Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Over that 5-week span since the end of August, in fact, the United States has added over 1.13 million new cases, or just under 20% of all cases (5.7 million) in children during the entire pandemic, based on the data in the AAP/CHA joint weekly report on COVID in children.

In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)

The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.

There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.

The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.

COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.

“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.

Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.

[email protected]

Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Over that 5-week span since the end of August, in fact, the United States has added over 1.13 million new cases, or just under 20% of all cases (5.7 million) in children during the entire pandemic, based on the data in the AAP/CHA joint weekly report on COVID in children.

In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)

The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.

There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.

The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.

COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.

“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.

Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.

[email protected]

Weekly COVID-19 cases in children dropped again, but the count remained above 200,000 for the fifth consecutive week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

Over that 5-week span since the end of August, in fact, the United States has added over 1.13 million new cases, or just under 20% of all cases (5.7 million) in children during the entire pandemic, based on the data in the AAP/CHA joint weekly report on COVID in children.

In the most recent week, Sept. 17-23, there were almost 207,000 new cases of COVID-19 in children, which represented 26.7% of all cases reported in the 46 states that are currently posting data by age on their COVID dashboards, the AAP and CHA said. (New York has never reported such data by age, and Alabama, Nebraska, and Texas have not updated their websites since July 29, June 24, and Aug. 26, respectively.)

The decline in new vaccinations among children, however, began before the summer surge in new cases hit its peak – 251,781 during the week of Aug. 27 to Sept. 2 – and has continued for 7 straight weeks in children aged 12-17 years, based on data from the Centers for Disease Control and Prevention.

There were about 172,000 COVID vaccine initiations in children aged 12-17 for the week of Sept. 21-27, the lowest number since April, before it was approved for use in 12- to 15-year-olds. That figure is down by almost a third from the previous week and by more than two-thirds since early August, just before the decline in vaccinations began, according to the CDC’s COVID Data Tracker.

The cumulative vaccine situation looks like this: Just over 13 million children under age 18 years have received at least one dose as of Sept. 27, and almost 10.6 million are fully vaccinated. By age group, 53.9% of 12- to 15-year-olds and 61.6% of 16- to 17-year-olds have received at least one dose, with corresponding figures of 43.3% and 51.3% for full vaccination, the CDC said.

COVID-related hospital admissions also continue to fall after peaking at 0.51 children aged 0-17 per 100,000 population on Sept. 4. The admission rate was down to 0.45 per 100,000 as of Sept. 17, and the latest 7-day average (Sept. 19-25) was 258 admissions, compared with a peak of 371 for the week of Aug. 29 to Sept. 4, the CDC reported.

“Although we have seen slight improvements in COVID-19 volumes in the past week, we are at the beginning of an anticipated increase in” multi-inflammatory syndrome in children, Margaret Rush, MD, president of Monroe Carell Jr. Children’s Hospital at Vanderbilt University, Nashville, Tenn., said at a recent hearing of the House Committee on Energy and Commerce’s Oversight subcommittee. That increase would be expected to produce “a secondary wave of seriously ill children 3-6 weeks after acute infection peaks in the community,” the American Hospital Association said.

Meanwhile, Dr. Rush noted, there are signs that seasonal viruses are coming into play. “With the emergence of the Delta variant, we’ve experienced a steep increase in COVID-19 hospitalizations among children on top of an early surge of [respiratory syncytial virus], a serious respiratory illness we usually see in the winter months,” she said in a prepared statement before her testimony.

[email protected]

A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.

Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA  vaccines, according to a report in JAMA Network Open.

In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.

Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.

PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.

No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.

This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.

“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.

In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).

“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.

The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.

Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.

A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.

Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.

High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.

The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.

“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”

The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.

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

A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.

Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA  vaccines, according to a report in JAMA Network Open.

In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.

Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.

PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.

No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.

This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.

“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.

In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).

“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.

The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.

Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.

A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.

Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.

High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.

The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.

“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”

The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.

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

A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.

Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA  vaccines, according to a report in JAMA Network Open.

In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.

Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.

PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.

No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.

This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.

“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.

In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).

“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.

The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.

Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.

A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.

Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.

High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.

The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.

“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”

The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.

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

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

On Sept. 1, Texas enacted astonishing legislation that effectively bans abortion after a fetal heartbeat is detected. In addition, it further empowers private citizens to sue anyone “aiding and abetting” patients who seek abortion services. Many organizations, including Planned Parenthood and the American College of Obstetricians and Gynecologists, have issued formalized statements condemning the bill. While we as obstetrician/gynecologists try to remain as nonpartisan as humanly possible in our patient care, unfortunately our specialty is inarguably one of the few in the medical field that is routinely significantly affected by federal and state politics.

It is no secret that Texas Senate Bill 8, otherwise referred to the “Texas Heartbeat Act,” will have devastating consequences for women, particularly women of color, but it will also have potentially catastrophic repercussions for patients who identify as LGBTQ. Overall, the LGBTQ population faces higher rates of poverty, unemployment, insurance coverage barriers, and provider discrimination because of their gender identity or sexual orientation, which can make access to abortion services challenging. Furthermore, they are more susceptible to hate-motivated violence and sexual assault and as a result, may seek to terminate pregnancies that result from these traumatic experiences.

A survey conducted by the Centers for Disease Control and Prevention examining rates of intimate partner violence and sexual violence found that 44% of lesbians and 61% of bisexual women experience rape and physical violence, compared with 35% of straight women.¹ A separate survey revealed that 47% of transgender people are sexually assaulted at some point in their lifetime, with rates reaching as high as 65% among transgender people of color.² Furthermore, many members of the LGBTQ population are misinformed or have misconceptions regarding their need for contraceptives and experience unintended pregnancies. As discussed in a previous column, one-third of pregnancies in transgender men were unplanned, and 20% of those patients were amenorrheic on testosterone at the time of conception.³

Current studies estimate that approximately 25% of all cisgender women will have an abortion. No corresponding data exist to describe the abortion rates of transgender and gender diverse patients.^4,5 Bills such as Texas SB8 make accessing safe abortions for patients virtually impossible and interferes with the ability for physicians to provide patients with much needed health care services. It further delegitimizes rape and incest victims and is almost punitive in requiring such victims to carry the unintended pregnancies resulting from these heinous acts to term.

Regardless of a provider’s feelings toward abortion or even gender-affirming care, it is undeniable that access to these services is necessary and should be readily available to patients seeking them. As we all took an oath in medical school to “do no harm,” we must not only abide by that solemn decree in everyday patient interactions, but also live by those words to advocate for our patients when politics prohibit appropriate care. While discussions surrounding abortion are often limited to cisgender, heterosexual patients, providers must also be aware that abortion access spans across a wider spectrum that includes the LGBTQ community. Our patients, and all patients, deserve equal access to abortion. This harmful law sets a dangerous precedent that could continue to threaten these services with detrimental effects to our patients.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta, GA: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

2. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

3. Abern L, Maguire K. Obstet Gynecol 2018;131:65S.

4. Jones RK et al. Abortion incidence and service availability in the Unites States, 2017. New York, NY: Guttmacher Institute: 2019.

5. Moseson H et al. Am J Obstet Gynecol 2021;224:376.e1-11.

The investigational oral, neuroactive, steroid-positive allosteric modulator SAGE-324/BIIB124 (SAGE-324) is effective for treating essential tremor – but problems with tolerability may limit its usefulness, new research suggests.

The phase 2 KINETIC trial involved patients with essential tremor. Among patients treated with SAGE-324 for 28 days, there was a statistically significant reduction in upper-limb tremors on day 29 – meeting the primary endpoint of the study.

However, moderate to severe treatment-emergent adverse events (TEAEs) led to many treatment and/or study discontinuations, the investigators reported.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Mechanism of action

Essential tremor affects an estimated 6.4 million adults in the United States. Available drugs are not helpful for 30%-50% of these patients. No new drug for this condition has been approved by the Food and Drug Administration for the past 50 years. Of the several drugs used to treat essential tremor, propranolol is the only one that has been approved, according to the American Academy of Neurology.

Deficits in inhibitory signaling via the gamma-aminobutyric acid system may have a role in the pathophysiology of essential tremor because the GABAergic system is the major neuroinhibitory system in the brain.

SAGE-324 is a steroid-positive allosteric modulator of the GABAA receptor. It acts on the receptor distant from the neuronal synapse to enhance GABAergic (inhibitory) signaling.

In the phase 2 multicenter KINETIC trial, investigators enrolled 69 patients aged 18-80 years. The patients had moderate to severe essential tremor, as determined on the basis of their having a score of 10 or higher on item 4 of the Essential Tremor Rating Assessment Scale (TETRAS) on screening day and at baseline/day 1 of the trial.

Participants did not take medications for essential tremor during the 28-day washout period. They were randomly assigned in a 1:1 ratio to receive SAGE-324 60 mg (n = 34) or placebo (n = 35) once daily. Dose reductions were allowed.

The groups were reasonably matched for age (mean, 69.4 years for SAGE-324 vs. 64.7 years for placebo) and dominant hand (right, 85.3% for SAGE-324 vs. 88.6% for placebo). Women composed 35.3% of the drug group and 57.1% of the placebo group.

The primary endpoint of the trial was change from baseline for the active drug in comparison with placebo on day 29 (1 day after the final dose) for upper-limb tremor, as measured by item 4 of TETRAS. There was also a 2-week follow-up with assessments on day 42.
 

Primary endpoint met, high dropout rate

Baseline mean TETRAS Performance Subscale item 4 scores were 12.82 for the SAGE-324 group and 12.28 for the placebo group.

On day 29, the least squares mean difference from baseline was –2.31 with SAGE-324 (n = 21) versus –1.24 with placebo (n = 33; P = .049). There was no difference between the SAGE-324 and placebo groups on day 42.

“Their significant reduction in upper-limb tremor score at day 29 corresponds to a 36% reduction from baseline in tremor amplitude in patients receiving SAGE-324, compared with a 21% reduction in tremor amplitude in patients receiving a placebo,” said lead investigator Kemi Bankole, MBBCh, of Sage Therapeutics.

“A reduction in tremor amplitude of 36% is a clinically significant improvement for most patients with essential tremor. For patients with moderate-severe tremor, a 41% improvement would be clinically noticeable and appreciated,” said Helen Colquhoun, MBChB, vice president at Sage.

“We believe patients with more severe tremor, that is, a TETRAS score of greater than 12, represent the majority of [essential tremor] patients getting diagnosed and seeking treatment today,” Dr. Colquhoun said.

There was an even greater reduction in tremor amplitude for the subgroup of patients with more severe tremor at baseline, meaning those with a median TETRAS score of 12 or greater (–2.75 for SAGE-324 vs. –1.05 for placebo; P = .0066).

These figures represented a 41% reduction from baseline in tremor amplitude for the SAGE-324 group, versus an 18% reduction in the placebo group. Again, the effect had disappeared in comparison with placebo at the 2-week off-drug follow-up on day 42.

Tolerability of SAGE-324 was a major problem, leading to dose reductions, treatment discontinuations, and study discontinuations. Of the 34 patients who received SAGE-324, 13 dropped out of the study, compared with 2 of 35 patients who received placebo.

Most TEAEs were moderate or severe in the SAGE-324 group, whereas most were mild in the placebo group.

The most common TEAEs for participants who received SAGE-324 were somnolence (67.6%) and dizziness (38.2%), followed by balance problems, diplopia, dysarthria, and gait disturbance. In the placebo group, somnolence affected 5.7%, and dizziness affected 11.4%. There were no deaths in either group.

