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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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Three drugs go head-to-head in advanced lung cancer study

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Changed
Mon, 11/29/2021 - 15:29

A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

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A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

A head-to-head comparison of immune checkpoint inhibitors atezolizumab and nivolumab and the chemotherapy drug docetaxel in patients with advanced non–small cell lung cancer (NSCLC), finds that atezolizumab was associated with a significantly longer overall survival than docetaxel and was on par with nivolumab.

The findings were reported in JAMA Network Open.

“Until recently, chemotherapy with platinum doublet was the standard first-line option for most patients with advanced NSCLC who did not have these genetic drivers or were not tested for them and remains the first choice in many parts of the world,” wrote the authors of the study which was led by Sreeram Ramagopalan, PhD, of F. Hoffmann-La Roche in Switzerland which funded the study.

Atezolizumab (Tecentriq, Genentech), which was approved in October by the U.S. Food and Drug Administration, is a monoclonal antibody that targets programmed cell death ligand 1 (PD-L1). It is also approved as monotherapy for patients with advanced NSCLC whose disease progressed despite treatment with platinum-based chemotherapy.

This is the first-known analysis that compares atezolizumab, nivolumab (Opdivo, Bristol Myers Squibb), and docetaxel (Taxotere, Sanofi) in patients outside of clinical trials, said Vivek Subbiah, MD, of MD Anderson Cancer Center and the study’s first author. “We have several new immune checkpoint inhibitors approved for treatment for NSCLC. Head-to-head comparison of the effectiveness of these agents in the real world are lacking,” he said.

Treatment with immune checkpoint inhibitors has shown improvement in the survival of patients with advanced NSCLC who failed chemotherapy treatment.

This study included 3,336 patients (mean age 67 years, 54.6% men) with advanced NSCLC who were treated with platinum-based chemotherapy. Data were collected from more than 1,000 clinics in the United States. Of the patients, 206 received atezolizumab, 500 received docetaxel, and 2,630 received nivolumab.

Patients were followed between May 2011 and March 2020. Atezolizumab and nivolumab showed a similar overall survival in these patients, but atezolizumab showed a longer overall survival, compared with docetaxel.

“Compared with docetaxel, atezolizumab was associated with significantly longer survival in the overall population and across all subgroups analyzed,” including patients with stage IIIB or IV cancer at diagnosis and nonsquamous NSCLC, the authors wrote. “Atezolizumab was associated with longer overall survival compared with docetaxel and was on par with nivolumab, supporting current clinical guidelines for systemic therapy for patients with advanced NSCLC in the U.S.”

Limitations of the study included its observational design and a small number of patients receiving atezolizumab. The authors suggested that studies using larger sample sizes are needed.

This study was funded by F. Hoffmann-La Roche. Genentech is a subsidiary of F. Hoffmann-La Roche.

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Colorectal cancer rates rising in people aged 50-54 years

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Mon, 11/29/2021 - 15:30

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

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New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

New U.S. data show that the incidence of colorectal cancer (CRC) is on the rise among people aged 50–54 years, mirroring the well-documented increases in early-onset CRC in persons younger than 50 years.

“It’s likely that the factors contributing to CRC at age 50–54 years are the same factors that contribute to early-onset CRC, which has increased in parallel,” Caitlin Murphy, PhD, MPH, with the University of Texas Health Science Center at Houston, said in an interview.

“Many studies published in just the last year show that the well-known risk factors of CRC in older adults, such as obesity or sedentary lifestyle, are risk factors of CRC in younger adults. Growing evidence also suggests that early life exposures, or exposures in childhood, infancy, or even in the womb, play an important role,” Dr. Murphy said.

The study was published online October 28 in Gastroenterology .

Dr. Murphy and colleagues examined trends in age-specific CRC incidence rates for individuals aged 45–49, 50–54, and 55–59 years using the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program.

During the period 1992–2018, there were a total of 101,609 cases of CRC among adults aged 45–59 years.

Further analysis showed that the CRC incidence rates rose from 23.4 to 34.0 per 100,000 among people aged 45–49 years and from 46.4 to 63.8 per 100,000 among those aged 50–54 years.

Conversely, incidence rates decreased among individuals aged 55–59 years, from 81.7 to 63.7 per 100,000 persons.

“Because of this opposing trend, or decreasing rates for age 55–59 years and increasing rates for age 50–54 years, incidence rates for the two age groups were nearly identical in 2016–18,” the researchers write.

They also found a “clear pattern” of increasing CRC incidence among adults in their early 50s, supporting the hypothesis that incidence rates increase at older ages as higher-risk generations mature, the researchers note.

These data send a clear message, Dr. Murphy told this news organization.

“Don’t delay colorectal cancer screening. Encourage on-time screening by discussing screening with patients before they reach the recommended age to initiate screening. The U.S. Preventive Services Task Force now recommends initiating average-risk screening at age 45 years,” Dr. Murphy said.
 

Concerning but not surprising

Rebecca Siegel, MPH, scientific director of Surveillance Research at the American Cancer Society, in Atlanta, who wasn’t involved in the study, said the results are “not surprising” and mirror the results of a 2017 study that showed that the incidence of CRC was increasing among individuals aged 50–54 years, as reported.

What’s “concerning,” Ms. Siegel said, is that people in this age group “have been recommended to be screened for CRC for decades. Hopefully, because the age to begin screening has been lowered from 50 to 45 years, this uptick will eventually flatten.”

David Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School, in Norfolk, Va., who also wasn’t involved in the study, said the increasing incidence is “concerning in this younger population, and similar to what is seen recently for the 45- to 49-year-old population.

“Recent data have linked dietary influences in the early development of precancerous colon polyps and colon cancer. The increased ingestion of processed foods and sugary beverages, most of which contain high fructose corn syrup, is very likely involved in the pathogenesis to explain these striking epidemiologic shifts,” Dr. Johnson said in an interview.

“These concerns will likely be compounded by the COVID-related adverse effects on people [in terms of] appropriate, timely colorectal cancer screening,” Dr. Johnson added.

The study was supported by the National Cancer Institute at the National Institutes of Health. Dr. Murphy has consulted for Freenome. Ms. Siegel and Dr. Johnson have reported no relevant financial relationships.

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

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CBT prevents depression in up to 50% of patients with insomnia

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Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

 

 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

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Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

 

 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

Cognitive-behavioral therapy (CBT) is linked to a significantly reduced risk of depression in patients with insomnia, new research shows.

Insomnia affects over 50% of older adults, and insomnia contributes to a twofold greater risk for major depression, investigators noted.

