Megan Brooks

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

Electroconvulsive therapy (ECT) is more effective than intravenous (IV) ketamine for patients experiencing a major depressive episode (MDE) in new findings that are in line with the KetECT study – the first head-to-head trial of ketamine and ECT.

The KetECT trial, which was published earlier this year, showed that ECT was more effective than IV ketamine for hospitalized patients with severe depression. ECT yielded higher remission rates and a greater reduction of symptoms.

Despite the apparent superiority of ECT over ketamine, the researchers of the current meta-analysis caution that treatment options for MDE “should still be individualized and patient-centered because ketamine’s faster antidepressant effects may still be desirable for certain patients with severe MDE who require quick recovery from the severity of depression.”

The study was published online in JAMA Psychiatry.
 

Confirmatory data

The review included six clinical trials with 340 patients with MDE. Of those patients, 162 were treated with ECT, and 178 were treated with ketamine. The mean age of the participants ranged from 37 to 52 years.

The primary efficacy outcome of interest was improvement of depressive symptoms.

ECT was superior to ketamine across different depressive symptom measures, reported Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues.

The standardized mean difference (SMD) was –0.59 (95% confidence interval [CI], –0.85 to –0.33) on the Montgomery-Åsberg Depression Rating Scale.

The SMD was –0.83 (95% CI, –1.22 to –0.44] on the Hamilton Depression Rating Scale and –0.86 (95% CI, –1.50 to –0.22) on the Beck Depression Inventory.

The overall pooled SMD for ECT, when compared with ketamine, was –0.69 (95% CI, –0.89 to –0.48), indicating that ECT was more efficacious than ketamine.

The researchers did not find any moderating effects of various factors, including age, male sex, and presence of psychotic features.

For cognition and memory performance, one study reported that the ketamine group outperformed the ECT group in cognition, but the effect size was small to moderate.

A separate study that reported memory performance found no difference between ketamine and ECT, though this study was likely underpowered to detect such differences, with a total sample size of 32.

“Because of underpowered study designs, no firm conclusions regarding cognition and memory performance can be made in this meta-analysis. Future research should address this issue,” the investigators wrote.
 

Unique side effects

Ketamine and ECT had unique adverse effect profiles.

With ketamine, there was a lower risk of headache and muscle pain but a higher risk of transient dissociative or depersonalization symptoms. With ECT, there was a lower risk of blurred vision, vertigo, and diplopia/nystagmus.

Only one study reported suicide attempts and suicide deaths, for which there was no marked difference between ECT and ketamine.

A limitation of the meta-analysis is the low to moderate methodologic quality of the studies that were included, as well as the use of different ketamine and/or ECT treatment protocols, which could have influenced efficacy and safety outcomes.

The researchers noted that more research is needed to optimize long-term treatment outcomes for both ketamine and ECT to prevent relapse, “which is of key importance for clinical practice.”

The study had no specific funding. Dr. Rhee currently serves as a co–editor-in-chief of Mental Health Science and will receive honorarium payments annually from the publisher, John Wiley & Sons. A complete list of the authors’ relevant financial relationships is available with the original article.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

A new study underscores the importance of COVID-19 and regular COVID-19 testing among adults with a recent cancer diagnosis.

The Indiana statewide study, conducted at the beginning of the pandemic, found that unvaccinated adults with cancer and SARS-CoV-2 infection were nearly seven times more likely to die from any cause than uninfected adults with cancer.

“This analysis provides additional empirical evidence on the magnitude of risk to patients with cancer whose immune systems are often weakened either by the disease or treatment,” the study team wrote.

The study was published online in JMIR Cancer.

Although evidence has consistently revealed similar findings, the risk of death among unvaccinated people with cancer and COVID-19 has not been nearly as high in previous studies, lead author Brian E. Dixon, PhD, MBA, with Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, said in a statement. Previous studies from China, for instance, reported a two- to threefold greater risk of all-cause mortality among unvaccinated adults with cancer and COVID-19.

A potential reason for this discrepancy, Dr. Dixon noted, is that earlier studies were “generally smaller and made calculations based on data from a single cancer center or health system.”

Another reason is testing for COVID-19 early in the pandemic was limited to symptomatic individuals who may have had more severe infections, possibly leading to an overestimate of the association between SARS-CoV-2 infection, cancer, and all-cause mortality.

In the current analysis, researchers used electronic health records linked to Indiana’s statewide SARS-CoV-2 testing database and state vital records to evaluate the association between SARS-CoV-2 infection and all-cause mortality among 41,924 adults newly diagnosed with cancer between Jan. 1, 2019, and Dec. 31, 2020.

