A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

[email protected]

A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

[email protected]

A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.

After classifying 68 patients into one of four obesity phenotypes through a series of tests and then tailoring drug treatment to the identified phenotype of each patient, researchers observed a 79% rate of greater than 10% weight loss versus baseline after 12 months. In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.

The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.

A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”

Personalized weight loss treatment isn’t new

“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.

The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.

The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.

Four obesity phenotypes

The researchers categorized patients into one of four types:

• Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
• Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
• “Emotional hunger,” assessed with two questionnaires.
• Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.

Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.

The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.

Phenotype-guided treatments

They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m².

The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.

The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).

Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.

“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”

“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?

“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.

[email protected]

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

On Dec. 1, the Centers for Medicare & Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule, which finalized proposed changes to Medicare reimbursement rates, including a significant negative budget neutrality adjustment. For hospitalists, the Society of Hospital Medicine estimates that the adjustment will amount to an estimated 8% reduction in Medicare reimbursement rates, which will go into effect on Jan. 1, 2021.

“These cuts are coming at the exact wrong time. During the chaos of 2020, when hospitalists have been essential to responding to the COVID-19 pandemic, they should not be met with a significant pay reduction in 2021,” said Eric E. Howell, MD, MHM, chief executive officer of the Society of Hospital Medicine. “While we at SHM support increasing pay for outpatient primary care, which is driving these cuts, we do not believe now is the right time to make significant adjustments to the Medicare Physician Fee Schedule. We now call on Congress to do the right thing for hospitalists and other frontline providers who have otherwise been lauded as heroes.”

SHM will continue to fight for hospitalists and to advocate to reverse these cuts. To send a message of support to your representatives, visit SHM’s Legislative Action Center and click on “Support the Holding Providers Harmless from Medicare Cuts During COVID-19 Act of 2020.” To learn more about and become involved with SHM’s advocacy efforts, visit hospitalmedicine.org/advocacy.

As I write this, we are entering the third surge of the COVID-19 pandemic, with new cases, hospitalizations, and deaths from COVID-19 skyrocketing around the country. Worst of all, this surge has been most severely affecting areas of the nation least prepared to handle it (rural) and populations already marginalized by the health care system (Latinx and Black). Despite the onslaught of COVID-19, “pandemic fatigue” has begun to set in amongst colleagues, friends, and family, leading to challenges in adhering to social distancing and other infection-control measures, both at work and home.

Royal Geographic Society, public domain, via Wikimedia Commons

In the face of the pandemic’s onslaught, hospitalists – who have faced the brunt of caring for patients with COVID-19, despite the absence of reporting about the subspecialty’s role – are faced with mustering the grit to respond with resolve, coordinated action, and empathy. Luckily, hospitalists are equipped with the very characteristics needed to lead teams, groups, and hospitals through the crisis of this pandemic. Ask yourself, why did you become a hospitalist? If you wanted steady predictability and control, there were many office-based specialties you could have chosen. You chose to become a hospitalist because you seek the challenges of clinical variety, problem-solving, systems improvement, and you are a natural team leader, whether you have been designated as such or not. In the words of John Quincy Adams, “if your actions inspire others to dream more, learn more, do more, and become more, you are a leader.”

As a leader, how can you lead your team through the series of trials and tribulations that this year has thrown at you? From COVID-19 to racism directed against Black and Latinx people to the behavioral health crisis, 2020 has likely made you feel as if you’re stuck in a ghoulish carnival fun house without an exit.

Yet this is where some leaders hit their stride, in what Bennis and Thomas describe as the “crucible of leadership.”¹ There are many types of “crucibles of leadership,” according to Bennis and Thomas, and this year has thrown most of these at us: prejudice/bias, physical fatigue and illness, sudden elevation of responsibility to lead new processes, not to mention family stressors. Leaders who succeed in guiding their colleagues through these challenges have manifested critical skills: engaging others in shared meaning, having a distinctive and compelling voice, displaying integrity, and having adaptive capacity.

What exactly is adaptive capacity, the most important of these, in my opinion? Adaptive capacity requires understanding the new context of a crisis and how it has shifted team members’ needs and perceptions. It also requires what Bennis and Thomas call hardiness and what I call grit – the ability to face adversity, get knocked down, get up, and do it again.

There is probably no better example of a crisis leader with extraordinary adaptive capacity than Anglo-Irish explorer Sir Ernest Shackleton. Bitten by the bug of exploration, Shackleton failed at reaching the South Pole (1908-1909) but subsequently attempted to cross the Antarctic, departing South Georgia Island on Dec. 5, 1914. Depressingly for Shackleton, his ship, the Endurance, became stuck in sea ice on Jan. 19, 1915 before even reaching the continent. Drifting with the ice floe, his crew had set up a winter station hoping to be released from the ice later, but the Endurance was crushed by the pressure of sea ice and sank on Nov. 21, 1915. From there, Shackleton hoped to drift north to Paulet Island, 250 miles away, but eventually was forced to take his crew on lifeboats to the nearest land, Elephant Island, 346 miles from where the Endurance sank. He then took five of his men on an open boat, 828-mile journey to South Georgia Island. Encountering hurricane-force winds, the team landed on South Georgia Island 15 days later, only to face a climb of 32 miles over mountainous terrain to reach a whaling station. Shackleton eventually organized his men’s rescue on Elephant Island, reaching them on Aug. 30, 1916, 4½ months after he had set out for South Georgia Island. His entire crew survived, only to have two of them killed later in World War I.

You might consider Shackleton a failure for not even coming close to his original goal, but his success in saving his crew is regarded as the epitome of crisis leadership. As Harvard Business School professor Nancy F. Koehn, PhD, whose case study of Shackleton is one of the most popular at HBS, stated, “He thought he was going to be an entrepreneur of exploration, but he became an entrepreneur of survival.”² Upon realizing the futility of his original mission, he pivoted immediately to the survival of his crew. “A man must shape himself to a new mark directly the old one goes to ground,” wrote Shackleton in his diary.³

Realizing that preserving his crew’s morale was critical, he maintained the crew’s everyday activities, despite the prospect of dying on the ice. He realized that he needed to keep up his own courage and confidence as well as that of his crew. Despite his ability to share the strategic focus of getting to safety with his men, he didn’t lose sight of day-to-day needs, such as keeping the crew entertained. When he encountered crew members who seemed problematic to his mission goals, he assigned them to his own tent.

Despite the extreme cold, his decision-making did not freeze – he acted decisively. He took risks when he thought appropriate, twice needing to abandon his efforts to drag a lifeboat full of supplies with his men toward the sea. “You can’t be afraid to make smart mistakes,” says Dr. Koehn. “That’s something we have no training in.”⁴ Most importantly, Shackleton took ultimate responsibility for his men’s survival, never resting until they had all been rescued. And he modeled a culture of shared responsibility for one another⁵ – he had once offered his only biscuit of the day on a prior expedition to his fellow explorer Frank Wild.

As winter arrives in 2020 and deepens into 2021, we will all be faced with leading our teams across the ice and to the safety of spring, and hopefully a vaccine. Whether we can get there with our entire crew depends on effective crisis leadership. But we can draw on the lessons provided by Shackleton and other crisis leaders in the past to guide us in the present.

Author disclosure: I studied the HBS case study “Leadership in Crisis: Ernest Shackleton and the Epic Voyage of the Endurance” as part of a 12-month certificate course in Safety, Quality, Informatics, and Leadership (SQIL) offered by Harvard Medical School.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. HBR’s 10 must reads on leadership. Boston: Harvard Business Review Press, 2011.

