MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

MADRID – Adding the oral Janus kinase (JAK) inhibitor baricitinib to standard atopic dermatitis therapy with low- and midpotency topical corticosteroids markedly improved disease severity and key patient-reported outcomes, compared with topical corticosteroids alone, in the phase 3, randomized, double-blind BREEZE-AD7 trial, Kristian Reich, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

Baricitinib, a JAK 1/2 inhibitor, had already proved superior to placebo as monotherapy for adults with moderate to severe atopic dermatitis in the phase 3 BREEZE-AD1 and -AD2 trials. But BREEZE-AD7 further advances the field because it’s the first phase 3 study testing the efficacy of a JAK inhibitor in combination with low- and midpotency topical steroids.

“I think this study is important because it looks into the situation that’s more like what happens in the real world, which is, as with dupilumab and other drugs, we use the systemic agent in combination with topical therapies and, in particular, with topical corticosteroids,” commented Dr. Reich, professor of dermatology at University Medical Center, Hamburg, and medical director at SCIderm, a scientific research company.

“This is what I think we can expect from existing and upcoming systemic therapies in atopic dermatitis: We will use them in combination with topical corticosteroids, and hopefully this will allow patients to dramatically reduce the concomitant use of topical corticosteroids, as shown here in BREEZE-AD7,” he added.

BREEZE-AD7 was a 16-week study that included 329 adults with moderate or severe atopic dermatitis who were randomized to low- and midpotency topical corticosteroids plus either baricitinib at 2 mg once daily, baricitinib at 4 mg once daily, or placebo. The group’s mean baseline Eczema Area and Severity Index (EASI) score was 29. Overall, 45% of participants had a baseline Investigator’s Global Assessment (IGA) of disease severity of 4 on a 0-4 scale.

The primary endpoint was achievement of an IGA of 0 or 1, meaning clear or almost clear, along with at least a 2-point IGA improvement from baseline at week 16. This was accomplished in 30.6% of those on 4 mg/day of baricitinib, 23.9% of patients in the 2-mg group, and 14.7% of controls.

The 4-mg dose of baricitinib was statistically superior to placebo; the 2-mg dose was not. However, Dr. Reich indicated he was untroubled by this because the primary endpoint was set at a high bar, and both doses of baricitinib proved to be significantly better than topical steroids plus placebo in terms of EASI 75 response rates, as well as reductions in itch, skin pain, and sleep problems, which aren’t captured in EASI scores (see graphic).

“One of my big learnings from this year’s EADV is that we have to rethink the dimensions of atopic dermatitis. I think we have underestimated the relevance of important symptoms such as itch, the impact atopic dermatitis has on pain, and the effect it has on sleeping problems,” the dermatologist said. “My feeling is that baricitinib is strongest in reducing itch, improving sleep, and reducing pain, but it also has good effects on the clinical signs of atopic dermatitis.”

The baricitinib-treated patients’ rapidity of improvement in the various endpoints was particularly impressive. Both doses of the JAK 1/2 inhibitor showed significant separation from the control group in the first week, and the majority of improvement occurred by week 4.

A key finding was that patients on baricitinib at 2 mg/day and 4 mg/day used a mean total of 162 g and 137 g of midpotency topical steroids, respectively, during the 16 weeks, compared with 225 g in the control group. The higher-dose baricitinib group was topical corticosteroid-free on 33% of study days, compared with 25% of days for the baricitinib 2 mg patients and 17% of days for controls.

In terms of safety, there was a case of pulmonary embolism in the higher-dose baricitinib group and an opportunistic toxoplasmosis eye infection in the control population. The frequency of oral herpes and herpes simplex virus infections was 2.8% in controls, 4.6% in the baricitinib 2-mg group, and 6.3% in the 4-mg group. There was also a signal of a dose-dependent increased risk of new-onset acne, with rates of 0.9% in controls and patients on baricitinib 2 mg, climbing to 3.6% with baricitinib 4 mg.

“In phase 2 results with upadacitinib [another oral JAK inhibitor], we saw that more than 10% of patients in the highest-dose group developed what was classified as acne. I cannot explain this, but it’s something we will monitor in the future,” Dr. Reich promised.

A fuller picture of baricitinib’s safety profile in the setting of atopic dermatitis clearly requires larger and longer-term studies, he added.

Baricitinib at the 2 mg daily dose is already marketed as Olumiant for the treatment of rheumatoid arthritis, with labeling that includes a boxed warning about serious infections, malignancy, and thrombosis. The Food and Drug Administration did not approve the 4-mg dose after determining that its higher safety hazard outweighed the efficacy advantage over the lower dose.

The BREEZE-AD7 study was sponsored by Eli Lilly. Dr. Reich reported serving as an adviser to, paid speaker for, and recipient of research grants from that pharmaceutical company and more than two dozen others.
 

bjancin@mdedge.com

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

In November 2019, more than 1,500 pediatric hospitalists will be first to take the subspecialty exam approved by the American Board of Pediatrics (ABP) for certification in pediatric hospital medicine (PHM). This landmark signifies the recognition of hospital medicine as an essential component of the health care landscape and further acknowledges the importance of our expanding field.

But recent controversy over the requirements set by the ABP to sit for the exam has highlighted the new considerations for practice management that will be associated with this change. The need to analyze and understand how PHM programs function has never been more important for hospital medicine groups that care for children. This information is essential if they are to remain nimble in their approach to the changes that will occur in the years ahead.

To understand the impact that the new subspecialty board exam will have on groups that care for children, we need to first understand the criteria for eligibility. As for all ABP subspecialty boards, applicants must be Pediatric Board certified. The ABP has established three pathways by which practitioners can attain eligibility to sit for the PHM exam.¹ Most currently practicing hospitalists have applied to take the exam under the “practice pathway,” which will be available temporarily to allow candidates to apply for the certifying exam based on experience rather than fellowship training. This temporary period will span the first three examination cycles (2019, 2021, 2023). The requirements for inclusion via this pathway, recently modified by the ABP in response to concerns voiced by the PHM community at large,² consist of the following:

1. Practice period of 4 years (with a start date of July 2015 to be eligible for the November 2019 exam.

2. Work hours for all PHM professional activities of more than 900-1000 hours/year.

3. Patient care hours in PHM of more than 450-500 hours per year, every year for the preceding 4 years.

4. Scope of practice covering the full range of hospitalized children.

5. Practice experience and hours acquired in the United States or Canada.

This set of criteria raises several questions about the eligibility of the physicians currently caring for children in the hospital setting. The State of Hospital Medicine Report is an excellent source of information about hospital medicine trends in staffing and much more. While the response to the survey is more robust from practices that care for adults only, important information can be gleaned from the participant groups that care for children.

Question 1: How many clinicians that care for children in the hospital are trained in pediatrics, thereby meeting the first criteria to sit for the boards?

Based on the 2018 State of Hospital Medicine Report, 100% of groups that treat only children had physicians trained in pediatrics, 41.7% employed physicians trained in med/peds, and 5.6% had clinicians trained in internal medicine.

In groups that treat both children and adults the variation in practitioner type was much broader. While 85.7% of groups reported employing physicians trained in internal medicine and 64.3% employed family medicine practitioners, only 35.7% reported employing physicians trained in pediatrics and 46.4% with training in med/peds. A smattering of other clinician types was also noted, most of which were not likely to be pediatrics trained.

If information based on this relatively small number of respondents is generalizable, it means that a large number of the practitioners currently caring for hospitalized children are not pediatrics board-certified and therefore will not be eligible to sit for the subspecialty exam.

Question 2: What portion of the current PHM new hires are fellowship trained?

The 2018 State of Hospital Medicine Report notes that over 50% of new physicians joining a group treating only children come directly from residency, while only 5.1% come from a hospital medicine fellowship. For groups that treat adults and children, this percentage is even more significant, with 63% coming directly from residency and only 2.2% coming from a fellowship program.