“We show that by treating insomnia with a simple behavioral approach called Cognitive Behavioral Therapy for Insomnia, or CBT-I, you can reduce the likelihood of developing depression by over 50%,” lead author Michael R. Irwin, MD, Cousins Distinguished Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, said in an interview.

The study is unique in that the treatment “is not just reducing depression, it’s preventing depression,” Dr. Irwin added.

The findings were published online Nov. 24 in JAMA Psychiatry.
 

Primary outcome met

The study included 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within the previous 12 months.

All were randomly assigned to receive either CBT-I or Sleep Education Therapy (SET).

CBT-I is a first-line treatment for insomnia that includes five components: cognitive therapy targeting dysfunctional thoughts about sleep, stimulus control, sleep restriction, sleep hygiene, and relaxation.

SET provides information on behavioral and environmental factors contributing to poor sleep. While sleep education provides tips on improving sleep, CBT-I helps patients implement those changes and behaviors, Dr. Irwin noted.

Both interventions were delivered by trained personnel in weekly 120-minute group sessions for 2 months, consistent with the format and duration of most CBT-I trials.

The primary outcome was time to incident or recurrent major depressive disorder as diagnosed by the Structured Clinical Interview of the DSM-5 every 6 months during 36 months of follow-up. A monthly Patient Health Questionnaire 9 (PHQ-9) was used to screen for depressive symptoms.

Results showed depression occurred in 12.2% of the CBT-I group versus 25.9% of the SET group. The hazard ratio (HR) for depression in the CBT-I group compared with the SET group was 0.51 (95% confidence interval, 0.29-0.88; P = .02). The number needed to treat to prevent incident or recurrent depression was 7.3.

After adjustment for factors affecting depression risk such as sex, educational level, income, comorbidity, and history of depression, the HR for depression in the CBT-I group versus the SET group was 0.45 (95% CI, 0.23-0.86; P = .02).

Treatment with CBT-I yielded an annual 4.1% incidence of depression, which is similar to the population rate and half the rate in SET, which was 8.6%.
 

‘Remission is key’

The secondary outcome was sustained remission of insomnia disorder. The investigators found a greater proportion of the CBT-I group than the SET group achieved remission after treatment (50.7% vs. 37.7%; 95% CI, 0.10-0.93; P = .02).

“Remission is really key to the benefits that we’re seeing,” said Dr. Irwin.

Inflammation may explain why insomnia raises the risk for depression, he noted. “We know sleep disturbance can lead to inflammation and we also know inflammation can produce depression,” Dr. Irwin said.

It is also possible insomnia leads to an impaired pleasure or reward system, which is linked to depression, he added.

The authors noted that because insomnia is associated with suicidal ideation and dementia, CBT-I may reduce risk for suicide or cognitive decline.

While 8-week CBT-I treatments are readily available, “unfortunately, most clinicians will prescribe medications,” said Dr. Irwin. He noted that in older adults, drugs are linked to adverse events such as falls and cognitive problems.

These new results “really argue that psychology and psychiatry need to be fully integrated into what we call collaborative care models,” Dr. Irwin said.

There were no adverse events during treatment, and none of the serious events that occurred during follow-up were attributed to the trial.
 

 

 

Convincing argument?

Commenting on the findings for this news organization, Philip R. Muskin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, said the study was “nicely written” and the authors put forward “a very convincing argument” for CBT-I to prevent depression.

“It’s eye opening in that it’s a robust study; it’s carefully done; subjects were followed for a long period of time, and it’s an accessible treatment,” said Dr. Muskin, who was not involved with the research.

The study also shows “it’s possible to intervene in something we know is a risk factor in elderly people,” he added. “We think of older people as being less malleable to these kinds of things, but they’re not. They clearly participated, and there wasn’t a huge dropout rate.”

Dr. Muskin noted that less than half of the older participants were married or had a partner. He would have liked more information on this status because being widowed or divorced, as well as when this life change occurred, could affect vulnerability to depression.

The authors of an accompanying editorial called the study “seminal,” and noted that insomnia treatment possibly preventing depressive disorders is a “major finding.”

Proving this preventive strategy is effective in older adults will be important because “insomnia and depression are highly prevalent in this population and the uptake of both preventive and treatment services is low,” wrote Pim Cuijpers, PhD, department of clinical, neuro, and developmental psychology, Amsterdam Public Health Research Institute, and Charles F. Reynolds III, MD, department of psychiatry, University of Pittsburgh.

If the reduced rates of depression observed in the study could be generalized to the total population with insomnia, “the incidence of major depression could be reduced considerably,” they wrote.

“Can we prevent depression through interventions aimed at procrastination in college students, interventions aimed at perfectionism in perinatal women, stress management training for employees, social skills training in adolescents?” they asked.

This approach to preventing depressive disorders “offers all kinds of new opportunities to develop and test indirect interventions” for problems that are significantly associated with the onset of depression, the editorialists wrote.

The study was funded by a grant from the National Institute on Aging to the University of California, which partially supported the authors’ salaries. Dr. Irwin, Dr. Muskin, and Dr. Cuijpers have reported no relevant financial relationships. Dr. Reynolds reported being coinventor of the Pittsburgh Sleep Quality Index, for which he receives royalties.

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

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Non–health care municipal services cut severe maternal morbidity rates

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Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Dr. Felix M. Muchomba

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

Dr. Aimee J. Palumbo

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

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Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Dr. Felix M. Muchomba

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

Dr. Aimee J. Palumbo

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

Municipal budget allocations can affect severe maternal morbidity (SMM) rates, a cross-sectional study published in JAMA Network Open reported.

Dr. Felix M. Muchomba

Led by Felix M. Muchomba, PhD, an assistant professor at Rutgers University School of Social Work in New Brunswick, N.J., the study found that local expenditures on fire and ambulance, transportation, health, housing, and libraries were negatively associated with SMM. Specifically, annual per-capita expenditures of $1,000 and higher in these categories were associated with a 35.4%-67.3% lower risk of SMM: odds ratios, 0.33 (95% confidence interval, 0.15-0.72) to 0.65 (95% CI, 0.46-0.91).

In contrast, expenditures on police were positively associated with SMM: OR, 1.15 (95% CI, 1.04-1.28).

In the first study of environmental services spending and SMM done at the municipal level – others have focused on state and county funding – Dr. Muchomba’s group analyzed 2008-2018 birth files linked to maternal hospital discharge records and U.S. Census municipal expenditures data.

