Fran Lowry

Treatment with the novel agent omecamtiv mecarbil did not improve exercise capacity in people with chronic heart failure with reduced ejection fraction (HFrEF), in the METEORIC-HF trial.

The double-blind, phase 3 study failed to achieve its primary endpoint of change in peak oxygen uptake (VO₂) after 20 weeks of treatment with omecamtiv mecarbil, compared with placebo.

There also was no benefit on secondary measures of total workload, ventilatory efficiency, and daily physical activity, according to results presented earlier this year at ACC 2022 and formally published this month in JAMA.

“These findings do not support the use of omecamtiv mecarbil for treatment of HFrEF for improvement of exercise capacity,” lead author Gregory D. Lewis, MD, Massachusetts General Hospital, Boston, and colleagues conclude in the paper.

Researchers had hoped that the oral selective myosin activator would prove useful in this subset of patients, having previously shown in the GALACTIC-HF trial to provide a significant improvement in heart failure (HF) events and cardiovascular death.

A prespecified subgroup analysis from that trial also found that HF patients with the lowest ejection fraction derived the greatest relative benefit from omecamtiv mecarbil.

“The lack of effect of omecamtiv mecarbil on exercise performance is inconsistent with its known mechanism of action of directly enhancing ventricular performance and reducing the risk of cardiovascular events,” Dr. Lewis and colleagues observe.

The drug’s novel mechanism of action, direct activation of myosin, contrasts with that of currently available inotropic agents, such as dobutamine or milrinone. It is not yet approved by the U.S. Food and Drug Administration but is scheduled for an advisory committee meeting on Dec. 13, 2022, and has been assigned a Prescription Drug User Fee Act date of Feb. 28, 2023.

METEORIC-HF randomly assigned 276 patients with New York Heart Association class II or III symptoms and a left ventricular ejection fraction of 35% or less to omecamtiv mecarbil (n = 185) or placebo (n = 91), given orally twice daily at a dose of 25 mg, 37.5 mg, or 50 mg based on target plasma levels for 20 weeks, on top of guideline-directed medical therapy.

The patients’ median age was 64 years and 15% were women. The median ejection fraction was 28% and median baseline peak VO₂ was 14.2 mL/kg per minute in the omecamtiv mecarbil group and 15.0 mL/kg per minute in the control group.

At 20 weeks, the mean change in peak VO₂ in the omecamtiv mecarbil group was –0.24 mL/kg per minute and 0.21 mL/kg per minute in the placebo group (95% confidence interval, –1.02-0.13; P = .13).

For the secondary outcomes, the change in workload achieved on stress testing declined in the omecamtiv mecarbil group (–3.8 vs. 1.6). The drug had a neutral effect on minute ventilation relative to carbon dioxide production throughout exercise (0.28 vs. –0.14 VE/VCO₂ slope) and average total daily activity units, measured over 2 weeks by accelerometer (–0.2 vs. –0.5).

The authors suggest that “one possible explanation for discordance between clinical events in a long-term follow-up study and exercise capacity improvement is that cardiac performance was not exclusively responsible for limiting exercise capacity in trial participants with HFrEF who were stable and very well treated with both pharmacologic and device HFrEF therapy.”

In an accompanying editorial, Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas, writes that another possible explanation is that participants in METEORIC-HF had less severe heart failure, compared with participants in GALACTIC-HF, and so were less likely to benefit from omecamtiv mecarbil.

METEORIC-HF excluded participants who had a HF hospitalization that required intravenous diuretics in the preceding 3 months, whereas 25% of participants in GALACTIC-HF were inpatients for decompensated HF and 36% had a HF hospitalization within the preceding 3 months.

Another plausible explanation for the differing results is that a therapy that improves long-term clinical outcomes may not improve exercise capacity, Dr. Drazner writes. “The available data are persuasive to suggest this may be the case.”

Some pharmacologic therapies, such as flosequinan, improved exercise capacity in patients with HF yet increased long-term mortality, he noted. Several medications that have a class I recommendation in the 2022 Heart Failure Guideline for the treatment of HFrEF also have not been shown to improve exercise capacity, as measured by peak VO₂ or by 6-minute walk distance.

In this context, Dr. Drazner said he doesn’t anticipate the METEORIC-HF findings to derail FDA approval. However, should the drug be approved, clinicians will have increasingly complex decisions to make about which therapies should be prescribed to which patients.

“Some clinicians may contemplate using omecamtiv mecarbil either in the subgroup of patients with very low ejection fractions or more severe disease, believing this strategy will maximize the benefits of this therapy, but those approaches should be pursued with caution given they are predicated on subgroup and post hoc analyses, respectively,” he wrote.

Dr. Drazner concludes that medications known to improve survival in patients with HFrEF are used at “disappointingly low rates and suboptimal doses in the United States. Implementation strategies to improve use of such therapies are needed, and those efforts should be prioritized before adoption of therapies that reduce morbidity but not cardiovascular mortality.”

The study was sponsored by Amgen and Cytokinetics. Dr. Lewis reports financial relationships with the National Institutes of Health, American Heart Association, Amgen, Cytokinetics, Applied Therapeutics, AstraZeneca, SoniVie, Pfizer, Merck, Boehringer Ingelheim, Novartis, American Regent, Cyclerion, MyoKardia, Novo Nordisk, and UpToDate. Dr. Drazner reports being a member of the writing committee of the 2022 Heart Failure guidelines; and that he is supported by the James M. Wooten Chair in Cardiology at the University of Texas Southwestern Medical Center, which was a clinical site in METEORIC-HF. However, Dr. Drazner was not a study investigator in the trial.

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

Treatment with the novel agent omecamtiv mecarbil did not improve exercise capacity in people with chronic heart failure with reduced ejection fraction (HFrEF), in the METEORIC-HF trial.

The double-blind, phase 3 study failed to achieve its primary endpoint of change in peak oxygen uptake (VO₂) after 20 weeks of treatment with omecamtiv mecarbil, compared with placebo.

There also was no benefit on secondary measures of total workload, ventilatory efficiency, and daily physical activity, according to results presented earlier this year at ACC 2022 and formally published this month in JAMA.

“These findings do not support the use of omecamtiv mecarbil for treatment of HFrEF for improvement of exercise capacity,” lead author Gregory D. Lewis, MD, Massachusetts General Hospital, Boston, and colleagues conclude in the paper.

Researchers had hoped that the oral selective myosin activator would prove useful in this subset of patients, having previously shown in the GALACTIC-HF trial to provide a significant improvement in heart failure (HF) events and cardiovascular death.

A prespecified subgroup analysis from that trial also found that HF patients with the lowest ejection fraction derived the greatest relative benefit from omecamtiv mecarbil.

“The lack of effect of omecamtiv mecarbil on exercise performance is inconsistent with its known mechanism of action of directly enhancing ventricular performance and reducing the risk of cardiovascular events,” Dr. Lewis and colleagues observe.

The drug’s novel mechanism of action, direct activation of myosin, contrasts with that of currently available inotropic agents, such as dobutamine or milrinone. It is not yet approved by the U.S. Food and Drug Administration but is scheduled for an advisory committee meeting on Dec. 13, 2022, and has been assigned a Prescription Drug User Fee Act date of Feb. 28, 2023.

METEORIC-HF randomly assigned 276 patients with New York Heart Association class II or III symptoms and a left ventricular ejection fraction of 35% or less to omecamtiv mecarbil (n = 185) or placebo (n = 91), given orally twice daily at a dose of 25 mg, 37.5 mg, or 50 mg based on target plasma levels for 20 weeks, on top of guideline-directed medical therapy.

The patients’ median age was 64 years and 15% were women. The median ejection fraction was 28% and median baseline peak VO₂ was 14.2 mL/kg per minute in the omecamtiv mecarbil group and 15.0 mL/kg per minute in the control group.

At 20 weeks, the mean change in peak VO₂ in the omecamtiv mecarbil group was –0.24 mL/kg per minute and 0.21 mL/kg per minute in the placebo group (95% confidence interval, –1.02-0.13; P = .13).

For the secondary outcomes, the change in workload achieved on stress testing declined in the omecamtiv mecarbil group (–3.8 vs. 1.6). The drug had a neutral effect on minute ventilation relative to carbon dioxide production throughout exercise (0.28 vs. –0.14 VE/VCO₂ slope) and average total daily activity units, measured over 2 weeks by accelerometer (–0.2 vs. –0.5).

