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.

On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.

At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.

“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”

The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.

Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.

Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.

These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.

Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.

Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.

“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.

So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.

Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.

“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”

Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.

“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”

Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.

“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.

Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.

Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.

Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.

Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.

A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.

Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.

“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”

Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.

If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.

In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.

Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.

The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.

For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.

This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.

But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.

A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.

“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.

“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”

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

On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.

At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.

“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”

The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.

Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.

Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.

These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.

Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.

Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.

“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.

So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.

Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.

“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”

Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.

“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”

Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.

“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.

Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.

Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.

Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.

Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.

A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.

Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.

“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”

Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.

If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.

In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.

Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.

The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.

For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.

This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.

But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.

A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.

“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.

“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”

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

On a recent Monday morning, a group of preschoolers filed into the gymnasium at Hillside School in the west Chicago suburbs. These 4- and 5-year-olds were the first of more than 200 students to get tested for the coronavirus that day – and every Monday – for the foreseeable future.

At the front of the line, a girl in a unicorn headband and sparkly pink skirt clutched a zip-close bag with her name on it. She pulled out a plastic tube with a small funnel attached. Next, Hillside superintendent Kevin Suchinski led the student to a spot marked off with red tape. Mr. Suchinski coached her how to carefully release – but not “spit” – about a half-teaspoon’s worth of saliva into the tube.

“You wait a second, you build up your saliva,” he told her. “You don’t talk, you think about pizza, hamburgers, French fries, ice cream. And you drop it right in there, OK?”

The results will come back within 24 hours. Any students who test positive are instructed to isolate, and the school nurse and administrative staff carry out contact tracing.

Hillside was among the first in Illinois to start regular testing. Now, almost half of Illinois’ 2 million students in grades K-12 attend schools rolling out similar programs. The initiative is supported by federal funding channeled through the state health department.

Schools in other states – such as Massachusetts, Maryland, New York and Colorado – also offer regular testing; Los Angeles public schools have gone further by making it mandatory.

These measures stand in sharp contrast to the confusion in states where people are still fighting about wearing masks in the classroom and other anti-COVID strategies, places where some schools have experienced outbreaks and even teacher deaths.

Within a few weeks of schools reopening, tens of thousands of students across the United States were sent home to quarantine. It’s a concern because options for K-12 students in quarantine are all over the map – with some schools offering virtual instruction and others providing little or no at-home options.

Mr. Suchinski hopes this investment in testing prevents virus detected at Hillside School from spreading into the wider community – and keeps kids learning.

“What we say to ourselves is: If we don’t do this program, we could be losing instruction because we’ve had to close down the school,” he said.

So far, the parents and guardians of two-thirds of all Hillside students have consented to testing. Mr. Suchinski said the school is working hard to get the remaining families on board by educating them about the importance – and benefit – of regular testing.

Every school that can manage it should consider testing students weekly – even twice a week, if possible, said Becky Smith, PhD. She’s an epidemiologist at the University of Illinois in Urbana-Champaign, which developed the saliva test Hillside and other Illinois schools are using. Smith pointed to several studies – including both peer-reviewed and preliminary research – that suggest rigorous testing and contact tracing are key to keeping the virus at bay in K-12 schools.

“If you’re lucky, you can get away without doing testing, [if] nobody comes to school with a raging infection and takes their mask off at lunchtime and infects everybody sitting at the table with them,” Dr. Smith said. “But relying on luck isn’t what we like to do.”

Julian Hernandez, a Hillside seventh grader, said he feels safer knowing that classmates infected with the virus will be prevented from spreading it to others.

“One of my friends – he got it a couple months ago while we was in school,” Julian recalled. “[He] and his brother had to go back home. ... They were OK. They only had mild symptoms.”

Brandon Muñoz, who’s in the fifth grade, said he’s glad to get tested because he’s too young for the vaccine – and he really doesn’t want to go back to Zoom school.

“Because I wanna really meet more people and friends and just not stay on the computer for too long,” Brandon explained.

Mr. Suchinski said Hillside also improved ventilation throughout the building, installing a new HVAC system and windows with screens in the cafeteria to bring more fresh air in the building.