2. Lagace M. Shackleton: An entrepreneur of survival. Harvard Business School. Working Knowledge website. Published 2003. Accessed 2020 Nov 19.

3. Koehn N. Leadership lessons from the Shackleton Expedition. The New York Times. 2011 Dec 25.

4. Potier B. Shackleton in business school. Harvard Public Affairs and Communications. The Harvard Gazette website. Published 2004. Accessed 2020 Nov 19.

5. Perkins D. 4 Lessons in crisis leadership from Shackleton’s expedition. In Leadership Essentials by HarpersCollins Leadership. Vol 2020. New York: HarpersCollins, 2020.

As I write this, we are entering the third surge of the COVID-19 pandemic, with new cases, hospitalizations, and deaths from COVID-19 skyrocketing around the country. Worst of all, this surge has been most severely affecting areas of the nation least prepared to handle it (rural) and populations already marginalized by the health care system (Latinx and Black). Despite the onslaught of COVID-19, “pandemic fatigue” has begun to set in amongst colleagues, friends, and family, leading to challenges in adhering to social distancing and other infection-control measures, both at work and home.

Royal Geographic Society, public domain, via Wikimedia Commons

In the face of the pandemic’s onslaught, hospitalists – who have faced the brunt of caring for patients with COVID-19, despite the absence of reporting about the subspecialty’s role – are faced with mustering the grit to respond with resolve, coordinated action, and empathy. Luckily, hospitalists are equipped with the very characteristics needed to lead teams, groups, and hospitals through the crisis of this pandemic. Ask yourself, why did you become a hospitalist? If you wanted steady predictability and control, there were many office-based specialties you could have chosen. You chose to become a hospitalist because you seek the challenges of clinical variety, problem-solving, systems improvement, and you are a natural team leader, whether you have been designated as such or not. In the words of John Quincy Adams, “if your actions inspire others to dream more, learn more, do more, and become more, you are a leader.”

As a leader, how can you lead your team through the series of trials and tribulations that this year has thrown at you? From COVID-19 to racism directed against Black and Latinx people to the behavioral health crisis, 2020 has likely made you feel as if you’re stuck in a ghoulish carnival fun house without an exit.

Yet this is where some leaders hit their stride, in what Bennis and Thomas describe as the “crucible of leadership.”¹ There are many types of “crucibles of leadership,” according to Bennis and Thomas, and this year has thrown most of these at us: prejudice/bias, physical fatigue and illness, sudden elevation of responsibility to lead new processes, not to mention family stressors. Leaders who succeed in guiding their colleagues through these challenges have manifested critical skills: engaging others in shared meaning, having a distinctive and compelling voice, displaying integrity, and having adaptive capacity.

What exactly is adaptive capacity, the most important of these, in my opinion? Adaptive capacity requires understanding the new context of a crisis and how it has shifted team members’ needs and perceptions. It also requires what Bennis and Thomas call hardiness and what I call grit – the ability to face adversity, get knocked down, get up, and do it again.

There is probably no better example of a crisis leader with extraordinary adaptive capacity than Anglo-Irish explorer Sir Ernest Shackleton. Bitten by the bug of exploration, Shackleton failed at reaching the South Pole (1908-1909) but subsequently attempted to cross the Antarctic, departing South Georgia Island on Dec. 5, 1914. Depressingly for Shackleton, his ship, the Endurance, became stuck in sea ice on Jan. 19, 1915 before even reaching the continent. Drifting with the ice floe, his crew had set up a winter station hoping to be released from the ice later, but the Endurance was crushed by the pressure of sea ice and sank on Nov. 21, 1915. From there, Shackleton hoped to drift north to Paulet Island, 250 miles away, but eventually was forced to take his crew on lifeboats to the nearest land, Elephant Island, 346 miles from where the Endurance sank. He then took five of his men on an open boat, 828-mile journey to South Georgia Island. Encountering hurricane-force winds, the team landed on South Georgia Island 15 days later, only to face a climb of 32 miles over mountainous terrain to reach a whaling station. Shackleton eventually organized his men’s rescue on Elephant Island, reaching them on Aug. 30, 1916, 4½ months after he had set out for South Georgia Island. His entire crew survived, only to have two of them killed later in World War I.

You might consider Shackleton a failure for not even coming close to his original goal, but his success in saving his crew is regarded as the epitome of crisis leadership. As Harvard Business School professor Nancy F. Koehn, PhD, whose case study of Shackleton is one of the most popular at HBS, stated, “He thought he was going to be an entrepreneur of exploration, but he became an entrepreneur of survival.”² Upon realizing the futility of his original mission, he pivoted immediately to the survival of his crew. “A man must shape himself to a new mark directly the old one goes to ground,” wrote Shackleton in his diary.³

Realizing that preserving his crew’s morale was critical, he maintained the crew’s everyday activities, despite the prospect of dying on the ice. He realized that he needed to keep up his own courage and confidence as well as that of his crew. Despite his ability to share the strategic focus of getting to safety with his men, he didn’t lose sight of day-to-day needs, such as keeping the crew entertained. When he encountered crew members who seemed problematic to his mission goals, he assigned them to his own tent.

Despite the extreme cold, his decision-making did not freeze – he acted decisively. He took risks when he thought appropriate, twice needing to abandon his efforts to drag a lifeboat full of supplies with his men toward the sea. “You can’t be afraid to make smart mistakes,” says Dr. Koehn. “That’s something we have no training in.”⁴ Most importantly, Shackleton took ultimate responsibility for his men’s survival, never resting until they had all been rescued. And he modeled a culture of shared responsibility for one another⁵ – he had once offered his only biscuit of the day on a prior expedition to his fellow explorer Frank Wild.

As winter arrives in 2020 and deepens into 2021, we will all be faced with leading our teams across the ice and to the safety of spring, and hopefully a vaccine. Whether we can get there with our entire crew depends on effective crisis leadership. But we can draw on the lessons provided by Shackleton and other crisis leaders in the past to guide us in the present.

Author disclosure: I studied the HBS case study “Leadership in Crisis: Ernest Shackleton and the Epic Voyage of the Endurance” as part of a 12-month certificate course in Safety, Quality, Informatics, and Leadership (SQIL) offered by Harvard Medical School.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. HBR’s 10 must reads on leadership. Boston: Harvard Business Review Press, 2011.

2. Lagace M. Shackleton: An entrepreneur of survival. Harvard Business School. Working Knowledge website. Published 2003. Accessed 2020 Nov 19.

3. Koehn N. Leadership lessons from the Shackleton Expedition. The New York Times. 2011 Dec 25.

4. Potier B. Shackleton in business school. Harvard Public Affairs and Communications. The Harvard Gazette website. Published 2004. Accessed 2020 Nov 19.

5. Perkins D. 4 Lessons in crisis leadership from Shackleton’s expedition. In Leadership Essentials by HarpersCollins Leadership. Vol 2020. New York: HarpersCollins, 2020.

As I write this, we are entering the third surge of the COVID-19 pandemic, with new cases, hospitalizations, and deaths from COVID-19 skyrocketing around the country. Worst of all, this surge has been most severely affecting areas of the nation least prepared to handle it (rural) and populations already marginalized by the health care system (Latinx and Black). Despite the onslaught of COVID-19, “pandemic fatigue” has begun to set in amongst colleagues, friends, and family, leading to challenges in adhering to social distancing and other infection-control measures, both at work and home.

