Vaccination tied to lower mortality in ventilated patients with COVID-19

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Mon, 10/17/2022 - 08:03

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

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Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

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Cleaning indoor air ‘next frontier’ for COVID, public health

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Thu, 10/13/2022 - 15:21

The COVID-19 pandemic is driving attention to clean indoor air like never before.

At a White House summit on Oct. 11, leaders from government, industry, and education came together to make a case that low-quality indoor air should warrant the same kind of outrage and action as low-quality water.

“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.

“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.

The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.

“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
 

Recent federal actions

Dr. Jha pointed to White House actions toward that end.

On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:

  • Create an action plan.
  • Optimize fresh air ventilation.
  • Enhance air filtration and cleaning.
  • Communicate with building occupants to increase awareness.

Those who pledge can download a badge to feature on their websites.

In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.

The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and  $122 billion for schools, through the American Rescue Plan.

The Department of Energy is offering one-on-one consultations to schools to drive air quality.
 

Calculate your ‘indoor age’

Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.

He asked people to multiply their age times 0.9 to calculate their “indoor age.”

Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.

When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”

Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:

  • Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
  • Maximize outdoor ventilation.
  • Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
  • Supplement with portable air cleaners.

It’s not a complete list, he said; “It’s where you should start.”
 

Indoor air innovations

Others are suggesting innovations in schools and businesses.

Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.

“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.

Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.

“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.

“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
 

Legislation like 1970 Clean Air Act needed?

Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.

He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.

Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”

Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.

“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.

The speakers declared no relevant financial relationships.

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

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The COVID-19 pandemic is driving attention to clean indoor air like never before.

At a White House summit on Oct. 11, leaders from government, industry, and education came together to make a case that low-quality indoor air should warrant the same kind of outrage and action as low-quality water.

“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.

“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.

The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.

“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
 

Recent federal actions

Dr. Jha pointed to White House actions toward that end.

On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:

  • Create an action plan.
  • Optimize fresh air ventilation.
  • Enhance air filtration and cleaning.
  • Communicate with building occupants to increase awareness.

Those who pledge can download a badge to feature on their websites.

In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.

The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and  $122 billion for schools, through the American Rescue Plan.

The Department of Energy is offering one-on-one consultations to schools to drive air quality.
 

Calculate your ‘indoor age’

Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.

He asked people to multiply their age times 0.9 to calculate their “indoor age.”

Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.

When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”

Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:

  • Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
  • Maximize outdoor ventilation.
  • Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
  • Supplement with portable air cleaners.

It’s not a complete list, he said; “It’s where you should start.”
 

Indoor air innovations

Others are suggesting innovations in schools and businesses.

Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.

“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.

Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.

“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.

“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
 

Legislation like 1970 Clean Air Act needed?

Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.

He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.

Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”

Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.

“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.

The speakers declared no relevant financial relationships.

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

The COVID-19 pandemic is driving attention to clean indoor air like never before.

At a White House summit on Oct. 11, leaders from government, industry, and education came together to make a case that low-quality indoor air should warrant the same kind of outrage and action as low-quality water.

“Indoor air is that next frontier when it comes to thinking about public health for humanity,” said Ashish Jha, MD, MPH, who heads the White House COVID response team.

“This once-in-a-century pandemic has given us a moment. A moment when we can drive significant structural changes in the air that we all breathe,” he said.

The threat is immediate, Dr. Jha said, explaining that the return of influenza this year and other circulating respiratory viruses on top of COVID cases could overwhelm the health system.

“We have to bring the burden of respiratory pathogens down and the single biggest structural change we can make as a society is to do for indoor air what we’ve done for water quality,” he said.
 

Recent federal actions

Dr. Jha pointed to White House actions toward that end.

On Oct. 11, the White House launched a new website asking building owners and operators to sign a pledge for clean air and agree to four principles:

  • Create an action plan.
  • Optimize fresh air ventilation.
  • Enhance air filtration and cleaning.
  • Communicate with building occupants to increase awareness.

Those who pledge can download a badge to feature on their websites.

In March, the White House launched the Clean Air in Buildings Challenge as a call to action for building owners and operators to improve ventilation, filtration, and facilities for cleaner indoor air.

The government has provided funds that can be used in schools, public buildings, and other locations to improve indoor air quality, including $350 billion for state and local governments and  $122 billion for schools, through the American Rescue Plan.

The Department of Energy is offering one-on-one consultations to schools to drive air quality.
 

Calculate your ‘indoor age’

Joseph Allen, DSc, MPH, director of the Healthy Buildings program and an associate professor at Harvard’s T. H. Chan School of Public Health in Boston, said that the indoor environment has an outsized effect on public health.

He asked people to multiply their age times 0.9 to calculate their “indoor age.”

Dr. Allen, 47, said that for him that number is 42 years spent inside spaces.

When most people realize they spend 90% of their time indoors, a startling possibility comes into play: “The person who manages your building has a greater impact on your health than your doctor,” he said. “Think about that.”

Dr. Allen led a team that published a report on four strategies every building should pursue to reduce COVID and other respiratory illnesses:

  • Give every building a tune-up. “We do this for our cars, we don’t do it for our buildings,” Dr. Allen said.
  • Maximize outdoor ventilation.
  • Upgrade filtration. “We need to move away from filters designed to protect equipment to filters designed to protect people. MERV 13 is the new minimum.”
  • Supplement with portable air cleaners.

It’s not a complete list, he said; “It’s where you should start.”
 

Indoor air innovations

Others are suggesting innovations in schools and businesses.

Denver (Colorado) Public School Superintendent Alex Marrero, EdD, said that the system is implementing an air quality dashboard to display performance on factors such as carbon dioxide levels, particulate matter, and volatile organic compounds in schools.

“When you’re deciding what school you’re going to visit or even enroll in, you’ll have a snapshot of what we’re able to gather. Hopefully we’ll have something up before the end of the school year,” he said.

Shelly L. Miller, PhD, professor of mechanical engineering in the environmental engineering program at the University of Colorado Boulder, said that germicidal ultraviolet disinfection, used currently in water quality, holds promise for cleaning the COVID virus and other pathogens from indoor air.

“We were looking at germicidal UV way back in the 2000s for an outbreak of tuberculosis. We continue to see that it’s effective for measles. Why can’t we put a little more emphasis on these technologies?” Dr. Miller asks, acknowledging that there is a lack of expertise in designing such systems and in training and maintenance.

“It’s not for everybody, but it’s for a lot more places than we’re using it now,” she said.
 

Legislation like 1970 Clean Air Act needed?

Richard Corsi, PhD, dean of the College of Engineering at the University of California, Davis, said that education is lacking on the subject and indoor air quality is taught as a class in only a few universities, including his own.

He suggested starting the education even much earlier, in high school biology, chemistry, and physics courses.

Relative to other fields, he said, research and funding for indoor air quality “has been anemic.”

Work on outdoor air quality has seen dramatic improvements over the years because of the 52-year-old Clean Air Act, he noted.

“We need something akin to the Clean Air Act for indoor air quality,” Dr. Corsi said.

The speakers declared no relevant financial relationships.

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

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E-health program improves perinatal depression

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Changed
Thu, 10/13/2022 - 15:06

Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

 

 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.

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Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

 

 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.

Patients with perinatal depression who used a specialized online tool showed improvement in symptoms, compared with controls who received routine care, based on data from 191 individuals.

Although perinatal depression affects approximately 17% of pregnant women and 13% of postpartum women, the condition is often underrecognized and undertreated, Brian Danaher, PhD, of Influents Innovations, Eugene, Ore., and colleagues wrote. Meta-analyses have shown that e-health interventions based on cognitive-behavioral therapy (CBT) can improve depression in general and perinatal depression in particular.

An e-health program known as the MomMoodBooster has demonstrated effectiveness at reducing postpartum depression, and the researchers evaluated the effectiveness of a perinatal version.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers randomized 95 pregnant women and 96 postpartum women who met screening criteria for depression to routine care for perinatal depression, which included a 24/7 crisis hotline and a referral network or PDP plus a version of the MomMoodBooster with a perinatal depression component (MMB2). Participants were aged 18 and older, with no active suicidal ideation. The average age was 32 years; 84% were non-Hispanic, 67% were White, and 94% were married or in a long-term relationship. During the 12 weeks, each of six sessions became accessible online in sequence.

