Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

When possible, diagnostic tests to determine the cause of a first stroke or transient ischemic attack (TIA) should be completed within 48 hours after symptom onset, the American Heart Association/American Stroke Association said in an updated clinical practice guideline.

“It is critically important to understand the best ways to prevent another stroke once someone has had a stroke or a TIA,” Dawn O. Kleindorfer, MD, chair of the guideline writing group, said in a news release.

“If we can pinpoint the cause of the first stroke or TIA, we can tailor strategies to prevent a second stroke,” said Dr. Kleindorfer, professor and chair, department of neurology, University of Michigan, Ann Arbor.

The updated guideline was published online May 24, 2021, in Stroke.

“The secondary prevention of stroke guideline is one of the ASA’s ‘flagship’ guidelines, last updated in 2014,” Dr. Kleindorfer said.

The update includes “a number of changes to the writing and formatting of this guideline to make it easier for professionals to understand and locate information more quickly, ultimately greatly improving patient care and preventing more strokes in our patients,” she noted.
 

Let pathogenic subtype guide prevention

For patients who have survived a stroke or TIA, management of vascular risk factors, particularly hypertension, diabetes, cholesterol/triglyceride levels, and smoking cessation, are key secondary prevention tactics, the guideline said.

Limiting salt intake and/or following a heart-healthy Mediterranean diet is also advised, as is engaging in at least moderate-intensity aerobic activity for at least 10 minutes four times a week or vigorous-intensity aerobic activity for at least 20 minutes twice a week.

“Approximately 80% of strokes can be prevented by controlling blood pressure, eating a healthy diet, engaging in regular physical activity, not smoking and maintaining a healthy weight,” Amytis Towfighi, MD, vice chair of the guideline writing group and director of neurologic services, Los Angeles County Department of Health Services, noted in the release.

For health care professionals, the guideline said specific recommendations for secondary prevention often depend on the ischemic stroke/TIA subtype. “Therefore, new in this guideline is a section describing recommendations for the diagnostic workup after ischemic stroke, to define ischemic stroke pathogenesis (when possible), and to identify targets for treatment to reduce the risk of recurrent ischemic stroke. Recommendations are now segregated by pathogenetic subtype,” the guideline stated.

Among the recommendations:

• Use multidisciplinary care teams to personalize care for patients and employ shared decision-making with the patient to develop care plans that incorporate a patient’s wishes, goals, and concerns.
• Screen for  and initiate anticoagulant drug therapy to reduce recurrent events.
• Prescribe antithrombotic therapy, including antiplatelets or anticoagulants, in the absence of contraindications. The guideline noted that the combination of antiplatelets and anticoagulation is typically not recommended for preventing second strokes and that dual antiplatelet therapy (DAPT) – taking  along with a second medication to prevent blood clotting – is recommended in the short term and only for specific patients: those with early arriving minor stroke and high-risk TIA or severe symptomatic stenosis.
• Consider  or carotid artery stenting for select patients with narrowing of carotid arteries.
• Aggressive medical management of risk factors and short-term DAPT are preferred for patients with severe intracranial stenosis thought to be the cause of first stroke or TIA.
• In some patients, it’s reasonable to consider percutaneous closure of .

The guideline is accompanied by a systematic review and meta-analysis regarding the benefits and risks of dual antiplatelet versus single antiplatelet therapy for secondary stroke prevention. The authors conclude that DAPT may be appropriate for select patients.

“Additional research is needed to determine: the optimal timing of starting treatment relative to the clinical event; the optimal duration of DAPT to maximize the risk-benefit ratio; whether additional populations excluded from POINT and CHANCE [two of the trials examined], such as those with major stroke, may also benefit from early DAPT; and whether certain genetic profiles eliminate the benefit of early DAPT,” concluded the reviewers, led by Devin Brown, MD, University of Michigan.

The guideline was prepared on behalf of and approved by the AHA Stroke Council’s Scientific Statements Oversight Committee on Clinical Practice Guidelines. The writing group included representatives from the AHA/ASA and the American Academy of Neurology. The guideline has been endorsed by the American Association of Neurological Surgeons/Congress of Neurological Surgeons and the Society of Vascular and Interventional Neurology. It has also been affirmed by the AAN as an educational tool for neurologists.

The research had no commercial funding.

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

The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement. 

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement. 

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.

Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.

Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”

In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”

The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.

The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.

California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.

“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
 

‘Discrimination must end’

Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.

The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.

In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.

The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.

Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm. 

The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.

However, the APA and other clinician groups said there is no question of harm.

“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement. 

APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.

No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.

“If upheld, the litigation will likely have significant impacts beyond the parties involved,” Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”

This article first appeared on Medscape.com.

As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.

“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”

Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”

The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.  

The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis. 

The boxed warning on the label has also been revised to include this information.

For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.

Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.  

Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.

According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.

PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.

The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.

The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died. 

Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.

The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).

Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.

During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.

The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.

Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.

Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.

Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.

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

The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.  

The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis. 

The boxed warning on the label has also been revised to include this information.

For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.

Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.  

Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.

According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.

PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.

The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.

The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died. 

Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.

The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).

Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.

During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.

The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.

Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.

Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.

Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.

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

The risk for serious liver injury with obeticholic acid (Ocaliva, Intercept Pharmaceuticals) has prompted the U.S. Food and Drug Administration to restrict its use in patients with primary biliary cholangitis (PBC) and advanced cirrhosis.  

The agency has added a new contraindication to the obeticholic acid prescribing information and patient medication guide stating that the drug should not be used in patients with PBC and advanced cirrhosis. 

The boxed warning on the label has also been revised to include this information.

For patients with PBC who do not have advanced cirrhosis, the FDA believes the benefits of Ocaliva outweigh the risks, based on the original clinical trials.

Five years ago, the FDA granted accelerated approval to obeticholic acid in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA, or as a monotherapy in adults who cannot tolerate UDCA.  

Since then, the FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure in patients with PBC and cirrhosis who were taking obeticholic acid at recommended doses.

According to the FDA, 18 of the cases happened in patients with PBC and compensated cirrhosis who experienced liver injury that led to decompensation. Ten of these patients had evidence or suspicion of portal hypertension at baseline; in the other eight patients, it was unclear whether portal hypertension was present.

PBC was not expected to progress rapidly in these patients, yet they experienced accelerated clinical deterioration within months of starting obeticholic acid, the FDA said.

The median time to liver decompensation after initiating treatment was 4 months (range, 2 weeks to 10 months). Four patients with PBC and compensated cirrhosis needed a liver transplant within 1.3 years after starting obeticholic acid, and one patient died from liver failure.

The other seven cases of serious liver injury occurred in patients with PBC and decompensated cirrhosis, two of whom died. 

Although there was a temporal relationship between starting obeticholic acid and liver injury, it is difficult to distinguish a drug-induced effect from disease progression in the patients with advanced baseline liver disease, the FDA cautioned.

The median time to a new decompensation event after starting the drug was 2.5 months (range, 10 days to 8 months).

Before starting obeticholic acid, clinicians should determine whether a patient with PBC has advanced cirrhosis as the drug is now contraindicated in these patients, the FDA said.

During obeticholic acid treatment, patients should be routinely monitored for progression of PBC with laboratory and clinical assessments to determine whether the drug needs to be discontinued.

The medication should be permanently discontinued in patients with cirrhosis who progress to advanced cirrhosis.

Patients should also be monitored for clinically significant liver-related adverse reactions that may manifest as development of acute-on-chronic liver disease with nausea, vomiting, diarrhea, jaundice, scleral icterus, and/or dark urine.

Obeticholic acid should be stopped permanently in any patient who develops these symptoms, the FDA advised.

Health care professionals are encouraged to report adverse events or side effects related to the use of obeticholic acid to MedWatch, FDA’s adverse event reporting site.

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

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

[email protected]

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

[email protected]

A single treatment with a commercially available 1,060-nm diode laser that features integrated skin cooling was found to be safe and effective for the reduction of unwanted fat of the abdomen and flanks, a small single-center study showed.

Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.

“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.

Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm² on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.

After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.

In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.

Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.

The work won a “best of session early career-clinical” abstract award from the ASLMS.

The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.

[email protected]

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

The long-term benefits of endocrine therapy in premenopausal breast cancer appear to differ according to whether patients are categorized as high or low molecular risk using the 70-gene signature (MammaPrint).

Based upon data from patients who had participated in the Stockholm tamoxifen (STO-5) trial, high-risk patients significantly benefited from goserelin treatment, whereas low-risk patients benefited more from tamoxifen treatment when compared with no endocrine therapy.

“Goserelin, tamoxifen, and the combination of the two, reduced the 20-year risk of distant occurrences and fatal breast cancer, compared to no endocrine therapy,” Annelie Johansson, MSc, said at the European Society for Medical Oncology: Breast Cancer virtual meeting.

“Our findings indicate that the long-term endocrine therapy benefit in premenopausal patients is influenced by molecular risk classification and thus tumor characteristics,” she added.

Ms. Johansson, a postdoctoral researcher in genomic breast cancer at the Karolinska Institutet in Stockholm, reported the results of the analysis as a late-breaking abstract at the meeting.

“I think this is an innovative translational study trying to use the multigene assay results to look at differential endocrine therapy effects,” said Prudence Francis, MD, the invited discussant for study.

However, there are relatively few patients in the various subgroups being tested, she added. “We’ve also got short duration of tamoxifen, only 2 years, we’ve got prior chemotherapy in some patients and absence of HER2 therapy, all of which might influence outcomes.”

