Alcohol-Associated Liver Disease’s Changing Demographics

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Alcohol-associated liver disease (ALD) is a significant global health concernaccounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.

ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.

“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.

Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
 

As Women Consume More Alcohol, ALD Follows

Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.

Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.

Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.

Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.

Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”

Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.

Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
 

 

 

Certain Ethnic, Racial Minorities Have Higher Rates of ALD

In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.

2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.

Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.

ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.

The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.

As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.

Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.

Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.

“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
 

ALD Rates High in Young Adults, but the Tide May Be Changing

Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.

In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.

ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.

From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”

Younger adults may be more susceptible to ALD due to the way they drink.

In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.

Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).

“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”

Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.

“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
 

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

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Alcohol-associated liver disease (ALD) is a significant global health concernaccounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.

ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.

“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.

Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
 

As Women Consume More Alcohol, ALD Follows

Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.

Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.

Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.

Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.

Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”

Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.

Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
 

 

 

Certain Ethnic, Racial Minorities Have Higher Rates of ALD

In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.

2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.

Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.

ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.

The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.

As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.

Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.

Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.

“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
 

ALD Rates High in Young Adults, but the Tide May Be Changing

Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.

In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.

ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.

From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”

Younger adults may be more susceptible to ALD due to the way they drink.

In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.

Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).

“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”

Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.

“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
 

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

 

Alcohol-associated liver disease (ALD) is a significant global health concernaccounting for approximately 5% of all disease and injury. In the United States, the prevalence of ALD has increased since 2014, and the trajectory accelerated during the COVID-19 pandemic.

ALD encompasses a spectrum of diseases that includes steatosis, fibrosis, cirrhosis, and hepatocellular carcinoma, as well as related complications. Although earlier stages of ALD may be asymptomatic, hepatologists and gastroenterologists rarely see patients at this point.

“Unfortunately, patients with ALD more often present in late stages of disease (decompensated cirrhosis) as compared with other chronic liver diseases, such as metabolic dysfunction-associated steatotic liver disease or hepatitis C,” Doug A. Simonetto, MD, associate professor of medicine and director of the Gastroenterology and Hepatology Fellowship Program at the Mayo Clinic, Rochester, Minnesota, told this news organization.

Recent data have identified three demographic groups experiencing higher rates of ALD relative to previous periods and who may therefore require special attention. Understanding what makes these groups increasingly susceptible to ALD may allow for improved screening, earlier diagnosis, and potentially the prevention of its most dire consequences.
 

As Women Consume More Alcohol, ALD Follows

Historically, men have had higher rates of alcohol use, heavy drinking, and alcohol disorders than women. But this gender gap has begun to narrow.

Men born in the early 1900s were 2.2 times more likely to drink alcohol and 3.6 times more likely to experience alcohol-related harms than women, according to a 2016 meta-analysis. By the end of the 1990s, however, women’s drinking had begun to catch up. Men still led in these categories, but only by 1.1 and 1.3 times, respectively.

Rates of binge drinking (defined as at least five drinks in men or at least four drinks in women in an approximately 2-hour period) are also converging between the sexes. The authors of a longitudinal analysis hypothesized that an uptick in young women reporting drinking for social reasons — from 53% in 1987 to 87% in 2020 — was a possible cause.

Greater alcohol consumption among women has translated into higher rates of ALD. Analyzing data from the Global Burden of Disease Study 2019, which looked at hundreds of diseases across 204 countries and territories, researchers reported that the worldwide prevalence of ALD among young women (15-49 years) rose within the past decade. Those in the 20- to 24-year-old age group had the most significant increases in ALD prevalence rates.

Recent US statistics highlight the relative imbalance in ALD’s impact on women, according to George F. Koob, PhD, director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

“The age-adjusted death rate from alcohol-associated liver cirrhosis increased by 47% between 2000 and 2019, with larger increases for females than for males (83.5% compared to 33%),” Dr. Koob told this news organization. “Larger increases for women are consistent with a general increase in alcohol use among adult women and larger increases in alcohol-related emergency department visits, hospitalizations, and deaths.”

Physiologically, women have a higher risk than men of developing ALD and more severe disease, even at lower levels of alcohol exposure. According to a 2021 review, several proposed mechanisms might play a role, including differences in alcohol metabolism and first-pass metabolism, hormones, and endotoxin and Kupffer cell activation.

Crucially, women are less likely than men to receive in-person therapy or approved medications for alcohol use disorder, according to a 2019 analysis of over 66,000 privately insured adult patients.
 

 

 

Certain Ethnic, Racial Minorities Have Higher Rates of ALD

In the United States, rates of ALD and associated complications are higher among certain minority groups, most prominently Hispanic and Native American individuals.

2021 analysis of three large US databases found that Hispanic ethnicity was associated with a 17% increased risk for acute-on-chronic liver failure in patients with ALD-related admissions.

Data also show that Hispanic and White patients have a higher proportion of alcoholic hepatitis than African American patients. And for Hispanic patients admitted for alcoholic hepatitis, they incur significantly more total hospital costs despite having similar mortality rates as White patients.

ALD-related mortality appears higher within certain subgroups of Hispanic patient populations. NIAAA surveillance reports track deaths resulting from cirrhosis in the White, Black, and Hispanic populations. From 2000 to 2019, these statistics show that although death rates from cirrhosis decreased for Hispanic White men, they increased for Hispanic White women, Dr. Koob said.

The latest data show that Native American populations are experiencing ALD at relatively higher rates than other racial/ethnic groups as well. An analysis of nearly 200,000 cirrhosis-related hospitalizations found that ALD, including alcoholic hepatitis, was the most common etiology in American Indian/Alaska Native patients. A separate analysis of the National Inpatient Sample database revealed that discharges resulting from ALD were disproportionately higher among Native American women.

As with Hispanic populations, ALD-associated mortality rates are also higher in Native American populations. The death rate from ALD increased for all racial and ethnic groups by 23.4% from 2019 to 2020, but the biggest increase occurred in the American Indian or Alaska Native populations (34.3% increase, from 20.1 to 27 per 100,000 people). Additionally, over the first two decades of the 21st century, mortality rates resulting from cirrhosis were highest among the American Indian and Alaska Native populations, according to a recently published systematic analysis of US health disparities across five racial/ethnic groups.

Discrepancies in these and other minority groups may be due partly to genetic mechanisms, such as the relatively higher frequency of the PNPLA3 G/G polymorphism, a known risk factor for the development of advanced ALD, among those with Native American ancestry. A host of complex socioeconomic factors, such as income discrepancies and access to care, likely contribute too.

Evidence suggests that alcohol screening interventions are not applied equally across various racial and ethnic groups, Dr. Koob noted.

“For instance, Subbaraman and colleagues reported that, compared to non-Hispanic White patients, those who identify as Hispanic, Black, or other race or ethnicity were less likely to be screened for alcohol use during visits to healthcare providers. This was particularly true for those with a high school education or less,” he told this news organization. “However, other studies have not found such disparities.”
 

ALD Rates High in Young Adults, but the Tide May Be Changing

Globally, the prevalence of ALD has increased among both adolescents and young adults since the beginning of the 21st century. The global incidence of alcohol-associated hepatitis in recent years has been greatest among those aged 15-44 years.

In the United States, the increasing rate of ALD-related hospitalizations is primarily driven by the rise in cases of alcoholic hepatitis and acute-on-chronic liver failure among those aged 35 years and younger.

ALD is now the most common indication for liver transplant in those younger than 40 years of age, having increased fourfold between 2003 and 2018.

From 2009 to 2016, people aged 25-34 years experienced the highest average annual increase in cirrhosis-related mortality (10.5%), a trend the authors noted was “driven entirely by alcohol-related liver disease.”

Younger adults may be more susceptible to ALD due to the way they drink.

In a 2021 analysis of the National Health and Nutrition Examination Survey database, the weighted prevalence of harmful alcohol use was 29.3% in those younger than 35 years, compared with 16.9% in those aged 35-64 years. Higher blood alcohol levels resulting from binge drinking may make patients more susceptible to bacterial translocation and liver fibrosis and can increase the likelihood of cirrhosis in those with an underlying metabolic syndrome.

Yet, Dr. Koob said, thinking of “young adults” as one cohort may be misguided because he’s found very different attitudes toward alcohol within that population. Cross-sectional survey data obtained from more than 180,000 young adults indicated that alcohol abstinence increased between 2002 and 2018. Young adults report various reasons for not drinking, ranging from lack of interest to financial and situational barriers (eg, not wanting to interfere with school or work).

“The tide is coming in and out at the same time,” he said. “Younger people under the age of 25 are drinking less each year, are increasingly interested in things like Dry January, and more than half view moderate levels of consumption as unhealthy. People who are 26 years and older are drinking more, are not as interested in cutting back or taking breaks, and are less likely to consider 1 or 2 drinks per day as potentially unhealthy.”

Dr. Koob would like to believe the positive trends around alcohol in the under-25 set prove not only resilient, but someday, dominant.

“We have seen historic increases in alcohol consumption in the last few years — the largest increases in more than 50 years. But we are hopeful that, as the younger cohorts age, we will see lower levels of drinking by adults in mid-life and beyond.”
 

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

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Signal of Suicide Ideation With GLP-1 RA Semaglutide, but Experts Urge Caution

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A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines. 

However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations. 

“Clinicians should not interpret these results as proof of causal relationship between suicidal ideation and semaglutide, as our pharmacovigilance study showed an association between the use of semaglutide and reports of suicidal ideation,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.

Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said. 

“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added. 

The study was published online on August 20 in JAMA Network Open
 

Emerging Concerns

GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe. 

Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs). 

They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozinmetformin, and orlistat as comparators. 

Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women). 

The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs. 

This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote. 

No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04). 

However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%). 
 

More Research Needed 

GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said. 

“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.

The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.

This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France. 

Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible. 

“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie. 

Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. 

The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”

Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”

“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said. 

The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest. 
 

A version of this article appeared on Medscape.com.