Regular testing is an added layer of protection, though not the only thing Hillside is relying on: About 90% of Hillside staff are vaccinated, Suchinski said, and students and staffers also wear masks.

Setting up a regular mass-testing program inside a K-12 school takes a good amount of coordination, which Mr. Suchinski can vouch for.

Last school year, Hillside school administrators facilitated the saliva sample collection without outside help. This year, the school tapped funding earmarked for K-12 coronavirus testing to hire COVID testers – who coordinate the collecting, transporting and processing of samples, and reporting results.

A couple of Hillside administrators help oversee the process on Mondays, and also facilitate testing for staff members, plus more frequent testing for a limited group of students: Athletes and children in band and extracurriculars test twice a week because they face greater risks of exposure to the virus from these activities.

Compared with a year ago, COVID testing is now both more affordable and much less invasive, said Mara Aspinall, who studies biomedical testing at Arizona State University. There’s also more help to cover costs.

“The Biden administration has allocated $11 billion to different programs for testing,” Ms. Aspinall said. “There should be no school – public, private or charter – that can’t access that money for testing.”

Creating a mass testing program from scratch is a big lift. But more than half of all states have announced programs to help schools access the money and handle the logistics.

If every school tested every student once a week, the roughly $11 billion earmarked for testing would likely run out in a couple of months. (This assumes $20 to buy and process each test.) Put another way, if a quarter of all U.S. schools tested students weekly, the funds could last the rest of the school year, Ms. Aspinall said.

In its guidance to K-12 schools, updated Aug. 5, the Centers for Disease Control and Prevention does not make a firm recommendation for this surveillance testing.

Instead, the CDC advises schools that choose to offer testing to work with public health officials to determine a suitable approach, given rates of community transmission and other factors.

The agency previously recommended screening at least once a week in all areas experiencing moderate to high levels of community transmission. As of Sept. 21, that included 95% of U.S. counties.

For school leaders looking to explore options, Ms. Aspinall suggests a resource she helped write, which is cited within the CDC guidance to schools: the Rockefeller Foundation’s National Testing Action Plan.

This spring – when Hillside was operating at about half capacity and before the more contagious delta variant took over – the school identified 13 positive cases among students and staffers via its weekly testing program. The overall positivity rate of about half a percent made some wonder if all that testing was necessary.

But Mr. Suchinski said that, by identifying the 13 positive cases, the school perhaps avoided more than a dozen potential outbreaks. Some of the positive cases were among people who weren’t showing symptoms but still could’ve spread the virus.

A couple of weeks into the new school year at Hillside, operating at full capacity, Mr. Suchinski said the excitement is palpable. Nowadays he’s balancing feelings of optimism with caution.

“It is great to hear kids laughing. It’s great to see kids on playgrounds,” Mr. Suchinski said.

“At the same time,” he added, “we know that we’re still fighting against the Delta variant and we have to keep our guard up.”

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

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.

Women with a history of polycystic ovary syndrome (PCOS) are more likely to experience somatic and urogenital symptoms post menopause, but they were no more likely to experience severe hot flashes than were other women with similar characteristics, according to research presented Sept. 24 at the hybrid annual meeting of the North American Menopause Society.

PCOS and vasomotor symptoms are each risk factors for cardiovascular disease, so researchers wanted to find out whether they were linked to one another, which might indicate that they are markers for the same underlying mechanisms that increase heart disease risk. The lack of an association, however, raises questions about how much each of these conditions might independently increase cardiovascular risk.

“Should we take a little more time to truly risk-assess these patients not just with their ASCVD risk score, but take into account that they have PCOS and they’re going through menopause, and how severe their hot flashes are?” asked Angie S. Lobo, MD, an internal medicine specialist at Mayo Clinic in Rochester, Minn., when she discussed her findings in an interview.

The association between PCOS and urogenital symptoms was surprising, Dr. Lobo said, but she said she suspects the reason for the finding may be the self-reported nature of the study.