Royal Geographic Society, public domain, via Wikimedia Commons

In the face of the pandemic’s onslaught, hospitalists – who have faced the brunt of caring for patients with COVID-19, despite the absence of reporting about the subspecialty’s role – are faced with mustering the grit to respond with resolve, coordinated action, and empathy. Luckily, hospitalists are equipped with the very characteristics needed to lead teams, groups, and hospitals through the crisis of this pandemic. Ask yourself, why did you become a hospitalist? If you wanted steady predictability and control, there were many office-based specialties you could have chosen. You chose to become a hospitalist because you seek the challenges of clinical variety, problem-solving, systems improvement, and you are a natural team leader, whether you have been designated as such or not. In the words of John Quincy Adams, “if your actions inspire others to dream more, learn more, do more, and become more, you are a leader.”

As a leader, how can you lead your team through the series of trials and tribulations that this year has thrown at you? From COVID-19 to racism directed against Black and Latinx people to the behavioral health crisis, 2020 has likely made you feel as if you’re stuck in a ghoulish carnival fun house without an exit.

Yet this is where some leaders hit their stride, in what Bennis and Thomas describe as the “crucible of leadership.”¹ There are many types of “crucibles of leadership,” according to Bennis and Thomas, and this year has thrown most of these at us: prejudice/bias, physical fatigue and illness, sudden elevation of responsibility to lead new processes, not to mention family stressors. Leaders who succeed in guiding their colleagues through these challenges have manifested critical skills: engaging others in shared meaning, having a distinctive and compelling voice, displaying integrity, and having adaptive capacity.

What exactly is adaptive capacity, the most important of these, in my opinion? Adaptive capacity requires understanding the new context of a crisis and how it has shifted team members’ needs and perceptions. It also requires what Bennis and Thomas call hardiness and what I call grit – the ability to face adversity, get knocked down, get up, and do it again.

There is probably no better example of a crisis leader with extraordinary adaptive capacity than Anglo-Irish explorer Sir Ernest Shackleton. Bitten by the bug of exploration, Shackleton failed at reaching the South Pole (1908-1909) but subsequently attempted to cross the Antarctic, departing South Georgia Island on Dec. 5, 1914. Depressingly for Shackleton, his ship, the Endurance, became stuck in sea ice on Jan. 19, 1915 before even reaching the continent. Drifting with the ice floe, his crew had set up a winter station hoping to be released from the ice later, but the Endurance was crushed by the pressure of sea ice and sank on Nov. 21, 1915. From there, Shackleton hoped to drift north to Paulet Island, 250 miles away, but eventually was forced to take his crew on lifeboats to the nearest land, Elephant Island, 346 miles from where the Endurance sank. He then took five of his men on an open boat, 828-mile journey to South Georgia Island. Encountering hurricane-force winds, the team landed on South Georgia Island 15 days later, only to face a climb of 32 miles over mountainous terrain to reach a whaling station. Shackleton eventually organized his men’s rescue on Elephant Island, reaching them on Aug. 30, 1916, 4½ months after he had set out for South Georgia Island. His entire crew survived, only to have two of them killed later in World War I.

You might consider Shackleton a failure for not even coming close to his original goal, but his success in saving his crew is regarded as the epitome of crisis leadership. As Harvard Business School professor Nancy F. Koehn, PhD, whose case study of Shackleton is one of the most popular at HBS, stated, “He thought he was going to be an entrepreneur of exploration, but he became an entrepreneur of survival.”² Upon realizing the futility of his original mission, he pivoted immediately to the survival of his crew. “A man must shape himself to a new mark directly the old one goes to ground,” wrote Shackleton in his diary.³

Realizing that preserving his crew’s morale was critical, he maintained the crew’s everyday activities, despite the prospect of dying on the ice. He realized that he needed to keep up his own courage and confidence as well as that of his crew. Despite his ability to share the strategic focus of getting to safety with his men, he didn’t lose sight of day-to-day needs, such as keeping the crew entertained. When he encountered crew members who seemed problematic to his mission goals, he assigned them to his own tent.

Despite the extreme cold, his decision-making did not freeze – he acted decisively. He took risks when he thought appropriate, twice needing to abandon his efforts to drag a lifeboat full of supplies with his men toward the sea. “You can’t be afraid to make smart mistakes,” says Dr. Koehn. “That’s something we have no training in.”⁴ Most importantly, Shackleton took ultimate responsibility for his men’s survival, never resting until they had all been rescued. And he modeled a culture of shared responsibility for one another⁵ – he had once offered his only biscuit of the day on a prior expedition to his fellow explorer Frank Wild.

As winter arrives in 2020 and deepens into 2021, we will all be faced with leading our teams across the ice and to the safety of spring, and hopefully a vaccine. Whether we can get there with our entire crew depends on effective crisis leadership. But we can draw on the lessons provided by Shackleton and other crisis leaders in the past to guide us in the present.

Author disclosure: I studied the HBS case study “Leadership in Crisis: Ernest Shackleton and the Epic Voyage of the Endurance” as part of a 12-month certificate course in Safety, Quality, Informatics, and Leadership (SQIL) offered by Harvard Medical School.
 

Dr. Chang is chief of pediatric hospital medicine at Baystate Children’s Hospital in Springfield, Mass., and associate professor of pediatrics at the University of Massachusetts, also in Springfield.

References

1. HBR’s 10 must reads on leadership. Boston: Harvard Business Review Press, 2011.

2. Lagace M. Shackleton: An entrepreneur of survival. Harvard Business School. Working Knowledge website. Published 2003. Accessed 2020 Nov 19.

3. Koehn N. Leadership lessons from the Shackleton Expedition. The New York Times. 2011 Dec 25.

4. Potier B. Shackleton in business school. Harvard Public Affairs and Communications. The Harvard Gazette website. Published 2004. Accessed 2020 Nov 19.

5. Perkins D. 4 Lessons in crisis leadership from Shackleton’s expedition. In Leadership Essentials by HarpersCollins Leadership. Vol 2020. New York: HarpersCollins, 2020.

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

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

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

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

Every Wednesday evening after supper, I record in a marble notebook some anthropomorphic measurements: my weight taken first thing Monday morning and my waist circumference. I also add how I did with exercise since the previous week’s entry and some comments about sleep, energy, and nutrition.

My personal log now comprises dozens of pages. To my surprise, the first entry was 5 years ago to the month. The earlier entries were far from weekly and contained a lot of narrative on how my food-restriction scheme that month was being violated.

Looking just at the numbers, I did about as well as a control group participant in any medical study of diet modification. Until just a few months ago, there was no trend in either weight or waist circumference over those 5 years, including 2 years of retirement. But it wasn’t for lack of trying. Keeping the journal for as long as I have – and recently, as consistently as I have – suggests serious intent but inadequate execution of the same principles I offered patients, who rarely did much better. But recent studies suggest that perhaps quite a few could.
 

Are we underestimating our patients’ potential?

A recent abstract from the European and International Congress on Obesity suggests that the impressions clinicians get from our office encounters may leave us underestimating the potential for our patients to lose enough weight to move them from one level of risk to another.

Using a national database of primary care visits, the investigators isolated about 550,000 records. Of these, about 60,000 (11%) had records showing weight reductions of 10%-25% (mean, 13%) over at least 4 years. Weight loss was by intent rather than from illness. The remaining individuals maintained their weight within 5% of the first measurement for the duration of the study.