The authors suggest that “one possible explanation for discordance between clinical events in a long-term follow-up study and exercise capacity improvement is that cardiac performance was not exclusively responsible for limiting exercise capacity in trial participants with HFrEF who were stable and very well treated with both pharmacologic and device HFrEF therapy.”

In an accompanying editorial, Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas, writes that another possible explanation is that participants in METEORIC-HF had less severe heart failure, compared with participants in GALACTIC-HF, and so were less likely to benefit from omecamtiv mecarbil.

METEORIC-HF excluded participants who had a HF hospitalization that required intravenous diuretics in the preceding 3 months, whereas 25% of participants in GALACTIC-HF were inpatients for decompensated HF and 36% had a HF hospitalization within the preceding 3 months.

Another plausible explanation for the differing results is that a therapy that improves long-term clinical outcomes may not improve exercise capacity, Dr. Drazner writes. “The available data are persuasive to suggest this may be the case.”

Some pharmacologic therapies, such as flosequinan, improved exercise capacity in patients with HF yet increased long-term mortality, he noted. Several medications that have a class I recommendation in the 2022 Heart Failure Guideline for the treatment of HFrEF also have not been shown to improve exercise capacity, as measured by peak VO₂ or by 6-minute walk distance.

In this context, Dr. Drazner said he doesn’t anticipate the METEORIC-HF findings to derail FDA approval. However, should the drug be approved, clinicians will have increasingly complex decisions to make about which therapies should be prescribed to which patients.

“Some clinicians may contemplate using omecamtiv mecarbil either in the subgroup of patients with very low ejection fractions or more severe disease, believing this strategy will maximize the benefits of this therapy, but those approaches should be pursued with caution given they are predicated on subgroup and post hoc analyses, respectively,” he wrote.

Dr. Drazner concludes that medications known to improve survival in patients with HFrEF are used at “disappointingly low rates and suboptimal doses in the United States. Implementation strategies to improve use of such therapies are needed, and those efforts should be prioritized before adoption of therapies that reduce morbidity but not cardiovascular mortality.”

The study was sponsored by Amgen and Cytokinetics. Dr. Lewis reports financial relationships with the National Institutes of Health, American Heart Association, Amgen, Cytokinetics, Applied Therapeutics, AstraZeneca, SoniVie, Pfizer, Merck, Boehringer Ingelheim, Novartis, American Regent, Cyclerion, MyoKardia, Novo Nordisk, and UpToDate. Dr. Drazner reports being a member of the writing committee of the 2022 Heart Failure guidelines; and that he is supported by the James M. Wooten Chair in Cardiology at the University of Texas Southwestern Medical Center, which was a clinical site in METEORIC-HF. However, Dr. Drazner was not a study investigator in the trial.

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

Treatment with the novel agent omecamtiv mecarbil did not improve exercise capacity in people with chronic heart failure with reduced ejection fraction (HFrEF), in the METEORIC-HF trial.

The double-blind, phase 3 study failed to achieve its primary endpoint of change in peak oxygen uptake (VO₂) after 20 weeks of treatment with omecamtiv mecarbil, compared with placebo.

There also was no benefit on secondary measures of total workload, ventilatory efficiency, and daily physical activity, according to results presented earlier this year at ACC 2022 and formally published this month in JAMA.

“These findings do not support the use of omecamtiv mecarbil for treatment of HFrEF for improvement of exercise capacity,” lead author Gregory D. Lewis, MD, Massachusetts General Hospital, Boston, and colleagues conclude in the paper.

Researchers had hoped that the oral selective myosin activator would prove useful in this subset of patients, having previously shown in the GALACTIC-HF trial to provide a significant improvement in heart failure (HF) events and cardiovascular death.

A prespecified subgroup analysis from that trial also found that HF patients with the lowest ejection fraction derived the greatest relative benefit from omecamtiv mecarbil.

“The lack of effect of omecamtiv mecarbil on exercise performance is inconsistent with its known mechanism of action of directly enhancing ventricular performance and reducing the risk of cardiovascular events,” Dr. Lewis and colleagues observe.

The drug’s novel mechanism of action, direct activation of myosin, contrasts with that of currently available inotropic agents, such as dobutamine or milrinone. It is not yet approved by the U.S. Food and Drug Administration but is scheduled for an advisory committee meeting on Dec. 13, 2022, and has been assigned a Prescription Drug User Fee Act date of Feb. 28, 2023.

METEORIC-HF randomly assigned 276 patients with New York Heart Association class II or III symptoms and a left ventricular ejection fraction of 35% or less to omecamtiv mecarbil (n = 185) or placebo (n = 91), given orally twice daily at a dose of 25 mg, 37.5 mg, or 50 mg based on target plasma levels for 20 weeks, on top of guideline-directed medical therapy.

The patients’ median age was 64 years and 15% were women. The median ejection fraction was 28% and median baseline peak VO₂ was 14.2 mL/kg per minute in the omecamtiv mecarbil group and 15.0 mL/kg per minute in the control group.

At 20 weeks, the mean change in peak VO₂ in the omecamtiv mecarbil group was –0.24 mL/kg per minute and 0.21 mL/kg per minute in the placebo group (95% confidence interval, –1.02-0.13; P = .13).

For the secondary outcomes, the change in workload achieved on stress testing declined in the omecamtiv mecarbil group (–3.8 vs. 1.6). The drug had a neutral effect on minute ventilation relative to carbon dioxide production throughout exercise (0.28 vs. –0.14 VE/VCO₂ slope) and average total daily activity units, measured over 2 weeks by accelerometer (–0.2 vs. –0.5).

The authors suggest that “one possible explanation for discordance between clinical events in a long-term follow-up study and exercise capacity improvement is that cardiac performance was not exclusively responsible for limiting exercise capacity in trial participants with HFrEF who were stable and very well treated with both pharmacologic and device HFrEF therapy.”

In an accompanying editorial, Mark H. Drazner, MD, MSc, University of Texas Southwestern Medical Center, Dallas, writes that another possible explanation is that participants in METEORIC-HF had less severe heart failure, compared with participants in GALACTIC-HF, and so were less likely to benefit from omecamtiv mecarbil.

METEORIC-HF excluded participants who had a HF hospitalization that required intravenous diuretics in the preceding 3 months, whereas 25% of participants in GALACTIC-HF were inpatients for decompensated HF and 36% had a HF hospitalization within the preceding 3 months.

Another plausible explanation for the differing results is that a therapy that improves long-term clinical outcomes may not improve exercise capacity, Dr. Drazner writes. “The available data are persuasive to suggest this may be the case.”

Some pharmacologic therapies, such as flosequinan, improved exercise capacity in patients with HF yet increased long-term mortality, he noted. Several medications that have a class I recommendation in the 2022 Heart Failure Guideline for the treatment of HFrEF also have not been shown to improve exercise capacity, as measured by peak VO₂ or by 6-minute walk distance.

In this context, Dr. Drazner said he doesn’t anticipate the METEORIC-HF findings to derail FDA approval. However, should the drug be approved, clinicians will have increasingly complex decisions to make about which therapies should be prescribed to which patients.

“Some clinicians may contemplate using omecamtiv mecarbil either in the subgroup of patients with very low ejection fractions or more severe disease, believing this strategy will maximize the benefits of this therapy, but those approaches should be pursued with caution given they are predicated on subgroup and post hoc analyses, respectively,” he wrote.

Dr. Drazner concludes that medications known to improve survival in patients with HFrEF are used at “disappointingly low rates and suboptimal doses in the United States. Implementation strategies to improve use of such therapies are needed, and those efforts should be prioritized before adoption of therapies that reduce morbidity but not cardiovascular mortality.”

The study was sponsored by Amgen and Cytokinetics. Dr. Lewis reports financial relationships with the National Institutes of Health, American Heart Association, Amgen, Cytokinetics, Applied Therapeutics, AstraZeneca, SoniVie, Pfizer, Merck, Boehringer Ingelheim, Novartis, American Regent, Cyclerion, MyoKardia, Novo Nordisk, and UpToDate. Dr. Drazner reports being a member of the writing committee of the 2022 Heart Failure guidelines; and that he is supported by the James M. Wooten Chair in Cardiology at the University of Texas Southwestern Medical Center, which was a clinical site in METEORIC-HF. However, Dr. Drazner was not a study investigator in the trial.