Dr. Colquhoun said these findings “are in line with our expectations for the 60-mg dose.”

More than one-third of the SAGE-324 group discontinued treatment before the end of the trial, and continuing treatment often required dose reductions. Only 24% completed the trial while taking the 60-mg dose; 15% completed the trial while taking 45 mg; and 24% did so while taking 30 mg.

Dr. Colquhoun noted that the company plans to initiate a phase 2b dose-ranging study later this year to optimize the dosing regimen with regard to tolerability and sustained tremor control.
 

No advantage over older drugs?

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said he had been aware of the study and was interested in seeing the results. However, he does not see an advantage with this drug, compared with what is already used for essential tremor.

“The response of people is not that different than when we treat them with the old barbiturates and benzodiazepines,” said Dr. Tagliati, who was not involved with the research.

He also noted the high rate of adverse events, particularly somnolence, and said that in his experience with current treatments, some patients prefer to live with their tremors rather than be sleepy and not thinking well.

Dr. Tagliati said he thinks use of SAGE-324 is going to be limited to patients who can tolerate it, “which was not that many.”

In addition, the trial was limited by its relatively small size, a “huge placebo effect,” and a high dropout rate in the active treatment arm, he concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Bankole and Dr. Calquhoun are employees of Sage. Dr. Tagliati reported no relevant financial relationships.

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

The investigational oral, neuroactive, steroid-positive allosteric modulator SAGE-324/BIIB124 (SAGE-324) is effective for treating essential tremor – but problems with tolerability may limit its usefulness, new research suggests.

The phase 2 KINETIC trial involved patients with essential tremor. Among patients treated with SAGE-324 for 28 days, there was a statistically significant reduction in upper-limb tremors on day 29 – meeting the primary endpoint of the study.

However, moderate to severe treatment-emergent adverse events (TEAEs) led to many treatment and/or study discontinuations, the investigators reported.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Mechanism of action

Essential tremor affects an estimated 6.4 million adults in the United States. Available drugs are not helpful for 30%-50% of these patients. No new drug for this condition has been approved by the Food and Drug Administration for the past 50 years. Of the several drugs used to treat essential tremor, propranolol is the only one that has been approved, according to the American Academy of Neurology.

Deficits in inhibitory signaling via the gamma-aminobutyric acid system may have a role in the pathophysiology of essential tremor because the GABAergic system is the major neuroinhibitory system in the brain.

SAGE-324 is a steroid-positive allosteric modulator of the GABAA receptor. It acts on the receptor distant from the neuronal synapse to enhance GABAergic (inhibitory) signaling.

In the phase 2 multicenter KINETIC trial, investigators enrolled 69 patients aged 18-80 years. The patients had moderate to severe essential tremor, as determined on the basis of their having a score of 10 or higher on item 4 of the Essential Tremor Rating Assessment Scale (TETRAS) on screening day and at baseline/day 1 of the trial.

Participants did not take medications for essential tremor during the 28-day washout period. They were randomly assigned in a 1:1 ratio to receive SAGE-324 60 mg (n = 34) or placebo (n = 35) once daily. Dose reductions were allowed.

The groups were reasonably matched for age (mean, 69.4 years for SAGE-324 vs. 64.7 years for placebo) and dominant hand (right, 85.3% for SAGE-324 vs. 88.6% for placebo). Women composed 35.3% of the drug group and 57.1% of the placebo group.

The primary endpoint of the trial was change from baseline for the active drug in comparison with placebo on day 29 (1 day after the final dose) for upper-limb tremor, as measured by item 4 of TETRAS. There was also a 2-week follow-up with assessments on day 42.
 

Primary endpoint met, high dropout rate

Baseline mean TETRAS Performance Subscale item 4 scores were 12.82 for the SAGE-324 group and 12.28 for the placebo group.

On day 29, the least squares mean difference from baseline was –2.31 with SAGE-324 (n = 21) versus –1.24 with placebo (n = 33; P = .049). There was no difference between the SAGE-324 and placebo groups on day 42.

“Their significant reduction in upper-limb tremor score at day 29 corresponds to a 36% reduction from baseline in tremor amplitude in patients receiving SAGE-324, compared with a 21% reduction in tremor amplitude in patients receiving a placebo,” said lead investigator Kemi Bankole, MBBCh, of Sage Therapeutics.

“A reduction in tremor amplitude of 36% is a clinically significant improvement for most patients with essential tremor. For patients with moderate-severe tremor, a 41% improvement would be clinically noticeable and appreciated,” said Helen Colquhoun, MBChB, vice president at Sage.

“We believe patients with more severe tremor, that is, a TETRAS score of greater than 12, represent the majority of [essential tremor] patients getting diagnosed and seeking treatment today,” Dr. Colquhoun said.

There was an even greater reduction in tremor amplitude for the subgroup of patients with more severe tremor at baseline, meaning those with a median TETRAS score of 12 or greater (–2.75 for SAGE-324 vs. –1.05 for placebo; P = .0066).

These figures represented a 41% reduction from baseline in tremor amplitude for the SAGE-324 group, versus an 18% reduction in the placebo group. Again, the effect had disappeared in comparison with placebo at the 2-week off-drug follow-up on day 42.

Tolerability of SAGE-324 was a major problem, leading to dose reductions, treatment discontinuations, and study discontinuations. Of the 34 patients who received SAGE-324, 13 dropped out of the study, compared with 2 of 35 patients who received placebo.

Most TEAEs were moderate or severe in the SAGE-324 group, whereas most were mild in the placebo group.

The most common TEAEs for participants who received SAGE-324 were somnolence (67.6%) and dizziness (38.2%), followed by balance problems, diplopia, dysarthria, and gait disturbance. In the placebo group, somnolence affected 5.7%, and dizziness affected 11.4%. There were no deaths in either group.

Dr. Colquhoun said these findings “are in line with our expectations for the 60-mg dose.”

More than one-third of the SAGE-324 group discontinued treatment before the end of the trial, and continuing treatment often required dose reductions. Only 24% completed the trial while taking the 60-mg dose; 15% completed the trial while taking 45 mg; and 24% did so while taking 30 mg.

Dr. Colquhoun noted that the company plans to initiate a phase 2b dose-ranging study later this year to optimize the dosing regimen with regard to tolerability and sustained tremor control.
 

No advantage over older drugs?

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said he had been aware of the study and was interested in seeing the results. However, he does not see an advantage with this drug, compared with what is already used for essential tremor.

“The response of people is not that different than when we treat them with the old barbiturates and benzodiazepines,” said Dr. Tagliati, who was not involved with the research.

He also noted the high rate of adverse events, particularly somnolence, and said that in his experience with current treatments, some patients prefer to live with their tremors rather than be sleepy and not thinking well.

Dr. Tagliati said he thinks use of SAGE-324 is going to be limited to patients who can tolerate it, “which was not that many.”

In addition, the trial was limited by its relatively small size, a “huge placebo effect,” and a high dropout rate in the active treatment arm, he concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Bankole and Dr. Calquhoun are employees of Sage. Dr. Tagliati reported no relevant financial relationships.

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

The investigational oral, neuroactive, steroid-positive allosteric modulator SAGE-324/BIIB124 (SAGE-324) is effective for treating essential tremor – but problems with tolerability may limit its usefulness, new research suggests.

The phase 2 KINETIC trial involved patients with essential tremor. Among patients treated with SAGE-324 for 28 days, there was a statistically significant reduction in upper-limb tremors on day 29 – meeting the primary endpoint of the study.

However, moderate to severe treatment-emergent adverse events (TEAEs) led to many treatment and/or study discontinuations, the investigators reported.

The findings were presented at the International Congress of Parkinson’s Disease and Movement Disorders.
 

Mechanism of action

Essential tremor affects an estimated 6.4 million adults in the United States. Available drugs are not helpful for 30%-50% of these patients. No new drug for this condition has been approved by the Food and Drug Administration for the past 50 years. Of the several drugs used to treat essential tremor, propranolol is the only one that has been approved, according to the American Academy of Neurology.

Deficits in inhibitory signaling via the gamma-aminobutyric acid system may have a role in the pathophysiology of essential tremor because the GABAergic system is the major neuroinhibitory system in the brain.

SAGE-324 is a steroid-positive allosteric modulator of the GABAA receptor. It acts on the receptor distant from the neuronal synapse to enhance GABAergic (inhibitory) signaling.

In the phase 2 multicenter KINETIC trial, investigators enrolled 69 patients aged 18-80 years. The patients had moderate to severe essential tremor, as determined on the basis of their having a score of 10 or higher on item 4 of the Essential Tremor Rating Assessment Scale (TETRAS) on screening day and at baseline/day 1 of the trial.

Participants did not take medications for essential tremor during the 28-day washout period. They were randomly assigned in a 1:1 ratio to receive SAGE-324 60 mg (n = 34) or placebo (n = 35) once daily. Dose reductions were allowed.

The groups were reasonably matched for age (mean, 69.4 years for SAGE-324 vs. 64.7 years for placebo) and dominant hand (right, 85.3% for SAGE-324 vs. 88.6% for placebo). Women composed 35.3% of the drug group and 57.1% of the placebo group.

The primary endpoint of the trial was change from baseline for the active drug in comparison with placebo on day 29 (1 day after the final dose) for upper-limb tremor, as measured by item 4 of TETRAS. There was also a 2-week follow-up with assessments on day 42.
 

Primary endpoint met, high dropout rate

Baseline mean TETRAS Performance Subscale item 4 scores were 12.82 for the SAGE-324 group and 12.28 for the placebo group.

On day 29, the least squares mean difference from baseline was –2.31 with SAGE-324 (n = 21) versus –1.24 with placebo (n = 33; P = .049). There was no difference between the SAGE-324 and placebo groups on day 42.

“Their significant reduction in upper-limb tremor score at day 29 corresponds to a 36% reduction from baseline in tremor amplitude in patients receiving SAGE-324, compared with a 21% reduction in tremor amplitude in patients receiving a placebo,” said lead investigator Kemi Bankole, MBBCh, of Sage Therapeutics.

“A reduction in tremor amplitude of 36% is a clinically significant improvement for most patients with essential tremor. For patients with moderate-severe tremor, a 41% improvement would be clinically noticeable and appreciated,” said Helen Colquhoun, MBChB, vice president at Sage.

“We believe patients with more severe tremor, that is, a TETRAS score of greater than 12, represent the majority of [essential tremor] patients getting diagnosed and seeking treatment today,” Dr. Colquhoun said.

There was an even greater reduction in tremor amplitude for the subgroup of patients with more severe tremor at baseline, meaning those with a median TETRAS score of 12 or greater (–2.75 for SAGE-324 vs. –1.05 for placebo; P = .0066).

These figures represented a 41% reduction from baseline in tremor amplitude for the SAGE-324 group, versus an 18% reduction in the placebo group. Again, the effect had disappeared in comparison with placebo at the 2-week off-drug follow-up on day 42.

Tolerability of SAGE-324 was a major problem, leading to dose reductions, treatment discontinuations, and study discontinuations. Of the 34 patients who received SAGE-324, 13 dropped out of the study, compared with 2 of 35 patients who received placebo.

Most TEAEs were moderate or severe in the SAGE-324 group, whereas most were mild in the placebo group.