Participants with stable body weight were compared with the successful weight reducers. This analysis showed that the risk for type 2 diabetes, osteoarthritis, sleep apnea, hypertension, and dyslipidemia all measurably declined in weight reducers. This held true whether the patient’s baseline body mass index (BMI) showed modest or severe obesity. Patients with the highest BMI at enrollment actually reduced their risks for hypertension and dyslipidemia below population norms.

This study raises tantalizing, as yet unanswered questions: How did the successful 11% achieve their weight loss goals? Was it via a weight loss program, bariatric surgery, dietitian consult, or with no external assistance?

And of great significance to clinicians: What happened to the people who achieved 5%-10% weight reduction, as that is a more typical outcome of diabetes prevention trials or studies of weight-loss medications? Were they excluded from the study because they did not lose enough weight to achieve the unequivocal health benefit?

Because the data came from an enormous database, the weight management strategies leading to success or failure – what we really need to know to nudge our own patients into the favorable categories – remain hidden.
 

The Advantage of Intensive Interventions

Some answers emerged from a recently reported study in the New England Journal of Medicine comparing supervised diet and lifestyle adjustments (treatment group) with the less intense oversight typically offered by primary care clinicians (usual-care group).

The treatment group not only received the intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, but also participated in mandated training sessions on how to best use the resources provided by the study. Much of the care was delegated by physicians to “coaches” who focused on nutrition, exercise, and behavioral health, including supermarket strategy.

Nearly a quarter of the participants in the intensive intervention group achieved the 10% weight reduction needed to change health risk in a meaningful way. A similar proportion lost less than 10% of their body weight, and about half did not have a notable weight change. Peak weight loss at 6 months averaged 17 lb, and 9.6 lb at 2 years. While this may not seem very impressive considering the extensive resources utilized, there were those who experienced an extraordinary health upgrade not otherwise available, short of bariatric surgery.
 

What does this mean for us?

Both studies indicate that, even under the best-controlled, resource-replete circumstances, the rate of failure to achieve desired progress is very high. But there is a success rate.

The likelihood of success is difficult to interpret from the European data, as it compared only those with major weight loss and those with weight stability, excluding patients with less robust loss or weight gain. The controlled study, however, holds forth an alluring opportunity benefiting a quarter of the targeted participants and even about 5% of the controls who realized that they were being observed.

We also learn that supervision requires a lot more than having a well-meaning but not very well-trained physician ask a patient to log measurements and food intake. Health coaches seem to make the impact.

Failure rates of 50% have a way of dampening enthusiasm, but it may be best to approach the scourge of obesity by offering treatment to everyone with the expectation that not all will experience greatly enhanced quality of life and longevity. Not everyone will benefit, but these two studies confirm that we do have an underutilized capacity to help more people benefit than we currently do.

Richard M. Plotzker, MD, is a retired endocrinologist with 40 years of experience treating patients in both the private practice and hospital settings. He has been a Medscape contributor since 2012.

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

Despite the surgery-sparing potential demonstrated by interventional endoscopic ultrasound (I-EUS), widespread clinical adoption will require more prospective trials, formalized training programs for endoscopists, and greater support from key stakeholders, according to an AGA white paper.

The publication, which was conceived during a session at the 2019 AGA Tech Summit, addresses the current status and future directions of I-EUS, included EUS-guided access, EUS-guided tumor ablation, and endohepatology.

“We hope this white paper guides those interested in adoption of these technologies into clinical practice and serves as a foundation for future research and innovation in the field,” the investigators wrote in Clinical Gastroenterology and Hepatology.

According to senior author senior author Joo Ha Hwang, MD, PhD, of Stanford (Calif.) University, and colleagues, some of the described techniques are not new, but they have yet to be fully realized.

“Some of these techniques initially were reported more than a decade ago,” the investigators wrote, “however, with further device development and refinement in technique there is potential for expanding the application of these techniques and new technologies to a broader group of interventional gastroenterologists.”

For each I-EUS modality, Dr. Hwang and colleagues reviewed available evidence, and if group consensus was reached, offered practical recommendations.
 

EUS-guided access

“There has been exponential growth in EUS-guided biliary (including gallbladder) access and drainage procedures, as well as entero-enteric anastomotic procedures in recent years,” the investigators wrote. “This change can be attributed to the availability of lumen-apposing metal stents (LAMS).”

Previous studies have reported promising success rates with LAMS across a variety of EUS-guided procedures, including biliary drainage (equal to or greater than 85%), gallbladder drainage (90%-98%), and gastrojejunostomy (greater than 90%).

Success with other techniques, however, has been mixed.

While LAMS “have gained popularity in the management of pseudocysts and walled-off necrotic collections,” data regarding superiority over plastic stents have been conflicting, and LAMS may increase risk of bleeding in necrotic cavities, wrote Dr. Hwang and colleagues.

“Placement of coaxial plastic stents through the lumen of LAMS has been advocated to try to minimize the risk of complications related to LAMS,” they added.

According to the white paper, EUS-guided pancreatic interventions remain most challenging; both pancreaticogastrostomy and EUS-guided pancreatic rendezvous are associated with technical failure rates up to 40%, and adverse event rates may be as high as 35%.

“Unlike other EUS-guided drainage and access procedures, there has been limited improvement in technology to make EUS-guided pancreatic access easier or safer,” the investigators noted.

Dr. Hwang and colleagues concluded this discussion of LAMS by calling for randomized prospective trials. They also noted the expense of LAMS, which may cost $4,000-$6,000.
 

EUS-guided tumor ablation

“Because of the close proximity of the gastrointestinal tract to organs such as the esophagus, liver, and pancreas, EUS would appear to be an ideal tool to provide imaging and potentially ablation of benign and malignant lesions in these locations,” wrote Dr. Hwang and colleagues.

But several challenges may stand in the way, they noted, including insufficient endoscope length and working channel caliber, “the tortuosity of the gastrointestinal lumen” and its location relative to some parts of the liver and pancreas, prohibitive tumor characteristics, and cost. In addition, concerns remain for collateral damage to surrounding organs.

“Further studies evaluating the safety and treatment response to ablation of solid neoplasms is required,” the investigators wrote, noting that this may require further development of noninvasive methods to monitor treated lesions.
 

EUS-guided liver applications

According to Dr. Hwang and colleagues, a growing body of evidence supports EUS-guided liver biopsy, including a high rate of histologic diagnoses (93.9%), Doppler-based detection of blood flow within the needle track prior to needle removal, ability to perform several needle actuations through a single puncture in the liver capsule, rapid patient recovery, ability to sample both liver lobes, potential for simultaneous endoscopy, and lower overall cost (accounting for complications, recovery time, and nondiagnostic yield).

And biopsies may be the first of many EUS-guided liver procedures to come, the investigators suggested.

“[EUS-guided liver biopsy] likely will be followed by EUS-guided portal pressure gradient measurement and EUS-guided shear wave elastography,” the investigators wrote. “There now is potential for a one-stop-shop diagnosis and staging of liver disease.”

Still, work is needed to facilitate greater clinical adoption of interventional EUS.

“[W]idespread implementation of interventional EUS is likely to require support from gastrointestinal societies and buy-in from other key stakeholders including payors,” wrote Dr. Hwang and colleagues. “Continued work by the gastrointestinal societies and manufacturers in providing training programs, and creating instruments, environments, and policies that motivate endoscopists to adopt new practices, is essential for growing the field of interventional EUS.”

The white paper was resulted from a session focused on interventional EUS a the 2019 ASGA Tech Summit, organized by the AGA Center for GI Innovation and Technology. The investigators disclosed additional relationships with Boston Scientific Corporation, Vyaire Medical, Cook Medical, and others.