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

Ontario physician Charles Godfrey, MD, who practiced medicine until the age of 102, making him one of the oldest people to ever practice medicine in North America, has died. He was 104 and died at his home in Madoc, Ont., just weeks shy of his 105th birthday.

“He had been quite vigorous up until that point,” his son, Mark Godfrey, told CTV News.

If it wasn’t for the pandemic, his father would have probably continued practicing for a little while longer, he added. “He was the smartest guy in the room, all my life, any room we were in.”

Charles Morris Godfrey was born Sept. 24, 1917, in Philadelphia, according to Wikipedia, but his family moved to Toronto when he was 7 years old. His father, a physiotherapist, encouraged him to study medicine.

Dr. Godfrey served in the Canadian military for 5½ years during World War II and qualified as a physiotherapist while serving.

After the war, he enrolled in the faculty of medicine at the University of Toronto and earned his degree in 1953. He paid for his tuition by working as a janitor and scrapyard worker.

In 1956, he studied neurology at Oxford (England) University on a McLaughlin fellowship and became a fellow of the Royal College of Physicians in 1958. He also earned a bachelor of arts degree in 1962 and his master of arts degree in 1975. He was studying for his PhD in the late 1980s, when he was in his 70s.

Upon his return from England in the late 1950s, Godfrey became director of the department of physical medicine and rehabilitation at Toronto East General Hospital. He subsequently worked at Toronto General Hospital, Sunnybrook Hospital, and the Toronto Rehab Hospital before joining Wellesley Hospital’s rheumatic disease unit, ultimately becoming head of the hospital’s rehabilitation clinic.

Dr. Godfrey was a professor in the department of rehabilitative medicine at the University of Toronto for over 2 decades. He was working 13-hour days teaching and maintaining his own practice well into his 70s. He would spend weekends at his country home in Madoc.

For over 20 years, he and his wife Margaret, a nurse, would spend 6 weeks each year as volunteers traveling to developing countries, such as Afghanistan and Pakistan, on lecture tours on behalf of CARE. Dr. Godfrey chaired CARE/MEDICO from 1983 to 1985 and subsequently served as chairman of CARE’s International Health Advisory Committee. In 1986, he was awarded the organization’s Distinguished Service Award.

In 1989, Dr. Godfrey was invested as a Member of the Order of Canada. His citation reads as follows:

“Deeply committed to humankind and the elimination of human suffering, and although of retirement age, he continues to be involved in an exhausting round of activity. Professor Emeritus of Rehabilitation Medicine at the University of Toronto, an environmentalist who was instrumental in the ‘People or Planes’ campaign opposing construction of the Pickering airport and a director of CARE/MEDICO, each year he takes his heart-felt concern for the welfare of the global community to Third World countries as a visiting volunteer doctor.”

Dr. Godfrey was also a political activist. When he learned about plans to build an international airport near his home in Uxbridge, Ont., he organized People or Planes, a group that successfully opposed the proposed airport. He was elected to the Ontario legislature as the Ontario New Democratic Party’s candidate for Durham West and served for 2 years as the NDP’s environment critic.

In 2020, grandson Frazey Ford posted a clip of his “immortal grandfather” being interviewed by David Suzuki as part of a CBC documentary on aging well.

Dr. Godfrey shared his secret to a long life: “The main thing is to keep interested in life,” he told Mr. Suzuki.

“That’s the secret, of course. If you stick in front of your television, you lose your interest in life. That’ll kill you next week. Certainly, the quality of stuff that’s being peddled on television these days is enough to make you wanna die pretty soon.”

A spokesperson for the University of Toronto’s department of medicine told CTV News that Dr. Godfrey was still working at four medical clinics in Toronto 4 days a week, even at age 102.

“He possessed a remarkable longevity in his practice, supported by his enduring love for medicine and incredible care for his patients,” the university said.

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

Ontario physician Charles Godfrey, MD, who practiced medicine until the age of 102, making him one of the oldest people to ever practice medicine in North America, has died. He was 104 and died at his home in Madoc, Ont., just weeks shy of his 105th birthday.

“He had been quite vigorous up until that point,” his son, Mark Godfrey, told CTV News.

If it wasn’t for the pandemic, his father would have probably continued practicing for a little while longer, he added. “He was the smartest guy in the room, all my life, any room we were in.”

Charles Morris Godfrey was born Sept. 24, 1917, in Philadelphia, according to Wikipedia, but his family moved to Toronto when he was 7 years old. His father, a physiotherapist, encouraged him to study medicine.

Dr. Godfrey served in the Canadian military for 5½ years during World War II and qualified as a physiotherapist while serving.

After the war, he enrolled in the faculty of medicine at the University of Toronto and earned his degree in 1953. He paid for his tuition by working as a janitor and scrapyard worker.

In 1956, he studied neurology at Oxford (England) University on a McLaughlin fellowship and became a fellow of the Royal College of Physicians in 1958. He also earned a bachelor of arts degree in 1962 and his master of arts degree in 1975. He was studying for his PhD in the late 1980s, when he was in his 70s.

Upon his return from England in the late 1950s, Godfrey became director of the department of physical medicine and rehabilitation at Toronto East General Hospital. He subsequently worked at Toronto General Hospital, Sunnybrook Hospital, and the Toronto Rehab Hospital before joining Wellesley Hospital’s rheumatic disease unit, ultimately becoming head of the hospital’s rehabilitation clinic.

Dr. Godfrey was a professor in the department of rehabilitative medicine at the University of Toronto for over 2 decades. He was working 13-hour days teaching and maintaining his own practice well into his 70s. He would spend weekends at his country home in Madoc.

For over 20 years, he and his wife Margaret, a nurse, would spend 6 weeks each year as volunteers traveling to developing countries, such as Afghanistan and Pakistan, on lecture tours on behalf of CARE. Dr. Godfrey chaired CARE/MEDICO from 1983 to 1985 and subsequently served as chairman of CARE’s International Health Advisory Committee. In 1986, he was awarded the organization’s Distinguished Service Award.

In 1989, Dr. Godfrey was invested as a Member of the Order of Canada. His citation reads as follows:

“Deeply committed to humankind and the elimination of human suffering, and although of retirement age, he continues to be involved in an exhausting round of activity. Professor Emeritus of Rehabilitation Medicine at the University of Toronto, an environmentalist who was instrumental in the ‘People or Planes’ campaign opposing construction of the Pickering airport and a director of CARE/MEDICO, each year he takes his heart-felt concern for the welfare of the global community to Third World countries as a visiting volunteer doctor.”

Dr. Godfrey was also a political activist. When he learned about plans to build an international airport near his home in Uxbridge, Ont., he organized People or Planes, a group that successfully opposed the proposed airport. He was elected to the Ontario legislature as the Ontario New Democratic Party’s candidate for Durham West and served for 2 years as the NDP’s environment critic.

In 2020, grandson Frazey Ford posted a clip of his “immortal grandfather” being interviewed by David Suzuki as part of a CBC documentary on aging well.

Dr. Godfrey shared his secret to a long life: “The main thing is to keep interested in life,” he told Mr. Suzuki.

“That’s the secret, of course. If you stick in front of your television, you lose your interest in life. That’ll kill you next week. Certainly, the quality of stuff that’s being peddled on television these days is enough to make you wanna die pretty soon.”

A spokesperson for the University of Toronto’s department of medicine told CTV News that Dr. Godfrey was still working at four medical clinics in Toronto 4 days a week, even at age 102.

“He possessed a remarkable longevity in his practice, supported by his enduring love for medicine and incredible care for his patients,” the university said.

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

Ontario physician Charles Godfrey, MD, who practiced medicine until the age of 102, making him one of the oldest people to ever practice medicine in North America, has died. He was 104 and died at his home in Madoc, Ont., just weeks shy of his 105th birthday.

“He had been quite vigorous up until that point,” his son, Mark Godfrey, told CTV News.

If it wasn’t for the pandemic, his father would have probably continued practicing for a little while longer, he added. “He was the smartest guy in the room, all my life, any room we were in.”

Charles Morris Godfrey was born Sept. 24, 1917, in Philadelphia, according to Wikipedia, but his family moved to Toronto when he was 7 years old. His father, a physiotherapist, encouraged him to study medicine.