Most people with cancer were White (78.4%) and about half were male. At the time of diagnosis, 17% had one comorbid condition and about 10% had two or more. Most patients had breast cancer (14%), prostate cancer (13%), or melanoma (13%).

During the study period, 2,894 patients (7%) tested positive for SARS-CoV-2.

In multivariate adjusted analysis, the risk of death among those newly diagnosed with cancer increased by 91% (adjusted hazard ratio, 1.91) during the first year of the pandemic before vaccines were available, compared with the year before (January 2019 to Jan. 14, 2020).

During the pandemic period, the risk of death was roughly threefold higher among adults 65 years old and older, compared with adults 18-44 years old (aHR, 3.35).

When looking at the time from a cancer diagnosis to SARS-CoV-2 infection, infection was associated with an almost sevenfold increase in all-cause mortality (aHR, 6.91). Adults 65 years old and older had an almost threefold increased risk of dying, compared with their younger peers (aHR, 2.74).

Dr. Dixon and colleagues also observed an increased risk of death in men with cancer and COVID, compared with women (aHR, 1.23) and those with at least two comorbid conditions versus none (aHR, 2.12). In addition, the risk of dying was 9% higher among Indiana’s rural population than urban dwellers.

Compared with other cancer types, individuals with lung cancer and other digestive cancers had the highest risk of death after SARS-CoV-2 infection (aHR, 1.45 and 1.80, respectively).

“Our findings highlight the increased risk of death for adult cancer patients who test positive for COVID and underscore the importance to cancer patients – including those in remission – of vaccinations, boosters, and regular COVID testing,” Dr. Dixon commented.

“Our results should encourage individuals diagnosed with cancer not only to take preventive action, but also to expeditiously seek out treatments available in the marketplace should they test positive for COVID,” he added.

Support for the study was provided by Indiana University Simon Cancer Center and the Centers for Disease Control and Prevention. The authors have disclosed no relevant financial relationships.

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

As monotherapy, the experimental drug REL-1017 (Relmada Therapeutics) has failed to show statistically significant improvement in depression symptoms compared with placebo in topline results from the phase 3 RELIANCE III trial.

The negative monotherapy data come on the heels of earlier phase 2 data showing a benefit of REL-1017 when used as add-on therapy for adults with major depressive disorder (MDD).

Despite the monotherapy results, Relmada reported in a release that it is continuing to enroll patients in two other phase 3 trials. However, RELIANCE I and RELIANCE II are assessing the drug only as adjunctive therapy.

“While these RELIANCE III results are disappointing for patients, the need for new, safe, and effective treatments for MDD continues to exist,” Maurizio Fava, MD, psychiatrist in chief at Massachusetts General Hospital, Boston, said in the release.

“We look forward to the data from the ongoing RELIANCE I and II trials of REL-1017, a potential new therapy for the adjunctive treatment of MDD,” Dr. Fava added.

REL-1017 is a novel N-methyl-D-aspartate receptor channel blocker that preferentially targets hyperactive channels while maintaining physiologic glutamatergic neurotransmission. RELIANCE III tested REL-1017 against placebo for 28 days in 232 adults with MDD.

The study did not achieve its primary endpoint, which was a statistically significant improvement in symptoms of depression compared with placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) on day 28.

At that time point, the REL-1017 treatment group showed a reduction in MADRS scores of 14.8 points, vs. 13.9 points for the placebo arm.

The placebo response was “higher than expected” – placebo “dramatically” outperformed REL-1017 at some study sites, Relmada said in the release.

The company added that it is “investigating the nature of these results.”

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

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

The COVID-19 pandemic fueled a sharp uptick in deaths related to chronic liver disease and cirrhosis among people with diabetes, largely owing to nonalcoholic fatty liver disease (NAFLD) and alcohol-related liver disease (ALD), new data show.

“Our observations confirm that COVID-19 had a higher likelihood of impacting vulnerable populations with pre-existing chronic liver diseases and diabetes, with a death rate as high as 10% in individuals with co-existing chronic liver disease and diabetes,” write the authors.

“The inability to attend regular outpatient clinics for close monitoring and treatment accompanied by diversion of health care resources to COVID-19 care may have resulted in the suboptimal or delayed clinical care of individuals with diabetes and chronic liver disease during the COVID-19 pandemic,” they add.

