Marcia Frellick

The U.S. Preventive Services Task Force on Apr. 12 posted draft recommendations on screening for depression and anxiety in children and adolescents.

For the first time, the USPSTF is recommending screening children ages 8 and older for anxiety.

It also recommended screening children ages 12 and older for depression, which was consistent with the USPSTF’s prior recommendations on the topic.

These B-grade draft recommendations are for children and teens who are not showing signs or symptoms of these conditions. The task force emphasized that anyone who has concerns about or shows signs of these conditions should be connected to care.

Task force member Martha Kubik, PhD, RN, a professor with George Mason University, Fairfax, Va, said in a statement: “Fortunately, we found that screening older children for anxiety and depression is effective in identifying these conditions so children and teens can be connected to the support they need.”

The group cited in its recommendation on anxiety the 2018-2019 National Survey of Children’s Health, which found that 7.8% of children and adolescents ages 3-17 years had a current anxiety disorder. It also noted that the National Survey on LGBTQ Youth Mental Health found that 72% of LGBTQ youth and 77% of transgender and nonbinary youth described general anxiety disorder symptoms.

“Anxiety disorders in childhood and adolescence are associated with an increased likelihood of a future anxiety disorder or depression,” the task force authors wrote.

They highlighted that “the prevalence of anxiety in Black youth may be evolving.” Previously, studies had suggested that young Black people may have had lower rates of mental health disorders, compared with their White counterparts.

“However, recent cohorts of Black children or adolescents have reported a higher prevalence of anxiety disorders than in the past,” the authors wrote.

Joanna Quigley, MD, clinical associate professor and associate medical director for child & adolescent services at the University of Michigan, Ann Arbor, said in an interview she was not surprised the USPSTF recommended screening for anxiety starting at age 8.

That’s when parents and providers see anxiety disorders begin to present or become more problematic, she said.

“It’s also acknowledging the importance of prevention,” she said. “The sooner we can identify these challenges for kids, the sooner we can intervene and have better outcomes for that child across their lifespan.”

Screening gets providers and families in the habit of thinking about these concerns when a child or adolescent comes in for another kind of visit, Dr. Quigley said. Chest pains in a well-child check, for example, may trigger thoughts to consider anxiety later if the child is brought in for a cardiac check for chest pains.

“It creates a culture of awareness that is important as well,” Dr. Quigley said. “I think part of what the task force is trying to do is saying that identifying anxiety can be a precursor to what could turn out to be related to depression or related to ADHD and factors we think about when we think about suicide risk as well.

“We’re seeing an increase in suicide in the younger age group as well, which is a huge concern, “ she noted.

Dr. Quigley said, if these recommendations are adopted after the comment period, pediatricians and family practice providers will likely be doing most of the screening for anxiety, but there may also be a role for the screening in pediatric subspecialty care, such as those treating children with chronic illness and in specialized mental health care.

She added: “This builds on the national conversation going on about the mental health crisis, declared a national emergency in the fall. This deserves attention in continuing the momentum.”
 

Factors that may signal higher risk for depression

While the USPSTF recommends screening for major depressive disorder in all adolescents aged 12 years and older, the USPSTF notes that several risk factors might help identify those at higher risk.

Markers for higher risk include a combination of factors such as a family history of depression, prior episode of depression, and other mental health or behavioral problems.

“Other psychosocial risk factors include childhood abuse or neglect, exposure to traumatic events, bullying (either as perpetrators or as victims), adverse life events, early exposure to stress, maltreatment, and an insecure parental relationship,” the task force authors wrote.

There was limited evidence, however, on the benefits and harms of screening children younger than 8 for anxiety and screening kids younger than 12 for depression.
 

Not enough evidence for suicide risk screening

The authors of the recommendations acknowledged that, while suicide is a leading cause of death for older children and teens, evidence is still too sparse to make recommendations regarding screening for suicide risk in those without signs or symptoms at any age.

They also explained that evidence is lacking and inconsistent on the effectiveness of treatment (psychotherapy, pharmacotherapy, or collaborative care) for suicide risk in improving outcomes in children and adolescents.

Comments on the USPSTF recommendations may be submitted until May 9, 2022. The USPSTF topic leads review all comments, revise the draft recommendations, put them to a vote by the full task force, and then post the final versions to the website.