The residents who recently graduated in 2019 are the last to be eligible to meet the practice duration criteria (4 years) during the “practice pathway” temporary period, thereby allowing them to sit for the subspecialty board exam without completing a fellowship. Recent surveys have shown that over 10% of graduating residents in pediatrics plan to pursue a career in PHM (over 280 respondents), however only under 75 fellows graduate from PHM fellowships each year.³ As the current number of fellowship positions in PHM are not adequate to meet the demand of the rapidly expanding workforce, groups treating children will need to continue to fill staff vacancies with variably trained clinicians.

In the years to come, information from the State of Hospital Medicine Report will be increasingly important, as programs that care for children meet the challenge of blending their workforce to include members with variable board certification and eligibility.

Question 3: How do the “patient care hours” and “work hours for all PHM activities” requirements affect currently practicing hospitalists in terms of their board eligibility?

Because of rigorous ABP criteria to sit for the PHM subspecialty exam, especially those regarding the minimum clinical and overall work hours in the care of children, many part time and med-peds practitioners may find that they are not board eligible. Variations in clinical coverage needs at individual sites, as well as competing nonclinical tasks in the adult setting, may limit pediatric-specific work hours for med/peds trained hospitalists.

As noted above, in groups that treat only children and groups that treat both adults and children, the 2018 State of Hospital Medicine Report shows that over 40% had physicians trained in med-peds. These highly trained and capable physicians will continue to be assets to their group; however, they may wish to find other ways to achieve merit-based distinction. For these physicians, the Fellow designation through SHM may provide an alternate means of recognition.

With the increasing complexity of staffing a workforce for the treatment of children that the PHM board subspecialty exam brings, the SHM Practice Analysis Committee developed a task force of pediatric leaders from across the country to aid in the development of additional pediatric-specific questions for the 2020 version of the State of Hospital Medicine Report. The questions to be included in the 2020 version will request information about the number of clinical hours (rather than shifts) per year required for full-time faculty, the percentage of the workforce that is part time, and the percentage of personnel in each group that is board certified in pediatric hospital medicine.

It is our hope that all groups treating children will respond to the 2020 State of Hospital Medicine survey, as a robust response will provide meaningful information to direct the leaders of these groups in the changing days ahead.

Dr. Gage is associate division chief, department of hospital medicine, at Phoenix Children’s Hospital and clinical associate professor, University of Arizona, Phoenix. She is a member of the SHM Practice Analysis Committee.

References

1. American Board of Pediatrics. Pediatric Hospital Medicine Certification. 2019 Edition.

2. American Board of Pediatrics. ABP responds to pediatric hospital medicine petition. 2019 Aug 29.

3. Pediatric Hospital Medicine Fellows. 2019 Edition.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.

NEW YORK – Career burnout is common is common among physicians and surgeons, but vascular surgeons might be able to lower their risk simply by taking steps to improve their posture in the operating room, according to data presented at a symposium on vascular and endovascular issues on an evolution that is already underway.

“We looked at physical pain and we were able to demonstrate a correlation with burnout. More pain, more burnout,” said Samuel R. Money, MD, division of vascular surgery, Mayo Clinic, Phoenix, Arizona.

Pain was a reasonable focus for efforts to identify causes of burnout because it is so common among vascular surgeons. In data recently published by Dr. Money and his coinvestigators, 78.3% reported moderate to severe physical pain at the end of a day of surgery (J Vasc Surg 2018;70:913-920).

“Forty percent of vascular surgeons have chronic pain,” Dr. Money said at the symposium sponsored by the Cleveland Clinic Foundation.

Physical pain is not the only cause of burnout, which affects 30% of vascular surgeons, according to data recently presented at the annual meeting of the Society of Vascular Surgery (J Vasc Surg 2019;69[6]:e97.). In that survey, physical pain was joined by work hours, documentation tasks, on-call frequency, and conflicts between work and personal life as significant factors.

“The average vascular surgeon in North America works 63 hours per week,” noted Dr. Money, adding that his survey found nearly 90% of surgeons operate on 3 or more days of every week. This amount of time in the operating room is relevant because almost all surgeons report some degree of pain after a procedure. In the survey, the proportion was greater than 95%.

Yet, risk of pain is modifiable.

“Body position matters,” said Dr. Money, citing studies showing that open procedures are most closely associated with neck pain whereas endovascular procedures are more likely to produce back pain. Although there is a high risk of either type of pain with these procedures, the types of predominant pain are consistent with the demands on body positioning.

“The more you lean forward, the more stress is placed on your neck and back. When standing straight, your head weighs 10-12 pounds, but leaning forward, it can put 60 pounds of pressure on your neck,” he said.

The relative stress can be measured objectively. Dr. Money cited work with a device that measures the body force in inertial measurement units (IMU). According to Dr. Money, the neck is in a high stress position about 75% of the time spent performing typical vascular surgery.

“The trunk is placed in a high stress position approximately 40% of the time, while the other parts of the body that were measured were not generally that bad,” Dr. Money said.

To avoid postural pain, which is not often stressed in surgical training, Dr. Money had specific recommendations. Some are obvious, such as positioning the operating table to minimize the amount of time the head is inclined. He also recommended positioning display monitors no more than 10-20 degrees below and no higher than eye level.

“If you sit down to perform tasks during the procedure, use an adjustable chair so that you can optimize the height,” he said.

He identified loupes as a risk factor for bad posture, and he stressed the importance of wearing lead garments only when necessary and adjusted properly.

“Padded floor mats? They really help,” Dr. Money said. He also recommended appropriate footwear and support stocking.

“Microbreaks are being used in a lot of professions. This means stopping for a moment to stretch every 15-30 minutes,” Dr. Money said.

As a first step, Dr. Money recommended simply developing posture awareness. Many surgeons are simply ignoring the risk and failing to optimize the ways they can increase their comfort during surgery.

Even before entering the surgical suite, regular exercise, yoga, and stretching are all strategies that have the potential to make a difference, according to Dr. Money.

The immediate goal is to reduce the physical pain that is an important occupational hazard for vascular surgeons, but the ultimate goal is to improve job satisfaction, an important defense against professional burnout.

NEW YORK – Published 12 months apart, guidelines on management of abdominal aortic aneurysm (AAA) from the European Society for Vascular Surgery are similar but diverged in instructive ways from those of the Society for Vascular Surgery, according to a critical review at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. “Some of the differences were almost unavoidable in the sense that the ESVS guidelines represent multiple idiosyncratic health care systems across Europe,” reported Ronald L. Dalman, MD, chief of vascular surgery, Stanford (Calif.) University.

Ted Bosworth/MDedge News

As a result, the ESVS guidelines provide very little specificity about pharmacologic options because of the differences in availability of these treatments within specific health systems. In addition, both open and endovascular aneurysm repair (EVAR) are given similar emphasis because of the limited availability of EVAR in some parts of Europe.

“The ESVS guidelines specifically recommend repair of an aneurysm within 8 weeks when repair is indicated, but there are not many aneurysms that go 8 weeks in the U.S. without being fixed by a fee-for-service surgeon,” Dr. Dalman observed.

The SVS AAA guidelines were published in January 2018 (J Vasc Surg 2018;67:2-77) and the ESVS guidelines followed 1 year later (Eur J Vasc Surg 2019;57:8-93).

The differences in the guidelines, although modest, are interesting because each set of guidelines was based largely on the same set of trials and published studies, according to Dr. Dalman, who was a coauthor of the SVS guidelines and an external reviewer for the ESVS guidelines.

In the lag between completion of the two guidelines, new information led to three ESVS additions not found in the SVS guidelines, according to Dr. Dalman. They involved the importance of considering aneurysm diameter as a prognostic factor, new understanding of the limitations on endovascular aneurysm sealing (EVAS), and new information about how aneurysm size should affect frequency of surveillance.

Overall, the U.S. guidelines contain 111 recommendations based on 177 references, while the ESVS guidelines contain 125 guidelines based on 189 references. In retrospect, Dr. Dalman believes both sets of guidelines omitted some clinically meaningful information, such as the risk of large-diameter devices for causing endoleaks.

The authors of the ESVS guidelines did have an opportunity to review of a draft of the SVS guidelines, so differences can be interpreted as intentional. For example, the SVS guidelines recommend risk calculators, but Dr. Dalman suggested that the authors of the ESVS guidelines were less convinced that their utility was established.