Donghee Kim, MD, PhD, with the Division of Gastroenterology and Hepatology, Stanford (Calif.) University School of Medicine, and colleagues report their findings in the journal Digestive and Liver Disease.
 

Vulnerable group

The researchers used U.S. national mortality data (2017-2020) to estimate chronic liver disease–related mortality trends among individuals with diabetes before and during the COVID-19 pandemic.

Before the pandemic, the quarterly mortality for chronic liver disease remained stable (quarterly percentage change, 0.6%) but then sharply increased during the pandemic (QPC, 8.6%).

A similar trend was seen with cirrhosis-related mortality (QPC, 0.3% before the pandemic vs. 8.4% during the pandemic).

NAFLD and ALD mortality among individuals with diabetes was steadily increasing before the pandemic (QPC, 4.2% and 3.5%, respectively) but showed a more rapid increase during the pandemic (QPC, 9.6% and 7.7%, respectively).

ALD-related mortality in men was more than threefold higher than in women, while NAFLD-related mortality in women was more than twofold higher than in men.

Mortality for hepatitis C virus infection declined before the pandemic (QPC, −3.3%) and remained stable during the pandemic.

COVID-19–related mortality among adults with chronic liver disease and diabetes also rose sharply during the pandemic – from 0.4% in the first quarter of 2020 to 12.9% in the last quarter of 2020 – with no considerable difference between men and women.
 

Blame it on lockdowns?

Dr. Kim and colleagues say research is needed to better understand the direct and indirect influence of COVID-19 on coexisting chronic liver disease and diabetes.

“It is plausible that psychosocial stress and a higher predisposition to psychiatric disorders during the COVID-19 pandemic can increase the risk of alcohol use disorder and ALD,” they write.

“Furthermore, it is prudent to suspect that COVID-19–related lockdowns may increase the risk of obesity, leading to a higher risk of insulin resistance and metabolic complications, including diabetes and NAFLD. Future studies are needed to improve our understanding of these possible pathogenetic links. More importantly, emergency preparedness or contingency plans must be in place to continue and provide uninterrupted care for chronic ailments during times of disaster,” they add.

The study had no specific funding. The authors report no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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

Contrary to some prior studies, new research suggests that a healthy diet, including the Mediterranean diet, does not reduce dementia risk.

After adjusting for relevant demographic and other lifestyle measures, there was no association between adherence to healthy dietary advice or the Mediterranean diet on the future risk of dementia or amyloid-beta (Abeta) accumulation.

OksanaKiian/Getty Images

“While our study does not rule out a possible association between diet and dementia, we did not find a link in our study, which had a long follow-up period, included younger participants than some other studies and did not require people to remember what foods they had eaten regularly years before,” study investigator Isabelle Glans, MD, of Lund (Sweden) University, said in a news release.

The findings were published online in Neurology.
 

No risk reduction

Several studies have investigated how dietary habits affect dementia risk, with inconsistent results.

The new findings are based on 28,025 adults (61% women; mean age, 58 years at baseline) who were free of dementia at baseline and were followed over a 20-year period as part of the Swedish Malmö Diet and Cancer Study. Dietary habits were assessed with a 7-day food diary, detailed food frequency questionnaire, and in-person interview.

During follow-up, 1,943 individuals (6.9%) developed dementia.

Compared with those who did not develop dementia, those who did develop dementia during follow-up were older and had a lower level of education and more cardiovascular risk factors and comorbidities at baseline.

Individuals who adhered to conventional healthy dietary recommendations did not have a lower risk of developing all-cause dementia (hazard ratio comparing worst with best adherence, 0.93; 95% confidence interval, 0.81-1.08), Alzheimer’s disease (HR, 1.03; 95% CI, 0.85-1.23) or vascular dementia (HR, 0.93; 95% CI, 0.69-1.26).

Adherence to the modified Mediterranean diet also did not appear to lower the risk of all-cause dementia (HR, 0.93; 95% CI, 0.75-1.15), Alzheimer’s disease (HR, 0.90; 95% CI, 0.68-1.19), or vascular dementia (HR, 1.00; 95% CI, 0.65-1.55).

There was also no significant association between diet and Alzheimer’s disease–related pathology, as measured by cerebrospinal fluid analysis of Abeta42 in a subgroup of 738 participants. Various sensitivity analyses yielded similar results.
 

Diet still matters

The authors of an accompanying editorial noted that diet as a “singular factor may not have a strong enough effect on cognition, but is more likely to be considered as one factor embedded with various others, the sum of which may influence the course of cognitive function (diet, regular exercise, vascular risk factor control, avoiding cigarette smoking, drinking alcohol in moderation, etc).