Dr. Godfrey served in the Canadian military for 5½ years during World War II and qualified as a physiotherapist while serving.

After the war, he enrolled in the faculty of medicine at the University of Toronto and earned his degree in 1953. He paid for his tuition by working as a janitor and scrapyard worker.

In 1956, he studied neurology at Oxford (England) University on a McLaughlin fellowship and became a fellow of the Royal College of Physicians in 1958. He also earned a bachelor of arts degree in 1962 and his master of arts degree in 1975. He was studying for his PhD in the late 1980s, when he was in his 70s.

Upon his return from England in the late 1950s, Godfrey became director of the department of physical medicine and rehabilitation at Toronto East General Hospital. He subsequently worked at Toronto General Hospital, Sunnybrook Hospital, and the Toronto Rehab Hospital before joining Wellesley Hospital’s rheumatic disease unit, ultimately becoming head of the hospital’s rehabilitation clinic.

Dr. Godfrey was a professor in the department of rehabilitative medicine at the University of Toronto for over 2 decades. He was working 13-hour days teaching and maintaining his own practice well into his 70s. He would spend weekends at his country home in Madoc.

For over 20 years, he and his wife Margaret, a nurse, would spend 6 weeks each year as volunteers traveling to developing countries, such as Afghanistan and Pakistan, on lecture tours on behalf of CARE. Dr. Godfrey chaired CARE/MEDICO from 1983 to 1985 and subsequently served as chairman of CARE’s International Health Advisory Committee. In 1986, he was awarded the organization’s Distinguished Service Award.

In 1989, Dr. Godfrey was invested as a Member of the Order of Canada. His citation reads as follows:

“Deeply committed to humankind and the elimination of human suffering, and although of retirement age, he continues to be involved in an exhausting round of activity. Professor Emeritus of Rehabilitation Medicine at the University of Toronto, an environmentalist who was instrumental in the ‘People or Planes’ campaign opposing construction of the Pickering airport and a director of CARE/MEDICO, each year he takes his heart-felt concern for the welfare of the global community to Third World countries as a visiting volunteer doctor.”

Dr. Godfrey was also a political activist. When he learned about plans to build an international airport near his home in Uxbridge, Ont., he organized People or Planes, a group that successfully opposed the proposed airport. He was elected to the Ontario legislature as the Ontario New Democratic Party’s candidate for Durham West and served for 2 years as the NDP’s environment critic.

In 2020, grandson Frazey Ford posted a clip of his “immortal grandfather” being interviewed by David Suzuki as part of a CBC documentary on aging well.

Dr. Godfrey shared his secret to a long life: “The main thing is to keep interested in life,” he told Mr. Suzuki.

“That’s the secret, of course. If you stick in front of your television, you lose your interest in life. That’ll kill you next week. Certainly, the quality of stuff that’s being peddled on television these days is enough to make you wanna die pretty soon.”

A spokesperson for the University of Toronto’s department of medicine told CTV News that Dr. Godfrey was still working at four medical clinics in Toronto 4 days a week, even at age 102.

“He possessed a remarkable longevity in his practice, supported by his enduring love for medicine and incredible care for his patients,” the university said.

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

The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

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

The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

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

The Canadian Task Force on Preventive Health Care recommends against the routine screening of all pregnant and postpartum women for depression using a standard questionnaire, according to its new guideline.

The basis for its position is the lack of evidence that such screening “adds value beyond discussions about overall wellbeing, depression, anxiety, and mood that are currently a part of established perinatal clinical care.

“We should not be using a one-size-fits all approach,” lead author Eddy Lang, MD, professor and head of emergency medicine at the Cumming School of Medicine, University of Calgary (Alta.), told this news organization.

Instead, the task force emphasizes regular clinical care, including asking patients about their wellbeing and support systems. The task force categorizes the recommendation as conditional and as having very low-certainty evidence.

The recommendation was published in CMAJ.
 

One randomized study

The task force is an independent panel of clinicians and scientists that makes recommendations on primary and secondary prevention in primary care. A working group of five members of the task force developed this recommendation with scientific support from Public Health Agency of Canada staff.

In its research, the task force found only one study that showed a benefit of routine depression screening in this population. This study was a randomized controlled trial conducted in Hong Kong. Researchers evaluated 462 postpartum women who were randomly assigned to receive screening with the Edinburgh Postnatal Depression Scale (EPDS) or no screening 2 months post partum.

“We found the effect of screening in this study to be very uncertain for the important outcomes of interest,” said Dr. Lang.

“These included parent-child stress, marital stress, and the number of infant hospital admissions. The effects of screening on all of these outcomes were very uncertain, mainly because it was such a small trial,” he said.

The task force also assessed how pregnant and postpartum women feel about being screened. What these women most wanted was a good relationship with a trusted primary care provider who would initiate discussions about their mental health in a caring atmosphere.

“Although they told us they liked the idea of universal screening, they admitted to their family doctors that they actually preferred to be asked about their wellbeing, [to be asked] how things were going at home, and [to have] a discussion about their mental health and wellbeing, rather than a formal screening process. They felt a discussion about depression with a primary health care provider during the pregnancy and postpartum period is critical,” said Dr. Lang.

Thus, the task force recommends “against instrument-based depression screening using a questionnaire with cutoff score to distinguish ‘screen positive’ and ‘screen negative’ administered to all individuals during pregnancy and the postpartum period (up to 1 year after childbirth).”
 

Screening remains common

“There’s a lot of uncertainty in the scientific community about whether it’s a good idea to administer a screening test to all pregnant and postpartum women to determine in a systematic way if they might be suffering from depression,” said Dr. Lang.

The task force recommended against screening for depression among perinatal or postpartum women in 2013, but screening is still performed in many provinces, said Dr. Lang.

Dr. Lang emphasized that the recommendation does not apply to usual care, in which the provider asks questions about and discusses a patient’s mental health and proceeds on the basis of their clinical judgment; nor does it apply to diagnostic pathways in which the clinician suspects that the individual may have depression and tests her accordingly.

“What we are saying in our recommendation is that all clinicians should ask about a patient’s wellbeing, about their mood, their anxiety, and these questions are an important part of the clinical assessment of pregnant and postpartum women. But we’re also saying the usefulness of doing so with a questionnaire and using a cutoff score on the questionnaire to decide who needs further assessment or possibly treatment is unproven by the research,” Dr. Lang said.
 

A growing problem

For Diane Francoeur, MD, CEO of the Society of Obstetricians and Gynecologists of Canada, this is all well and good, but the reality is that such screening is better than nothing.

Quebec is the only Canadian province that conducts universal screening for all pregnant and postpartum women, Dr. Francoeur said in an interview. She was not part of the task force.

“I agree that it should be more than one approach, but the problem is that there is such a shortage of resources. There are many issues that can arise when you follow a woman during her pregnancy,” she said.

Dr. Francoeur said that COVID-19 has been particularly tough on women, including pregnant and postpartum women, who are the most vulnerable.

“Especially during the COVID era, it was astonishing how women were not doing well. Their stress level was so high. We need to have a specific approach dedicated to prenatal mental health, because it’s a problem that is bigger than it used to be,” she said.

Violence against women has increased considerably since the beginning of the COVID-19 pandemic, said Dr. Francoeur. “Many more women have been killed by their partners. We have never seen anything like this before, and I hope we will never see this again,” she said.

“Help was more available a few years ago, but now, it’s really hard if and when you need to have a quick consultation with a specialist and the woman is really depressed. It can take forever. So, it’s okay to screen, but then, what’s next? Who is going to be there to take these women and help them? And we don’t have the answer,” Dr. Francoeur said.

Pregnant and postpartum women who suffer from depression need more than pills, she added. “We reassure them and treat their depression pharmacologically, but it’s also a time to give appropriate support and help them through the pregnancy and get well prepared to receive their newborn, because, as we now know, that first year of life is really important for the child, and the mom needs to be supported.”

Funding for the Canadian Task Force on Preventive Health Care is provided by the Public Health Agency of Canada. Dr. Lang and Dr. Francoeur reported no relevant financial relationships.

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

The addition of social determinants of health (SDOH) to machine-learning risk-prediction models improved forecasts of in-hospital mortality in Black adults hospitalized for heart failure (HF) but didn’t show similar ability in non-Black patients, in a study based in part on the American Heart Association–sponsored Get with the Guidelines in Heart Failure (GWTG-HF) registry.