The decision not to recommend a door-to-treatment time for ruptured aneurysms, as in the SVS recommendations, might have been in deference to disparate practice across European countries, Dr. Dalman suggested.

Ultimately, the guidelines are “substantially similar,” according to Dr. Dalman, but he expressed concerned that neither guideline is accompanied by a specific mechanism or recommended strategy to ensure implementation.

Many of the SVS recommendations are likely to be translated into quality metrics at U.S. institutions, but “there are implementation issues” for ensuring that each guideline is applied, Dr. Dalman said.

Given the agreement on the vast majority of the recommendations, Dr. Dalman suggested that “it might be time to consider global guidelines” for management of AAA and other vascular diseases. Some type of language might be required to accommodate divergent resources or practices across borders, but Dr. Dalman questioned the need to review the same literature to arrive at mostly the same conclusions.

NEW YORK – Published 12 months apart, guidelines on management of abdominal aortic aneurysm (AAA) from the European Society for Vascular Surgery are similar but diverged in instructive ways from those of the Society for Vascular Surgery, according to a critical review at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. “Some of the differences were almost unavoidable in the sense that the ESVS guidelines represent multiple idiosyncratic health care systems across Europe,” reported Ronald L. Dalman, MD, chief of vascular surgery, Stanford (Calif.) University.

Ted Bosworth/MDedge News

As a result, the ESVS guidelines provide very little specificity about pharmacologic options because of the differences in availability of these treatments within specific health systems. In addition, both open and endovascular aneurysm repair (EVAR) are given similar emphasis because of the limited availability of EVAR in some parts of Europe.

“The ESVS guidelines specifically recommend repair of an aneurysm within 8 weeks when repair is indicated, but there are not many aneurysms that go 8 weeks in the U.S. without being fixed by a fee-for-service surgeon,” Dr. Dalman observed.

The SVS AAA guidelines were published in January 2018 (J Vasc Surg 2018;67:2-77) and the ESVS guidelines followed 1 year later (Eur J Vasc Surg 2019;57:8-93).

The differences in the guidelines, although modest, are interesting because each set of guidelines was based largely on the same set of trials and published studies, according to Dr. Dalman, who was a coauthor of the SVS guidelines and an external reviewer for the ESVS guidelines.

In the lag between completion of the two guidelines, new information led to three ESVS additions not found in the SVS guidelines, according to Dr. Dalman. They involved the importance of considering aneurysm diameter as a prognostic factor, new understanding of the limitations on endovascular aneurysm sealing (EVAS), and new information about how aneurysm size should affect frequency of surveillance.

Overall, the U.S. guidelines contain 111 recommendations based on 177 references, while the ESVS guidelines contain 125 guidelines based on 189 references. In retrospect, Dr. Dalman believes both sets of guidelines omitted some clinically meaningful information, such as the risk of large-diameter devices for causing endoleaks.

The authors of the ESVS guidelines did have an opportunity to review of a draft of the SVS guidelines, so differences can be interpreted as intentional. For example, the SVS guidelines recommend risk calculators, but Dr. Dalman suggested that the authors of the ESVS guidelines were less convinced that their utility was established.

The decision not to recommend a door-to-treatment time for ruptured aneurysms, as in the SVS recommendations, might have been in deference to disparate practice across European countries, Dr. Dalman suggested.

Ultimately, the guidelines are “substantially similar,” according to Dr. Dalman, but he expressed concerned that neither guideline is accompanied by a specific mechanism or recommended strategy to ensure implementation.

Many of the SVS recommendations are likely to be translated into quality metrics at U.S. institutions, but “there are implementation issues” for ensuring that each guideline is applied, Dr. Dalman said.

Given the agreement on the vast majority of the recommendations, Dr. Dalman suggested that “it might be time to consider global guidelines” for management of AAA and other vascular diseases. Some type of language might be required to accommodate divergent resources or practices across borders, but Dr. Dalman questioned the need to review the same literature to arrive at mostly the same conclusions.

NEW YORK – Published 12 months apart, guidelines on management of abdominal aortic aneurysm (AAA) from the European Society for Vascular Surgery are similar but diverged in instructive ways from those of the Society for Vascular Surgery, according to a critical review at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation. “Some of the differences were almost unavoidable in the sense that the ESVS guidelines represent multiple idiosyncratic health care systems across Europe,” reported Ronald L. Dalman, MD, chief of vascular surgery, Stanford (Calif.) University.

Ted Bosworth/MDedge News

As a result, the ESVS guidelines provide very little specificity about pharmacologic options because of the differences in availability of these treatments within specific health systems. In addition, both open and endovascular aneurysm repair (EVAR) are given similar emphasis because of the limited availability of EVAR in some parts of Europe.

“The ESVS guidelines specifically recommend repair of an aneurysm within 8 weeks when repair is indicated, but there are not many aneurysms that go 8 weeks in the U.S. without being fixed by a fee-for-service surgeon,” Dr. Dalman observed.

The SVS AAA guidelines were published in January 2018 (J Vasc Surg 2018;67:2-77) and the ESVS guidelines followed 1 year later (Eur J Vasc Surg 2019;57:8-93).

The differences in the guidelines, although modest, are interesting because each set of guidelines was based largely on the same set of trials and published studies, according to Dr. Dalman, who was a coauthor of the SVS guidelines and an external reviewer for the ESVS guidelines.

In the lag between completion of the two guidelines, new information led to three ESVS additions not found in the SVS guidelines, according to Dr. Dalman. They involved the importance of considering aneurysm diameter as a prognostic factor, new understanding of the limitations on endovascular aneurysm sealing (EVAS), and new information about how aneurysm size should affect frequency of surveillance.

Overall, the U.S. guidelines contain 111 recommendations based on 177 references, while the ESVS guidelines contain 125 guidelines based on 189 references. In retrospect, Dr. Dalman believes both sets of guidelines omitted some clinically meaningful information, such as the risk of large-diameter devices for causing endoleaks.

The authors of the ESVS guidelines did have an opportunity to review of a draft of the SVS guidelines, so differences can be interpreted as intentional. For example, the SVS guidelines recommend risk calculators, but Dr. Dalman suggested that the authors of the ESVS guidelines were less convinced that their utility was established.

The decision not to recommend a door-to-treatment time for ruptured aneurysms, as in the SVS recommendations, might have been in deference to disparate practice across European countries, Dr. Dalman suggested.

Ultimately, the guidelines are “substantially similar,” according to Dr. Dalman, but he expressed concerned that neither guideline is accompanied by a specific mechanism or recommended strategy to ensure implementation.

Many of the SVS recommendations are likely to be translated into quality metrics at U.S. institutions, but “there are implementation issues” for ensuring that each guideline is applied, Dr. Dalman said.

Given the agreement on the vast majority of the recommendations, Dr. Dalman suggested that “it might be time to consider global guidelines” for management of AAA and other vascular diseases. Some type of language might be required to accommodate divergent resources or practices across borders, but Dr. Dalman questioned the need to review the same literature to arrive at mostly the same conclusions.

NEW YORK – The dual challenges of teaching open vascular surgery techniques when few are performed and reaching a generation that has a different attitude to absorbing information requires new and innovative approaches, according to an academic surgeon speaking at symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

Ted Bosworth/MDedge News

“The see one, do one, teach one approach to surgical training is no longer possible,” explained R. Clement Darling III, MD, chief of the division of vascular surgery at Albany (N.Y.) Medical Center Hospital.

For open procedures, the problem is a rapidly declining number of cases in the era of endovascular surgery, but Dr. Darling also recommended adjusting training to the outlook and expectations of a new generation. First observed in the millennial generation, an attitude of firm work-related boundaries is also being seen in generation Z. Generation Z, characterized by birth after 1995, is just now beginning to reach residency programs.

“The approach to work-life balance is extremely different for these individuals than it was for my generation,” Dr. Darling said. While previous generations were often motivated by fear and pressure, newer generations appear to respond less well to anxiety.

“People learn differently. Some from their tactile sense, some intellectually, and some from fear or pressure, but mostly, particularly those who are younger, now learn from positive reinforcement,” Dr. Darling said.