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First Non-Prescription Continuous Glucose Monitor Launches

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Tue, 08/27/2024 - 09:26

The first — but not the last — over-the-counter continuous glucose monitor (CGM) is now available for people older than 18 years who don’t use insulin and who aren’t at a risk for hypoglycemia.

Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.

As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.

“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.

Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.

He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”

The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.

Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.” 

Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”

However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”

Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”

Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.

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

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The first — but not the last — over-the-counter continuous glucose monitor (CGM) is now available for people older than 18 years who don’t use insulin and who aren’t at a risk for hypoglycemia.

Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.

As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.

“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.

Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.

He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”

The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.

Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.” 

Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”

However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”

Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”

Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.

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

The first — but not the last — over-the-counter continuous glucose monitor (CGM) is now available for people older than 18 years who don’t use insulin and who aren’t at a risk for hypoglycemia.

Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.

As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.

“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.

Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.

He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”

The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.

Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.” 

Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”

However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”

Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”

Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.

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

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Evidence Growing for Inflammation’s Role in Elevating Risk for Psychiatric Illness

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Tue, 08/27/2024 - 09:27

New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

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New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

New research provides more evidence that inflammation may contribute to the development of psychiatric disorders and suggests that measuring certain inflammatory biomarkers may aid in the early identification of individuals at high risk.

Using large-scale datasets, researchers found that elevated levels of certain inflammatory biomarkers, particularly leukocytes, haptoglobin, and C-reactive protein (CRP), and lower levels of anti-inflammatory immunoglobulin G (IgG) were associated with an increased risk for psychiatric disorders. 

Individuals with psychiatric disorders had persistently higher levels of leukocytes and haptoglobin, as well as persistently lower levels of IgG, than controls during the 30 years before diagnosis, which suggest “long-term processes and may aid in the identification of individuals at high risk,” the researchers wrote. 

In addition, a higher level of leukocytes was consistently associated with increased odds of depression across different methods of Mendelian randomization (MR) analysis, “indicating a possible causal relationship between leukocytes and depression,” they said. 

The study, with first author Yu Zeng, MSc, with the Mental Health Center and West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China, was published online on August 21 in JAMA Psychiatry
 

Inflammatory Phenotype

Individuals with psychiatric disorders have been found to have elevated levels of inflammatory biomarkers, but prospective evidence is limited regarding the association between inflammatory biomarkers and subsequent psychiatric disorders risk. 

To investigate further, the researchers employed a “triangulation” approach consisting of an exploration dataset of 585,279 adults in the Swedish AMORIS cohort with no prior psychiatric diagnoses and a measurement of at least one inflammatory biomarker, a validation dataset of 485,620 UK Biobank participants, and genetic and MR analyses using genome-wide association study summary statistics.

In the AMORIS cohort, individuals with a higher than median level of leukocytes (hazard ratio [HR], 1.11), haptoglobin (HR, 1.13), or CRP (HR, 1.02) had an elevated risk for any psychiatric disorder. In contrast, there was an inverse association for IgG level (HR, 0.92). 

“The estimates were comparable for depression, anxiety, and stress-related disorders, specifically, and these results were largely validated in the UK Biobank,” the authors reported. 

In trajectory analyses, compared with controls, individuals with psychiatric disorders had higher leukocyte and haptoglobin levels and lower IgG up to three decades before being diagnosed. 

The MR analysis suggested a possible causal relationship between leukocytes and depression. 

The underlying mechanisms for the associations of serum leukocytes, haptoglobin, CRP, and IgG with psychiatry disorders remain unclear.

“Possible explanations mainly include blood-brain barrier disruption, microglia activation, neurotransmission impairment, and other interactions between inflammations and neuropathology,” the researchers wrote. 

A related paper published online on August 21 in JAMA Psychiatry looked at trajectories of inflammation in childhood and risk for mental and cardiometabolic disorders in adulthood. 

This longitudinal cohort study found that having persistently raised levels of inflammation as measured by CRP throughout childhood and adolescence, peaking at age 9 years, were associated with an increased risk of developing psychosis disorder, severe depression, and higher levels of insulin resistance.
 

Support for Precision Psychiatry

This study is “another strong indication that inflammation plays a role in depression,” Andrew H. Miller, MD, professor of psychiatry and behavioral sciences and director of the behavioral immunology program, Emory University School of Medicine, Atlanta, Georgia, who wasn’t involved in the study, told this news organization. 

“The work adds to the mounting data that there exists an inflammatory phenotype of depression that may uniquely respond to treatment and may have a unique trajectory,” Dr. Miller said. 

“Eventually the field will want to embrace this novel phenotype and better understand how to recognize it and treat it. This is our entrée into precision psychiatry where we identify the right treatment for the right patient at the right time based on an understanding of the underlying cause of their illness,” Dr. Miller added. 

Also weighing in, Alexander B. Niculescu III, MD, PhD, professor of psychiatry and medical neuroscience, Indiana University School of Medicine, Indianapolis, cautioned that these biomarkers are “very nonspecific and are likely related to these subjects that go on to develop psychiatric disorders having more stressful, adverse life trajectories.”

“There are better, more specific blood biomarkers for psychiatric disorders already available,” Dr. Niculescu told this news organization.

His group recently reported that a panel of blood-based biomarkers can distinguish between depression and bipolar disorder, predict a person’s future risk for these disorders, and inform more tailored medication choices. 

Notably, they observed a strong circadian clock gene component to mood disorders, which helps explain why some patients’ conditions become worse with seasonal changes. It also explains the sleep alterations that occur among patients with mood disorders, they said.

This study had no commercial funding. Yu Zeng and Dr. Miller had no relevant disclosures. Dr. Niculescu is a cofounder of MindX Sciences and is listed as inventor on a patent application filed by Indiana University.
 

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

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Why Tradwives Are Trending

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Changed
Mon, 08/26/2024 - 15:36

“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder

Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.

Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.

It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.



Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.

Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.

Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.

Kaiser Permanente
Dr. Jeffrey Benabio

We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.

As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.

Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.

Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

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“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder

Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.

Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.

It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.



Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.

Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.

Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.

Kaiser Permanente
Dr. Jeffrey Benabio

We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.

As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.

Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.

Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

“Why, I guess you can,” Ma said doubtfully. She did not like to see women working in the fields. Ma and her girls were … above doing men’s work. — Laura Ingalls Wilder

Sometimes a dad has to feed his little ones. I take pride in making my mac and cheese from scratch. Unlike those modern out-of-the-box dads, I grate fresh Parmesan and cheddar myself. Authentic, but I’m no match for the “Trad Wives.” For some, like Hannah Neelman known as @BallarinaFarms, mac and cheese takes days to prepare. She first has to milk the cows, boil the milk for cheese, gather eggs, and make pasta from home-milled flour. Instagram and TikTok are buzzing with tradwives like her. Tradwives, short for traditional wives, post and promote conventional values in gorgeous cottagecore images. Sometimes in prairie dresses, often cooking with Le Creuset pans on AGA ranges, they are proud to serve their husband and brood who wait patiently sitting at their (19th-century farmhouse) tables.

Somehow, this romanticizing of women in old-fashioned homemaking roles, cooking, cleaning, and caring for children is trending in 2024. There is a spectrum of viewpoints but most labeled as tradwives glorify women who choose to feed families rather than build careers. Offstage are their husbands who implicitly benefit from their wives’ choices and capabilities.

It’s no coincidence that this hot tradwife trend is both controversial and popular — nothing feeds the algorithm like drama and dispute. At the extreme of tradwife content are orthodox religious or alt-right posts advising women to be servants to their husbands and to put family as their only priority. Watch enough of this content and you’ll likely find the algorithm dripping controversial anti-vax and conspiracy content in your feed. The irresistible combination of bucolic images and rage bait has led to tradwife content being viewed hundreds of millions of times. Audience reactions of love or hate are visceral. But pitting career women against tradwives is a trap. Despite provocative “feminist women hate god and family” or “tradwives promote slavery” posts, most purveyors of this content seem to enjoy their roles and, if anything, are only looking for likes and paid promotions.



Women in medicine whom I spoke with didn’t seem bothered, or surprised, by the tradwife trend. Who doesn’t love idyllic scenes of family and homesteads? The trouble is the expectation that women be both. Competent doctor by day and wild blueberry scones by day as well. FIGS and frilly dresses. Rhomboid flaps and darned socks (though the stitch might be the same). This is why the tradwife trend showcases the most difficult, exacting, and time consuming of household chores — it’s physiologically impossible to see patients 50 hours a week and churn your own butter. The movement is trying to say it’s impossible to do both, so just choose one. As a former Juilliard-trained ballerina, Ms. Neelman was certainly accustomed to performing at the highest level. A generous interpretation of her work is that she cannot be it all and so choosing to be a homemaker is freeing even if perhaps not her life’s ambition. Whether her life is enjoyable or forced drudgery is only hers to know. It seems the contented homemaker might offer a different kind of empowerment — one that centers around domesticity and nurturing. A rejection of perceived overreach of feminism.

Yet, some of the most competent, generous, and assiduous physicians in our department are moms and wives. They somehow manage to run the home operations, coordinate kids’ schedules, pack lunches (including their husbands’) and make homemade angel food cake with fresh whipped cream for dessert (it was delicious). I am in awe of their prodigious productivity and I realize that not all women can be like them nor all families like theirs.

Yet, I wonder how this trend might resonate — or clash — with the lives of the women in medicine more generally. The tradwife movement seems to offer a stark choice to the professional lives of female doctors, who find themselves at the intersection of high-stakes careers and the relentless demands of home. It raises questions about the pressures we place on ourselves and how we define success and fulfillment. The tradwife movement also reflects broader societal tensions — between tradition and progress, individualism and community, modernity and nostalgia. It invites us to reflect on our values and the choices we make, both in our personal lives and as a society.