SOURCE: DeWitt JM et al. Clin Gastroenterol Hepatol. 2020 Sep 17. doi: 10.1016/j.cgh.2020.09.029.

This story was updated on 12/4/2020.

Despite the surgery-sparing potential demonstrated by interventional endoscopic ultrasound (I-EUS), widespread clinical adoption will require more prospective trials, formalized training programs for endoscopists, and greater support from key stakeholders, according to an AGA white paper.

The publication, which was conceived during a session at the 2019 AGA Tech Summit, addresses the current status and future directions of I-EUS, included EUS-guided access, EUS-guided tumor ablation, and endohepatology.

“We hope this white paper guides those interested in adoption of these technologies into clinical practice and serves as a foundation for future research and innovation in the field,” the investigators wrote in Clinical Gastroenterology and Hepatology.

According to senior author senior author Joo Ha Hwang, MD, PhD, of Stanford (Calif.) University, and colleagues, some of the described techniques are not new, but they have yet to be fully realized.

“Some of these techniques initially were reported more than a decade ago,” the investigators wrote, “however, with further device development and refinement in technique there is potential for expanding the application of these techniques and new technologies to a broader group of interventional gastroenterologists.”

For each I-EUS modality, Dr. Hwang and colleagues reviewed available evidence, and if group consensus was reached, offered practical recommendations.
 

EUS-guided access

“There has been exponential growth in EUS-guided biliary (including gallbladder) access and drainage procedures, as well as entero-enteric anastomotic procedures in recent years,” the investigators wrote. “This change can be attributed to the availability of lumen-apposing metal stents (LAMS).”

Previous studies have reported promising success rates with LAMS across a variety of EUS-guided procedures, including biliary drainage (equal to or greater than 85%), gallbladder drainage (90%-98%), and gastrojejunostomy (greater than 90%).

Success with other techniques, however, has been mixed.

While LAMS “have gained popularity in the management of pseudocysts and walled-off necrotic collections,” data regarding superiority over plastic stents have been conflicting, and LAMS may increase risk of bleeding in necrotic cavities, wrote Dr. Hwang and colleagues.

“Placement of coaxial plastic stents through the lumen of LAMS has been advocated to try to minimize the risk of complications related to LAMS,” they added.

According to the white paper, EUS-guided pancreatic interventions remain most challenging; both pancreaticogastrostomy and EUS-guided pancreatic rendezvous are associated with technical failure rates up to 40%, and adverse event rates may be as high as 35%.

“Unlike other EUS-guided drainage and access procedures, there has been limited improvement in technology to make EUS-guided pancreatic access easier or safer,” the investigators noted.

Dr. Hwang and colleagues concluded this discussion of LAMS by calling for randomized prospective trials. They also noted the expense of LAMS, which may cost $4,000-$6,000.
 

EUS-guided tumor ablation

“Because of the close proximity of the gastrointestinal tract to organs such as the esophagus, liver, and pancreas, EUS would appear to be an ideal tool to provide imaging and potentially ablation of benign and malignant lesions in these locations,” wrote Dr. Hwang and colleagues.

But several challenges may stand in the way, they noted, including insufficient endoscope length and working channel caliber, “the tortuosity of the gastrointestinal lumen” and its location relative to some parts of the liver and pancreas, prohibitive tumor characteristics, and cost. In addition, concerns remain for collateral damage to surrounding organs.

“Further studies evaluating the safety and treatment response to ablation of solid neoplasms is required,” the investigators wrote, noting that this may require further development of noninvasive methods to monitor treated lesions.
 

EUS-guided liver applications

According to Dr. Hwang and colleagues, a growing body of evidence supports EUS-guided liver biopsy, including a high rate of histologic diagnoses (93.9%), Doppler-based detection of blood flow within the needle track prior to needle removal, ability to perform several needle actuations through a single puncture in the liver capsule, rapid patient recovery, ability to sample both liver lobes, potential for simultaneous endoscopy, and lower overall cost (accounting for complications, recovery time, and nondiagnostic yield).

And biopsies may be the first of many EUS-guided liver procedures to come, the investigators suggested.

“[EUS-guided liver biopsy] likely will be followed by EUS-guided portal pressure gradient measurement and EUS-guided shear wave elastography,” the investigators wrote. “There now is potential for a one-stop-shop diagnosis and staging of liver disease.”

Still, work is needed to facilitate greater clinical adoption of interventional EUS.

“[W]idespread implementation of interventional EUS is likely to require support from gastrointestinal societies and buy-in from other key stakeholders including payors,” wrote Dr. Hwang and colleagues. “Continued work by the gastrointestinal societies and manufacturers in providing training programs, and creating instruments, environments, and policies that motivate endoscopists to adopt new practices, is essential for growing the field of interventional EUS.”

The white paper was resulted from a session focused on interventional EUS a the 2019 ASGA Tech Summit, organized by the AGA Center for GI Innovation and Technology. The investigators disclosed additional relationships with Boston Scientific Corporation, Vyaire Medical, Cook Medical, and others.

SOURCE: DeWitt JM et al. Clin Gastroenterol Hepatol. 2020 Sep 17. doi: 10.1016/j.cgh.2020.09.029.

This story was updated on 12/4/2020.

Despite the surgery-sparing potential demonstrated by interventional endoscopic ultrasound (I-EUS), widespread clinical adoption will require more prospective trials, formalized training programs for endoscopists, and greater support from key stakeholders, according to an AGA white paper.

The publication, which was conceived during a session at the 2019 AGA Tech Summit, addresses the current status and future directions of I-EUS, included EUS-guided access, EUS-guided tumor ablation, and endohepatology.

“We hope this white paper guides those interested in adoption of these technologies into clinical practice and serves as a foundation for future research and innovation in the field,” the investigators wrote in Clinical Gastroenterology and Hepatology.

According to senior author senior author Joo Ha Hwang, MD, PhD, of Stanford (Calif.) University, and colleagues, some of the described techniques are not new, but they have yet to be fully realized.

“Some of these techniques initially were reported more than a decade ago,” the investigators wrote, “however, with further device development and refinement in technique there is potential for expanding the application of these techniques and new technologies to a broader group of interventional gastroenterologists.”

For each I-EUS modality, Dr. Hwang and colleagues reviewed available evidence, and if group consensus was reached, offered practical recommendations.
 

EUS-guided access

“There has been exponential growth in EUS-guided biliary (including gallbladder) access and drainage procedures, as well as entero-enteric anastomotic procedures in recent years,” the investigators wrote. “This change can be attributed to the availability of lumen-apposing metal stents (LAMS).”

Previous studies have reported promising success rates with LAMS across a variety of EUS-guided procedures, including biliary drainage (equal to or greater than 85%), gallbladder drainage (90%-98%), and gastrojejunostomy (greater than 90%).

Success with other techniques, however, has been mixed.

While LAMS “have gained popularity in the management of pseudocysts and walled-off necrotic collections,” data regarding superiority over plastic stents have been conflicting, and LAMS may increase risk of bleeding in necrotic cavities, wrote Dr. Hwang and colleagues.

“Placement of coaxial plastic stents through the lumen of LAMS has been advocated to try to minimize the risk of complications related to LAMS,” they added.

According to the white paper, EUS-guided pancreatic interventions remain most challenging; both pancreaticogastrostomy and EUS-guided pancreatic rendezvous are associated with technical failure rates up to 40%, and adverse event rates may be as high as 35%.

