Mental Health

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

The American Academy of Pediatrics is cautioning physicians and parents to be on the lookout for unnecessary diagnostic testing associated with several common pediatric conditions.

Children seen for these conditions in emergency settings and even in primary care offices could experience avoidable pain, exposure to harmful radiation, and other harms, according to the group.

“The emergency department has the ability to rapidly perform myriad diagnostic tests and receive results quickly,” said Paul Mullan, MD, MPH, chair of the AAP’s Section of Emergency Medicine’s Choosing Wisely task force. “However, this comes with the danger of diagnostic overtesting.”

The five recommendations are as follows:

• Radiographs should not be obtained for children with bronchiolitis, croup, asthma, or first-time wheezing.
• Laboratory tests for screening should not be undertaken in the medical clearance process of children who require inpatient psychiatric admission unless clinically indicated.
• Laboratory testing or a CT scan of the head should not be ordered for a child with an unprovoked, generalized seizure or a simple febrile seizure whose mental status has returned to baseline.
• Abdominal radiographs should not be obtained for suspected constipation.
• Comprehensive viral panel testing should not be undertaken for children who are suspected of having respiratory viral illnesses.

The AAP task force partnered with Choosing Wisely Canada to create the recommendations. The list is the first of its kind to be published jointly by two countries, according to the release.

“We hope this Choosing Wisely list will encourage clinicians to rely on their clinical skills and avoid unnecessary tests,” said Dr. Mullan, who is also a physician at Children’s Hospital of the King’s Daughters and professor of pediatrics at Eastern Virginia Medical School, Norfolk.

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

As fentanyl-related overdose deaths continue to increase, clinicians should take note of important differences that set the drug apart from the other drugs of misuse – and the troubling reality that fentanyl now contaminates most of them.

“It would be fair to tell patients, if you’re buying any illicit drugs – pills, powder, liquid, whatever it is, you’ve got to assume it’s either contaminated with or replaced by fentanyl,” said Edwin Salsitz, MD, an associate clinical professor at the Icahn School of Medicine at Mount Sinai, New York, during a presentation on the subject at the 21st Annual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

In many if not most cases, he noted, patients become addicted to fentanyl unknowingly. They assume they are ingesting oxycodone, cocaine, or another drug, and have no realization that they are even exposed to fentanyl until they test positive for it – or overdose.

Meanwhile, the high potency of fentanyl can overcome the opioid blockade of addiction treatment therapies – methadone and buprenorphine – that take away the high that users get from less potent drugs such as heroin.

“Fentanyl is overcoming this blockade that methadone and buprenorphine used to provide,” Dr. Salsitz said. “With fentanyl having such a higher potency, patients are saying ‘no, I still feel the fentanyl effects,’ and they continue feeling it even with 200 milligrams of methadone or 24 milligrams of buprenorphine.”
 

‘Wooden chest syndrome’

Among the lesser-known dangers of fentanyl is the possibility that some overdose deaths may occur as the result of a syndrome previously reported as a rare complication following the medical use of fentanyl in critically ill patients – fentanyl-induced chest-wall rigidity, or “wooden chest syndrome,” Dr. Salsitz explained.

In such cases, the muscles of respiration become rigid and paralyzed, causing suffocation within a matter of minutes – too soon to benefit from the overdose rescue medication naloxone.

In one recent study published in Clinical Toxicology , nearly half of fentanyl overdose deaths were found to have occurred even before the body had a chance to produce norfentanyl, a metabolite of fentanyl that takes only about 2-3 minutes to appear in the system, suggesting the deaths occurred rapidly.

In the study of 48 fentanyl deaths, no appreciable concentrations of norfentanyl could be detected in 20 of the 48 overdose deaths (42%), and concentrations were less than 1 ng/mL in 25 cases (52%).

“The lack of any measurable norfentanyl in half of our cases suggests a very rapid death, consistent with acute chest rigidity,” the authors reported.

“In several cases fentanyl concentrations were strikingly high (22 ng/mL and 20 ng/mL) with no norfentanyl detected,” they said.

Dr. Salsitz noted that the syndrome is not well known among the addiction treatment community.

“This is different than the usual respiratory opioid overdose where there’s a gradual decrease in the breathing rate and a gradual decrease in how much air is going in and out of the lungs,” Dr. Salsitz explained.

“With those cases, some may survive for an hour or longer, allowing time for someone to administer naloxone or to get the patient to the emergency room,” he said. “But with this, breathing stops and people can die within minutes.

“I think that this is one of the reasons that fentanyl deaths keep going up despite more and more naloxone availability out there,” he said.
 

Clearance may take longer

In toxicology testing for fentanyl, clinicians should also note the important difference between fentanyl and other opioids – that fentanyl, because of its high lipophilicity, may be detected in urine toxicology testing up to 3 weeks after last use. This is much longer than the 2- to 4-day clearance observed with other opioids, possibly causing patients to continue to test positive for the drug weeks after cessation.

This effect was observed in one recent study of 12 opioid use disorder patients in a residential treatment program who had previously been exposed to daily fentanyl.

The study showed the mean amount of time of fentanyl clearance was 2 weeks, with a range of 4-26 days after last use.

The authors pointed out that the findings “might explain recent reports of difficulty in buprenorphine inductions for persons who use fentanyl, and point to a need to better understand the pharmacokinetics of fentanyl in the context of opioid withdrawal in persons who regularly use fentanyl.”

Though the study was small, Dr. Salsitz said “that’s not a stumbling block to the important finding that, with regular use of fentanyl, the drug may stay in the urine for a long time.”

Dr. Salsitz noted that similar observations have been made at his center, with clinicians logically assuming that patients were still somehow getting fentanyl.

“When we initially found this in patients, we thought that they were using on the unit, perhaps that they brought in the fentanyl, because otherwise how could it stay in the urine that long,” he noted. “But fentanyl appears to be more lipophilic and gets into the fat; it’s then excreted very slowly and then stays in the urine.”

Dr. Salsitz said most practitioners think of fentanyl as a short-acting drug, so “it’s important to realize that people may continue to test positive and it should be thought of as a long-acting opioid.”
 

Opiate screening tests don’t work

Dr. Salsitz warned of another misconception in fentanyl testing – the common mistake of assuming that fentanyl should show up in a test for opiates – when in fact fentanyl is not, technically, an opiate.

“The word opiate only refers to morphine, codeine, heroin and sometimes hydrocodone,” he explained. “Other opioids are classified as semisynthetic, such as oxycodone, or synthetics, such as fentanyl and methadone, buprenorphine.”

“In order to detect the synthetics, you must have a separate strip for each one of those drugs. They will not show up positive on a screen for opiates,” he noted.

The belief that fentanyl and other synthetic and semisynthetic opioids will show positive on an opiate screen is a common misconception, he said. “The misunderstanding in toxicology interpretation is a problem for many practitioners, [but] it’s essential to understand because otherwise false assumptions about the patient will be considered.”

Another important testing misreading can occur with the antidepressant drug trazodone, which Dr. Salsitz cautioned may falsely test as positive for fentanyl on immunoassays.

“Trazodone is very commonly used in addiction treatment centers, but it can give a false positive on the fentanyl immunoassay and we’ve had a number of those cases,” he said.

Dr. Salsitz had no disclosures to report.

The Psychopharmacology Update was sponsored by Medscape Live. Medscape Live and this news organization are owned by the same parent company.

As fentanyl-related overdose deaths continue to increase, clinicians should take note of important differences that set the drug apart from the other drugs of misuse – and the troubling reality that fentanyl now contaminates most of them.

“It would be fair to tell patients, if you’re buying any illicit drugs – pills, powder, liquid, whatever it is, you’ve got to assume it’s either contaminated with or replaced by fentanyl,” said Edwin Salsitz, MD, an associate clinical professor at the Icahn School of Medicine at Mount Sinai, New York, during a presentation on the subject at the 21st Annual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

In many if not most cases, he noted, patients become addicted to fentanyl unknowingly. They assume they are ingesting oxycodone, cocaine, or another drug, and have no realization that they are even exposed to fentanyl until they test positive for it – or overdose.

Meanwhile, the high potency of fentanyl can overcome the opioid blockade of addiction treatment therapies – methadone and buprenorphine – that take away the high that users get from less potent drugs such as heroin.

“Fentanyl is overcoming this blockade that methadone and buprenorphine used to provide,” Dr. Salsitz said. “With fentanyl having such a higher potency, patients are saying ‘no, I still feel the fentanyl effects,’ and they continue feeling it even with 200 milligrams of methadone or 24 milligrams of buprenorphine.”
 

‘Wooden chest syndrome’

Among the lesser-known dangers of fentanyl is the possibility that some overdose deaths may occur as the result of a syndrome previously reported as a rare complication following the medical use of fentanyl in critically ill patients – fentanyl-induced chest-wall rigidity, or “wooden chest syndrome,” Dr. Salsitz explained.

In such cases, the muscles of respiration become rigid and paralyzed, causing suffocation within a matter of minutes – too soon to benefit from the overdose rescue medication naloxone.

In one recent study published in Clinical Toxicology , nearly half of fentanyl overdose deaths were found to have occurred even before the body had a chance to produce norfentanyl, a metabolite of fentanyl that takes only about 2-3 minutes to appear in the system, suggesting the deaths occurred rapidly.

In the study of 48 fentanyl deaths, no appreciable concentrations of norfentanyl could be detected in 20 of the 48 overdose deaths (42%), and concentrations were less than 1 ng/mL in 25 cases (52%).

“The lack of any measurable norfentanyl in half of our cases suggests a very rapid death, consistent with acute chest rigidity,” the authors reported.

“In several cases fentanyl concentrations were strikingly high (22 ng/mL and 20 ng/mL) with no norfentanyl detected,” they said.

Dr. Salsitz noted that the syndrome is not well known among the addiction treatment community.

“This is different than the usual respiratory opioid overdose where there’s a gradual decrease in the breathing rate and a gradual decrease in how much air is going in and out of the lungs,” Dr. Salsitz explained.

“With those cases, some may survive for an hour or longer, allowing time for someone to administer naloxone or to get the patient to the emergency room,” he said. “But with this, breathing stops and people can die within minutes.

“I think that this is one of the reasons that fentanyl deaths keep going up despite more and more naloxone availability out there,” he said.
 

Clearance may take longer

In toxicology testing for fentanyl, clinicians should also note the important difference between fentanyl and other opioids – that fentanyl, because of its high lipophilicity, may be detected in urine toxicology testing up to 3 weeks after last use. This is much longer than the 2- to 4-day clearance observed with other opioids, possibly causing patients to continue to test positive for the drug weeks after cessation.

This effect was observed in one recent study of 12 opioid use disorder patients in a residential treatment program who had previously been exposed to daily fentanyl.

The study showed the mean amount of time of fentanyl clearance was 2 weeks, with a range of 4-26 days after last use.

The authors pointed out that the findings “might explain recent reports of difficulty in buprenorphine inductions for persons who use fentanyl, and point to a need to better understand the pharmacokinetics of fentanyl in the context of opioid withdrawal in persons who regularly use fentanyl.”

Though the study was small, Dr. Salsitz said “that’s not a stumbling block to the important finding that, with regular use of fentanyl, the drug may stay in the urine for a long time.”

Dr. Salsitz noted that similar observations have been made at his center, with clinicians logically assuming that patients were still somehow getting fentanyl.

“When we initially found this in patients, we thought that they were using on the unit, perhaps that they brought in the fentanyl, because otherwise how could it stay in the urine that long,” he noted. “But fentanyl appears to be more lipophilic and gets into the fat; it’s then excreted very slowly and then stays in the urine.”

Dr. Salsitz said most practitioners think of fentanyl as a short-acting drug, so “it’s important to realize that people may continue to test positive and it should be thought of as a long-acting opioid.”
 

Opiate screening tests don’t work

Dr. Salsitz warned of another misconception in fentanyl testing – the common mistake of assuming that fentanyl should show up in a test for opiates – when in fact fentanyl is not, technically, an opiate.

“The word opiate only refers to morphine, codeine, heroin and sometimes hydrocodone,” he explained. “Other opioids are classified as semisynthetic, such as oxycodone, or synthetics, such as fentanyl and methadone, buprenorphine.”