The task force authors and Dr. Quigley reported no financial disclosures.

The U.S. Preventive Services Task Force on Apr. 12 posted draft recommendations on screening for depression and anxiety in children and adolescents.

For the first time, the USPSTF is recommending screening children ages 8 and older for anxiety.

It also recommended screening children ages 12 and older for depression, which was consistent with the USPSTF’s prior recommendations on the topic.

These B-grade draft recommendations are for children and teens who are not showing signs or symptoms of these conditions. The task force emphasized that anyone who has concerns about or shows signs of these conditions should be connected to care.

Task force member Martha Kubik, PhD, RN, a professor with George Mason University, Fairfax, Va, said in a statement: “Fortunately, we found that screening older children for anxiety and depression is effective in identifying these conditions so children and teens can be connected to the support they need.”

The group cited in its recommendation on anxiety the 2018-2019 National Survey of Children’s Health, which found that 7.8% of children and adolescents ages 3-17 years had a current anxiety disorder. It also noted that the National Survey on LGBTQ Youth Mental Health found that 72% of LGBTQ youth and 77% of transgender and nonbinary youth described general anxiety disorder symptoms.

“Anxiety disorders in childhood and adolescence are associated with an increased likelihood of a future anxiety disorder or depression,” the task force authors wrote.

They highlighted that “the prevalence of anxiety in Black youth may be evolving.” Previously, studies had suggested that young Black people may have had lower rates of mental health disorders, compared with their White counterparts.

“However, recent cohorts of Black children or adolescents have reported a higher prevalence of anxiety disorders than in the past,” the authors wrote.

Joanna Quigley, MD, clinical associate professor and associate medical director for child & adolescent services at the University of Michigan, Ann Arbor, said in an interview she was not surprised the USPSTF recommended screening for anxiety starting at age 8.

That’s when parents and providers see anxiety disorders begin to present or become more problematic, she said.

“It’s also acknowledging the importance of prevention,” she said. “The sooner we can identify these challenges for kids, the sooner we can intervene and have better outcomes for that child across their lifespan.”

Screening gets providers and families in the habit of thinking about these concerns when a child or adolescent comes in for another kind of visit, Dr. Quigley said. Chest pains in a well-child check, for example, may trigger thoughts to consider anxiety later if the child is brought in for a cardiac check for chest pains.

“It creates a culture of awareness that is important as well,” Dr. Quigley said. “I think part of what the task force is trying to do is saying that identifying anxiety can be a precursor to what could turn out to be related to depression or related to ADHD and factors we think about when we think about suicide risk as well.

“We’re seeing an increase in suicide in the younger age group as well, which is a huge concern, “ she noted.

Dr. Quigley said, if these recommendations are adopted after the comment period, pediatricians and family practice providers will likely be doing most of the screening for anxiety, but there may also be a role for the screening in pediatric subspecialty care, such as those treating children with chronic illness and in specialized mental health care.

She added: “This builds on the national conversation going on about the mental health crisis, declared a national emergency in the fall. This deserves attention in continuing the momentum.”
 

Factors that may signal higher risk for depression

While the USPSTF recommends screening for major depressive disorder in all adolescents aged 12 years and older, the USPSTF notes that several risk factors might help identify those at higher risk.

Markers for higher risk include a combination of factors such as a family history of depression, prior episode of depression, and other mental health or behavioral problems.

“Other psychosocial risk factors include childhood abuse or neglect, exposure to traumatic events, bullying (either as perpetrators or as victims), adverse life events, early exposure to stress, maltreatment, and an insecure parental relationship,” the task force authors wrote.

There was limited evidence, however, on the benefits and harms of screening children younger than 8 for anxiety and screening kids younger than 12 for depression.
 

Not enough evidence for suicide risk screening

The authors of the recommendations acknowledged that, while suicide is a leading cause of death for older children and teens, evidence is still too sparse to make recommendations regarding screening for suicide risk in those without signs or symptoms at any age.

They also explained that evidence is lacking and inconsistent on the effectiveness of treatment (psychotherapy, pharmacotherapy, or collaborative care) for suicide risk in improving outcomes in children and adolescents.