The primary endpoint was the change in outcomes at 12 weeks after the start of the program, with depressive symptom severity measured using the Patient Health Questionnaire (PHQ-9). Anxiety was assessed as a secondary outcome by using the Depression Anxiety Stress Scale. The minimal clinically important difference (MCID) was used to evaluate clinical significance, and was defined as a reduction in PHQ-9 of at least 5 points from baseline.

After controlling for perinatal status at baseline and assessment time, the MMB2 group had significantly greater decreases in depression severity and stress compared with the routine care group. In addition, based on MCID, significantly more women in the MMB2 group showed improvements in depression, compared with the routine care group (43% vs. 26%; odds ratio, 2.12; P = .015).

A total of 88 of the 89 women in the MMB2 group accessed the sessions, and approximately half (49%) viewed all six sessions.

Of the women who used the MMB2 program, 96% said that it was easy to use, 93% said they would recommend it, and 83% said it was helpful to them.

The study findings were limited by several factors including the lack of long-term follow-up data and inability to determine the durability of the treatment effects, the researchers noted. Another key limitation is the demographics of the study population (slightly older and a greater proportion of White individuals than the national average), which may not be representative of all perinatal women in the United States.

However, the results are consistent with findings from previous studies, including meta-analyses of CBT-based programs, the researchers wrote.

“When used in a largely self-directed approach, MMB2 could fill the gap when in-person treatment options are limited as well as for women whose circumstances (COVID) and/or concerns (stigma, costs) reduce the acceptability of in-person help,” they said. Use of e-health programs such as MMB2 could increase the scope of treatment for perinatal depression.
 

 

 

Expanding e-health options may improve outcomes and reduce disparities

Perinatal and postpartum depression is one of the most common conditions affecting pregnancy, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview. “Depression can have serious consequences for both maternal and neonatal well-being, including preterm birth, low birth weight, and poor bonding, as well as delayed emotional and cognitive development of the newborn.

“While clinicians are encouraged to screen patients during and after pregnancy for signs and symptoms of depression, once identified, the availability of effective treatment is limited. Access to mental health resources is a long-standing disparity in medicine, and therefore research investigating readily available e-health treatment strategies is critically important,” said Dr. Tanner, who was not involved in the study.

In the current study, “I was surprised by the number of patients who saw a clinically significant improvement in depression scores in such a short period of time. An average of only 20 days elapsed between baseline and post-test scores and almost 43% of patients showed improvement. Mental health interventions typically take longer to demonstrate an effect, both medication and talk therapies,” she said.  

“The largest barrier to adoption of any e-health modality into clinical practice is often the cost of implementation and maintaining infrastructure,” said Dr. Tanner. “A cost-effectiveness analysis of this intervention would be helpful to better delineate the value of such of program in comparison to more traditional treatments.”

More research is needed on the effectiveness of the intervention for specific populations, such as groups with lower socioeconomic status and patients with chronic mood disorders, Dr. Tanner said. “Additionally, introducing the program in locations with limited access to mental health resources would support more widespread implementation.”

The study was supported by the National Institutes of Mental Health. The researchers had no financial conflicts to disclose. Dr. Tanner had no financial conflicts to disclose.

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FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY

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Psychiatrist sentenced to 11 years for sledgehammer attack against another psychiatrist

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A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

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A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

 

A New York psychiatrist who has been suspended from practicing pending an investigation by state licensing authorities has been sentenced to 11 years in state prison for her role in the attempted murder of her child’s father, who is also a psychiatrist.

Pamela Buchbinder pled guilty to first-degree burglary and assault on September 7, almost exactly 10 years after the November 2012 attack on Michael Weiss, MD. Weiss was beaten with a sledgehammer and stabbed multiple times but survived the attack.

The September plea deal was announced by the Manhattan district attorney, who said that Ms. Buchbinder acknowledged she had enlisted the help of her then-19-year-old cousin Jacob Nolan to kill Dr. Weiss. Ms. Buchbinder was in a custody battle with Dr. Weiss over their then-5-year-old child.

At the Oct. 11 sentencing, Ms. Buchbinder and her defense attorney attempted to withdraw that plea. NBC4 New York reported that Buchbinder claimed she was not in her right mind on the day of the plea because she had received a “contact high” from others in her holding cell who were using synthetic marijuana and that she had not taken her prescribed medications that day.

The judge did not entertain the request and proceeded with the sentencing.

Ms. Buchbinder has been held at Rikers Island prison, in East Elmhurst, N.Y., since she was arrested in 2017, so has already served 5 years of her 11-year sentence. She must also serve 5 years of postrelease probation.
 

Insurance policy beneficiary

Ms. Buchbinder’s cousin was convicted of second-degree attempted murder in 2016 and was sentenced to 9.5 years in prison.

In a 2017 interview with CBS News, Mr. Nolan, who said he was “bipolar,” claimed Ms. Buchbinder had manipulated him into trying to kill her child’s father by telling him “horror stories” about Weiss. Soon after the interview, Ms. Buchbinder was arrested.

In 2022, the New York Post reported that Ms. Buchbinder had been named a beneficiary of Dr. Weiss’ $1.5 million life insurance policy several days before the attack.

Prosecutors had surveillance footage of Ms. Buchbinder with Nolan at a Manhattan hardware store purchasing the sledgehammer. According to the CBS report, at the time of her arrest, she also was apparently preparing to flee.

She was denied bail and has been held at Rikers Island since her arrest.

Ms. Buchbinder was licensed to practice in New York in 1999. In April 2018, the New York State Board for Professional Medical Conduct issued an interim order that precluded her from practicing medicine in New York.

The interim order will be in effect until the board completes its investigation. As of press time, the board had not updated its files.

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

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PsA Guidelines

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Suicide notes offer ‘unique window’ into motives, risks in the elderly

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Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.

A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.

“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.

“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.

The study was published online in The American Journal of Geriatric Psychiatry.
 

Opportunity for intervention

Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.

Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.

The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.

Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.

In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.

The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).

The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).

Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
 

Common themes

Four major themes emerged in the analysis of the suicide notes.

Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).

The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:

  • Suicide as a way out or solution to an insoluble problem.
  • Suicide as the final act in a long road of suffering.
  • Suicide as the logical culmination of life (the person “lived a good life”).

“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.

“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.

“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
 

Untangling suicide drivers

Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”

University of Rochester Medical Center
Dr. Yeates Conwell

Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.

However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.

“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.

No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.

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

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Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.

A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.

“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.

“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.

The study was published online in The American Journal of Geriatric Psychiatry.
 

Opportunity for intervention

Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.

Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.

The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.

Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.

In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.

The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).

The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).

Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
 

Common themes

Four major themes emerged in the analysis of the suicide notes.

Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).

The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:

  • Suicide as a way out or solution to an insoluble problem.
  • Suicide as the final act in a long road of suffering.
  • Suicide as the logical culmination of life (the person “lived a good life”).

“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.

“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.

“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
 

Untangling suicide drivers

Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”

University of Rochester Medical Center
Dr. Yeates Conwell

Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.

However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.

“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.

No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.

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

Suicide notes left by elderly people provide a unique opportunity to better understand and prevent suicide in this often vulnerable population.

A new analysis of notes penned by seniors who died by suicide reveals several common themes. These include feeling as if they were a burden, feelings of guilt, experiencing mental illness, loneliness, or isolation, as well as poor health and/or disability.

“The most important message [in our findings] is that there is hope,” study investigator Ari B. Cuperfain, MD, Temerty Faculty of Medicine, University of Toronto, told this news organization.

“Suicide risk is modifiable, and we encourage that care providers sensitively explore thoughts of suicide in patients expressing depressive thoughts or difficulty coping with other life stressors,” he said.

The study was published online in The American Journal of Geriatric Psychiatry.
 

Opportunity for intervention

Most previous studies of late-life suicide have focused on risk factors rather than the themes and meaning underlying individuals’ distress.

Dr. Cuperfain’s group had previously analyzed suicide notes to “explore the relationship between suicide and an individual’s experience with mental health care in all age groups,” he said. For the current study, the investigators analyzed the subset of notes written exclusively by older adults.

The researchers “hypothesized that suicide notes could provide a unique window into the thought processes of older adults during a critical window for mental health intervention,” he added.

Although effective screening for suicidality in older adults can mitigate suicide risk, the frequency of suicide screening decreases with increasing age, the authors noted.