Kaiser Permanente
Dr. Jeffrey Benabio

We are fortunate that in 2024 so many women dedicate themselves to medicine. Having more women join medicine has improved the quality of care and the experience for our patients. In addition to the friction of inequalities such as bias, discrimination, and even assault for women in medicine, there is also the burden of unrealistic expectations that they can do it all. I don’t criticize tradwives for the choices they make but am ever more grateful for the women who have also added medicine as a priority.

As for assisting and accommodating women in medicine, we have come a way but can do more. At the least, rejecting the view that homemaking is women’s work would help. Often unnoticed is the immense volume of work that gets done at home by women. Men sharing more of this work-after-work can enable women to spend more time in their careers and not feel guilty that the homestead is suffering. Yes, doing the plant operations like fixing a leaky faucet is useful, but so would be getting the kids dressed, scheduling their volleyball, or prepping a lovely lunch for them.

Whilst it’s impossible for women in medicine to lead Instagrammable tradwife lives, we can get closer to it if we do our best to share the work. And I understand there is nothing sexier than a man scrambling eggs in an apron. Get ready, TikTok.

Dr. Benabio is chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

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From Baghdad to Boston: The Making of a Blood Cancer Specialist

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Changed
Mon, 08/26/2024 - 14:57

 

A few years after moving with her family from Iraq to the United States, Areej El-Jawahri, MD, entered the University of Michigan with plans to study law. Then her close friend was diagnosed with terminal cancer. This friend’s wrenching experiences during her final days convinced Dr. El-Jawahri to follow a new career path, one devoted to healing. Today, she practices hematology at Massachusetts General Hospital, Boston, and is a leading advocate for palliative care in oncology.

In an interview, Dr. El-Jawahri spoke about her journey from Baghdad to Boston and the future of palliative medicine in hematology.

Question: Where did you grow up?

Dr. El-Jawahri:
My family is from Baghdad, Iraq, and I was born there. We moved to the States when I was 14. I came to Michigan not speaking a word of English. My parents — my father is a mechanical engineer, and my mom is a computer engineer — chose to live in a very white neighborhood in Farmington Hills, in the suburbs of Detroit. The neighborhood did not have any immigrants or Arab Americans. There are a lot of Arab Americans in Michigan, but they chose for me not to hang out with them early on so that I could learn the language. It was a really good choice.

Question: What happened to your college friend?

Dr. El-Jawahri:
She had a brain tumor and ended up receiving intensive care at the end of life. We had a lot of conversations about her wishes and desires, but none of those were honored. Her ending was not something that she wanted, nor did it honor her memory.

Question: What do you think went wrong?

Dr. El-Jawahri:
She was getting treatment for her family’s sake. The idea of losing her was too hard for them. I remember vividly the conversations where she would say, “I just hope I don’t end up in the hospital at the end of life.” We had that conversation explicitly. But because we were young, her family was very involved in her care. A lot of the decision-making was very complicated.

Question: How did this experience change your career path?

Dr. El-Jawahri:
I went into medicine specifically to become an oncologist and cure cancer. The naive 20-year-old in me said, “Nobody should die this miserable death. I’m going to go in, and I’m going to cure it.”

Question: How did palliative medicine become your major focus?

Dr. El-Jawahri:
During my first year at Harvard Medical School, I took a course that’s called “Living With Life-Threatening Illness.” It allows medical students to spend their entire first year getting to know a patient living with a serious illness. We’d spend weekly coffee or lunch breaks with them, where we’d hear about their experiences. After every weekly meeting with a patient, we also had a group meeting with several students and group facilitators to talk about — and process — the interactions we had with patients. I was assigned a woman who was living with metastatic breast cancer. I was also introduced to the field of palliative care and how it helps patients manage complex symptoms and process and cope with a difficult diagnosis. It also cultivates the understanding to make informed decisions about their care. That’s when I knew what I wanted to do for the rest of my life — figure out ways to integrate these palliative and supportive care concepts and improve the lived experience of patients and families within the oncology setting.

Question: What happened next?

Dr. El-Jawahri:
When I was a first-year intern, I went to residency at Massachusetts General Hospital. I was on an oncology service and admitted a young college student who was diagnosed with acute myeloid leukemia. She was an athlete, and every time she went up the stairs to her dorm, she was getting very short of breath. She went to a walk-in clinic because when you’re 20 and you’re healthy, you don’t think you need anything. They did some blood work, and 2 hours later, they called her and said, “You probably have leukemia. You need to go to the emergency department immediately.” There she saw an emergency doctor who said, “You will be admitted to the hospital. You have leukemia. I’m calling an oncologist, and you’ll probably have to start chemotherapy within the next day or two.”

Question: What was that experience like for the patient?

Dr. El-Jawahri:
I’ve never seen someone so scared. The first question she asked me was about her family, who were from North Carolina. She said, “It feels like everybody thinks that I’m dying. Do you think my family will have time to get here?” They were in a car driving over. This is not a unique story in this population. Unfortunately, these patients experience the most traumatic way of being diagnosed and probably the most traumatic experience in oncology. They’re being abducted into a hospital environment, losing all control and starting immediate therapy. Then, for the first 4-6 weeks, they experience immense toxicity, side effects like nausea, vomiting, diarrhea, and mucositis, where they have painful mouth and throat sores that require intravenous pain medications. This causes real posttraumatic stress. After seeing that woman, I made the decision to work in leukemia and transplants to try to make things a little bit better for these patients.

Question: How did the patient fare?

Dr. El-Jawahri:
She actually did great and was cured of her disease. Many of our patients with leukemia, especially younger ones, do well in terms of survival. But they struggle with the trauma of their diagnosis and the distress of the acute treatment period. Even in the curative setting, helping patients to cope with a traumatic diagnosis can have a big impact on their quality of life, how they feel, and their long-term outcomes in terms of psychological stress, depression, anxiety, and posttraumatic stress. But so often, our patients with leukemia are not offered palliative care and supportive care because they’re going to be cured.

Question: What is an important lesson from your research into palliative care in hematology?

Dr. El-Jawahri:
We can make things better for patients and families by integrating palliative care clinicians into the care of patients. Patients receiving palliative care are more likely to document their end-of-life preferences and discuss them with their clinicians, and they’re less likely to be hospitalized at the end of life. When you ask patients with cancer where do they want to die, many of patients say, “I want to die at home. I don’t want to be in a hospital.” A lot of the work I’m doing now is focused on creating digital apps with components of palliative care and supportive care interventions. Patients can administer these interventions to themselves and learn how to effectively cope and deal with their illness. Some patients may do well with a digital app, but others may actually need the in-person touch. Some may need a hybrid approach. One of the other future directions for us is thinking about how we optimize supportive care interventions. Which ones do we give to which patient?

Question: Considering all that you’ve learned since college, how do you think your sick friend should have been treated?

Dr. El-Jawahri:
She was neither introduced to the term palliative care nor to palliative care specialists. Now the standard of care — especially in patients with advanced cancer — is to integrate palliative care clinicians early in the course of illness. We would have loved for her to have a palliative care clinician who didn’t replace the oncologist but rather helped the patient, family, and oncologist communicate more effectively with one another. We hear all the time from patients who say different things to their oncologist than to their palliative care clinician. It’s not like my friend wasn’t able to communicate with her oncologist. But maybe part of it was that she wanted to not disappoint her oncologist [by ending treatment].

Question: Could you tell me about the research you presented at ASCO 2024 regarding 115 adult patients with acute myeloid leukemia and high-risk myelodysplastic syndrome who were receiving non-intensive chemotherapy?

Dr. El-Jawahri:
These patients receive therapy that requires frequent clinic visits and often substantially impairs their quality of life. We know this population often does not engage in any timely discussion with their clinicians about their end-of-life care preferences. This multisite randomized clinical trial assigned patients to receive usual oncology care [with palliative care consultations only upon request] vs to see palliative care clinicians monthly in the outpatient setting and twice weekly every time they were hospitalized. The intervention focused on how to help patients manage their symptoms and end-of-life communication in particular. The primary outcome of the study was time from the documentation of end-of-life care preferences to death.

Question: What did you learn?

Dr. El-Jawahri:
This is one of the first studies to highlight the impact of palliative care integration on end-of-life care preferences and discussions and documentation in this population. Patients receiving the palliative care intervention were much more likely to discuss their end-of-life care preferences (96.5% vs 68.4%; P < .001). More importantly, those receiving the intervention had a much longer time from documentation of end-of-life care preferences to death. On average, patients in the palliative care intervention group vs the usual care group had a mean of 41 vs 1.5 days from documentation of their preferences to death (P < .001). In the intervention group, these conversations were happening early enough for patients to plan, talk to their families, and discuss their wishes. In the usual care group, they were happening acutely while these patients were dying. We also learned that patients receiving palliative care intervention were less likely to be hospitalized at the end of life (70.6% vs 91.9%; P = .031) and had better quality of life (138.6 vs 125.5; P = .010).

Question: What’s next for your research in this area?

Dr. El-Jawahri:
We are doing a large-scale randomized, comparative effectiveness trial of specialty palliative care vs primary palliative care in 11,150 patients with acute myeloid leukemia across 20 institutions in the United States. We expect results in 2028.

Question: What are you hoping to understand?

Dr. El-Jawahri:
We will never have enough specialty palliative care clinicians to take care of all patients with serious illness. As a result, we have to learn how palliative care works: How does it improve outcomes? How do we potentially take what palliative care clinicians do and try to integrate it into regular oncology practice? A lot of the work that I’m excited about now regards what we call primary palliative care. How do we train oncology clinicians to incorporate palliative care skills in their practices so we’re able to better meet the needs of our patients and their families? What we’d love to understand from future research is which patient populations need specialty palliative care and which patients can do just fine with an oncology clinician who has a lot of good palliative care skills integrated into their practice.

Dr. El-Jawahri disclosed consulting for Incyte and Novartis.