For teaching open procedures at his own institution, Dr. Darling has switched from the traditional model of one-on-one instruction undertaken in the surgical suite to a group approach. The limited number of open cases was the impetus, but group instruction now extends beyond the operating room.

“We have a meeting before the case, when we go over the technical aspects,” Dr. Darling explained. Fellows are asked to envision and describe potential problems and potential solutions.

“We try to make them visualize as well as verbalize exactly what will be done in the operating room,” Dr. Darling said. The plans are outlined carefully “so no one does any thinking in the OR. All the thinking is done in advance.”

Videos and simulators are teaching aids, but a great deal of learning can be accomplished independent of doing, according to Dr. Darling. Moreover, understanding the anatomy, which comes before developing surgical skills, is the same for open and endovascular procedures, so each is relevant to the other.

After witnessing an open case, all of the trainees along with the nurses and attending physicians go through a debriefing to consider the potential lessons. At Dr. Darling’s center, open procedures increasingly involve sicker and older patients, conferring case analysis with a particularly vital learning function in the curriculum.

Because of the diminishing number of open cases and the diminishing open skills, even among experienced vascular surgeons, residents in an increasing number of training programs “graduate without any open experience, which is a little shocking,” Dr. Darling said.

Importantly, group instruction, although valuable and necessary for exposing residents and fellows to open vascular surgery, has its own lessons to impart even if it was born out of necessity.

“We always emphasize that it is not the sewing that counts, it is the setup that counts,” said Dr. Darling, indicating that this is a clear message when the group is assembled for case planning. The group planning also emphasizes that surgery is a team sport.

“All of us is smarter than one of us,” said Dr. Darling, articulating the implicit message of group training.

Although this is a departure from a bygone era where infallible surgeons ruled the OR, it is fits nicely with changing attitudes about the best attributes of a competent surgeon.

NEW YORK – The dual challenges of teaching open vascular surgery techniques when few are performed and reaching a generation that has a different attitude to absorbing information requires new and innovative approaches, according to an academic surgeon speaking at symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

Ted Bosworth/MDedge News

“The see one, do one, teach one approach to surgical training is no longer possible,” explained R. Clement Darling III, MD, chief of the division of vascular surgery at Albany (N.Y.) Medical Center Hospital.

For open procedures, the problem is a rapidly declining number of cases in the era of endovascular surgery, but Dr. Darling also recommended adjusting training to the outlook and expectations of a new generation. First observed in the millennial generation, an attitude of firm work-related boundaries is also being seen in generation Z. Generation Z, characterized by birth after 1995, is just now beginning to reach residency programs.

“The approach to work-life balance is extremely different for these individuals than it was for my generation,” Dr. Darling said. While previous generations were often motivated by fear and pressure, newer generations appear to respond less well to anxiety.

“People learn differently. Some from their tactile sense, some intellectually, and some from fear or pressure, but mostly, particularly those who are younger, now learn from positive reinforcement,” Dr. Darling said.

For teaching open procedures at his own institution, Dr. Darling has switched from the traditional model of one-on-one instruction undertaken in the surgical suite to a group approach. The limited number of open cases was the impetus, but group instruction now extends beyond the operating room.

“We have a meeting before the case, when we go over the technical aspects,” Dr. Darling explained. Fellows are asked to envision and describe potential problems and potential solutions.

“We try to make them visualize as well as verbalize exactly what will be done in the operating room,” Dr. Darling said. The plans are outlined carefully “so no one does any thinking in the OR. All the thinking is done in advance.”

Videos and simulators are teaching aids, but a great deal of learning can be accomplished independent of doing, according to Dr. Darling. Moreover, understanding the anatomy, which comes before developing surgical skills, is the same for open and endovascular procedures, so each is relevant to the other.

After witnessing an open case, all of the trainees along with the nurses and attending physicians go through a debriefing to consider the potential lessons. At Dr. Darling’s center, open procedures increasingly involve sicker and older patients, conferring case analysis with a particularly vital learning function in the curriculum.

Because of the diminishing number of open cases and the diminishing open skills, even among experienced vascular surgeons, residents in an increasing number of training programs “graduate without any open experience, which is a little shocking,” Dr. Darling said.

Importantly, group instruction, although valuable and necessary for exposing residents and fellows to open vascular surgery, has its own lessons to impart even if it was born out of necessity.

“We always emphasize that it is not the sewing that counts, it is the setup that counts,” said Dr. Darling, indicating that this is a clear message when the group is assembled for case planning. The group planning also emphasizes that surgery is a team sport.

“All of us is smarter than one of us,” said Dr. Darling, articulating the implicit message of group training.

Although this is a departure from a bygone era where infallible surgeons ruled the OR, it is fits nicely with changing attitudes about the best attributes of a competent surgeon.

NEW YORK – The dual challenges of teaching open vascular surgery techniques when few are performed and reaching a generation that has a different attitude to absorbing information requires new and innovative approaches, according to an academic surgeon speaking at symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation.

Ted Bosworth/MDedge News

“The see one, do one, teach one approach to surgical training is no longer possible,” explained R. Clement Darling III, MD, chief of the division of vascular surgery at Albany (N.Y.) Medical Center Hospital.

For open procedures, the problem is a rapidly declining number of cases in the era of endovascular surgery, but Dr. Darling also recommended adjusting training to the outlook and expectations of a new generation. First observed in the millennial generation, an attitude of firm work-related boundaries is also being seen in generation Z. Generation Z, characterized by birth after 1995, is just now beginning to reach residency programs.

“The approach to work-life balance is extremely different for these individuals than it was for my generation,” Dr. Darling said. While previous generations were often motivated by fear and pressure, newer generations appear to respond less well to anxiety.

“People learn differently. Some from their tactile sense, some intellectually, and some from fear or pressure, but mostly, particularly those who are younger, now learn from positive reinforcement,” Dr. Darling said.

For teaching open procedures at his own institution, Dr. Darling has switched from the traditional model of one-on-one instruction undertaken in the surgical suite to a group approach. The limited number of open cases was the impetus, but group instruction now extends beyond the operating room.

“We have a meeting before the case, when we go over the technical aspects,” Dr. Darling explained. Fellows are asked to envision and describe potential problems and potential solutions.

“We try to make them visualize as well as verbalize exactly what will be done in the operating room,” Dr. Darling said. The plans are outlined carefully “so no one does any thinking in the OR. All the thinking is done in advance.”

Videos and simulators are teaching aids, but a great deal of learning can be accomplished independent of doing, according to Dr. Darling. Moreover, understanding the anatomy, which comes before developing surgical skills, is the same for open and endovascular procedures, so each is relevant to the other.

After witnessing an open case, all of the trainees along with the nurses and attending physicians go through a debriefing to consider the potential lessons. At Dr. Darling’s center, open procedures increasingly involve sicker and older patients, conferring case analysis with a particularly vital learning function in the curriculum.

Because of the diminishing number of open cases and the diminishing open skills, even among experienced vascular surgeons, residents in an increasing number of training programs “graduate without any open experience, which is a little shocking,” Dr. Darling said.

Importantly, group instruction, although valuable and necessary for exposing residents and fellows to open vascular surgery, has its own lessons to impart even if it was born out of necessity.

“We always emphasize that it is not the sewing that counts, it is the setup that counts,” said Dr. Darling, indicating that this is a clear message when the group is assembled for case planning. The group planning also emphasizes that surgery is a team sport.

“All of us is smarter than one of us,” said Dr. Darling, articulating the implicit message of group training.

Although this is a departure from a bygone era where infallible surgeons ruled the OR, it is fits nicely with changing attitudes about the best attributes of a competent surgeon.

NEW YORK – Numerous experts, including a past president of the Society for Clinical Vascular Surgery, lined up at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation to explain why there is a critical need for a separate vascular surgery board with membership on the American Board of Medical Specialties.

Ted Bosworth/MDedge News

Not least of the reasons is, “We need to control our destiny by training more residents and fellows in vascular surgery,” said Alan M. Dietzek, MD, who served as SCVS president in 2018 and is an active vascular surgeon in Danbury, Conn.

According to Dr. Dietzek, the American Board of Surgeons recently rejected an application for a vascular resident review committee (RRC), which develops and controls training within a specialty.