In addition, suicide attempts are typically more often fatal in older adults than in the general population. Understanding the motivations for suicide in this vulnerable population can inform potential interventions.

The researchers used a constructivist grounded theory framework to analyze suicide notes available from their previous study and notes obtained from the Office of the Coroner in Toronto from adults aged 65 years and older (n = 29; mean [SD], age 76.2 [8.3] years; 79% men).

The investigators began with open coding of the notes, “specifying a short name to a segment of data that summarizes and accounts for each piece of data.” They then used a series of techniques to identify terms and themes (repeated patterns of ideas reflected in the data).

Once themes had been determined, they identified “pathways between these themes and the final act of suicide.”
 

Common themes

Four major themes emerged in the analysis of the suicide notes.

Recurring terms included “pain,” “[poor] sleep,” or “[wakeful] nights,” as well as “sorry” (either about past actions or about the suicide), and “I just can’t” (referring to the inability to carry on).

The suicide notes “provided the older writers’ conceptual schema for suicide, elucidating the cognitive process linking their narratives to the acts of suicide.” Examples included the following:

  • Suicide as a way out or solution to an insoluble problem.
  • Suicide as the final act in a long road of suffering.
  • Suicide as the logical culmination of life (the person “lived a good life”).

“Our study enriches the understanding of ‘why’ rather than just ‘which’ older adults die by suicide,” the authors noted.

“Care providers can help older adults at risk of suicide through a combination of treatment options. These include physician involvement to manage depression, psychosis, or pain, psychotherapy to reframe certain ways of thinking, or social activities to reduce isolation,” Dr. Cuperfain said.

“By understanding the experiences of older adults and what is underlying their suicidal thoughts, these interventions can be tailored specifically for the individual experiencing distress,” he added.
 

Untangling suicide drivers

Commenting on the study, Yeates Conwell, MD, professor and vice chair, department of psychiatry, University of Rochester (N.Y.) Medical Center, said that “by analyzing the suicide notes of older people who died by suicide, the paper lends a unique perspective to our understanding of why they may have taken their lives.”

University of Rochester Medical Center
Dr. Yeates Conwell

Dr. Conwell, director of the geriatric psychiatry program and codirector of the Center for the Study and Prevention of Suicide, University of Rochester, and author of an accompanying editorial, said that “by including the decedent’s own voice, the analysis of notes is a useful complement to other approaches used for the study of suicide in this age group”.

However, “like all other approaches, it is subject to potential biases in interpretation. The meaning in the notes must be derived with careful consideration of context, both what is said and what is not said, and the likelihood that both overt and covert messages are contained in and between their lines,” cautioned Dr. Conwell.

“Acknowledging the strength and limitations of each approach to the study of suicide death, together they can help untangle its drivers and support the search for effective, acceptable, and scalable prevention interventions. No one approach alone, however, will reveal the ‘cause’ of suicide,” Dr. Conwell wrote.

No source of study funding was provided. Dr. Cuperfain reports no relevant financial relationships. The other authors’ disclosures are listed on the original article. Dr. Conwell reports no relevant financial relationships.

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

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FROM THE AMERICAN JOURNAL OF GERIATRIC PSYCHIATRY

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Baby, that bill is high: Private equity ‘gambit’ squeezes excessive ER charges from routine births

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Elizabeth Huffner thinks it is obvious: A full-term, healthy pregnancy results in a birth.

“When your due date has come and gone, you’re expecting a baby any minute,” Ms. Huffner said. So she was surprised to discover she was an “unknown accident” – at least from a billing standpoint – when she went to the hospital during labor. Her bill included a charge for something she said she didn’t know she’d ever entered: an obstetrics ED.

That’s where a doctor briefly checked her cervix, timed her contractions, and monitored the fetal heartbeat before telling her to go home and come back later. The area is separated from the rest of the labor-and-delivery department by a curtain. The hospital got about $1,300 for that visit – $530 of it from Ms. Huffner’s pocket.

In recent years, hospitals of every stripe have opened obstetrics EDs, or OBEDs. They come with a requirement that patients with pregnancy or postpartum medical concerns be seen quickly by a qualified provider, which can be important in a real emergency. But it also means healthy patients like Ms. Huffner get bills for emergency care they didn’t know they got.

“It should be a cautionary tale to every woman,” said Ms. Huffner, of Rockford, Ill.

Three of the four major companies that set up and staff OBEDs are affiliated with private equity firms, which are known for making a profit on quick-turnaround investments. Private equity has been around for a long time in other medical specialties, and researchers are now tracking its move into women’s health care, including obstetrics. These private equity–associated practices come with a promise of increased patient satisfaction and better care, which can help the hospital avoid malpractice costs from bad outcomes.

But private equity also is trying to boost revenue. Robert Wachter, MD, chair of the department of medicine at the University of California, San Francisco, calls the private equity encroachment into medicine “worrisome.”

“Hospitals will do what they can do to maximize income as long as they’re not breaking the rules,” Dr. Wachter said. “And it sounds like that’s sort of what they’re doing with this ER gambit.”
 

Surprising bills

KHN reviewed the bills of a dozen patients in five states who said they were hit with surprise emergency charges for being triaged in an OBED while in labor. That included a woman in Grand Junction, Colo., who said she felt “gaslit” when she had to pay $300 in emergency charges for the care she received in the small room where they confirmed she was in full-term labor. And in Kansas, a family said they were paying $400 for the same services, also rendered in a “very tiny” room – even though HCA Healthcare, the national for-profit chain that runs the hospital, told KHN that emergency charges are supposed to be waived if the patient is admitted for delivery.

Few of the patients KHN interviewed could recall being told that they were accessing emergency services, nor did they recall entering a space that looked like an ED or was marked as one. Insurance denied the charges in some cases. But in others families were left to pay hundreds of dollars for their share of the tab – adding to already large hospital bills. Several patients reported noticing big jumps in cost for their most recent births, compared with those of previous children, even though they did not notice any changes to the facilities where they delivered.

Three physicians in Colorado told KHN that the hospitals where they work made minimal changes when the institutions opened OBEDs: The facilities were the same triage rooms as before, just with a different sign outside – and different billing practices.

“When I see somebody for a really minor thing, like, someone who comes in at 38 weeks, thinks she’s in labor, but she’s not in labor, gets discharged home – I feel really bad,” said Vanessa Gilliland, MD, who until recently worked as a hospitalist in OBEDs at two hospitals near Denver. “I hope she doesn’t get some $500 bill for just coming in for that.”

The bills generated by encounters with OBEDs can be baffling to patients.

Clara Love and Jonathan Guerra-Rodríguez, MD, an ICU nurse and an internist, respectively, found a charge for the highest level of emergency care in the bill for their son’s birth. It took months of back and forth – and the looming threat of collections – before the hospital explained that the charge was for treatment in an obstetrics ED, the triage area where a nurse examined Ms. Love before she was admitted in full-term labor. “I don’t like using hyperbole, but as a provider I have never seen anything like this,” Dr. Guerra-Rodríguez said.

Patients with medical backgrounds may be more likely than other people to notice these unusual charges, which can be hidden in long or opaque billing documents. A physician assistant in North Carolina and an ICU nurse in Texas also were shocked by the OBED charges they faced.

Figuring out where OBEDs even are can be difficult.

Health departments in California, Colorado, Massachusetts, and New York said they do not track hospitals that open OBEDs because they are considered an extension of a hospital’s main ED. Neither do professional groups like the American Hospital Association, the American College of Obstetricians and Gynecologists, and the Joint Commission, which accredits health care programs across the country.

Some hospitals state clearly on their websites that they have an OBED. A few hospitals state that visiting their OBED will incur emergency room charges. Other hospitals with OBEDs don’t mention their existence at all.
 

 

 

Origins of the OBED concept

Three of the main companies that set up and staff OBEDs – the OB Hospitalist Group, or OBHG; TeamHealth; and Envision Healthcare – are affiliated with private equity firms. The fourth, Pediatrix Medical Group, formerly known as Mednax, is publicly traded. All are for-profit companies.