“In order to detect the synthetics, you must have a separate strip for each one of those drugs. They will not show up positive on a screen for opiates,” he noted.

The belief that fentanyl and other synthetic and semisynthetic opioids will show positive on an opiate screen is a common misconception, he said. “The misunderstanding in toxicology interpretation is a problem for many practitioners, [but] it’s essential to understand because otherwise false assumptions about the patient will be considered.”

Another important testing misreading can occur with the antidepressant drug trazodone, which Dr. Salsitz cautioned may falsely test as positive for fentanyl on immunoassays.

“Trazodone is very commonly used in addiction treatment centers, but it can give a false positive on the fentanyl immunoassay and we’ve had a number of those cases,” he said.

Dr. Salsitz had no disclosures to report.

The Psychopharmacology Update was sponsored by Medscape Live. Medscape Live and this news organization are owned by the same parent company.

As fentanyl-related overdose deaths continue to increase, clinicians should take note of important differences that set the drug apart from the other drugs of misuse – and the troubling reality that fentanyl now contaminates most of them.

“It would be fair to tell patients, if you’re buying any illicit drugs – pills, powder, liquid, whatever it is, you’ve got to assume it’s either contaminated with or replaced by fentanyl,” said Edwin Salsitz, MD, an associate clinical professor at the Icahn School of Medicine at Mount Sinai, New York, during a presentation on the subject at the 21st Annual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

In many if not most cases, he noted, patients become addicted to fentanyl unknowingly. They assume they are ingesting oxycodone, cocaine, or another drug, and have no realization that they are even exposed to fentanyl until they test positive for it – or overdose.

Meanwhile, the high potency of fentanyl can overcome the opioid blockade of addiction treatment therapies – methadone and buprenorphine – that take away the high that users get from less potent drugs such as heroin.

“Fentanyl is overcoming this blockade that methadone and buprenorphine used to provide,” Dr. Salsitz said. “With fentanyl having such a higher potency, patients are saying ‘no, I still feel the fentanyl effects,’ and they continue feeling it even with 200 milligrams of methadone or 24 milligrams of buprenorphine.”
 

‘Wooden chest syndrome’

Among the lesser-known dangers of fentanyl is the possibility that some overdose deaths may occur as the result of a syndrome previously reported as a rare complication following the medical use of fentanyl in critically ill patients – fentanyl-induced chest-wall rigidity, or “wooden chest syndrome,” Dr. Salsitz explained.

In such cases, the muscles of respiration become rigid and paralyzed, causing suffocation within a matter of minutes – too soon to benefit from the overdose rescue medication naloxone.

In one recent study published in Clinical Toxicology , nearly half of fentanyl overdose deaths were found to have occurred even before the body had a chance to produce norfentanyl, a metabolite of fentanyl that takes only about 2-3 minutes to appear in the system, suggesting the deaths occurred rapidly.

In the study of 48 fentanyl deaths, no appreciable concentrations of norfentanyl could be detected in 20 of the 48 overdose deaths (42%), and concentrations were less than 1 ng/mL in 25 cases (52%).

“The lack of any measurable norfentanyl in half of our cases suggests a very rapid death, consistent with acute chest rigidity,” the authors reported.

“In several cases fentanyl concentrations were strikingly high (22 ng/mL and 20 ng/mL) with no norfentanyl detected,” they said.

Dr. Salsitz noted that the syndrome is not well known among the addiction treatment community.

“This is different than the usual respiratory opioid overdose where there’s a gradual decrease in the breathing rate and a gradual decrease in how much air is going in and out of the lungs,” Dr. Salsitz explained.

“With those cases, some may survive for an hour or longer, allowing time for someone to administer naloxone or to get the patient to the emergency room,” he said. “But with this, breathing stops and people can die within minutes.

“I think that this is one of the reasons that fentanyl deaths keep going up despite more and more naloxone availability out there,” he said.
 

Clearance may take longer

In toxicology testing for fentanyl, clinicians should also note the important difference between fentanyl and other opioids – that fentanyl, because of its high lipophilicity, may be detected in urine toxicology testing up to 3 weeks after last use. This is much longer than the 2- to 4-day clearance observed with other opioids, possibly causing patients to continue to test positive for the drug weeks after cessation.

This effect was observed in one recent study of 12 opioid use disorder patients in a residential treatment program who had previously been exposed to daily fentanyl.

The study showed the mean amount of time of fentanyl clearance was 2 weeks, with a range of 4-26 days after last use.

The authors pointed out that the findings “might explain recent reports of difficulty in buprenorphine inductions for persons who use fentanyl, and point to a need to better understand the pharmacokinetics of fentanyl in the context of opioid withdrawal in persons who regularly use fentanyl.”

Though the study was small, Dr. Salsitz said “that’s not a stumbling block to the important finding that, with regular use of fentanyl, the drug may stay in the urine for a long time.”

Dr. Salsitz noted that similar observations have been made at his center, with clinicians logically assuming that patients were still somehow getting fentanyl.

“When we initially found this in patients, we thought that they were using on the unit, perhaps that they brought in the fentanyl, because otherwise how could it stay in the urine that long,” he noted. “But fentanyl appears to be more lipophilic and gets into the fat; it’s then excreted very slowly and then stays in the urine.”

Dr. Salsitz said most practitioners think of fentanyl as a short-acting drug, so “it’s important to realize that people may continue to test positive and it should be thought of as a long-acting opioid.”
 

Opiate screening tests don’t work

Dr. Salsitz warned of another misconception in fentanyl testing – the common mistake of assuming that fentanyl should show up in a test for opiates – when in fact fentanyl is not, technically, an opiate.

“The word opiate only refers to morphine, codeine, heroin and sometimes hydrocodone,” he explained. “Other opioids are classified as semisynthetic, such as oxycodone, or synthetics, such as fentanyl and methadone, buprenorphine.”

“In order to detect the synthetics, you must have a separate strip for each one of those drugs. They will not show up positive on a screen for opiates,” he noted.

The belief that fentanyl and other synthetic and semisynthetic opioids will show positive on an opiate screen is a common misconception, he said. “The misunderstanding in toxicology interpretation is a problem for many practitioners, [but] it’s essential to understand because otherwise false assumptions about the patient will be considered.”

Another important testing misreading can occur with the antidepressant drug trazodone, which Dr. Salsitz cautioned may falsely test as positive for fentanyl on immunoassays.

“Trazodone is very commonly used in addiction treatment centers, but it can give a false positive on the fentanyl immunoassay and we’ve had a number of those cases,” he said.

Dr. Salsitz had no disclosures to report.

The Psychopharmacology Update was sponsored by Medscape Live. Medscape Live and this news organization are owned by the same parent company.

SAN FRANCISCO – Widely anticipated data from a phase 3 trial of the monoclonal antibody lecanemab suggest the drug “modestly” relieved cognitive impairment in patients with early Alzheimer’s disease (AD) – but at a cost.

In the CLARITY AD trial, adverse events (AEs) were common compared with placebo, including amyloid-related edema and effusions; and a recent news report linked a second death to the drug.

Moving forward, “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease,” wrote Christopher H. van Dyck, MD, Yale University, New Haven, Conn., and colleagues.

The full trial findings were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, with simultaneous publication on Nov. 29 in the New England Journal of Medicine.
 

Complications in the field

The phase 3 trial of lecanemab has been closely watched in AD circles, especially considering positive early data released in September and reported by this news organization at that time.

The Food and Drug Administration is expected to make a decision about possible approval of the drug in January 2023. Only one other antiamyloid treatment, the highly controversial and expensive aducanumab (Aduhelm), is currently approved by the FDA.

For the new 18-month, randomized, double-blind CLARITY AD trial, researchers enrolled 1,795 patients aged 50-90 years (average age, 71 years) with early AD. All were randomly assigned to receive either a placebo (n = 898) or intravenous lecanemab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively targets amyloid beta (A-beta) protofibrils, at 10 mg/kg of body weight every 2 weeks (n = 897).

The study ran from 2019 to 2021. The participants (52% women, 20% non-White) were recruited in North America, Europe, and Asia. Safety data included all participants, and the modified intention-to-treat group included 1,734 participants, with 859 receiving lecanemab and 875 receiving placebo.

The primary endpoint was the Clinical Dementia Rating–Sum of Boxes (CDR-SB). Scores from 0.5 to 6 are signs of early AD, according to the study. The mean baseline score for both groups was 3.2. The adjusted mean change at 18 months was 1.21 for lecanemab versus 1.66 for placebo (difference, –0.45; 95% confidence interval [CI], –0.67 to –0.23; P < .001).

As Dr. van Dyck noted in his presentation at the CTAD meting, this represents a 27% slowing of the decline in the lecanemab group.

The published findings do not speculate about how this difference would affect the day-to-day life of participants who took the drug, although it does refer to “modestly less decline” of cognition/function in the lecanemab group.

Other measurements that suggest cognitive improvements in the lecanemab group versus placebo include the Alzheimer’s Disease Assessment Scale–Cognitive Subscale score (mean difference, –1.44; 95% CI, –2.27 to –0.61), the Alzheimer’s Disease Composite Score (mean difference, –0.05; 95% CI, –.074 to –.027,), and the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment score (mean difference, 2.0; 95% CI, 1.2-2.8; all, P < .001).

Overall, Dr. van Dyck said, “Lecanemab met the primary and secondary endpoints versus placebo at 18 months, with highly significant differences starting at 6 months.”

In a substudy of 698 participants, results showed that amyloid burden fell at a higher rate in the lecanemab group than in the placebo group (difference, –59.1 centiloids; 95% CI, –62.6 to –55.6).

“Lecanemab has high selectivity for soluble aggregated species of A-beta as compared with monomeric amyloid, with moderate selectivity for fibrillar amyloid; this profile is considered to target the most toxic pathologic amyloid species,” the researchers wrote.
 

Concerning AE data

With respect to AEs, deaths occurred in both groups (0.7% in those who took lecanemab and 0.8% in those who took the placebo). The researchers did not attribute any deaths to the drug. However, according to a report in the journal Science published Nov. 27, a 65-year-old woman who was taking the drug as part of a clinical trial “recently died from a massive brain hemorrhage that some researchers link to the drug.”

The woman, the second person “whose death was linked to lecanemab,” died after suffering a stroke. Researchers summarized a case report as saying that the drug “contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels.”

Eisai, which sponsored the new trial, told Science that “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.”

In a CTAD presentation, study coauthor Marwan Sabbagh, MD, Barrow Neurological Institute, Phoenix, said two hemorrhage-related deaths occurred in an open-label extension. One was in the context of a tissue plasminogen activator treatment for a stroke, which fits with the description of the case in the Science report. “Causality with lecanemab is a little difficult ...,” he said. “Patients on anticoagulation might need further consideration.”

In the CLARITY AD Trial, serious AEs occurred in 14% of the lecanemab group, leading to discontinuation 6.9% of the time, and in 11.3% of the placebo group, leading to discontinuation 2.9% of the time, the investigators reported.

They added that, in the lecanemab group, the most common AEs, defined as affecting more than 10% of participants, were infusion-related reactions (26.4% vs. 7.4% for placebo); amyloid-related imaging abnormalities with cerebral microhemorrhages, cerebral macrohemorrhages, or superficial siderosis (17.3% vs. 9%, respectively); amyloid-related imaging abnormalities with edema or effusions (12.6% vs. 1.7%); headache (11.1% vs. 8.1%); and falls (10.4% vs. 9.6%).

In addition, macrohemorrhage was reported in 0.6% of the lecanemab group and 0.1% of the placebo group.
 

Cautious optimism

In separate interviews, two Alzheimer’s specialists who weren’t involved in the study praised the trial and described the findings as “exciting.” But they also highlighted its limitations.

Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School and chief medical officer of Linus Health, said the study represents impressive progress after 60-plus trials examining anti-amyloid monoclonal antibodies. “This is the first trial that shows a clinical benefit that can be measured,” he said.

