Federal Practitioner

Yao and colleagues confirmed that there are well-known risk factors for recurrence of HCC after surgical resection. They retrospectively analyzed 1424 patients who underwent resection with curative intent for Barcelona Clinical Liver Cancer (BCLC) stage 0/A HCC in several centers in China. Of those patients, 679 (47.7%) developed recurrence at a median follow-up of 54.8 months, including 408 (60.1%) with an early recurrence (≤ 2 years after surgery) and 271 (39.9%) with a late recurrence (> 2 years). Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative alpha-fetoprotein (AFP) level > 400 µg/L (aHR 1.28; P = .004), tumor size > 5 cm (aHR 1.74; P < .001), the presence of satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative HCC recurrence. The authors concluded that those patients with risk factors for recurrence would benefit from more intensive surveillance and potentially additional liver-directed therapy with curative intent.

Not all patients with hepatitis C virus (HCV) infection and HCC are offered antiviral therapy. Takaura and colleagues confirmed that active HCV infection worsens the prognosis of patients with very early-stage HCC who undergo treatment with radiofrequency ablation (RFA). In this single-center retrospective study, 302 patients with BCLC stage 0 HCC who underwent RFA were analyzed. Of those patients, 195 had evidence of HCV, and 132 had an active infection. The authors concluded that active HCV infection was a significant risk factor for shorter overall survival (aHR 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with active HCV infection had a shorter median overall survival (66 months vs 145 months) and recurrence-free survival (20 months vs 31 months) (both P < .001). Therefore, treatment of active HCV should be offered to patients even after the development of HCC.

Kuroda and colleagues retrospectively analyzed a multicenter cohort of 247 patients with unresectable HCC treated with lenvatinib between 2018 and 2020. Out of those, 63 patients who received lenvatinib and transarterial chemoembolization (TACE) sequential therapy were propensity-score matched to those receiving lenvatinib monotherapy. The overall survival and progression-free survival in the sequential group were significantly higher than those in the lenvatinib monotherapy group, 31.2 (26.4-34.3) vs 15.7 (13.1-19.4) months and 12.2 (8.5-17.3) vs 6.7 (5.3-10.2) months (P = .002 and P = .037), respectively. Multivariate analysis showed that the deep response was independently associated with the initial response to levatinib; the partial response showed an odds ratio of 13.75 (95% CI 0.41-1.32; P < .001). The authors concluded that sequential therapy might provide more clinical benefits than lenvatinib monotherapy in patients who responded to initial lenvatinib treatment, with objective response to initial lenvatinib being an independent factor predicting sequential therapy deep response.

Yao and colleagues confirmed that there are well-known risk factors for recurrence of HCC after surgical resection. They retrospectively analyzed 1424 patients who underwent resection with curative intent for Barcelona Clinical Liver Cancer (BCLC) stage 0/A HCC in several centers in China. Of those patients, 679 (47.7%) developed recurrence at a median follow-up of 54.8 months, including 408 (60.1%) with an early recurrence (≤ 2 years after surgery) and 271 (39.9%) with a late recurrence (> 2 years). Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative alpha-fetoprotein (AFP) level > 400 µg/L (aHR 1.28; P = .004), tumor size > 5 cm (aHR 1.74; P < .001), the presence of satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative HCC recurrence. The authors concluded that those patients with risk factors for recurrence would benefit from more intensive surveillance and potentially additional liver-directed therapy with curative intent.

Not all patients with hepatitis C virus (HCV) infection and HCC are offered antiviral therapy. Takaura and colleagues confirmed that active HCV infection worsens the prognosis of patients with very early-stage HCC who undergo treatment with radiofrequency ablation (RFA). In this single-center retrospective study, 302 patients with BCLC stage 0 HCC who underwent RFA were analyzed. Of those patients, 195 had evidence of HCV, and 132 had an active infection. The authors concluded that active HCV infection was a significant risk factor for shorter overall survival (aHR 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with active HCV infection had a shorter median overall survival (66 months vs 145 months) and recurrence-free survival (20 months vs 31 months) (both P < .001). Therefore, treatment of active HCV should be offered to patients even after the development of HCC.

Kuroda and colleagues retrospectively analyzed a multicenter cohort of 247 patients with unresectable HCC treated with lenvatinib between 2018 and 2020. Out of those, 63 patients who received lenvatinib and transarterial chemoembolization (TACE) sequential therapy were propensity-score matched to those receiving lenvatinib monotherapy. The overall survival and progression-free survival in the sequential group were significantly higher than those in the lenvatinib monotherapy group, 31.2 (26.4-34.3) vs 15.7 (13.1-19.4) months and 12.2 (8.5-17.3) vs 6.7 (5.3-10.2) months (P = .002 and P = .037), respectively. Multivariate analysis showed that the deep response was independently associated with the initial response to levatinib; the partial response showed an odds ratio of 13.75 (95% CI 0.41-1.32; P < .001). The authors concluded that sequential therapy might provide more clinical benefits than lenvatinib monotherapy in patients who responded to initial lenvatinib treatment, with objective response to initial lenvatinib being an independent factor predicting sequential therapy deep response.