Several are clear about the revenue benefits of opening OBEDs. TeamHealth – one of the country’s dominant ER staffing companies – is owned by private equity firm Blackstone and has faced criticism from lawmakers for high ER bills. In a document aimed at hospital administrators, TeamHealth says OBEDs are good for “boosting hospital revenues” with “little to no structural investment for the hospital.” It markets OBED success stories to potential customers, highlighting hospitals in California and South Florida where OBEDs reportedly improved patient care – and “produced additional revenue through OBED services.” OBHG, which staffs close to 200 OBEDs in 33 states, markets a scoring tool designed to help hospitals maximize charges from OBEDs and has marketed its services to about 3,000 hospitals.

Staffing companies and hospitals, contacted by KHN, said that OBEDs help deliver better care and that private equity involvement doesn’t impede that care.

Data from Colorado offers a window into how hospitals may be shifting the way they bill for triaging healthy labor. In an analysis for KHN, the Center for Improving Value in Health Care found that the share of uncomplicated vaginal deliveries that had an ED charge embedded in their bills more than doubled in Colorado from 2016 to 2020. It is still a small segment of births, however, rising from 1.4% to 3.3%.

Major staffing companies are set up to charge for every single little thing, said Wayne Farley, MD. He would know: He used to have a leadership role in one of those major staffing companies, the private equity-backed Envision, after it bought his previous employer. Now he’s a practicing ob.gyn. hospitalist at four OBEDs and a consultant who helps hospitals start OBEDs.

“I’ve actually thought about creating a business where I review billings for these patients and help them fight claims,” said Dr. Farley, who thinks a high-level emergency charge makes sense only if the patient had serious complications or required a high level of care.

Proponents of OBEDs say converting a triage room into an obstetrics ED can help pay for a hospital to hire 24/7 hospitalists. In labor and delivery, that means obstetric specialists are available purely to respond to patients who come to the hospital, rather than juggling those cases with clinic visits. Supporters of OBEDs say there’s evidence that having hospitalists on hand is safer for patients and can reduce unnecessary cesarean sections.

“That’s no excuse,” said Lawrence Casalino, MD, a physician and health policy researcher at Weill Cornell Medicine, New York. “To have people get an emergency room charge when they don’t even know they’re in an emergency room – I mean, that doesn’t meet the laugh test.”

But Christopher Swain, MD, who founded the OB Hospitalist Group and is credited with inventing the OBED concept, said that having round-the-clock hospitalists on staff is essential for giving pregnant patients good care and that starting an OBED can help pay for those hospitalists.

Dr. Swain said he started the nation’s first OBED in 2006 in Kissimmee, Fla. He said that, at early-adopter hospitals, OBEDs helped pay to have a doctor available on the labor-and-delivery floor 24/7 and that hospitals subsequently saw better outcomes and lower malpractice rates.

“We feel like we fixed something,” Dr. Swain said. “I feel like we really helped to move the bar to improve the quality of care and to provide better outcomes.”

Dr. Swain is no longer affiliated with OBHG, which has been in private equity hands since at least 2013. The company has recently gone so far as to present OBEDs as part of the solution to the country’s maternal mortality problem. Hospitals such as an Ascension St. Joseph’s hospital in Milwaukee have echoed that statement in their reasons for opening an OBED.

But Dr. Wachter – who coined the term “hospitalist” and who generally believes the presence of hospitalists leads to better care – thinks that reasoning is questionable, especially because hospitals find ways to pay for hospitalists in other specialties without engineering new facility fees.

“I’m always a little skeptical of the justification,” Dr. Wachter said. “They will always have a rationale for why income maximization is a reasonable and moral strategy.”
 

 

 

Private equity’s footprint in women’s health care

Dr. Farley estimates that he has helped set up OBEDs – including Colorado’s first in 2013 – in at least 30 hospitals. He’s aware of hospitals that claim they have OBEDs when the only change they’ve made is to have an ob.gyn. on site round the clock.

“You can’t just hang out a shingle and say: ‘We have an OBED.’ It’s an investment on the part of the hospital,” he said. That means having, among other things, a separate entrance from the rest of the labor-and-delivery department, clear signage inside and outside the hospital, and a separate waiting room. Some hospitals he has worked with have invested millions of dollars in upgrading facilities for their OBED.

Private equity firms often promise more efficient management, plus investment in technology and facilities that could improve patient care or satisfaction. In some parts of health care, that could really help, said Ambar La Forgia, PhD, who researches health care management at the University of California, Berkeley, and is studying private equity investment in fertility care. But Dr. La Forgia said that in much of health care, gauging whether such firms are truly maintaining or improving the quality of care is difficult.

“Private equity is about being able to extract some sort of value very quickly,” Dr. La Forgia said. “And in health care, when prices are so opaque and there’s so much lack of transparency, a lot of those impacts on the prices are eventually going to fall on the patient.”

It’s changing circumstances for doctors, too. Michelle Barhaghi, MD, a Colorado obstetrician, said OBEDs may make sense in busy, urban hospitals with lots of patients who did not get prenatal care. But now they’re cropping up everywhere. “From a doctor standpoint, none of us want these jobs because now we’re like a resident again, where we have to see every single patient that walks through that door,” said Dr. Barhaghi, rather than triaging many cases on the phone with a nurse.

Still, private equity is continuing its advance into women’s health care.

Indeed, Dr. Barhaghi said private equity came knocking on her door earlier this year: Women’s Care Enterprises, backed by private equity company BC Partners, wanted to know whether she would consider selling her practice. She said “no.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Elizabeth Huffner thinks it is obvious: A full-term, healthy pregnancy results in a birth.

“When your due date has come and gone, you’re expecting a baby any minute,” Ms. Huffner said. So she was surprised to discover she was an “unknown accident” – at least from a billing standpoint – when she went to the hospital during labor. Her bill included a charge for something she said she didn’t know she’d ever entered: an obstetrics ED.

That’s where a doctor briefly checked her cervix, timed her contractions, and monitored the fetal heartbeat before telling her to go home and come back later. The area is separated from the rest of the labor-and-delivery department by a curtain. The hospital got about $1,300 for that visit – $530 of it from Ms. Huffner’s pocket.

In recent years, hospitals of every stripe have opened obstetrics EDs, or OBEDs. They come with a requirement that patients with pregnancy or postpartum medical concerns be seen quickly by a qualified provider, which can be important in a real emergency. But it also means healthy patients like Ms. Huffner get bills for emergency care they didn’t know they got.

“It should be a cautionary tale to every woman,” said Ms. Huffner, of Rockford, Ill.

Three of the four major companies that set up and staff OBEDs are affiliated with private equity firms, which are known for making a profit on quick-turnaround investments. Private equity has been around for a long time in other medical specialties, and researchers are now tracking its move into women’s health care, including obstetrics. These private equity–associated practices come with a promise of increased patient satisfaction and better care, which can help the hospital avoid malpractice costs from bad outcomes.

But private equity also is trying to boost revenue. Robert Wachter, MD, chair of the department of medicine at the University of California, San Francisco, calls the private equity encroachment into medicine “worrisome.”

“Hospitals will do what they can do to maximize income as long as they’re not breaking the rules,” Dr. Wachter said. “And it sounds like that’s sort of what they’re doing with this ER gambit.”
 

Surprising bills

KHN reviewed the bills of a dozen patients in five states who said they were hit with surprise emergency charges for being triaged in an OBED while in labor. That included a woman in Grand Junction, Colo., who said she felt “gaslit” when she had to pay $300 in emergency charges for the care she received in the small room where they confirmed she was in full-term labor. And in Kansas, a family said they were paying $400 for the same services, also rendered in a “very tiny” room – even though HCA Healthcare, the national for-profit chain that runs the hospital, told KHN that emergency charges are supposed to be waived if the patient is admitted for delivery.

Few of the patients KHN interviewed could recall being told that they were accessing emergency services, nor did they recall entering a space that looked like an ED or was marked as one. Insurance denied the charges in some cases. But in others families were left to pay hundreds of dollars for their share of the tab – adding to already large hospital bills. Several patients reported noticing big jumps in cost for their most recent births, compared with those of previous children, even though they did not notice any changes to the facilities where they delivered.

Three physicians in Colorado told KHN that the hospitals where they work made minimal changes when the institutions opened OBEDs: The facilities were the same triage rooms as before, just with a different sign outside – and different billing practices.