However, it’s unclear whether the changes “are really going to make a difference in people’s lives,” he said. The drug is likely to be expensive, owing to the large investment needed for research, he added, and patients will have to undergo costly testing, such as PET scans and spinal taps.

Still, “this could be a valuable adjunct to the armamentarium we have,” which includes interventions such as lifestyle changes, he said.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, noted that the trial reached its primary and secondary endpoints and that the drug had what he called a “modest” effect on cognition.

However, the drugmaker will need to explore the adverse effects, he said, especially among patients with atrial fibrillation who take anticoagulants. And, he said, medicine is still far from the ultimate goal – fully reversing cognitive decline.

Michael Weiner, MD, president of the CTAD22 Scientific Committee, noted in a press release that there is “growing evidence” that some antiamyloid therapies, “especially lecanemab and donanemab” have shown promising results.

“Unfortunately, these treatments are also associated with abnormal differences seen in imaging, including brain swelling and bleeding in the brain,” said Dr. Weiner, professor of radiology, medicine, and neurology at the University of California, San Francisco.

“There is considerable controversy concerning the significance and impact of these findings, including whether or not governments and medical insurance will provide financial coverage for such treatments,” he added.
 

Rave reviews from the Alzheimer’s Association

In a statement, the Alzheimer’s Association raved about lecanemab and declared that the FDA should approve lecanemab on an accelerated basis. The study “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease ...” the association said, adding that “it could mean many months more of recognizing their spouse, children and grandchildren.”

The association, which is a staunch supporter of aducanumab, called on the Centers for Medicare & Medicaid Services to cover the drug if the FDA approves it. The association’s statement did not address the drug’s potential high cost, the adverse effects, or the two reported deaths.

The trial was supported by Eisai (regulatory sponsor) with partial funding from Biogen. Dr. van Dyck reports having received research grants from Biogen, Eisai, Biohaven, Cerevel Therapeutics, Eli Lilly, Genentech, Janssen, Novartis, and UCB. He has been a consultant to Cerevel, Eisai, Ono Pharmaceutical, and Roche. Relevant financial relationships for the other investigators are fully listed in the original article.

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

SAN FRANCISCO – Widely anticipated data from a phase 3 trial of the monoclonal antibody lecanemab suggest the drug “modestly” relieved cognitive impairment in patients with early Alzheimer’s disease (AD) – but at a cost.

In the CLARITY AD trial, adverse events (AEs) were common compared with placebo, including amyloid-related edema and effusions; and a recent news report linked a second death to the drug.

Moving forward, “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease,” wrote Christopher H. van Dyck, MD, Yale University, New Haven, Conn., and colleagues.

The full trial findings were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, with simultaneous publication on Nov. 29 in the New England Journal of Medicine.
 

Complications in the field

The phase 3 trial of lecanemab has been closely watched in AD circles, especially considering positive early data released in September and reported by this news organization at that time.

The Food and Drug Administration is expected to make a decision about possible approval of the drug in January 2023. Only one other antiamyloid treatment, the highly controversial and expensive aducanumab (Aduhelm), is currently approved by the FDA.

For the new 18-month, randomized, double-blind CLARITY AD trial, researchers enrolled 1,795 patients aged 50-90 years (average age, 71 years) with early AD. All were randomly assigned to receive either a placebo (n = 898) or intravenous lecanemab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively targets amyloid beta (A-beta) protofibrils, at 10 mg/kg of body weight every 2 weeks (n = 897).

The study ran from 2019 to 2021. The participants (52% women, 20% non-White) were recruited in North America, Europe, and Asia. Safety data included all participants, and the modified intention-to-treat group included 1,734 participants, with 859 receiving lecanemab and 875 receiving placebo.

The primary endpoint was the Clinical Dementia Rating–Sum of Boxes (CDR-SB). Scores from 0.5 to 6 are signs of early AD, according to the study. The mean baseline score for both groups was 3.2. The adjusted mean change at 18 months was 1.21 for lecanemab versus 1.66 for placebo (difference, –0.45; 95% confidence interval [CI], –0.67 to –0.23; P < .001).

As Dr. van Dyck noted in his presentation at the CTAD meting, this represents a 27% slowing of the decline in the lecanemab group.

The published findings do not speculate about how this difference would affect the day-to-day life of participants who took the drug, although it does refer to “modestly less decline” of cognition/function in the lecanemab group.

Other measurements that suggest cognitive improvements in the lecanemab group versus placebo include the Alzheimer’s Disease Assessment Scale–Cognitive Subscale score (mean difference, –1.44; 95% CI, –2.27 to –0.61), the Alzheimer’s Disease Composite Score (mean difference, –0.05; 95% CI, –.074 to –.027,), and the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment score (mean difference, 2.0; 95% CI, 1.2-2.8; all, P < .001).

Overall, Dr. van Dyck said, “Lecanemab met the primary and secondary endpoints versus placebo at 18 months, with highly significant differences starting at 6 months.”

In a substudy of 698 participants, results showed that amyloid burden fell at a higher rate in the lecanemab group than in the placebo group (difference, –59.1 centiloids; 95% CI, –62.6 to –55.6).

“Lecanemab has high selectivity for soluble aggregated species of A-beta as compared with monomeric amyloid, with moderate selectivity for fibrillar amyloid; this profile is considered to target the most toxic pathologic amyloid species,” the researchers wrote.
 

Concerning AE data

With respect to AEs, deaths occurred in both groups (0.7% in those who took lecanemab and 0.8% in those who took the placebo). The researchers did not attribute any deaths to the drug. However, according to a report in the journal Science published Nov. 27, a 65-year-old woman who was taking the drug as part of a clinical trial “recently died from a massive brain hemorrhage that some researchers link to the drug.”

The woman, the second person “whose death was linked to lecanemab,” died after suffering a stroke. Researchers summarized a case report as saying that the drug “contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels.”

Eisai, which sponsored the new trial, told Science that “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.”

In a CTAD presentation, study coauthor Marwan Sabbagh, MD, Barrow Neurological Institute, Phoenix, said two hemorrhage-related deaths occurred in an open-label extension. One was in the context of a tissue plasminogen activator treatment for a stroke, which fits with the description of the case in the Science report. “Causality with lecanemab is a little difficult ...,” he said. “Patients on anticoagulation might need further consideration.”

In the CLARITY AD Trial, serious AEs occurred in 14% of the lecanemab group, leading to discontinuation 6.9% of the time, and in 11.3% of the placebo group, leading to discontinuation 2.9% of the time, the investigators reported.

They added that, in the lecanemab group, the most common AEs, defined as affecting more than 10% of participants, were infusion-related reactions (26.4% vs. 7.4% for placebo); amyloid-related imaging abnormalities with cerebral microhemorrhages, cerebral macrohemorrhages, or superficial siderosis (17.3% vs. 9%, respectively); amyloid-related imaging abnormalities with edema or effusions (12.6% vs. 1.7%); headache (11.1% vs. 8.1%); and falls (10.4% vs. 9.6%).

In addition, macrohemorrhage was reported in 0.6% of the lecanemab group and 0.1% of the placebo group.
 

Cautious optimism

In separate interviews, two Alzheimer’s specialists who weren’t involved in the study praised the trial and described the findings as “exciting.” But they also highlighted its limitations.

Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School and chief medical officer of Linus Health, said the study represents impressive progress after 60-plus trials examining anti-amyloid monoclonal antibodies. “This is the first trial that shows a clinical benefit that can be measured,” he said.

However, it’s unclear whether the changes “are really going to make a difference in people’s lives,” he said. The drug is likely to be expensive, owing to the large investment needed for research, he added, and patients will have to undergo costly testing, such as PET scans and spinal taps.

Still, “this could be a valuable adjunct to the armamentarium we have,” which includes interventions such as lifestyle changes, he said.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, noted that the trial reached its primary and secondary endpoints and that the drug had what he called a “modest” effect on cognition.

However, the drugmaker will need to explore the adverse effects, he said, especially among patients with atrial fibrillation who take anticoagulants. And, he said, medicine is still far from the ultimate goal – fully reversing cognitive decline.

Michael Weiner, MD, president of the CTAD22 Scientific Committee, noted in a press release that there is “growing evidence” that some antiamyloid therapies, “especially lecanemab and donanemab” have shown promising results.

“Unfortunately, these treatments are also associated with abnormal differences seen in imaging, including brain swelling and bleeding in the brain,” said Dr. Weiner, professor of radiology, medicine, and neurology at the University of California, San Francisco.

“There is considerable controversy concerning the significance and impact of these findings, including whether or not governments and medical insurance will provide financial coverage for such treatments,” he added.
 

Rave reviews from the Alzheimer’s Association

In a statement, the Alzheimer’s Association raved about lecanemab and declared that the FDA should approve lecanemab on an accelerated basis. The study “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease ...” the association said, adding that “it could mean many months more of recognizing their spouse, children and grandchildren.”

The association, which is a staunch supporter of aducanumab, called on the Centers for Medicare & Medicaid Services to cover the drug if the FDA approves it. The association’s statement did not address the drug’s potential high cost, the adverse effects, or the two reported deaths.

The trial was supported by Eisai (regulatory sponsor) with partial funding from Biogen. Dr. van Dyck reports having received research grants from Biogen, Eisai, Biohaven, Cerevel Therapeutics, Eli Lilly, Genentech, Janssen, Novartis, and UCB. He has been a consultant to Cerevel, Eisai, Ono Pharmaceutical, and Roche. Relevant financial relationships for the other investigators are fully listed in the original article.

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

SAN FRANCISCO – Widely anticipated data from a phase 3 trial of the monoclonal antibody lecanemab suggest the drug “modestly” relieved cognitive impairment in patients with early Alzheimer’s disease (AD) – but at a cost.

In the CLARITY AD trial, adverse events (AEs) were common compared with placebo, including amyloid-related edema and effusions; and a recent news report linked a second death to the drug.

Moving forward, “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease,” wrote Christopher H. van Dyck, MD, Yale University, New Haven, Conn., and colleagues.

The full trial findings were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, with simultaneous publication on Nov. 29 in the New England Journal of Medicine.
 

Complications in the field

The phase 3 trial of lecanemab has been closely watched in AD circles, especially considering positive early data released in September and reported by this news organization at that time.

The Food and Drug Administration is expected to make a decision about possible approval of the drug in January 2023. Only one other antiamyloid treatment, the highly controversial and expensive aducanumab (Aduhelm), is currently approved by the FDA.

For the new 18-month, randomized, double-blind CLARITY AD trial, researchers enrolled 1,795 patients aged 50-90 years (average age, 71 years) with early AD. All were randomly assigned to receive either a placebo (n = 898) or intravenous lecanemab, a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively targets amyloid beta (A-beta) protofibrils, at 10 mg/kg of body weight every 2 weeks (n = 897).

The study ran from 2019 to 2021. The participants (52% women, 20% non-White) were recruited in North America, Europe, and Asia. Safety data included all participants, and the modified intention-to-treat group included 1,734 participants, with 859 receiving lecanemab and 875 receiving placebo.

The primary endpoint was the Clinical Dementia Rating–Sum of Boxes (CDR-SB). Scores from 0.5 to 6 are signs of early AD, according to the study. The mean baseline score for both groups was 3.2. The adjusted mean change at 18 months was 1.21 for lecanemab versus 1.66 for placebo (difference, –0.45; 95% confidence interval [CI], –0.67 to –0.23; P < .001).

As Dr. van Dyck noted in his presentation at the CTAD meting, this represents a 27% slowing of the decline in the lecanemab group.

The published findings do not speculate about how this difference would affect the day-to-day life of participants who took the drug, although it does refer to “modestly less decline” of cognition/function in the lecanemab group.

Other measurements that suggest cognitive improvements in the lecanemab group versus placebo include the Alzheimer’s Disease Assessment Scale–Cognitive Subscale score (mean difference, –1.44; 95% CI, –2.27 to –0.61), the Alzheimer’s Disease Composite Score (mean difference, –0.05; 95% CI, –.074 to –.027,), and the Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment score (mean difference, 2.0; 95% CI, 1.2-2.8; all, P < .001).

Overall, Dr. van Dyck said, “Lecanemab met the primary and secondary endpoints versus placebo at 18 months, with highly significant differences starting at 6 months.”

