The median overall survival was 16 months.

Dr. Patel said that this “demonstrates that entrectinib induces durable and clinically meaningful systemic responses in patients with gastrointestinal carcinomas harboring NTRK fusions.”

He noted that entrectinib is “overall very well tolerated, with very few dose interruptions or reductions, and the discontinuation rate was very low.” The majority of adverse events were of grade 1/2. The most common event was change in taste, which occurred in 37.3% of patients. There were no treatment-related deaths.

“The main take-away point from this abstract is that, though they are rare, if we identify patients with NTRK fusions during the course of the disease, we can offer them benefit from entrectinib, and I would argue that ... we should be screening patients for NTRK fusions much more frequently,” Dr. Patel added.

In the second study, a Belgian team performed immunohistochemistry (IHC) analysis followed by next-generation sequencing on archived samples of biliopancreatic cancers to determine the prevalence of NTRK fusions.

They found just one fusion among almost 150 biliary tract cancers and none in nearly 300 pancreatic adenocarcinomas.

Lead author Anne Demols, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, CUB Hôpital Erasme, Brussels, Belgium, said the results show that, “consistent” with their low frequency in solid tumors, NTRK gene fusions are “also rare” in biliopancreatic cancers.

“Given this low frequency, testing and identification are of high clinical importance, due to possible treatment with pan-TRK inhibitors,” she said.

She added that a two-step diagnosis is recommended, in that it is both “time saving” and economical, and that next-generation sequencing is “mandatory” to confirm a positive result on IHC.

For discussant Juan W. Valle, MD, professor of medical oncology at the University of Manchester, United Kingdom, the results of the second study reinforce the take-home message of the first.

He said that “two-step diagnosis can preselect patients suitable for next-generation sequencing assay, and what we saw from the previous [study] is that the therapeutic implications make this an important diagnosis.”

Valle noted that there is an “immortal time bias” in the trial analysis, because patients had to be well enough to undergo at least 6 months of follow-up, and that “future work will focus on the best platform to use for known, as well as the identification of new, fusion partners.”

He highlighted the “improved response rate and progression-free survival” achieved with entrectinib among patients with gastrointestinal cancers harboring NTRK fusions, which will benefit patient outcomes.

Pashtoon Kasi, MD, a gastrointestinal oncologist at the University of Iowa Holden Comprehensive Cancer Center, Iowa City, commented on Twitter that, for him, the results were more than just about the impressive response rate but how “brisk, robust, and durable these tend to be.”

In his experience, even patients with stage IV disease who have responded to entrectinib have been able to undergo “secondary ‘curative’ resections.”

The ALKA-372-001, STARTRK-1 and STARTRK-2 studies were sponsored by F. Hoffmann-La Roche. The study by Demols and colleagues was funded by a research grant from Bayer Health. Dr. Patel reports relationships with Nektar Therapeutic, MSD, and Fate Therapeutics. Demols reports relationships with Bayer, Ipsen, Vifor, Servier and Roche. Dr. Valle reports relationships with numerous companies.

This article first appeared on Medscape.com.

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Radiomics, a growing area of cancer research that extracts noninvasive biomarkers from medical imaging, may be able to improve lung cancer screening by identifying patients with early stage disease at high risk for poorer outcomes.

This is the conclusion from a group of researchers who used data from the National Lung Screening Trial (NLST) to develop and validate a model based on radiomics that could identify a vulnerable high-risk group of early stage patients associated with poor outcomes. These patients would generally require aggressive follow-up and/or adjuvant therapy.

The study was published June 29 in Nature Scientific Reports.

Radiomics, also known as quantitative image features, are noninvasive biomarkers that are generated from medical imaging. An emerging translational field of research, radiomics extracts large amounts of features from radiographic medical images using data-characterization algorithms, which reflect the underlying tumor pathophysiology and heterogeneity.

The authors note that radiomics has many advantages over circulating and tissue-based biomarkers, as these quantitative image features are rapidly calculated from standard-of-care imaging and reflect the entire tumor burden – and not just a sample as is the case with tissue-based biomarkers.

“We view radiomics as a decision support tool across the cancer control continuum, whether it be screening and early detection, diagnosis, prognostication, or treatment response,” said lead author Matthew B. Schabath, PhD, associate member in cancer epidemiology at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida.