“If you ask the question, you get the answer,” Dr. Lobo said. ”Are we just not asking the right questions to our patients? And should we be doing this more often? This is an exciting finding because there’s so much room to improve the clinical care of our patients.”

The researchers analyzed data from 3,308 women, ages 45-60, in a cross-sectional study from the Data Registry on the Experiences of Aging, Menopause, and Sexuality (DREAMS). The study occurred at Mayo Clinic locations between May 2015 and December 2019 in Rochester, Minn., in Scottsdale, Ariz., and in Jacksonville, Fla.

The women were an average 53 years old and were primarily White, educated, and postmenopausal. Among the 4.6% of women with a self-reported history of PCOS, 56% of them reported depression symptoms, compared to 42% of women without PCOS. Those with PCOS also had nearly twice the prevalence of obesity – 42% versus 22.5% among women without PCOS – and had a higher average overall score on the Menopause Rating Scale (17.7 vs. 14.7; P < .001).

Although women with PCOS initially had a greater burden of psychological symptoms on the same scale, that association disappeared after adjustment for menopause status, body mass index, depression, anxiety, and current use of hormone therapy. Even after adjustment, however, women with PCOS had higher average scores for somatic symptoms (6.7 vs. 5.6) and urogenital symptoms (5.2 vs. 4.3) than those of women without PCOS (P < .001).

Severe or very severe hot flashes were no more likely in women with a history of PCOS than in the other women in the study.

”The mechanisms underlying the correlation between PCOS and menopause symptoms in the psychological and urogenital symptom domains requires further study, although the well-known association between PCOS and mood disorders may explain the high psychological symptom burden in these women during the menopause transition,” the authors concluded.

Rachael B. Smith, DO, clinical assistant professor of ob.gyn. at the University of Arizona in Phoenix, said she was not surprised to see an association between PCOS and menopause symptoms overall, but she was surprised that PCOS did not correlate with severity of vasomotor symptoms. But Dr. Smith pointed out that the sample size of women with PCOS is fairly small (n = 151).

“Given that PCOS prevalence is about 6%-10%, I feel this association should be further studied to improve our counseling and treatment for this PCOS population,” Dr. Smith, who was not involved in the research, said in an interview. “The take-home message for physicians is improved patient-tailored counseling that takes into account patients’ prior medical history of PCOS.”

Although it will require more research to find out, Dr. Smith said she suspects that PCOS and vasomotor symptoms are additive risk factors for cardiovascular disease. She also noted that the study is limited by the homogeneity of the study population.

The research was funded by the National Institutes of Health. Dr. Lobo and Dr. Smith had no disclosures.

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

The risk of developing psoriatic arthritis (PsA) may increase as the severity of psoriasis increases, results from a large analysis of U.S. medical records demonstrated.

Factors that predict the development of psoriasis in patients with psoriasis include nail, inverse, and scalp psoriasis; family history of PsA; as well as severity of skin disease. And like psoriasis, “PsA is associated with a multitude of comorbidities, including cardiovascular disease, metabolic syndrome, Crohn’s disease, obesity, diabetes, uveitis, anxiety, and depression, with correspondingly higher healthcare utilization and direct healthcare costs,” wrote corresponding author Joseph F. Merola, MD, MMSc, and colleagues. The study was published online in the Journal of the American Academy of Dermatology. “Timely and accurate diagnosis of PsA is important for improved patient outcomes and appropriate disease management and may prevent prolonged inflammation that leads to structural joint damage and worsening physical function,” they added.

The mean time of onset of PsA among patients with psoriasis who develop PsA is 10 years after the first signs of psoriasis appear. An estimated 20%-30% of patients with psoriasis have a concurrent diagnosis of PsA, and the annual incidence of PsA has been reported to be 2.7 cases per 100 patients with psoriasis. While previous studies have suggested that a higher incidence of PsA is associated with greater disease severity, there are limited data in the United States on the topic.