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

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A few years after moving with her family from Iraq to the United States, Areej El-Jawahri, MD, entered the University of Michigan with plans to study law. Then her close friend was diagnosed with terminal cancer. This friend’s wrenching experiences during her final days convinced Dr. El-Jawahri to follow a new career path, one devoted to healing. Today, she practices hematology at Massachusetts General Hospital, Boston, and is a leading advocate for palliative care in oncology.

In an interview, Dr. El-Jawahri spoke about her journey from Baghdad to Boston and the future of palliative medicine in hematology.

Question: Where did you grow up?

Dr. El-Jawahri:
My family is from Baghdad, Iraq, and I was born there. We moved to the States when I was 14. I came to Michigan not speaking a word of English. My parents — my father is a mechanical engineer, and my mom is a computer engineer — chose to live in a very white neighborhood in Farmington Hills, in the suburbs of Detroit. The neighborhood did not have any immigrants or Arab Americans. There are a lot of Arab Americans in Michigan, but they chose for me not to hang out with them early on so that I could learn the language. It was a really good choice.

Question: What happened to your college friend?

Dr. El-Jawahri:
She had a brain tumor and ended up receiving intensive care at the end of life. We had a lot of conversations about her wishes and desires, but none of those were honored. Her ending was not something that she wanted, nor did it honor her memory.

Question: What do you think went wrong?

Dr. El-Jawahri:
She was getting treatment for her family’s sake. The idea of losing her was too hard for them. I remember vividly the conversations where she would say, “I just hope I don’t end up in the hospital at the end of life.” We had that conversation explicitly. But because we were young, her family was very involved in her care. A lot of the decision-making was very complicated.

Question: How did this experience change your career path?

Dr. El-Jawahri:
I went into medicine specifically to become an oncologist and cure cancer. The naive 20-year-old in me said, “Nobody should die this miserable death. I’m going to go in, and I’m going to cure it.”

Question: How did palliative medicine become your major focus?

Dr. El-Jawahri:
During my first year at Harvard Medical School, I took a course that’s called “Living With Life-Threatening Illness.” It allows medical students to spend their entire first year getting to know a patient living with a serious illness. We’d spend weekly coffee or lunch breaks with them, where we’d hear about their experiences. After every weekly meeting with a patient, we also had a group meeting with several students and group facilitators to talk about — and process — the interactions we had with patients. I was assigned a woman who was living with metastatic breast cancer. I was also introduced to the field of palliative care and how it helps patients manage complex symptoms and process and cope with a difficult diagnosis. It also cultivates the understanding to make informed decisions about their care. That’s when I knew what I wanted to do for the rest of my life — figure out ways to integrate these palliative and supportive care concepts and improve the lived experience of patients and families within the oncology setting.

Question: What happened next?

Dr. El-Jawahri:
When I was a first-year intern, I went to residency at Massachusetts General Hospital. I was on an oncology service and admitted a young college student who was diagnosed with acute myeloid leukemia. She was an athlete, and every time she went up the stairs to her dorm, she was getting very short of breath. She went to a walk-in clinic because when you’re 20 and you’re healthy, you don’t think you need anything. They did some blood work, and 2 hours later, they called her and said, “You probably have leukemia. You need to go to the emergency department immediately.” There she saw an emergency doctor who said, “You will be admitted to the hospital. You have leukemia. I’m calling an oncologist, and you’ll probably have to start chemotherapy within the next day or two.”

Question: What was that experience like for the patient?

Dr. El-Jawahri:
I’ve never seen someone so scared. The first question she asked me was about her family, who were from North Carolina. She said, “It feels like everybody thinks that I’m dying. Do you think my family will have time to get here?” They were in a car driving over. This is not a unique story in this population. Unfortunately, these patients experience the most traumatic way of being diagnosed and probably the most traumatic experience in oncology. They’re being abducted into a hospital environment, losing all control and starting immediate therapy. Then, for the first 4-6 weeks, they experience immense toxicity, side effects like nausea, vomiting, diarrhea, and mucositis, where they have painful mouth and throat sores that require intravenous pain medications. This causes real posttraumatic stress. After seeing that woman, I made the decision to work in leukemia and transplants to try to make things a little bit better for these patients.

Question: How did the patient fare?

Dr. El-Jawahri:
She actually did great and was cured of her disease. Many of our patients with leukemia, especially younger ones, do well in terms of survival. But they struggle with the trauma of their diagnosis and the distress of the acute treatment period. Even in the curative setting, helping patients to cope with a traumatic diagnosis can have a big impact on their quality of life, how they feel, and their long-term outcomes in terms of psychological stress, depression, anxiety, and posttraumatic stress. But so often, our patients with leukemia are not offered palliative care and supportive care because they’re going to be cured.

Question: What is an important lesson from your research into palliative care in hematology?

Dr. El-Jawahri:
We can make things better for patients and families by integrating palliative care clinicians into the care of patients. Patients receiving palliative care are more likely to document their end-of-life preferences and discuss them with their clinicians, and they’re less likely to be hospitalized at the end of life. When you ask patients with cancer where do they want to die, many of patients say, “I want to die at home. I don’t want to be in a hospital.” A lot of the work I’m doing now is focused on creating digital apps with components of palliative care and supportive care interventions. Patients can administer these interventions to themselves and learn how to effectively cope and deal with their illness. Some patients may do well with a digital app, but others may actually need the in-person touch. Some may need a hybrid approach. One of the other future directions for us is thinking about how we optimize supportive care interventions. Which ones do we give to which patient?

Question: Considering all that you’ve learned since college, how do you think your sick friend should have been treated?

Dr. El-Jawahri:
She was neither introduced to the term palliative care nor to palliative care specialists. Now the standard of care — especially in patients with advanced cancer — is to integrate palliative care clinicians early in the course of illness. We would have loved for her to have a palliative care clinician who didn’t replace the oncologist but rather helped the patient, family, and oncologist communicate more effectively with one another. We hear all the time from patients who say different things to their oncologist than to their palliative care clinician. It’s not like my friend wasn’t able to communicate with her oncologist. But maybe part of it was that she wanted to not disappoint her oncologist [by ending treatment].

Question: Could you tell me about the research you presented at ASCO 2024 regarding 115 adult patients with acute myeloid leukemia and high-risk myelodysplastic syndrome who were receiving non-intensive chemotherapy?

Dr. El-Jawahri:
These patients receive therapy that requires frequent clinic visits and often substantially impairs their quality of life. We know this population often does not engage in any timely discussion with their clinicians about their end-of-life care preferences. This multisite randomized clinical trial assigned patients to receive usual oncology care [with palliative care consultations only upon request] vs to see palliative care clinicians monthly in the outpatient setting and twice weekly every time they were hospitalized. The intervention focused on how to help patients manage their symptoms and end-of-life communication in particular. The primary outcome of the study was time from the documentation of end-of-life care preferences to death.

Question: What did you learn?

Dr. El-Jawahri:
This is one of the first studies to highlight the impact of palliative care integration on end-of-life care preferences and discussions and documentation in this population. Patients receiving the palliative care intervention were much more likely to discuss their end-of-life care preferences (96.5% vs 68.4%; P < .001). More importantly, those receiving the intervention had a much longer time from documentation of end-of-life care preferences to death. On average, patients in the palliative care intervention group vs the usual care group had a mean of 41 vs 1.5 days from documentation of their preferences to death (P < .001). In the intervention group, these conversations were happening early enough for patients to plan, talk to their families, and discuss their wishes. In the usual care group, they were happening acutely while these patients were dying. We also learned that patients receiving palliative care intervention were less likely to be hospitalized at the end of life (70.6% vs 91.9%; P = .031) and had better quality of life (138.6 vs 125.5; P = .010).

Question: What’s next for your research in this area?

Dr. El-Jawahri:
We are doing a large-scale randomized, comparative effectiveness trial of specialty palliative care vs primary palliative care in 11,150 patients with acute myeloid leukemia across 20 institutions in the United States. We expect results in 2028.

Question: What are you hoping to understand?

Dr. El-Jawahri:
We will never have enough specialty palliative care clinicians to take care of all patients with serious illness. As a result, we have to learn how palliative care works: How does it improve outcomes? How do we potentially take what palliative care clinicians do and try to integrate it into regular oncology practice? A lot of the work that I’m excited about now regards what we call primary palliative care. How do we train oncology clinicians to incorporate palliative care skills in their practices so we’re able to better meet the needs of our patients and their families? What we’d love to understand from future research is which patient populations need specialty palliative care and which patients can do just fine with an oncology clinician who has a lot of good palliative care skills integrated into their practice.

Dr. El-Jawahri disclosed consulting for Incyte and Novartis.

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

 

A few years after moving with her family from Iraq to the United States, Areej El-Jawahri, MD, entered the University of Michigan with plans to study law. Then her close friend was diagnosed with terminal cancer. This friend’s wrenching experiences during her final days convinced Dr. El-Jawahri to follow a new career path, one devoted to healing. Today, she practices hematology at Massachusetts General Hospital, Boston, and is a leading advocate for palliative care in oncology.

In an interview, Dr. El-Jawahri spoke about her journey from Baghdad to Boston and the future of palliative medicine in hematology.

Question: Where did you grow up?

Dr. El-Jawahri:
My family is from Baghdad, Iraq, and I was born there. We moved to the States when I was 14. I came to Michigan not speaking a word of English. My parents — my father is a mechanical engineer, and my mom is a computer engineer — chose to live in a very white neighborhood in Farmington Hills, in the suburbs of Detroit. The neighborhood did not have any immigrants or Arab Americans. There are a lot of Arab Americans in Michigan, but they chose for me not to hang out with them early on so that I could learn the language. It was a really good choice.

Question: What happened to your college friend?

Dr. El-Jawahri:
She had a brain tumor and ended up receiving intensive care at the end of life. We had a lot of conversations about her wishes and desires, but none of those were honored. Her ending was not something that she wanted, nor did it honor her memory.

Question: What do you think went wrong?