“When I see somebody for a really minor thing, like, someone who comes in at 38 weeks, thinks she’s in labor, but she’s not in labor, gets discharged home – I feel really bad,” said Vanessa Gilliland, MD, who until recently worked as a hospitalist in OBEDs at two hospitals near Denver. “I hope she doesn’t get some $500 bill for just coming in for that.”

The bills generated by encounters with OBEDs can be baffling to patients.

Clara Love and Jonathan Guerra-Rodríguez, MD, an ICU nurse and an internist, respectively, found a charge for the highest level of emergency care in the bill for their son’s birth. It took months of back and forth – and the looming threat of collections – before the hospital explained that the charge was for treatment in an obstetrics ED, the triage area where a nurse examined Ms. Love before she was admitted in full-term labor. “I don’t like using hyperbole, but as a provider I have never seen anything like this,” Dr. Guerra-Rodríguez said.

Patients with medical backgrounds may be more likely than other people to notice these unusual charges, which can be hidden in long or opaque billing documents. A physician assistant in North Carolina and an ICU nurse in Texas also were shocked by the OBED charges they faced.

Figuring out where OBEDs even are can be difficult.

Health departments in California, Colorado, Massachusetts, and New York said they do not track hospitals that open OBEDs because they are considered an extension of a hospital’s main ED. Neither do professional groups like the American Hospital Association, the American College of Obstetricians and Gynecologists, and the Joint Commission, which accredits health care programs across the country.

Some hospitals state clearly on their websites that they have an OBED. A few hospitals state that visiting their OBED will incur emergency room charges. Other hospitals with OBEDs don’t mention their existence at all.
 

 

 

Origins of the OBED concept

Three of the main companies that set up and staff OBEDs – the OB Hospitalist Group, or OBHG; TeamHealth; and Envision Healthcare – are affiliated with private equity firms. The fourth, Pediatrix Medical Group, formerly known as Mednax, is publicly traded. All are for-profit companies.

Several are clear about the revenue benefits of opening OBEDs. TeamHealth – one of the country’s dominant ER staffing companies – is owned by private equity firm Blackstone and has faced criticism from lawmakers for high ER bills. In a document aimed at hospital administrators, TeamHealth says OBEDs are good for “boosting hospital revenues” with “little to no structural investment for the hospital.” It markets OBED success stories to potential customers, highlighting hospitals in California and South Florida where OBEDs reportedly improved patient care – and “produced additional revenue through OBED services.” OBHG, which staffs close to 200 OBEDs in 33 states, markets a scoring tool designed to help hospitals maximize charges from OBEDs and has marketed its services to about 3,000 hospitals.

Staffing companies and hospitals, contacted by KHN, said that OBEDs help deliver better care and that private equity involvement doesn’t impede that care.

Data from Colorado offers a window into how hospitals may be shifting the way they bill for triaging healthy labor. In an analysis for KHN, the Center for Improving Value in Health Care found that the share of uncomplicated vaginal deliveries that had an ED charge embedded in their bills more than doubled in Colorado from 2016 to 2020. It is still a small segment of births, however, rising from 1.4% to 3.3%.

Major staffing companies are set up to charge for every single little thing, said Wayne Farley, MD. He would know: He used to have a leadership role in one of those major staffing companies, the private equity-backed Envision, after it bought his previous employer. Now he’s a practicing ob.gyn. hospitalist at four OBEDs and a consultant who helps hospitals start OBEDs.

“I’ve actually thought about creating a business where I review billings for these patients and help them fight claims,” said Dr. Farley, who thinks a high-level emergency charge makes sense only if the patient had serious complications or required a high level of care.

Proponents of OBEDs say converting a triage room into an obstetrics ED can help pay for a hospital to hire 24/7 hospitalists. In labor and delivery, that means obstetric specialists are available purely to respond to patients who come to the hospital, rather than juggling those cases with clinic visits. Supporters of OBEDs say there’s evidence that having hospitalists on hand is safer for patients and can reduce unnecessary cesarean sections.

“That’s no excuse,” said Lawrence Casalino, MD, a physician and health policy researcher at Weill Cornell Medicine, New York. “To have people get an emergency room charge when they don’t even know they’re in an emergency room – I mean, that doesn’t meet the laugh test.”

But Christopher Swain, MD, who founded the OB Hospitalist Group and is credited with inventing the OBED concept, said that having round-the-clock hospitalists on staff is essential for giving pregnant patients good care and that starting an OBED can help pay for those hospitalists.

Dr. Swain said he started the nation’s first OBED in 2006 in Kissimmee, Fla. He said that, at early-adopter hospitals, OBEDs helped pay to have a doctor available on the labor-and-delivery floor 24/7 and that hospitals subsequently saw better outcomes and lower malpractice rates.

“We feel like we fixed something,” Dr. Swain said. “I feel like we really helped to move the bar to improve the quality of care and to provide better outcomes.”

Dr. Swain is no longer affiliated with OBHG, which has been in private equity hands since at least 2013. The company has recently gone so far as to present OBEDs as part of the solution to the country’s maternal mortality problem. Hospitals such as an Ascension St. Joseph’s hospital in Milwaukee have echoed that statement in their reasons for opening an OBED.

But Dr. Wachter – who coined the term “hospitalist” and who generally believes the presence of hospitalists leads to better care – thinks that reasoning is questionable, especially because hospitals find ways to pay for hospitalists in other specialties without engineering new facility fees.

“I’m always a little skeptical of the justification,” Dr. Wachter said. “They will always have a rationale for why income maximization is a reasonable and moral strategy.”
 

 

 

Private equity’s footprint in women’s health care

Dr. Farley estimates that he has helped set up OBEDs – including Colorado’s first in 2013 – in at least 30 hospitals. He’s aware of hospitals that claim they have OBEDs when the only change they’ve made is to have an ob.gyn. on site round the clock.

“You can’t just hang out a shingle and say: ‘We have an OBED.’ It’s an investment on the part of the hospital,” he said. That means having, among other things, a separate entrance from the rest of the labor-and-delivery department, clear signage inside and outside the hospital, and a separate waiting room. Some hospitals he has worked with have invested millions of dollars in upgrading facilities for their OBED.

Private equity firms often promise more efficient management, plus investment in technology and facilities that could improve patient care or satisfaction. In some parts of health care, that could really help, said Ambar La Forgia, PhD, who researches health care management at the University of California, Berkeley, and is studying private equity investment in fertility care. But Dr. La Forgia said that in much of health care, gauging whether such firms are truly maintaining or improving the quality of care is difficult.

“Private equity is about being able to extract some sort of value very quickly,” Dr. La Forgia said. “And in health care, when prices are so opaque and there’s so much lack of transparency, a lot of those impacts on the prices are eventually going to fall on the patient.”

It’s changing circumstances for doctors, too. Michelle Barhaghi, MD, a Colorado obstetrician, said OBEDs may make sense in busy, urban hospitals with lots of patients who did not get prenatal care. But now they’re cropping up everywhere. “From a doctor standpoint, none of us want these jobs because now we’re like a resident again, where we have to see every single patient that walks through that door,” said Dr. Barhaghi, rather than triaging many cases on the phone with a nurse.

Still, private equity is continuing its advance into women’s health care.

Indeed, Dr. Barhaghi said private equity came knocking on her door earlier this year: Women’s Care Enterprises, backed by private equity company BC Partners, wanted to know whether she would consider selling her practice. She said “no.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Elizabeth Huffner thinks it is obvious: A full-term, healthy pregnancy results in a birth.

“When your due date has come and gone, you’re expecting a baby any minute,” Ms. Huffner said. So she was surprised to discover she was an “unknown accident” – at least from a billing standpoint – when she went to the hospital during labor. Her bill included a charge for something she said she didn’t know she’d ever entered: an obstetrics ED.

That’s where a doctor briefly checked her cervix, timed her contractions, and monitored the fetal heartbeat before telling her to go home and come back later. The area is separated from the rest of the labor-and-delivery department by a curtain. The hospital got about $1,300 for that visit – $530 of it from Ms. Huffner’s pocket.

In recent years, hospitals of every stripe have opened obstetrics EDs, or OBEDs. They come with a requirement that patients with pregnancy or postpartum medical concerns be seen quickly by a qualified provider, which can be important in a real emergency. But it also means healthy patients like Ms. Huffner get bills for emergency care they didn’t know they got.

“It should be a cautionary tale to every woman,” said Ms. Huffner, of Rockford, Ill.