As a result, Dr. Francis, who is head of medical oncology at the Peter MacCallum Cancer Centre and a consultant Medical Oncologist at St. Vincent’s Hospital Melbourne, called the findings purely “hypothesis generating.”
 

Study details and results

The analysis was based on data from the STO-5 trial, which had recruited just over 900 patients between 1990 and 1997. Patients were stratified according to their lymph node status and some received chemotherapy with or without locoregional radiotherapy before being randomized to one of four study arms: goserelin alone, tamoxifen alone, the combination of the two, or no endocrine therapy.

Ms. Johansson noted that they were able to obtain the primary tumor blocks from 729 patients in the past year, of whom 610 were estrogen receptor positive. The analysis according to the 70-gene signature was then based on data from 465 patients: 131 had been treated with goserelin, 105 with tamoxifen, 120 with both, and 109 had received no endocrine treatment.

We have complete 20-year follow-up from high-quality Swedish National registries,” Ms. Johansson said, observing that the median age in the trial was 46 years.

Before stratifying patients into high and low risk using the 70-gene signature, the risk for having a distant recurrence, compared with no endocrine therapy was reduced by 52% with goserelin (hazard ratio, .48), 41% with tamoxifen (HR, 0.59), and 33% with both in combination (HR, 0.67).

After stratification, however, goserelin was associated with a 78% reduction of distant recurrence versus no endocrine treatment in high-risk patients (HR, 0.22) and a 20% reduction in low-risk patients (HR, 0.80).

Results in high- and low-risk patients with tamoxifen versus no endocrine treatment were a respective 31% reduction (HR, 0.69) and 62% reduction (HR, 0.38), and a respective 36% (HR, 0.64) and 28% (HR, 0.72) for the combination.

A further analysis was performed to compare between the active treatment arms, and this suggested a greater benefit of goserelin in patients at high risk when compared with both tamoxifen (HR, 0.30) and the combination (HR, 0.33).

Dr. Francis commented: “it is a bit surprising to find that goserelin appeared to be also better than the combination,” and it is something that the research team is looking into.

“One hypothesis might be if you look how the different treatments are working,” Ms. Johansson said. “Goserelin is very efficient in lowering the estrogen levels in premenopausal patients, suppressing the ovarian production of estrogen whereas tamoxifen can act both as an antagonist and agonist.

“So, we are thinking that maybe the addition of tamoxifen, with the agonistic properties of tamoxifen, might then make the goserelin not as efficient. But that’s of course, just a hypothesis right now and we need to look into this further,” she said.

The work was funded by The Swedish Research Council (Vetenskapsrådet), The Swedish Research Council for Health, Working life and Welfare, and the Swedish Cancer Society (Cancerfonden). Ms. Johansson had no personal disclosures; one of the coauthors was a coinventor of MammaPrint. Dr. Francis disclosed receiving travel support for overseas lectures from Ipsen and Novartis and acting as a medical oncology editor for Elsevier.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

Many Mohs surgeons are struggling on the job, and women seem to be especially vulnerable, a new survey suggests.

In a measurement of well-being, 40% of members of the American College of Mohs

Surgery (ACMS) who responded to the survey – and 52% of women – scored at a level considered “at-risk” for adverse outcomes, such as poor quality of life.

“I didn’t think the numbers were going to be that high,” said study author Kemi O. Awe, MD, PhD, a dermatology resident at the University of Alabama at Birmingham, especially in light of Mohs surgery’s reputation as being an especially desirable field in dermatology. She presented the findings at the annual meeting of the ACMS.

Dr. Awe, who hopes to become a Mohs surgeon herself, said in an interview that she launched the study in part to understand how colleagues are faring. “Dermatology is known as a specialty that has a good lifestyle and less stress, but the rate of burnout is actually going up.”

For the study, Dr. Awe and colleagues sent a survey to ACMS members between October and December 2020. The 91 respondents had an average age of 46, and 58% were male. Most practiced in academic facilities (56%), while the rest worked in private practice (39%) or multispecialty (4%) practices. Almost all (89%) were married or in partnerships.

The survey calculated scores on the expanded Physician Well Being Index, a validated tool for measuring physician distress. Forty percent of 68 respondents to this part of the survey got a score of 3 or higher, which the study describes as “a threshold for respondents who are ‘at-risk’ of adverse outcomes such as poor quality of life, depression, and a high level of fatigue.”

Women were more likely to be considered at risk (52%) than men (28%). “This isn’t different than what’s already out there: Female physicians are more likely to be burned out compared to men,” Dr. Awe said.

Compared with their male counterparts, female Mohs surgeons were more likely to say that time at work, malpractice concerns, insurance reimbursement, and compensation structure negatively affected their well-being (P ≤ .05).