Dr. El-Jawahri:
She was getting treatment for her family’s sake. The idea of losing her was too hard for them. I remember vividly the conversations where she would say, “I just hope I don’t end up in the hospital at the end of life.” We had that conversation explicitly. But because we were young, her family was very involved in her care. A lot of the decision-making was very complicated.

Question: How did this experience change your career path?

Dr. El-Jawahri:
I went into medicine specifically to become an oncologist and cure cancer. The naive 20-year-old in me said, “Nobody should die this miserable death. I’m going to go in, and I’m going to cure it.”

Question: How did palliative medicine become your major focus?

Dr. El-Jawahri:
During my first year at Harvard Medical School, I took a course that’s called “Living With Life-Threatening Illness.” It allows medical students to spend their entire first year getting to know a patient living with a serious illness. We’d spend weekly coffee or lunch breaks with them, where we’d hear about their experiences. After every weekly meeting with a patient, we also had a group meeting with several students and group facilitators to talk about — and process — the interactions we had with patients. I was assigned a woman who was living with metastatic breast cancer. I was also introduced to the field of palliative care and how it helps patients manage complex symptoms and process and cope with a difficult diagnosis. It also cultivates the understanding to make informed decisions about their care. That’s when I knew what I wanted to do for the rest of my life — figure out ways to integrate these palliative and supportive care concepts and improve the lived experience of patients and families within the oncology setting.

Question: What happened next?

Dr. El-Jawahri:
When I was a first-year intern, I went to residency at Massachusetts General Hospital. I was on an oncology service and admitted a young college student who was diagnosed with acute myeloid leukemia. She was an athlete, and every time she went up the stairs to her dorm, she was getting very short of breath. She went to a walk-in clinic because when you’re 20 and you’re healthy, you don’t think you need anything. They did some blood work, and 2 hours later, they called her and said, “You probably have leukemia. You need to go to the emergency department immediately.” There she saw an emergency doctor who said, “You will be admitted to the hospital. You have leukemia. I’m calling an oncologist, and you’ll probably have to start chemotherapy within the next day or two.”

Question: What was that experience like for the patient?

Dr. El-Jawahri:
I’ve never seen someone so scared. The first question she asked me was about her family, who were from North Carolina. She said, “It feels like everybody thinks that I’m dying. Do you think my family will have time to get here?” They were in a car driving over. This is not a unique story in this population. Unfortunately, these patients experience the most traumatic way of being diagnosed and probably the most traumatic experience in oncology. They’re being abducted into a hospital environment, losing all control and starting immediate therapy. Then, for the first 4-6 weeks, they experience immense toxicity, side effects like nausea, vomiting, diarrhea, and mucositis, where they have painful mouth and throat sores that require intravenous pain medications. This causes real posttraumatic stress. After seeing that woman, I made the decision to work in leukemia and transplants to try to make things a little bit better for these patients.

Question: How did the patient fare?

Dr. El-Jawahri:
She actually did great and was cured of her disease. Many of our patients with leukemia, especially younger ones, do well in terms of survival. But they struggle with the trauma of their diagnosis and the distress of the acute treatment period. Even in the curative setting, helping patients to cope with a traumatic diagnosis can have a big impact on their quality of life, how they feel, and their long-term outcomes in terms of psychological stress, depression, anxiety, and posttraumatic stress. But so often, our patients with leukemia are not offered palliative care and supportive care because they’re going to be cured.

Question: What is an important lesson from your research into palliative care in hematology?

Dr. El-Jawahri:
We can make things better for patients and families by integrating palliative care clinicians into the care of patients. Patients receiving palliative care are more likely to document their end-of-life preferences and discuss them with their clinicians, and they’re less likely to be hospitalized at the end of life. When you ask patients with cancer where do they want to die, many of patients say, “I want to die at home. I don’t want to be in a hospital.” A lot of the work I’m doing now is focused on creating digital apps with components of palliative care and supportive care interventions. Patients can administer these interventions to themselves and learn how to effectively cope and deal with their illness. Some patients may do well with a digital app, but others may actually need the in-person touch. Some may need a hybrid approach. One of the other future directions for us is thinking about how we optimize supportive care interventions. Which ones do we give to which patient?

Question: Considering all that you’ve learned since college, how do you think your sick friend should have been treated?

Dr. El-Jawahri:
She was neither introduced to the term palliative care nor to palliative care specialists. Now the standard of care — especially in patients with advanced cancer — is to integrate palliative care clinicians early in the course of illness. We would have loved for her to have a palliative care clinician who didn’t replace the oncologist but rather helped the patient, family, and oncologist communicate more effectively with one another. We hear all the time from patients who say different things to their oncologist than to their palliative care clinician. It’s not like my friend wasn’t able to communicate with her oncologist. But maybe part of it was that she wanted to not disappoint her oncologist [by ending treatment].

Question: Could you tell me about the research you presented at ASCO 2024 regarding 115 adult patients with acute myeloid leukemia and high-risk myelodysplastic syndrome who were receiving non-intensive chemotherapy?

Dr. El-Jawahri:
These patients receive therapy that requires frequent clinic visits and often substantially impairs their quality of life. We know this population often does not engage in any timely discussion with their clinicians about their end-of-life care preferences. This multisite randomized clinical trial assigned patients to receive usual oncology care [with palliative care consultations only upon request] vs to see palliative care clinicians monthly in the outpatient setting and twice weekly every time they were hospitalized. The intervention focused on how to help patients manage their symptoms and end-of-life communication in particular. The primary outcome of the study was time from the documentation of end-of-life care preferences to death.

Question: What did you learn?

Dr. El-Jawahri:
This is one of the first studies to highlight the impact of palliative care integration on end-of-life care preferences and discussions and documentation in this population. Patients receiving the palliative care intervention were much more likely to discuss their end-of-life care preferences (96.5% vs 68.4%; P < .001). More importantly, those receiving the intervention had a much longer time from documentation of end-of-life care preferences to death. On average, patients in the palliative care intervention group vs the usual care group had a mean of 41 vs 1.5 days from documentation of their preferences to death (P < .001). In the intervention group, these conversations were happening early enough for patients to plan, talk to their families, and discuss their wishes. In the usual care group, they were happening acutely while these patients were dying. We also learned that patients receiving palliative care intervention were less likely to be hospitalized at the end of life (70.6% vs 91.9%; P = .031) and had better quality of life (138.6 vs 125.5; P = .010).

Question: What’s next for your research in this area?

Dr. El-Jawahri:
We are doing a large-scale randomized, comparative effectiveness trial of specialty palliative care vs primary palliative care in 11,150 patients with acute myeloid leukemia across 20 institutions in the United States. We expect results in 2028.

Question: What are you hoping to understand?

Dr. El-Jawahri:
We will never have enough specialty palliative care clinicians to take care of all patients with serious illness. As a result, we have to learn how palliative care works: How does it improve outcomes? How do we potentially take what palliative care clinicians do and try to integrate it into regular oncology practice? A lot of the work that I’m excited about now regards what we call primary palliative care. How do we train oncology clinicians to incorporate palliative care skills in their practices so we’re able to better meet the needs of our patients and their families? What we’d love to understand from future research is which patient populations need specialty palliative care and which patients can do just fine with an oncology clinician who has a lot of good palliative care skills integrated into their practice.

Dr. El-Jawahri disclosed consulting for Incyte and Novartis.

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

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Timing of iPLEDGE Updates Unclear

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Mon, 08/26/2024 - 13:14

After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital
Dr. John Barbieri

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

 

 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

  • Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
  • Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
  • Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
  • Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
  • Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital
Dr. John Barbieri

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

 

 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

  • Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
  • Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
  • Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
  • Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
  • Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital
Dr. John Barbieri

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

 

 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

  • Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
  • Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
  • Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
  • Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
  • Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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We Asked 7 Doctors: How Do You Get Patients to Exercise?

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Tue, 08/27/2024 - 10:09

We know exercise can be a powerful medical intervention. Now scientists are finally starting to understand why.

recent study in rats found that exercise positively changes virtually every tissue in the body. The research was part of a large National Institutes of Health initiative called MoTrPAC (Molecular Transducers of Physical Activity Consortium) to understand how physical activity improves health and prevents disease. As part of the project, a large human study is also underway.

“What was mind-blowing to me was just how much every organ changed,” said cardiologist Euan A. Ashley, MD, professor of medicine at Stanford University, Stanford, California, and the study’s lead author. “You really are a different person on exercise.”

The study examined hundreds of previously sedentary rats that exercised on a treadmill for 8 weeks. Their tissues were compared with a control group of rats that stayed sedentary.

Your patients, unlike lab animals, can’t be randomly assigned to run on a treadmill until you switch the machine off.

So how do you persuade your patients to become more active?

We asked seven doctors what works for them. They shared 10 of their most effective persuasion tactics.
 

1. Focus on the First Step

“It’s easy to say you want to change behavior,” said Jordan Metzl, MD, a sports medicine specialist at the Hospital for Special Surgery in New York City who instructs medical students on how to prescribe exercise. “It’s much more difficult to do it.”

He compares it with moving a tractor tire from point A to point B. The hardest part is lifting the tire off the ground and starting to move it. “Once it’s rolling, it takes much less effort to keep it going in the same direction,” he said.

How much exercise a patient does is irrelevant until they’ve given that tire its first push.

“Any amount of exercise is better than nothing,” Dr. Ashley said. “Let’s just start with that. Making the move from sitting a lot to standing more has genuine health benefits.” 
 

2. Mind Your Language

Many patients have a deep-rooted aversion to words and phrases associated with physical activity.

“Exercise” is one. “Working out” is another.

“I often tell them they just have to start moving,” said Chris Raynor, MD, an orthopedic surgeon based in Ottawa, Ontario. “Don’t think about it as working out. Think about it as just moving. Start with something they already like doing and work from there.”
 

3. Make It Manageable

This also applies to patients who’re injured and either waiting for or recovering from surgery.