In a substudy of 698 participants, results showed that amyloid burden fell at a higher rate in the lecanemab group than in the placebo group (difference, –59.1 centiloids; 95% CI, –62.6 to –55.6).

“Lecanemab has high selectivity for soluble aggregated species of A-beta as compared with monomeric amyloid, with moderate selectivity for fibrillar amyloid; this profile is considered to target the most toxic pathologic amyloid species,” the researchers wrote.
 

Concerning AE data

With respect to AEs, deaths occurred in both groups (0.7% in those who took lecanemab and 0.8% in those who took the placebo). The researchers did not attribute any deaths to the drug. However, according to a report in the journal Science published Nov. 27, a 65-year-old woman who was taking the drug as part of a clinical trial “recently died from a massive brain hemorrhage that some researchers link to the drug.”

The woman, the second person “whose death was linked to lecanemab,” died after suffering a stroke. Researchers summarized a case report as saying that the drug “contributed to her brain hemorrhage after biweekly infusions of lecanemab inflamed and weakened the blood vessels.”

Eisai, which sponsored the new trial, told Science that “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause.”

In a CTAD presentation, study coauthor Marwan Sabbagh, MD, Barrow Neurological Institute, Phoenix, said two hemorrhage-related deaths occurred in an open-label extension. One was in the context of a tissue plasminogen activator treatment for a stroke, which fits with the description of the case in the Science report. “Causality with lecanemab is a little difficult ...,” he said. “Patients on anticoagulation might need further consideration.”

In the CLARITY AD Trial, serious AEs occurred in 14% of the lecanemab group, leading to discontinuation 6.9% of the time, and in 11.3% of the placebo group, leading to discontinuation 2.9% of the time, the investigators reported.

They added that, in the lecanemab group, the most common AEs, defined as affecting more than 10% of participants, were infusion-related reactions (26.4% vs. 7.4% for placebo); amyloid-related imaging abnormalities with cerebral microhemorrhages, cerebral macrohemorrhages, or superficial siderosis (17.3% vs. 9%, respectively); amyloid-related imaging abnormalities with edema or effusions (12.6% vs. 1.7%); headache (11.1% vs. 8.1%); and falls (10.4% vs. 9.6%).

In addition, macrohemorrhage was reported in 0.6% of the lecanemab group and 0.1% of the placebo group.
 

Cautious optimism

In separate interviews, two Alzheimer’s specialists who weren’t involved in the study praised the trial and described the findings as “exciting.” But they also highlighted its limitations.

Alvaro Pascual-Leone, MD, PhD, professor of neurology at Harvard Medical School and chief medical officer of Linus Health, said the study represents impressive progress after 60-plus trials examining anti-amyloid monoclonal antibodies. “This is the first trial that shows a clinical benefit that can be measured,” he said.

However, it’s unclear whether the changes “are really going to make a difference in people’s lives,” he said. The drug is likely to be expensive, owing to the large investment needed for research, he added, and patients will have to undergo costly testing, such as PET scans and spinal taps.

Still, “this could be a valuable adjunct to the armamentarium we have,” which includes interventions such as lifestyle changes, he said.

Howard Fillit, MD, cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation, noted that the trial reached its primary and secondary endpoints and that the drug had what he called a “modest” effect on cognition.

However, the drugmaker will need to explore the adverse effects, he said, especially among patients with atrial fibrillation who take anticoagulants. And, he said, medicine is still far from the ultimate goal – fully reversing cognitive decline.

Michael Weiner, MD, president of the CTAD22 Scientific Committee, noted in a press release that there is “growing evidence” that some antiamyloid therapies, “especially lecanemab and donanemab” have shown promising results.

“Unfortunately, these treatments are also associated with abnormal differences seen in imaging, including brain swelling and bleeding in the brain,” said Dr. Weiner, professor of radiology, medicine, and neurology at the University of California, San Francisco.

“There is considerable controversy concerning the significance and impact of these findings, including whether or not governments and medical insurance will provide financial coverage for such treatments,” he added.
 

Rave reviews from the Alzheimer’s Association

In a statement, the Alzheimer’s Association raved about lecanemab and declared that the FDA should approve lecanemab on an accelerated basis. The study “confirms this treatment can meaningfully change the course of the disease for people in the earliest stages of Alzheimer’s disease ...” the association said, adding that “it could mean many months more of recognizing their spouse, children and grandchildren.”

The association, which is a staunch supporter of aducanumab, called on the Centers for Medicare & Medicaid Services to cover the drug if the FDA approves it. The association’s statement did not address the drug’s potential high cost, the adverse effects, or the two reported deaths.

The trial was supported by Eisai (regulatory sponsor) with partial funding from Biogen. Dr. van Dyck reports having received research grants from Biogen, Eisai, Biohaven, Cerevel Therapeutics, Eli Lilly, Genentech, Janssen, Novartis, and UCB. He has been a consultant to Cerevel, Eisai, Ono Pharmaceutical, and Roche. Relevant financial relationships for the other investigators are fully listed in the original article.

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

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

Rates of youth suicides at the county level increased as mental health professional shortages increased, based on data from more than 5,000 youth suicides across all counties in the United States.

Suicide remains the second leading cause of death among adolescents in the United States, and shortages of pediatric mental health providers are well known, but the association between mental health workforce shortages and youth suicides at the local level has not been well studied, Jennifer A. Hoffmann, MD, of Northwestern University, Chicago, and colleagues wrote.

Previous studies have shown few or no child psychiatrists or child-focused mental health professionals in most counties across the United States, and shortages are more likely in rural and high-poverty counties, the researchers noted.

In a cross-sectional study published in JAMA Pediatrics, the researchers reviewed all youth suicide data from January 2015 to Dec. 31, 2016 using the Centers for Disease Control and Prevention’s Compressed Mortality File. They used a multivariate binomial regression model to examine the association between youth suicide rates and the presence or absence of mental health care. Mental health care shortages were based on data from the U.S. Health Resources and Services Administration’s assessment of the number of mental health professionals relative to the country population and the availability of nearby services. Areas identified as having shortages were designated as Health Professional Shortage Areas (HPSAs) and scored on a severity level of 0-25, with higher scores indicating greater shortages. Approximately two-thirds (67.6%) of the 3,133 counties included in the study met criteria for mental health workforce shortage areas.

The researchers identified 5,034 suicides in youth aged 5-19 years during the study period, for an annual rate of 3.99 per 100,000 individuals. Of these, 72.8% were male and 68.2% were non-Hispanic White.

Overall, a county designation of mental health care shortage was significantly associated with an increased rate of youth suicide (adjusted incidence rate ratio, 1.16) and also increased rate of youth firearm suicide (aIRR, 1.27) after controlling for county and socioeconomic characteristics including the presence of a children’s mental health hospital, the percentage of children without health insurance, median household income, and racial makeup of the county.

The adjusted youth suicide rate increased by 4% for every 1-point increase in the HPSA score in counties with designated mental health workforce shortages.

The adjusted youth suicide rates were higher in counties with a lower median household income, and youth suicides increased with increases in the percentages of uninsured children, the researchers wrote.

“Reducing poverty, addressing social determinants of health, and improving insurance coverage may be considered as components of a multipronged societal strategy to improve child health and reduce youth suicides,” they said. “Efforts are needed to enhance the mental health professional workforce to match current levels of need.” Possible strategies to increase the pediatric mental health workforce may include improving reimbursement and integrating mental health care into primary care and schools by expanding telehealth services.

The study findings were limited by several factors including the potential misclassification of demographics or cause of death, the researchers noted. Other limitations included the inability to assess actual use of mental health services or firearm ownership in a household, and the possible differences between county-level associations and those of a city, neighborhood, or individual.

However, the results indicate that mental health professional workforce shortages were associated with increased youth suicide rates, and the data may inform local-level suicide prevention efforts, they concluded.
 

Data support the need for early intervention

“It was very important to conduct this study at this time because mental health problems, to include suicidal ideation, continue to increase in adolescents,” Peter L. Loper Jr., MD, of the University of South Carolina, Columbia, said in an interview. “This study reinforces the immense import of sufficient mental health workforce to mitigate this increasing risk of suicide in adolescents.”

Dr. Loper said: “I believe that early intervention, or consistent access to mental health services, can go a very long way in preventing suicide in adolescents.

“I think the primary implications of this study are more relevant at the systems level, and reinforce the necessity of clinicians advocating for policies that address mental health workforce shortages in counties that are underserved,” he added.

However, “One primary barrier to increasing the number of mental health professionals at a local level, and specifically the number of child psychiatrists, is that demand is currently outpacing supply,” said Dr. Loper, a pediatrician and psychiatrist who was not involved in the study. “As the study authors cite, increasing telepsychiatry services and increasing mental health workforce specifically in the primary care setting may help offset these deficiencies,” he noted. Looking ahead, primary prevention of mental health problems by grassroots efforts is vital to stopping the trend in increased youth suicides and more mental health professionals are needed to mitigate the phenomenon of isolation and the degradation of community constructs.

As for additional research, Dr. Loper agreed with the study authors comments on the need for “more granular data” to better understand the correlation between mental health workforce and suicide in adolescents. “Data that captures city or neighborhood statistics related to mental health workforce and adolescent suicide could go a long way in our efforts to continue to better understand this very important correlation.”

The study was supported by an Academic Pediatric Association Young Investigator Award. Dr. Hoffmann disclosed research funding from the U.S. Agency for Healthcare Research and Quality unrelated to the current study. Dr. Loper had no financial conflicts to disclose.

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

Intermittent fasting (IF), defined as fasting for more than eight hours at a time, is a trend that is growing in popularity. Yet new research shows it may be linked to eating disorder (ED) behaviors.

Researchers from the University of Toronto analyzed data from more than 2700 adolescents and young adults from the Canadian Study of Adolescent Health Behaviors, and found that for women, IF was significantly associated with overeating, binge eating, vomiting, laxative use, and compulsive exercise.

IF in women was also associated with higher scores on the Eating Disorder Examination Questionnaire (EDE-Q), which was used to determine ED psychopathology.

Study investigator Kyle Ganson, PhD, assistant professor in the Factor-Inwentash Faculty of Social Work at the University of Toronto, said in an interview that evidence on the effectiveness of IF for weight loss and disease prevention is mixed, and that it’s important to understand the potential harms of IF – even if there are benefits for some.

“If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors, requiring health care professionals to be very aware of this contemporary and popular dietary trend, despite proponents on social media touting the effectiveness and benefits,” he said.

The study was published online in Eating Behaviors.
 

Touted for health benefits

The practice of IF has been gaining popularity partly because of reputable medical experts touting its health benefits. Johns Hopkins Medicine, for instance, cited evidence that IF boosts working memory, improves blood pressure, enhances physical performance, and prevents obesity. Yet there has been little research on its harms.

As part of the Canadian Study of Adolescent Health Behaviors, Dr. Ganson and associates analyzed data on 2,700 adolescents and young adults aged 16-30 recruited from social media ads in November and December 2021. The sample included women, men, and transgender or gender-nonconforming individuals.

Study participants answered questions about weight perception, current weight change behavior, engagement in IF, and participation in eating disorder behaviors. They were also administered the EDE-Q, which measures eating disorder psychopathology.

In total, 47% of women (n = 1,470), 38% of men (n = 1,060), and 52% transgender or gender-nonconforming individuals (n = 225) reported engaging in IF during the past year.

Dr. Ganson and associates found that, for women, IF in the past 12 months and past 30 days were significantly associated with all eating disorder behaviors, including overeating, loss of control, binge eating, vomiting, laxative use, compulsive exercise, and fasting – as well as higher overall EDE-Q global scores.

For men, IF in the past 12 months was significantly associated with compulsive exercise, and higher overall EDE-Q global scores.

The team found that for TGNC participants, IF was positively associated with higher EDE-Q global scores.

The investigators acknowledged some limitations with the study – the method of recruiting, which involved ads placed on social media, could cause selection bias. In addition to this, data collection methods relied heavily on participants’ self-reporting, which could also be susceptible to bias.