Yao and colleagues confirmed that there are well-known risk factors for recurrence of HCC after surgical resection. They retrospectively analyzed 1424 patients who underwent resection with curative intent for Barcelona Clinical Liver Cancer (BCLC) stage 0/A HCC in several centers in China. Of those patients, 679 (47.7%) developed recurrence at a median follow-up of 54.8 months, including 408 (60.1%) with an early recurrence (≤ 2 years after surgery) and 271 (39.9%) with a late recurrence (> 2 years). Cirrhosis (adjusted hazard ratio [aHR] 1.49; P < .001), preoperative alpha-fetoprotein (AFP) level > 400 µg/L (aHR 1.28; P = .004), tumor size > 5 cm (aHR 1.74; P < .001), the presence of satellite nodules (aHR 1.35; P = .040), multiple tumors (aHR 1.63; P = .015), microvascular invasion (aHR 1.51; P < .001), and intraoperative blood transfusion (aHR 1.50; P = .013) were identified as independent risk factors associated with postoperative HCC recurrence. The authors concluded that those patients with risk factors for recurrence would benefit from more intensive surveillance and potentially additional liver-directed therapy with curative intent.

Not all patients with hepatitis C virus (HCV) infection and HCC are offered antiviral therapy. Takaura and colleagues confirmed that active HCV infection worsens the prognosis of patients with very early-stage HCC who undergo treatment with radiofrequency ablation (RFA). In this single-center retrospective study, 302 patients with BCLC stage 0 HCC who underwent RFA were analyzed. Of those patients, 195 had evidence of HCV, and 132 had an active infection. The authors concluded that active HCV infection was a significant risk factor for shorter overall survival (aHR 2.17; P = .003) and early recurrence of HCC (aHR 1.47; P = .022). Patients with active HCV infection had a shorter median overall survival (66 months vs 145 months) and recurrence-free survival (20 months vs 31 months) (both P < .001). Therefore, treatment of active HCV should be offered to patients even after the development of HCC.

Kuroda and colleagues retrospectively analyzed a multicenter cohort of 247 patients with unresectable HCC treated with lenvatinib between 2018 and 2020. Out of those, 63 patients who received lenvatinib and transarterial chemoembolization (TACE) sequential therapy were propensity-score matched to those receiving lenvatinib monotherapy. The overall survival and progression-free survival in the sequential group were significantly higher than those in the lenvatinib monotherapy group, 31.2 (26.4-34.3) vs 15.7 (13.1-19.4) months and 12.2 (8.5-17.3) vs 6.7 (5.3-10.2) months (P = .002 and P = .037), respectively. Multivariate analysis showed that the deep response was independently associated with the initial response to levatinib; the partial response showed an odds ratio of 13.75 (95% CI 0.41-1.32; P < .001). The authors concluded that sequential therapy might provide more clinical benefits than lenvatinib monotherapy in patients who responded to initial lenvatinib treatment, with objective response to initial lenvatinib being an independent factor predicting sequential therapy deep response.

CHICAGO - Patients 80 years or older undergoing primary total knee arthroplasty (TKA) have similar odds of complications, compared with 65- to 79-year-old patients, an analysis of more than 1.7 million cases suggests.

Priscilla Varghese, MBA, MS, and an MD candidate at State University of New York, Brooklyn, led the research, presented at the American Academy of Orthopaedic Surgeons 2022 annual meeting.

Ms. Varghese’s team queried a Medicare claims database for the years 2005-2014 and analyzed information from 295,908 octogenarians and 1.4 million control patients aged 65-79 who received TKA.

Study group patients were randomly matched to controls in a 1:5 ratio according to gender and comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, diabetes, peripheral vascular disease, and kidney failure.

Octogenarians were found to have higher incidence and odds of 90-day readmission rates (10.59% vs. 9.35%; odds ratio, 1.15; 95% confidence interval, 1.13-1.16; P < .0001).   

Hospital stays were also longer (3.69 days ± 1.95 vs. 3.23 days ± 1.83; P < .0001), compared with controls.

Reassuring older patients

However, Ms. Varghese told this news organization she was surprised to find that the older group had equal incidence and odds of developing medical complications (1.26% vs. 1.26%; OR, 0.99; 95% CI, 0.96-1.03; P =.99).

“That’s a really important piece of information to have when we are advising 80-year-olds – to be able to say their risk of adverse outcomes is similar to someone who’s 10 years, 15 years younger,” she said. “It’s really reassuring.”

These results offer good news to older patients who might be hesitant to undergo the surgery, and good news in general as life expectancy increases and people stay active long into their later years, forecasting the need for more knee replacements.

The number of total knee replacements is expected to rise dramatically in the United States.

In a 2017 study published in Osteoarthritis Cartilage, the authors write, “the number of TKAs in the U.S., which already has the highest [incidence rate] of knee arthroplasty in the world, is expected to increase 143% by 2050.”

Thomas Fleeter, MD, an orthopedic surgeon practicing in Reston, Virginia, who was not involved in the study, told this news organization this study reinforces that “it’s OK to do knee replacements in elderly people; you just have to pick the right ones.”

He pointed out that the study also showed that the 80-and-older patients don’t have the added risk of loosening their mechanical components after the surgery, likely because they are less inclined than their younger counterparts to follow surgery with strenuous activities.

In a subanalysis, revision rates were also lower for the octogenarians (0.01% vs. 0.02% for controls).

Octogenarians who had TKA were found to have lower incidence and odds (1.6% vs. 1.93%; OR, 0.86; 95% CI, 0.83-0.88, P < .001) of implant-related complications, compared with the younger group.

The increased length of stay would be expected, Dr. Fleeter said, because those 80-plus may need a bit more help getting out of bed and may not have as much support at home.

A total knee replacement can have the substantial benefit of improving octogenarians’ ability to maintain their independence longer by facilitating driving or walking.

“It’s a small and manageable risk if you pick the right patients,” he said.

Demand for TKAs rises as population ages

As patients are living longer and wanting to maintain their mobility and as obesity rates are rising, more older patients will seek total knee replacements, especially since the payoff is high, Ms. Varghese noted.

“People who undergo this operation tend to show remarkable decreases in pain and increases in range of motion,” she said.