“Joints like motion,” said Rachel M. Frank, MD, an orthopedic surgeon at the University of Colorado Sports Medicine, Denver, Colorado. “The more mobile you can be, the easier your recovery’s going to be.”

That can be a challenge for a patient who wasn’t active before the injury, especially if he or she is fixed on the idea that exercise doesn’t matter unless they do it for 30-45 minutes at a time.

“I try to break it down into manageable bits they can do at home,” Dr. Frank said. “I say, ‘Look, you brush your teeth twice a day, right? Can you do these exercises for 5 or 10 minutes before or after you brush your teeth?’ ”
 

 

 

4. Connect Their Interests to Their Activity Level

Chad Waterbury, DPT, thought he knew how to motivate a postsurgical patient to become more active and improve her odds for a full recovery. He told her she’d feel better and have more energy — all the usual selling points.

None of it impressed her.

But one day she mentioned that she’d recently become a grandmother for the first time. Dr. Waterbury, a physical therapist based in Los Angeles, noticed how she lit up when she talked about her new granddaughter.

“So I started giving her scenarios, like taking her daughter to Disneyland when she’s 9 or 10. You have to be somewhat fit to do something like that.”

It worked, and Dr. Waterbury learned a fundamental lesson in motivation. “You have to connect the exercise to something that’s important in their life,” he said.
 

5. Don’t Let a Crisis Go to Waste

“There are very few things more motivating than having a heart attack,” Dr. Ashley said. “For the vast majority of people, that’s a very sobering moment where they reassess everything in their lives.”

There’ll never be a better time to persuade a patient to become more active. In his cardiology practice, Dr. Ashley has seen a lot of patients make that switch.

“They really do start to prioritize their health in a way they never did before,” he said.
 

6. Emphasize the Practical Over the Ideal

Not all patients attach negative feelings to working out. For some, it’s the goal.

Todd Ivan, MD, calls it the “ ’I need to get to the gym’ lament”: Something they’ve aspired to but rarely if ever done.

“I tell them I’d welcome a half-hour walk every day to get started,” said Dr. Ivan, a consultation-liaison psychiatrist at Summa Health in Akron, Ohio. “It’s a way to introduce the idea that fitness begins with small adjustments.”
 

7. Go Beneath the Surface

“Exercise doesn’t generally result in great weight loss,” said endocrinologist Karl Nadolsky, DO, an obesity specialist and co-host of the Docs Who Lift podcast.

But a lot of his patients struggle to break that connection. It’s understandable, given how many times they’ve been told they’d weigh less if they moved more.

Dr. Nadolsky tells them it’s what’s on the inside that counts. “I explain it as very literal, meaning their physical health, metabolic health, and mental health.”

By reframing physical activity with an internal rather than external focus — the plumbing and wiring vs the shutters and shingles — he gives them permission to approach exercise as a health upgrade rather than yet another part of their lifelong struggle to lose weight.

“A significant number of our patients respond well to that,” he said.
 

8. Appeal to Their Intellect

Some patients think like doctors: No matter how reluctant they may be to change their mind about something, they’ll respond to evidence.

Dr. Frank has learned to identify these scientifically inclined patients. “I’ll flood them with data,” she said. “I’ll say, ‘These studies show that if you do x, y, z, your outcome will be better.’ ”

Dr. Ashley takes a similar approach when his patients give him the most common reason for not exercising: “I don’t have time.”

He tells them that exercise doesn’t take time. It gives you time.

That’s according to a 2012 study of more than 650,000 adults that associated physical activity with an increased lifespan.

As one of the authors said in an interview, a middle-aged person who gets 150 minutes a week of moderate exercise will, on average, gain 7 more minutes of life for each minute of exercise, compared with someone who doesn’t get any exercise.

The strategy works because it brings patients out of their day-to-day lives and into the future, Dr. Ashley said.

“What about your entire life?” he asks them. “You’re actually in this world for 80-plus years, you hope. How are you going to spend that? You have to think about that when you’re in your 40s and 50s.”
 

 

 

9. Show Them the Money

Illness and injury, on top of everything else, can be really expensive.

Even with good insurance, a health problem that requires surgery and/or hospitalization might cost thousands of dollars out of pocket. With mediocre insurance, it might be tens of thousands.

Sometimes, Dr. Frank said, it helps to remind patients of the price they paid for their treatment. “I’ll say, ‘Let’s get moving so you don’t have to pay for this again.’ ”

Protecting their investment can be a powerful motivation.
 

10. Make It a Team Effort

While the doctors we interviewed have a wide range of specialties — cardiology, sports medicine, psychiatry, endocrinology, orthopedics, and physical therapy — their patients have one thing in common.

They don’t want to be in a doctor’s office. It means they have something, need something, or broke something.

It might be a treatable condition that’s merely inconvenient or a life-threatening event that’s flat-out terrifying.

Whatever it is, it pulls them out of their normal world. It can be a lonely, disorienting experience.

Sometimes the best thing a doctor can do is stay connected with the patient. “This is like a team sport,” Dr. Frank tells her patients. “I’m going to be your coach, but you’re the captain of the team.”

In some cases, she’ll ask the patient to message her on the portal after completing the daily or weekly exercises. That alone might motivate the patient — especially when she responds to their messages.

After all, nobody wants to let the coach down.
 

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

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We know exercise can be a powerful medical intervention. Now scientists are finally starting to understand why.

recent study in rats found that exercise positively changes virtually every tissue in the body. The research was part of a large National Institutes of Health initiative called MoTrPAC (Molecular Transducers of Physical Activity Consortium) to understand how physical activity improves health and prevents disease. As part of the project, a large human study is also underway.

“What was mind-blowing to me was just how much every organ changed,” said cardiologist Euan A. Ashley, MD, professor of medicine at Stanford University, Stanford, California, and the study’s lead author. “You really are a different person on exercise.”

The study examined hundreds of previously sedentary rats that exercised on a treadmill for 8 weeks. Their tissues were compared with a control group of rats that stayed sedentary.

Your patients, unlike lab animals, can’t be randomly assigned to run on a treadmill until you switch the machine off.

So how do you persuade your patients to become more active?

We asked seven doctors what works for them. They shared 10 of their most effective persuasion tactics.
 

1. Focus on the First Step

“It’s easy to say you want to change behavior,” said Jordan Metzl, MD, a sports medicine specialist at the Hospital for Special Surgery in New York City who instructs medical students on how to prescribe exercise. “It’s much more difficult to do it.”

He compares it with moving a tractor tire from point A to point B. The hardest part is lifting the tire off the ground and starting to move it. “Once it’s rolling, it takes much less effort to keep it going in the same direction,” he said.

How much exercise a patient does is irrelevant until they’ve given that tire its first push.

“Any amount of exercise is better than nothing,” Dr. Ashley said. “Let’s just start with that. Making the move from sitting a lot to standing more has genuine health benefits.” 
 

2. Mind Your Language

Many patients have a deep-rooted aversion to words and phrases associated with physical activity.

“Exercise” is one. “Working out” is another.

“I often tell them they just have to start moving,” said Chris Raynor, MD, an orthopedic surgeon based in Ottawa, Ontario. “Don’t think about it as working out. Think about it as just moving. Start with something they already like doing and work from there.”
 

3. Make It Manageable

This also applies to patients who’re injured and either waiting for or recovering from surgery.

“Joints like motion,” said Rachel M. Frank, MD, an orthopedic surgeon at the University of Colorado Sports Medicine, Denver, Colorado. “The more mobile you can be, the easier your recovery’s going to be.”

That can be a challenge for a patient who wasn’t active before the injury, especially if he or she is fixed on the idea that exercise doesn’t matter unless they do it for 30-45 minutes at a time.

“I try to break it down into manageable bits they can do at home,” Dr. Frank said. “I say, ‘Look, you brush your teeth twice a day, right? Can you do these exercises for 5 or 10 minutes before or after you brush your teeth?’ ”
 

 

 

4. Connect Their Interests to Their Activity Level

Chad Waterbury, DPT, thought he knew how to motivate a postsurgical patient to become more active and improve her odds for a full recovery. He told her she’d feel better and have more energy — all the usual selling points.

None of it impressed her.

But one day she mentioned that she’d recently become a grandmother for the first time. Dr. Waterbury, a physical therapist based in Los Angeles, noticed how she lit up when she talked about her new granddaughter.

“So I started giving her scenarios, like taking her daughter to Disneyland when she’s 9 or 10. You have to be somewhat fit to do something like that.”

It worked, and Dr. Waterbury learned a fundamental lesson in motivation. “You have to connect the exercise to something that’s important in their life,” he said.
 

5. Don’t Let a Crisis Go to Waste

“There are very few things more motivating than having a heart attack,” Dr. Ashley said. “For the vast majority of people, that’s a very sobering moment where they reassess everything in their lives.”

There’ll never be a better time to persuade a patient to become more active. In his cardiology practice, Dr. Ashley has seen a lot of patients make that switch.

“They really do start to prioritize their health in a way they never did before,” he said.
 

6. Emphasize the Practical Over the Ideal

Not all patients attach negative feelings to working out. For some, it’s the goal.

Todd Ivan, MD, calls it the “ ’I need to get to the gym’ lament”: Something they’ve aspired to but rarely if ever done.

“I tell them I’d welcome a half-hour walk every day to get started,” said Dr. Ivan, a consultation-liaison psychiatrist at Summa Health in Akron, Ohio. “It’s a way to introduce the idea that fitness begins with small adjustments.”
 

7. Go Beneath the Surface

“Exercise doesn’t generally result in great weight loss,” said endocrinologist Karl Nadolsky, DO, an obesity specialist and co-host of the Docs Who Lift podcast.

But a lot of his patients struggle to break that connection. It’s understandable, given how many times they’ve been told they’d weigh less if they moved more.

Dr. Nadolsky tells them it’s what’s on the inside that counts. “I explain it as very literal, meaning their physical health, metabolic health, and mental health.”