“A vascular surgery RRC would facilitate more applications [for training] as well as innovations in specialized programs, which we could certainly use in aortic and venous fellowships,” Dr. Dietzek said. “All ABMS-recognized boards have their own RRC.”

Other speakers, including Timothy M. Sullivan, MD, a professor of surgery at the University of Minnesota, Minneapolis, made the same point. He also believes that a vascular surgery RRC is pivotal in establishing recognition for the specialty and what it offers.

From his perspective, O. William Brown, MD, a vascular surgeon from Bingham Falls, Minn., believes that creating a vascular surgery board will increase recognition in general. Like the others, he maintained that an independent board could draw attention to the specific skills of vascular surgeons, creating a basis for attracting patients, advocating for their needs, and lobbying for resources.

Many experts, including Dr. Brown, believe that the specialty of vascular surgery already meets the qualifications for creating an independent board. However, Dr. Dietzek said that membership in ABMS is dependent on support from the Society of Vascular Surgeons, “and we don’t have that yet.”

In the title of his talk on creating a vascular surgery board, Dr. Brown called for the SVS Executive Committee to “recognize this need and go after it with full force.”

Dr. Dietzek believes the SVS should survey the membership. If there is support for an independent board, it should move ahead with the appropriate support.

“Can we afford it? Other small boards have done just fine,” said Dr. Dietzek, citing the American Board of Colorectal Surgery and the American Board of Thoracic Surgery. He said both are doing well financially, and he provided estimates suggesting that a vascular surgery board would also achieve firm financial footing.

The value of an independent board in exercising control over training programs is part of a larger issue of self-determination, according to Dr. Dietzek. For example, vascular surgeons have “little or no control over the priorities or the budget” at most institutions where they work. An established and recognized vascular surgery board could help these specialists define their identity and separate from other surgical specialties to create their own divisions or departments.

Others who spoke on this topic agreed. Many expressed concern about marginalization by hospital administrators who are often unclear on what vascular surgeons do. A vascular surgery board has the potential to provide a degree of stature that is now lacking.

“We need to build relationships with hospital administrators, politicians, and the insurance industry. This is critical,” Dr. Dietzek said. He believes a vascular surgery board offers an opportunity to achieve these goals and “help us control our own destiny.”

Dr. Dietzek and the other participants report no financial conflicts of interest relevant to this topic.

NEW YORK – Numerous experts, including a past president of the Society for Clinical Vascular Surgery, lined up at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation to explain why there is a critical need for a separate vascular surgery board with membership on the American Board of Medical Specialties.

Ted Bosworth/MDedge News

Not least of the reasons is, “We need to control our destiny by training more residents and fellows in vascular surgery,” said Alan M. Dietzek, MD, who served as SCVS president in 2018 and is an active vascular surgeon in Danbury, Conn.

According to Dr. Dietzek, the American Board of Surgeons recently rejected an application for a vascular resident review committee (RRC), which develops and controls training within a specialty.

“A vascular surgery RRC would facilitate more applications [for training] as well as innovations in specialized programs, which we could certainly use in aortic and venous fellowships,” Dr. Dietzek said. “All ABMS-recognized boards have their own RRC.”

Other speakers, including Timothy M. Sullivan, MD, a professor of surgery at the University of Minnesota, Minneapolis, made the same point. He also believes that a vascular surgery RRC is pivotal in establishing recognition for the specialty and what it offers.

From his perspective, O. William Brown, MD, a vascular surgeon from Bingham Falls, Minn., believes that creating a vascular surgery board will increase recognition in general. Like the others, he maintained that an independent board could draw attention to the specific skills of vascular surgeons, creating a basis for attracting patients, advocating for their needs, and lobbying for resources.

Many experts, including Dr. Brown, believe that the specialty of vascular surgery already meets the qualifications for creating an independent board. However, Dr. Dietzek said that membership in ABMS is dependent on support from the Society of Vascular Surgeons, “and we don’t have that yet.”

In the title of his talk on creating a vascular surgery board, Dr. Brown called for the SVS Executive Committee to “recognize this need and go after it with full force.”

Dr. Dietzek believes the SVS should survey the membership. If there is support for an independent board, it should move ahead with the appropriate support.

“Can we afford it? Other small boards have done just fine,” said Dr. Dietzek, citing the American Board of Colorectal Surgery and the American Board of Thoracic Surgery. He said both are doing well financially, and he provided estimates suggesting that a vascular surgery board would also achieve firm financial footing.

The value of an independent board in exercising control over training programs is part of a larger issue of self-determination, according to Dr. Dietzek. For example, vascular surgeons have “little or no control over the priorities or the budget” at most institutions where they work. An established and recognized vascular surgery board could help these specialists define their identity and separate from other surgical specialties to create their own divisions or departments.

Others who spoke on this topic agreed. Many expressed concern about marginalization by hospital administrators who are often unclear on what vascular surgeons do. A vascular surgery board has the potential to provide a degree of stature that is now lacking.

“We need to build relationships with hospital administrators, politicians, and the insurance industry. This is critical,” Dr. Dietzek said. He believes a vascular surgery board offers an opportunity to achieve these goals and “help us control our own destiny.”

Dr. Dietzek and the other participants report no financial conflicts of interest relevant to this topic.

NEW YORK – Numerous experts, including a past president of the Society for Clinical Vascular Surgery, lined up at a symposium on vascular and endovascular issues sponsored by the Cleveland Clinic Foundation to explain why there is a critical need for a separate vascular surgery board with membership on the American Board of Medical Specialties.

Ted Bosworth/MDedge News

Not least of the reasons is, “We need to control our destiny by training more residents and fellows in vascular surgery,” said Alan M. Dietzek, MD, who served as SCVS president in 2018 and is an active vascular surgeon in Danbury, Conn.

According to Dr. Dietzek, the American Board of Surgeons recently rejected an application for a vascular resident review committee (RRC), which develops and controls training within a specialty.

“A vascular surgery RRC would facilitate more applications [for training] as well as innovations in specialized programs, which we could certainly use in aortic and venous fellowships,” Dr. Dietzek said. “All ABMS-recognized boards have their own RRC.”

Other speakers, including Timothy M. Sullivan, MD, a professor of surgery at the University of Minnesota, Minneapolis, made the same point. He also believes that a vascular surgery RRC is pivotal in establishing recognition for the specialty and what it offers.

From his perspective, O. William Brown, MD, a vascular surgeon from Bingham Falls, Minn., believes that creating a vascular surgery board will increase recognition in general. Like the others, he maintained that an independent board could draw attention to the specific skills of vascular surgeons, creating a basis for attracting patients, advocating for their needs, and lobbying for resources.

Many experts, including Dr. Brown, believe that the specialty of vascular surgery already meets the qualifications for creating an independent board. However, Dr. Dietzek said that membership in ABMS is dependent on support from the Society of Vascular Surgeons, “and we don’t have that yet.”

In the title of his talk on creating a vascular surgery board, Dr. Brown called for the SVS Executive Committee to “recognize this need and go after it with full force.”

Dr. Dietzek believes the SVS should survey the membership. If there is support for an independent board, it should move ahead with the appropriate support.

“Can we afford it? Other small boards have done just fine,” said Dr. Dietzek, citing the American Board of Colorectal Surgery and the American Board of Thoracic Surgery. He said both are doing well financially, and he provided estimates suggesting that a vascular surgery board would also achieve firm financial footing.

The value of an independent board in exercising control over training programs is part of a larger issue of self-determination, according to Dr. Dietzek. For example, vascular surgeons have “little or no control over the priorities or the budget” at most institutions where they work. An established and recognized vascular surgery board could help these specialists define their identity and separate from other surgical specialties to create their own divisions or departments.

Others who spoke on this topic agreed. Many expressed concern about marginalization by hospital administrators who are often unclear on what vascular surgeons do. A vascular surgery board has the potential to provide a degree of stature that is now lacking.

“We need to build relationships with hospital administrators, politicians, and the insurance industry. This is critical,” Dr. Dietzek said. He believes a vascular surgery board offers an opportunity to achieve these goals and “help us control our own destiny.”