“Radiomic features are generated from standard-of-care imaging and validated radiomic models can provide real-time decision support information to clinicians,” he explained.

Last year, another study showed that combining radiomics and imaging may be able to determine which patients with lung cancer were most likely to respond to chemotherapy. The researchers used CT imaging of radiomic features from within and outside the lung nodule and found it could predict time to progression and overall survival, as well as response to chemotherapy, in patients with non–small cell lung cancer (NSCLC).

Anant Madabhushi, PhD, a professor of biomedical engineering and director of the Center for Computational Imaging and Personalized Diagnostics at Case Western Reserve University, Cleveland, commented that the new study is “complementary and supports the premise that radiomics both from inside and outside the tumor can tell us about outcome and treatment response.”

Dr. Madabhushi also noted his group has released several other studies along similar lines, including a study showing how radiomics can predict the benefit of adjuvant therapy in lung cancer, a study showing how radiomics can predict recurrence in early stage NSCLC, and a study showing that radiomics can predict survival and response to immunotherapy in NSCLC.

Improving current lung cancer screening

The landmark NLST showed that, as compared with chest x-rays, low-dose helical computed tomography (LDCT) was associated with a 20% relative reduction in lung cancer mortality in high-risk individuals. However, LDCT screening can lead to overdiagnosis and subsequent overtreatment of slow-growing, indolent cancers.

“Current lung cancer screening inclusion criteria in the US are largely based on the criteria used in the NLST,” Dr. Schabath told Medscape Medical News. “Though the NLST clearly demonstrated that screening LDCT is a lifesaving tool, the NLST was not designed to create public policy.”

He pointed out that fewer than 30% of Americans diagnosed with lung cancer meet the current screening entry criteria and that subsequent trials (e.g., NELSON, LUSI, or MILD) used broader and more inclusive criteria and also showed the efficacy of LDCT for early detection of lung cancer. “Thus, there should be consideration in making the lung cancer screening guidelines more inclusive,” said Dr. Schabath.

“Additionally, adjunct risk-stratification tools, such as blood-based biomarkers, could be an important complement to determine who should be part of a lung cancer screening program,” he said. “This could be particularly salient for people who have no or very few risk factors, such as never smokers.”

Pinpointing poor outcomes

In the current study, Dr. Schabath and colleagues used publicly available data and LDCT images from the NLST to generate radiomic features from screen detected, incidentally-diagnosed lung cancers. Radiomic features describing size, shape, volume, and textural characteristics were then calculated from both the intratumoral and peritumoral regions.

Patients were divided into training and test cohorts, and an external cohort of non-screen-detected lung cancer patients was used for further validation. There were no statistically significant differences between training and test cohorts for most demographics, including age, sex, smoking status, number of pack-years smoked, treatment, stage, and baseline screening result. However, self-reported chronic obstructive pulmonary disease (COPD) was significantly higher in the test cohort compared with the training group (16% vs. 7%; P = .02).

A total of 91 stable and reproducible radiomics features (peritumoral and intratumoral) were identified and 40 (26 peritumoral and 14 intratumoral) were significantly associated with overall survival in the training cohort. The features were subsequently narrowed to four, and backward elimination analyses identified a single model. Patients were then stratified into three risk-groups: low risk, intermediate risk, and high risk.

According to their model, the high-risk group had worse overall survival (hazard ratio, 9.91; 25% 2.5-year and 0% 5-year OS) as compared with the low-risk group (HR, 1.00; 93% 2.5-year and 78% 5-year OS).

The final model was validated in the test group and then replicated in the non–screen-detected patients with adenocarcinoma patients. Since the disease stage differed significantly across the risk groups, the model was stratified by stage and the authors found “compelling” results among early-stage patients, who generally have good outcomes. In this subset, the high-risk group was associated with a worse overall survival (HR, 2.63; 56% 2.5-year and 42% 5-year OS) vs. the low-risk group (HR, 1.00; 75% 2.5-year and 75% 5-year OS).

“We have ongoing studies to determine if these results are consistent in the real-world setting of lung cancer screening across multiple centers,” said Dr. Schabath. “If the NELSON, LUSI, or MILD trial data become publicly available, we will certainly pursue validating our results in those clinical trials.”

The study was funded by the National Cancer Institute. Dr. Schabath and Dr. Madabhushi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.