Three of the four major companies that set up and staff OBEDs are affiliated with private equity firms, which are known for making a profit on quick-turnaround investments. Private equity has been around for a long time in other medical specialties, and researchers are now tracking its move into women’s health care, including obstetrics. These private equity–associated practices come with a promise of increased patient satisfaction and better care, which can help the hospital avoid malpractice costs from bad outcomes.

But private equity also is trying to boost revenue. Robert Wachter, MD, chair of the department of medicine at the University of California, San Francisco, calls the private equity encroachment into medicine “worrisome.”

“Hospitals will do what they can do to maximize income as long as they’re not breaking the rules,” Dr. Wachter said. “And it sounds like that’s sort of what they’re doing with this ER gambit.”
 

Surprising bills

KHN reviewed the bills of a dozen patients in five states who said they were hit with surprise emergency charges for being triaged in an OBED while in labor. That included a woman in Grand Junction, Colo., who said she felt “gaslit” when she had to pay $300 in emergency charges for the care she received in the small room where they confirmed she was in full-term labor. And in Kansas, a family said they were paying $400 for the same services, also rendered in a “very tiny” room – even though HCA Healthcare, the national for-profit chain that runs the hospital, told KHN that emergency charges are supposed to be waived if the patient is admitted for delivery.

Few of the patients KHN interviewed could recall being told that they were accessing emergency services, nor did they recall entering a space that looked like an ED or was marked as one. Insurance denied the charges in some cases. But in others families were left to pay hundreds of dollars for their share of the tab – adding to already large hospital bills. Several patients reported noticing big jumps in cost for their most recent births, compared with those of previous children, even though they did not notice any changes to the facilities where they delivered.

Three physicians in Colorado told KHN that the hospitals where they work made minimal changes when the institutions opened OBEDs: The facilities were the same triage rooms as before, just with a different sign outside – and different billing practices.

“When I see somebody for a really minor thing, like, someone who comes in at 38 weeks, thinks she’s in labor, but she’s not in labor, gets discharged home – I feel really bad,” said Vanessa Gilliland, MD, who until recently worked as a hospitalist in OBEDs at two hospitals near Denver. “I hope she doesn’t get some $500 bill for just coming in for that.”

The bills generated by encounters with OBEDs can be baffling to patients.

Clara Love and Jonathan Guerra-Rodríguez, MD, an ICU nurse and an internist, respectively, found a charge for the highest level of emergency care in the bill for their son’s birth. It took months of back and forth – and the looming threat of collections – before the hospital explained that the charge was for treatment in an obstetrics ED, the triage area where a nurse examined Ms. Love before she was admitted in full-term labor. “I don’t like using hyperbole, but as a provider I have never seen anything like this,” Dr. Guerra-Rodríguez said.

Patients with medical backgrounds may be more likely than other people to notice these unusual charges, which can be hidden in long or opaque billing documents. A physician assistant in North Carolina and an ICU nurse in Texas also were shocked by the OBED charges they faced.

Figuring out where OBEDs even are can be difficult.

Health departments in California, Colorado, Massachusetts, and New York said they do not track hospitals that open OBEDs because they are considered an extension of a hospital’s main ED. Neither do professional groups like the American Hospital Association, the American College of Obstetricians and Gynecologists, and the Joint Commission, which accredits health care programs across the country.

Some hospitals state clearly on their websites that they have an OBED. A few hospitals state that visiting their OBED will incur emergency room charges. Other hospitals with OBEDs don’t mention their existence at all.
 

 

 

Origins of the OBED concept

Three of the main companies that set up and staff OBEDs – the OB Hospitalist Group, or OBHG; TeamHealth; and Envision Healthcare – are affiliated with private equity firms. The fourth, Pediatrix Medical Group, formerly known as Mednax, is publicly traded. All are for-profit companies.

Several are clear about the revenue benefits of opening OBEDs. TeamHealth – one of the country’s dominant ER staffing companies – is owned by private equity firm Blackstone and has faced criticism from lawmakers for high ER bills. In a document aimed at hospital administrators, TeamHealth says OBEDs are good for “boosting hospital revenues” with “little to no structural investment for the hospital.” It markets OBED success stories to potential customers, highlighting hospitals in California and South Florida where OBEDs reportedly improved patient care – and “produced additional revenue through OBED services.” OBHG, which staffs close to 200 OBEDs in 33 states, markets a scoring tool designed to help hospitals maximize charges from OBEDs and has marketed its services to about 3,000 hospitals.

Staffing companies and hospitals, contacted by KHN, said that OBEDs help deliver better care and that private equity involvement doesn’t impede that care.

Data from Colorado offers a window into how hospitals may be shifting the way they bill for triaging healthy labor. In an analysis for KHN, the Center for Improving Value in Health Care found that the share of uncomplicated vaginal deliveries that had an ED charge embedded in their bills more than doubled in Colorado from 2016 to 2020. It is still a small segment of births, however, rising from 1.4% to 3.3%.

Major staffing companies are set up to charge for every single little thing, said Wayne Farley, MD. He would know: He used to have a leadership role in one of those major staffing companies, the private equity-backed Envision, after it bought his previous employer. Now he’s a practicing ob.gyn. hospitalist at four OBEDs and a consultant who helps hospitals start OBEDs.

“I’ve actually thought about creating a business where I review billings for these patients and help them fight claims,” said Dr. Farley, who thinks a high-level emergency charge makes sense only if the patient had serious complications or required a high level of care.

Proponents of OBEDs say converting a triage room into an obstetrics ED can help pay for a hospital to hire 24/7 hospitalists. In labor and delivery, that means obstetric specialists are available purely to respond to patients who come to the hospital, rather than juggling those cases with clinic visits. Supporters of OBEDs say there’s evidence that having hospitalists on hand is safer for patients and can reduce unnecessary cesarean sections.

“That’s no excuse,” said Lawrence Casalino, MD, a physician and health policy researcher at Weill Cornell Medicine, New York. “To have people get an emergency room charge when they don’t even know they’re in an emergency room – I mean, that doesn’t meet the laugh test.”

But Christopher Swain, MD, who founded the OB Hospitalist Group and is credited with inventing the OBED concept, said that having round-the-clock hospitalists on staff is essential for giving pregnant patients good care and that starting an OBED can help pay for those hospitalists.

Dr. Swain said he started the nation’s first OBED in 2006 in Kissimmee, Fla. He said that, at early-adopter hospitals, OBEDs helped pay to have a doctor available on the labor-and-delivery floor 24/7 and that hospitals subsequently saw better outcomes and lower malpractice rates.

“We feel like we fixed something,” Dr. Swain said. “I feel like we really helped to move the bar to improve the quality of care and to provide better outcomes.”

Dr. Swain is no longer affiliated with OBHG, which has been in private equity hands since at least 2013. The company has recently gone so far as to present OBEDs as part of the solution to the country’s maternal mortality problem. Hospitals such as an Ascension St. Joseph’s hospital in Milwaukee have echoed that statement in their reasons for opening an OBED.

But Dr. Wachter – who coined the term “hospitalist” and who generally believes the presence of hospitalists leads to better care – thinks that reasoning is questionable, especially because hospitals find ways to pay for hospitalists in other specialties without engineering new facility fees.

“I’m always a little skeptical of the justification,” Dr. Wachter said. “They will always have a rationale for why income maximization is a reasonable and moral strategy.”
 

 

 

Private equity’s footprint in women’s health care

Dr. Farley estimates that he has helped set up OBEDs – including Colorado’s first in 2013 – in at least 30 hospitals. He’s aware of hospitals that claim they have OBEDs when the only change they’ve made is to have an ob.gyn. on site round the clock.

“You can’t just hang out a shingle and say: ‘We have an OBED.’ It’s an investment on the part of the hospital,” he said. That means having, among other things, a separate entrance from the rest of the labor-and-delivery department, clear signage inside and outside the hospital, and a separate waiting room. Some hospitals he has worked with have invested millions of dollars in upgrading facilities for their OBED.

Private equity firms often promise more efficient management, plus investment in technology and facilities that could improve patient care or satisfaction. In some parts of health care, that could really help, said Ambar La Forgia, PhD, who researches health care management at the University of California, Berkeley, and is studying private equity investment in fertility care. But Dr. La Forgia said that in much of health care, gauging whether such firms are truly maintaining or improving the quality of care is difficult.