“Certainly, there needs to be more investigation on this dietary practice,” said Dr. Ganson. “If anything, this study shines light on the fact that engagement in IF may be connected with problematic ED behaviors requiring healthcare professionals to be very aware of this contemporary and popular dietary trend – despite proponents on social media touting the effectiveness and benefits.”
 

Screening warranted

Dr. Ganson noted that additional research is needed to support the findings from his study, and to further illuminate the potential harms of IF.

Health care professionals “need to be aware of common, contemporary dietary trends that young people engage in and are commonly discussed on social media, such as IF,” he noted. In addition, he’d like to see health care professionals assess their patients for IF who are dieting and to follow-up with assessments for ED-related attitudes and behaviors.

“Additionally, there are likely bidirectional relationships between IF and ED attitudes and behaviors, so professionals should be aware the ways in which ED behaviors are masked as IF engagement,” Dr. Ganson said.
 

More research needed

Commenting on the findings, Angela Guarda, MD, professor of eating disorders at Johns Hopkins University and director of the eating disorders program at Johns Hopkins Hospital, both in Baltimore, said more research is needed on outcomes for IF.

“We lack a definitive answer. The reality is that IF may help some and harm others and is most likely not healthy for all,” she said, noting that the study results “support what many in the eating disorders field believe, namely that IF for someone who is at risk for an eating disorder is likely to be ill advised.”

She added that “continued research is needed to establish its safety, and for whom it may be a therapeutic versus an iatrogenic recommendation.”

The study was funded by the Connaught New Researcher Award. The authors reported no relevant financial relationships.

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

THE CASE

Alex T,* a 23-year-old first-time mom, presented to the family medicine office for her baby’s 2-week appointment. When asked how she was doing, she began to cry. She said, “I feel crazy” and indicated that she was feeling down and overwhelmed, and was struggling to bond with the baby. She filled out an Edinburgh Postnatal Depression Scale, a standard postpartum depression (PPD) screen; her score, 15 out of 30, was suggestive of depression. Ms. T had been coming to the practice for the past 3 years and had no significant physical or mental health history. She and the baby did not live with the baby’s father, and his degree of presence in their lives varied.

●How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

PPD, traditionally defined as depression in the postpartum period for as long as a year after childbirth, is a common, underdiagnosed outcome of both normal and complicated pregnancies.¹ Peripartum depression, which includes PPD and depression during pregnancy, occurs in approximately 10% of pregnancies.^2,3 When depression first appears in the postpartum period, most women develop symptoms in the first month after delivery (54% of cases) or in the next 2 to 4 months (40%).⁴

The most significant risk factor for PPD is previous depression, peripartum or otherwise.^1,4-6 Other common risk factors include major life events or stressors during or after pregnancy, domestic violence, poor social support, and preterm birth or an infant admission to the neonatal intensive care unit.^1,7 Women with a self-perceived negative birth experience are also likely to experience PPD.⁸ PPD can be associated with significant morbidity and mortality, with suicide a more common cause of maternal mortality than either hemorrhage or hypertensive disorders of pregnancy.⁹

Women with postpartum anemia and low ferritin stores are more prone to depression than are those with normal levels.

Early diagnosis and intervention are crucial to improving patient outcomes. Women with PPD initiate breastfeeding at lower rates and continue for shorter durations.¹⁰ PPD also affects maternal–infant bonding; may adversely affect an infant’s social, cognitive, and language development; and may lead to attachment disorders of infancy.^11,12 In severe cases, it can lead to failure to thrive or infanticide.¹¹

When to screen. The US Preventive Services Task Force (USPSTF) recommends clinicians screen for depression in pregnant and postpartum women (Grade B^a) and for women at increased risk, provide or refer to counseling interventions (Grade B^a).^13,14 The American College of Obstetricians and Gynecologists (ACOG) recommends screening at least once in the postpartum period.¹⁵ Repeat screening at follow-up in the later postpartum period increases the likelihood of diagnosis.¹⁶ Screening for PPD as part of well-child care improves maternal outcomes, and the American Academy of Pediatrics recommends screening at the 1-, 2-, 4-, and 6-month visits.^11,17 These screens are separately billable. Family physicians are uniquely suited to screening at both well-child and postpartum visits, as many women share a medical home with their child, and those who do not are equally willing to receive medical advice from their child’s physician.¹⁸

Continue to: Is it "the blues" or something else? Diagnosing PPD

Many new mothers experience postpartum blues, which manifest as tearfulness, insomnia, irritability, and anxiety. The postpartum blues, however, don’t meet the criteria for major depressive disorder and typically resolve within 14 days of delivery.^19-21 On the other end of the spectrum is postpartum psychosis, which is severe and rare, and can also affect new mothers.

Screening for PPD. The most commonly used screening tool for PPD is the Edinburgh Postnatal Depression Scale (EPDS 10), a free 10-item instrument scored out of 30 possible points, with any score ≥ 13 suggesting PPD.²² The EPDS 10 has a sensitivity of 74% and specificity of 97% for the diagnosis of PPD.²³ Other screening options include the Beck Depression Inventory II (BDI-II) and the Patient Health Questionnaire 9 (PHQ-9). The 21-item BDI-II takes longer to perform and is less sensitive (57%) than the EPDS.¹ The PHQ-9, which asks about some symptoms common to the postpartum period (including sleep changes), is less specific than the EPDS (sensitivity, 75%; specificity, 90%).¹ The EPDS also includes screening questions about anxiety.¹

A positive depression screen, or any positive response to a question on suicidal ideation, should be followed up for confirmation using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria for major depressive disorder with peripartum onset.²⁴ Women with PPD should also be asked about current or prior symptoms of bipolar disorder or mania.²⁵ Up to 67% of women with bipolar disorder may relapse postpartum, and they also have an elevated risk of postpartum psychosis.²⁶ The Mood Disorder Questionnaire is a useful tool if a concern for bipolar depression arises.²⁷

Refer any woman in whom bipolar depression is a concern to a clinician experienced with its management. The presence of auditory or visual hallucinations should also be assessed as indicators of postpartum psychosis. Active suicidal or homicidal ideation and postpartum psychosis all require emergent psychiatric care.^21,22 Intimate partner violence may also exist or escalate in the postpartum period and may exacerbate PPD. Both ACOG and the USPSTF recommend screening postpartum women for intimate partner violence.^28,29

Also consider possible medical causes of PPD symptoms. Hypothyroidism in the postpartum period may manifest with some similar symptoms to PPD and is commonly underdiagnosed.^22,30 Women with postpartum anemia and low ferritin stores also have a higher likelihood of PPD (odds ratio, 1.7-4.64), and postpartum iron supplementation may reduce this risk (number needed to treat = 4 in at least 1 randomized controlled trial).³¹ When anemia is present, ensure that it is properly treated.

Continue to: Steps you can take to manage pPD

Refer any woman who has PPD to a qualified therapist whenever possible. Generally, the psychological recommendations for treatment of PPD are very similar to recommendations for general treatment of depression. Psychotherapy on its own is considered a first-line treatment for mild-to-moderate PPD, and medication plus psychotherapy is considered first-line treatment for severe PPD.³² (Worth noting: It may also be useful to offer counseling to a patient who appears distressed, even if she does not fully meet all DSM-5 criteria.)

Of the psychotherapy options, cognitive behavioral therapy is supported by the most evidence.

Of the psychotherapy options, cognitive behavioral therapy (CBT) is supported by the most evidence. There is also evidence for the use of interpersonal therapy (IPT), especially in higher socioeconomic status populations.³³ Key therapeutic targets in IPT are increasing behavioral engagement (eg, reaching out to friends), decreasing negative self-talk (eg, “I am a bad mother”), and negotiating roles and support (eg, both mom’s and family members’ expectations of new motherhood). There is mixed evidence for recommending exercise as a treatment for PPD.^32,34 However, as exercise is a low-risk intervention, you may choose to make that recommendation to patients. Additionally, including partners/support people in treatment/visits for PPD has been shown to increase positive outcomes.³⁵

When medication is considered, selective serotonin reuptake inhibitors (SSRIs) are most commonly used. Research indicates that SSRIs are significantly more effective than placebo for treatment of women with PPD.³⁶ Sertraline, in particular, has shown to be both effective in treating PPD and safe in lactation.^37,38 Dosing and duration of therapy are equivalent to treatment of major depression outside the perinatal period. Consult a trusted source on medications in lactation before prescribing any antidepressant to a breastfeeding mother. One resource is the National Institutes of Health drugs and lactation database (LactMed; www.ncbi.nlm.nih.gov/books/NBK501922/), which provides detailed information on the levels of medications in breastmilk and their potential effects on an infant.

Women with severe, refractory PPD may require hospitalization. Additional treatment options for women with severe, refractory PPD include electroconvulsive therapy or the new medication brexanolone, which is administered as a 60-hour continuous infusion.^39,40

THE CASE

Further conversation with Ms. T revealed that she met the criteria for PPD (major depressive disorder with peripartum onset). She denied suicidal or homicidal ideation and was not experiencing any symptoms of psychosis. A complete blood count was drawn and showed no anemia, and her thyroid-stimulating hormone level was within normal limits. She had a good support network at home, with both her mom and sister taking shifts to help her get some extra rest and allow her to attend medical appointments. She said there was no domestic violence.

Ms. T was introduced to the clinic’s embedded counselor, who scheduled a follow-up appointment within the week to start CBT. After a discussion of risks and benefits, Ms. T also started a low dose of sertraline once daily. At follow-up postpartum visits, she reported significant improvement in her mood. She and her physician decided to taper her SSRI medication at 3 months postpartum. Screens for depression at her infant’s 4- and 6-month well-child visits in the office were reassuringly negative.

^a There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.

CORRESPONDENCE
Katherine Buck, PhD, JPS Family Health Center, 1500 South Main Street, 4th Floor, Fort Worth, TX 76110; [email protected]

THE CASE

Alex T,* a 23-year-old first-time mom, presented to the family medicine office for her baby’s 2-week appointment. When asked how she was doing, she began to cry. She said, “I feel crazy” and indicated that she was feeling down and overwhelmed, and was struggling to bond with the baby. She filled out an Edinburgh Postnatal Depression Scale, a standard postpartum depression (PPD) screen; her score, 15 out of 30, was suggestive of depression. Ms. T had been coming to the practice for the past 3 years and had no significant physical or mental health history. She and the baby did not live with the baby’s father, and his degree of presence in their lives varied.

●How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

PPD, traditionally defined as depression in the postpartum period for as long as a year after childbirth, is a common, underdiagnosed outcome of both normal and complicated pregnancies.¹ Peripartum depression, which includes PPD and depression during pregnancy, occurs in approximately 10% of pregnancies.^2,3 When depression first appears in the postpartum period, most women develop symptoms in the first month after delivery (54% of cases) or in the next 2 to 4 months (40%).⁴

The most significant risk factor for PPD is previous depression, peripartum or otherwise.^1,4-6 Other common risk factors include major life events or stressors during or after pregnancy, domestic violence, poor social support, and preterm birth or an infant admission to the neonatal intensive care unit.^1,7 Women with a self-perceived negative birth experience are also likely to experience PPD.⁸ PPD can be associated with significant morbidity and mortality, with suicide a more common cause of maternal mortality than either hemorrhage or hypertensive disorders of pregnancy.⁹

Women with postpartum anemia and low ferritin stores are more prone to depression than are those with normal levels.

Early diagnosis and intervention are crucial to improving patient outcomes. Women with PPD initiate breastfeeding at lower rates and continue for shorter durations.¹⁰ PPD also affects maternal–infant bonding; may adversely affect an infant’s social, cognitive, and language development; and may lead to attachment disorders of infancy.^11,12 In severe cases, it can lead to failure to thrive or infanticide.¹¹

When to screen. The US Preventive Services Task Force (USPSTF) recommends clinicians screen for depression in pregnant and postpartum women (Grade B^a) and for women at increased risk, provide or refer to counseling interventions (Grade B^a).^13,14 The American College of Obstetricians and Gynecologists (ACOG) recommends screening at least once in the postpartum period.¹⁵ Repeat screening at follow-up in the later postpartum period increases the likelihood of diagnosis.¹⁶ Screening for PPD as part of well-child care improves maternal outcomes, and the American Academy of Pediatrics recommends screening at the 1-, 2-, 4-, and 6-month visits.^11,17 These screens are separately billable. Family physicians are uniquely suited to screening at both well-child and postpartum visits, as many women share a medical home with their child, and those who do not are equally willing to receive medical advice from their child’s physician.¹⁸

Continue to: Is it "the blues" or something else? Diagnosing PPD

Many new mothers experience postpartum blues, which manifest as tearfulness, insomnia, irritability, and anxiety. The postpartum blues, however, don’t meet the criteria for major depressive disorder and typically resolve within 14 days of delivery.^19-21 On the other end of the spectrum is postpartum psychosis, which is severe and rare, and can also affect new mothers.