The study’s cohort comprised 1,001,410 mothers giving birth in New Jersey hospitals with a mean age of 29.8 years. Of these,10.9 % were Asian, 14.8% were Black, 28.0% were Hispanic, and 44.7% were White.

Per-capita municipal expenditures were reviewed for a broad range of city services: education, public health, fire and ambulance, parks, recreation, natural resources, housing, community development, public welfare; police; transportation, and libraries. “Each year municipalities spend about $600 billion nationwide on local services, investing far more than counties do,” Dr. Muchomba said.

Among developed nations, the United States has a rate of high maternal morbidity, a determinant of maternal mortality, and New Jersey has one of the highest rates in the country, although, paradoxically, it has one of the lowest state poverty rates and one of the highest state income levels, he added, said explaining the impetus for the study.

Previous research has found that state and local investment in non–health specific services can reduce infant mortality rates (IMR). Last year, for example, a national study of 2000-2016 data led by Neal D. Goldstein, PhD, MRI, an assistant professor of epidemiology and biostatistics at Drexel University in Philadelphia, reported that a $0.30 per-person increase in environmental spending was associated with a decrease of 0.03 deaths per 1,000 live births, and a $0.73 per-person increase in social services spending was associated with a decrease of 0.02 deaths per 1,000 live births. “IMR is reflective of, and amenable to broad social, economic, and health care delivery contexts within a society. State and local governments, via increased social and environmental expenditures, have the potential to reduce, albeit not eliminate, IMR disparities,” Dr. Goldstein’s group wrote in Pediatrics.

Dr. Aimee J. Palumbo

According to Aimee J. Palumbo, PhD, MPH, an assistant professor in the department of epidemiology & biostatistics in the College of Public Health at Temple University in Philadelphia, who was not involved in the study, the current study’s results are broadly consistent with those of the Goldstein study, of which she is a coauthor, in that it shows spending on public welfare is associated with better outcomes following birth.

“This analysis, however, is done at the municipality level, which allows it to evaluate variations in spending that occur at more local levels, rather than the state level like ours,” she said in an interview. “The researchers are also able to control for individual-level factors,” which is good as it is really suggestive of the impact that spending has on outcomes after controlling for some individual characteristics.”

Both studies speak to the importance of exploring funding for social services and specific programs that affect health, Dr. Palumbo added.

Services that affect nonmedical determinants of health broadly affect how people live their daily lives, Dr. Muchomba said – where they live, how they get to work and to medical appointments, where they shop, how they engage in recreation.

“Housing is very important for mothers since it provides a safe space to shelter during pregnancy and during recovery from childbirth. It’s a safe place to store medications and to prepare healthy food,” he continued. “But much of the housing in New Jersey is very expensive, and some mothers may have to decide between paying the rent and buying healthy food.”

In other benefits, local services spending provides transportation to jobs and health care, bus shelters, effective waste management, viable sidewalks, safe crosswalks, and public exercise venues that help to reduce obesity.

The category that Dr. Muchomba is most often asked about is libraries. “Why libraries? Our hypothesis is that libraries provide some low-income people with their only access to computers and the Internet. They’re a major resource for information and a proxy for the delivery of other services,” he said. In addition, many libraries offer English as a second language classes, which may increase health literacy among immigrants.

A major objective of the 2020 Maternal Health Action Plan of the U.S. Department of Health & Human Services is to better target resources by identifying problem spots for maternal morbidity and mortality. “Our findings strongly suggest that surveillance at the municipal level, a level rarely considered in studies of health outcomes, would be important for success in such efforts,” the authors wrote.

Dr. Muchomba believes doctors can have a role to play in targeting of spending for local services that can reduce maternal morbidity and mortality. “Many physicians are engaged in community health outreach efforts. As respected people in the community, they need to be aware of these other determinants of health that may be driving maternal morbidity rates in their communities.”

This research was supported by the Robert Wood Johnson Foundation, the National Center for Advancing Translational Sciences, the U.S. Department of Health & Human Services Health Resources and Service Administration and the Child Health Institute of New Jersey. Dr. Muchomba reported a grant from Eunice Kennedy Shriver National Institute of Child Health and Human Development outside of the submitted work. Dr. Palumbo had no potential competing interests to disclose.

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Clinical Edge Journal Scan Commentary: HCC December 2021

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Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Hepatocellular carcinoma (HCC) benefits from multidisciplinary care. This month we will review articles that address different approaches to the treatment for HCC, their outcomes, and potential complications.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

Author and Disclosure Information

Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Author and Disclosure Information

Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology,  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Dr. Damjanov scans the journals, so you don’t have to!
Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Hepatocellular carcinoma (HCC) benefits from multidisciplinary care. This month we will review articles that address different approaches to the treatment for HCC, their outcomes, and potential complications.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

Nevena Damjanov, MD
Hepatocellular carcinoma (HCC) benefits from multidisciplinary care. This month we will review articles that address different approaches to the treatment for HCC, their outcomes, and potential complications.

Laparoscopic HCC resections are increasing worldwide. Ivanics et al. report on a retrospective single-institution experience in North America that involves 149 patients who were matched by propensity score. Laparoscopic liver resection was performed in 57, and open liver resection was completed in 92. The laparoscopic liver resection group experienced a lower number of serious complications (14% vs 29%; P = .01). The 1-year overall survival (OS) rate was 90.9% vs 91.3% in the laparoscopic liver resection versus open liver resection group, while 3-year OS was 79.3% vs 88.5%, and 5-year OS was 70.5% vs 83.1% (P = .26). The cumulative incidence of recurrence at 1 year was 31.1% vs 18.9% in the laparoscopic liver resection versus open liver resection group, at 3 years was 59.7% vs 40.6%, and at 5 years was 62.9% vs 49.2% (P = .06). The authors concluded that laparoscopic HCC resection had fewer short-term complications, and statistically equivalent tumor control, compared to open liver resection, and should be considered as an option for treatment of patients with resectable liver cancer.