This study has the advantage of a more personalized look at risks of TKA because it stratifies age groups.

“The literature tends to look at the elderly population as one big cohort – 65 and older,” Ms. Varghese said. “We were able to provide patients more specific data.”

Ms. Varghese and Dr. Fleeter have disclosed no relevant financial relationships.

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

CHICAGO - Patients 80 years or older undergoing primary total knee arthroplasty (TKA) have similar odds of complications, compared with 65- to 79-year-old patients, an analysis of more than 1.7 million cases suggests.

Priscilla Varghese, MBA, MS, and an MD candidate at State University of New York, Brooklyn, led the research, presented at the American Academy of Orthopaedic Surgeons 2022 annual meeting.

Ms. Varghese’s team queried a Medicare claims database for the years 2005-2014 and analyzed information from 295,908 octogenarians and 1.4 million control patients aged 65-79 who received TKA.

Study group patients were randomly matched to controls in a 1:5 ratio according to gender and comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, diabetes, peripheral vascular disease, and kidney failure.

Octogenarians were found to have higher incidence and odds of 90-day readmission rates (10.59% vs. 9.35%; odds ratio, 1.15; 95% confidence interval, 1.13-1.16; P < .0001).   

Hospital stays were also longer (3.69 days ± 1.95 vs. 3.23 days ± 1.83; P < .0001), compared with controls.

Reassuring older patients

However, Ms. Varghese told this news organization she was surprised to find that the older group had equal incidence and odds of developing medical complications (1.26% vs. 1.26%; OR, 0.99; 95% CI, 0.96-1.03; P =.99).

“That’s a really important piece of information to have when we are advising 80-year-olds – to be able to say their risk of adverse outcomes is similar to someone who’s 10 years, 15 years younger,” she said. “It’s really reassuring.”

These results offer good news to older patients who might be hesitant to undergo the surgery, and good news in general as life expectancy increases and people stay active long into their later years, forecasting the need for more knee replacements.

The number of total knee replacements is expected to rise dramatically in the United States.

In a 2017 study published in Osteoarthritis Cartilage, the authors write, “the number of TKAs in the U.S., which already has the highest [incidence rate] of knee arthroplasty in the world, is expected to increase 143% by 2050.”

Thomas Fleeter, MD, an orthopedic surgeon practicing in Reston, Virginia, who was not involved in the study, told this news organization this study reinforces that “it’s OK to do knee replacements in elderly people; you just have to pick the right ones.”

He pointed out that the study also showed that the 80-and-older patients don’t have the added risk of loosening their mechanical components after the surgery, likely because they are less inclined than their younger counterparts to follow surgery with strenuous activities.

In a subanalysis, revision rates were also lower for the octogenarians (0.01% vs. 0.02% for controls).

Octogenarians who had TKA were found to have lower incidence and odds (1.6% vs. 1.93%; OR, 0.86; 95% CI, 0.83-0.88, P < .001) of implant-related complications, compared with the younger group.

The increased length of stay would be expected, Dr. Fleeter said, because those 80-plus may need a bit more help getting out of bed and may not have as much support at home.

A total knee replacement can have the substantial benefit of improving octogenarians’ ability to maintain their independence longer by facilitating driving or walking.

“It’s a small and manageable risk if you pick the right patients,” he said.

Demand for TKAs rises as population ages

As patients are living longer and wanting to maintain their mobility and as obesity rates are rising, more older patients will seek total knee replacements, especially since the payoff is high, Ms. Varghese noted.

“People who undergo this operation tend to show remarkable decreases in pain and increases in range of motion,” she said.

This study has the advantage of a more personalized look at risks of TKA because it stratifies age groups.

“The literature tends to look at the elderly population as one big cohort – 65 and older,” Ms. Varghese said. “We were able to provide patients more specific data.”

Ms. Varghese and Dr. Fleeter have disclosed no relevant financial relationships.

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

CHICAGO - Patients 80 years or older undergoing primary total knee arthroplasty (TKA) have similar odds of complications, compared with 65- to 79-year-old patients, an analysis of more than 1.7 million cases suggests.

Priscilla Varghese, MBA, MS, and an MD candidate at State University of New York, Brooklyn, led the research, presented at the American Academy of Orthopaedic Surgeons 2022 annual meeting.

Ms. Varghese’s team queried a Medicare claims database for the years 2005-2014 and analyzed information from 295,908 octogenarians and 1.4 million control patients aged 65-79 who received TKA.

Study group patients were randomly matched to controls in a 1:5 ratio according to gender and comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, diabetes, peripheral vascular disease, and kidney failure.

Octogenarians were found to have higher incidence and odds of 90-day readmission rates (10.59% vs. 9.35%; odds ratio, 1.15; 95% confidence interval, 1.13-1.16; P < .0001).   

Hospital stays were also longer (3.69 days ± 1.95 vs. 3.23 days ± 1.83; P < .0001), compared with controls.

Reassuring older patients

However, Ms. Varghese told this news organization she was surprised to find that the older group had equal incidence and odds of developing medical complications (1.26% vs. 1.26%; OR, 0.99; 95% CI, 0.96-1.03; P =.99).

“That’s a really important piece of information to have when we are advising 80-year-olds – to be able to say their risk of adverse outcomes is similar to someone who’s 10 years, 15 years younger,” she said. “It’s really reassuring.”

These results offer good news to older patients who might be hesitant to undergo the surgery, and good news in general as life expectancy increases and people stay active long into their later years, forecasting the need for more knee replacements.

The number of total knee replacements is expected to rise dramatically in the United States.