Screening for PPD. The most commonly used screening tool for PPD is the Edinburgh Postnatal Depression Scale (EPDS 10), a free 10-item instrument scored out of 30 possible points, with any score ≥ 13 suggesting PPD.²² The EPDS 10 has a sensitivity of 74% and specificity of 97% for the diagnosis of PPD.²³ Other screening options include the Beck Depression Inventory II (BDI-II) and the Patient Health Questionnaire 9 (PHQ-9). The 21-item BDI-II takes longer to perform and is less sensitive (57%) than the EPDS.¹ The PHQ-9, which asks about some symptoms common to the postpartum period (including sleep changes), is less specific than the EPDS (sensitivity, 75%; specificity, 90%).¹ The EPDS also includes screening questions about anxiety.¹

A positive depression screen, or any positive response to a question on suicidal ideation, should be followed up for confirmation using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria for major depressive disorder with peripartum onset.²⁴ Women with PPD should also be asked about current or prior symptoms of bipolar disorder or mania.²⁵ Up to 67% of women with bipolar disorder may relapse postpartum, and they also have an elevated risk of postpartum psychosis.²⁶ The Mood Disorder Questionnaire is a useful tool if a concern for bipolar depression arises.²⁷

Refer any woman in whom bipolar depression is a concern to a clinician experienced with its management. The presence of auditory or visual hallucinations should also be assessed as indicators of postpartum psychosis. Active suicidal or homicidal ideation and postpartum psychosis all require emergent psychiatric care.^21,22 Intimate partner violence may also exist or escalate in the postpartum period and may exacerbate PPD. Both ACOG and the USPSTF recommend screening postpartum women for intimate partner violence.^28,29

Also consider possible medical causes of PPD symptoms. Hypothyroidism in the postpartum period may manifest with some similar symptoms to PPD and is commonly underdiagnosed.^22,30 Women with postpartum anemia and low ferritin stores also have a higher likelihood of PPD (odds ratio, 1.7-4.64), and postpartum iron supplementation may reduce this risk (number needed to treat = 4 in at least 1 randomized controlled trial).³¹ When anemia is present, ensure that it is properly treated.

Continue to: Steps you can take to manage pPD

Refer any woman who has PPD to a qualified therapist whenever possible. Generally, the psychological recommendations for treatment of PPD are very similar to recommendations for general treatment of depression. Psychotherapy on its own is considered a first-line treatment for mild-to-moderate PPD, and medication plus psychotherapy is considered first-line treatment for severe PPD.³² (Worth noting: It may also be useful to offer counseling to a patient who appears distressed, even if she does not fully meet all DSM-5 criteria.)

Of the psychotherapy options, cognitive behavioral therapy is supported by the most evidence.

Of the psychotherapy options, cognitive behavioral therapy (CBT) is supported by the most evidence. There is also evidence for the use of interpersonal therapy (IPT), especially in higher socioeconomic status populations.³³ Key therapeutic targets in IPT are increasing behavioral engagement (eg, reaching out to friends), decreasing negative self-talk (eg, “I am a bad mother”), and negotiating roles and support (eg, both mom’s and family members’ expectations of new motherhood). There is mixed evidence for recommending exercise as a treatment for PPD.^32,34 However, as exercise is a low-risk intervention, you may choose to make that recommendation to patients. Additionally, including partners/support people in treatment/visits for PPD has been shown to increase positive outcomes.³⁵

When medication is considered, selective serotonin reuptake inhibitors (SSRIs) are most commonly used. Research indicates that SSRIs are significantly more effective than placebo for treatment of women with PPD.³⁶ Sertraline, in particular, has shown to be both effective in treating PPD and safe in lactation.^37,38 Dosing and duration of therapy are equivalent to treatment of major depression outside the perinatal period. Consult a trusted source on medications in lactation before prescribing any antidepressant to a breastfeeding mother. One resource is the National Institutes of Health drugs and lactation database (LactMed; www.ncbi.nlm.nih.gov/books/NBK501922/), which provides detailed information on the levels of medications in breastmilk and their potential effects on an infant.

Women with severe, refractory PPD may require hospitalization. Additional treatment options for women with severe, refractory PPD include electroconvulsive therapy or the new medication brexanolone, which is administered as a 60-hour continuous infusion.^39,40

THE CASE

Further conversation with Ms. T revealed that she met the criteria for PPD (major depressive disorder with peripartum onset). She denied suicidal or homicidal ideation and was not experiencing any symptoms of psychosis. A complete blood count was drawn and showed no anemia, and her thyroid-stimulating hormone level was within normal limits. She had a good support network at home, with both her mom and sister taking shifts to help her get some extra rest and allow her to attend medical appointments. She said there was no domestic violence.

Ms. T was introduced to the clinic’s embedded counselor, who scheduled a follow-up appointment within the week to start CBT. After a discussion of risks and benefits, Ms. T also started a low dose of sertraline once daily. At follow-up postpartum visits, she reported significant improvement in her mood. She and her physician decided to taper her SSRI medication at 3 months postpartum. Screens for depression at her infant’s 4- and 6-month well-child visits in the office were reassuringly negative.

^a There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.

CORRESPONDENCE
Katherine Buck, PhD, JPS Family Health Center, 1500 South Main Street, 4th Floor, Fort Worth, TX 76110; [email protected]

THE CASE

Alex T,* a 23-year-old first-time mom, presented to the family medicine office for her baby’s 2-week appointment. When asked how she was doing, she began to cry. She said, “I feel crazy” and indicated that she was feeling down and overwhelmed, and was struggling to bond with the baby. She filled out an Edinburgh Postnatal Depression Scale, a standard postpartum depression (PPD) screen; her score, 15 out of 30, was suggestive of depression. Ms. T had been coming to the practice for the past 3 years and had no significant physical or mental health history. She and the baby did not live with the baby’s father, and his degree of presence in their lives varied.

●How would you proceed with this patient?

* The patient’s name has been changed to protect her identity.

PPD, traditionally defined as depression in the postpartum period for as long as a year after childbirth, is a common, underdiagnosed outcome of both normal and complicated pregnancies.¹ Peripartum depression, which includes PPD and depression during pregnancy, occurs in approximately 10% of pregnancies.^2,3 When depression first appears in the postpartum period, most women develop symptoms in the first month after delivery (54% of cases) or in the next 2 to 4 months (40%).⁴

The most significant risk factor for PPD is previous depression, peripartum or otherwise.^1,4-6 Other common risk factors include major life events or stressors during or after pregnancy, domestic violence, poor social support, and preterm birth or an infant admission to the neonatal intensive care unit.^1,7 Women with a self-perceived negative birth experience are also likely to experience PPD.⁸ PPD can be associated with significant morbidity and mortality, with suicide a more common cause of maternal mortality than either hemorrhage or hypertensive disorders of pregnancy.⁹

Women with postpartum anemia and low ferritin stores are more prone to depression than are those with normal levels.

Early diagnosis and intervention are crucial to improving patient outcomes. Women with PPD initiate breastfeeding at lower rates and continue for shorter durations.¹⁰ PPD also affects maternal–infant bonding; may adversely affect an infant’s social, cognitive, and language development; and may lead to attachment disorders of infancy.^11,12 In severe cases, it can lead to failure to thrive or infanticide.¹¹

When to screen. The US Preventive Services Task Force (USPSTF) recommends clinicians screen for depression in pregnant and postpartum women (Grade B^a) and for women at increased risk, provide or refer to counseling interventions (Grade B^a).^13,14 The American College of Obstetricians and Gynecologists (ACOG) recommends screening at least once in the postpartum period.¹⁵ Repeat screening at follow-up in the later postpartum period increases the likelihood of diagnosis.¹⁶ Screening for PPD as part of well-child care improves maternal outcomes, and the American Academy of Pediatrics recommends screening at the 1-, 2-, 4-, and 6-month visits.^11,17 These screens are separately billable. Family physicians are uniquely suited to screening at both well-child and postpartum visits, as many women share a medical home with their child, and those who do not are equally willing to receive medical advice from their child’s physician.¹⁸

Continue to: Is it "the blues" or something else? Diagnosing PPD

Many new mothers experience postpartum blues, which manifest as tearfulness, insomnia, irritability, and anxiety. The postpartum blues, however, don’t meet the criteria for major depressive disorder and typically resolve within 14 days of delivery.^19-21 On the other end of the spectrum is postpartum psychosis, which is severe and rare, and can also affect new mothers.

Screening for PPD. The most commonly used screening tool for PPD is the Edinburgh Postnatal Depression Scale (EPDS 10), a free 10-item instrument scored out of 30 possible points, with any score ≥ 13 suggesting PPD.²² The EPDS 10 has a sensitivity of 74% and specificity of 97% for the diagnosis of PPD.²³ Other screening options include the Beck Depression Inventory II (BDI-II) and the Patient Health Questionnaire 9 (PHQ-9). The 21-item BDI-II takes longer to perform and is less sensitive (57%) than the EPDS.¹ The PHQ-9, which asks about some symptoms common to the postpartum period (including sleep changes), is less specific than the EPDS (sensitivity, 75%; specificity, 90%).¹ The EPDS also includes screening questions about anxiety.¹

A positive depression screen, or any positive response to a question on suicidal ideation, should be followed up for confirmation using the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria for major depressive disorder with peripartum onset.²⁴ Women with PPD should also be asked about current or prior symptoms of bipolar disorder or mania.²⁵ Up to 67% of women with bipolar disorder may relapse postpartum, and they also have an elevated risk of postpartum psychosis.²⁶ The Mood Disorder Questionnaire is a useful tool if a concern for bipolar depression arises.²⁷

Refer any woman in whom bipolar depression is a concern to a clinician experienced with its management. The presence of auditory or visual hallucinations should also be assessed as indicators of postpartum psychosis. Active suicidal or homicidal ideation and postpartum psychosis all require emergent psychiatric care.^21,22 Intimate partner violence may also exist or escalate in the postpartum period and may exacerbate PPD. Both ACOG and the USPSTF recommend screening postpartum women for intimate partner violence.^28,29

Also consider possible medical causes of PPD symptoms. Hypothyroidism in the postpartum period may manifest with some similar symptoms to PPD and is commonly underdiagnosed.^22,30 Women with postpartum anemia and low ferritin stores also have a higher likelihood of PPD (odds ratio, 1.7-4.64), and postpartum iron supplementation may reduce this risk (number needed to treat = 4 in at least 1 randomized controlled trial).³¹ When anemia is present, ensure that it is properly treated.

Continue to: Steps you can take to manage pPD

Refer any woman who has PPD to a qualified therapist whenever possible. Generally, the psychological recommendations for treatment of PPD are very similar to recommendations for general treatment of depression. Psychotherapy on its own is considered a first-line treatment for mild-to-moderate PPD, and medication plus psychotherapy is considered first-line treatment for severe PPD.³² (Worth noting: It may also be useful to offer counseling to a patient who appears distressed, even if she does not fully meet all DSM-5 criteria.)

Of the psychotherapy options, cognitive behavioral therapy is supported by the most evidence.