The novel risk-prediction tool bolstered by SDOH at the zip-code level – including household income, number of adults without a high-school degree, poverty and unemployment rates, and other factors – stratified risk more sharply in Black patients than more standard models, including some based on multivariable logistic regression.

“Traditional risk models that exist for heart failure assign lower risks to Black individuals if everything else is held constant,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, told this news organization.

“I think that is problematic, because if Black patients are considered lower risk, they may not get appropriate risk-based therapies that are being provided. We wanted to move away from this approach and use a more race-agnostic approach,” said Dr. Pandey, who is senior author on the study published  in JAMA Cardiology, with lead author Matthew W. Segar, MD, Texas Heart Institute, Houston.

The training dataset for the prediction model consisted of 123,634 patients hospitalized with HF (mean age, 71 years), of whom 47% were women, enrolled in the GWTG-HF registry from 2010 through 2020.

The machine-learning models showed “excellent performance” when applied to an internal subset cohort of 82,420 patients, with a C statistic of 0.81 for Black patients and 0.82 for non-Black patients, the authors report, and in a real-world cohort of 553,506 patients, with C statistics of 0.74 and 0.75, respectively. The models performed similarly well, they write, in an external validation cohort derived from the ARIC registry, with C statistics of 0.79 and 0.80, respectively.

The machine-learning models’ performance surpassed that of the GWTG-HF risk-score model, C statistics 0.69 for both Black and non-Black patients, and other logistic regression models in which race was a covariate, the authors state.

“We also observed significant race-specific differences in the population-attributable risk of in-hospital mortality associated with the SDOH, with a significantly greater contribution of these parameters to the overall in-hospital mortality risk in Black patients versus non-Black patients,” they write.

For Black patients, five of the SDOH parameters were among the top 20 covariate predictors of in-hospital mortality: mean income level, vacancy and unemployment rates, proportion of the population without a high school degree, and proportion older than 65 years. Together they accounted for 11.6% of population-attributable risk for in-hospital death.

Only one SDOH parameter – percentage of population older than 65 years – made the top 20 for non-Black patients, with a population-attributable risk of 0.5%, the group reports.

“I hope our work spurs future investigations to better understand how social determinants contribute to risk and how they can be incorporated in management of these patients,” Dr. Pandey said.

“I commend the authors for attempting to address SDOH as a potential contributor to some of the differences in outcomes among patients with heart failure,” writes Eldrin F. Lewis, MD, MPH, Stanford University School of Medicine, Palo Alto, Calif., in an accompanying editorial.

“It is imperative that we use these newer techniques to go beyond simply predicting which groups are at heightened risk and leverage the data to create solutions that will reduce those risks for the individual patient,” Dr. Lewis states.

“We should use these tools to reduce racial and ethnic differences in the operations of health care systems, potential bias in management decisions, and inactivity due to the difficulty in getting guideline-directed medical therapy into the hands of people who may have limited resources with minimal out-of-pocket costs,” he writes.

The models assessed in the current report “set a new bar for risk prediction: Integration of a comprehensive set of demographics, comorbidities, and social determinants with machine learning obviates race and ethnicity in risk prediction,” contend JAMA Cardiology deputy editor Clyde W. Yancy, MD, and associate editor Sadiya S. Khan, MD, both from Northwestern University Feinberg School of Medicine, Chicago, in an accompanying editor’s note.

“This more careful incorporation of individual-level, neighborhood-level, and hospital-level social factors,” they conclude, “is now a candidate template for future risk models.”

Dr. Pandey discloses grant funding from Applied Therapeutics and Gilead Sciences; consulting for or serving as an advisor to Tricog Health, Eli Lilly, Rivus, and Roche Diagnostics; receiving nonfinancial support from Pfizer and Merck; and research support from the Texas Health Resources Clinical Scholarship, the Gilead Sciences Research Scholar Program, the National Institute on Aging GEMSSTAR Grant, and Applied Therapeutics. Dr. Segar discloses receiving nonfinancial support from Pfizer and Merck. Other disclosures are in the report. Dr. Lewis reported no disclosures. Dr. Yancy and Dr. Khan had no relevant disclosures.

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

The addition of social determinants of health (SDOH) to machine-learning risk-prediction models improved forecasts of in-hospital mortality in Black adults hospitalized for heart failure (HF) but didn’t show similar ability in non-Black patients, in a study based in part on the American Heart Association–sponsored Get with the Guidelines in Heart Failure (GWTG-HF) registry.

The novel risk-prediction tool bolstered by SDOH at the zip-code level – including household income, number of adults without a high-school degree, poverty and unemployment rates, and other factors – stratified risk more sharply in Black patients than more standard models, including some based on multivariable logistic regression.

“Traditional risk models that exist for heart failure assign lower risks to Black individuals if everything else is held constant,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, told this news organization.

“I think that is problematic, because if Black patients are considered lower risk, they may not get appropriate risk-based therapies that are being provided. We wanted to move away from this approach and use a more race-agnostic approach,” said Dr. Pandey, who is senior author on the study published  in JAMA Cardiology, with lead author Matthew W. Segar, MD, Texas Heart Institute, Houston.

The training dataset for the prediction model consisted of 123,634 patients hospitalized with HF (mean age, 71 years), of whom 47% were women, enrolled in the GWTG-HF registry from 2010 through 2020.

The machine-learning models showed “excellent performance” when applied to an internal subset cohort of 82,420 patients, with a C statistic of 0.81 for Black patients and 0.82 for non-Black patients, the authors report, and in a real-world cohort of 553,506 patients, with C statistics of 0.74 and 0.75, respectively. The models performed similarly well, they write, in an external validation cohort derived from the ARIC registry, with C statistics of 0.79 and 0.80, respectively.

The machine-learning models’ performance surpassed that of the GWTG-HF risk-score model, C statistics 0.69 for both Black and non-Black patients, and other logistic regression models in which race was a covariate, the authors state.

“We also observed significant race-specific differences in the population-attributable risk of in-hospital mortality associated with the SDOH, with a significantly greater contribution of these parameters to the overall in-hospital mortality risk in Black patients versus non-Black patients,” they write.

For Black patients, five of the SDOH parameters were among the top 20 covariate predictors of in-hospital mortality: mean income level, vacancy and unemployment rates, proportion of the population without a high school degree, and proportion older than 65 years. Together they accounted for 11.6% of population-attributable risk for in-hospital death.

Only one SDOH parameter – percentage of population older than 65 years – made the top 20 for non-Black patients, with a population-attributable risk of 0.5%, the group reports.

“I hope our work spurs future investigations to better understand how social determinants contribute to risk and how they can be incorporated in management of these patients,” Dr. Pandey said.

“I commend the authors for attempting to address SDOH as a potential contributor to some of the differences in outcomes among patients with heart failure,” writes Eldrin F. Lewis, MD, MPH, Stanford University School of Medicine, Palo Alto, Calif., in an accompanying editorial.

“It is imperative that we use these newer techniques to go beyond simply predicting which groups are at heightened risk and leverage the data to create solutions that will reduce those risks for the individual patient,” Dr. Lewis states.

“We should use these tools to reduce racial and ethnic differences in the operations of health care systems, potential bias in management decisions, and inactivity due to the difficulty in getting guideline-directed medical therapy into the hands of people who may have limited resources with minimal out-of-pocket costs,” he writes.

The models assessed in the current report “set a new bar for risk prediction: Integration of a comprehensive set of demographics, comorbidities, and social determinants with machine learning obviates race and ethnicity in risk prediction,” contend JAMA Cardiology deputy editor Clyde W. Yancy, MD, and associate editor Sadiya S. Khan, MD, both from Northwestern University Feinberg School of Medicine, Chicago, in an accompanying editor’s note.

“This more careful incorporation of individual-level, neighborhood-level, and hospital-level social factors,” they conclude, “is now a candidate template for future risk models.”

Dr. Pandey discloses grant funding from Applied Therapeutics and Gilead Sciences; consulting for or serving as an advisor to Tricog Health, Eli Lilly, Rivus, and Roche Diagnostics; receiving nonfinancial support from Pfizer and Merck; and research support from the Texas Health Resources Clinical Scholarship, the Gilead Sciences Research Scholar Program, the National Institute on Aging GEMSSTAR Grant, and Applied Therapeutics. Dr. Segar discloses receiving nonfinancial support from Pfizer and Merck. Other disclosures are in the report. Dr. Lewis reported no disclosures. Dr. Yancy and Dr. Khan had no relevant disclosures.