The most common TEAEs for participants who received SAGE-324 were somnolence (67.6%) and dizziness (38.2%), followed by balance problems, diplopia, dysarthria, and gait disturbance. In the placebo group, somnolence affected 5.7%, and dizziness affected 11.4%. There were no deaths in either group.

Dr. Colquhoun said these findings “are in line with our expectations for the 60-mg dose.”

More than one-third of the SAGE-324 group discontinued treatment before the end of the trial, and continuing treatment often required dose reductions. Only 24% completed the trial while taking the 60-mg dose; 15% completed the trial while taking 45 mg; and 24% did so while taking 30 mg.

Dr. Colquhoun noted that the company plans to initiate a phase 2b dose-ranging study later this year to optimize the dosing regimen with regard to tolerability and sustained tremor control.
 

No advantage over older drugs?

Commenting on the findings, Michele Tagliati, MD, director of the movement disorders program at Cedars-Sinai Medical Center, Los Angeles, said he had been aware of the study and was interested in seeing the results. However, he does not see an advantage with this drug, compared with what is already used for essential tremor.

“The response of people is not that different than when we treat them with the old barbiturates and benzodiazepines,” said Dr. Tagliati, who was not involved with the research.

He also noted the high rate of adverse events, particularly somnolence, and said that in his experience with current treatments, some patients prefer to live with their tremors rather than be sleepy and not thinking well.

Dr. Tagliati said he thinks use of SAGE-324 is going to be limited to patients who can tolerate it, “which was not that many.”

In addition, the trial was limited by its relatively small size, a “huge placebo effect,” and a high dropout rate in the active treatment arm, he concluded.

The study was funded by Sage Therapeutics and Biogen. Dr. Bankole and Dr. Calquhoun are employees of Sage. Dr. Tagliati reported no relevant financial relationships.

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

The US Department of Veterans Affairs (VA) has issued a new policy statement to help ensure that active-duty service members who were discharged for their sexual orientation under the Don’t Ask, Don’t Tell policy will be able to receive full VA benefits.

“[A] great injustice was remedied and a tremendous weight was finally lifted off the shoulders of tens of thousands of dedicated American service members,” President Biden said on September 20 as the country commemorated the 10th anniversary of the repeal of “Don’t Ask, Don’t Tell,” the policy that barred lesbian, gay, bisexual, transgender, and queer (LGBTQ+) service members from serving openly.

Prior to DADT, if active-duty service members spoke out about their sexual orientation, they ran the risk of being hounded, shunned, in some cases assaulted, and discharged. If they kept it a secret, they felt they were living a lie, unable to be their whole selves. More than 100,000 were discharged because of their sexual orientation or gender identity.

Although Don’t Ask, Don’t Tell was a “compromise” law that purposed to protect them, LGBTQ+ service members were still at risk for harassment and abuse. Nor did the law protect them from discharge. Some 14,000 LGBTQ+ service members were discharged while DADT was in effect. And those who received “other than honorable” (OTH) discharges could be excluded from receiving services and benefits.

The 2011 repeal followed a “hard-fought battle,” said a release from the Human Rights Campaign, which led a coalition of members, supporters, elected officials, 70+ organizations, and 20,000 veterans to get the law overturned. HRC staff coordinated grassroots efforts and sent 19 million e-mails to members and supporters, in turn generating an “unprecedented” 625,000 e-mails and 50,000 handwritten letters to members of Congress.

After the repeal, the VA began the long process of inclusion for LGBTQ+ veterans. “At VA, we continuously work not only to meet the needs of LGBTQ+ veterans, but also to address ongoing issues that LGBTQ+ veterans face as a result of the military’s decades-long official policy of homophobia and transphobia,” Kayla Williams, assistant secretary for public affairs in VA’s Office of Public and Intergovernmental Affairs wrote in the Secretary’s blog.

The VA “recognizes that the trauma caused by the military’s decades-long policy of discrimination against LGBTQ+ people cannot be undone in a few short months,” she continued, but the Biden administration and Secretary McDonough are “taking the steps necessary to begin addressing the pain that such policies have created.”

President Biden, in his remarks, noted that as a US Senator, he had supported allowing service members to serve openly and, as Vice President, championed the repeal. He said, “I am honored to be Commander-in-Chief of the strongest and most inclusive military in our nation’s history. Today, our military doesn’t just welcome LGBTQ+ service members—it is led at the highest levels by brave LGBTQ+ veterans, including Under Secretary of the Air Force Gina Ortiz Jones and Assistant Secretary of Defense for Readiness Shawn Skelly, who served under Don’t Ask, Don’t Tell. I was gratified to appoint the first openly gay Senate-confirmed Cabinet member, Secretary Pete Buttigieg, a lieutenant in the U.S. Navy Reserve and Afghanistan veteran who joined the military under the Don’t Ask, Don’t Tell policy. And during my first week in office, I proudly delivered on my pledge to repeal the discriminatory ban on open service by patriotic transgender service members.”

In early September, Rep. Chris Pappas (D-NH), a member of the House Veterans Affairs Committee and Co-Chair of the Equality Caucus, reintroduced the SERVE (Securing the Rights our Veterans Earned) Act. The act, which is co-sponsored by Reps. Mike Levin (D-CA), Kathleen Rice (D-NY), Anthony Brown (D-MD), and Jackie Speier (D-CA), would ensure LGBTQ+ veterans who received an OTH or Entry-Level Separation discharge solely due to sexual orientation or gender identity are afforded the VA benefits they rightfully earned, including access to VA healthcare, and education, burial and memorial services, and home loans. The act includes veterans who were issued “blue discharges” during World War II and veterans discharged under former President Trump’s ban on transgender service members. The legislation has been endorsed by the Congressional LGBTQ+ Equality Caucus and is supported by more than 45 representatives.

There are processes for those veterans through which they can have their discharge papers and separation statuses reviewed and modified, Pappas said in a release, but “it can take months for the changes to take effect, and many of these veterans do not even realize they are eligible.”

Earlier this year, Veterans Affairs Secretary Denis McDonough made it a priority to ensure that LGBTQ+ veterans have the same level of access to VA care and services that all other veterans have. Among other things, he established a task force to examine how VA policies hinder or prohibit access to care and services and remove barriers that transgender veterans face in accessing gender-affirming care.

The VA is also taking steps, Williams noted, to clarify VA policy for veterans who were given OTH discharges based on homosexual conduct, gender identity or HIV status. Under this newly issued guidance, VA adjudicators shall find that all discharged service members whose separation was due to sexual orientation, gender identity or HIV status are considered “Veterans” who may be eligible for VA benefits, like VR&E, home loan guaranty, compensation and pension, health care, homeless program and/or burial benefits, so long as the record does not implicate a statutory or regulatory bar to benefits.

The policy statement does not represent a change in law, as veterans who were discharged under DADT alone have been generally eligible for benefits under current statute and regulation. However, it reiterates what constitutes eligibility for benefits under law. In addition, every Character of Discharge case that is initially considered for denial will also get a second look before that action is taken.

“Given that large numbers of LGBTQ+ veterans who were affected by previous homophobic and transphobic policies have not applied for a discharge upgrade due to the perception that the process could be onerous,” Williams wrote, “we are hopeful that this policy statement encourages more of them to contact VA to determine their eligibility for care and services.”

Today, according to the Human Right Campaign, nearly 6.1% of US military personnel self-identify as LGBTQ. Williams, herself a bisexual veteran, said she chose to present as straight during the push to repeal DADT. “I could talk credibly about how the lack of sufficient Arabic linguists harmed our effectiveness downrange, and my own identity seemed irrelevant. It took many years for me to shed the toxic legacy of having served under DADT and come back out of the closet; I’m proud to recognize this anniversary as my authentic self.”

The US Department of Veterans Affairs (VA) has issued a new policy statement to help ensure that active-duty service members who were discharged for their sexual orientation under the Don’t Ask, Don’t Tell policy will be able to receive full VA benefits.

“[A] great injustice was remedied and a tremendous weight was finally lifted off the shoulders of tens of thousands of dedicated American service members,” President Biden said on September 20 as the country commemorated the 10th anniversary of the repeal of “Don’t Ask, Don’t Tell,” the policy that barred lesbian, gay, bisexual, transgender, and queer (LGBTQ+) service members from serving openly.

Prior to DADT, if active-duty service members spoke out about their sexual orientation, they ran the risk of being hounded, shunned, in some cases assaulted, and discharged. If they kept it a secret, they felt they were living a lie, unable to be their whole selves. More than 100,000 were discharged because of their sexual orientation or gender identity.

Although Don’t Ask, Don’t Tell was a “compromise” law that purposed to protect them, LGBTQ+ service members were still at risk for harassment and abuse. Nor did the law protect them from discharge. Some 14,000 LGBTQ+ service members were discharged while DADT was in effect. And those who received “other than honorable” (OTH) discharges could be excluded from receiving services and benefits.

The 2011 repeal followed a “hard-fought battle,” said a release from the Human Rights Campaign, which led a coalition of members, supporters, elected officials, 70+ organizations, and 20,000 veterans to get the law overturned. HRC staff coordinated grassroots efforts and sent 19 million e-mails to members and supporters, in turn generating an “unprecedented” 625,000 e-mails and 50,000 handwritten letters to members of Congress.

After the repeal, the VA began the long process of inclusion for LGBTQ+ veterans. “At VA, we continuously work not only to meet the needs of LGBTQ+ veterans, but also to address ongoing issues that LGBTQ+ veterans face as a result of the military’s decades-long official policy of homophobia and transphobia,” Kayla Williams, assistant secretary for public affairs in VA’s Office of Public and Intergovernmental Affairs wrote in the Secretary’s blog.

The VA “recognizes that the trauma caused by the military’s decades-long policy of discrimination against LGBTQ+ people cannot be undone in a few short months,” she continued, but the Biden administration and Secretary McDonough are “taking the steps necessary to begin addressing the pain that such policies have created.”

President Biden, in his remarks, noted that as a US Senator, he had supported allowing service members to serve openly and, as Vice President, championed the repeal. He said, “I am honored to be Commander-in-Chief of the strongest and most inclusive military in our nation’s history. Today, our military doesn’t just welcome LGBTQ+ service members—it is led at the highest levels by brave LGBTQ+ veterans, including Under Secretary of the Air Force Gina Ortiz Jones and Assistant Secretary of Defense for Readiness Shawn Skelly, who served under Don’t Ask, Don’t Tell. I was gratified to appoint the first openly gay Senate-confirmed Cabinet member, Secretary Pete Buttigieg, a lieutenant in the U.S. Navy Reserve and Afghanistan veteran who joined the military under the Don’t Ask, Don’t Tell policy. And during my first week in office, I proudly delivered on my pledge to repeal the discriminatory ban on open service by patriotic transgender service members.”

In early September, Rep. Chris Pappas (D-NH), a member of the House Veterans Affairs Committee and Co-Chair of the Equality Caucus, reintroduced the SERVE (Securing the Rights our Veterans Earned) Act. The act, which is co-sponsored by Reps. Mike Levin (D-CA), Kathleen Rice (D-NY), Anthony Brown (D-MD), and Jackie Speier (D-CA), would ensure LGBTQ+ veterans who received an OTH or Entry-Level Separation discharge solely due to sexual orientation or gender identity are afforded the VA benefits they rightfully earned, including access to VA healthcare, and education, burial and memorial services, and home loans. The act includes veterans who were issued “blue discharges” during World War II and veterans discharged under former President Trump’s ban on transgender service members. The legislation has been endorsed by the Congressional LGBTQ+ Equality Caucus and is supported by more than 45 representatives.