Comments on the USPSTF recommendations may be submitted until May 9, 2022. The USPSTF topic leads review all comments, revise the draft recommendations, put them to a vote by the full task force, and then post the final versions to the website.

The task force authors and Dr. Quigley reported no financial disclosures.

The U.S. Preventive Services Task Force on Apr. 12 posted draft recommendations on screening for depression and anxiety in children and adolescents.

For the first time, the USPSTF is recommending screening children ages 8 and older for anxiety.

It also recommended screening children ages 12 and older for depression, which was consistent with the USPSTF’s prior recommendations on the topic.

These B-grade draft recommendations are for children and teens who are not showing signs or symptoms of these conditions. The task force emphasized that anyone who has concerns about or shows signs of these conditions should be connected to care.

Task force member Martha Kubik, PhD, RN, a professor with George Mason University, Fairfax, Va, said in a statement: “Fortunately, we found that screening older children for anxiety and depression is effective in identifying these conditions so children and teens can be connected to the support they need.”

The group cited in its recommendation on anxiety the 2018-2019 National Survey of Children’s Health, which found that 7.8% of children and adolescents ages 3-17 years had a current anxiety disorder. It also noted that the National Survey on LGBTQ Youth Mental Health found that 72% of LGBTQ youth and 77% of transgender and nonbinary youth described general anxiety disorder symptoms.

“Anxiety disorders in childhood and adolescence are associated with an increased likelihood of a future anxiety disorder or depression,” the task force authors wrote.

They highlighted that “the prevalence of anxiety in Black youth may be evolving.” Previously, studies had suggested that young Black people may have had lower rates of mental health disorders, compared with their White counterparts.

“However, recent cohorts of Black children or adolescents have reported a higher prevalence of anxiety disorders than in the past,” the authors wrote.

Joanna Quigley, MD, clinical associate professor and associate medical director for child & adolescent services at the University of Michigan, Ann Arbor, said in an interview she was not surprised the USPSTF recommended screening for anxiety starting at age 8.

That’s when parents and providers see anxiety disorders begin to present or become more problematic, she said.

“It’s also acknowledging the importance of prevention,” she said. “The sooner we can identify these challenges for kids, the sooner we can intervene and have better outcomes for that child across their lifespan.”

Screening gets providers and families in the habit of thinking about these concerns when a child or adolescent comes in for another kind of visit, Dr. Quigley said. Chest pains in a well-child check, for example, may trigger thoughts to consider anxiety later if the child is brought in for a cardiac check for chest pains.

“It creates a culture of awareness that is important as well,” Dr. Quigley said. “I think part of what the task force is trying to do is saying that identifying anxiety can be a precursor to what could turn out to be related to depression or related to ADHD and factors we think about when we think about suicide risk as well.

“We’re seeing an increase in suicide in the younger age group as well, which is a huge concern, “ she noted.

Dr. Quigley said, if these recommendations are adopted after the comment period, pediatricians and family practice providers will likely be doing most of the screening for anxiety, but there may also be a role for the screening in pediatric subspecialty care, such as those treating children with chronic illness and in specialized mental health care.

She added: “This builds on the national conversation going on about the mental health crisis, declared a national emergency in the fall. This deserves attention in continuing the momentum.”
 

Factors that may signal higher risk for depression

While the USPSTF recommends screening for major depressive disorder in all adolescents aged 12 years and older, the USPSTF notes that several risk factors might help identify those at higher risk.

Markers for higher risk include a combination of factors such as a family history of depression, prior episode of depression, and other mental health or behavioral problems.

“Other psychosocial risk factors include childhood abuse or neglect, exposure to traumatic events, bullying (either as perpetrators or as victims), adverse life events, early exposure to stress, maltreatment, and an insecure parental relationship,” the task force authors wrote.

There was limited evidence, however, on the benefits and harms of screening children younger than 8 for anxiety and screening kids younger than 12 for depression.
 

Not enough evidence for suicide risk screening

The authors of the recommendations acknowledged that, while suicide is a leading cause of death for older children and teens, evidence is still too sparse to make recommendations regarding screening for suicide risk in those without signs or symptoms at any age.