Radioembolization is a common treatment for liver-dominant HCC. Selective internal radiation therapy (SIRT) has a high objective response rate, but has yet to demonstrate a OS benefit. This could be due to incidental damage to the healthy liver, resulting in scarring, liver decompensation and a shorter survival. Van Doom et al. retrospectively analyzed 69 patients with advanced HCC who underwent SIRT. The primary outcome was the percentage of patients who developed Child-Pugh (CP) ≥ B7 liver disease after SIRT. The secondary outcomes were OS and response. After a median follow-up of 30 months, 38/69 patients (55%) developed CP ≥ B7. A lower ALBI score at baseline was significantly associated with a better outcome. The median OS in the SIRT-treated patients was 18 months (95% CI 14–22) compared to a case-matched cohort of 300 patients treated with sorafenib between 2007 and 2016 where the median OS was 8 months (95% CI 6–12; p = 0.0027). The authors concluded that patients with intermediate- or advanced-stage HCC treated with SIRT have a substantial risk of developing liver decompensation, but improved patient selection using the ALBI score may mitigate this risk. Note is made that the sorafenib patients were treated at a time when limited systemic options were available.

Finally, Peng et al. analyzed 699 adults with newly diagnosed HCC who were initially treated with transarterial chemoembolization (TACE) between 2010 and 2013. Initial treatment with TACE resulted in a complete response (CR) in 22.3% of the patients. The patients with a CR had a better OS than those who did not achieve CR (35.8 vs 24.0 months, P < 0.001). Predictors of lower likelihood of CR included CP B cirrhosis, higher tumor load, bilobar tumor, alpha-fetoprotein (AFP) level ≥20, and platelet counts >150,000. The authors concluded that TACE is an excellent treatment for selected patients with localized HCC.

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Short-acting opioids needed for withdrawal in U.S. hospitals, say experts

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Thu, 12/09/2021 - 11:54

 

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

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Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

 

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

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Social media use associated with depression in adults

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Tue, 11/23/2021 - 14:09

The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

 

 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

 

 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

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The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

 

 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

 

 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

 

 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

 

 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

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Predicting cardiac shock mortality in the ICU

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Tue, 11/23/2021 - 14:09

Addition of echocardiogram measurement of biventricular dysfunction improved the accuracy of prognosis among patients with cardiac shock (CS) in the cardiac intensive care unit.

In patients in the cardiac ICU with CS, biventricular dysfunction (BVD), as assessed using transthoracic echocardiography, improves clinical risk stratification when combined with the Society for Cardiovascular Angiography and Interventions shock stage.

No improvements in risk stratification was seen with patients with left or right ventricular systolic dysfunction (LVSD or RVSD) alone, according to an article published in the journal Chest.

Ventricular systolic dysfunction is commonly seen in patients who have suffered cardiac shock, most often on the left side. Although echocardiography is often performed on these patients during diagnosis, previous studies looking at ventricular dysfunction used invasive hemodynamic parameters, which made it challenging to incorporate their findings into general cardiac ICU practice.
 

Pinning down cardiac shock

Although treatment of acute MI and heart failure has improved greatly, particularly with the implementation of percutaneous coronary intervention (primary PCI) for ST-segment elevation MI. This has reduced the rate of future heart failure, but cardiac shock can occur before or after the procedure, with a 30-day mortality of 30%-40%. This outcome hasn’t improved in the last 20 years.

Efforts to improve cardiac shock outcomes through percutaneous mechanical circulatory support devices have been hindered by the fact that CS patients are heterogeneous, and prognosis may depend on a range of factors.

SCAI was developed as a five-stage classification system for CS to improve communication of patient status, as well as to improve differentiation among patients participation in clinical trials. It does not include measures of ventricular dysfunction.
 

Simple measure boosts prognosis accuracy

The new work adds an additional layer to the SCAI shock stage. “Adding echocardiography allows discrimination between levels of risk for each SCAI stage,” said David Baran, MD, who was asked for comment. Dr. Baran was the lead author on the original SCAI study and is system director of advanced heart failure at Sentara Heart Hospital, as well as a professor of medicine at Eastern Virginia Medical School, both in Norfolk.

The work also underscores the value of repeated measures of prognosis during a patient’s stay in the ICU. “If a patient is not improving, it may prompt a consideration of whether transfer or consultation with a tertiary center may be of value. Conversely, if a patient doesn’t have high-risk features and is responding to therapy, it is reassuring to have data supporting low mortality with that care plan,” said Dr. Baran.

The study may be biased, since not every patient undergoes an echocardiogram. Still, “the authors make a convincing case that biventricular dysfunction is a powerful negative marker across the spectrum of SCAI stages,” said Dr. Baran.

Echocardiography is simple and generally available, and some are even portable and used with a smartphone. But patient body size interferes with echocardiography, as can the presence of a ventilator or multiple surgical dressings. “The key advantage of echo is that it is completely noninvasive and can be brought to the patient in the ICU, unlike other testing which involves moving the patient to the testing environment,” said Dr. Baran.

The researchers analyzed data from 3,158 patients admitted to the cardiac ICU at the Mayo Clinic Hospital St. Mary’s Campus in Rochester, Minn., 51.8% of whom had acute coronary syndromes. They defined LVSD as a left ventricular ejection fraction less than 40%, and RVSD as at least moderate systolic dysfunction determined by semiquantitative measurement. BVD constituted the presence of both LVSD and RVSD. They examined the association of in-hospital mortality with these parameters combined with SCAI stage.
 

 

 

BVD a risk factor

Overall in-hospital mortality was 10%. A total of 22.3% of patients had LVSD and 11.8% had RVSD; 16.4% had moderate or greater BVD. There was no association between LVSD or RVSD and in-hospital mortality after adjustment for SCAI stage, but there was a significant association for BVD (adjusted hazard ratio, 1.815; P = .0023). When combined with SCAI, BVC led to an improved ability to predict hospital mortality (area under the curve, 0.784 vs. 0.766; P < .001). Adding semiquantitative RVSD and LVSD led to more improvement (AUC, 0.794; P < .01 vs. both).

RVSD was associated with higher in-hospital mortality (adjusted odds ratio, 1.421; P = .02), and there was a trend toward greater mortality with LVSD (aOR, 1.336; P = .06). There was little change when SCAI shock stage A patients were excluded (aOR, 1.840; P < .001).

Patients with BVD had greater in-hospital mortality than those without ventricular dysfunction (aOR, 1.815; P = .0023), but other between-group comparisons were not significant.

The researchers performed a classification and regression tree analysis using left ventricular ejection fraction (LVEF) and semiquantitative RVSD. It found that RVSD was a better predictor of in-hospital mortality than LVSD, and the best cutoff for LVSD was different among patients with RVSD and patients without RVSD.

Patients with mild or greater RVD and LVEF greater than 24% were considered high risk; those with borderline or low RVSD and LVEF less than 33%, or mild or greater RVSD with LVEF of at least 24%, were considered intermediate risk. Patients with borderline or no RVSD and LVEF of at least 33% were considered low risk. Hospital mortality was 22% in the high-risk group, 12.2% in the intermediate group, and 3.3% in the low-risk group (aOR vs. intermediate, 0.493; P = .0006; aOR vs. high risk, 0.357; P < .0001).