For the study, Dr. Merola, a dermatologist and rheumatologist who directs the Center for Skin and Related Musculoskeletal Diseases at Brigham and Women’s Hospital, Boston, and his colleagues drew from the Optum EHR database to identify adult patients newly diagnosed with psoriasis between Jan. 1, 2009, and March 31, 2019. Patients diagnosed with psoriasis or PsA prior to the index date were excluded from the analysis for evaluation of incidence but included for evaluation of prevalence. The patients were followed from the index date until the earliest PsA event, death, or end of study or follow-up, whichever came first. The researchers calculated the incidence of PsA among adults with psoriasis as the number of incident PsA events divided by the number of patient-years (PY) at risk, which was reported as the raw incidence per 100 psoriasis PY. They calculated the prevalence of PsA among adults with psoriasis as “the number of prevalent PsA events divided by the number of eligible patients with [psoriasis] and reported by years in the follow-up period,” which was a median of 3.7 years.

A total of 114,868 patients were included in the analysis. At baseline, their mean age was 54 years, 53% were female, 89% were White, and 39% were obese. Most patients (102,553) were on nonsystemic agents during the year after their psoriasis diagnosis, while 6,345 were on nonbiologic systemic therapies (NBSTs) and 5,970 were on biologics. The researchers classified patients as having mild psoriasis if they were taking nonsystemic agents, moderate disease if they were taking NBSTs, or severe disease if they were taking biologics.

The overall incidence rate of PsA was 2.9 events per 100 PY and increased by severity of disease. When calculated by severity, the incidence was 2.1 events per 100 PY for patients with mild psoriasis, 9.9 events per 100 PY for those with moderate psoriasis, and 17.6 events per 100 PY for those with severe psoriasis.

When the researchers excluded patients diagnosed with PsA up to 1 year after being diagnosed with psoriasis, the overall incidence was lower (1.7 events per 100 PY), with similar trends for categories of treatment severity. Specifically, the incidence was 1.5, 3.1, and 4.7 events per 100 PY among those with mild, moderate, and severe psoriasis, based on their treatment groups, respectively.

Among the 120,523 patients with psoriasis who were eligible for the assessment of prevalence of PsA, the overall 5-year prevalence of PsA was 14.2% and rose with severity of disease: 9.9% in patients with mild psoriasis, 35% in patients with moderate psoriasis, and 54.9% in patients with severe psoriasis.

Other predictors of PsA onset for both index-date cohorts included weight of 90 kg or greater, female gender, age group 25-65 years (compared with the age group over 65 years), and rheumatic risk factors such as wrist pain and unspecified rheumatism.

“To ensure timely diagnosis and treatment for management and prevention of PsA, patients with [psoriasis] should be routinely screened, especially those with more severe disease and other PsA risk factors,” the authors advised.

Dr. Merola and colleagues acknowledged certain limitations of their analysis, including the potential for selection bias and its reliance on EHR data which “lacked clinical measures of disease severity such as the PASI, and data on BSA were not available for all study participants; therefore, treatment groups were used as a surrogate for disease severity,” they wrote. “As a result, some patients may have been miscategorized, especially patients with severe disease who were untreated.”

The study was sponsored by Novartis. Dr. Merola disclosed that he is a consultant and/or investigator for Merck, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Celgene, Sanofi, Regeneron, Arena, Sun Pharmaceuticals, Biogen, Pfizer, EMD Serono, Avotres, and LEO Pharma. Four authors are Novartis employees, or employees of a consulting company that provides services to Novartis; and another author disclosed serving as an investigator or consultant for several pharmaceutical companies, including Novartis.

[email protected]

The 34% reduction in disease recurrence for adjuvant atezolizumab in PD-L1 tumor cells of at least 50% stage II-IIIA patients in the IMpower010 clinical trial, may change the standard of care for early-stage non–small cell lung cancer (NSCLC), according to Enriqueta Felip, MD, the head of thoracic and head and neck cancer unit at Vall d’Hebron Institute of Oncology, Hospital, Barcelona.