Of the psychotherapy options, cognitive behavioral therapy (CBT) is supported by the most evidence. There is also evidence for the use of interpersonal therapy (IPT), especially in higher socioeconomic status populations.³³ Key therapeutic targets in IPT are increasing behavioral engagement (eg, reaching out to friends), decreasing negative self-talk (eg, “I am a bad mother”), and negotiating roles and support (eg, both mom’s and family members’ expectations of new motherhood). There is mixed evidence for recommending exercise as a treatment for PPD.^32,34 However, as exercise is a low-risk intervention, you may choose to make that recommendation to patients. Additionally, including partners/support people in treatment/visits for PPD has been shown to increase positive outcomes.³⁵

When medication is considered, selective serotonin reuptake inhibitors (SSRIs) are most commonly used. Research indicates that SSRIs are significantly more effective than placebo for treatment of women with PPD.³⁶ Sertraline, in particular, has shown to be both effective in treating PPD and safe in lactation.^37,38 Dosing and duration of therapy are equivalent to treatment of major depression outside the perinatal period. Consult a trusted source on medications in lactation before prescribing any antidepressant to a breastfeeding mother. One resource is the National Institutes of Health drugs and lactation database (LactMed; www.ncbi.nlm.nih.gov/books/NBK501922/), which provides detailed information on the levels of medications in breastmilk and their potential effects on an infant.

Women with severe, refractory PPD may require hospitalization. Additional treatment options for women with severe, refractory PPD include electroconvulsive therapy or the new medication brexanolone, which is administered as a 60-hour continuous infusion.^39,40

THE CASE

Further conversation with Ms. T revealed that she met the criteria for PPD (major depressive disorder with peripartum onset). She denied suicidal or homicidal ideation and was not experiencing any symptoms of psychosis. A complete blood count was drawn and showed no anemia, and her thyroid-stimulating hormone level was within normal limits. She had a good support network at home, with both her mom and sister taking shifts to help her get some extra rest and allow her to attend medical appointments. She said there was no domestic violence.

Ms. T was introduced to the clinic’s embedded counselor, who scheduled a follow-up appointment within the week to start CBT. After a discussion of risks and benefits, Ms. T also started a low dose of sertraline once daily. At follow-up postpartum visits, she reported significant improvement in her mood. She and her physician decided to taper her SSRI medication at 3 months postpartum. Screens for depression at her infant’s 4- and 6-month well-child visits in the office were reassuringly negative.

^a There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.

CORRESPONDENCE
Katherine Buck, PhD, JPS Family Health Center, 1500 South Main Street, 4th Floor, Fort Worth, TX 76110; [email protected]

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

Texas-based researchers have developed a vaccine that blocks the euphoric effects of fentanyl, a potent synthetic opioid that is increasingly involved in opioid overdose deaths in the United States.

In studies in male and female mice, the vaccine generated significant and long-lasting levels of anti-fentanyl antibodies that were highly effective at reducing the antinociceptive, behavioral, and physiological effects of the drug.

The vaccine prevents fentanyl from entering the brain. “Thus, the individual will not feel the euphoric effects and can ‘get back on the wagon’ to sobriety,” lead investigator Colin Haile, MD, PhD, with University of Houston and founding member of the UH Drug Discovery Institute, said in a news release. The study was published online in the journal Pharmaceutics.

“The anti-fentanyl antibodies were specific to fentanyl and a fentanyl derivative and did not cross-react with other opioids, such as morphine. That means a vaccinated person would still be able to be treated for pain relief with other opioids,” said Dr. Haile.

The vaccine did not cause any adverse effects in the immunized mice. The research team plans to start manufacturing clinical-grade vaccine in the coming months with clinical trials in humans planned soon.

If proven safe and effective in clinical testing, the vaccine could have major implications for the nation’s opioid epidemic by becoming a relapse prevention agent for people trying to quit using opioids, the researchers note.

The United States in 2021 recorded more than 107,000 drug overdose deaths – a record high, according to federal health officials – and fentanyl was involved in most of these deaths. 

Senior author Therese Kosten, PhD, director of the UH Developmental, Cognitive & Behavioral Neuroscience program, calls the new fentanyl vaccine a potential “game changer.”

“Fentanyl use and overdose is a particular treatment challenge that is not adequately addressed with current medications because of its pharmacodynamics, and managing acute overdose with the short-acting naloxone [Narcan] is not appropriately effective as multiple doses of naloxone are often needed to reverse fentanyl’s fatal effects,” said Dr. Kosten.

Funding for the study was provided by the Department of Defense through the Alcohol and Substance Abuse Disorders Program managed by RTI International’s Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has funded Dr. Haile’s lab for several years to develop the anti-fentanyl vaccine. The authors have no relevant conflicts of interest. A provisional patent has been submitted by the University of Houston on behalf of four of the investigators containing technology related to the fentanyl vaccine.

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

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From Milwaukee County Behavioral Health Services, Milwaukee, WI.

Abstract

Objectives: The goal of this study was to determine whether a single-item quality of life (QOL) measure could serve as a useful population health–level metric within the Quadruple Aim framework in a publicly funded behavioral health system.

Design: This was a retrospective, cross-sectional study that examined the correlation between the single-item QOL measure and several other key measures of the social determinants of health and a composite measure of acute service utilization for all patients receiving mental health and substance use services in a community behavioral health system.

Methods: Data were collected for 4488 patients who had at least 1 assessment between October 1, 2020, and September 30, 2021. Data on social determinants of health were obtained through patient self-report; acute service use data were obtained from electronic health records.

Results: Statistical analyses revealed results in the expected direction for all relationships tested. Patients with higher QOL were more likely to report “Good” or better self-rated physical health, be employed, have a private residence, and report recent positive social interactions, and were less likely to have received acute services in the previous 90 days.

Conclusion: A single-item QOL measure shows promise as a general, minimally burdensome whole-system metric that can function as a target for population health management efforts in a large behavioral health system. Future research should explore whether this QOL measure is sensitive to change over time and examine its temporal relationship with other key outcome metrics.

Keywords: Quadruple Aim, single-item measures, social determinants of health, acute service utilization metrics.

The Triple Aim for health care—improving the individual experience of care, increasing the health of populations, and reducing the costs of care—was first proposed in 2008.¹ More recently, some have advocated for an expanded focus to include a fourth aim: the quality of staff work life.² Since this seminal paper was published, many health care systems have endeavored to adopt and implement the Quadruple Aim^3,4; however, the concepts representing each of the aims are not universally defined,³ nor are the measures needed to populate the Quadruple Aim always available within the health system in question.⁵

Although several assessment models and frameworks that provide guidance to stakeholders have been developed,^6,7 it is ultimately up to organizations themselves to determine which measures they should deploy to best represent the different quadrants of the Quadruple Aim.⁶ Evidence suggests, however, that quality measurement, and the administrative time required to conduct it, can be both financially and emotionally burdensome to providers and health systems.^8-10 Thus, it is incumbent on organizations to select a set of measures that are not only meaningful but as parsimonious as possible.^6,11,12

Quality of life (QOL) is a potential candidate to assess the aim of population health. Brief health-related QOL questions have long been used in epidemiological surveys, such as the Behavioral Risk Factor Surveillance System survey.¹³ Such questions are also a key component of community health frameworks, such as the County Health Rankings developed by the University of Wisconsin Population Health Institute.¹⁴ Furthermore, Humana recently revealed that increasing the number of physical and mental health “Healthy Days” (which are among the Centers for Disease Control and Prevention’s Health-Related Quality of Life questions¹⁵) among the members enrolled in their insurance plan would become a major goal for the organization.^16,17 Many of these measures, while brief, focus on QOL as a function of health, often as a self-rated construct (from “Poor” to “Excellent”) or in the form of days of poor physical or mental health in the past 30 days,¹⁵ rather than evaluating QOL itself; however, several authors have pointed out that health status and QOL are related but distinct concepts.^18,19

Brief single-item assessments focused specifically on QOL have been developed and implemented within nonclinical²⁰ and clinical populations, including individuals with cancer,²¹ adults with disabilities,²² individuals with cystic fibrosis,²³ and children with epilepsy.²⁴ Despite the long history of QOL assessment in behavioral health treatment,²⁵ single-item measures have not been widely implemented in this population.

Milwaukee County Behavioral Health Services (BHS), a publicly funded, county-based behavioral health care system in Milwaukee, Wisconsin, provides inpatient and ambulatory treatment, psychiatric emergency care, withdrawal management, care management, crisis services, and other support services to individuals in Milwaukee County. In 2018 the community services arm of BHS began implementing a single QOL question from the World Health Organization’s WHOQOL-BREF²⁶: On a 5-point rating scale of “Very Poor” to “Very Good,” “How would you rate your overall quality of life right now?” Previous research by Atroszko and colleagues,²⁰ which used a similar approach with the same item from the WHOQOL-BREF, reported correlations in the expected direction of the single-item QOL measure with perceived stress, depression, anxiety, loneliness, and daily hours of sleep. This study’s sample, however, comprised opportunistically recruited college students, not a clinical population. Further, the researchers did not examine the relationship of QOL with acute service utilization or other measures of the social determinants of health, such as housing, employment, or social connectedness.

The following study was designed to extend these results by focusing on a clinical population—individuals with mental health or substance use issues—being served in a large, publicly funded behavioral health system in Milwaukee, Wisconsin. The objective of this study was to determine whether a single-item QOL measure could be used as a brief, parsimonious measure of overall population health by examining its relationship with other key outcome measures for patients receiving services from BHS. This study was reviewed and approved by BHS’s Institutional Review Board.

Methods

All patients engaged in nonacute community services are offered a standardized assessment that includes, among other measures, items related to QOL, housing status, employment status, self-rated physical health, and social connectedness. This assessment is administered at intake, discharge, and every 6 months while patients are enrolled in services. Patients who received at least 1 assessment between October 1, 2020, and September 30, 2021, were included in the analyses. Patients receiving crisis, inpatient, or withdrawal management services alone (ie, did not receive any other community-based services) were not offered the standard assessment and thus were not included in the analyses. If patients had more than 1 assessment during this time period, QOL data from the last assessment were used. Data on housing (private residence status, defined as adults living alone or with others without supervision in a house or apartment), employment status, self-rated physical health, and social connectedness (measured by asking people whether they have had positive interactions with family or friends in the past 30 days) were extracted from the same timepoint as well.

Also included in the analyses were rates of acute service utilization, in which any patient with at least 1 visit to BHS’s psychiatric emergency department, withdrawal management facility, or psychiatric inpatient facility in the 90 days prior to the date of the assessment received a code of “Yes,” and any patient who did not receive any of these services received a code of “No.” Chi-square analyses were conducted to determine the relationship between QOL rankings (“Very Poor,” “Poor,” “Neither Good nor Poor,” “Good,” and “Very Good”) and housing, employment, self-rated physical health, social connectedness, and 90-day acute service use. All acute service utilization data were obtained from BHS’s electronic health records system. All data used in the study were stored on a secure, password-protected server. All analyses were conducted with SPSS software (SPSS 28; IBM).

Results

Data were available for 4488 patients who received an assessment between October 1, 2020, and September 30, 2021 (total numbers per item vary because some items had missing data; see supplementary eTables 1-3 for sample size per item). Demographics of the patient sample are listed in Table 1; the demographics of the patients who were missing data for specific outcomes are presented in eTables 1-3.

Statistical analyses revealed results in the expected direction for all relationships tested (Table 2). As patients’ self-reported QOL improved, so did the likelihood of higher rates of self-reported “Good” or better physical health, which was 576% higher among individuals who reported “Very Good” QOL relative to those who reported “Very Poor” QOL. Similarly, when compared with individuals with “Very Poor” QOL, individuals who reported “Very Good” QOL were 21.91% more likely to report having a private residence, 126.7% more likely to report being employed, and 29.17% more likely to report having had positive social interactions with family and friends in the past 30 days. There was an inverse relationship between QOL and the likelihood that a patient had received at least 1 admission for an acute service in the previous 90 days, such that patients who reported “Very Good” QOL were 86.34% less likely to have had an admission compared to patients with “Very Poor” QOL (2.8% vs 20.5%, respectively). The relationships among the criterion variables used in this study are presented in Table 3.