The study authors disclosed no relevant financial relationships.

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

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Addition of echocardiogram measurement of biventricular dysfunction improved the accuracy of prognosis among patients with cardiac shock (CS) in the cardiac intensive care unit.

In patients in the cardiac ICU with CS, biventricular dysfunction (BVD), as assessed using transthoracic echocardiography, improves clinical risk stratification when combined with the Society for Cardiovascular Angiography and Interventions shock stage.

No improvements in risk stratification was seen with patients with left or right ventricular systolic dysfunction (LVSD or RVSD) alone, according to an article published in the journal Chest.

Ventricular systolic dysfunction is commonly seen in patients who have suffered cardiac shock, most often on the left side. Although echocardiography is often performed on these patients during diagnosis, previous studies looking at ventricular dysfunction used invasive hemodynamic parameters, which made it challenging to incorporate their findings into general cardiac ICU practice.
 

Pinning down cardiac shock

Although treatment of acute MI and heart failure has improved greatly, particularly with the implementation of percutaneous coronary intervention (primary PCI) for ST-segment elevation MI. This has reduced the rate of future heart failure, but cardiac shock can occur before or after the procedure, with a 30-day mortality of 30%-40%. This outcome hasn’t improved in the last 20 years.

Efforts to improve cardiac shock outcomes through percutaneous mechanical circulatory support devices have been hindered by the fact that CS patients are heterogeneous, and prognosis may depend on a range of factors.

SCAI was developed as a five-stage classification system for CS to improve communication of patient status, as well as to improve differentiation among patients participation in clinical trials. It does not include measures of ventricular dysfunction.
 

Simple measure boosts prognosis accuracy

The new work adds an additional layer to the SCAI shock stage. “Adding echocardiography allows discrimination between levels of risk for each SCAI stage,” said David Baran, MD, who was asked for comment. Dr. Baran was the lead author on the original SCAI study and is system director of advanced heart failure at Sentara Heart Hospital, as well as a professor of medicine at Eastern Virginia Medical School, both in Norfolk.

The work also underscores the value of repeated measures of prognosis during a patient’s stay in the ICU. “If a patient is not improving, it may prompt a consideration of whether transfer or consultation with a tertiary center may be of value. Conversely, if a patient doesn’t have high-risk features and is responding to therapy, it is reassuring to have data supporting low mortality with that care plan,” said Dr. Baran.

The study may be biased, since not every patient undergoes an echocardiogram. Still, “the authors make a convincing case that biventricular dysfunction is a powerful negative marker across the spectrum of SCAI stages,” said Dr. Baran.

Echocardiography is simple and generally available, and some are even portable and used with a smartphone. But patient body size interferes with echocardiography, as can the presence of a ventilator or multiple surgical dressings. “The key advantage of echo is that it is completely noninvasive and can be brought to the patient in the ICU, unlike other testing which involves moving the patient to the testing environment,” said Dr. Baran.

The researchers analyzed data from 3,158 patients admitted to the cardiac ICU at the Mayo Clinic Hospital St. Mary’s Campus in Rochester, Minn., 51.8% of whom had acute coronary syndromes. They defined LVSD as a left ventricular ejection fraction less than 40%, and RVSD as at least moderate systolic dysfunction determined by semiquantitative measurement. BVD constituted the presence of both LVSD and RVSD. They examined the association of in-hospital mortality with these parameters combined with SCAI stage.
 

 

 

BVD a risk factor

Overall in-hospital mortality was 10%. A total of 22.3% of patients had LVSD and 11.8% had RVSD; 16.4% had moderate or greater BVD. There was no association between LVSD or RVSD and in-hospital mortality after adjustment for SCAI stage, but there was a significant association for BVD (adjusted hazard ratio, 1.815; P = .0023). When combined with SCAI, BVC led to an improved ability to predict hospital mortality (area under the curve, 0.784 vs. 0.766; P < .001). Adding semiquantitative RVSD and LVSD led to more improvement (AUC, 0.794; P < .01 vs. both).

RVSD was associated with higher in-hospital mortality (adjusted odds ratio, 1.421; P = .02), and there was a trend toward greater mortality with LVSD (aOR, 1.336; P = .06). There was little change when SCAI shock stage A patients were excluded (aOR, 1.840; P < .001).

Patients with BVD had greater in-hospital mortality than those without ventricular dysfunction (aOR, 1.815; P = .0023), but other between-group comparisons were not significant.

The researchers performed a classification and regression tree analysis using left ventricular ejection fraction (LVEF) and semiquantitative RVSD. It found that RVSD was a better predictor of in-hospital mortality than LVSD, and the best cutoff for LVSD was different among patients with RVSD and patients without RVSD.

Patients with mild or greater RVD and LVEF greater than 24% were considered high risk; those with borderline or low RVSD and LVEF less than 33%, or mild or greater RVSD with LVEF of at least 24%, were considered intermediate risk. Patients with borderline or no RVSD and LVEF of at least 33% were considered low risk. Hospital mortality was 22% in the high-risk group, 12.2% in the intermediate group, and 3.3% in the low-risk group (aOR vs. intermediate, 0.493; P = .0006; aOR vs. high risk, 0.357; P < .0001).

The study authors disclosed no relevant financial relationships.

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

Addition of echocardiogram measurement of biventricular dysfunction improved the accuracy of prognosis among patients with cardiac shock (CS) in the cardiac intensive care unit.

In patients in the cardiac ICU with CS, biventricular dysfunction (BVD), as assessed using transthoracic echocardiography, improves clinical risk stratification when combined with the Society for Cardiovascular Angiography and Interventions shock stage.

No improvements in risk stratification was seen with patients with left or right ventricular systolic dysfunction (LVSD or RVSD) alone, according to an article published in the journal Chest.

Ventricular systolic dysfunction is commonly seen in patients who have suffered cardiac shock, most often on the left side. Although echocardiography is often performed on these patients during diagnosis, previous studies looking at ventricular dysfunction used invasive hemodynamic parameters, which made it challenging to incorporate their findings into general cardiac ICU practice.
 

Pinning down cardiac shock

Although treatment of acute MI and heart failure has improved greatly, particularly with the implementation of percutaneous coronary intervention (primary PCI) for ST-segment elevation MI. This has reduced the rate of future heart failure, but cardiac shock can occur before or after the procedure, with a 30-day mortality of 30%-40%. This outcome hasn’t improved in the last 20 years.