IMpower010 is the first positive randomized phase 3 study to show significant disease-free survival (DFS) improvement with adjuvant cancer immunotherapy (atezolizumab, anti–programmed death–ligand 1, and platinum-based chemotherapy) in this population, Dr. Felip said in a presentation at the 2021 European Society for Medical Oncology Congress on Sept. 20 (abstract LBA9).

High unmet need

Up to 60% of patients with stage I-III NSCLC still experience disease relapse despite having received treatment, Dr. Felip said. IMpower010 included 1,280 patients who received up to four cycles of chemotherapy (cisplatin with pemetrexed, gemcitabine, docetaxel, or vinorelbine) after completely resected stage IB-IIIA NSCLC. Patients were randomized to open label to atezolizumab (1,200 mg every 21 days for 16 cycles or best supportive care (BSC). The primary endpoint of investigator-assessed DFS in the stage II-IIIA population (n = 1,005) was stratified according to three groups: PD-L1 tumor cells of at least 1% (stage II-IIIA), all-randomized (stage II-IIIA) and intention-to-treat (stage IB-IIIA).

Median disease-free survival in PD-L1 tumor cells of at least 1% was not estimated in the atezolizumab group and was 35.3 months in the BSC group (95% CI, 29.0 to NE). In the all-randomized group, median DFS was 42.3 months in the atezolizumab group (95% CI, 36.0 to NE) and 35.3 months in the BSC group (95% CI, 30.4-46.4) with a stratified hazard ratio of 0.79 (95% CI, 0.64-0.96; P = .02). In the intent-to-treat population, median DFS was not evaluable in the atezolizumab group and 37.2 months in the BSC group (95% CI, 31.6 to NE) with a hazard ratio of 0.81 (95% CI, 0.67-0.99; P = .04).
 

DFS hazard ratio 0.43 in TC ≥50% group

Looking at DFS by PD-L1 status in the population with and without known EGFR/ALK+ disease, Dr. Felip said that the hazard ratio for the tumor cells of at least 50% group (n = 229) was 0.43 (95% CI, 0.27-0.68), as compared with 0.87 (95% CI, 0.60-1.26) for the tumor cells 1%-49% group. With EGFR/ALK+ patients excluded, the respective HRs were similar (0.43/0.82). Considering DFS events including only disease recurrence, disease incidence was 29.4%/44.7% in the atezolizumab and BSC groups, respectively for those with PD-L1 tumor cells of at least 1%. The same pattern of atezolizumab benefit persisted in the all-randomized and intent-to-treat groups.

An assessment according to regions of relapse (locoregional only, distant only, locoregional and distant, CNS only, second primary lung) revealed no differences in the three groups. Analysis of time from randomization to relapse revealed regional differences in the PD-L1 tumor cells of at least 1% group with a median time to any relapse of 17.6 months in the atezolizumab group and 10.9 months in the BSC group. Time from randomization to relapse was generally similar for atezolizumab and best supportive care in the all randomized and intent-to-treat groups (about 11-12 months).

“The greatest magnitude of disease-free survival benefit was observed in the PD-L1 tumor cell of at least 50% population with a hazard ratio of 0.43,” Dr. Felip said. In a post hoc analysis excluding patients with known EFGR/ALK with NSCLC, she said that hazard ratios were numerically improved in most PD-L1 subgroups. Postrelapse cancer immunotherapies were used at a higher rate in the BSC arm of the trial. “Longer-term follow-up is warranted and may reveal differences in relapse patterns and treatment options.
 

Playing with the immune system

Benjamin Besse, MD, director of oncology and chair of the EORTC Lung Group at Paris-Saclay University, acknowledged the disease-free survival benefit with atezolizumab in IMpower010 and underscored that adjuvant immunotherapy has been changing treatment in resected cancers across tumor types (i.e., melanoma, renal cell carcinoma, NSCLC). He voiced some concerns, including the absence of benefit in PD-L1 less than 1%, pneumonectomy and EGFRmut/ALK+ patients, and generally the potential “when you play with the immune system for there to be a dark side too.” Dr. Besse said delayed side effects in 43.2% of patients , citing a recent report of chronic, mostly grade 1-2 immune-related adverse events following (>12 weeks after discontinuation) adjuvant anti–PD-1 therapy for high-risk resected melanoma. He mentioned, however, that the rate of second primary lung tumors in the atezolizumab group (1.4%) was lower than in the BSC group (2.6%), with generally similar rates between immuno- and nonimmunotherapies in melanoma and breast cancer trials.