There are processes for those veterans through which they can have their discharge papers and separation statuses reviewed and modified, Pappas said in a release, but “it can take months for the changes to take effect, and many of these veterans do not even realize they are eligible.”

Earlier this year, Veterans Affairs Secretary Denis McDonough made it a priority to ensure that LGBTQ+ veterans have the same level of access to VA care and services that all other veterans have. Among other things, he established a task force to examine how VA policies hinder or prohibit access to care and services and remove barriers that transgender veterans face in accessing gender-affirming care.

The VA is also taking steps, Williams noted, to clarify VA policy for veterans who were given OTH discharges based on homosexual conduct, gender identity or HIV status. Under this newly issued guidance, VA adjudicators shall find that all discharged service members whose separation was due to sexual orientation, gender identity or HIV status are considered “Veterans” who may be eligible for VA benefits, like VR&E, home loan guaranty, compensation and pension, health care, homeless program and/or burial benefits, so long as the record does not implicate a statutory or regulatory bar to benefits.

The policy statement does not represent a change in law, as veterans who were discharged under DADT alone have been generally eligible for benefits under current statute and regulation. However, it reiterates what constitutes eligibility for benefits under law. In addition, every Character of Discharge case that is initially considered for denial will also get a second look before that action is taken.

“Given that large numbers of LGBTQ+ veterans who were affected by previous homophobic and transphobic policies have not applied for a discharge upgrade due to the perception that the process could be onerous,” Williams wrote, “we are hopeful that this policy statement encourages more of them to contact VA to determine their eligibility for care and services.”

Today, according to the Human Right Campaign, nearly 6.1% of US military personnel self-identify as LGBTQ. Williams, herself a bisexual veteran, said she chose to present as straight during the push to repeal DADT. “I could talk credibly about how the lack of sufficient Arabic linguists harmed our effectiveness downrange, and my own identity seemed irrelevant. It took many years for me to shed the toxic legacy of having served under DADT and come back out of the closet; I’m proud to recognize this anniversary as my authentic self.”

The US Department of Veterans Affairs (VA) has issued a new policy statement to help ensure that active-duty service members who were discharged for their sexual orientation under the Don’t Ask, Don’t Tell policy will be able to receive full VA benefits.

“[A] great injustice was remedied and a tremendous weight was finally lifted off the shoulders of tens of thousands of dedicated American service members,” President Biden said on September 20 as the country commemorated the 10th anniversary of the repeal of “Don’t Ask, Don’t Tell,” the policy that barred lesbian, gay, bisexual, transgender, and queer (LGBTQ+) service members from serving openly.

Prior to DADT, if active-duty service members spoke out about their sexual orientation, they ran the risk of being hounded, shunned, in some cases assaulted, and discharged. If they kept it a secret, they felt they were living a lie, unable to be their whole selves. More than 100,000 were discharged because of their sexual orientation or gender identity.

Although Don’t Ask, Don’t Tell was a “compromise” law that purposed to protect them, LGBTQ+ service members were still at risk for harassment and abuse. Nor did the law protect them from discharge. Some 14,000 LGBTQ+ service members were discharged while DADT was in effect. And those who received “other than honorable” (OTH) discharges could be excluded from receiving services and benefits.

The 2011 repeal followed a “hard-fought battle,” said a release from the Human Rights Campaign, which led a coalition of members, supporters, elected officials, 70+ organizations, and 20,000 veterans to get the law overturned. HRC staff coordinated grassroots efforts and sent 19 million e-mails to members and supporters, in turn generating an “unprecedented” 625,000 e-mails and 50,000 handwritten letters to members of Congress.

After the repeal, the VA began the long process of inclusion for LGBTQ+ veterans. “At VA, we continuously work not only to meet the needs of LGBTQ+ veterans, but also to address ongoing issues that LGBTQ+ veterans face as a result of the military’s decades-long official policy of homophobia and transphobia,” Kayla Williams, assistant secretary for public affairs in VA’s Office of Public and Intergovernmental Affairs wrote in the Secretary’s blog.

The VA “recognizes that the trauma caused by the military’s decades-long policy of discrimination against LGBTQ+ people cannot be undone in a few short months,” she continued, but the Biden administration and Secretary McDonough are “taking the steps necessary to begin addressing the pain that such policies have created.”

President Biden, in his remarks, noted that as a US Senator, he had supported allowing service members to serve openly and, as Vice President, championed the repeal. He said, “I am honored to be Commander-in-Chief of the strongest and most inclusive military in our nation’s history. Today, our military doesn’t just welcome LGBTQ+ service members—it is led at the highest levels by brave LGBTQ+ veterans, including Under Secretary of the Air Force Gina Ortiz Jones and Assistant Secretary of Defense for Readiness Shawn Skelly, who served under Don’t Ask, Don’t Tell. I was gratified to appoint the first openly gay Senate-confirmed Cabinet member, Secretary Pete Buttigieg, a lieutenant in the U.S. Navy Reserve and Afghanistan veteran who joined the military under the Don’t Ask, Don’t Tell policy. And during my first week in office, I proudly delivered on my pledge to repeal the discriminatory ban on open service by patriotic transgender service members.”

In early September, Rep. Chris Pappas (D-NH), a member of the House Veterans Affairs Committee and Co-Chair of the Equality Caucus, reintroduced the SERVE (Securing the Rights our Veterans Earned) Act. The act, which is co-sponsored by Reps. Mike Levin (D-CA), Kathleen Rice (D-NY), Anthony Brown (D-MD), and Jackie Speier (D-CA), would ensure LGBTQ+ veterans who received an OTH or Entry-Level Separation discharge solely due to sexual orientation or gender identity are afforded the VA benefits they rightfully earned, including access to VA healthcare, and education, burial and memorial services, and home loans. The act includes veterans who were issued “blue discharges” during World War II and veterans discharged under former President Trump’s ban on transgender service members. The legislation has been endorsed by the Congressional LGBTQ+ Equality Caucus and is supported by more than 45 representatives.

There are processes for those veterans through which they can have their discharge papers and separation statuses reviewed and modified, Pappas said in a release, but “it can take months for the changes to take effect, and many of these veterans do not even realize they are eligible.”

Earlier this year, Veterans Affairs Secretary Denis McDonough made it a priority to ensure that LGBTQ+ veterans have the same level of access to VA care and services that all other veterans have. Among other things, he established a task force to examine how VA policies hinder or prohibit access to care and services and remove barriers that transgender veterans face in accessing gender-affirming care.

The VA is also taking steps, Williams noted, to clarify VA policy for veterans who were given OTH discharges based on homosexual conduct, gender identity or HIV status. Under this newly issued guidance, VA adjudicators shall find that all discharged service members whose separation was due to sexual orientation, gender identity or HIV status are considered “Veterans” who may be eligible for VA benefits, like VR&E, home loan guaranty, compensation and pension, health care, homeless program and/or burial benefits, so long as the record does not implicate a statutory or regulatory bar to benefits.

The policy statement does not represent a change in law, as veterans who were discharged under DADT alone have been generally eligible for benefits under current statute and regulation. However, it reiterates what constitutes eligibility for benefits under law. In addition, every Character of Discharge case that is initially considered for denial will also get a second look before that action is taken.

“Given that large numbers of LGBTQ+ veterans who were affected by previous homophobic and transphobic policies have not applied for a discharge upgrade due to the perception that the process could be onerous,” Williams wrote, “we are hopeful that this policy statement encourages more of them to contact VA to determine their eligibility for care and services.”

Today, according to the Human Right Campaign, nearly 6.1% of US military personnel self-identify as LGBTQ. Williams, herself a bisexual veteran, said she chose to present as straight during the push to repeal DADT. “I could talk credibly about how the lack of sufficient Arabic linguists harmed our effectiveness downrange, and my own identity seemed irrelevant. It took many years for me to shed the toxic legacy of having served under DADT and come back out of the closet; I’m proud to recognize this anniversary as my authentic self.”

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Adults admitted to general medical-surgical wards who experience in-hospital deterioration have a disproportionate effect on hospital mortality and length of stay.¹ Not long ago, systematic electronic capture of vital signs—arguably the most important predictors of impending deterioration—was restricted to intensive care units (ICUs). Deployment of comprehensive electronic health records (EHRs) and handheld charting tools have made vital signs data more accessible, expanding the possibilities of early detection.

In this issue, Peelen et al² report their scoping review of contemporary EHR-based predictive models for identifying ward patients at risk for deterioration. They identified 22 publications suitable for review. Impressively, some studies report extraordinary statistical performance, with positive predictive values (PPVs) exceeding 50% and with 12- to 24-hour lead times to prepare a clinician response. However, only five algorithms were implemented in an EHR and only three were used clinically. Peelen et al also quantified 48 barriers to and 54 facilitators of the implementation and use of these models. Improved statistical performance (higher PPVs) compared to manually assigned scores were the most important facilitators, while implementation in the context of daily practice (alarm fatigue, integration with existing workflows) were the most important barriers.

These reports invite an obvious question: If the models are this good, why have we not seen more reports of improved patient outcomes? Based on our own recent experience successfully deploying and evaluating the Advance Alert Monitor Program for early detection in a 21-hospital system,³ we suspect that there are several factors at play. Despite the relative computational ease of developing high-performing predictive models, it can be very challenging to create the right dataset (extracting and formatting data, standardizing variable definitions across different EHR builds). Investigators may also underestimate the difficulty of what can be implemented—and sustained—in real-world clinical practice. We encountered substantial difficulty, for example, around alarm fatigue mitigation and the relationship of alerts to end-of-life decisions. Greater attention to implementation is necessary to advance the field.

We suggest that four critical questions be considered when creating in-hospital predictive models. First, what are the statistical characteristics of a model around the likely clinical decision point? Simply having a high C-statistic is insufficient—what matters is the alert’s PPV at a clinically actionable threshold.⁴ Second, workflow burden—how many alerts per day at my hospital—must be measured, including other processes potentially affected by the new system. Third, will the extra work identify a meaningful proportion of the avoidable bad outcomes? Finally, how will model use affect care of patients near the end of life? Alerts for these patients may not make clinical sense and might even interfere with overall care (eg, by triggering an unwanted ICU transfer).

Implementation requires more than data scientists. Consideration must be given to system governance, predictive model maintenance (models can actually decalibrate over time!), and financing (not just the computation side—someone needs to pay for training clinicians and ensuring proper staffing of the clinical response).

Last, rigorous model evaluation must be undertaken. Given the increasing capabilities of comprehensive EHRs, patient-level randomization is becoming more feasible. But even randomized deployments present challenges. Since ward patients are a heterogeneous population, quantifying process-outcome relationships may be difficult. Alternative approaches to quantification of the impact of bundled interventions may need to be considered—not just for initial deployment, but on an ongoing basis. Peelen et al² have effectively summarized the state of published predictive models, which hold the tantalizing possibility of meaningful improvement: saved lives, decreased morbidity. Now, we must work together to address the identified gaps so that, one day, implementation of real-time models is routine, and the promise of in-hospital predictive analytics is fulfilled.

Adults admitted to general medical-surgical wards who experience in-hospital deterioration have a disproportionate effect on hospital mortality and length of stay.¹ Not long ago, systematic electronic capture of vital signs—arguably the most important predictors of impending deterioration—was restricted to intensive care units (ICUs). Deployment of comprehensive electronic health records (EHRs) and handheld charting tools have made vital signs data more accessible, expanding the possibilities of early detection.