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

The addition of social determinants of health (SDOH) to machine-learning risk-prediction models improved forecasts of in-hospital mortality in Black adults hospitalized for heart failure (HF) but didn’t show similar ability in non-Black patients, in a study based in part on the American Heart Association–sponsored Get with the Guidelines in Heart Failure (GWTG-HF) registry.

The novel risk-prediction tool bolstered by SDOH at the zip-code level – including household income, number of adults without a high-school degree, poverty and unemployment rates, and other factors – stratified risk more sharply in Black patients than more standard models, including some based on multivariable logistic regression.

“Traditional risk models that exist for heart failure assign lower risks to Black individuals if everything else is held constant,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, told this news organization.

“I think that is problematic, because if Black patients are considered lower risk, they may not get appropriate risk-based therapies that are being provided. We wanted to move away from this approach and use a more race-agnostic approach,” said Dr. Pandey, who is senior author on the study published  in JAMA Cardiology, with lead author Matthew W. Segar, MD, Texas Heart Institute, Houston.

The training dataset for the prediction model consisted of 123,634 patients hospitalized with HF (mean age, 71 years), of whom 47% were women, enrolled in the GWTG-HF registry from 2010 through 2020.

The machine-learning models showed “excellent performance” when applied to an internal subset cohort of 82,420 patients, with a C statistic of 0.81 for Black patients and 0.82 for non-Black patients, the authors report, and in a real-world cohort of 553,506 patients, with C statistics of 0.74 and 0.75, respectively. The models performed similarly well, they write, in an external validation cohort derived from the ARIC registry, with C statistics of 0.79 and 0.80, respectively.

The machine-learning models’ performance surpassed that of the GWTG-HF risk-score model, C statistics 0.69 for both Black and non-Black patients, and other logistic regression models in which race was a covariate, the authors state.

“We also observed significant race-specific differences in the population-attributable risk of in-hospital mortality associated with the SDOH, with a significantly greater contribution of these parameters to the overall in-hospital mortality risk in Black patients versus non-Black patients,” they write.

For Black patients, five of the SDOH parameters were among the top 20 covariate predictors of in-hospital mortality: mean income level, vacancy and unemployment rates, proportion of the population without a high school degree, and proportion older than 65 years. Together they accounted for 11.6% of population-attributable risk for in-hospital death.

Only one SDOH parameter – percentage of population older than 65 years – made the top 20 for non-Black patients, with a population-attributable risk of 0.5%, the group reports.

“I hope our work spurs future investigations to better understand how social determinants contribute to risk and how they can be incorporated in management of these patients,” Dr. Pandey said.

“I commend the authors for attempting to address SDOH as a potential contributor to some of the differences in outcomes among patients with heart failure,” writes Eldrin F. Lewis, MD, MPH, Stanford University School of Medicine, Palo Alto, Calif., in an accompanying editorial.

“It is imperative that we use these newer techniques to go beyond simply predicting which groups are at heightened risk and leverage the data to create solutions that will reduce those risks for the individual patient,” Dr. Lewis states.

“We should use these tools to reduce racial and ethnic differences in the operations of health care systems, potential bias in management decisions, and inactivity due to the difficulty in getting guideline-directed medical therapy into the hands of people who may have limited resources with minimal out-of-pocket costs,” he writes.

The models assessed in the current report “set a new bar for risk prediction: Integration of a comprehensive set of demographics, comorbidities, and social determinants with machine learning obviates race and ethnicity in risk prediction,” contend JAMA Cardiology deputy editor Clyde W. Yancy, MD, and associate editor Sadiya S. Khan, MD, both from Northwestern University Feinberg School of Medicine, Chicago, in an accompanying editor’s note.

“This more careful incorporation of individual-level, neighborhood-level, and hospital-level social factors,” they conclude, “is now a candidate template for future risk models.”

Dr. Pandey discloses grant funding from Applied Therapeutics and Gilead Sciences; consulting for or serving as an advisor to Tricog Health, Eli Lilly, Rivus, and Roche Diagnostics; receiving nonfinancial support from Pfizer and Merck; and research support from the Texas Health Resources Clinical Scholarship, the Gilead Sciences Research Scholar Program, the National Institute on Aging GEMSSTAR Grant, and Applied Therapeutics. Dr. Segar discloses receiving nonfinancial support from Pfizer and Merck. Other disclosures are in the report. Dr. Lewis reported no disclosures. Dr. Yancy and Dr. Khan had no relevant disclosures.

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

A unique primary care program successfully manages patients with depression and comorbid posttraumatic stress disorder and, if widely implemented, may result in more rapid treatment and help alleviate wait times for specialty psychiatric care.

“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.

“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Common bedfellows

Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.

Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”

“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.

The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.

The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.

During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.

To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.

Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.

Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.

No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).

Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.

Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.

“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
 

A model for other settings?

Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”

“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.

Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.

This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.

Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.

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

A unique primary care program successfully manages patients with depression and comorbid posttraumatic stress disorder and, if widely implemented, may result in more rapid treatment and help alleviate wait times for specialty psychiatric care.

“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.

“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Common bedfellows

Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.

Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”

“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.

The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.

The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.

During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.

To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.

Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.

Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.

No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).

Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.

Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.

“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
 

A model for other settings?

Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”

“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.

Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.

This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.

Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.

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

A unique primary care program successfully manages patients with depression and comorbid posttraumatic stress disorder and, if widely implemented, may result in more rapid treatment and help alleviate wait times for specialty psychiatric care.

“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.

“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Common bedfellows

Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.

Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”

“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.

The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.

The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.

During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.

To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.

Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.

Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.

No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).

Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.

Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.

“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
 

A model for other settings?

Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”

“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.

Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.

This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.

Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.

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

Electroconvulsive therapy (ECT) may lower mortality for patients with treatment-resistant major depressive disorder (MDD), new research suggests.

In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.

This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.

“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.

“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Lower mortality

Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.

“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”

For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.

The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.

Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.

A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).

“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.

He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.

“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.

After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).

In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.

“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.

Designations of extreme and major loss of function were derived from ICD codes.

“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
 

A lifesaving treatment

Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.

“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.

He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.

Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.

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

Electroconvulsive therapy (ECT) may lower mortality for patients with treatment-resistant major depressive disorder (MDD), new research suggests.

In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.

This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.

“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.

“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Lower mortality

Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.

“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”

For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.

The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.

Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.

A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).

“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.

He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.

“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.

After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).

In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.

“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.

Designations of extreme and major loss of function were derived from ICD codes.

“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
 

A lifesaving treatment

Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.

“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.

He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.

Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.

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

Electroconvulsive therapy (ECT) may lower mortality for patients with treatment-resistant major depressive disorder (MDD), new research suggests.

In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.

This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.

“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.

“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.

The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
 

Lower mortality

Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.

“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”

For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.

The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.

Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.

A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).

“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.

He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.

“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.

After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).

In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.

“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.

Designations of extreme and major loss of function were derived from ICD codes.

“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
 

A lifesaving treatment

Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.

“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.

He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.

Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.

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

The novel antidepressant seltorexant (Janssen Pharmaceuticals) may be beneficial for patients with concomitant major depressive disorder (MDD) and sleep disturbance, new research suggests.

In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.

“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.

University of Pennsylvania

Clinically meaningful?

In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.

In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).

They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.

The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).

Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.

Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
 

The LSM average distance

The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).

At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).

The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).

Seltorexant 20 mg was especially effective in patients who had more severe insomnia.

Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”

Ohio State University

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

The novel antidepressant seltorexant (Janssen Pharmaceuticals) may be beneficial for patients with concomitant major depressive disorder (MDD) and sleep disturbance, new research suggests.

In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.

“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.

University of Pennsylvania

Clinically meaningful?

In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.

In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).

They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.

The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).

Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.

Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
 

The LSM average distance

The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).

At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).

The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).

Seltorexant 20 mg was especially effective in patients who had more severe insomnia.

Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”

Ohio State University

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

The novel antidepressant seltorexant (Janssen Pharmaceuticals) may be beneficial for patients with concomitant major depressive disorder (MDD) and sleep disturbance, new research suggests.

In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.

“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.

University of Pennsylvania

Clinically meaningful?

In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.