Efforts to improve cardiac shock outcomes through percutaneous mechanical circulatory support devices have been hindered by the fact that CS patients are heterogeneous, and prognosis may depend on a range of factors.

SCAI was developed as a five-stage classification system for CS to improve communication of patient status, as well as to improve differentiation among patients participation in clinical trials. It does not include measures of ventricular dysfunction.
 

Simple measure boosts prognosis accuracy

The new work adds an additional layer to the SCAI shock stage. “Adding echocardiography allows discrimination between levels of risk for each SCAI stage,” said David Baran, MD, who was asked for comment. Dr. Baran was the lead author on the original SCAI study and is system director of advanced heart failure at Sentara Heart Hospital, as well as a professor of medicine at Eastern Virginia Medical School, both in Norfolk.

The work also underscores the value of repeated measures of prognosis during a patient’s stay in the ICU. “If a patient is not improving, it may prompt a consideration of whether transfer or consultation with a tertiary center may be of value. Conversely, if a patient doesn’t have high-risk features and is responding to therapy, it is reassuring to have data supporting low mortality with that care plan,” said Dr. Baran.

The study may be biased, since not every patient undergoes an echocardiogram. Still, “the authors make a convincing case that biventricular dysfunction is a powerful negative marker across the spectrum of SCAI stages,” said Dr. Baran.

Echocardiography is simple and generally available, and some are even portable and used with a smartphone. But patient body size interferes with echocardiography, as can the presence of a ventilator or multiple surgical dressings. “The key advantage of echo is that it is completely noninvasive and can be brought to the patient in the ICU, unlike other testing which involves moving the patient to the testing environment,” said Dr. Baran.

The researchers analyzed data from 3,158 patients admitted to the cardiac ICU at the Mayo Clinic Hospital St. Mary’s Campus in Rochester, Minn., 51.8% of whom had acute coronary syndromes. They defined LVSD as a left ventricular ejection fraction less than 40%, and RVSD as at least moderate systolic dysfunction determined by semiquantitative measurement. BVD constituted the presence of both LVSD and RVSD. They examined the association of in-hospital mortality with these parameters combined with SCAI stage.
 

 

 

BVD a risk factor

Overall in-hospital mortality was 10%. A total of 22.3% of patients had LVSD and 11.8% had RVSD; 16.4% had moderate or greater BVD. There was no association between LVSD or RVSD and in-hospital mortality after adjustment for SCAI stage, but there was a significant association for BVD (adjusted hazard ratio, 1.815; P = .0023). When combined with SCAI, BVC led to an improved ability to predict hospital mortality (area under the curve, 0.784 vs. 0.766; P < .001). Adding semiquantitative RVSD and LVSD led to more improvement (AUC, 0.794; P < .01 vs. both).

RVSD was associated with higher in-hospital mortality (adjusted odds ratio, 1.421; P = .02), and there was a trend toward greater mortality with LVSD (aOR, 1.336; P = .06). There was little change when SCAI shock stage A patients were excluded (aOR, 1.840; P < .001).

Patients with BVD had greater in-hospital mortality than those without ventricular dysfunction (aOR, 1.815; P = .0023), but other between-group comparisons were not significant.

The researchers performed a classification and regression tree analysis using left ventricular ejection fraction (LVEF) and semiquantitative RVSD. It found that RVSD was a better predictor of in-hospital mortality than LVSD, and the best cutoff for LVSD was different among patients with RVSD and patients without RVSD.

Patients with mild or greater RVD and LVEF greater than 24% were considered high risk; those with borderline or low RVSD and LVEF less than 33%, or mild or greater RVSD with LVEF of at least 24%, were considered intermediate risk. Patients with borderline or no RVSD and LVEF of at least 33% were considered low risk. Hospital mortality was 22% in the high-risk group, 12.2% in the intermediate group, and 3.3% in the low-risk group (aOR vs. intermediate, 0.493; P = .0006; aOR vs. high risk, 0.357; P < .0001).

The study authors disclosed no relevant financial relationships.

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

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HCV screening in pregnancy: Reducing the risk for casualties in the quest for elimination

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Tue, 11/23/2021 - 14:10

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

  • Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
  • Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
  • Be aware that intrahepatic is more common with HCV.
  • Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

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Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

  • Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
  • Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
  • Be aware that intrahepatic is more common with HCV.
  • Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

Because hepatitis C virus (HCV) infection is typically asymptomatic, its presence can easily be overlooked without appropriate screening efforts. For those screening efforts to be effective, they must keep pace with the changing demographic face of this increasingly prevalent but treatable disease.

Perhaps the most dramatic shift in HCV demographics in recent years has been the increase of infections among those born after 1965, a trend primarily driven by the opioid epidemic. In addition, data from the National Notifiable Diseases Surveillance System show that cases of diagnosed HCV doubled among women of childbearing age from 2006 to 2014, with new infections in younger women surpassing those in older age groups.

With such trends in mind, the Centers for Disease Control and Prevention broadened their recommendations regarding HCV in 2020 to include one-time testing in all adults aged 18 years and older and screening of all pregnant women during each pregnancy, except where the prevalence of infection is less than 0.1%, a threshold that no state has yet achieved.

The US Preventive Services Task Force (USPSTF) subsequently followed suit in their own recommendations.

The American Association for the Study of Liver Diseases/Infectious Diseases Society of America have long advocated for extensive expansion in their screening recommendations for HCV, including pregnancy.

Although the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine did not immediately adopt these recommendations, they have since endorsed them in May 2021 and June 2021, respectively.
 

The hepatologist perspective

As a practicing hepatologist, this seems like an uncontroversial recommendation. Obstetricians already screen for hepatitis B virus in each pregnancy. It should be easy to add HCV testing to the same lab testing.

Risk-based screening has repeatedly been demonstrated to be ineffective. It should be easier to test all women than to ask prying questions about high-risk behaviors.

Given the increase of injection drug use and resultant HCV infections in women of childbearing age, this seems like a perfect opportunity to identify chronically infected women and counsel them on transmission and cure. And pregnancy is also unique in that it is a time of near-universal health coverage.

Let’s address some of the operational issues.

The diagnostic cascade for HCV can be made very easy. HCV antibody testing is our standard screening test and, when positive, can automatically reflex to HCV polymerase chain reaction (PCR), the diagnostic test. Thus, with one blood sample, you can both screen for and diagnose infection.