In a 2017 study published in Osteoarthritis Cartilage, the authors write, “the number of TKAs in the U.S., which already has the highest [incidence rate] of knee arthroplasty in the world, is expected to increase 143% by 2050.”

Thomas Fleeter, MD, an orthopedic surgeon practicing in Reston, Virginia, who was not involved in the study, told this news organization this study reinforces that “it’s OK to do knee replacements in elderly people; you just have to pick the right ones.”

He pointed out that the study also showed that the 80-and-older patients don’t have the added risk of loosening their mechanical components after the surgery, likely because they are less inclined than their younger counterparts to follow surgery with strenuous activities.

In a subanalysis, revision rates were also lower for the octogenarians (0.01% vs. 0.02% for controls).

Octogenarians who had TKA were found to have lower incidence and odds (1.6% vs. 1.93%; OR, 0.86; 95% CI, 0.83-0.88, P < .001) of implant-related complications, compared with the younger group.

The increased length of stay would be expected, Dr. Fleeter said, because those 80-plus may need a bit more help getting out of bed and may not have as much support at home.

A total knee replacement can have the substantial benefit of improving octogenarians’ ability to maintain their independence longer by facilitating driving or walking.

“It’s a small and manageable risk if you pick the right patients,” he said.

Demand for TKAs rises as population ages

As patients are living longer and wanting to maintain their mobility and as obesity rates are rising, more older patients will seek total knee replacements, especially since the payoff is high, Ms. Varghese noted.

“People who undergo this operation tend to show remarkable decreases in pain and increases in range of motion,” she said.

This study has the advantage of a more personalized look at risks of TKA because it stratifies age groups.

“The literature tends to look at the elderly population as one big cohort – 65 and older,” Ms. Varghese said. “We were able to provide patients more specific data.”

Ms. Varghese and Dr. Fleeter have disclosed no relevant financial relationships.

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

Perioperative immunotherapy appears to be safe in the setting of resectable hepatocellular carcinoma (HCC), according to findings from an open-label phase 2 clinical trial published in The Lancet Gastroenterology and Hepatolgy.

The study compared the anti-PD1 antibody nivolumab (Opdivo, Bristol Myers Squibb) alone and nivolumab plus the anti-CTLA-4 antibody ipilimumab (Yervoy, Bristol Myers Squibb) among patients with resectable disease at a single center in Sweden. The treatments were found to be “safe and feasible in patients with resectable hepatocellular carcinoma,” wrote researchers who were led by Ahmed O. Kaseb, MD, a medical oncologist with MD Anderson Cancer Center, Houston.

The rate of 5-year tumor recurrence following HCC resection can be as high as 70%, and there are no approved neoadjuvant or adjuvant therapies.

Immune checkpoint therapy has not been well studied in early-stage HCC, but it is used in advanced HCC.

The combination of PDL1 blockade with atezolizumab and VEGF blockade with bevacizumab, is currently a first-line treatment for advanced HCC. “Checkpoint inhibitors targeting PD1 and PDL1 and CTLA4 are active, tolerable, and clinically beneficial against advanced HCC,” according to researchers writing in a Nature Reviews article published in April 2021.

There are other promising immunotherapies under study for HCC, such as additional checkpoint inhibitors, adoptive cell transfer, vaccination, and virotherapy.
 

Small study of 27 patients

The Lancet study included 27 patients (64 years mean age, 19 patients were male). Twenty-three percent of patients on nivolumab alone had a partial pathological response at week 6, while none in the combination group had a response. Among 20 patients who underwent surgery, 3 of 9 (33%) and 3 of 11 (27%) in the combination group experienced a major pathological response. Two patients in the nivolumab and three patients in the combination group achieved a complete pathological response.

Disease progression occurred in 7 of 12 patients who were evaluated in the nivolumab group, and 4 of 13 patients in the combination group. Estimated median time to disease progression in the nivolumab group was 9.4 months (95% confidence interval, 1.47 to not estimable) and 19.53 months (95% CI, 2.33 to not estimable) in the combination group. Two-year progression-free survival was estimated to be 42% (95% CI, 21%-81%) in the nivolumab group and 26% (95% CI, 8%-78%, no significant difference) in the combination group.

Among 20 patients who underwent surgery, 6 patients had experienced a major pathological response. None of the 6 patients had a recurrence after a median follow-up of 26.8 months, versus 7 recurrences among 14 patients without a pathological response (log-rank P = .049).

Seventy-seven percent of patients in the nivolumab group experienced at least one adverse event (23% grade 3-4), as did 86% in the combination group (43% grade 3-4, difference nonsignificant). No patients delayed or canceled surgery because of adverse events.

Patients who had a major pathological response on the combination treatment had higher levels of immune infiltration versus baseline values. Those who had complete pathological responses in the nivolumab group had high infiltration at baseline. Those results imply some optimism for further study. “These data suggest that, with the immune-priming ability of anti–CTLA-4 treatment, nivolumab plus ipilimumab was able to generate a major pathological response even in tumours that had low immune infiltration at baseline,” the authors wrote.

The study was limited by its open-label nature and small sample size, and it was conducted at a single center.

The study was funded by Bristol Myers Squibb and the National Institutes of Health. Dr. Kaseb reports consulting, advisory roles or stock ownership, or both with Bristol-Myers Squibb.
 

Perioperative immunotherapy appears to be safe in the setting of resectable hepatocellular carcinoma (HCC), according to findings from an open-label phase 2 clinical trial published in The Lancet Gastroenterology and Hepatolgy.

The study compared the anti-PD1 antibody nivolumab (Opdivo, Bristol Myers Squibb) alone and nivolumab plus the anti-CTLA-4 antibody ipilimumab (Yervoy, Bristol Myers Squibb) among patients with resectable disease at a single center in Sweden. The treatments were found to be “safe and feasible in patients with resectable hepatocellular carcinoma,” wrote researchers who were led by Ahmed O. Kaseb, MD, a medical oncologist with MD Anderson Cancer Center, Houston.