“IMpower 010 is the first adjuvant study establishing immune checkpoint blockade as a new standard of care. We need to cure more, not to delay relapse,” he said. The optimal population for treatment is still yet to be defined, as is the best perioperative strategy, Dr. Besse added. “If approved I would prescribe adjuvant atezolizumab ... until I see the overall survival curves.”

IMpower010 was funded by–F. Hoffmann-La Roche. Dr. Felip disclosed numerous financial interests, including having received financial support from F. Hoffmann–La Roche, AstraZeneca, Amgen, and Merck, among other pharmaceutical companies.

The 34% reduction in disease recurrence for adjuvant atezolizumab in PD-L1 tumor cells of at least 50% stage II-IIIA patients in the IMpower010 clinical trial, may change the standard of care for early-stage non–small cell lung cancer (NSCLC), according to Enriqueta Felip, MD, the head of thoracic and head and neck cancer unit at Vall d’Hebron Institute of Oncology, Hospital, Barcelona.

IMpower010 is the first positive randomized phase 3 study to show significant disease-free survival (DFS) improvement with adjuvant cancer immunotherapy (atezolizumab, anti–programmed death–ligand 1, and platinum-based chemotherapy) in this population, Dr. Felip said in a presentation at the 2021 European Society for Medical Oncology Congress on Sept. 20 (abstract LBA9).

High unmet need

Up to 60% of patients with stage I-III NSCLC still experience disease relapse despite having received treatment, Dr. Felip said. IMpower010 included 1,280 patients who received up to four cycles of chemotherapy (cisplatin with pemetrexed, gemcitabine, docetaxel, or vinorelbine) after completely resected stage IB-IIIA NSCLC. Patients were randomized to open label to atezolizumab (1,200 mg every 21 days for 16 cycles or best supportive care (BSC). The primary endpoint of investigator-assessed DFS in the stage II-IIIA population (n = 1,005) was stratified according to three groups: PD-L1 tumor cells of at least 1% (stage II-IIIA), all-randomized (stage II-IIIA) and intention-to-treat (stage IB-IIIA).

Median disease-free survival in PD-L1 tumor cells of at least 1% was not estimated in the atezolizumab group and was 35.3 months in the BSC group (95% CI, 29.0 to NE). In the all-randomized group, median DFS was 42.3 months in the atezolizumab group (95% CI, 36.0 to NE) and 35.3 months in the BSC group (95% CI, 30.4-46.4) with a stratified hazard ratio of 0.79 (95% CI, 0.64-0.96; P = .02). In the intent-to-treat population, median DFS was not evaluable in the atezolizumab group and 37.2 months in the BSC group (95% CI, 31.6 to NE) with a hazard ratio of 0.81 (95% CI, 0.67-0.99; P = .04).
 

DFS hazard ratio 0.43 in TC ≥50% group

Looking at DFS by PD-L1 status in the population with and without known EGFR/ALK+ disease, Dr. Felip said that the hazard ratio for the tumor cells of at least 50% group (n = 229) was 0.43 (95% CI, 0.27-0.68), as compared with 0.87 (95% CI, 0.60-1.26) for the tumor cells 1%-49% group. With EGFR/ALK+ patients excluded, the respective HRs were similar (0.43/0.82). Considering DFS events including only disease recurrence, disease incidence was 29.4%/44.7% in the atezolizumab and BSC groups, respectively for those with PD-L1 tumor cells of at least 1%. The same pattern of atezolizumab benefit persisted in the all-randomized and intent-to-treat groups.