They also explained that evidence is lacking and inconsistent on the effectiveness of treatment (psychotherapy, pharmacotherapy, or collaborative care) for suicide risk in improving outcomes in children and adolescents.

Comments on the USPSTF recommendations may be submitted until May 9, 2022. The USPSTF topic leads review all comments, revise the draft recommendations, put them to a vote by the full task force, and then post the final versions to the website.

The task force authors and Dr. Quigley reported no financial disclosures.

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

A vibrating wearable device helped people with gastroesophageal reflux disease (GERD) stay positioned on their left side while sleeping, alleviating night time reflux symptoms, compared with sham treatment, a small, randomized study suggests.

People often report having more reflux symptoms when sleeping on their right side, and experimental studies suggest that sleeping on the right side is associated with higher esophageal acid exposure time and slower esophageal acid clearance, compared with sleeping on the left side, the authors wrote.

They cite a possible cause as the stomach being above the esophagus when a person is sleeping on their right side, resulting in more reflux.

“There are two very exciting new things that can be learned,” Arjan Bredenoord, MD, PhD, a principal investigator of the study and professor of neurogastroenterology and motility at the Academic Medical Center in Amsterdam, told this news organization. “First, we show that a device that trains people to sleep on the left side really helps to relieve nocturnal reflux symptoms. Second, the study was performed completely remotely, with the patients being at home.”

“The devices were shipped to the patients. All contact was via video calling, and questionnaires were done via links in emails that were linked to secure databases to store the patients’ symptom responses,” he added.

The findings were published online in Clinical Gastroenterology and Hepatology.
 

A study in sleep positional therapy

Researchers performed a double-blind, randomized, sham-controlled trial in 100 patients with night time GERD symptoms who wore a programmed device (about 1.5 inches square) on their chest, midsternum.

Patients were advised to sleep on their left side and randomly assigned (1:1) either to a group whose device produced a gentle vibration when they flipped onto their right side throughout sleep or to the group whose device vibrated when they flipped to the right side but only for the first 20 minutes of use (the sham intervention).

The primary outcome for success was at least a 50% reduction in the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score. Secondary outcomes included change in sleep position and reflux symptoms.

In the intention-to-treat analysis, the rate of treatment success was 44% in the intervention group versus 24% in the sham group. The risk difference was 20% (95% confidence interval, 1.8% to 38.2%; P = .03).

Treatment led to a significant avoidance of sleeping on the right side (intervention 2.2% vs. sham 23.5%; P ≤ .0001) and an increased time of sleeping on the left side (intervention 60.9% vs. sham 38.5%; P ≤ .0001).

Patients in the intervention group also had more reflux-free nights (9 nights vs. 6 nights for the sham group).

After 2 weeks of treatment, the average total N-GSSIQ scores were lower in the active device group (18.8 vs. 23.7 in the sham group; P = .04).
 

Most with GERD have night time symptoms

The authors pointed out that up to 80% of patients with GERD experience symptoms during the night, such as heartburn and regurgitation, which can significantly impair sleep quality and daytime functioning.

Solutions are of high interest because current measures have shortcomings.

Raising the head-end of the bed and lengthening the time between dinner and bedtime have limited effect, the authors explained. And while proton pump inhibitors are very effective for daytime symptoms, they have limited efficacy for night time reflux symptoms.

Antireflux pillows, which are designed to keep patients on their left side through the night, have been found to result in less recumbent acid exposure and less self-reported night time reflux symptoms, but they do not allow for spontaneous body movements and can be uncomfortable, they explained.

The lightweight vibration device, made by Side Sleep Technologies BV, registers the sleep position of a subject at 30-second intervals. It categorizes sleep position as supine, right, left, prone, or upright.

Michiel Allessie, CEO of Side Sleep Technologies, told this news organization that the wearable V1.0 is sold as a consumer electronic device rather than a medical device in the United Kingdom for £99. He said the company expects to sell the V1.0 in the United States starting in June, with a target price of $99.
 

Promising but device still needs real-world testing

When asked to comment, Philip Katz, MD, a gastroenterologist at Weill Cornell Medicine, New York, said it was a fantastic study scientifically and academically incredibly interesting, but the device is not a panacea.

Dr. Katz said he will remain skeptical until the device is tested in real life and added that it’s important to remember this is one study with 100 people.