In this issue, Peelen et al² report their scoping review of contemporary EHR-based predictive models for identifying ward patients at risk for deterioration. They identified 22 publications suitable for review. Impressively, some studies report extraordinary statistical performance, with positive predictive values (PPVs) exceeding 50% and with 12- to 24-hour lead times to prepare a clinician response. However, only five algorithms were implemented in an EHR and only three were used clinically. Peelen et al also quantified 48 barriers to and 54 facilitators of the implementation and use of these models. Improved statistical performance (higher PPVs) compared to manually assigned scores were the most important facilitators, while implementation in the context of daily practice (alarm fatigue, integration with existing workflows) were the most important barriers.

These reports invite an obvious question: If the models are this good, why have we not seen more reports of improved patient outcomes? Based on our own recent experience successfully deploying and evaluating the Advance Alert Monitor Program for early detection in a 21-hospital system,³ we suspect that there are several factors at play. Despite the relative computational ease of developing high-performing predictive models, it can be very challenging to create the right dataset (extracting and formatting data, standardizing variable definitions across different EHR builds). Investigators may also underestimate the difficulty of what can be implemented—and sustained—in real-world clinical practice. We encountered substantial difficulty, for example, around alarm fatigue mitigation and the relationship of alerts to end-of-life decisions. Greater attention to implementation is necessary to advance the field.

We suggest that four critical questions be considered when creating in-hospital predictive models. First, what are the statistical characteristics of a model around the likely clinical decision point? Simply having a high C-statistic is insufficient—what matters is the alert’s PPV at a clinically actionable threshold.⁴ Second, workflow burden—how many alerts per day at my hospital—must be measured, including other processes potentially affected by the new system. Third, will the extra work identify a meaningful proportion of the avoidable bad outcomes? Finally, how will model use affect care of patients near the end of life? Alerts for these patients may not make clinical sense and might even interfere with overall care (eg, by triggering an unwanted ICU transfer).

Implementation requires more than data scientists. Consideration must be given to system governance, predictive model maintenance (models can actually decalibrate over time!), and financing (not just the computation side—someone needs to pay for training clinicians and ensuring proper staffing of the clinical response).

Last, rigorous model evaluation must be undertaken. Given the increasing capabilities of comprehensive EHRs, patient-level randomization is becoming more feasible. But even randomized deployments present challenges. Since ward patients are a heterogeneous population, quantifying process-outcome relationships may be difficult. Alternative approaches to quantification of the impact of bundled interventions may need to be considered—not just for initial deployment, but on an ongoing basis. Peelen et al² have effectively summarized the state of published predictive models, which hold the tantalizing possibility of meaningful improvement: saved lives, decreased morbidity. Now, we must work together to address the identified gaps so that, one day, implementation of real-time models is routine, and the promise of in-hospital predictive analytics is fulfilled.

Adults admitted to general medical-surgical wards who experience in-hospital deterioration have a disproportionate effect on hospital mortality and length of stay.¹ Not long ago, systematic electronic capture of vital signs—arguably the most important predictors of impending deterioration—was restricted to intensive care units (ICUs). Deployment of comprehensive electronic health records (EHRs) and handheld charting tools have made vital signs data more accessible, expanding the possibilities of early detection.

In this issue, Peelen et al² report their scoping review of contemporary EHR-based predictive models for identifying ward patients at risk for deterioration. They identified 22 publications suitable for review. Impressively, some studies report extraordinary statistical performance, with positive predictive values (PPVs) exceeding 50% and with 12- to 24-hour lead times to prepare a clinician response. However, only five algorithms were implemented in an EHR and only three were used clinically. Peelen et al also quantified 48 barriers to and 54 facilitators of the implementation and use of these models. Improved statistical performance (higher PPVs) compared to manually assigned scores were the most important facilitators, while implementation in the context of daily practice (alarm fatigue, integration with existing workflows) were the most important barriers.

These reports invite an obvious question: If the models are this good, why have we not seen more reports of improved patient outcomes? Based on our own recent experience successfully deploying and evaluating the Advance Alert Monitor Program for early detection in a 21-hospital system,³ we suspect that there are several factors at play. Despite the relative computational ease of developing high-performing predictive models, it can be very challenging to create the right dataset (extracting and formatting data, standardizing variable definitions across different EHR builds). Investigators may also underestimate the difficulty of what can be implemented—and sustained—in real-world clinical practice. We encountered substantial difficulty, for example, around alarm fatigue mitigation and the relationship of alerts to end-of-life decisions. Greater attention to implementation is necessary to advance the field.

We suggest that four critical questions be considered when creating in-hospital predictive models. First, what are the statistical characteristics of a model around the likely clinical decision point? Simply having a high C-statistic is insufficient—what matters is the alert’s PPV at a clinically actionable threshold.⁴ Second, workflow burden—how many alerts per day at my hospital—must be measured, including other processes potentially affected by the new system. Third, will the extra work identify a meaningful proportion of the avoidable bad outcomes? Finally, how will model use affect care of patients near the end of life? Alerts for these patients may not make clinical sense and might even interfere with overall care (eg, by triggering an unwanted ICU transfer).

Implementation requires more than data scientists. Consideration must be given to system governance, predictive model maintenance (models can actually decalibrate over time!), and financing (not just the computation side—someone needs to pay for training clinicians and ensuring proper staffing of the clinical response).

Last, rigorous model evaluation must be undertaken. Given the increasing capabilities of comprehensive EHRs, patient-level randomization is becoming more feasible. But even randomized deployments present challenges. Since ward patients are a heterogeneous population, quantifying process-outcome relationships may be difficult. Alternative approaches to quantification of the impact of bundled interventions may need to be considered—not just for initial deployment, but on an ongoing basis. Peelen et al² have effectively summarized the state of published predictive models, which hold the tantalizing possibility of meaningful improvement: saved lives, decreased morbidity. Now, we must work together to address the identified gaps so that, one day, implementation of real-time models is routine, and the promise of in-hospital predictive analytics is fulfilled.

In 2016, a study was published that continues to shock observers today.¹ Examining 200 medical trainees, researchers reported that an alarming percentage of these individuals held false beliefs about Black bodies, including 22% believing that nerve endings in Black persons are less sensitive than nerve endings in White persons and 63% believing that Black skin is thicker than White skin. Furthermore, the study found that those who held these false beliefs about biological differences between Black and White individuals were also less likely to recommend pain treatment to Black patients in a follow-up case vignette. Two years later, in an evaluation of racial differences in opioid prescribing in the United States published in Epidemiology, one of the authors suggested, “It’s an extremely rare case where racial biases actually protected the population [Black individuals] being discriminated against.”²

These studies provide the background for the analysis by Rambachan et al³ published in this issue of the Journal of Hospital Medicine. The authors examined a diverse cohort of more than 10,000 patients hospitalized on a general medicine service at an academic medical center in San Francisco from 2012 to 2018. Black patients were significantly less likely to receive an opioid prescription at discharge, and when they did, were discharged on opioids for fewer days than White patients. No other racial group experienced such a disparity, with Asian patients more likely to receive opioids at discharge. Whereas these findings align with myriad studies demonstrating racial disparities in opioid prescribing,⁴ the authors focus on patients admitted to a general medicine service, where most hospitalized patients receive medical care daily.

The authors concede that determining the etiology of these disparities was beyond the scope of their study, yet this is the exact question we must answer today. Why should the color of a patient’s skin continue to determine the type, and duration, of care they receive, especially when treating pain? The authors hypothesize that individual factors such as provider bias and systemic factors, including limited guidelines on pain management, may drive the observed racial inequities. This progression from individual- and institutional- to community- and policy-level determinants offers a useful framework for understanding the drivers of disparities in opioid prescribing. It also provides an agenda for future research that can guide us from simply detecting disparities to understanding and eliminating them. Furthermore, it is important to examine care team provider characteristics, including race/ethnicity, years in practice, education level (eg, resident vs attending),⁵ experience with implicit bias training, and differential referral to specialists, such as pain, palliative care, and addiction providers. Factors associated with the facility where a patient is hospitalized also warrant further exploration, including the diversity of medical and nonmedical staff as well as patients.⁶ Examining these factors will allow us to move closer toward implementing effective interventions that eliminate disparities in pain treatment.

The authors begin to provide us with possible levers to pull to address the inequities in opioid prescribing. They suggest provider-level bias training, improved institutional tracking of disparities, and policy-level solutions to address the persistent dearth of diversity in the healthcare workforce. While these broad solutions may address health disparities across the medical field, targeted solutions are needed to directly address inequities in pain treatment. First, we must explore the reasons for disparities in the prevalence, presentation, and management of pain in Black populations. These reasons may include occupational exposures or injuries, psychological stress (often associated with racism), and a disproportionate presence of chronic medical comorbidities. Second, health systems can implement a standardized system for opioid prescribing, supported by pharmacy expertise and considering clinical diagnoses, to reduce subjectivity associated with determining the appropriateness of an opioid prescription. Third, health systems must improve access to addiction, harm reduction, and pain specialty services to effectively manage comorbid conditions in at-risk patients.⁷ Furthermore, we must look beyond traditional measures of healthcare access, such as insurance coverage, to address social determinants of health, such as distance to pharmacy, housing security, employment status, and experience with the criminal justice system, which may influence a patient’s receipt of a prescription. Finally, as a society, we must prioritize early training of healthcare providers, long before the undergraduate and graduate medical education level, to practice medicine without stigmatizing biases and stereotypes related to drug use in communities of color.⁸

The pattern of racial and ethnic disparities in healthcare has been documented for decades, with an ever-increasing depth of the different ways in which minoritized patients are undertreated. Despite this breadth of research, our understanding of the etiology of these inequities and development and implementation of interventions to reduce them remain limited. Rambachan et al³ do a commendable job highlighting further racial disparities in opioid prescribing in hospitalized patients and provide another opportunity to answer the important questions plaguing health care today: Why do these disparities exist and what can be done to address them? The urgency we take towards answering these questions will confirm our commitment to achieving antiracism in medicine and prioritizing health equity. Black lives are depending on it.

In 2016, a study was published that continues to shock observers today.¹ Examining 200 medical trainees, researchers reported that an alarming percentage of these individuals held false beliefs about Black bodies, including 22% believing that nerve endings in Black persons are less sensitive than nerve endings in White persons and 63% believing that Black skin is thicker than White skin. Furthermore, the study found that those who held these false beliefs about biological differences between Black and White individuals were also less likely to recommend pain treatment to Black patients in a follow-up case vignette. Two years later, in an evaluation of racial differences in opioid prescribing in the United States published in Epidemiology, one of the authors suggested, “It’s an extremely rare case where racial biases actually protected the population [Black individuals] being discriminated against.”²

These studies provide the background for the analysis by Rambachan et al³ published in this issue of the Journal of Hospital Medicine. The authors examined a diverse cohort of more than 10,000 patients hospitalized on a general medicine service at an academic medical center in San Francisco from 2012 to 2018. Black patients were significantly less likely to receive an opioid prescription at discharge, and when they did, were discharged on opioids for fewer days than White patients. No other racial group experienced such a disparity, with Asian patients more likely to receive opioids at discharge. Whereas these findings align with myriad studies demonstrating racial disparities in opioid prescribing,⁴ the authors focus on patients admitted to a general medicine service, where most hospitalized patients receive medical care daily.