The rate of 5-year tumor recurrence following HCC resection can be as high as 70%, and there are no approved neoadjuvant or adjuvant therapies.

Immune checkpoint therapy has not been well studied in early-stage HCC, but it is used in advanced HCC.

The combination of PDL1 blockade with atezolizumab and VEGF blockade with bevacizumab, is currently a first-line treatment for advanced HCC. “Checkpoint inhibitors targeting PD1 and PDL1 and CTLA4 are active, tolerable, and clinically beneficial against advanced HCC,” according to researchers writing in a Nature Reviews article published in April 2021.

There are other promising immunotherapies under study for HCC, such as additional checkpoint inhibitors, adoptive cell transfer, vaccination, and virotherapy.
 

Small study of 27 patients

The Lancet study included 27 patients (64 years mean age, 19 patients were male). Twenty-three percent of patients on nivolumab alone had a partial pathological response at week 6, while none in the combination group had a response. Among 20 patients who underwent surgery, 3 of 9 (33%) and 3 of 11 (27%) in the combination group experienced a major pathological response. Two patients in the nivolumab and three patients in the combination group achieved a complete pathological response.

Disease progression occurred in 7 of 12 patients who were evaluated in the nivolumab group, and 4 of 13 patients in the combination group. Estimated median time to disease progression in the nivolumab group was 9.4 months (95% confidence interval, 1.47 to not estimable) and 19.53 months (95% CI, 2.33 to not estimable) in the combination group. Two-year progression-free survival was estimated to be 42% (95% CI, 21%-81%) in the nivolumab group and 26% (95% CI, 8%-78%, no significant difference) in the combination group.

Among 20 patients who underwent surgery, 6 patients had experienced a major pathological response. None of the 6 patients had a recurrence after a median follow-up of 26.8 months, versus 7 recurrences among 14 patients without a pathological response (log-rank P = .049).

Seventy-seven percent of patients in the nivolumab group experienced at least one adverse event (23% grade 3-4), as did 86% in the combination group (43% grade 3-4, difference nonsignificant). No patients delayed or canceled surgery because of adverse events.

Patients who had a major pathological response on the combination treatment had higher levels of immune infiltration versus baseline values. Those who had complete pathological responses in the nivolumab group had high infiltration at baseline. Those results imply some optimism for further study. “These data suggest that, with the immune-priming ability of anti–CTLA-4 treatment, nivolumab plus ipilimumab was able to generate a major pathological response even in tumours that had low immune infiltration at baseline,” the authors wrote.

The study was limited by its open-label nature and small sample size, and it was conducted at a single center.

The study was funded by Bristol Myers Squibb and the National Institutes of Health. Dr. Kaseb reports consulting, advisory roles or stock ownership, or both with Bristol-Myers Squibb.
 

Perioperative immunotherapy appears to be safe in the setting of resectable hepatocellular carcinoma (HCC), according to findings from an open-label phase 2 clinical trial published in The Lancet Gastroenterology and Hepatolgy.

The study compared the anti-PD1 antibody nivolumab (Opdivo, Bristol Myers Squibb) alone and nivolumab plus the anti-CTLA-4 antibody ipilimumab (Yervoy, Bristol Myers Squibb) among patients with resectable disease at a single center in Sweden. The treatments were found to be “safe and feasible in patients with resectable hepatocellular carcinoma,” wrote researchers who were led by Ahmed O. Kaseb, MD, a medical oncologist with MD Anderson Cancer Center, Houston.

The rate of 5-year tumor recurrence following HCC resection can be as high as 70%, and there are no approved neoadjuvant or adjuvant therapies.

Immune checkpoint therapy has not been well studied in early-stage HCC, but it is used in advanced HCC.

The combination of PDL1 blockade with atezolizumab and VEGF blockade with bevacizumab, is currently a first-line treatment for advanced HCC. “Checkpoint inhibitors targeting PD1 and PDL1 and CTLA4 are active, tolerable, and clinically beneficial against advanced HCC,” according to researchers writing in a Nature Reviews article published in April 2021.

There are other promising immunotherapies under study for HCC, such as additional checkpoint inhibitors, adoptive cell transfer, vaccination, and virotherapy.
 

Small study of 27 patients

The Lancet study included 27 patients (64 years mean age, 19 patients were male). Twenty-three percent of patients on nivolumab alone had a partial pathological response at week 6, while none in the combination group had a response. Among 20 patients who underwent surgery, 3 of 9 (33%) and 3 of 11 (27%) in the combination group experienced a major pathological response. Two patients in the nivolumab and three patients in the combination group achieved a complete pathological response.

Disease progression occurred in 7 of 12 patients who were evaluated in the nivolumab group, and 4 of 13 patients in the combination group. Estimated median time to disease progression in the nivolumab group was 9.4 months (95% confidence interval, 1.47 to not estimable) and 19.53 months (95% CI, 2.33 to not estimable) in the combination group. Two-year progression-free survival was estimated to be 42% (95% CI, 21%-81%) in the nivolumab group and 26% (95% CI, 8%-78%, no significant difference) in the combination group.

Among 20 patients who underwent surgery, 6 patients had experienced a major pathological response. None of the 6 patients had a recurrence after a median follow-up of 26.8 months, versus 7 recurrences among 14 patients without a pathological response (log-rank P = .049).

Seventy-seven percent of patients in the nivolumab group experienced at least one adverse event (23% grade 3-4), as did 86% in the combination group (43% grade 3-4, difference nonsignificant). No patients delayed or canceled surgery because of adverse events.