“Unlike other EUS-guided drainage and access procedures, there has been limited improvement in technology to make EUS-guided pancreatic access easier or safer,” the investigators noted.

Dr. Hwang and colleagues concluded this discussion of LAMS by calling for randomized prospective trials. They also noted the expense of LAMS, which may cost $4,000-$6,000.
 

EUS-guided tumor ablation

“Because of the close proximity of the gastrointestinal tract to organs such as the esophagus, liver, and pancreas, EUS would appear to be an ideal tool to provide imaging and potentially ablation of benign and malignant lesions in these locations,” wrote Dr. Hwang and colleagues.

But several challenges may stand in the way, they noted, including insufficient endoscope length and working channel caliber, “the tortuosity of the gastrointestinal lumen” and its location relative to some parts of the liver and pancreas, prohibitive tumor characteristics, and cost. In addition, concerns remain for collateral damage to surrounding organs.

“Further studies evaluating the safety and treatment response to ablation of solid neoplasms is required,” the investigators wrote, noting that this may require further development of noninvasive methods to monitor treated lesions.
 

EUS-guided liver applications

According to Dr. Hwang and colleagues, a growing body of evidence supports EUS-guided liver biopsy, including a high rate of histologic diagnoses (93.9%), Doppler-based detection of blood flow within the needle track prior to needle removal, ability to perform several needle actuations through a single puncture in the liver capsule, rapid patient recovery, ability to sample both liver lobes, potential for simultaneous endoscopy, and lower overall cost (accounting for complications, recovery time, and nondiagnostic yield).

And biopsies may be the first of many EUS-guided liver procedures to come, the investigators suggested.

“[EUS-guided liver biopsy] likely will be followed by EUS-guided portal pressure gradient measurement and EUS-guided shear wave elastography,” the investigators wrote. “There now is potential for a one-stop-shop diagnosis and staging of liver disease.”

Still, work is needed to facilitate greater clinical adoption of interventional EUS.

“[W]idespread implementation of interventional EUS is likely to require support from gastrointestinal societies and buy-in from other key stakeholders including payors,” wrote Dr. Hwang and colleagues. “Continued work by the gastrointestinal societies and manufacturers in providing training programs, and creating instruments, environments, and policies that motivate endoscopists to adopt new practices, is essential for growing the field of interventional EUS.”

The white paper was resulted from a session focused on interventional EUS a the 2019 ASGA Tech Summit, organized by the AGA Center for GI Innovation and Technology. The investigators disclosed additional relationships with Boston Scientific Corporation, Vyaire Medical, Cook Medical, and others.

SOURCE: DeWitt JM et al. Clin Gastroenterol Hepatol. 2020 Sep 17. doi: 10.1016/j.cgh.2020.09.029.

This story was updated on 12/4/2020.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

The American Gastroenterological Association has published a Clinical Practice Update for management of inflammatory bowel disease (IBD) in elderly patients, including 15 best practice advice statements.

According to lead author Ashwin N. Ananthakrishnan, MD, MPH, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues, this topic is becoming increasingly relevant, as the population is aging, and prevalence of IBD among elderly is rising approximately 5% per year.

“Up to 15% of IBD in North America and Asia is diagnosed after the age of 60 years,” the investigators wrote in Gastroenterology.

Dr. Ananthakrishnan and colleagues noted that “care of elderly IBD patients poses unique challenges with respect to diagnosis and therapeutic decision-making.”

Challenges include greater frequency of comorbidities, increased risk of infection with anti–tumor necrosis factor therapy, increased risk of lymphoma with thiopurine therapy, greater likelihood of surgical complications, and, for Crohn’s disease, an elevated mortality rate, according to the update.

Another challenge is a lack of data.

“It should be noted that most clinical data to inform these practices are based on observational data or indirect evidence as elderly IBD patients comprise a very small proportion of subjects enrolled in IBD clinical trials or long-term pharmacovigilance initiatives,” the investigators wrote.

With this in mind, the update offers guidance for diagnosis, treatment, and ongoing health maintenance.
 

Diagnosis

Dr. Ananthakrishnan and colleagues first suggested that clinicians remain vigilant for IBD in elderly people, in consideration of the 15% prevalence rate in this subpopulation.

For elderly individuals with a low probability of IBD, the investigators recommended fecal calprotectin or lactoferrin to determine if endoscopy is needed. For elderly patients with chronic diarrhea or hematochezia, plus moderate to high suspicion of IBD, colorectal neoplasia, or microscopic colitis, they recommended colonoscopy.

Lastly, the expert panel suggested that elderly patients presenting with segmental left-sided colitis and diverticulosis may also have Crohn’s disease or IBD unclassified.
 

Treatment

The clinical practice update offers 10 best practice statements for treating elderly patients with IBD. There is a recurring emphasis on treatment personalization, which should be informed by patient goals and priorities, risk/presence of severe disease, chronological age, functional status, independence, comorbidities, frailty, and several other age-associated risk factors (e.g., venous thromboembolism).

Concerning specific therapies, the investigators cautioned against systemic corticosteroids for maintenance therapy; instead, nonsystemic corticosteroids (e.g., budesonide) are favored, or possibly early biological therapy if budesonide is not indicated. When selecting a biologic, Dr. Ananthakrishnan and colleagues recommended those associated with a lower risk of malignancy and infection (e.g., ustekinumab or vedolizumab).

The advantages of thiopurine monotherapy being oral, relatively inexpensive compared to biologicals and having a long track record of success in maintenance of remission must be balanced against the need for ongoing serological monitoring, and increased risk of some malignancies.

Finally, the expert panel recommended that all elderly patients receive multidisciplinary care, which may include primary care providers, mental health professionals, nutritionists, and other specialists. It may also be productive to consult with family and caregivers during treatment planning.

Health maintenance

The last two best practice advice statements concern health maintenance.

First, the investigators recommended that elderly patients with IBD adhere to vaccination schedules, including herpes zoster, pneumococcus, and influenza vaccines, ideally, before starting immunosuppression.

Second, Dr. Ananthakrishnan and colleagues advised that cessation of colorectal cancer surveillance may be considered in elderly patients with IBD; however, this decision should take into account a variety of factors, including comorbidities, age, life expectancy, likelihood of endoscopic resection, and surgical candidacy.

The review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board. The investigators disclosed relationships with Gilead, Sun Pharma, Kyn Therapeutics, and others.

SOURCE: Ananthakrishnan AN et al. Gastroenterology. 2020 Sep 30. doi: 10.1053/j.gastro.2020.08.060.

This story was updated on 12/4/2020.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

The rate of unintended pregnancies in the United States has decreased to approximately 45%, based on data published in 2016, and “for the first time in many years, this decrease affected women of all race/ethnicity, income levels, and education levels,” Eve Espey, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists.

Changes in contraceptive choices drove much of this decrease, said Dr. Espey, professor of obstetrics and gynecology at the University of New Mexico, Albuquerque.

Help patients feel empowered

Overall, the goal of contraception should be to empower women and people to make the reproductive decisions that are best for them. “My own approach to contraceptive counseling has changed over the years; I currently start by asking if the patient wants to talk about contraception,” Dr. Espey said.

The COVID-19 pandemic has impacted many women’s reproductive options and plans, she said.

A survey showed that after COVID-19, more than 40% of women reported changing their plans about childbearing, 34% wanted to get pregnant later, and 33% reported trouble getting birth control or getting an appointment with a health care provider, she said.