Current guidelines do not recommend treating HCV during pregnancy, although therapy can be considered on an individual basis. Linkage to a knowledgeable provider who can discuss transmission and treatment, as well as assess the stage of liver injury, should decrease the burden on the ob.gyn.

The impact on pregnancy is marginal. HCV should not change either the mode of delivery or the decision to breastfeed. The AASLD/IDSA guidance outlines only four recommendations for monitoring during pregnancy:

  • Obtain HCV RNA to see whether the infection is active and assess liver function at initiation of prenatal care.
  • Prenatal care should be tailored to the pregnancy. There is no modification recommended to decrease mother-to-child transmission (MTCT).
  • Be aware that intrahepatic is more common with HCV.
  • Women with have a higher rate of adverse outcomes and should be linked to a high-risk obstetrics specialist.

But of course, what seems easy to one specialist may not be true of another. With that in mind, let’s hear the ob.gyn. perspective on these updated screening recommendations.
 

The ob.gyn. perspective

Recent guidelines from the CDC, ACOG, and SMFM recommend universal screening for HCV in all pregnant women. The increased availability of highly effective antiviral regimens makes universal screening a logical strategy, especially to identify candidates for this curative treatment. What is questionable, however, is the recommended timing by which this screening should take place.

HCV screening during pregnancy, as currently recommended, provides no immediate benefit for the pregnant woman or the fetus/neonate, given that antiviral treatments have not been approved during gestation, and there are no known measures that decrease MTCT or change routine perinatal care.

We also must not forget that a significant proportion of women in the United States, particularly those with limited resources, do not receive prenatal care at all. Most of them, however, will present to a hospital for delivery. Consequently, compliance with screening might be higher if performed at the time of delivery rather than antepartum.

Deferring screening until the intrapartum or immediate postpartum period, at least until antiviral treatment during pregnancy becomes a reality, was discussed. The rationale was that this approach might obviate the need to deal with the unintended consequences and burden of testing for HCV during pregnancy. Ultimately, ACOG and SMFM fell in line with the CDC recommendations.

Despite the lack of robust evidence regarding the risk for MTCT associated with commonly performed obstetric procedures (for example, genetic amniocentesis, artificial rupture of the membranes during labor, placement of an intrauterine pressure catheter), clinicians may be reluctant to perform them in HCV-infected women, resulting in potential deviations from the obstetric standard of care.

Similarly, it is likely that patients may choose to have a cesarean delivery for the sole purpose of decreasing MTCT, despite the lack of evidence for this. Such ill-advised patient-driven decisions are increasingly likely in the current environment, where social media can rapidly disseminate misinformation.
 

Implications for pediatric patients

One cannot isolate HCV screening in pregnancy from the consequences that may potentially occur as part of the infant’s transition to the care of a pediatrician.

Even though MTCT is estimated to occur in just 5%-15% of cases, all children born to HCV viremic mothers should be screened for HCV.

Traditionally, screening for HCV antibodies occurred after 18 months of age. In those who test positive, HCV PCR testing is recommended at 3 years. However, this algorithm is being called into question because only approximately one-third of infants are successfully screened.

HCV RNA testing in the first year after birth has been suggested. However, even proponents of this approach concur that all management decisions should be deferred until after the age of 3 years, when medications are approved for pediatric use.

In addition, HCV testing would be required again before considering therapy because children have higher rates of spontaneous clearance.
 

Seeking consensus beyond the controversy

Controversy remains surrounding the most recent update to the HCV screening guidelines. The current recommendation to screen during pregnancy cannot modify the risk for MTCT, has no impact on decisions regarding mode of delivery or breastfeeding, and could potentially cause harm by making obstetricians defer necessary invasive procedures even though there are no data linking them to an increase in MTCT.

Yet after extensive debate, the CDC, USPSTF, AASLD/IDSA, ACOG, and SMFM all developed their current recommendations to initiate HCV screening during pregnancy. To make this successful, screening algorithms need to be simple and consistent across all society recommendations.

HCV antibody testing should always reflex to the diagnostic test (HCV PCR) to allow confirmation in those who test positive without requiring an additional blood test. Viremic mothers (those who are HCV positive on PCR) should be linked to a provider who can discuss prognosis, transmission, and treatment. The importance of screening the infant also must be communicated to the parents and pediatrician alike.

Dr. Reau has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Gilead, Arbutus, Intercept, and Salix; received research grants from AbbVie and Gilead; and received income from AASLD. Dr. Pacheco disclosed no relevant financial relationships.
 

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

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Survival the same for younger and older patients with metastatic CRC

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Tue, 11/23/2021 - 14:10

Even though younger patients with metastatic colorectal cancer (CRC) tend to be fitter and receive more intensive treatment compared with older patients, overall survival (OS) and progression-free survival (PFS) are remarkably similar between the two groups, according to a large phase 3 randomized trial.

“Colorectal cancer is on track to be the leading cause of cancer death in patients 20 to 49 by the year 2040, so it is important to understand survival in this population,” lead author Marla Lipsyc-Sharf, MD, Young-Onset Colorectal Cancer Center, Dana-Farber Cancer Center, Boston, said in an interview. “The most important point for oncologists to take away from our study is that the survival of young-onset colorectal cancer does not seem to be different from that in older patients.”

Previous studies comparing survival in younger versus older patients with metastatic CRC have yielded conflicting results. Dr. Lipsyc-Sharf and colleagues set out to clarify the literature in their large randomized study, published online on Oct. 12 in the Journal of the National Cancer Institute.

Dr. Lipsyc-Sharf and colleagues enrolled 2,326 eligible patients in the Cancer and Leukemia Group B (CALGB)/SWOG 80405 (Alliance) trial to evaluate the efficacy of chemotherapy plus a biologic to treat metastatic CRC. Slightly over 22% of participants (514 patients) were under age 50 at study enrollment, with a median age of 44.3 years vs. 62.5 in those patients older than 50.

The primary outcome was OS and secondary outcomes included PFS, defined as time from study entry until disease progression or death from any cause. At a follow-up of 6 years, median OS was 27.07 months in the young CRC cohort compared with 26.12 months in the older CRC cohort.

Similarly, median PFS in both younger and older cohorts was virtually identical at 10.87 months versus 10.55 months, respectively. Patients younger than age 35 did have a shorter median OS of 21.95 months and PFS of 9.33 months compared with 26.12 months and 10.55 months, respectively, for those 50 and older, but neither difference was significant.