He also wondered whether there might be an even better solution in a well-designed wedge, for example, and whether the buzzing of this product might affect sleep quality. If so, would that be worth the tradeoff?

Dr. Katz noted that busy physicians may not have the time to determine whether patients truly have nocturnal GERD or just similar symptoms. This study included people who were carefully screened by the researchers for nocturnal reflux symptoms, he pointed out.

Based on this study, Dr. Katz said he would tell patients, “You have a 50% chance to be helped because their primary outcome was met by 44%.”

He said the decision is up to the patients and comes down to this: “It’s better than nothing for sure. Is it worth $100? You tell me.”

Dr. Bredenoord said the next step is a study using pH-impedance monitoring of the esophagus to show that there is also an effect on reflux episodes.

The investigational medical devices were provided free of charge and without restrictions by Side Sleep Technologies BV. Dr. Bredenoord disclosed research funding from Nutricia, Norgine, SST, Thelial, and Bayer; speaker and/or consulting fees from Laborie, EsoCap, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Reckett Benkiser, Regeneron, and AstraZeneca; and previously owned shares in Side Sleep Technologies BV. Another coauthor received research funding from Boston Scientific and speaker and/or consulting fees from Cook and Olympus. The remaining authors have disclosed no relevant financial relationships. Dr. Katz reported being a consultant for Phathom Pharmaceuticals and Sebela.

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

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.

The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.

The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”

“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.

Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
 

Upgrade to new models to decrease infections

Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.

The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.

Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)

Fully Disposable:

Ambu Innovation GmbH, Duodenoscope model aScope Duodeno

Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope

Disposable Components:

Fujifilm Corporation, Duodenoscope model ED-580XT 

Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V 

Pentax Medical, Duodenoscope model ED34-i10T2 

Pentax Medical, Duodenoscope model ED32-i10 

Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.

“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
 

Postmarket surveillance studies

In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.

In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.

The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.

“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.

Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.

In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.

According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.

However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.

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

Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.

The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.

The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”

“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.

Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
 

Upgrade to new models to decrease infections

Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.

The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.

Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)

Fully Disposable:

Ambu Innovation GmbH, Duodenoscope model aScope Duodeno

Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope

Disposable Components:

Fujifilm Corporation, Duodenoscope model ED-580XT 

Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V 

Pentax Medical, Duodenoscope model ED34-i10T2 

Pentax Medical, Duodenoscope model ED32-i10 

Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.

“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
 

Postmarket surveillance studies

In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.

In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.

The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.

“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.

Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.

In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.

According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.

However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.

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

Health care facilities and providers should complete the transition to fully disposable duodenoscopes and those with disposable components, the U.S. Food and Drug Administration announced this week after an analysis of postmarket surveillance studies was completed.

The FDA’s directive updates its April 2020 recommendations on the subject. It cites concerns about cleaning fixed endcap duodenoscopes and the increasing availability of models that eliminate the need for reprocessing.

The announcement highlighted the potential for a dramatic difference in between-patient contamination risk, reducing it “by half or more as compared to reusable, or fixed endcaps.”

“Interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%,” the FDA writes.

Duodenoscopes are used in more than 500,000 procedures each year in the United States and are key in assessing and treating diseases and conditions of the pancreas and bile ducts.
 

Upgrade to new models to decrease infections

Manufacturers no longer market fixed endcap models in the United States, but some health care facilities continue to use them. The FDA recommends that all fixed endcap models be replaced.

The FDA says some manufacturers are offering replacement programs to upgrade to a model with a disposable component at no cost.

Two fully disposable models and five with disposable components have been cleared by the FDA. (One model is no longer marketed and thus not listed here.)

Fully Disposable:

Ambu Innovation GmbH, Duodenoscope model aScope Duodeno

Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope

Disposable Components:

Fujifilm Corporation, Duodenoscope model ED-580XT 

Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V 

Pentax Medical, Duodenoscope model ED34-i10T2 

Pentax Medical, Duodenoscope model ED32-i10 

Additionally, the failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient transferring to a subsequent patient.

“In rare cases, this can lead to patient-to-patient disease transmission,” the FDA says.
 