Dr. Dietzek and the other participants report no financial conflicts of interest relevant to this topic.

People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.

“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.

Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.

Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.

PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.

“The findings associate for the first time a behavioral measure of PUM ... with neural anomalies in reward processing,” they wrote. “The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”

The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.

The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.

cpalmer@mdedge.com

SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.

People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.

“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.

Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.

Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.

PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.

“The findings associate for the first time a behavioral measure of PUM ... with neural anomalies in reward processing,” they wrote. “The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”

The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.

The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.

cpalmer@mdedge.com

SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.

People with remitted bipolar I disorder appear to show lower rather than higher activity in the ventral striatum in anticipation of monetary gains, compared with controls, results of a small study suggest. In addition, associations were found between positive urgency measure (PUM) and blunted activity in the nucleus accumbens in individuals with bipolar I.

“Together, these findings suggest that individuals with remitted bipolar disorder show blunted ventral striatal responses during anticipation of conventional rewards (e.g., money),” wrote lead author Sheri L. Johnson, PhD, and associates. The study was published in Neuroimage: Clinical.

Dr. Johnson’s team recruited the participants through advertisements online and in the community. Their study included 24 people with bipolar I (14 men; mean age, 36.22 years) and 24 controls without bipolar (13 men; mean age, 33.92 years), reported Dr. Johnson, of the University of California, Berkeley, and associates. The investigators used a version of the Monetary Incentive Delay Task to elicit neural and behavioral responses and their outcomes during fMRI.

Whole brain analyses found that, compared with the control group, those in the bipolar group “showed less activity for the gain anticipation contrast specifically in the ventral striatum (including the right [nucleus accumbens] and right globus pallidus), as well as less activity for the gain outcome contrast in the left occipital gyrus,” the investigators wrote.

PUM, a dimensional trait, was designed to assess tendencies to act “regrettably” or “impulsively” during states of positive emotion. PUM scores have been correlated with outcomes such as lower functioning in behavior, decreased quality of life, and worse outcomes in bipolar disorder. The investigators hoped that, by including PUM to help evaluate group differences, they could account for inconsistent findings regarding associations of neural imaging and reward responses.

“The findings associate for the first time a behavioral measure of PUM ... with neural anomalies in reward processing,” they wrote. “The current findings imply that, in individuals with bipolar disorder, individual differences in PUM may also help account for blunted [nucleus accumbens] during reward anticipation.”

The study’s sample size limited the power to detect small effects or interactions. The researchers felt, though, that the sample was well matched and adequately powered for the primary variables of interest.

The authors had no conflicts of interest to disclose. The study was funded by a grant from the National Institute of Mental Health.

cpalmer@mdedge.com

SOURCE: Johnson SL et al. Neuroimage Clin. 2019. doi: 10.1016/j.nicl.2019.102018.

The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.

Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.

“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”

The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

Find the full press release and more information on other ranitidine recalls on the FDA website.

lfranki@mdedge.com

The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.

Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.

“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”

The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

Find the full press release and more information on other ranitidine recalls on the FDA website.

lfranki@mdedge.com

The ranitidine recall saga continues as two more companies have issued voluntary recalls of their repackaged ranitidine products because of possibly unacceptable levels of N-nitrosodimethylamine (NDMA), according to the Food and Drug Administration.

Golden State Medical Supply has recalled 150-mg and 300-mg ranitidine capsules, manufactured by Novitium, and Precision Dose has recalled a ranitidine oral solution at 150 mg/mL, manufactured by Amneal Pharmaceuticals.

“FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 ng/day or 0.32 parts per million for ranitidine),” the FDA said. The agency has “posted the results of its testing of ranitidine samples and has asked companies to conduct their own laboratory testing.”

The FDA added that consumers taking over-the-counter ranitidine can consider alternatives such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).

Find the full press release and more information on other ranitidine recalls on the FDA website.

lfranki@mdedge.com

BOSTON – Treatment of persons who inject drugs, updates in pangenotypic direct-acting antiviral therapy, the benefits of sustained virologic response, and preemptive therapy in donor-positive organ transplantation topped the list of notable hepatitis C–related abstracts this year at the annual meeting of the American Association for the Study of Liver Diseases.

That’s according to Marc Ghany, MD, of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, who gave a hepatitis C debrief to attendees on the final day of the meeting. Here are some of the meeting highlights as summarized by Dr. Ghany in this well-attended last-day session.
 

Treatment of HCV in people who inject drugs

Emerging data suggest it is feasible to treat hepatitis C virus (HCV) infection in persons who inject drugs (PWIDs); however, overcoming adherence issues remains a challenge, Dr. Ghany told attendees.

According to one study presented at AASLD by Dhiman and coauthors (Abstract 0165), decentralized care of PWIDs using direct-acting antiviral (DAA) therapy was safe and effective, even in those with cirrhosis. Authors demonstrated an “impressive” rate of sustained virologic response at 12 weeks (SVR12) of 91% by a modified intention-to-treat analysis, Dr. Ghany said; however, treatment interruptions were frequent and reduced the overall SVR rate in the study to 78%.

Other studies at the meeting looked at strategies to improve DAA efficacy in this population of patients at high risk of nonadherence, including use of a digital medicine program (Abstract 1554) and a model of care in which an internist-addiction medicine specialist evaluated opiate-dependent patients for HCV infection in a hepatology clinic (Abstract 1589).

Reinfection remains a focus of research in PWIDs. At this meeting, Janjua and coauthors reported that DAA-treated PWIDs in British Columbia had a threefold higher rate of reinfection versus non-PWIDs; however, there were no detected reinfections among PWIDs who had received uninterrupted opioid agonist therapy. “These data suggested that opioid agonist therapy should be given before and after HCV treatment in persons who inject drugs to prevent the infection,” Dr. Ghany said in his presentation.
 

Updates on pangenotypic DAA therapy

Jonas and coauthors (Abstract 1551) reported on the safety and efficacy of glecaprevir/pibrentasvir for 8 weeks in children with chronic HCV infection enrolled in the ongoing phase 2/3 DORA study. The SVR12 was high, according to Dr. Ghany, at 96% overall, and consistent across age cohorts from 3 to less than 12 years of age.

“In the near future, we should have a safe and effective regimen (approved) for children 3 years or older,” Dr. Ghany said. “I think this will serve us well, as we try to eliminate HCV in children, who number up to 5 million cases worldwide.”

A short course of glecaprevir/pibrentasvir is approved for patients with HCV and compensated cirrhosis, and data to support that was presented last year at The Liver Meeting; however, data were not presented on patients with genotype 3, the most difficult-to-treat genotype, Dr. Ghany said. That gap was filled at this year’s meeting with a report (Abstract LP9) showing SVR12 rates of 98.4% per protocol and 95.2% in intention-to-treat analysis.
 

Relationship of SVR to clinical outcomes

While the impact of sustained virologic response (SVR) on all-cause mortality is clear in patients with HCV, less is known about the effect of SVR on liver-related mortality and other outcomes, Dr. Ghany said. In one study presented here (Abstract 0039), based on analysis of a Veterans Affairs database of patients with chronic HCV infection, SVR was linked to a significant reduction in liver-related mortality, while in another report (Abstract 0037), SVR was associated with significant reductions in acute coronary syndromes, end-stage renal disease, and ischemic stroke.

Similarly, a multinational, propensity score–matched analysis (Abstract 0040) demonstrated that SVR had an impact on 5-year overall survival and liver-related survival in patients with HCV-related hepatocellular carcinoma (HCC). “For HCC patients who are candidates for HCC therapy, consideration should also be given to treating these individuals (with DAA therapy) because of the impact on overall survival,” Dr. Ghany said.
 

Preemptive DAA therapy in organ transplantation

Exciting new data show that preemptive therapy, given for short durations, appears to either prevent or cure HCV infection after organ transplant, said Dr. Ghany.