It’s unclear whether there’s a well-being gender gap among dermatologists overall, however. Dr. Awe highlighted a 2019 survey of 108 dermatologists that found no significant difference in overall burnout between men and women – about 42% of both genders reported symptoms. But the survey did find that “dermatologists with children living at home had significantly higher levels of burnout,” with a P value of .03.

Dr. Awe said the findings offer insight into what to look out for when pursuing a career as a Mohs surgeon. “There’s potentially excess stress about being a Mohs surgeon,” she said, although the field also has a reputation as being fulfilling and rewarding.

In an interview, Stanford (Calif.) University dermatologist Zakia Rahman, MD, praised the study and said it “certainly provides a framework to address professional fulfillment amongst Mohs surgeons.”

For now, dermatologists can focus on strategies that can reduce burnout in the field, Sailesh Konda, MD, a Mohs surgeon at the Univeristy of Florida, Gainesville, said in an interview. Dr. Konda highlighted a report published in 2020 that, he said, "recommended focusing on incremental changes that help restore autonomy and control over work, connecting with colleagues within dermatology and the broader medical community, developing self-awareness and recognition of a perfectionist mindset, and restoring meaning and joy to patient care.”*

No funding is reported for the study. Dr. Awe, Dr. Rahman, and Dr. Konda have no relevant disclosures.

*This story was updated on June 2 for clarity.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.

Converge 2021 session

LAMA’s DRAMA: Left AMA – Documentation and Rules of AMA

Presenter

Venkatrao Medarametla, MD, SFHM

Session summary

Most hospitalists equate LAMA (left against medical advice) patients with noncompliance and stop at that. During the recent SHM Converge conference session on LAMA, Dr. Venkatrao Medarametla, medical director for hospital medicine at Baystate Medical Center, Springfield, Mass., delved into the etiology and pathophysiology of LAMA discharges.

According to Dr. Medarametla, LAMA accounts for 1.4% of all discharges amounting to more than 500,000 discharges per year nationwide. LAMA discharges are at high risk for readmissions (20%-40% higher), have longer length of stay on readmission, higher morbidity and mortality (10% higher), and result in higher costs of care (56% higher).

The reasons for LAMA discharges could be broadly divided into patient and provider factors. Patient factors include refusal to wait for administrative delays, extenuating domestic and social concerns, conflicts with care providers, disagreement with providers’ judgment of health status, mistrust of the health system, substance dependence with inadequate treatment for withdrawal, patient’s perception of respect, stereotyping or stigma, and even ambiance and diet at the hospital.

Provider factors include conflict with the patient, concerns of legal and ethical responsibilities, formally distancing from nonstandard plan, and deflecting blame for worse outcomes.

Faced with a LAMA discharge, the important role of a hospitalist is to assess capacity. Help may be sought from other specialists such as psychiatrists and geriatricians. Some of the best practices also include a clear discussion of risks of outpatient treatment, exploration of safe alternative care plans, patient-centered care, shared decision-making (e.g., needle exchange), and harm reduction.

Dr. Medarametla advised hospitalists not to rely on the AMA forms the patients are asked to sign for liability protection. The forms may not stand up to legal scrutiny. Excellent documentation regarding the details of discussions with the patient, and determination of capacity encompassing the patients’ understanding, reasoning, and insight should be made. Hospitalists can also assess the barriers and mitigate them. Appropriate outpatient and alternative treatment plans should be explored. Postdischarge care and follow ups also should be facilitated.

According to Dr. Medarametla, another myth about AMA discharge is that insurance will not pay for it. About 57% of a survey sample of attendings and residents believed the same, and 66% heard other providers telling patients that insurance would not cover the AMA discharges. In a multicentric study of 526 patients, payment was refused only in 4.1% of AMA cases, mostly for administrative reasons.

Another prevalent myth is that patients who leave AMA will lose their right to follow up. Prescriptions also could be given to LAMA patients provided hospitalists adhere to detailed and relevant documentation. Overall, the session was very interesting and informative.
 

Key takeaways

• There are patient and provider factors leading to LAMA.
• Patients signing an AMA form does not provide legal protection for providers, but a stream-lined discharge process and a detailed documentation are likely to.
• There is no evidence that insurance companies will not pay for LAMA discharges.
• LAMA patients could be given prescriptions and follow up as long as they are well documented.

References

Schaefer G et al. Financial responsibility of hospitalized patients who left against medical advice: Medical urban legend? J Gen Intern Med. 2012 Jul;27(7):825-30. doi: 10.1007/s11606-012-1984-x.

Wigder H et al. Insurance companies refusing payment for patients who leave the emergency department against medical advice is a myth. Ann Emerg Med. 2010 Apr;55(4):393. doi: 10.1016/j.annemergmed.2009.11.024.

Dr. Kumar is a hospitalist in Port Huron, Mich. He is a member of the editorial advisory board for the Hospitalist.