ACOG issued a statement in March 2020 about the provision of contraception and how contraception is an essential component of comprehensive health care. The COVID-19 ACOG guidance on contraception includes use of telehealth for services including screening new patients, offering prescriptions and refills as appropriate, and managing side effects. Providers can counsel patients on the use of emergency contraception and provide advance prescriptions for ulipristal acetate, and ideally provide a year’s worth of prescription refills to reduce pharmacy visits, although not all insurance companies allow this, Dr. Espey noted.

ACOG’s COVID-19 guidance on the use of LARCs includes preserving access when possible, and focusing on postpartum contraception as a key access point.

“The postpartum period is a very convenient time for patients who want contraceptives, including LARC,” especially since they are already in the hospital setting, Dr. Espey said. However, it is important to preserve patients’ reproductive autonomy and avoid placing barriers to LARC removal for those who request it, she emphasized.
 

Consider MEC categories for contraception

When advising patients about contraception, Dr. Espey noted the development of a simple app with the U.S. Medical Eligibility Criteria (MEC) as a useful tool. The app includes the four MEC categories based on the latest evidence-based guidance from the Centers for Disease Control and Prevention on contraceptive practice.

Patients in category 1 have no restriction on the use of a particular contraceptive method; category 2 means that “advantages generally outweigh the theoretical or proven risks”; in category 3, these risks usually outweigh the advantages; and category 4 indicates “unacceptable health risk if the contraceptive method is used,” according to the MEC.

“What complicates category 3 is that many patients have a condition that is associated with adverse outcomes in pregnancy,” Dr. Espey noted, “So it is even more important that category 3 options only be considered if other options are not available or not acceptable to the patient,”

For example, a patient with complicated diabetes who wants depot medroxyprogesterone acetate (DMPA) for contraception for a year must weigh the benefits with the theoretical risk of thromboembolic disease related to a higher dose progestin, and the fact that the injection is not reversible in the case of an adverse event. “Close follow-up is recommended for patients using contraception with category 3 recommendations,” Dr. Espey emphasized.

Some new elements of contraception that are ongoing in the pandemic health care setting include increased pharmacist prescribing of hormonal contraception, Dr. Espey said. Over-the-counter access to contraception is not yet an option, but a progestin-only pill will likely be the first, she added.

Although the Essure birth control implant is no longer available in the United States, new options for a contraceptive patch (Twirla [ethinyl estradiol and levonorgestrel] and Xulane [ethinyl estradiol and norelgestromin]) offer weekly contraceptive options for women with a body mass index less than 30 kg/m².
 

Annovera offers more options

The newest choice on the market is Annovera, a flexible ring that delivers 150 mcg/day of segesterone acetate and 13 mcg/day of ethinyl estradiol. The ring is meant to remain in place for 21 days, with 7 days out, to repeat for a year.

During the question-and-answer session, Dr. Espey was asked whether it would be an off-label use to leave Annovera in continuously. Although this has not been studied, there is no biologically plausible reason not to leave it in for a year without taking it out. In either case, this is a patient-controlled LARC, she said.

Overall, “it remains to be seen how Annovera will do, as a potentially exciting, new, long-acting option” she said. “A major advantage is that it is controlled by the user,” she noted. However, “the price point will be very important as well.”

As for the off-label use by women with a BMI greater than 29 kg/m², it is complicated. Two women with higher BMIs enrolled in clinical trials developed venous thromboembolisms, so an increased risk can’t be ruled out, although the good news is that BMI has not been shown to impact effectiveness of the product, she added.
 

IUDs appropriate for younger women

When asked for her guidelines about IUD options in the absence of head-to-head trials, Dr. Espey said that she often recommends either Mirena and Liletta. These levonorgestrel-releasing IUDS are essentially the same, can be used off label for 7 years (both are currently Food and Drug Administration approved for 6 years), and have a favorable bleeding profile. Other IUDs are marketed as having a smaller diameter designed for increased patient comfort with insertion, but she views this as less important than bleeding profile and duration given the length of time the device is in place.

Dr. Espey added that she doesn’t see age as a barrier to IUD use, and that the evidence does not support an increased risk of infertility. In fact, “we are seeing a higher demand among younger and nulliparous women.”

“We should respect the reproductive autonomy and the choices that our patients make,” Dr. Espey concluded.

Dr. Espey had no relevant financial disclosures. She is a member of the Ob.Gyn. News editorial advisory board.

Frontline pembrolizumab (Keytruda) significantly improved progression-free survival (PFS), compared with chemotherapy among patients with microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) metastatic colorectal cancer, according to results from the KEYNOTE-177 study.

At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.

“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).

The study has now been published in the New England Journal of Medicine.

Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.

He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.

Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.

These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
 

Study details

The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.

The study’s two primary endpoints were PFS and overall survival.

At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).

At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.

The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.

Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.

Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.

Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
 

Preferred choice

In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.

“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.

The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.

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

Frontline pembrolizumab (Keytruda) significantly improved progression-free survival (PFS), compared with chemotherapy among patients with microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) metastatic colorectal cancer, according to results from the KEYNOTE-177 study.

At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.

“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).

The study has now been published in the New England Journal of Medicine.

Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.

He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.

Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.

These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
 

Study details

The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.

The study’s two primary endpoints were PFS and overall survival.

At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).

At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.

The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.

Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.

Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.

Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
 

Preferred choice

In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.

“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.

The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.

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

Frontline pembrolizumab (Keytruda) significantly improved progression-free survival (PFS), compared with chemotherapy among patients with microsatellite instability–high/mismatch repair–deficient (MSI-H/dMMR) metastatic colorectal cancer, according to results from the KEYNOTE-177 study.

At a median follow-up of 32.4 months, PFS was 16.5 months for patients who received pembrolizumab versus 8.2 months for the chemotherapy group.

“In the past, no medical treatment has shown such difference in terms of improvement of PFS in metastatic colorectal cancer,” commented lead author Thierry André, MD, of Hôpital Saint Antoine, Paris, France, when presenting this study earlier this year at the annual meeting of the American Society of Clinical Oncology.

“I think this is setting a new standard of care,” said Michael J. Overman, MD, of the University of Texas MD Anderson Cancer Center, Houston, who was the invited discussant at the ASCO meeting. However, he also pointed out that, despite the higher overall response rate (43.8% vs. 33.1% with chemotherapy), the rate of progressive disease was higher in the pembrolizumab arm than in the chemotherapy arm (29.4% vs. 12.3% for patients who received chemotherapy).

The study has now been published in the New England Journal of Medicine.

Pembrolizumab is the “preferred choice” for patients with MSI-H/dMMR colorectal cancer because of “the durability of response, better safety profile, and improved quality of life associated with immunotherapy as compared with chemotherapy,” Axel Grothey, MD, GI cancer research, West Cancer Center and Research Institute, Germantown, Tenn., wrote in an accompanying editorial.

He noted that, in colorectal cancer, only 4%-5% of metastatic cancers show the MSI-H/dMMR phenotype; the prevalence is greater in BRAF V600E–mutated cancers, in cancers originating on the right side, and among female patients.

Immune checkpoint inhibitors have already demonstrated “convincing activity” in MSI-H/dMMR colorectal cancers, and pembrolizumab as well as nivolumab (Opdivo), with or without ipilimumab (Yervoy), are approved for use as salvage therapy in colorectal cancer, he noted.

These results for use as a first-line therapy in his patient population have been “long awaited,” he commented.
 