Postmarket surveillance studies

In 2015, the FDA ordered three manufacturers of reusable devices (Fujifilm, Olympus, and Pentax) to conduct postmarket surveillance studies to determine contamination rates after reprocessing.

In 2019, the FDA also ordered postmarket surveillance studies to the makers of duodenoscopes with disposable endcaps to verify that the new designs reduce the contamination rate.

The final results of the fixed endcap design indicate that contamination rates were as high as 6.6% with high-concern organisms after contamination. High-concern organisms are those more often associated with disease, such as E coli and Pseudomonas contamination.

“As a result, Pentax and Olympus are withdrawing their fixed endcap duodenoscopes from the market, and Fujifilm has completed withdrawal of its fixed endcap duodenoscope,” the FDA writes.

Studies are not yet complete for duodenoscopes with removable components. As of August 12, 2021, the Fujifilm ED-580XT duodenoscope with a removable cap had 57% of the samples required. Interim results indicate that no samples tested positive for enough low-concern organisms to indicate a reprocessing failure, and only 0.5% tested positive for high-concern organisms.

In addition to the contamination risk sampling, each manufacturer was ordered to do postmarket surveillance studies to evaluate whether staff could understand and follow the manufacturer’s reprocessing instructions in real-world health care settings.

According to the FDA, the results showed that users frequently had difficulty understanding and following the manufacturers’ instructions and were not able to successfully complete reprocessing with the older models.

However, the newer models had high user success rates for understanding instructions and correctly performing reprocessing tasks, the FDA says.

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

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Premature births from cesarean (C-section) and induced deliveries dropped abruptly by 6.5% from the projected number in the first month of the COVID-19 pandemic and stayed at the lower rate consistently throughout the year, researchers have found.

Results of the study, led by Daniel Dench, PhD, assistant professor at the Georgia Institute of Technology School of Economics in Atlanta, were published online in Pediatrics.

The authors say their findings help answer the question of whether numbers of preterm (less than 37 weeks gestation) C-sections and induced deliveries would change if women didn’t see their physicians during pregnancy as often, especially in person, and raise the question of whether some birth interventions by physicians may not be necessary. The pandemic gave researchers a natural, ethical way to study the question.

The researchers found that in March 2020 – the start of business closures and stay-at-home orders around the country – preterm births from C-sections or induced deliveries immediately fell from the forecast number for the month by 0.4 percentage points. For the rest of 2020, the number remained on average 0.35 percentage points below the numbers predicted.

That means 350 fewer preterm C-sections and induced deliveries per 100,000 live births, or 10,000 fewer overall, the authors said.

Dr. Dench told this publication the numbers for those births had been steady from January 2010 to February 2020, but the pattern “diverges from this trend very clearly beginning exactly in March 2020 and does not return to trend by December 2020.”

Meanwhile, during the study period, the number of full-term cesarean and induced deliveries stayed steady and started to increase slightly in 2020. Researchers also adjusted for seasonality as, for example, preterm births are higher on average in February than in March.

So far, Dr. Dench said in a press release, it’s not clear whether the lower numbers mean physicians didn’t deliver babies that ended up surviving in the womb anyway or if they missed some that would die in the womb without intervention.

To better understand those implications, Dr. Dench says he is turning to fetal death records for March-December 2020 and he said he expects to have those results analyzed by the end of the year.

If there was no change in fetal deaths at the same time as the drop in preterm births, Dr. Dench said, that could point to physician interventions that may not have been necessary.

Mya R. Zapata, MD, an obstetrician-gynecologist with UCLA Health, who was not involved with the study, told this publication that checking the fetal deaths is a good start and an objective outcome in answering the question, but she points out there are other outcomes that will take a deeper analysis, such as whether there are differences later in developmental outcomes after fewer physician visits.

“It’s always a good question for health care,” she said, “are we doing more than we need to?”

Dr. Zapata is the obstetrics service chief for UCLA’s labor and delivery unit and was an integral part of decision-making as to what services were essential and for which patients. She said the fewer visits and fewer ultrasounds the researchers describe fit with what ob.gyns. at UCLA experienced as the pandemic hit.

“We really tried to hone in on people who were at highest risk for an adverse outcome,” she said. “I still have the question of whether there were things we missed in low-risk people. It will take time to get the entire answer. But it does make us reflect that perhaps less intervention could be better for patients and easier. It’s our job in medicine to keep asking the question of what is essential and safe and not just continue with current practice because that’s what we’ve always done.”