By reframing physical activity with an internal rather than external focus — the plumbing and wiring vs the shutters and shingles — he gives them permission to approach exercise as a health upgrade rather than yet another part of their lifelong struggle to lose weight.

“A significant number of our patients respond well to that,” he said.
 

8. Appeal to Their Intellect

Some patients think like doctors: No matter how reluctant they may be to change their mind about something, they’ll respond to evidence.

Dr. Frank has learned to identify these scientifically inclined patients. “I’ll flood them with data,” she said. “I’ll say, ‘These studies show that if you do x, y, z, your outcome will be better.’ ”

Dr. Ashley takes a similar approach when his patients give him the most common reason for not exercising: “I don’t have time.”

He tells them that exercise doesn’t take time. It gives you time.

That’s according to a 2012 study of more than 650,000 adults that associated physical activity with an increased lifespan.

As one of the authors said in an interview, a middle-aged person who gets 150 minutes a week of moderate exercise will, on average, gain 7 more minutes of life for each minute of exercise, compared with someone who doesn’t get any exercise.

The strategy works because it brings patients out of their day-to-day lives and into the future, Dr. Ashley said.

“What about your entire life?” he asks them. “You’re actually in this world for 80-plus years, you hope. How are you going to spend that? You have to think about that when you’re in your 40s and 50s.”
 

 

 

9. Show Them the Money

Illness and injury, on top of everything else, can be really expensive.

Even with good insurance, a health problem that requires surgery and/or hospitalization might cost thousands of dollars out of pocket. With mediocre insurance, it might be tens of thousands.

Sometimes, Dr. Frank said, it helps to remind patients of the price they paid for their treatment. “I’ll say, ‘Let’s get moving so you don’t have to pay for this again.’ ”

Protecting their investment can be a powerful motivation.
 

10. Make It a Team Effort

While the doctors we interviewed have a wide range of specialties — cardiology, sports medicine, psychiatry, endocrinology, orthopedics, and physical therapy — their patients have one thing in common.

They don’t want to be in a doctor’s office. It means they have something, need something, or broke something.

It might be a treatable condition that’s merely inconvenient or a life-threatening event that’s flat-out terrifying.

Whatever it is, it pulls them out of their normal world. It can be a lonely, disorienting experience.

Sometimes the best thing a doctor can do is stay connected with the patient. “This is like a team sport,” Dr. Frank tells her patients. “I’m going to be your coach, but you’re the captain of the team.”

In some cases, she’ll ask the patient to message her on the portal after completing the daily or weekly exercises. That alone might motivate the patient — especially when she responds to their messages.

After all, nobody wants to let the coach down.
 

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

We know exercise can be a powerful medical intervention. Now scientists are finally starting to understand why.

recent study in rats found that exercise positively changes virtually every tissue in the body. The research was part of a large National Institutes of Health initiative called MoTrPAC (Molecular Transducers of Physical Activity Consortium) to understand how physical activity improves health and prevents disease. As part of the project, a large human study is also underway.

“What was mind-blowing to me was just how much every organ changed,” said cardiologist Euan A. Ashley, MD, professor of medicine at Stanford University, Stanford, California, and the study’s lead author. “You really are a different person on exercise.”

The study examined hundreds of previously sedentary rats that exercised on a treadmill for 8 weeks. Their tissues were compared with a control group of rats that stayed sedentary.

Your patients, unlike lab animals, can’t be randomly assigned to run on a treadmill until you switch the machine off.

So how do you persuade your patients to become more active?

We asked seven doctors what works for them. They shared 10 of their most effective persuasion tactics.
 

1. Focus on the First Step

“It’s easy to say you want to change behavior,” said Jordan Metzl, MD, a sports medicine specialist at the Hospital for Special Surgery in New York City who instructs medical students on how to prescribe exercise. “It’s much more difficult to do it.”

He compares it with moving a tractor tire from point A to point B. The hardest part is lifting the tire off the ground and starting to move it. “Once it’s rolling, it takes much less effort to keep it going in the same direction,” he said.

How much exercise a patient does is irrelevant until they’ve given that tire its first push.

“Any amount of exercise is better than nothing,” Dr. Ashley said. “Let’s just start with that. Making the move from sitting a lot to standing more has genuine health benefits.” 
 

2. Mind Your Language

Many patients have a deep-rooted aversion to words and phrases associated with physical activity.

“Exercise” is one. “Working out” is another.

“I often tell them they just have to start moving,” said Chris Raynor, MD, an orthopedic surgeon based in Ottawa, Ontario. “Don’t think about it as working out. Think about it as just moving. Start with something they already like doing and work from there.”
 

3. Make It Manageable

This also applies to patients who’re injured and either waiting for or recovering from surgery.

“Joints like motion,” said Rachel M. Frank, MD, an orthopedic surgeon at the University of Colorado Sports Medicine, Denver, Colorado. “The more mobile you can be, the easier your recovery’s going to be.”

That can be a challenge for a patient who wasn’t active before the injury, especially if he or she is fixed on the idea that exercise doesn’t matter unless they do it for 30-45 minutes at a time.

“I try to break it down into manageable bits they can do at home,” Dr. Frank said. “I say, ‘Look, you brush your teeth twice a day, right? Can you do these exercises for 5 or 10 minutes before or after you brush your teeth?’ ”
 

 

 

4. Connect Their Interests to Their Activity Level

Chad Waterbury, DPT, thought he knew how to motivate a postsurgical patient to become more active and improve her odds for a full recovery. He told her she’d feel better and have more energy — all the usual selling points.

None of it impressed her.

But one day she mentioned that she’d recently become a grandmother for the first time. Dr. Waterbury, a physical therapist based in Los Angeles, noticed how she lit up when she talked about her new granddaughter.

“So I started giving her scenarios, like taking her daughter to Disneyland when she’s 9 or 10. You have to be somewhat fit to do something like that.”

It worked, and Dr. Waterbury learned a fundamental lesson in motivation. “You have to connect the exercise to something that’s important in their life,” he said.
 

5. Don’t Let a Crisis Go to Waste

“There are very few things more motivating than having a heart attack,” Dr. Ashley said. “For the vast majority of people, that’s a very sobering moment where they reassess everything in their lives.”

There’ll never be a better time to persuade a patient to become more active. In his cardiology practice, Dr. Ashley has seen a lot of patients make that switch.

“They really do start to prioritize their health in a way they never did before,” he said.
 

6. Emphasize the Practical Over the Ideal

Not all patients attach negative feelings to working out. For some, it’s the goal.

Todd Ivan, MD, calls it the “ ’I need to get to the gym’ lament”: Something they’ve aspired to but rarely if ever done.

“I tell them I’d welcome a half-hour walk every day to get started,” said Dr. Ivan, a consultation-liaison psychiatrist at Summa Health in Akron, Ohio. “It’s a way to introduce the idea that fitness begins with small adjustments.”
 

7. Go Beneath the Surface

“Exercise doesn’t generally result in great weight loss,” said endocrinologist Karl Nadolsky, DO, an obesity specialist and co-host of the Docs Who Lift podcast.

But a lot of his patients struggle to break that connection. It’s understandable, given how many times they’ve been told they’d weigh less if they moved more.

Dr. Nadolsky tells them it’s what’s on the inside that counts. “I explain it as very literal, meaning their physical health, metabolic health, and mental health.”

By reframing physical activity with an internal rather than external focus — the plumbing and wiring vs the shutters and shingles — he gives them permission to approach exercise as a health upgrade rather than yet another part of their lifelong struggle to lose weight.

“A significant number of our patients respond well to that,” he said.
 

8. Appeal to Their Intellect

Some patients think like doctors: No matter how reluctant they may be to change their mind about something, they’ll respond to evidence.

Dr. Frank has learned to identify these scientifically inclined patients. “I’ll flood them with data,” she said. “I’ll say, ‘These studies show that if you do x, y, z, your outcome will be better.’ ”

Dr. Ashley takes a similar approach when his patients give him the most common reason for not exercising: “I don’t have time.”

He tells them that exercise doesn’t take time. It gives you time.

That’s according to a 2012 study of more than 650,000 adults that associated physical activity with an increased lifespan.

As one of the authors said in an interview, a middle-aged person who gets 150 minutes a week of moderate exercise will, on average, gain 7 more minutes of life for each minute of exercise, compared with someone who doesn’t get any exercise.

The strategy works because it brings patients out of their day-to-day lives and into the future, Dr. Ashley said.

“What about your entire life?” he asks them. “You’re actually in this world for 80-plus years, you hope. How are you going to spend that? You have to think about that when you’re in your 40s and 50s.”
 

 

 

9. Show Them the Money

Illness and injury, on top of everything else, can be really expensive.

Even with good insurance, a health problem that requires surgery and/or hospitalization might cost thousands of dollars out of pocket. With mediocre insurance, it might be tens of thousands.

Sometimes, Dr. Frank said, it helps to remind patients of the price they paid for their treatment. “I’ll say, ‘Let’s get moving so you don’t have to pay for this again.’ ”

Protecting their investment can be a powerful motivation.
 

10. Make It a Team Effort

While the doctors we interviewed have a wide range of specialties — cardiology, sports medicine, psychiatry, endocrinology, orthopedics, and physical therapy — their patients have one thing in common.

They don’t want to be in a doctor’s office. It means they have something, need something, or broke something.

It might be a treatable condition that’s merely inconvenient or a life-threatening event that’s flat-out terrifying.

Whatever it is, it pulls them out of their normal world. It can be a lonely, disorienting experience.

Sometimes the best thing a doctor can do is stay connected with the patient. “This is like a team sport,” Dr. Frank tells her patients. “I’m going to be your coach, but you’re the captain of the team.”

In some cases, she’ll ask the patient to message her on the portal after completing the daily or weekly exercises. That alone might motivate the patient — especially when she responds to their messages.