Study details

The KEYNOTE-177 trial included 307 patients with confirmed, untreated MSI-H/dMMR metastatic colorectal cancer who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks for up to 35 cycles (n = 153) or the investigators’ choice of chemotherapy (n = 154). Chemotherapy regimens included modified FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) alone or in combination with either bevacizumab or cetuximab, or FOLFIRI (leucovorin, fluorouracil, irinotecan) alone or in combination with either bevacizumab or cetuximab. Patients in the chemotherapy group could cross over to pembrolizumab therapy after disease progression.

The study’s two primary endpoints were PFS and overall survival.

At the second interim analysis, at a median follow-up (from randomization to data cutoff) of 32.4 months, pembrolizumab proved superior to chemotherapy with regard to PFS (hazard ratio, 0.60; P = .0002).

At 12 months and at 24 months, the estimated percentages of those alive without disease progression were 55.3% and 48.3%, respectively (95% confidence interval, 39.9-56.2) in the pembrolizumab group and 37.3% and 18.6%, respectively, in the chemotherapy group.

The mean PFS after 24 months of follow-up was 13.7 months for patients who received pembrolizumab versus 10.8 months for those who received chemotherapy. PFS was consistently longer with pembrolizumab across key prespecified subgroups. Complete responses were achieved in 11% of patients treated with pembrolizumab and in 4% of those treated with chemotherapy. At 24 months, 83% of patients in the pembrolizumab group had ongoing responses, compared with 35% in the chemotherapy group.

Overall survival data continue to evolve, the authors commented, noting that 56 patients in the pembrolizumab group and 69 in the chemotherapy group have died. The independent data-monitoring committee has recommended that the trial continue without any changes to the final analysis for assessment of overall survival until 190 overall deaths have occurred or until 12 months after the second interim analysis.

Crossover will be a factor when overall survival is assessed, the authors noted. At the time of data cutoff, 56 of 154 patients (36%) who received chemotherapy had crossed over to the pembrolizumab group after their disease had progressed. In addition, 35 patients in the chemotherapy group received anti–programmed death-1 or PD-ligand 1 therapies outside the trial. This extrapolates to a crossover rate of 59% in the intention-to-treat population.

Treatment-related adverse events of grade 3 or higher were more common in the chemotherapy group (66% vs. 22%). Immune-mediated adverse events and infusion reactions were more common with pembrolizumab than with chemotherapy (31% and 13%, respectively). Adverse events that were common with chemotherapy included gastrointestinal events, fatigue, neutropenia, and peripheral sensory neuropathy.
 

Preferred choice

In the accompanying editorial, Dr. Grothey pointed out that the results of this trial “deserve some scrutiny,” because disease progression was higher in the pembrolizumab group. This is mirrored by early poorer performance among patients treated with pembrolizumab versus chemotherapy until about 6.5 months after onset of therapy. After that, the “pembrolizumab group showed protracted improvement – a phenomenon seen in various other trials with PD-1 antibodies in gastrointestinal cancers.

“It appears that a subgroup not yet clearly defined within the MSI-H–dMMR population does not have a response to immune checkpoint inhibitors,” Dr. Grothey wrote.

The study was funded by Merck. Dr. André has received honoraria from Amgen, GlaxoSmithKline, and Pierre Fabre Pharmaceuticals; consulting fees and travel support from Bristol-Myers Squibb; advisory board fees and honoraria from F. Hoffmann–La Roche; advisory board fees from Gritstone Oncology, Halliodx, and Tesaro; grant support, paid to Hôpitaux de Paris; advisory board fees, honoraria, and travel support from Merck Sharp and Dohme; consulting fees and honoraria from Servier; and honoraria and travel support from Ventana Medical Systems. Dr. Grothey has received grants and nonfinancial support from Bayer; grants from Boston Biomedicals; grants from OBI Pharmaceuticals, Array/Pfizer, Natera, Merck, and Bristol-Myers Squibb; and grants and nonfinancial support from Roche/ Genentech outside the submitted work.

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

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

Menstrual cup use is becoming increasingly popular as an option for menstrual hygiene among women in the United States, but little is known about the potential for IUD expulsion with menstrual cup use, Jill Long, MD, said at the 2020 virtual meeting of the American College of Obstetricians and Gynecologists. 

Dr. Long cited a 2019 Internet survey of IUD users in which 11% reported menstrual cup use; reports of IUD expulsion were approximately three times higher among menstrual cup users. The results of the survey were limited by the self-reported responses and lack of data on when the expulsions occurred related to menstrual cup use.

Similar concerns about expulsion surfaced in an ongoing phase 3, randomized trial designed to support the marketing application of the Mona Lisa NT Cu380 Mini IUD, which is not currently approved in the United States.

“Nine months into the study, more expulsions were observed than expected, particularly among menstrual cup users,” said Dr. Long, medical officer and project officer for the Contraceptive Clinical Trials Network at the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers then began to advise study participants to avoid menstrual cup use, and to collect data on use of menstrual hygiene products.

The preliminary study results reported by Dr. Long included 1,092 women assigned in a 4:1 ratio to receive the Mona Lisa NT Cu380 Mini and ParaGard, an IUD approved in the United States. Participants had follow-up visits at 6 weeks and at 3, 6, 12, 24, and 36 months after placement to verify the IUD position.

At 34 months, the overall rate of IUD expulsion was 9%. Of 277 women who reported menstrual cup use, the expulsion rate was 18%, compared with a 6% expulsion rates among the 704 women who reported tampon use.
 

Patient behavior persists despite advisory

Overall IUD expulsion was not significantly different among patients enrolled before and after the advisory against menstrual cup use (9.8% vs. 8.8%, respectively). In addition, menstrual cup use did not decrease after the implementation of the advisory (24% preadvisory vs. 28% post advisory).

The expulsion rates between menstrual cup users and nonusers were significantly different at both 12 months (14% vs. 5%) and 24 months (21% vs. 6%).

In addition, the researchers created a category of accidental self-removal, defined as the percent of expulsions occurring at the time the menstrual hygiene product was removed. Accidental self-removal was significantly higher among menstrual cup users, compared with tampon users (43% vs. 10%).

Study limitations included study blinding with regard to IUD type, parity, and age, so the impact of these factors on expulsion remains unclear, Dr. Long said. In addition, data on menstrual hygiene product use was collected retrospectively for the first 9 months, and no data were available on the impact on expulsion of combined use of menstrual cups and tampons.

Despite the apparent lack of impact of counseling, “women should be informed of the increased risk of expulsion if they choose to use menstrual cups concurrently with copper IUDs,” Dr. Long concluded.
 

More data to come from further analysis

During a question-and-answer session following the presentation, Dr. Long was asked whether suction might contribute to expulsion. “We advised subjects to break the seal on the menstrual cup prior to removal, but we did not see a decrease in expulsion rates with menstrual cup use after this advisory,” she said.

“The type of menstrual cup may be a factor,” she added. “We still need to analyze the data by the type of menstrual cup used as different cups have different degrees of suction.”

When asked about the potential role of coital activity on expulsion, Dr. Long said that the researchers had not yet reviewed coital activity logs to compare expulsion data with the timing of sexual activity.

Any increased pregnancy rates among menstrual cup users are “unlikely, but we don’t know for sure,” she added.

The current study also did not evaluate quantitative differences in bleeding, and participants are using bleeding diaries, Dr. Long noted. She added that participants are able to report problems with bleeding to the study sites, and that these are captured as adverse events.

The study was supported by a partnership between NICHD and FHI 360, a nonprofit human development organization based in North Carolina, with FHI 360 funding from the Bill and Melinda Gates Foundation. Dr. Long had no financial conflicts to disclose.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.