“Diet should not be forgotten and it still matters” but should be regarded as “one part of a multidomain intervention with respect to cognitive performance,” wrote Nils Peters, MD, with the University of Basel (Switzerland), and Benedetta Nacmias, PhD, with the University of Florence (Italy)).

“Key questions that remain include how to provide evidence for promoting the implications of dietary habits on cognition? Overall, dietary strategies will most likely be implicated either in order to reduce the increasing number of older subjects with dementia, or to extend healthy life expectancy, or both,” Dr. Peters and Dr. Nacmias said.

The study had no commercial funding. Dr. Glans, Dr. Peters, and Dr. Nacmias disclosed no relevant financial relationships.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

Patient-reported symptoms and quality of life should guide treatment for the roughly 8.5 million people in the United States living with peripheral artery disease (PAD), the American Heart Association said in a new scientific statement released Oct. 13.

“The person living with PAD is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” Kim G. Smolderen, PhD, lead author of the statement writing group, says in a release.

“We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective,” adds Dr. Smolderen, co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University, New Haven, Conn.

The statement, “Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment,” is published online in Circulation.

It comes on the heels of a 2021 AHA statement urging greater attention to PAD, which is underdiagnosed and undertreated in the United States despite its high prevalence.
 

Fragmented care

Dr. Smolderen said that the multidisciplinary writing group was united in one overarching goal: “How can we disrupt the fragmented care model for PAD and make PAD care more accountable, value-based, and patient-centered?”

“True disruption is needed in a clinical space where the treatment of lower-extremity disease lies in the hands of many different specialties and variability in care and outcomes is a major concern,” Dr. Smolderen said.

The statement calls for improving and individualizing PAD care by gathering feedback from their experience through treatment using systematic and validated patient-reported outcome measures (PROMs).

PROMs for PAD include the Walking Impairment Questionnaire (WIQ), the Vascular Quality of Life Questionnaire (VascuQoL), and Peripheral Artery Questionnaire (PAQ).
 

Accountability tied to reimbursement

Dr. Smolderen noted that PROMs are increasingly being integrated into definitions of what it means to deliver high-quality, patient-centered care, and PROMs scores may directly impact reimbursement.

“Using a template that has been implemented in other medical conditions, we propose a shift in metrics that will tell us whether high-quality PAD care has been delivered from a patients’ perspective,” Dr. Smolderen told this news organization.

That is, “have we been able to improve the health status of that person’s life? We may have removed the blockage in the arteries, but will the patient feel that this intervention has addressed their PAD-specific health status goals?”

To facilitate accountability in quality PAD care, the writing group calls for developing, testing, and implementing PAD-specific patient-reported outcomes performance measures – or PRO-PMs.

Pilot efforts demonstrating feasibility of PRO-PMs in various practice settings are needed, as is implementation research evaluating the integration of PRO-PMs and pragmatic clinical trial evidence to demonstrate efficacy of the use of PROs in real world care settings to improve overall PAD outcomes, the writing group says.

“Following that experience and data, we believe value-based models can be proposed integrating PRO information that will affect accountability in PAD care and may ultimately affect reimbursement,” Dr. Smolderen said.

“Adoption of this new paradigm will further improve the quality of care for PAD and will put the patient front and center, as an agent in their care,” she added.

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery, and vascular medicine.

This research had no commercial funding. Dr. Smolderen has disclosed relationships with Optum, Abbott, Cook Medical, Happify, and Tegus.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The U.S. Food and Drug Administration has confirmed a nationwide shortage of the immediate release formulation of amphetamine mixed salts (Adderall, Adderall IR), which are approved for treating attention deficit hyperactivity disorder and narcolepsy.

The FDA announcement follows weeks of reports of a shortage of the drug by pharmacy chains and Adderall users.

The agency said it is in “frequent” contact with all manufacturers of Adderall – and reported that one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.

Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through those producers, the FDA noted.

“Until supply is restored, there are alternative therapies, including the extended-release version of amphetamine mixed salts, available to health care professionals and their patients for amphetamine mixed salts’ approved indications,” the agency said.

Patients should work with their health care provider to determine their best treatment option, it added.

The organization is continuing to monitor the supply of Adderall and to help manufacturers resolve the shortage.

Its Drug Shortage webpage has additional information about the situation and is updated regularly.

“We continue to use all the tools we have available to help keep supply available for patients and will provide public updates regarding the Adderall shortage,” the FDA said.

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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