Patients who had a major pathological response on the combination treatment had higher levels of immune infiltration versus baseline values. Those who had complete pathological responses in the nivolumab group had high infiltration at baseline. Those results imply some optimism for further study. “These data suggest that, with the immune-priming ability of anti–CTLA-4 treatment, nivolumab plus ipilimumab was able to generate a major pathological response even in tumours that had low immune infiltration at baseline,” the authors wrote.

The study was limited by its open-label nature and small sample size, and it was conducted at a single center.

The study was funded by Bristol Myers Squibb and the National Institutes of Health. Dr. Kaseb reports consulting, advisory roles or stock ownership, or both with Bristol-Myers Squibb.
 

Younger, nonsmoking oral cancer patients have a higher risk of death than that of young smokers, and the outcomes may be related to immune deficiencies. The finding comes from a database of oral cavity squamous cell carcinoma (OSCC) patients treated between 1985 and 2015.

“Recent studies have shown an association between high neutrophil to lymphocyte ratio as a marker for poor outcome in several different cancers. This ratio is a surrogate marker for a patient’s immune function. A high ratio indicates an impaired immune function. This means that the ability for the immune system to identify and eradicate abnormal cells which have the potential to form cancer cells is impaired. We don’t know why this is occurring,” said Ian Ganly, MD, PhD, a head and neck surgeon with Memorial Sloan Kettering Cancer Center in New York.

Dr. Ganly is lead author of the new study, published online March 5 in Oral Oncology.

“Physicians should be aware these patients may have impaired immunity and may have a more aggressive presentation and clinical behavior. Such patients may require more comprehensive staging investigations for cancer and may require more comprehensive treatment. Following treatment these patients should also have a detailed and regular follow-up examination with appropriate imaging to detect early recurrence,” he said in an interview.

The research also suggests that immunotherapy may be effective in this group. “However, our findings are only preliminary and further research into this area is required before such therapy can be justified,” Dr. Ganly said.

The study comprised 2,073 patients overall (median age, 62; 43.5% female) and 100 younger nonsmoking patients (median age, 34; 56.0% female). After multivariate analysis, compared to young smokers, nonsmokers with OSCC had a greater risk of mortality (P = .0229), although they had a lower mortality risk than both smokers and nonsmokers over 40. After adjustments, young nonsmokers had a mortality resembling that of older patients, while mortality among young smokers was distinctly lower than that of older patients.

In a subset of 88 young nonsmoking patients, there was a higher neutrophil-to-lymphocyte ratio (median, 2.456) than that of similarly aged patients with thyroid cancer (median, 2.000; P = .0093) or salivary gland benign pathologies (median, 2.158; P = .0343).

The researchers are now studying the genomics of tumors found in smokers and nonsmokers and comparing them to tumors in older smokers and nonsmokers with OSCCs. They are performing a similar comparison of the immune environment of the tumors and patients’ immune system function. “For the genomics aspect I am looking to see if there are any unique alterations in the young nonsmokers that may explain the biology of these cancers. If so, there may be some alterations that can be targeted with new drugs. For the immune aspect, our goal is to see if there are any specific alterations in immune function unique to this population. Then it may be possible to deliver specific types of immunotherapy that focus in on these deficiencies,” said Dr. Ganly.

The study was funded by Fundación Alfonso Martín Escudero and the National Institutes of Health. Dr. Ganly has no relevant financial disclosures.

Younger, nonsmoking oral cancer patients have a higher risk of death than that of young smokers, and the outcomes may be related to immune deficiencies. The finding comes from a database of oral cavity squamous cell carcinoma (OSCC) patients treated between 1985 and 2015.

“Recent studies have shown an association between high neutrophil to lymphocyte ratio as a marker for poor outcome in several different cancers. This ratio is a surrogate marker for a patient’s immune function. A high ratio indicates an impaired immune function. This means that the ability for the immune system to identify and eradicate abnormal cells which have the potential to form cancer cells is impaired. We don’t know why this is occurring,” said Ian Ganly, MD, PhD, a head and neck surgeon with Memorial Sloan Kettering Cancer Center in New York.

Dr. Ganly is lead author of the new study, published online March 5 in Oral Oncology.

“Physicians should be aware these patients may have impaired immunity and may have a more aggressive presentation and clinical behavior. Such patients may require more comprehensive staging investigations for cancer and may require more comprehensive treatment. Following treatment these patients should also have a detailed and regular follow-up examination with appropriate imaging to detect early recurrence,” he said in an interview.

The research also suggests that immunotherapy may be effective in this group. “However, our findings are only preliminary and further research into this area is required before such therapy can be justified,” Dr. Ganly said.

The study comprised 2,073 patients overall (median age, 62; 43.5% female) and 100 younger nonsmoking patients (median age, 34; 56.0% female). After multivariate analysis, compared to young smokers, nonsmokers with OSCC had a greater risk of mortality (P = .0229), although they had a lower mortality risk than both smokers and nonsmokers over 40. After adjustments, young nonsmokers had a mortality resembling that of older patients, while mortality among young smokers was distinctly lower than that of older patients.

In a subset of 88 young nonsmoking patients, there was a higher neutrophil-to-lymphocyte ratio (median, 2.456) than that of similarly aged patients with thyroid cancer (median, 2.000; P = .0093) or salivary gland benign pathologies (median, 2.158; P = .0343).