The similar OS between the younger and older patients with metastatic CRC is “particularly interesting,” the authors noted, given that younger patients should, in theory, have done better than their older peers. Younger patients tend to have better overall health (less diabetes, greater physical activity), have more left-sided CRC, (which is associated with a better prognosis), and receive more intensive therapy.

“It’s not clear at this time why the young-onset CRC patients – despite having these more favorable characteristics – did not have improved survival compared to older patients,” Dr. Lipsyc-Sharf said.  

The authors suggest that this similar survival may be because younger patients tend to be diagnosed at more advanced stages, due to differences in underlying tumor biology, or due to other unknown factors. However, “additional investigation into the tumor biology, clinical characteristics, and optimal treatment of patients with [early onset] CRC is essential,” the authors concluded.

The work was supported by the National Cancer Institute of the National Institutes of Health and, in part, by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Dr. Lipsyc-Sharf has reported no relevant financial relationships.

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

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Even though younger patients with metastatic colorectal cancer (CRC) tend to be fitter and receive more intensive treatment compared with older patients, overall survival (OS) and progression-free survival (PFS) are remarkably similar between the two groups, according to a large phase 3 randomized trial.

“Colorectal cancer is on track to be the leading cause of cancer death in patients 20 to 49 by the year 2040, so it is important to understand survival in this population,” lead author Marla Lipsyc-Sharf, MD, Young-Onset Colorectal Cancer Center, Dana-Farber Cancer Center, Boston, said in an interview. “The most important point for oncologists to take away from our study is that the survival of young-onset colorectal cancer does not seem to be different from that in older patients.”

Previous studies comparing survival in younger versus older patients with metastatic CRC have yielded conflicting results. Dr. Lipsyc-Sharf and colleagues set out to clarify the literature in their large randomized study, published online on Oct. 12 in the Journal of the National Cancer Institute.

Dr. Lipsyc-Sharf and colleagues enrolled 2,326 eligible patients in the Cancer and Leukemia Group B (CALGB)/SWOG 80405 (Alliance) trial to evaluate the efficacy of chemotherapy plus a biologic to treat metastatic CRC. Slightly over 22% of participants (514 patients) were under age 50 at study enrollment, with a median age of 44.3 years vs. 62.5 in those patients older than 50.

The primary outcome was OS and secondary outcomes included PFS, defined as time from study entry until disease progression or death from any cause. At a follow-up of 6 years, median OS was 27.07 months in the young CRC cohort compared with 26.12 months in the older CRC cohort.

Similarly, median PFS in both younger and older cohorts was virtually identical at 10.87 months versus 10.55 months, respectively. Patients younger than age 35 did have a shorter median OS of 21.95 months and PFS of 9.33 months compared with 26.12 months and 10.55 months, respectively, for those 50 and older, but neither difference was significant.

The similar OS between the younger and older patients with metastatic CRC is “particularly interesting,” the authors noted, given that younger patients should, in theory, have done better than their older peers. Younger patients tend to have better overall health (less diabetes, greater physical activity), have more left-sided CRC, (which is associated with a better prognosis), and receive more intensive therapy.

“It’s not clear at this time why the young-onset CRC patients – despite having these more favorable characteristics – did not have improved survival compared to older patients,” Dr. Lipsyc-Sharf said.  

The authors suggest that this similar survival may be because younger patients tend to be diagnosed at more advanced stages, due to differences in underlying tumor biology, or due to other unknown factors. However, “additional investigation into the tumor biology, clinical characteristics, and optimal treatment of patients with [early onset] CRC is essential,” the authors concluded.

The work was supported by the National Cancer Institute of the National Institutes of Health and, in part, by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Dr. Lipsyc-Sharf has reported no relevant financial relationships.

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

Even though younger patients with metastatic colorectal cancer (CRC) tend to be fitter and receive more intensive treatment compared with older patients, overall survival (OS) and progression-free survival (PFS) are remarkably similar between the two groups, according to a large phase 3 randomized trial.

“Colorectal cancer is on track to be the leading cause of cancer death in patients 20 to 49 by the year 2040, so it is important to understand survival in this population,” lead author Marla Lipsyc-Sharf, MD, Young-Onset Colorectal Cancer Center, Dana-Farber Cancer Center, Boston, said in an interview. “The most important point for oncologists to take away from our study is that the survival of young-onset colorectal cancer does not seem to be different from that in older patients.”

Previous studies comparing survival in younger versus older patients with metastatic CRC have yielded conflicting results. Dr. Lipsyc-Sharf and colleagues set out to clarify the literature in their large randomized study, published online on Oct. 12 in the Journal of the National Cancer Institute.

Dr. Lipsyc-Sharf and colleagues enrolled 2,326 eligible patients in the Cancer and Leukemia Group B (CALGB)/SWOG 80405 (Alliance) trial to evaluate the efficacy of chemotherapy plus a biologic to treat metastatic CRC. Slightly over 22% of participants (514 patients) were under age 50 at study enrollment, with a median age of 44.3 years vs. 62.5 in those patients older than 50.

The primary outcome was OS and secondary outcomes included PFS, defined as time from study entry until disease progression or death from any cause. At a follow-up of 6 years, median OS was 27.07 months in the young CRC cohort compared with 26.12 months in the older CRC cohort.

Similarly, median PFS in both younger and older cohorts was virtually identical at 10.87 months versus 10.55 months, respectively. Patients younger than age 35 did have a shorter median OS of 21.95 months and PFS of 9.33 months compared with 26.12 months and 10.55 months, respectively, for those 50 and older, but neither difference was significant.

The similar OS between the younger and older patients with metastatic CRC is “particularly interesting,” the authors noted, given that younger patients should, in theory, have done better than their older peers. Younger patients tend to have better overall health (less diabetes, greater physical activity), have more left-sided CRC, (which is associated with a better prognosis), and receive more intensive therapy.

“It’s not clear at this time why the young-onset CRC patients – despite having these more favorable characteristics – did not have improved survival compared to older patients,” Dr. Lipsyc-Sharf said.  

The authors suggest that this similar survival may be because younger patients tend to be diagnosed at more advanced stages, due to differences in underlying tumor biology, or due to other unknown factors. However, “additional investigation into the tumor biology, clinical characteristics, and optimal treatment of patients with [early onset] CRC is essential,” the authors concluded.

The work was supported by the National Cancer Institute of the National Institutes of Health and, in part, by Bristol Myers Squibb, Genentech, Pfizer, and Sanofi. Dr. Lipsyc-Sharf has reported no relevant financial relationships.

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

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