In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).

They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.

The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).

Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.

Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
 

The LSM average distance

The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).

At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).

The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).

Seltorexant 20 mg was especially effective in patients who had more severe insomnia.

Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”

Ohio State University

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

Social engagement such as participation in community or school-based activities may mitigate psychosis risk in susceptible youth living in disadvantaged communities, new research suggests.

A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.

“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.

Emory University

A personal connection

It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.

“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.

Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.

“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.

“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.

To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.

The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.

Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.

Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
 

Lower hippocampal volume

Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.

Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.

However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.

“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.

“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.

Dr. Ku noted social engagement might look different in urban versus rural settings.

“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
 

Interesting, innovative

Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”

Ohio State University

Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.

The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.

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

Social engagement such as participation in community or school-based activities may mitigate psychosis risk in susceptible youth living in disadvantaged communities, new research suggests.

A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.

“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.

Emory University

A personal connection

It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.

“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.

Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.

“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.

“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.

To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.

The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.

Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.

Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
 

Lower hippocampal volume

Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.

Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.

However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.

“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.

“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.

Dr. Ku noted social engagement might look different in urban versus rural settings.

“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
 

Interesting, innovative

Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”

Ohio State University

Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.

The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.

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

Social engagement such as participation in community or school-based activities may mitigate psychosis risk in susceptible youth living in disadvantaged communities, new research suggests.

A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.

“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.

Emory University

A personal connection

It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.

“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.

Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.

“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.

“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.

To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.

The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.

Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.

Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
 

Lower hippocampal volume

Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.

Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.

However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.

“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.

“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.

Dr. Ku noted social engagement might look different in urban versus rural settings.

“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
 

Interesting, innovative

Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”

Ohio State University

Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.

The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.

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

At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.

In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).

Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Courtesy The Feinstein Institutes

Potential alternative to meds

“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.

Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.

Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.

Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.

“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.

The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.

The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
 

Promising findings

At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.

By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.

In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.

The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.

Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”

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

The first international survey of parental benefits and policies among cardiovascular training programs shows wide variability among institutions.

Although a majority of cardiology fellows became parents during training, the survey found that family benefits and policies were not uniformly available and that knowledge about the existence of such policies was low across all institutions.

The findings are published in the Journal of the American College of Cardiology.

Such variability highlights disparities in real-world experiences, say Estefania Oliveros, MD, Temple University Hospital, Philadelphia, and colleagues.

“There are no policies to protect cardiology trainees when they become parents that are uniform across the United States or even internationally, even though, according to our survey, 61.7% become parents during training,” Dr. Oliveros told this news organization.

Dr. Oliveros said she wanted to learn more about the status of institutional practices surrounding pregnant trainees during cardiovascular fellowship, not only in the U.S., but internationally: “I wanted to study this because of my own experience.”

“I was probably the first pregnant trainee at my institution, and there were no specific policies in place, so I had to find out on my own what to do about radiation safety, where I would breastfeed, schedule changes, how that would impact my graduation time, things like that,” Dr. Oliveros said. “It would be nice if you had the resources and your institution could accommodate your needs, instead of every time you have a pregnant person on your staff, you have to reinvent the wheel.”

Dr. Oliveros and colleagues conducted an online survey during August 2020-October 2020 that was distributed via social media. Responses were made anonymous to encourage unbiased feedback.

Among the 417 completed responses, 47 (11.3%) were from training program directors, 146 (35%) from current or former pregnant trainees, and 224 (53.7%) from current or former trainees who were not pregnant during cardiology training. Two-thirds of the respondents (67.1%) were parents.

Most survey respondents said they became pregnant during the third year of general cardiology (29.1%), followed by the first year of general cardiology (26.3%), and the second year of general cardiology (23.5%).

Only 13 of the 47 training program directors (27.7%) received guidance or training on how to accommodate pregnant trainees during fellowship.

Additionally, 26% of the trainees reported their institution had readily available breastfeeding and pumping policies, 39% responded that their institution had no such policies, and 34.9% said they did not know.

Nearly one-half of the programs offered rearrangement of schedules because of radiation concerns, 27.5% did not.

The amount of parental leave varied greatly worldwide. For Europe, Central and South America, Africa, and Australia, the average parental leave was more than 4 months; for Canada, it was more than 3 months; for the United States, it was 1 to 2 months; and for Asia, it was 3 to 4 weeks.

“There is no uniformity, no policies for things like breastfeeding or places where you can pump. None of that is installed, even though by law we’re supposed to have these things,” Dr. Oliveros said.

In all countries, paternity leave was uncommon (2.6% of respondents), even though 48.5% of the programs had paternity leave.

“I would like to see associations, program directors, even trainees helping each other in finding ways to accommodate parents to promote wellness and assure that trainees can have both good training and life balance,” she added.

In an accompanying editorial, Ileana L. Piña, MD, MPH, Thomas Jefferson Institute, Philadelphia, writes: “Enough has been said about our need for a greater percentage of women cardiologists. There is no need to further debate that fact. However, it is puzzling that despite > 50% of medical students being women, the cardiology specialty is fraught with recent survey reports of hostility in the workplace, concerns of long hours, exposure to radiation, and poor work-life balance that can compel trainees to choose delaying pregnancy or taking unpaid leave, which will, in turn, delay training. Therefore, it is not surprising that only 14.9% of cardiologist specialists and 21.9% of cardiology fellows are women.”

Dr. Piña notes that while the authors understand that it’s difficult to change national policies, they issue a “call to action” for organizations and program directors to demonstrate leadership by developing fair and balanced decisions regarding parental policies.

“Those decisions are so impactful that they can change career trajectories for the better or worse ... the current status is unacceptable and must change for the benefit of all trainees, their families, and the program directors. The problem is too important and pervasive,” she adds.

Dr. Piña concludes: “Perhaps if the women who are the subjects of, and often the unwitting party to, administrative decisions about their lives, choices, and welfare were invited to contribute to the changes, we would finally see an increase in the number of women in cardiology careers. After all, aren’t we about diversity and belonging?”

“We need to normalize pregnancy and parental leave across the globe,” Laxmi S. Mehta, MD, Ohio State University Weiner Medical Center, Columbus, said in an interview.

As previously reported, Dr. Mehta recently led a study that surveyed 323 women cardiologists who were working while they were pregnant. Her study found that 75% of these women experienced discriminatory maternity leave practices, some of which were likely violations of the federal Family and Medical Leave Act.

“If we want more women to pursue a career in cardiology, then employers and health systems need to adequately support parenthood, including allowing people to spend uninterrupted time with their newborns without the fear of discrimination, retaliation, or financial burden,” Dr. Mehta said.

Limitations of the study are the small sample size, potential for bias associated with social media distribution, and the fact that 75% of respondents were women, Dr. Oliveros and colleagues write.

Dr. Oliveros, Dr. Piña, and Dr. Mehta report no relevant financial relationships.

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

The first international survey of parental benefits and policies among cardiovascular training programs shows wide variability among institutions.

Although a majority of cardiology fellows became parents during training, the survey found that family benefits and policies were not uniformly available and that knowledge about the existence of such policies was low across all institutions.

The findings are published in the Journal of the American College of Cardiology.

Such variability highlights disparities in real-world experiences, say Estefania Oliveros, MD, Temple University Hospital, Philadelphia, and colleagues.

“There are no policies to protect cardiology trainees when they become parents that are uniform across the United States or even internationally, even though, according to our survey, 61.7% become parents during training,” Dr. Oliveros told this news organization.

Dr. Oliveros said she wanted to learn more about the status of institutional practices surrounding pregnant trainees during cardiovascular fellowship, not only in the U.S., but internationally: “I wanted to study this because of my own experience.”

“I was probably the first pregnant trainee at my institution, and there were no specific policies in place, so I had to find out on my own what to do about radiation safety, where I would breastfeed, schedule changes, how that would impact my graduation time, things like that,” Dr. Oliveros said. “It would be nice if you had the resources and your institution could accommodate your needs, instead of every time you have a pregnant person on your staff, you have to reinvent the wheel.”

Dr. Oliveros and colleagues conducted an online survey during August 2020-October 2020 that was distributed via social media. Responses were made anonymous to encourage unbiased feedback.

Among the 417 completed responses, 47 (11.3%) were from training program directors, 146 (35%) from current or former pregnant trainees, and 224 (53.7%) from current or former trainees who were not pregnant during cardiology training. Two-thirds of the respondents (67.1%) were parents.