An assessment according to regions of relapse (locoregional only, distant only, locoregional and distant, CNS only, second primary lung) revealed no differences in the three groups. Analysis of time from randomization to relapse revealed regional differences in the PD-L1 tumor cells of at least 1% group with a median time to any relapse of 17.6 months in the atezolizumab group and 10.9 months in the BSC group. Time from randomization to relapse was generally similar for atezolizumab and best supportive care in the all randomized and intent-to-treat groups (about 11-12 months).

“The greatest magnitude of disease-free survival benefit was observed in the PD-L1 tumor cell of at least 50% population with a hazard ratio of 0.43,” Dr. Felip said. In a post hoc analysis excluding patients with known EFGR/ALK with NSCLC, she said that hazard ratios were numerically improved in most PD-L1 subgroups. Postrelapse cancer immunotherapies were used at a higher rate in the BSC arm of the trial. “Longer-term follow-up is warranted and may reveal differences in relapse patterns and treatment options.
 

Playing with the immune system

Benjamin Besse, MD, director of oncology and chair of the EORTC Lung Group at Paris-Saclay University, acknowledged the disease-free survival benefit with atezolizumab in IMpower010 and underscored that adjuvant immunotherapy has been changing treatment in resected cancers across tumor types (i.e., melanoma, renal cell carcinoma, NSCLC). He voiced some concerns, including the absence of benefit in PD-L1 less than 1%, pneumonectomy and EGFRmut/ALK+ patients, and generally the potential “when you play with the immune system for there to be a dark side too.” Dr. Besse said delayed side effects in 43.2% of patients , citing a recent report of chronic, mostly grade 1-2 immune-related adverse events following (>12 weeks after discontinuation) adjuvant anti–PD-1 therapy for high-risk resected melanoma. He mentioned, however, that the rate of second primary lung tumors in the atezolizumab group (1.4%) was lower than in the BSC group (2.6%), with generally similar rates between immuno- and nonimmunotherapies in melanoma and breast cancer trials.

“IMpower 010 is the first adjuvant study establishing immune checkpoint blockade as a new standard of care. We need to cure more, not to delay relapse,” he said. The optimal population for treatment is still yet to be defined, as is the best perioperative strategy, Dr. Besse added. “If approved I would prescribe adjuvant atezolizumab ... until I see the overall survival curves.”

IMpower010 was funded by–F. Hoffmann-La Roche. Dr. Felip disclosed numerous financial interests, including having received financial support from F. Hoffmann–La Roche, AstraZeneca, Amgen, and Merck, among other pharmaceutical companies.

The 34% reduction in disease recurrence for adjuvant atezolizumab in PD-L1 tumor cells of at least 50% stage II-IIIA patients in the IMpower010 clinical trial, may change the standard of care for early-stage non–small cell lung cancer (NSCLC), according to Enriqueta Felip, MD, the head of thoracic and head and neck cancer unit at Vall d’Hebron Institute of Oncology, Hospital, Barcelona.

IMpower010 is the first positive randomized phase 3 study to show significant disease-free survival (DFS) improvement with adjuvant cancer immunotherapy (atezolizumab, anti–programmed death–ligand 1, and platinum-based chemotherapy) in this population, Dr. Felip said in a presentation at the 2021 European Society for Medical Oncology Congress on Sept. 20 (abstract LBA9).

High unmet need

Up to 60% of patients with stage I-III NSCLC still experience disease relapse despite having received treatment, Dr. Felip said. IMpower010 included 1,280 patients who received up to four cycles of chemotherapy (cisplatin with pemetrexed, gemcitabine, docetaxel, or vinorelbine) after completely resected stage IB-IIIA NSCLC. Patients were randomized to open label to atezolizumab (1,200 mg every 21 days for 16 cycles or best supportive care (BSC). The primary endpoint of investigator-assessed DFS in the stage II-IIIA population (n = 1,005) was stratified according to three groups: PD-L1 tumor cells of at least 1% (stage II-IIIA), all-randomized (stage II-IIIA) and intention-to-treat (stage IB-IIIA).