The amount of data gave the researchers an unusual view. They studied 38,891,271 singleton births in the United States from 2010 to 2020 with data from the National Center for Health Statistics.

“If you look at 1,000 births in a single hospital, or even at 30,000 births across a hospital system, you wouldn’t be able to see the drop as clearly,” Dr. Dench said. “The drop we detected is a huge change, but you might miss it in a small sample.”

The researchers acknowledge a limitation of the study is that half of all preterm C-sections and induced deliveries happen because of a ruptured membrane, a spontaneous cause. Those instances can’t be distinguished from the ones caused by doctors’ interventions in this study.

“Still, these findings are significant because the causes for preterm births are not always known,” the authors wrote in the press release.

The study authors and Dr. Zapata reported no relevant financial relationships.

Certain reproductive factors are associated with greater or lower risk of dementia, according to researchers who conducted a large population-based study with UK Biobank data.

Jessica Gong, a PhD candidate at the George Institute for Global Health at University of New South Wales in Australia, and coauthors found a greater dementia risk in women with early and late menarche, women who were younger when they first gave birth, and those who had had a hysterectomy, especially those who had a hysterectomy without concomitant oophorectomy or with a previous oophorectomy.

After controlling for key confounders, the researchers found lower risk of all-cause dementia if women had ever been pregnant, ever had an abortion, had a longer reproductive span, or had later menopause.

Use of oral contraceptive pills was associated with a lower dementia risk, they found.

In this study, there was no evidence that hormone therapy (HT) was associated with dementia risk (hazard ratio, 0.99, 95% confidence interval [0.90-1.09], P =.0828).

The analysis, published online April 5 in PLOS Medicine, comprised 273,240 women and 228,957 men without prevalent dementia.

The authors noted that dementia rates are increasing. Globally, 50 million people live with dementia, and the number is expected to triple by 2050, according to Alzheimer’s Disease International.

“Our study identified certain reproductive factors related to shorter exposure to endogenous estrogen were associated with increased risk of dementia, highlighting the susceptibility in dementia risk pertaining to women,” Ms. Gong told this publication.
 

Risk comparison of men and women

Men were included in this study to compare the association between number of children fathered and the risk of all-cause dementia, with the association in their female counterparts.

The U-shaped associations between the number of children and dementia risk were similar for both sexes, suggesting that the risk difference in women may not be associated with factors associated with childbearing

“It may be more related to social and behavioral factors in parenthood, rather than biological factors involved in childbearing,” Ms. Gong said.

Compared with those with two children, for those without children, the multiple adjusted HR (95% CI) was 1.18 (1.04, 1.33) (P = .027) for women and 1.10 (0.98-1.23) P = .164) for men.

For those with four or more children, the HR was 1.14 (0.98, 1.33) (P = .132) for women and 1.26 (1.10-1.45) (P = .003) for men.

Rachel Buckley, PhD, assistant professor of neurology with a dual appointment at Brigham and Women’s and Massachusetts General hospitals in Boston, told this publication she found the comparison of dementia risk with number of children in men and women “fascinating.”

She said the argument usually is that if women have had more births, then they have had more estrogen through their body because women get a huge injection of hormones in pregnancy.

“The idea is that the more pregnancies you have the more protected you are. But this study put that on its head, because if men and women are showing increased [dementia] risk in the number of children they have, it suggests there must be something about having the children – not necessarily the circulating hormones – that might be having an impact,” Dr. Buckley said.

“I had never thought to compare the number of children in men. I do find that very interesting,” she said.

As for the lack of a link between HT and dementia risk, in this study she said, she wouldn’t shut the door on that discussion just yet.

She noted the long history of controversy in the field about whether there is a protective factor against dementia for estrogen or whether exposure to estrogen leads to increased risk.

Before the landmark Women’s Health Initiative (WHI) study in the 1990s, she pointed out, there was evidence in many observational studies that women who had longer exposure to estrogen – whether that was earlier age at first period and later age at menopause combined or women had taken hormone therapy at some point, had less risk for dementia.