The authors concede that determining the etiology of these disparities was beyond the scope of their study, yet this is the exact question we must answer today. Why should the color of a patient’s skin continue to determine the type, and duration, of care they receive, especially when treating pain? The authors hypothesize that individual factors such as provider bias and systemic factors, including limited guidelines on pain management, may drive the observed racial inequities. This progression from individual- and institutional- to community- and policy-level determinants offers a useful framework for understanding the drivers of disparities in opioid prescribing. It also provides an agenda for future research that can guide us from simply detecting disparities to understanding and eliminating them. Furthermore, it is important to examine care team provider characteristics, including race/ethnicity, years in practice, education level (eg, resident vs attending),⁵ experience with implicit bias training, and differential referral to specialists, such as pain, palliative care, and addiction providers. Factors associated with the facility where a patient is hospitalized also warrant further exploration, including the diversity of medical and nonmedical staff as well as patients.⁶ Examining these factors will allow us to move closer toward implementing effective interventions that eliminate disparities in pain treatment.

The authors begin to provide us with possible levers to pull to address the inequities in opioid prescribing. They suggest provider-level bias training, improved institutional tracking of disparities, and policy-level solutions to address the persistent dearth of diversity in the healthcare workforce. While these broad solutions may address health disparities across the medical field, targeted solutions are needed to directly address inequities in pain treatment. First, we must explore the reasons for disparities in the prevalence, presentation, and management of pain in Black populations. These reasons may include occupational exposures or injuries, psychological stress (often associated with racism), and a disproportionate presence of chronic medical comorbidities. Second, health systems can implement a standardized system for opioid prescribing, supported by pharmacy expertise and considering clinical diagnoses, to reduce subjectivity associated with determining the appropriateness of an opioid prescription. Third, health systems must improve access to addiction, harm reduction, and pain specialty services to effectively manage comorbid conditions in at-risk patients.⁷ Furthermore, we must look beyond traditional measures of healthcare access, such as insurance coverage, to address social determinants of health, such as distance to pharmacy, housing security, employment status, and experience with the criminal justice system, which may influence a patient’s receipt of a prescription. Finally, as a society, we must prioritize early training of healthcare providers, long before the undergraduate and graduate medical education level, to practice medicine without stigmatizing biases and stereotypes related to drug use in communities of color.⁸

The pattern of racial and ethnic disparities in healthcare has been documented for decades, with an ever-increasing depth of the different ways in which minoritized patients are undertreated. Despite this breadth of research, our understanding of the etiology of these inequities and development and implementation of interventions to reduce them remain limited. Rambachan et al³ do a commendable job highlighting further racial disparities in opioid prescribing in hospitalized patients and provide another opportunity to answer the important questions plaguing health care today: Why do these disparities exist and what can be done to address them? The urgency we take towards answering these questions will confirm our commitment to achieving antiracism in medicine and prioritizing health equity. Black lives are depending on it.

In 2016, a study was published that continues to shock observers today.¹ Examining 200 medical trainees, researchers reported that an alarming percentage of these individuals held false beliefs about Black bodies, including 22% believing that nerve endings in Black persons are less sensitive than nerve endings in White persons and 63% believing that Black skin is thicker than White skin. Furthermore, the study found that those who held these false beliefs about biological differences between Black and White individuals were also less likely to recommend pain treatment to Black patients in a follow-up case vignette. Two years later, in an evaluation of racial differences in opioid prescribing in the United States published in Epidemiology, one of the authors suggested, “It’s an extremely rare case where racial biases actually protected the population [Black individuals] being discriminated against.”²

These studies provide the background for the analysis by Rambachan et al³ published in this issue of the Journal of Hospital Medicine. The authors examined a diverse cohort of more than 10,000 patients hospitalized on a general medicine service at an academic medical center in San Francisco from 2012 to 2018. Black patients were significantly less likely to receive an opioid prescription at discharge, and when they did, were discharged on opioids for fewer days than White patients. No other racial group experienced such a disparity, with Asian patients more likely to receive opioids at discharge. Whereas these findings align with myriad studies demonstrating racial disparities in opioid prescribing,⁴ the authors focus on patients admitted to a general medicine service, where most hospitalized patients receive medical care daily.

The authors concede that determining the etiology of these disparities was beyond the scope of their study, yet this is the exact question we must answer today. Why should the color of a patient’s skin continue to determine the type, and duration, of care they receive, especially when treating pain? The authors hypothesize that individual factors such as provider bias and systemic factors, including limited guidelines on pain management, may drive the observed racial inequities. This progression from individual- and institutional- to community- and policy-level determinants offers a useful framework for understanding the drivers of disparities in opioid prescribing. It also provides an agenda for future research that can guide us from simply detecting disparities to understanding and eliminating them. Furthermore, it is important to examine care team provider characteristics, including race/ethnicity, years in practice, education level (eg, resident vs attending),⁵ experience with implicit bias training, and differential referral to specialists, such as pain, palliative care, and addiction providers. Factors associated with the facility where a patient is hospitalized also warrant further exploration, including the diversity of medical and nonmedical staff as well as patients.⁶ Examining these factors will allow us to move closer toward implementing effective interventions that eliminate disparities in pain treatment.

The authors begin to provide us with possible levers to pull to address the inequities in opioid prescribing. They suggest provider-level bias training, improved institutional tracking of disparities, and policy-level solutions to address the persistent dearth of diversity in the healthcare workforce. While these broad solutions may address health disparities across the medical field, targeted solutions are needed to directly address inequities in pain treatment. First, we must explore the reasons for disparities in the prevalence, presentation, and management of pain in Black populations. These reasons may include occupational exposures or injuries, psychological stress (often associated with racism), and a disproportionate presence of chronic medical comorbidities. Second, health systems can implement a standardized system for opioid prescribing, supported by pharmacy expertise and considering clinical diagnoses, to reduce subjectivity associated with determining the appropriateness of an opioid prescription. Third, health systems must improve access to addiction, harm reduction, and pain specialty services to effectively manage comorbid conditions in at-risk patients.⁷ Furthermore, we must look beyond traditional measures of healthcare access, such as insurance coverage, to address social determinants of health, such as distance to pharmacy, housing security, employment status, and experience with the criminal justice system, which may influence a patient’s receipt of a prescription. Finally, as a society, we must prioritize early training of healthcare providers, long before the undergraduate and graduate medical education level, to practice medicine without stigmatizing biases and stereotypes related to drug use in communities of color.⁸

The pattern of racial and ethnic disparities in healthcare has been documented for decades, with an ever-increasing depth of the different ways in which minoritized patients are undertreated. Despite this breadth of research, our understanding of the etiology of these inequities and development and implementation of interventions to reduce them remain limited. Rambachan et al³ do a commendable job highlighting further racial disparities in opioid prescribing in hospitalized patients and provide another opportunity to answer the important questions plaguing health care today: Why do these disparities exist and what can be done to address them? The urgency we take towards answering these questions will confirm our commitment to achieving antiracism in medicine and prioritizing health equity. Black lives are depending on it.

“Well begun is half done.” — Aristotle

In the clinical environment, team composition changes frequently and time is limited. As a result, teams often jump directly into patient care, addressing issues related to interpersonal dynamics only after they arise. Team leaders can accelerate the process of forming highly effective teams by deliberately leveraging principles of teaming, or the process of “how to turn a group of strangers into a team.”¹

On the first day with a new team, a common misconception is that teaming will take away time, when in fact it will save time. Investing a few minutes before rounds to clarify roles and expectations can streamline subsequent shared work. For example, an attending might request to accompany residents and medical students for new admissions in the last 2 hours of the workday, rather than following the usual pattern of discussing the case after the team completes a full evaluation on their own. Importantly, attendings should clarify their intent—to preserve learning opportunities while helping teams wrap up on time—and their role, which is to provide real-time feedback, facilitate decision-making, or assist with documentation. This 2-minute upfront investment results in improved team camaraderie, better task coordination, and fewer late days in the hospital.

By integrating a few positively framed, thoughtful questions into introductions, teams may also discover surprising expertise or valuable perspectives that positively impact team performance.² For example, in lieu of questions about level of training or hometown, you might ask, “What is an experience outside the hospital that helps you inside the hospital?” or “What skills allow you to contribute best on teams?” These questions might lead, for example, a medical student to leverage her background in computer science to help her team design new electronic health record shortcuts. Or, they might enable a resident with a personal history of leukemia to help the team communicate with a young patient facing a prolonged hospitalization for a newly diagnosed serious illness. With typical introductions, these opportunities and unexpected solutions can easily be missed.

As part of teaming, members should also explicitly share individual work-style preferences to avoid misunderstandings that may adversely affect subsequent work. On new teams, members—especially trainees—expend considerable energy scrutinizing subtle behaviors, such as a clarifying question or a blank stare, to assess whether their performance is perceived favorably. That energy can be reallocated to more important tasks by encouraging each person to state nuances of their work style that may be misinterpreted. For example, an attending might share, “I ask questions to identify what to teach, not to judge knowledge, so don’t worry about saying you don’t know,” whereas a resident might warn, “I have trouble concentrating when I’m hungry, so I often get impatient if we don’t take a break for lunch.” Without this information, a student might feel unnecessarily embarrassed by an attending on rounds, and an attending might incorrectly interpret a resident’s impatience around lunchtime as a reflection of low commitment. Individual work styles vary, and recognizing these differences upfront allows teams to maintain a sharper focus on more important issues, such as clinical care.

In the hospital, we find ourselves in perpetual motion, with frequent transitions of care and new team members. Teaming offers a concrete method to proactively avoid predictable challenges and to enable teams to become more efficient, effective, and connected. Furthermore, teaming empowers us to substitute the uncertainty of ever-changing teams with the excitement of discovering what each new team can achieve through intentional leadership at the outset.

“Well begun is half done.” — Aristotle

In the clinical environment, team composition changes frequently and time is limited. As a result, teams often jump directly into patient care, addressing issues related to interpersonal dynamics only after they arise. Team leaders can accelerate the process of forming highly effective teams by deliberately leveraging principles of teaming, or the process of “how to turn a group of strangers into a team.”¹

On the first day with a new team, a common misconception is that teaming will take away time, when in fact it will save time. Investing a few minutes before rounds to clarify roles and expectations can streamline subsequent shared work. For example, an attending might request to accompany residents and medical students for new admissions in the last 2 hours of the workday, rather than following the usual pattern of discussing the case after the team completes a full evaluation on their own. Importantly, attendings should clarify their intent—to preserve learning opportunities while helping teams wrap up on time—and their role, which is to provide real-time feedback, facilitate decision-making, or assist with documentation. This 2-minute upfront investment results in improved team camaraderie, better task coordination, and fewer late days in the hospital.

By integrating a few positively framed, thoughtful questions into introductions, teams may also discover surprising expertise or valuable perspectives that positively impact team performance.² For example, in lieu of questions about level of training or hometown, you might ask, “What is an experience outside the hospital that helps you inside the hospital?” or “What skills allow you to contribute best on teams?” These questions might lead, for example, a medical student to leverage her background in computer science to help her team design new electronic health record shortcuts. Or, they might enable a resident with a personal history of leukemia to help the team communicate with a young patient facing a prolonged hospitalization for a newly diagnosed serious illness. With typical introductions, these opportunities and unexpected solutions can easily be missed.