Median disease-free survival in PD-L1 tumor cells of at least 1% was not estimated in the atezolizumab group and was 35.3 months in the BSC group (95% CI, 29.0 to NE). In the all-randomized group, median DFS was 42.3 months in the atezolizumab group (95% CI, 36.0 to NE) and 35.3 months in the BSC group (95% CI, 30.4-46.4) with a stratified hazard ratio of 0.79 (95% CI, 0.64-0.96; P = .02). In the intent-to-treat population, median DFS was not evaluable in the atezolizumab group and 37.2 months in the BSC group (95% CI, 31.6 to NE) with a hazard ratio of 0.81 (95% CI, 0.67-0.99; P = .04).
 

DFS hazard ratio 0.43 in TC ≥50% group

Looking at DFS by PD-L1 status in the population with and without known EGFR/ALK+ disease, Dr. Felip said that the hazard ratio for the tumor cells of at least 50% group (n = 229) was 0.43 (95% CI, 0.27-0.68), as compared with 0.87 (95% CI, 0.60-1.26) for the tumor cells 1%-49% group. With EGFR/ALK+ patients excluded, the respective HRs were similar (0.43/0.82). Considering DFS events including only disease recurrence, disease incidence was 29.4%/44.7% in the atezolizumab and BSC groups, respectively for those with PD-L1 tumor cells of at least 1%. The same pattern of atezolizumab benefit persisted in the all-randomized and intent-to-treat groups.

An assessment according to regions of relapse (locoregional only, distant only, locoregional and distant, CNS only, second primary lung) revealed no differences in the three groups. Analysis of time from randomization to relapse revealed regional differences in the PD-L1 tumor cells of at least 1% group with a median time to any relapse of 17.6 months in the atezolizumab group and 10.9 months in the BSC group. Time from randomization to relapse was generally similar for atezolizumab and best supportive care in the all randomized and intent-to-treat groups (about 11-12 months).

“The greatest magnitude of disease-free survival benefit was observed in the PD-L1 tumor cell of at least 50% population with a hazard ratio of 0.43,” Dr. Felip said. In a post hoc analysis excluding patients with known EFGR/ALK with NSCLC, she said that hazard ratios were numerically improved in most PD-L1 subgroups. Postrelapse cancer immunotherapies were used at a higher rate in the BSC arm of the trial. “Longer-term follow-up is warranted and may reveal differences in relapse patterns and treatment options.
 

Playing with the immune system

Benjamin Besse, MD, director of oncology and chair of the EORTC Lung Group at Paris-Saclay University, acknowledged the disease-free survival benefit with atezolizumab in IMpower010 and underscored that adjuvant immunotherapy has been changing treatment in resected cancers across tumor types (i.e., melanoma, renal cell carcinoma, NSCLC). He voiced some concerns, including the absence of benefit in PD-L1 less than 1%, pneumonectomy and EGFRmut/ALK+ patients, and generally the potential “when you play with the immune system for there to be a dark side too.” Dr. Besse said delayed side effects in 43.2% of patients , citing a recent report of chronic, mostly grade 1-2 immune-related adverse events following (>12 weeks after discontinuation) adjuvant anti–PD-1 therapy for high-risk resected melanoma. He mentioned, however, that the rate of second primary lung tumors in the atezolizumab group (1.4%) was lower than in the BSC group (2.6%), with generally similar rates between immuno- and nonimmunotherapies in melanoma and breast cancer trials.

“IMpower 010 is the first adjuvant study establishing immune checkpoint blockade as a new standard of care. We need to cure more, not to delay relapse,” he said. The optimal population for treatment is still yet to be defined, as is the best perioperative strategy, Dr. Besse added. “If approved I would prescribe adjuvant atezolizumab ... until I see the overall survival curves.”

IMpower010 was funded by–F. Hoffmann-La Roche. Dr. Felip disclosed numerous financial interests, including having received financial support from F. Hoffmann–La Roche, AstraZeneca, Amgen, and Merck, among other pharmaceutical companies.