“Private equity is about being able to extract some sort of value very quickly,” Dr. La Forgia said. “And in health care, when prices are so opaque and there’s so much lack of transparency, a lot of those impacts on the prices are eventually going to fall on the patient.”

It’s changing circumstances for doctors, too. Michelle Barhaghi, MD, a Colorado obstetrician, said OBEDs may make sense in busy, urban hospitals with lots of patients who did not get prenatal care. But now they’re cropping up everywhere. “From a doctor standpoint, none of us want these jobs because now we’re like a resident again, where we have to see every single patient that walks through that door,” said Dr. Barhaghi, rather than triaging many cases on the phone with a nurse.

Still, private equity is continuing its advance into women’s health care.

Indeed, Dr. Barhaghi said private equity came knocking on her door earlier this year: Women’s Care Enterprises, backed by private equity company BC Partners, wanted to know whether she would consider selling her practice. She said “no.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Combination of energy-based treatments found to improve Becker’s nevi

Article Type
Changed
Fri, 10/14/2022 - 08:24

Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Shelby Kubicki

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.



The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Dr. Vincent Richer


Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on the study, characterized Becker’s nevus as a difficult-to-treat condition that is made even more difficult to treat in skin types III-VI.

“Combining laser hair removal using appropriate wavelengths with 1,550-nm nonablative fractional resurfacing yielded good clinical results with few recurrences,” he said in an interview with this news organization. “Though it was a small series, it definitely is an interesting option for practicing dermatologists who encounter patients interested in improving the appearance of a Becker’s nevus.”

The researchers reported having no relevant disclosures.

Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory boards for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

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Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Shelby Kubicki

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.



The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Dr. Vincent Richer


Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on the study, characterized Becker’s nevus as a difficult-to-treat condition that is made even more difficult to treat in skin types III-VI.

“Combining laser hair removal using appropriate wavelengths with 1,550-nm nonablative fractional resurfacing yielded good clinical results with few recurrences,” he said in an interview with this news organization. “Though it was a small series, it definitely is an interesting option for practicing dermatologists who encounter patients interested in improving the appearance of a Becker’s nevus.”

The researchers reported having no relevant disclosures.

Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory boards for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Shelby Kubicki

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.



The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Dr. Vincent Richer


Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on the study, characterized Becker’s nevus as a difficult-to-treat condition that is made even more difficult to treat in skin types III-VI.

“Combining laser hair removal using appropriate wavelengths with 1,550-nm nonablative fractional resurfacing yielded good clinical results with few recurrences,” he said in an interview with this news organization. “Though it was a small series, it definitely is an interesting option for practicing dermatologists who encounter patients interested in improving the appearance of a Becker’s nevus.”

The researchers reported having no relevant disclosures.

Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory boards for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

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FDA approves self-administered, SubQ furosemide preparation

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Mon, 10/17/2022 - 08:04

The Food and Drug Administration has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure and volume overload, the company has announced.

The product is indicated for use with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use subcutaneous administration device, which affixes to the abdomen.

Olivier Le Moal/Getty Images

The infuser is loaded by the patient or caregiver with a prefilled cartridge and is programmed to deliver Furoscix 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg, scPharmaceuticals said in a press release on the drug approval.

Furosemide, a loop diuretic and one of the world’s most frequently used drugs, is conventionally given intravenously in the hospital or orally on an outpatient basis.

The company describes its furosemide preparation, used with the infuser, as “the first and only FDA-approved subcutaneous loop diuretic that delivers [intravenous]-equivalent diuresis at home.” It has been shown to “produce similar diuresis and natriuresis compared to intravenous furosemide.”

“This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of [intravenous] diuretics, which typically requires admission to the hospital,” William T. Abraham, MD, said in the press release.

The FDA approval “is significant and will allow patients to be treated outside of the hospital setting,” said Dr. Abraham, of Ohio State University, Columbus, and an scPharmaceuticals board member.

The Furoscix indication doesn’t cover emergent use or use in acute pulmonary edema, nor is it meant to be used chronically “and should be replaced with oral diuretics as soon as practical,” the company states.

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

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The Food and Drug Administration has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure and volume overload, the company has announced.

The product is indicated for use with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use subcutaneous administration device, which affixes to the abdomen.

Olivier Le Moal/Getty Images

The infuser is loaded by the patient or caregiver with a prefilled cartridge and is programmed to deliver Furoscix 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg, scPharmaceuticals said in a press release on the drug approval.

Furosemide, a loop diuretic and one of the world’s most frequently used drugs, is conventionally given intravenously in the hospital or orally on an outpatient basis.

The company describes its furosemide preparation, used with the infuser, as “the first and only FDA-approved subcutaneous loop diuretic that delivers [intravenous]-equivalent diuresis at home.” It has been shown to “produce similar diuresis and natriuresis compared to intravenous furosemide.”

“This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of [intravenous] diuretics, which typically requires admission to the hospital,” William T. Abraham, MD, said in the press release.

The FDA approval “is significant and will allow patients to be treated outside of the hospital setting,” said Dr. Abraham, of Ohio State University, Columbus, and an scPharmaceuticals board member.

The Furoscix indication doesn’t cover emergent use or use in acute pulmonary edema, nor is it meant to be used chronically “and should be replaced with oral diuretics as soon as practical,” the company states.

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

The Food and Drug Administration has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure and volume overload, the company has announced.

The product is indicated for use with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use subcutaneous administration device, which affixes to the abdomen.

Olivier Le Moal/Getty Images

The infuser is loaded by the patient or caregiver with a prefilled cartridge and is programmed to deliver Furoscix 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg, scPharmaceuticals said in a press release on the drug approval.

Furosemide, a loop diuretic and one of the world’s most frequently used drugs, is conventionally given intravenously in the hospital or orally on an outpatient basis.

The company describes its furosemide preparation, used with the infuser, as “the first and only FDA-approved subcutaneous loop diuretic that delivers [intravenous]-equivalent diuresis at home.” It has been shown to “produce similar diuresis and natriuresis compared to intravenous furosemide.”

“This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of [intravenous] diuretics, which typically requires admission to the hospital,” William T. Abraham, MD, said in the press release.

The FDA approval “is significant and will allow patients to be treated outside of the hospital setting,” said Dr. Abraham, of Ohio State University, Columbus, and an scPharmaceuticals board member.

The Furoscix indication doesn’t cover emergent use or use in acute pulmonary edema, nor is it meant to be used chronically “and should be replaced with oral diuretics as soon as practical,” the company states.

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

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Loan forgiveness and med school debt: What about me?

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Changed
Thu, 10/13/2022 - 13:16

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I run the division of medical ethics at New York University Grossman School of Medicine.

Many of you know that President Biden created a loan forgiveness program, forgiving up to $10,000 against federal student loans, including graduate and undergraduate education. The Department of Education is supposed to provide up to $20,000 in debt cancellation to Pell Grant recipients who have loans that are held by the Department of Education. Borrowers can get this relief if their income is less than $125,000 for an individual or $250,000 for married couples.

Many people have looked at this and said, “Hey, wait a minute. I paid off my loans. I didn’t get any reimbursement. That isn’t fair.”

One group saddled with massive debt are people who are still carrying their medical school loans, who often still have huge amounts of debt, and either because of the income limits or because they don’t qualify because this debt was accrued long in the past, they’re saying, “What about me? Don’t you want to give any relief to me?”

This is a topic near and dear to my heart because I happen to be at a medical school, NYU, that has decided for the two medical schools it runs – our main campus, NYU in Manhattan and NYU Langone out on Long Island – that we’re going to go tuition free. We’ve done it for a couple of years.

We did it because I think all the administrators and faculty understood the tremendous burden that debt poses on people who both carry forward their undergraduate debt and then have medical school debt. This really leads to very difficult situations – which we have great empathy for – about what specialty you’re going to go into, whether you have to moonlight, and how you’re going to manage a huge burden of debt.

Many people don’t have sympathy out in the public. They say doctors make a large amount of money and they live a nice lifestyle, so we’re not going to relieve their debt. The reality is that, whoever you are, short of Bill Gates or Elon Musk, having hundreds of thousands of dollars of debt is no easy task to live with and to work off.