The researchers are now studying the genomics of tumors found in smokers and nonsmokers and comparing them to tumors in older smokers and nonsmokers with OSCCs. They are performing a similar comparison of the immune environment of the tumors and patients’ immune system function. “For the genomics aspect I am looking to see if there are any unique alterations in the young nonsmokers that may explain the biology of these cancers. If so, there may be some alterations that can be targeted with new drugs. For the immune aspect, our goal is to see if there are any specific alterations in immune function unique to this population. Then it may be possible to deliver specific types of immunotherapy that focus in on these deficiencies,” said Dr. Ganly.

The study was funded by Fundación Alfonso Martín Escudero and the National Institutes of Health. Dr. Ganly has no relevant financial disclosures.

Younger, nonsmoking oral cancer patients have a higher risk of death than that of young smokers, and the outcomes may be related to immune deficiencies. The finding comes from a database of oral cavity squamous cell carcinoma (OSCC) patients treated between 1985 and 2015.

“Recent studies have shown an association between high neutrophil to lymphocyte ratio as a marker for poor outcome in several different cancers. This ratio is a surrogate marker for a patient’s immune function. A high ratio indicates an impaired immune function. This means that the ability for the immune system to identify and eradicate abnormal cells which have the potential to form cancer cells is impaired. We don’t know why this is occurring,” said Ian Ganly, MD, PhD, a head and neck surgeon with Memorial Sloan Kettering Cancer Center in New York.

Dr. Ganly is lead author of the new study, published online March 5 in Oral Oncology.

“Physicians should be aware these patients may have impaired immunity and may have a more aggressive presentation and clinical behavior. Such patients may require more comprehensive staging investigations for cancer and may require more comprehensive treatment. Following treatment these patients should also have a detailed and regular follow-up examination with appropriate imaging to detect early recurrence,” he said in an interview.

The research also suggests that immunotherapy may be effective in this group. “However, our findings are only preliminary and further research into this area is required before such therapy can be justified,” Dr. Ganly said.

The study comprised 2,073 patients overall (median age, 62; 43.5% female) and 100 younger nonsmoking patients (median age, 34; 56.0% female). After multivariate analysis, compared to young smokers, nonsmokers with OSCC had a greater risk of mortality (P = .0229), although they had a lower mortality risk than both smokers and nonsmokers over 40. After adjustments, young nonsmokers had a mortality resembling that of older patients, while mortality among young smokers was distinctly lower than that of older patients.

In a subset of 88 young nonsmoking patients, there was a higher neutrophil-to-lymphocyte ratio (median, 2.456) than that of similarly aged patients with thyroid cancer (median, 2.000; P = .0093) or salivary gland benign pathologies (median, 2.158; P = .0343).

The researchers are now studying the genomics of tumors found in smokers and nonsmokers and comparing them to tumors in older smokers and nonsmokers with OSCCs. They are performing a similar comparison of the immune environment of the tumors and patients’ immune system function. “For the genomics aspect I am looking to see if there are any unique alterations in the young nonsmokers that may explain the biology of these cancers. If so, there may be some alterations that can be targeted with new drugs. For the immune aspect, our goal is to see if there are any specific alterations in immune function unique to this population. Then it may be possible to deliver specific types of immunotherapy that focus in on these deficiencies,” said Dr. Ganly.

The study was funded by Fundación Alfonso Martín Escudero and the National Institutes of Health. Dr. Ganly has no relevant financial disclosures.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

A congressional oversight subcommittee is investigating the Food and Drug Administration’s regulation of a high-risk heart pump, citing safety issues detailed by ProPublica.

The HeartWare Ventricular Assist Device, created to treat patients with severe heart failure, stopped meeting key federal standards as early as 2014. But the FDA took no decisive action even as those problems persisted, and thousands of Americans continued to be implanted with the pump.

By the end of 2020, the FDA had received more than 3,000 reports of deaths related to the HeartWare device, according to a ProPublica data analysis. A father of four died as his children tried to resuscitate him when his device suddenly stopped. A teenager died after vomiting blood in the middle of the night, while his mother struggled to restart a faulty pump.

“I am concerned by FDA’s slow action, over multiple administrations, to protect patients from this product despite early warning signs,” Rep. Raja Krishnamoorthi, D-Ill., said in a scathing letter sent March 22 to the agency’s commissioner, Robert Califf, MD.

Mr. Krishnamoorthi, the chairman of the U.S. House Committee on Oversight and Reform’s Subcommittee on Economic and Consumer Policy, requested information on how the FDA made regulatory decisions related to the HeartWare device and why it didn’t take further action.

The FDA did not provide comment to ProPublica on the subcommittee’s investigation and said it would respond directly to Mr. Krishnamoorthi. It also reiterated its response to ProPublica’s findings and said the agency had been closely overseeing the HeartWare device since 2012, with patient safety as its “highest priority.”

Medtronic, the company that acquired HeartWare in 2016, took the device off the market in June 2021. The company said that new data showed a competing heart pump had better outcomes. In response to the ProPublica investigation 2 months later, the company said it took the FDA’s inspections seriously and had worked closely with the agency to address issues with the device.

Medtronic declined to comment on the subcommittee’s investigation.

Mr. Krishnamoorthi asked in the letter if any steps were being taken to address how patients, doctors and other federal agencies are notified of problems that the FDA finds with medical devices.

Many patients told ProPublica they were never informed of issues with the HeartWare pump before or after their implants. Some people who still have the device said they weren’t told when it was taken off the market. Medtronic said in December it had confirmed 90% of U.S. patients had received notification of the HeartWare discontinuation, but that it was still working to reach the other 10%.

About 2,000 patients still had HeartWare pumps as of last year. The FDA and Medtronic recommended against removing those devices barring medical necessity because the surgery to do so carries a high risk.

In his letter, Mr. Krishnamoorthi gave the FDA a deadline of April 5 to respond.
 