As part of teaming, members should also explicitly share individual work-style preferences to avoid misunderstandings that may adversely affect subsequent work. On new teams, members—especially trainees—expend considerable energy scrutinizing subtle behaviors, such as a clarifying question or a blank stare, to assess whether their performance is perceived favorably. That energy can be reallocated to more important tasks by encouraging each person to state nuances of their work style that may be misinterpreted. For example, an attending might share, “I ask questions to identify what to teach, not to judge knowledge, so don’t worry about saying you don’t know,” whereas a resident might warn, “I have trouble concentrating when I’m hungry, so I often get impatient if we don’t take a break for lunch.” Without this information, a student might feel unnecessarily embarrassed by an attending on rounds, and an attending might incorrectly interpret a resident’s impatience around lunchtime as a reflection of low commitment. Individual work styles vary, and recognizing these differences upfront allows teams to maintain a sharper focus on more important issues, such as clinical care.

In the hospital, we find ourselves in perpetual motion, with frequent transitions of care and new team members. Teaming offers a concrete method to proactively avoid predictable challenges and to enable teams to become more efficient, effective, and connected. Furthermore, teaming empowers us to substitute the uncertainty of ever-changing teams with the excitement of discovering what each new team can achieve through intentional leadership at the outset.

“Well begun is half done.” — Aristotle

In the clinical environment, team composition changes frequently and time is limited. As a result, teams often jump directly into patient care, addressing issues related to interpersonal dynamics only after they arise. Team leaders can accelerate the process of forming highly effective teams by deliberately leveraging principles of teaming, or the process of “how to turn a group of strangers into a team.”¹

On the first day with a new team, a common misconception is that teaming will take away time, when in fact it will save time. Investing a few minutes before rounds to clarify roles and expectations can streamline subsequent shared work. For example, an attending might request to accompany residents and medical students for new admissions in the last 2 hours of the workday, rather than following the usual pattern of discussing the case after the team completes a full evaluation on their own. Importantly, attendings should clarify their intent—to preserve learning opportunities while helping teams wrap up on time—and their role, which is to provide real-time feedback, facilitate decision-making, or assist with documentation. This 2-minute upfront investment results in improved team camaraderie, better task coordination, and fewer late days in the hospital.

By integrating a few positively framed, thoughtful questions into introductions, teams may also discover surprising expertise or valuable perspectives that positively impact team performance.² For example, in lieu of questions about level of training or hometown, you might ask, “What is an experience outside the hospital that helps you inside the hospital?” or “What skills allow you to contribute best on teams?” These questions might lead, for example, a medical student to leverage her background in computer science to help her team design new electronic health record shortcuts. Or, they might enable a resident with a personal history of leukemia to help the team communicate with a young patient facing a prolonged hospitalization for a newly diagnosed serious illness. With typical introductions, these opportunities and unexpected solutions can easily be missed.

As part of teaming, members should also explicitly share individual work-style preferences to avoid misunderstandings that may adversely affect subsequent work. On new teams, members—especially trainees—expend considerable energy scrutinizing subtle behaviors, such as a clarifying question or a blank stare, to assess whether their performance is perceived favorably. That energy can be reallocated to more important tasks by encouraging each person to state nuances of their work style that may be misinterpreted. For example, an attending might share, “I ask questions to identify what to teach, not to judge knowledge, so don’t worry about saying you don’t know,” whereas a resident might warn, “I have trouble concentrating when I’m hungry, so I often get impatient if we don’t take a break for lunch.” Without this information, a student might feel unnecessarily embarrassed by an attending on rounds, and an attending might incorrectly interpret a resident’s impatience around lunchtime as a reflection of low commitment. Individual work styles vary, and recognizing these differences upfront allows teams to maintain a sharper focus on more important issues, such as clinical care.

In the hospital, we find ourselves in perpetual motion, with frequent transitions of care and new team members. Teaming offers a concrete method to proactively avoid predictable challenges and to enable teams to become more efficient, effective, and connected. Furthermore, teaming empowers us to substitute the uncertainty of ever-changing teams with the excitement of discovering what each new team can achieve through intentional leadership at the outset.

Chi-Cheng Huang, MD, SFHM, was recently was named one of the Notable Asian/Pacific American Physicians in U.S. History by the American Board of Internal Medicine. May was Asian/Pacific American Heritage Month. Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System (Winston-Salem, N.C.) and associate professor at Wake Forest School of Medicine.

Dr. Huang is a board-certified hospitalist and pediatrician, and he is the founder of the Bolivian Children Project, a non-profit organization that focuses on sheltering street children in La Paz and other areas of Bolivia. Dr. Huang was inspired to start the project during a year sabbatical from medical school. He worked at an orphanage and cared for children who were victims of physical abuse. The Bolivian Children Project supports those children, and Dr. Huang’s book, When Invisible Children Sing, tells their story.
 

Joshua Lenchus, DO, RPh, SFHM, has been elected president of the Florida Medical Association. It is the first time in its history that the FMA will have a DO as its president. Dr. Lenchus is a hospitalist and chief medical officer at the Broward Health Medical Center in Fort Lauderdale, Fla.

Mark V. Williams, MD, MHM, will join Washington University School of Medicine and BJC HealthCare, both in St. Louis, as professor and chief for the Division of Hospital Medicine in October 2021. Dr. Williams is currently professor and director of the Center for Health Services Research at the University of Kentucky and chief quality officer at UK HealthCare, both in Lexington.

Dr. Williams was a founding member of the Society of Hospital Medicine, one of the first two elected members of the Board of SHM, its former president, founding editor of the Journal of Hospital Medicine, and principal investigator for Project BOOST. He established the first hospitalist program at a public hospital (Grady Memorial in Atlanta) in 1998, and later became the founding chief of the Division of Hospital Medicine in 2007 at Northwestern University School of Medicine in Chicago. At the University of Kentucky, he established the Center for Health Services Research and the Division of Hospital Medicine in 2014.

At Washington University, Dr. Williams will be tasked with translating the division of hospital medicine’s scholarly work, innovation, and research into practice improvement, focusing on developing new systems of health care delivery that are patient-centered, cost effective, and provide outstanding value.
 

Jordan Messler, MD, SFHM, has been named the new chief medical officer at Glytec (Waltham, Mass.), where he has worked as executive director of clinical practice since 2018. Dr. Messler will be tasked with leading strategy and product development while also supporting efforts in quality care, customer relations, and delivery of products.

Glytec provides insulin management software across the care continuum and is touted as the only cloud-based software provider of its kind. Dr. Messler’s background includes expertise in glycemic management. In addition, he still works as a hospitalist at Morton Plant Hospitalist Group (Clearwater, Fla.).

Dr. Messler is a senior fellow with SHM and is physician editor of SHM’s official blog The Hospital Leader.
 

Tiffani Maycock, DO, recently was named to the Board of Directors for the American Board of Family Medicine. Dr. Maycock is director of the Selma Family Medicine Residency Program at the University of Alabama at Birmingham, where she is an assistant professor in the department of family medicine.

Dr. Maycock helped create hospitalist services at Vaughan Regional Medical Center (Selma, Ala.) – Selma Family Medicine’s primary teaching site – and currently serves as its hospitalist director and on its Medical Executive Committee. She has worked at the facility since 2017.
 

Preetham Talari, MD, SFHM, has been named associate chief of quality safety for the Division of Hospital Medicine at the University of Kentucky’s UK HealthCare (Lexington, Ky.). Dr. Talari is an associate professor of internal medicine in the Division of Hospital Medicine at the UK College of Medicine.

Over the last decade, Dr. Talari’s work in quality, safety, and health care leadership has positioned him as a leader in several UK Healthcare committees and transformation projects. In his role as associate chief, Dr. Talari collaborates with hospital medicine directors, enterprise leadership, and medical education leadership to improve the system’s quality of care.

Dr. Talari is the president of the Kentucky chapter of SHM and is a member of SHM’s Hospital Quality and Patient Safety Committee.
 

Adrian Paraschiv, MD, FHM, is being recognized by Continental Who’s Who as a Trusted Internist and Hospitalist in the field of Medicine in acknowledgment of his commitment to providing quality health care services.

Dr. Paraschiv is a board-certified Internist at Garnet Health Medical Center in Middletown, N.Y. He also serves in an administrative capacity as the Garnet Health Doctors Hospitalist Division’s Associate Program Director. He is also the Director of Clinical Informatics. Dr. Paraschiv is certified as the Epic physician builder in analytics, information technology, and improved documentation.
 

DCH Health System (Tuscaloosa, Ala.) recently selected Capstone Health Services Foundation (Tuscaloosa) and IN Compass Health Inc. (Alpharetta, Ga.) as its joint hospitalist service provider for facilities in Northport and Tuscaloosa. Capstone will provide the physicians, while IN Compass will handle staffing management of the hospitalists, as well as day-to-day operations and calculating quality care metrics. The agreement is slated to begin on Oct. 1, 2021, at Northport Medical Center, and on Nov. 1, 2021, at DCH Regional Medical Center.

Capstone is an affiliate of the University of Alabama and oversees University Hospitalist Group, which currently provides hospitalists at DCH Regional Medical Center. Its partnership with IN Compass includes working together in recruiting and hiring physicians for both facilities.
 

UPMC Kane Medical Center (Kane, Pa.) recently announced the creation of a virtual telemedicine hospitalist program. UPMC Kane is partnering with the UPMC Center for Community Hospitalist Medicine to create this new mode of care.

Telehospitalists will care for UPMC Kane patients using advanced diagnostic technique and high-definition cameras. The physicians will bring expert service to Kane 24 hours per day utilizing physicians and specialists based in Pittsburgh. Those hospitalists will work with local nurse practitioners and support staff and deliver care to Kane patients.
 

Wake Forest Baptist Health (Winston-Salem, N.C.) has launched a Hospitalist at Home program with hopes of keeping patients safe while also reducing time they spend in the hospital. The telehealth initiative kicked into gear at the start of 2021 and considered the first of its kind in the region.

Patients who qualify for the program establish a plan before they leave the hospital. Wake Forest Baptist Health paramedics makes home visits and conducts care with a hospitalist reviewing the visit virtually. Those appointments continue until the patient does not require monitoring.

The impetus of creating the program was the COVID-19 pandemic, however, Wake Forest said it expects to care for between 75-100 patients through Hospitalist at Home at any one time.

Chi-Cheng Huang, MD, SFHM, was recently was named one of the Notable Asian/Pacific American Physicians in U.S. History by the American Board of Internal Medicine. May was Asian/Pacific American Heritage Month. Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System (Winston-Salem, N.C.) and associate professor at Wake Forest School of Medicine.

Dr. Huang is a board-certified hospitalist and pediatrician, and he is the founder of the Bolivian Children Project, a non-profit organization that focuses on sheltering street children in La Paz and other areas of Bolivia. Dr. Huang was inspired to start the project during a year sabbatical from medical school. He worked at an orphanage and cared for children who were victims of physical abuse. The Bolivian Children Project supports those children, and Dr. Huang’s book, When Invisible Children Sing, tells their story.
 

Joshua Lenchus, DO, RPh, SFHM, has been elected president of the Florida Medical Association. It is the first time in its history that the FMA will have a DO as its president. Dr. Lenchus is a hospitalist and chief medical officer at the Broward Health Medical Center in Fort Lauderdale, Fla.

Mark V. Williams, MD, MHM, will join Washington University School of Medicine and BJC HealthCare, both in St. Louis, as professor and chief for the Division of Hospital Medicine in October 2021. Dr. Williams is currently professor and director of the Center for Health Services Research at the University of Kentucky and chief quality officer at UK HealthCare, both in Lexington.