Most survey respondents said they became pregnant during the third year of general cardiology (29.1%), followed by the first year of general cardiology (26.3%), and the second year of general cardiology (23.5%).

Only 13 of the 47 training program directors (27.7%) received guidance or training on how to accommodate pregnant trainees during fellowship.

Additionally, 26% of the trainees reported their institution had readily available breastfeeding and pumping policies, 39% responded that their institution had no such policies, and 34.9% said they did not know.

Nearly one-half of the programs offered rearrangement of schedules because of radiation concerns, 27.5% did not.

The amount of parental leave varied greatly worldwide. For Europe, Central and South America, Africa, and Australia, the average parental leave was more than 4 months; for Canada, it was more than 3 months; for the United States, it was 1 to 2 months; and for Asia, it was 3 to 4 weeks.

“There is no uniformity, no policies for things like breastfeeding or places where you can pump. None of that is installed, even though by law we’re supposed to have these things,” Dr. Oliveros said.

In all countries, paternity leave was uncommon (2.6% of respondents), even though 48.5% of the programs had paternity leave.

“I would like to see associations, program directors, even trainees helping each other in finding ways to accommodate parents to promote wellness and assure that trainees can have both good training and life balance,” she added.

In an accompanying editorial, Ileana L. Piña, MD, MPH, Thomas Jefferson Institute, Philadelphia, writes: “Enough has been said about our need for a greater percentage of women cardiologists. There is no need to further debate that fact. However, it is puzzling that despite > 50% of medical students being women, the cardiology specialty is fraught with recent survey reports of hostility in the workplace, concerns of long hours, exposure to radiation, and poor work-life balance that can compel trainees to choose delaying pregnancy or taking unpaid leave, which will, in turn, delay training. Therefore, it is not surprising that only 14.9% of cardiologist specialists and 21.9% of cardiology fellows are women.”

Dr. Piña notes that while the authors understand that it’s difficult to change national policies, they issue a “call to action” for organizations and program directors to demonstrate leadership by developing fair and balanced decisions regarding parental policies.

“Those decisions are so impactful that they can change career trajectories for the better or worse ... the current status is unacceptable and must change for the benefit of all trainees, their families, and the program directors. The problem is too important and pervasive,” she adds.

Dr. Piña concludes: “Perhaps if the women who are the subjects of, and often the unwitting party to, administrative decisions about their lives, choices, and welfare were invited to contribute to the changes, we would finally see an increase in the number of women in cardiology careers. After all, aren’t we about diversity and belonging?”

“We need to normalize pregnancy and parental leave across the globe,” Laxmi S. Mehta, MD, Ohio State University Weiner Medical Center, Columbus, said in an interview.

As previously reported, Dr. Mehta recently led a study that surveyed 323 women cardiologists who were working while they were pregnant. Her study found that 75% of these women experienced discriminatory maternity leave practices, some of which were likely violations of the federal Family and Medical Leave Act.

“If we want more women to pursue a career in cardiology, then employers and health systems need to adequately support parenthood, including allowing people to spend uninterrupted time with their newborns without the fear of discrimination, retaliation, or financial burden,” Dr. Mehta said.

Limitations of the study are the small sample size, potential for bias associated with social media distribution, and the fact that 75% of respondents were women, Dr. Oliveros and colleagues write.

Dr. Oliveros, Dr. Piña, and Dr. Mehta report no relevant financial relationships.

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

The first international survey of parental benefits and policies among cardiovascular training programs shows wide variability among institutions.

Although a majority of cardiology fellows became parents during training, the survey found that family benefits and policies were not uniformly available and that knowledge about the existence of such policies was low across all institutions.

The findings are published in the Journal of the American College of Cardiology.

Such variability highlights disparities in real-world experiences, say Estefania Oliveros, MD, Temple University Hospital, Philadelphia, and colleagues.

“There are no policies to protect cardiology trainees when they become parents that are uniform across the United States or even internationally, even though, according to our survey, 61.7% become parents during training,” Dr. Oliveros told this news organization.

Dr. Oliveros said she wanted to learn more about the status of institutional practices surrounding pregnant trainees during cardiovascular fellowship, not only in the U.S., but internationally: “I wanted to study this because of my own experience.”

“I was probably the first pregnant trainee at my institution, and there were no specific policies in place, so I had to find out on my own what to do about radiation safety, where I would breastfeed, schedule changes, how that would impact my graduation time, things like that,” Dr. Oliveros said. “It would be nice if you had the resources and your institution could accommodate your needs, instead of every time you have a pregnant person on your staff, you have to reinvent the wheel.”

Dr. Oliveros and colleagues conducted an online survey during August 2020-October 2020 that was distributed via social media. Responses were made anonymous to encourage unbiased feedback.

Among the 417 completed responses, 47 (11.3%) were from training program directors, 146 (35%) from current or former pregnant trainees, and 224 (53.7%) from current or former trainees who were not pregnant during cardiology training. Two-thirds of the respondents (67.1%) were parents.

Most survey respondents said they became pregnant during the third year of general cardiology (29.1%), followed by the first year of general cardiology (26.3%), and the second year of general cardiology (23.5%).

Only 13 of the 47 training program directors (27.7%) received guidance or training on how to accommodate pregnant trainees during fellowship.

Additionally, 26% of the trainees reported their institution had readily available breastfeeding and pumping policies, 39% responded that their institution had no such policies, and 34.9% said they did not know.

Nearly one-half of the programs offered rearrangement of schedules because of radiation concerns, 27.5% did not.

The amount of parental leave varied greatly worldwide. For Europe, Central and South America, Africa, and Australia, the average parental leave was more than 4 months; for Canada, it was more than 3 months; for the United States, it was 1 to 2 months; and for Asia, it was 3 to 4 weeks.

“There is no uniformity, no policies for things like breastfeeding or places where you can pump. None of that is installed, even though by law we’re supposed to have these things,” Dr. Oliveros said.

In all countries, paternity leave was uncommon (2.6% of respondents), even though 48.5% of the programs had paternity leave.

“I would like to see associations, program directors, even trainees helping each other in finding ways to accommodate parents to promote wellness and assure that trainees can have both good training and life balance,” she added.

In an accompanying editorial, Ileana L. Piña, MD, MPH, Thomas Jefferson Institute, Philadelphia, writes: “Enough has been said about our need for a greater percentage of women cardiologists. There is no need to further debate that fact. However, it is puzzling that despite > 50% of medical students being women, the cardiology specialty is fraught with recent survey reports of hostility in the workplace, concerns of long hours, exposure to radiation, and poor work-life balance that can compel trainees to choose delaying pregnancy or taking unpaid leave, which will, in turn, delay training. Therefore, it is not surprising that only 14.9% of cardiologist specialists and 21.9% of cardiology fellows are women.”

Dr. Piña notes that while the authors understand that it’s difficult to change national policies, they issue a “call to action” for organizations and program directors to demonstrate leadership by developing fair and balanced decisions regarding parental policies.

“Those decisions are so impactful that they can change career trajectories for the better or worse ... the current status is unacceptable and must change for the benefit of all trainees, their families, and the program directors. The problem is too important and pervasive,” she adds.

Dr. Piña concludes: “Perhaps if the women who are the subjects of, and often the unwitting party to, administrative decisions about their lives, choices, and welfare were invited to contribute to the changes, we would finally see an increase in the number of women in cardiology careers. After all, aren’t we about diversity and belonging?”

“We need to normalize pregnancy and parental leave across the globe,” Laxmi S. Mehta, MD, Ohio State University Weiner Medical Center, Columbus, said in an interview.

As previously reported, Dr. Mehta recently led a study that surveyed 323 women cardiologists who were working while they were pregnant. Her study found that 75% of these women experienced discriminatory maternity leave practices, some of which were likely violations of the federal Family and Medical Leave Act.

“If we want more women to pursue a career in cardiology, then employers and health systems need to adequately support parenthood, including allowing people to spend uninterrupted time with their newborns without the fear of discrimination, retaliation, or financial burden,” Dr. Mehta said.

Limitations of the study are the small sample size, potential for bias associated with social media distribution, and the fact that 75% of respondents were women, Dr. Oliveros and colleagues write.

Dr. Oliveros, Dr. Piña, and Dr. Mehta report no relevant financial relationships.

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