A retrospective analysis by Wijarnpreecha and colleagues (Abstract 0003) showed that 12 or 24 weeks of direct-acting antiviral (DAA) therapy resulted in an SVR12 for 24 out of 24 HCV-seropositive to HCV-seronegative liver transplants, while Durand and colleagues (Abstract 0042) showed that just 4 weeks of pre- and postexposure DAA prophylaxis resulted in SVR12s for 9 out of 9 HCV donor-positive, recipient-negative kidney transplants. Finally, Feld and coauthors (Abstract 0038) showed that preemptive ezetimibe with DAA therapy for 7 days prevented or rapidly cured infection in an experience that included 16 HCV-positive organ donors and 25 HCV-negative recipients.

“While these data are very encouraging, I think we do need to have long-term follow-up of these patients for graft survival, as well as the effect on wait times,” Dr. Ghany said.

Dr. Ghany reported no disclosures related to his presentation.

BOSTON – Treatment of persons who inject drugs, updates in pangenotypic direct-acting antiviral therapy, the benefits of sustained virologic response, and preemptive therapy in donor-positive organ transplantation topped the list of notable hepatitis C–related abstracts this year at the annual meeting of the American Association for the Study of Liver Diseases.

That’s according to Marc Ghany, MD, of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, who gave a hepatitis C debrief to attendees on the final day of the meeting. Here are some of the meeting highlights as summarized by Dr. Ghany in this well-attended last-day session.
 

Treatment of HCV in people who inject drugs

Emerging data suggest it is feasible to treat hepatitis C virus (HCV) infection in persons who inject drugs (PWIDs); however, overcoming adherence issues remains a challenge, Dr. Ghany told attendees.

According to one study presented at AASLD by Dhiman and coauthors (Abstract 0165), decentralized care of PWIDs using direct-acting antiviral (DAA) therapy was safe and effective, even in those with cirrhosis. Authors demonstrated an “impressive” rate of sustained virologic response at 12 weeks (SVR12) of 91% by a modified intention-to-treat analysis, Dr. Ghany said; however, treatment interruptions were frequent and reduced the overall SVR rate in the study to 78%.

Other studies at the meeting looked at strategies to improve DAA efficacy in this population of patients at high risk of nonadherence, including use of a digital medicine program (Abstract 1554) and a model of care in which an internist-addiction medicine specialist evaluated opiate-dependent patients for HCV infection in a hepatology clinic (Abstract 1589).

Reinfection remains a focus of research in PWIDs. At this meeting, Janjua and coauthors reported that DAA-treated PWIDs in British Columbia had a threefold higher rate of reinfection versus non-PWIDs; however, there were no detected reinfections among PWIDs who had received uninterrupted opioid agonist therapy. “These data suggested that opioid agonist therapy should be given before and after HCV treatment in persons who inject drugs to prevent the infection,” Dr. Ghany said in his presentation.
 

Updates on pangenotypic DAA therapy

Jonas and coauthors (Abstract 1551) reported on the safety and efficacy of glecaprevir/pibrentasvir for 8 weeks in children with chronic HCV infection enrolled in the ongoing phase 2/3 DORA study. The SVR12 was high, according to Dr. Ghany, at 96% overall, and consistent across age cohorts from 3 to less than 12 years of age.

“In the near future, we should have a safe and effective regimen (approved) for children 3 years or older,” Dr. Ghany said. “I think this will serve us well, as we try to eliminate HCV in children, who number up to 5 million cases worldwide.”

A short course of glecaprevir/pibrentasvir is approved for patients with HCV and compensated cirrhosis, and data to support that was presented last year at The Liver Meeting; however, data were not presented on patients with genotype 3, the most difficult-to-treat genotype, Dr. Ghany said. That gap was filled at this year’s meeting with a report (Abstract LP9) showing SVR12 rates of 98.4% per protocol and 95.2% in intention-to-treat analysis.
 

Relationship of SVR to clinical outcomes

While the impact of sustained virologic response (SVR) on all-cause mortality is clear in patients with HCV, less is known about the effect of SVR on liver-related mortality and other outcomes, Dr. Ghany said. In one study presented here (Abstract 0039), based on analysis of a Veterans Affairs database of patients with chronic HCV infection, SVR was linked to a significant reduction in liver-related mortality, while in another report (Abstract 0037), SVR was associated with significant reductions in acute coronary syndromes, end-stage renal disease, and ischemic stroke.

Similarly, a multinational, propensity score–matched analysis (Abstract 0040) demonstrated that SVR had an impact on 5-year overall survival and liver-related survival in patients with HCV-related hepatocellular carcinoma (HCC). “For HCC patients who are candidates for HCC therapy, consideration should also be given to treating these individuals (with DAA therapy) because of the impact on overall survival,” Dr. Ghany said.
 

Preemptive DAA therapy in organ transplantation

Exciting new data show that preemptive therapy, given for short durations, appears to either prevent or cure HCV infection after organ transplant, said Dr. Ghany.

A retrospective analysis by Wijarnpreecha and colleagues (Abstract 0003) showed that 12 or 24 weeks of direct-acting antiviral (DAA) therapy resulted in an SVR12 for 24 out of 24 HCV-seropositive to HCV-seronegative liver transplants, while Durand and colleagues (Abstract 0042) showed that just 4 weeks of pre- and postexposure DAA prophylaxis resulted in SVR12s for 9 out of 9 HCV donor-positive, recipient-negative kidney transplants. Finally, Feld and coauthors (Abstract 0038) showed that preemptive ezetimibe with DAA therapy for 7 days prevented or rapidly cured infection in an experience that included 16 HCV-positive organ donors and 25 HCV-negative recipients.

“While these data are very encouraging, I think we do need to have long-term follow-up of these patients for graft survival, as well as the effect on wait times,” Dr. Ghany said.

Dr. Ghany reported no disclosures related to his presentation.

BOSTON – Treatment of persons who inject drugs, updates in pangenotypic direct-acting antiviral therapy, the benefits of sustained virologic response, and preemptive therapy in donor-positive organ transplantation topped the list of notable hepatitis C–related abstracts this year at the annual meeting of the American Association for the Study of Liver Diseases.

That’s according to Marc Ghany, MD, of the liver diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health, who gave a hepatitis C debrief to attendees on the final day of the meeting. Here are some of the meeting highlights as summarized by Dr. Ghany in this well-attended last-day session.
 

Treatment of HCV in people who inject drugs

Emerging data suggest it is feasible to treat hepatitis C virus (HCV) infection in persons who inject drugs (PWIDs); however, overcoming adherence issues remains a challenge, Dr. Ghany told attendees.

According to one study presented at AASLD by Dhiman and coauthors (Abstract 0165), decentralized care of PWIDs using direct-acting antiviral (DAA) therapy was safe and effective, even in those with cirrhosis. Authors demonstrated an “impressive” rate of sustained virologic response at 12 weeks (SVR12) of 91% by a modified intention-to-treat analysis, Dr. Ghany said; however, treatment interruptions were frequent and reduced the overall SVR rate in the study to 78%.

Other studies at the meeting looked at strategies to improve DAA efficacy in this population of patients at high risk of nonadherence, including use of a digital medicine program (Abstract 1554) and a model of care in which an internist-addiction medicine specialist evaluated opiate-dependent patients for HCV infection in a hepatology clinic (Abstract 1589).

Reinfection remains a focus of research in PWIDs. At this meeting, Janjua and coauthors reported that DAA-treated PWIDs in British Columbia had a threefold higher rate of reinfection versus non-PWIDs; however, there were no detected reinfections among PWIDs who had received uninterrupted opioid agonist therapy. “These data suggested that opioid agonist therapy should be given before and after HCV treatment in persons who inject drugs to prevent the infection,” Dr. Ghany said in his presentation.
 

Updates on pangenotypic DAA therapy

Jonas and coauthors (Abstract 1551) reported on the safety and efficacy of glecaprevir/pibrentasvir for 8 weeks in children with chronic HCV infection enrolled in the ongoing phase 2/3 DORA study. The SVR12 was high, according to Dr. Ghany, at 96% overall, and consistent across age cohorts from 3 to less than 12 years of age.

“In the near future, we should have a safe and effective regimen (approved) for children 3 years or older,” Dr. Ghany said. “I think this will serve us well, as we try to eliminate HCV in children, who number up to 5 million cases worldwide.”