This story was originally published on ProPublica. ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories as soon as they’re published.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

City dwellers with high exposure to green space have a significantly lower risk of developing schizophrenia than their counterparts who live in areas with little green space, a new study shows.

The investigators, led by Martin Rotenberg, MD, of Centre for Addiction and Mental Health and the University of Toronto, found individuals living in areas with the lowest levels of green space were 24% more likely to develop schizophrenia.

This study contributes to a growing body of evidence showing the importance of exposure to green space to mental health.

“These findings contribute to a growing evidence base that environmental factors may play a role in the etiology of schizophrenia,” the researchers write.

The study was published online Feb. 4 in the Canadian Journal of Psychiatry.
 

Underlying mechanism unknown

For the study, researchers used a retrospective population-based cohort of 649,020 individuals between ages 14 and 40 years from different neighborhoods in Toronto.

Green space was calculated using geospatial data of all public parks and green spaces in the city; data were drawn from the Urban Health Equity Assessment and Response Tool.

Over a 10-year period, 4,841 participants were diagnosed with schizophrenia.

Those who lived in neighborhoods with the least amount of green space were significantly more likely to develop schizophrenia than those who lived in areas with the most green space, even after adjusting for age, sex, and neighborhood-level marginalization (adjusted incidence rate ratio, 1.24; 95% confidence interval, 1.06-1.45).

Overall, schizophrenia risk was also elevated in men vs. women (adjusted IRR, 1.59; 95% CI, 1.50-1.68). Those living in areas with moderate amounts of green space did not have an increased schizophrenia risk.

“We found that residing in an area with the lowest amount of green space was associated with an increased risk of developing schizophrenia, independent of other sociodemographic and socioenvironmental factors,” the researchers note. “The underlying mechanism at play is unknown and requires further study.”

One possibility, they added, is that exposure to green space may reduce the risk of air pollution, which other studies have suggested may be associated with increased schizophrenia risk.

The new study builds on a 2018 report from Denmark that showed a 52% increased risk of psychotic disorders in adulthood among people who spent their childhood in neighborhoods with little green space.
 

Important, longitudinal data

Commenting on the findings, John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, said the study provides important longitudinal data.

“The 10-year duration of the study and large sample size make the results very compelling and help confirm what has been thought about green space and risk of schizophrenia,” Dr. Torous said.

“Often, we think of green space at a very macro level,” he added. “This study is important because it shows us that green space matters on a block-by-block level just as much.”

The study was unfunded. The authors and Dr. Torous have disclosed no relevant financial relationships.

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

City dwellers with high exposure to green space have a significantly lower risk of developing schizophrenia than their counterparts who live in areas with little green space, a new study shows.

The investigators, led by Martin Rotenberg, MD, of Centre for Addiction and Mental Health and the University of Toronto, found individuals living in areas with the lowest levels of green space were 24% more likely to develop schizophrenia.

This study contributes to a growing body of evidence showing the importance of exposure to green space to mental health.

“These findings contribute to a growing evidence base that environmental factors may play a role in the etiology of schizophrenia,” the researchers write.

The study was published online Feb. 4 in the Canadian Journal of Psychiatry.
 

Underlying mechanism unknown

For the study, researchers used a retrospective population-based cohort of 649,020 individuals between ages 14 and 40 years from different neighborhoods in Toronto.

Green space was calculated using geospatial data of all public parks and green spaces in the city; data were drawn from the Urban Health Equity Assessment and Response Tool.

Over a 10-year period, 4,841 participants were diagnosed with schizophrenia.

Those who lived in neighborhoods with the least amount of green space were significantly more likely to develop schizophrenia than those who lived in areas with the most green space, even after adjusting for age, sex, and neighborhood-level marginalization (adjusted incidence rate ratio, 1.24; 95% confidence interval, 1.06-1.45).

Overall, schizophrenia risk was also elevated in men vs. women (adjusted IRR, 1.59; 95% CI, 1.50-1.68). Those living in areas with moderate amounts of green space did not have an increased schizophrenia risk.

“We found that residing in an area with the lowest amount of green space was associated with an increased risk of developing schizophrenia, independent of other sociodemographic and socioenvironmental factors,” the researchers note. “The underlying mechanism at play is unknown and requires further study.”

One possibility, they added, is that exposure to green space may reduce the risk of air pollution, which other studies have suggested may be associated with increased schizophrenia risk.

The new study builds on a 2018 report from Denmark that showed a 52% increased risk of psychotic disorders in adulthood among people who spent their childhood in neighborhoods with little green space.
 

Important, longitudinal data

Commenting on the findings, John Torous, MD, director of digital psychiatry at Beth Israel Deaconess Medical Center, Boston, said the study provides important longitudinal data.

“The 10-year duration of the study and large sample size make the results very compelling and help confirm what has been thought about green space and risk of schizophrenia,” Dr. Torous said.

“Often, we think of green space at a very macro level,” he added. “This study is important because it shows us that green space matters on a block-by-block level just as much.”

The study was unfunded. The authors and Dr. Torous have disclosed no relevant financial relationships.

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

City dwellers with high exposure to green space have a significantly lower risk of developing schizophrenia than their counterparts who live in areas with little green space, a new study shows.

The investigators, led by Martin Rotenberg, MD, of Centre for Addiction and Mental Health and the University of Toronto, found individuals living in areas with the lowest levels of green space were 24% more likely to develop schizophrenia.

This study contributes to a growing body of evidence showing the importance of exposure to green space to mental health.

“These findings contribute to a growing evidence base that environmental factors may play a role in the etiology of schizophrenia,” the researchers write.

The study was published online Feb. 4 in the Canadian Journal of Psychiatry.