After all, nobody wants to let the coach down.
 

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

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Unseen Toll: Cancer Patients’ Spouses Face Higher Suicide Risk

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Changed
Mon, 08/26/2024 - 12:04

 

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Spouses of patients with cancer face a significantly higher risk for suicide attempts and deaths, especially within the first year after their spouse is diagnosed with cancer, according to an analysis based in Denmark.

METHODOLOGY:

  • A growing body of evidence has revealed higher levels of psychological distress and an increased risk for psychiatric disorders among spouses of patients with cancer, but less is known about suicidal behaviors among spouses.
  • In a recent analysis, researchers assessed the risk for suicide attempts and suicide deaths among the spouses of patients with cancer in a nationwide cohort based in Denmark.
  • Researchers collected registry-based data from 1986 to 2016, comparing suicide attempts and deaths between individuals with a spouse diagnosed with cancer and those without. Suicide attempts were identified through The Danish National Patient Register and The Danish Psychiatric Central Research Register, and suicide deaths were identified through The Danish Register of Causes of Death.
  • A total of 409,338 spouses of patients with cancer (exposed group) were compared with 2,046,682 matched control participants (unexposed group). The participants were followed from cohort entry until a first suicide attempt, suicide death, death from other causes, emigration, or December 31, 2016, whichever came first.

TAKEAWAY:

  • Spouses of patients with cancer had an increased risk for suicide attempts (hazard ratio [HR], 1.28) and suicide deaths (HR, 1.47), especially within the first year after a cancer diagnosis (HR for attempts, 1.45; HR for deaths, 2.56).
  • The increased risk for suicide attempts was more pronounced among men (HR, 1.42), those with a lower household income (HR, 1.39), and those with a history of cancer themselves (HR, 1.57).
  • Among those who attempted suicide, researchers observed positive associations for most, but not all, cancer types and for cancers diagnosed at regional spread or an advanced stage (HR, 1.66) or an unknown stage (HR, 1.28), as well as following the death of the spouse to cancer (HR, 1.57).
  • Researchers also observed an increased risk for suicide death for most, but not all, cancer types and greater increases for cancers diagnosed at more advanced stages (HR, 1.61) or unknown stages (HR, 1.52), as well as following the spouse’s death (HR, 1.70).

IN PRACTICE:

“To our knowledge, this nationwide cohort study is the first to show that spouses of patients with cancer have an elevated risk of both suicide attempt and suicide death,” the authors concluded. “These findings suggest a need for clinical and societal awareness to prevent suicidal behaviors among spouses of patients with cancer, particularly during the first year following the cancer diagnosis.” 

In an accompanying editorial, experts noted that “the mental health impacts may well be higher in countries that have more restricted healthcare access,” given that Denmark has universal healthcare. The editorialists also noted the “pressing need to integrate spousal health more fully into cancer survivorship care. 

“Psychosocial distress should no longer be a hidden and unaddressed cause of suffering in spouses of patients with cancer,” they wrote.

 

 

SOURCE:

The study, led by Qianwei Liu, MD, PhD, Institute of Environmental Medicine, Karolinska Institutet in Stockholm, Sweden, and the accompanying editorial were published online in JAMA Oncology.

LIMITATIONS:

Residual confounding was one potential limitation, though the researchers tried to control for several important confounders. The result may not be generalizable to other countries with different healthcare systems, cultural contexts, or burdens of cancer and suicidal behaviors.

DISCLOSURES:

One coauthor reported receiving grants from Forte during the conduct of the study. Another coauthor

disclosed receiving grants from the Swedish Cancer Society. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Could Baseline MRIs Reshape Prostate Cancer Risk Assessment?

Article Type
Changed
Mon, 08/26/2024 - 09:12

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

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Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

Adding baseline MRI to conventional prostate cancer risk stratification could improve prognostic accuracy, potentially affecting active surveillance and treatment decisions for some patients, according to the investigators on a new trial.

The multicenter, real-world trial showed that men with low-risk or favorable intermediate-risk disease who had higher Prostate Imaging Reporting and Data System (PI-RADS) scores at baseline were more likely to be reclassified with more aggressive disease on a future biopsy, wrote lead author Kiran R. Nandalur, MD and colleagues. The study was published in The Journal of Urology.

This means that without MRI, some cases of prostate cancer are being labeled as lower-risk than they actually are.

The investigators noted that MRI is increasingly being used to choose patients who are appropriate for active surveillance instead of treatment, but related clinical data are scarce.

Although PI-RADS is the preferred metric for characterizing prostate tumors via MRI, “most previous studies on the prognostic implications of baseline PI-RADS score included smaller populations from academic centers, limited inclusion of clinical and pathologic data into models, and/or [are] ambiguous on the implications of PI-RADS score,” they wrote.

These knowledge gaps prompted the present study.
 

How Were Baseline MRI Findings Related to Prostate Cancer Disease Risk?

The dataset included 1491 men with prostate cancer that was diagnosed at 46 hospital-based, academic, or private practice urology groups. All had low-risk or favorable intermediate-risk disease and had undergone MRI within 6 months before or after initial biopsy, along with enrollment in active surveillance.

“A novel aspect of this study was that the MRIs were not read by dedicated prostate MRI experts at academic institutions, but rather a mix of community and academic radiologists,” Dr. Nandalur, medical director of Corewell Health East Radiology, Royal Oak, Michigan, said in an interview.

After traditional risk factors were accounted for, baseline PI-RADS (four or more lesions) was significantly associated with increased likelihood of biopsy reclassification to high-grade prostate cancer on surveillance biopsy (hazard ratio, 2.3; 95% CI 1.6-3.2; P < .001). 

“These patients with suspicious lesions on their initial MRI were more than twice as likely to have higher-grade disease within 5 years,” Nandalur noted. “This result was not only seen in the low-risk group but also in the favorable intermediate-risk group, which hasn’t been shown before.”

Grade group 2 vs 1 and increasing age were also associated with significantly increased risk for reclassification to a more aggressive cancer type.
 

How Might These Findings Improve Outcomes in Patients With Prostate Cancer?

Currently, 60%-70% of patients with low-risk disease choose active surveillance over immediate treatment, whereas 20% with favorable intermediate-risk disease choose active surveillance, according to Dr. Nandalur.

For low-risk patients, PI-RADS score is unlikely to change this decision, although surveillance intervals could be adjusted in accordance with risk. More notably, those with favorable intermediate-risk disease may benefit from considering PI-RADS score when choosing between active surveillance and immediate treatment.

“Most of the management strategies for prostate cancer are based on just your lab values and your pathology,” Dr. Nandalur said, “but this study shows that maybe we should start taking MRI into account — into the general paradigm of management of prostate cancer.”

Ideally, he added, prospective studies will confirm these findings, although such studies can be challenging to perform and similar data have historically been sufficient to reshape clinical practice.

“We are hoping that [baseline PI-RADS score] will be adopted into the NCCN [National Comprehensive Cancer Network] guidelines,” Dr. Nandalur said.
 

 

 

How Likely Are These Findings to Reshape Clinical Practice?

“The study’s large, multicenter cohort and its focus on the prognostic value of baseline MRI in active surveillance make it a crucial contribution to the field, providing evidence that can potentially refine patient management strategies in clinical practice,” Ismail Baris Turkbey, MD, FSAR, head of MRI Section, Molecular Imaging Branch, National Cancer Institute, Rockville, Maryland, said in a written comment.

“The findings from this study are likely to have a significant impact on clinical practice and potentially influence future guidelines in the management of localized prostate cancer, particularly in the context of active surveillance,” Dr. Turkbey said. “MRI, already a commonly used imaging modality in prostate cancer management, may become an even more integral part of the initial assessment and ongoing monitoring of patients with low or favorable-intermediate risk prostate cancer.”

Dr. Turkbey noted several strengths of the study.  

First, the size and the diversity of the cohort, along with the variety of treatment centers, support generalizability of findings. Second, the study pinpoints a “critical aspect” of active surveillance by uncovering the link between baseline MRI findings and later risk reclassification. Finally, the study also showed that increasing age was associated with higher likelihood of risk reclassification, “further emphasizing the need for personalized risk assessment” among these patients.
 

What Were Some Limitations of This Study?

“One important limitation is the lack of inter-reader agreement for PI-RADS evaluations for baseline MRIs,” Dr. Turkbey said. “Variation of PI-RADS is quite known, and centralized evaluations could have made this study stronger. Same applies for centralized quality evaluation of MRIs using The Prostate Imaging Quality (PI-QUAL) score. These items are difficult to do in a multicenter prospective data registry, and maybe authors will consider including these additional analyses in their future work.” 

How Does This New Approach to Prostate Cancer Risk Assessment Compare With Recent Advances in AI-Based Risk Assessment?

Over the past few years, artificial intelligence (AI)–assisted risk assessment in prostate cancer has been gaining increasing attention. Recently, for example, Artera, a self-styled “precision medicine company,” released the first AI tool to help patients choose between active surveillance and active treatment on the basis of analysis of digital pathology images. 

When asked to compare this approach with the methods used in the present study, Dr. Nandalur called the AI model “a step forward” but noted that it still relies on conventional risk criteria.

“Our data show imaging with MRI has independent prognostic information for prostate cancer patients considering active surveillance, over and above these traditional factors,” he said. “Moreover, this predictive ability of MRI was seen in low and favorable intermediate risk groups, so the additive value is broad.”

Still, he predicted that the future will not involve a binary choice, but a combination approach.

“The exciting aspect is that MRI results can eventually be added to this novel AI model and further improve prediction models for patients,” Dr. Nandalur said. “The combination of recent AI models and MRI will likely represent the future paradigm for prostate cancer patients considering active surveillance versus immediate treatment.”

The study was supported by Blue Cross and Blue Shield of Michigan. The investigators and Dr. Turkbey reported no conflicts of interest.

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

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FROM THE JOURNAL OF UROLOGY

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