Still, when we created free tuition at NYU for our medical school, there were many people who paid high tuition fees in the past. Some of them said to us, “What about me?” We decided not to try to do anything retrospectively. The plan was to build up enough money so that we could handle no-cost tuition going forward. We didn’t really have it in our pocketbook to help people who’d already paid their debts or were saddled with NYU debt. Is it fair? No, it’s probably not fair, but it’s an improvement.

That’s what I want people to think about who are saying, “What about my medical school debt? What about my undergraduate plus medical school debt?” I think we should be grateful when efforts are being made to reduce very burdensome student loans that people have. It’s good to give that benefit and move it forward.

Does that mean no one should get anything unless everyone with any kind of debt from school is covered? I don’t think so. I don’t think that’s fair either.

It is possible that we could continue to agitate politically and say, let’s go after some of the health care debt. Let’s go after some of the things that are still driving people to have to work more than they would or to choose specialties that they really don’t want to be in because they have to make up that debt.

It doesn’t mean the last word has been said about the politics of debt relief or, for that matter, the price of going to medical school in the first place and trying to see whether that can be driven down.

I don’t think it’s right to say, “If I can’t benefit, given the huge burden that I’m carrying, then I’m not going to try to give relief to others.” I think we’re relieving debt to the extent that we can do it. The nation can afford it. Going forward is a good thing. It’s wrong to create those gigantic debts in the first place.

What are we going to do about the past? We may decide that we need some sort of forgiveness or reparations for loans that were built up for others going backwards. I wouldn’t hold hostage the future and our children to what was probably a very poor, unethical practice about saddling doctors and others in the past with huge debt.

I’m Art Caplan at the division of medical ethics at New York University Grossman School of Medicine. Thank you for watching.

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

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This transcript has been edited for clarity.

Hi. I’m Art Caplan. I run the division of medical ethics at New York University Grossman School of Medicine.

Many of you know that President Biden created a loan forgiveness program, forgiving up to $10,000 against federal student loans, including graduate and undergraduate education. The Department of Education is supposed to provide up to $20,000 in debt cancellation to Pell Grant recipients who have loans that are held by the Department of Education. Borrowers can get this relief if their income is less than $125,000 for an individual or $250,000 for married couples.

Many people have looked at this and said, “Hey, wait a minute. I paid off my loans. I didn’t get any reimbursement. That isn’t fair.”

One group saddled with massive debt are people who are still carrying their medical school loans, who often still have huge amounts of debt, and either because of the income limits or because they don’t qualify because this debt was accrued long in the past, they’re saying, “What about me? Don’t you want to give any relief to me?”

This is a topic near and dear to my heart because I happen to be at a medical school, NYU, that has decided for the two medical schools it runs – our main campus, NYU in Manhattan and NYU Langone out on Long Island – that we’re going to go tuition free. We’ve done it for a couple of years.

We did it because I think all the administrators and faculty understood the tremendous burden that debt poses on people who both carry forward their undergraduate debt and then have medical school debt. This really leads to very difficult situations – which we have great empathy for – about what specialty you’re going to go into, whether you have to moonlight, and how you’re going to manage a huge burden of debt.

Many people don’t have sympathy out in the public. They say doctors make a large amount of money and they live a nice lifestyle, so we’re not going to relieve their debt. The reality is that, whoever you are, short of Bill Gates or Elon Musk, having hundreds of thousands of dollars of debt is no easy task to live with and to work off.

Still, when we created free tuition at NYU for our medical school, there were many people who paid high tuition fees in the past. Some of them said to us, “What about me?” We decided not to try to do anything retrospectively. The plan was to build up enough money so that we could handle no-cost tuition going forward. We didn’t really have it in our pocketbook to help people who’d already paid their debts or were saddled with NYU debt. Is it fair? No, it’s probably not fair, but it’s an improvement.

That’s what I want people to think about who are saying, “What about my medical school debt? What about my undergraduate plus medical school debt?” I think we should be grateful when efforts are being made to reduce very burdensome student loans that people have. It’s good to give that benefit and move it forward.

Does that mean no one should get anything unless everyone with any kind of debt from school is covered? I don’t think so. I don’t think that’s fair either.

It is possible that we could continue to agitate politically and say, let’s go after some of the health care debt. Let’s go after some of the things that are still driving people to have to work more than they would or to choose specialties that they really don’t want to be in because they have to make up that debt.

It doesn’t mean the last word has been said about the politics of debt relief or, for that matter, the price of going to medical school in the first place and trying to see whether that can be driven down.

I don’t think it’s right to say, “If I can’t benefit, given the huge burden that I’m carrying, then I’m not going to try to give relief to others.” I think we’re relieving debt to the extent that we can do it. The nation can afford it. Going forward is a good thing. It’s wrong to create those gigantic debts in the first place.

What are we going to do about the past? We may decide that we need some sort of forgiveness or reparations for loans that were built up for others going backwards. I wouldn’t hold hostage the future and our children to what was probably a very poor, unethical practice about saddling doctors and others in the past with huge debt.

I’m Art Caplan at the division of medical ethics at New York University Grossman School of Medicine. Thank you for watching.

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

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I run the division of medical ethics at New York University Grossman School of Medicine.

Many of you know that President Biden created a loan forgiveness program, forgiving up to $10,000 against federal student loans, including graduate and undergraduate education. The Department of Education is supposed to provide up to $20,000 in debt cancellation to Pell Grant recipients who have loans that are held by the Department of Education. Borrowers can get this relief if their income is less than $125,000 for an individual or $250,000 for married couples.

Many people have looked at this and said, “Hey, wait a minute. I paid off my loans. I didn’t get any reimbursement. That isn’t fair.”

One group saddled with massive debt are people who are still carrying their medical school loans, who often still have huge amounts of debt, and either because of the income limits or because they don’t qualify because this debt was accrued long in the past, they’re saying, “What about me? Don’t you want to give any relief to me?”

This is a topic near and dear to my heart because I happen to be at a medical school, NYU, that has decided for the two medical schools it runs – our main campus, NYU in Manhattan and NYU Langone out on Long Island – that we’re going to go tuition free. We’ve done it for a couple of years.

We did it because I think all the administrators and faculty understood the tremendous burden that debt poses on people who both carry forward their undergraduate debt and then have medical school debt. This really leads to very difficult situations – which we have great empathy for – about what specialty you’re going to go into, whether you have to moonlight, and how you’re going to manage a huge burden of debt.

Many people don’t have sympathy out in the public. They say doctors make a large amount of money and they live a nice lifestyle, so we’re not going to relieve their debt. The reality is that, whoever you are, short of Bill Gates or Elon Musk, having hundreds of thousands of dollars of debt is no easy task to live with and to work off.

Still, when we created free tuition at NYU for our medical school, there were many people who paid high tuition fees in the past. Some of them said to us, “What about me?” We decided not to try to do anything retrospectively. The plan was to build up enough money so that we could handle no-cost tuition going forward. We didn’t really have it in our pocketbook to help people who’d already paid their debts or were saddled with NYU debt. Is it fair? No, it’s probably not fair, but it’s an improvement.

That’s what I want people to think about who are saying, “What about my medical school debt? What about my undergraduate plus medical school debt?” I think we should be grateful when efforts are being made to reduce very burdensome student loans that people have. It’s good to give that benefit and move it forward.

Does that mean no one should get anything unless everyone with any kind of debt from school is covered? I don’t think so. I don’t think that’s fair either.

It is possible that we could continue to agitate politically and say, let’s go after some of the health care debt. Let’s go after some of the things that are still driving people to have to work more than they would or to choose specialties that they really don’t want to be in because they have to make up that debt.

It doesn’t mean the last word has been said about the politics of debt relief or, for that matter, the price of going to medical school in the first place and trying to see whether that can be driven down.

I don’t think it’s right to say, “If I can’t benefit, given the huge burden that I’m carrying, then I’m not going to try to give relief to others.” I think we’re relieving debt to the extent that we can do it. The nation can afford it. Going forward is a good thing. It’s wrong to create those gigantic debts in the first place.

What are we going to do about the past? We may decide that we need some sort of forgiveness or reparations for loans that were built up for others going backwards. I wouldn’t hold hostage the future and our children to what was probably a very poor, unethical practice about saddling doctors and others in the past with huge debt.

I’m Art Caplan at the division of medical ethics at New York University Grossman School of Medicine. Thank you for watching.

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

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