Dr. Williams was a founding member of the Society of Hospital Medicine, one of the first two elected members of the Board of SHM, its former president, founding editor of the Journal of Hospital Medicine, and principal investigator for Project BOOST. He established the first hospitalist program at a public hospital (Grady Memorial in Atlanta) in 1998, and later became the founding chief of the Division of Hospital Medicine in 2007 at Northwestern University School of Medicine in Chicago. At the University of Kentucky, he established the Center for Health Services Research and the Division of Hospital Medicine in 2014.

At Washington University, Dr. Williams will be tasked with translating the division of hospital medicine’s scholarly work, innovation, and research into practice improvement, focusing on developing new systems of health care delivery that are patient-centered, cost effective, and provide outstanding value.
 

Jordan Messler, MD, SFHM, has been named the new chief medical officer at Glytec (Waltham, Mass.), where he has worked as executive director of clinical practice since 2018. Dr. Messler will be tasked with leading strategy and product development while also supporting efforts in quality care, customer relations, and delivery of products.

Glytec provides insulin management software across the care continuum and is touted as the only cloud-based software provider of its kind. Dr. Messler’s background includes expertise in glycemic management. In addition, he still works as a hospitalist at Morton Plant Hospitalist Group (Clearwater, Fla.).

Dr. Messler is a senior fellow with SHM and is physician editor of SHM’s official blog The Hospital Leader.
 

Tiffani Maycock, DO, recently was named to the Board of Directors for the American Board of Family Medicine. Dr. Maycock is director of the Selma Family Medicine Residency Program at the University of Alabama at Birmingham, where she is an assistant professor in the department of family medicine.

Dr. Maycock helped create hospitalist services at Vaughan Regional Medical Center (Selma, Ala.) – Selma Family Medicine’s primary teaching site – and currently serves as its hospitalist director and on its Medical Executive Committee. She has worked at the facility since 2017.
 

Preetham Talari, MD, SFHM, has been named associate chief of quality safety for the Division of Hospital Medicine at the University of Kentucky’s UK HealthCare (Lexington, Ky.). Dr. Talari is an associate professor of internal medicine in the Division of Hospital Medicine at the UK College of Medicine.

Over the last decade, Dr. Talari’s work in quality, safety, and health care leadership has positioned him as a leader in several UK Healthcare committees and transformation projects. In his role as associate chief, Dr. Talari collaborates with hospital medicine directors, enterprise leadership, and medical education leadership to improve the system’s quality of care.

Dr. Talari is the president of the Kentucky chapter of SHM and is a member of SHM’s Hospital Quality and Patient Safety Committee.
 

Adrian Paraschiv, MD, FHM, is being recognized by Continental Who’s Who as a Trusted Internist and Hospitalist in the field of Medicine in acknowledgment of his commitment to providing quality health care services.

Dr. Paraschiv is a board-certified Internist at Garnet Health Medical Center in Middletown, N.Y. He also serves in an administrative capacity as the Garnet Health Doctors Hospitalist Division’s Associate Program Director. He is also the Director of Clinical Informatics. Dr. Paraschiv is certified as the Epic physician builder in analytics, information technology, and improved documentation.
 

DCH Health System (Tuscaloosa, Ala.) recently selected Capstone Health Services Foundation (Tuscaloosa) and IN Compass Health Inc. (Alpharetta, Ga.) as its joint hospitalist service provider for facilities in Northport and Tuscaloosa. Capstone will provide the physicians, while IN Compass will handle staffing management of the hospitalists, as well as day-to-day operations and calculating quality care metrics. The agreement is slated to begin on Oct. 1, 2021, at Northport Medical Center, and on Nov. 1, 2021, at DCH Regional Medical Center.

Capstone is an affiliate of the University of Alabama and oversees University Hospitalist Group, which currently provides hospitalists at DCH Regional Medical Center. Its partnership with IN Compass includes working together in recruiting and hiring physicians for both facilities.
 

UPMC Kane Medical Center (Kane, Pa.) recently announced the creation of a virtual telemedicine hospitalist program. UPMC Kane is partnering with the UPMC Center for Community Hospitalist Medicine to create this new mode of care.

Telehospitalists will care for UPMC Kane patients using advanced diagnostic technique and high-definition cameras. The physicians will bring expert service to Kane 24 hours per day utilizing physicians and specialists based in Pittsburgh. Those hospitalists will work with local nurse practitioners and support staff and deliver care to Kane patients.
 

Wake Forest Baptist Health (Winston-Salem, N.C.) has launched a Hospitalist at Home program with hopes of keeping patients safe while also reducing time they spend in the hospital. The telehealth initiative kicked into gear at the start of 2021 and considered the first of its kind in the region.

Patients who qualify for the program establish a plan before they leave the hospital. Wake Forest Baptist Health paramedics makes home visits and conducts care with a hospitalist reviewing the visit virtually. Those appointments continue until the patient does not require monitoring.

The impetus of creating the program was the COVID-19 pandemic, however, Wake Forest said it expects to care for between 75-100 patients through Hospitalist at Home at any one time.

Chi-Cheng Huang, MD, SFHM, was recently was named one of the Notable Asian/Pacific American Physicians in U.S. History by the American Board of Internal Medicine. May was Asian/Pacific American Heritage Month. Dr. Huang is the executive medical director and service line director of general medicine and hospital medicine within the Wake Forest Baptist Health System (Winston-Salem, N.C.) and associate professor at Wake Forest School of Medicine.

Dr. Huang is a board-certified hospitalist and pediatrician, and he is the founder of the Bolivian Children Project, a non-profit organization that focuses on sheltering street children in La Paz and other areas of Bolivia. Dr. Huang was inspired to start the project during a year sabbatical from medical school. He worked at an orphanage and cared for children who were victims of physical abuse. The Bolivian Children Project supports those children, and Dr. Huang’s book, When Invisible Children Sing, tells their story.
 

Joshua Lenchus, DO, RPh, SFHM, has been elected president of the Florida Medical Association. It is the first time in its history that the FMA will have a DO as its president. Dr. Lenchus is a hospitalist and chief medical officer at the Broward Health Medical Center in Fort Lauderdale, Fla.

Mark V. Williams, MD, MHM, will join Washington University School of Medicine and BJC HealthCare, both in St. Louis, as professor and chief for the Division of Hospital Medicine in October 2021. Dr. Williams is currently professor and director of the Center for Health Services Research at the University of Kentucky and chief quality officer at UK HealthCare, both in Lexington.

Dr. Williams was a founding member of the Society of Hospital Medicine, one of the first two elected members of the Board of SHM, its former president, founding editor of the Journal of Hospital Medicine, and principal investigator for Project BOOST. He established the first hospitalist program at a public hospital (Grady Memorial in Atlanta) in 1998, and later became the founding chief of the Division of Hospital Medicine in 2007 at Northwestern University School of Medicine in Chicago. At the University of Kentucky, he established the Center for Health Services Research and the Division of Hospital Medicine in 2014.

At Washington University, Dr. Williams will be tasked with translating the division of hospital medicine’s scholarly work, innovation, and research into practice improvement, focusing on developing new systems of health care delivery that are patient-centered, cost effective, and provide outstanding value.
 

Jordan Messler, MD, SFHM, has been named the new chief medical officer at Glytec (Waltham, Mass.), where he has worked as executive director of clinical practice since 2018. Dr. Messler will be tasked with leading strategy and product development while also supporting efforts in quality care, customer relations, and delivery of products.

Glytec provides insulin management software across the care continuum and is touted as the only cloud-based software provider of its kind. Dr. Messler’s background includes expertise in glycemic management. In addition, he still works as a hospitalist at Morton Plant Hospitalist Group (Clearwater, Fla.).

Dr. Messler is a senior fellow with SHM and is physician editor of SHM’s official blog The Hospital Leader.
 

Tiffani Maycock, DO, recently was named to the Board of Directors for the American Board of Family Medicine. Dr. Maycock is director of the Selma Family Medicine Residency Program at the University of Alabama at Birmingham, where she is an assistant professor in the department of family medicine.

Dr. Maycock helped create hospitalist services at Vaughan Regional Medical Center (Selma, Ala.) – Selma Family Medicine’s primary teaching site – and currently serves as its hospitalist director and on its Medical Executive Committee. She has worked at the facility since 2017.
 

Preetham Talari, MD, SFHM, has been named associate chief of quality safety for the Division of Hospital Medicine at the University of Kentucky’s UK HealthCare (Lexington, Ky.). Dr. Talari is an associate professor of internal medicine in the Division of Hospital Medicine at the UK College of Medicine.

Over the last decade, Dr. Talari’s work in quality, safety, and health care leadership has positioned him as a leader in several UK Healthcare committees and transformation projects. In his role as associate chief, Dr. Talari collaborates with hospital medicine directors, enterprise leadership, and medical education leadership to improve the system’s quality of care.

Dr. Talari is the president of the Kentucky chapter of SHM and is a member of SHM’s Hospital Quality and Patient Safety Committee.
 

Adrian Paraschiv, MD, FHM, is being recognized by Continental Who’s Who as a Trusted Internist and Hospitalist in the field of Medicine in acknowledgment of his commitment to providing quality health care services.

Dr. Paraschiv is a board-certified Internist at Garnet Health Medical Center in Middletown, N.Y. He also serves in an administrative capacity as the Garnet Health Doctors Hospitalist Division’s Associate Program Director. He is also the Director of Clinical Informatics. Dr. Paraschiv is certified as the Epic physician builder in analytics, information technology, and improved documentation.
 

DCH Health System (Tuscaloosa, Ala.) recently selected Capstone Health Services Foundation (Tuscaloosa) and IN Compass Health Inc. (Alpharetta, Ga.) as its joint hospitalist service provider for facilities in Northport and Tuscaloosa. Capstone will provide the physicians, while IN Compass will handle staffing management of the hospitalists, as well as day-to-day operations and calculating quality care metrics. The agreement is slated to begin on Oct. 1, 2021, at Northport Medical Center, and on Nov. 1, 2021, at DCH Regional Medical Center.

Capstone is an affiliate of the University of Alabama and oversees University Hospitalist Group, which currently provides hospitalists at DCH Regional Medical Center. Its partnership with IN Compass includes working together in recruiting and hiring physicians for both facilities.
 

UPMC Kane Medical Center (Kane, Pa.) recently announced the creation of a virtual telemedicine hospitalist program. UPMC Kane is partnering with the UPMC Center for Community Hospitalist Medicine to create this new mode of care.

Telehospitalists will care for UPMC Kane patients using advanced diagnostic technique and high-definition cameras. The physicians will bring expert service to Kane 24 hours per day utilizing physicians and specialists based in Pittsburgh. Those hospitalists will work with local nurse practitioners and support staff and deliver care to Kane patients.
 

Wake Forest Baptist Health (Winston-Salem, N.C.) has launched a Hospitalist at Home program with hopes of keeping patients safe while also reducing time they spend in the hospital. The telehealth initiative kicked into gear at the start of 2021 and considered the first of its kind in the region.

Patients who qualify for the program establish a plan before they leave the hospital. Wake Forest Baptist Health paramedics makes home visits and conducts care with a hospitalist reviewing the visit virtually. Those appointments continue until the patient does not require monitoring.

The impetus of creating the program was the COVID-19 pandemic, however, Wake Forest said it expects to care for between 75-100 patients through Hospitalist at Home at any one time.