A short course of glecaprevir/pibrentasvir is approved for patients with HCV and compensated cirrhosis, and data to support that was presented last year at The Liver Meeting; however, data were not presented on patients with genotype 3, the most difficult-to-treat genotype, Dr. Ghany said. That gap was filled at this year’s meeting with a report (Abstract LP9) showing SVR12 rates of 98.4% per protocol and 95.2% in intention-to-treat analysis.
 

Relationship of SVR to clinical outcomes

While the impact of sustained virologic response (SVR) on all-cause mortality is clear in patients with HCV, less is known about the effect of SVR on liver-related mortality and other outcomes, Dr. Ghany said. In one study presented here (Abstract 0039), based on analysis of a Veterans Affairs database of patients with chronic HCV infection, SVR was linked to a significant reduction in liver-related mortality, while in another report (Abstract 0037), SVR was associated with significant reductions in acute coronary syndromes, end-stage renal disease, and ischemic stroke.

Similarly, a multinational, propensity score–matched analysis (Abstract 0040) demonstrated that SVR had an impact on 5-year overall survival and liver-related survival in patients with HCV-related hepatocellular carcinoma (HCC). “For HCC patients who are candidates for HCC therapy, consideration should also be given to treating these individuals (with DAA therapy) because of the impact on overall survival,” Dr. Ghany said.
 

Preemptive DAA therapy in organ transplantation

Exciting new data show that preemptive therapy, given for short durations, appears to either prevent or cure HCV infection after organ transplant, said Dr. Ghany.

A retrospective analysis by Wijarnpreecha and colleagues (Abstract 0003) showed that 12 or 24 weeks of direct-acting antiviral (DAA) therapy resulted in an SVR12 for 24 out of 24 HCV-seropositive to HCV-seronegative liver transplants, while Durand and colleagues (Abstract 0042) showed that just 4 weeks of pre- and postexposure DAA prophylaxis resulted in SVR12s for 9 out of 9 HCV donor-positive, recipient-negative kidney transplants. Finally, Feld and coauthors (Abstract 0038) showed that preemptive ezetimibe with DAA therapy for 7 days prevented or rapidly cured infection in an experience that included 16 HCV-positive organ donors and 25 HCV-negative recipients.

“While these data are very encouraging, I think we do need to have long-term follow-up of these patients for graft survival, as well as the effect on wait times,” Dr. Ghany said.

Dr. Ghany reported no disclosures related to his presentation.

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.

In this edition of “How I Will Treat My Next Patient,” I highlight two articles that demonstrate the safety of established treatments – nephrectomy and stereotactic ablative body radiotherapy (SABR) – in patient populations that previously may have been excluded from those treatments at many centers.

Nephrectomy in advanced RCC

Nirmish Singla, MD, and colleagues reported a single-center retrospective cohort study, assessing outcomes of 11 nephrectomies (10 radical, 1 partial) in 10 patients with advanced renal cell carcinoma (RCC) who had received front- or later-line immune checkpoint inhibitor therapy (ICIs). Half had received nivolumab alone; the others received nivolumab plus ipilimumab. Surgery was performed laparoscopically in five cases (Urol Oncol. 2019 Dec;37[12]:924-31).

No patient experienced a major intraoperative complication. Four experienced postoperative complications, the majority of which were addressed with interventional radiology procedures. The median hospital stay was 4 days. One patient died of progressive disease more than 3 months after surgery, and another died of pulmonary embolism and sepsis. Six of the 10 patients did not have any complications or readmissions. There were no immune-related toxicities and no wound-healing issues. ICI therapy was resumed postoperatively in six patients.

At nephrectomy (plus or minus metastatectomy), one patient achieved a response to immunotherapy in the primary tumor, and three of four patients who underwent resection of hepatic, pulmonary, or adrenal metastases had no detectable cancer. All surgical margins were negative.

During a median postoperative follow-up of 180 days, nephrectomy following ICI was safe. Pathologic response in both the primary tumor and metastatic sites was encouraging.

What this means in clinical practice

In medical school, all of us are admonished not to be afraid to unlearn something and to learn something new. Historically, nephrectomy was felt to be helpful in improving overall survival in patients with advanced RCC. Effective targeted therapies and ICIs have caused us to question the role of nephrectomy and its timing, since 20%-40% of patients who have apparently localized RCC at the time of nephrectomy develop recurrences within 3 years. Preoperative therapy could mitigate potentially aggressive tumor biology, treat micrometastatic disease, and help select patients who should not be treated surgically.

In the CARMENA trial of the treatment of advanced RCC patients with the tyrosine kinase inhibitor sunitinib versus nephrectomy followed by sunitinib, most patients could avoid nephrectomy without compromising survival (N Engl J Med. 2018; 379:417-27). Results were updated at the 2019 annual meeting of the American Society of Clinical Oncology. Overall, nephrectomy was not beneficial. However, delayed nephrectomy (after sunitinib) appeared be beneficial for good responders with only one IMDC (International Metastatic RCC Database Consortium) risk factor and only one metastatic site.

The small study by Dr. Singla and colleagues illustrates that nephrectomy is feasible after ICI, plus or minus anti-CTLA4-targeted treatment, and that favorable histologic results can be achieved. With ICI plus or minus anti-CTLA4-targeted treatment, no patient had progressive disease prior to surgery. This experience is germane in view of recently updated results of the CheckMate 214 trial, showing superior overall survival, response rates, and response duration for nivolumab plus ipilimumab, in comparison with sunitinib.

There are still unresolved questions, including whether these favorable outcomes can be achieved in community practice and whether there are genomic or immunohistochemistry expression profiles to select patients who can benefit from this approach. It’s unclear whether there are practical issues that influence outcome, such as type of ICI, number of preoperative treatment cycles, and additional systemic therapies including postoperative treatment. However, the current series rings the starting bell for the study of those questions and a promising era for patients with this deadly disease.
 

SABR in moderately central NSCLC

SABR to peripheral, small non–small cell lung cancers (NSCLCs) produces high local control rates, with low grade 3-4 toxicity, and is an alternative to resection in patients who are unfit for surgery. In a pragmatic, community-based, prospective cohort experience in Scotland, Robert Rulach, MBChB, and colleagues, treated 50 T1-2N0M0 NSCLC patients with SABR 50-Gy in five fractions (Clin Oncol. 2019 Oct 10. doi: 10.1016/j.clon.2019.09.055). The dose and fractionation schedule was safe and effective in the phase 1/2 RTOG 0813 trial and is concordant with guidelines from the National Comprehensive Cancer Network (NCCN).

All of the tumors were moderately central, as in the RTOG trial. One patient had an additional tumor that was ultracentral. Notably, 84% of patients were deemed medically unfit for surgery.

All patients completed radiotherapy without treatment delays. Two patients died within 90 days of treatment. There were no grade 4 or grade 5 toxicities and the overall rate of grade 3 toxicity was 4%. With a median follow-up of 25.2 months, 34 patients died: 18 from causes unrelated to cancer and 16 from cancer recurrence. The median overall survival was 27 months. The 2-year overall survival rate was 67.6%, commensurate with the rate seen in RTOG 0813.

The researchers concluded that, for frail patients with centrally-located NSCLC treated uniformly in a community practice, SABR with the RTOG 0813 treatment protocol produced acceptable toxicity and overall survival comparable with the published literature.

What this means in clinical practice

The results and conclusions of the study by Dr. Rulach and colleagues are straightforward: SABR can be used for centrally-located NSCLC without producing massive hemoptysis, bronchial stricture, and fistula formation. Since the majority of patients had no histologic diagnosis, T1N0 lesions, and no routine follow-up CT scans beyond 3 months post treatment, conclusions beyond that are unjustified.

In a community-based practice, NCCN guideline–concordant SABR treatment in moderately centrally-located NSCLC was safely delivered. For the burgeoning population of medically inoperable and/or elderly NSCLC patients, this alone is reassuring for clinicians and is helpful information for patients who require and/or desire nonsurgical treatment.
 

Dr. Lyss has been a community-based medical oncologist and clinical researcher for more than 35 years, practicing in St. Louis. His clinical and research interests are in the prevention, diagnosis, and treatment of breast and lung cancers and in expanding access to clinical trials to medically underserved populations.