Discussion

The results of this preliminary analysis suggest that self-rated QOL is related to key health, social determinants of health, and acute service utilization metrics. These data are important for several reasons. First, because QOL is a diagnostically agnostic measure, it is a cross-cutting measure to use with clinically diverse populations receiving an array of different services. Second, at 1 item, the QOL measure is extremely brief and therefore minimally onerous to implement for both patients and administratively overburdened providers. Third, its correlation with other key metrics suggests that it can function as a broad population health measure for health care organizations because individuals with higher QOL will also likely have better outcomes in other key areas. This suggests that it has the potential to broadly represent the overall status of a population of patients, thus functioning as a type of “whole system” measure, which the Institute for Healthcare Improvement describes as “a small set of measures that reflect a health system’s overall performance on core dimensions of quality guided by the Triple Aim.”⁷ These whole system measures can help focus an organization’s strategic initiatives and efforts on the issues that matter most to the patients and community it serves.

The relationship of QOL to acute service utilization deserves special mention. As an administrative measure, utilization is not susceptible to the same response bias as the other self-reported variables. Furthermore, acute services are costly to health systems, and hospital readmissions are associated with payment reductions in the Centers for Medicare and Medicaid Services (CMS) Hospital Readmissions Reduction Program for hospitals that fail to meet certain performance targets.²⁷ Thus, because of its alignment with federal mandates, improved QOL (and potentially concomitant decreases in acute service use) may have significant financial implications for health systems as well.

This study was limited by several factors. First, it was focused on a population receiving publicly funded behavioral health services with strict eligibility requirements, one of which stipulated that individuals must be at 200% or less of the Federal Poverty Level; therefore, the results might not be applicable to health systems with a more clinically or socioeconomically diverse patient population. Second, because these data are cross-sectional, it was not possible to determine whether QOL improved over time or whether changes in QOL covaried longitudinally with the other metrics under observation. For example, if patients’ QOL improved from the first to last assessment, did their employment or residential status improve as well, or were these patients more likely to be employed at their first assessment? Furthermore, if there was covariance, did changes in employment, housing status, and so on precede changes in QOL or vice versa? Multiple longitudinal observations would help to address these questions and will be the focus of future analyses.

Conclusion

This preliminary study suggests that a single-item QOL measure may be a valuable population health–level metric for health systems. It requires little administrative effort on the part of either the clinician or patient. It is also agnostic with regard to clinical issue or treatment approach and can therefore admit of a range of diagnoses or patient-specific, idiosyncratic recovery goals. It is correlated with other key health, social determinants of health, and acute service utilization indicators and can therefore serve as a “whole system” measure because of its ability to broadly represent improvements in an entire population. Furthermore, QOL is patient-centered in that data are obtained through patient self-report, which is a high priority for CMS and other health care organizations.²⁸ In summary, a single-item QOL measure holds promise for health care organizations looking to implement the Quadruple Aim and assess the health of the populations they serve in a manner that is simple, efficient, and patient-centered.

Acknowledgments: The author thanks Jennifer Wittwer for her thoughtful comments on the initial draft of this manuscript and Gary Kraft for his help extracting the data used in the analyses.

Corresponding author: Walter Matthew Drymalski, PhD; [email protected]

Disclosures: None reported.

From the Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA.

Clinical inertia is defined as the failure of clinicians to initiate or escalate guideline-directed medical therapy to achieve treatment goals for well-defined clinical conditions.^1,2 Evidence-based guidelines recommend optimal disease management with readily available medical therapies throughout the phases of clinical care. Unfortunately, the care provided to individual patients undergoes multiple modifications throughout the disease course, resulting in divergent pathways, significant deviations from treatment guidelines, and failure of “safeguard” checkpoints to reinstate, initiate, optimize, or stop treatments. Clinical inertia generally describes rigidity or resistance to change around implementing evidence-based guidelines. Furthermore, this term describes treatment behavior on the part of an individual clinician, not organizational inertia, which generally encompasses both internal (immediate clinical practice settings) and external factors (national and international guidelines and recommendations), eventually leading to resistance to optimizing disease treatment and therapeutic regimens. Individual clinicians’ clinical inertia in the form of resistance to guideline implementation and evidence-based principles can be one factor that drives organizational inertia. In turn, such individual behavior can be dictated by personal beliefs, knowledge, interpretation, skills, management principles, and biases. The terms therapeutic inertia or clinical inertia should not be confused with nonadherence from the patient’s standpoint when the clinician follows the best practice guidelines.³

Clinical inertia has been described in several clinical domains, including diabetes,^4,5 hypertension,^6,7 heart failure,⁸ depression,⁹ pulmonary medicine,¹⁰ and complex disease management.¹¹ Clinicians can set suboptimal treatment goals due to specific beliefs and attitudes around optimal therapeutic goals. For example, when treating a patient with a chronic disease that is presently stable, a clinician could elect to initiate suboptimal treatment, as escalation of treatment might not be the priority in stable disease; they also may have concerns about overtreatment. Other factors that can contribute to clinical inertia (ie, undertreatment in the presence of indications for treatment) include those related to the patient, the clinical setting, and the organization, along with the importance of individualizing therapies in specific patients. Organizational inertia is the initial global resistance by the system to implementation, which can slow the dissemination and adaptation of best practices but eventually declines over time. Individual clinical inertia, on the other hand, will likely persist after the system-level rollout of guideline-based approaches.

The trajectory of dissemination, implementation, and adaptation of innovations and best practices is illustrated in the Figure. When the guidelines and medical societies endorse the adaptation of innovations or practice change after the benefits of such innovations/change have been established by the regulatory bodies, uptake can be hindered by both organizational and clinical inertia. Overcoming inertia to system-level changes requires addressing individual clinicians, along with practice and organizational factors, in order to ensure systematic adaptations. From the clinicians’ view, training and cognitive interventions to improve the adaptation and coping skills can improve understanding of treatment options through standardized educational and behavioral modification tools, direct and indirect feedback around performance, and decision support through a continuous improvement approach on both individual and system levels.

Addressing inertia in clinical practice requires a deep understanding of the individual and organizational elements that foster resistance to adapting best practice models. Research that explores tools and approaches to overcome inertia in managing complex diseases is a key step in advancing clinical innovation and disseminating best practices.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Disclosures: None reported.

From the Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA.

Clinical inertia is defined as the failure of clinicians to initiate or escalate guideline-directed medical therapy to achieve treatment goals for well-defined clinical conditions.^1,2 Evidence-based guidelines recommend optimal disease management with readily available medical therapies throughout the phases of clinical care. Unfortunately, the care provided to individual patients undergoes multiple modifications throughout the disease course, resulting in divergent pathways, significant deviations from treatment guidelines, and failure of “safeguard” checkpoints to reinstate, initiate, optimize, or stop treatments. Clinical inertia generally describes rigidity or resistance to change around implementing evidence-based guidelines. Furthermore, this term describes treatment behavior on the part of an individual clinician, not organizational inertia, which generally encompasses both internal (immediate clinical practice settings) and external factors (national and international guidelines and recommendations), eventually leading to resistance to optimizing disease treatment and therapeutic regimens. Individual clinicians’ clinical inertia in the form of resistance to guideline implementation and evidence-based principles can be one factor that drives organizational inertia. In turn, such individual behavior can be dictated by personal beliefs, knowledge, interpretation, skills, management principles, and biases. The terms therapeutic inertia or clinical inertia should not be confused with nonadherence from the patient’s standpoint when the clinician follows the best practice guidelines.³

Clinical inertia has been described in several clinical domains, including diabetes,^4,5 hypertension,^6,7 heart failure,⁸ depression,⁹ pulmonary medicine,¹⁰ and complex disease management.¹¹ Clinicians can set suboptimal treatment goals due to specific beliefs and attitudes around optimal therapeutic goals. For example, when treating a patient with a chronic disease that is presently stable, a clinician could elect to initiate suboptimal treatment, as escalation of treatment might not be the priority in stable disease; they also may have concerns about overtreatment. Other factors that can contribute to clinical inertia (ie, undertreatment in the presence of indications for treatment) include those related to the patient, the clinical setting, and the organization, along with the importance of individualizing therapies in specific patients. Organizational inertia is the initial global resistance by the system to implementation, which can slow the dissemination and adaptation of best practices but eventually declines over time. Individual clinical inertia, on the other hand, will likely persist after the system-level rollout of guideline-based approaches.

The trajectory of dissemination, implementation, and adaptation of innovations and best practices is illustrated in the Figure. When the guidelines and medical societies endorse the adaptation of innovations or practice change after the benefits of such innovations/change have been established by the regulatory bodies, uptake can be hindered by both organizational and clinical inertia. Overcoming inertia to system-level changes requires addressing individual clinicians, along with practice and organizational factors, in order to ensure systematic adaptations. From the clinicians’ view, training and cognitive interventions to improve the adaptation and coping skills can improve understanding of treatment options through standardized educational and behavioral modification tools, direct and indirect feedback around performance, and decision support through a continuous improvement approach on both individual and system levels.

Addressing inertia in clinical practice requires a deep understanding of the individual and organizational elements that foster resistance to adapting best practice models. Research that explores tools and approaches to overcome inertia in managing complex diseases is a key step in advancing clinical innovation and disseminating best practices.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Disclosures: None reported.

From the Department of Medicine, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA.

Clinical inertia is defined as the failure of clinicians to initiate or escalate guideline-directed medical therapy to achieve treatment goals for well-defined clinical conditions.^1,2 Evidence-based guidelines recommend optimal disease management with readily available medical therapies throughout the phases of clinical care. Unfortunately, the care provided to individual patients undergoes multiple modifications throughout the disease course, resulting in divergent pathways, significant deviations from treatment guidelines, and failure of “safeguard” checkpoints to reinstate, initiate, optimize, or stop treatments. Clinical inertia generally describes rigidity or resistance to change around implementing evidence-based guidelines. Furthermore, this term describes treatment behavior on the part of an individual clinician, not organizational inertia, which generally encompasses both internal (immediate clinical practice settings) and external factors (national and international guidelines and recommendations), eventually leading to resistance to optimizing disease treatment and therapeutic regimens. Individual clinicians’ clinical inertia in the form of resistance to guideline implementation and evidence-based principles can be one factor that drives organizational inertia. In turn, such individual behavior can be dictated by personal beliefs, knowledge, interpretation, skills, management principles, and biases. The terms therapeutic inertia or clinical inertia should not be confused with nonadherence from the patient’s standpoint when the clinician follows the best practice guidelines.³

Clinical inertia has been described in several clinical domains, including diabetes,^4,5 hypertension,^6,7 heart failure,⁸ depression,⁹ pulmonary medicine,¹⁰ and complex disease management.¹¹ Clinicians can set suboptimal treatment goals due to specific beliefs and attitudes around optimal therapeutic goals. For example, when treating a patient with a chronic disease that is presently stable, a clinician could elect to initiate suboptimal treatment, as escalation of treatment might not be the priority in stable disease; they also may have concerns about overtreatment. Other factors that can contribute to clinical inertia (ie, undertreatment in the presence of indications for treatment) include those related to the patient, the clinical setting, and the organization, along with the importance of individualizing therapies in specific patients. Organizational inertia is the initial global resistance by the system to implementation, which can slow the dissemination and adaptation of best practices but eventually declines over time. Individual clinical inertia, on the other hand, will likely persist after the system-level rollout of guideline-based approaches.

The trajectory of dissemination, implementation, and adaptation of innovations and best practices is illustrated in the Figure. When the guidelines and medical societies endorse the adaptation of innovations or practice change after the benefits of such innovations/change have been established by the regulatory bodies, uptake can be hindered by both organizational and clinical inertia. Overcoming inertia to system-level changes requires addressing individual clinicians, along with practice and organizational factors, in order to ensure systematic adaptations. From the clinicians’ view, training and cognitive interventions to improve the adaptation and coping skills can improve understanding of treatment options through standardized educational and behavioral modification tools, direct and indirect feedback around performance, and decision support through a continuous improvement approach on both individual and system levels.

Addressing inertia in clinical practice requires a deep understanding of the individual and organizational elements that foster resistance to adapting best practice models. Research that explores tools and approaches to overcome inertia in managing complex diseases is a key step in advancing clinical innovation and disseminating best practices.

Corresponding author: Ebrahim Barkoudah, MD, MPH; [email protected]

Disclosures: None reported.