Dr. Buckley said that in a secondary outcome of WHI, however, “there was increased risk for progression to dementia in women who were taking hormone therapy which essentially flipped the field on its ahead because until that point everybody thought that estrogen was a protective factor.”

She said although this study found no association with dementia, she still thinks HT has a role to play and that it may just need to be better tailored to individuals.

“If you think about it, we have our tailored cocktail of hormones in our body and who’s to say that my hormones are going to be the same as yours? Why should you and I be put on the same hormone therapy and assume that will give us the same outcome? I think we could do a lot better with customization and calibration of hormones to aid in women’s health.”
 

Lifetime approach to dementia

Ms. Gong says future dementia risk-reduction strategies should consider sex-specific risk, and consider the reproductive events that took place in women’s lifespans as well as their entire hormone history when assessing dementia risk, to ensure that the strategies are sex sensitive.

Dr. Buckley agrees: “I don’t think we should ever think about dementia in terms of 65 onwards. We know this disease is insidious and it starts very, very early.”

Regarding limitations, the authors noted that it was a retrospective study that included self-reported measures of reproductive factors, which may be inherently subject to recall bias.

A coauthor does consultant work for Amgen, Freeline, and Kirin outside the submitted work. There were no other relevant financial disclosures.

Certain reproductive factors are associated with greater or lower risk of dementia, according to researchers who conducted a large population-based study with UK Biobank data.

Jessica Gong, a PhD candidate at the George Institute for Global Health at University of New South Wales in Australia, and coauthors found a greater dementia risk in women with early and late menarche, women who were younger when they first gave birth, and those who had had a hysterectomy, especially those who had a hysterectomy without concomitant oophorectomy or with a previous oophorectomy.

After controlling for key confounders, the researchers found lower risk of all-cause dementia if women had ever been pregnant, ever had an abortion, had a longer reproductive span, or had later menopause.

Use of oral contraceptive pills was associated with a lower dementia risk, they found.

In this study, there was no evidence that hormone therapy (HT) was associated with dementia risk (hazard ratio, 0.99, 95% confidence interval [0.90-1.09], P =.0828).

The analysis, published online April 5 in PLOS Medicine, comprised 273,240 women and 228,957 men without prevalent dementia.

The authors noted that dementia rates are increasing. Globally, 50 million people live with dementia, and the number is expected to triple by 2050, according to Alzheimer’s Disease International.

“Our study identified certain reproductive factors related to shorter exposure to endogenous estrogen were associated with increased risk of dementia, highlighting the susceptibility in dementia risk pertaining to women,” Ms. Gong told this publication.
 

Risk comparison of men and women

Men were included in this study to compare the association between number of children fathered and the risk of all-cause dementia, with the association in their female counterparts.

The U-shaped associations between the number of children and dementia risk were similar for both sexes, suggesting that the risk difference in women may not be associated with factors associated with childbearing

“It may be more related to social and behavioral factors in parenthood, rather than biological factors involved in childbearing,” Ms. Gong said.

Compared with those with two children, for those without children, the multiple adjusted HR (95% CI) was 1.18 (1.04, 1.33) (P = .027) for women and 1.10 (0.98-1.23) P = .164) for men.

For those with four or more children, the HR was 1.14 (0.98, 1.33) (P = .132) for women and 1.26 (1.10-1.45) (P = .003) for men.

Rachel Buckley, PhD, assistant professor of neurology with a dual appointment at Brigham and Women’s and Massachusetts General hospitals in Boston, told this publication she found the comparison of dementia risk with number of children in men and women “fascinating.”

She said the argument usually is that if women have had more births, then they have had more estrogen through their body because women get a huge injection of hormones in pregnancy.

“The idea is that the more pregnancies you have the more protected you are. But this study put that on its head, because if men and women are showing increased [dementia] risk in the number of children they have, it suggests there must be something about having the children – not necessarily the circulating hormones – that might be having an impact,” Dr. Buckley said.

“I had never thought to compare the number of children in men. I do find that very interesting,” she said.

As for the lack of a link between HT and dementia risk, in this study she said, she wouldn’t shut the door on that discussion just yet.

She noted the long history of controversy in the field about whether there is a protective factor against dementia for estrogen or whether exposure to estrogen leads to increased risk.

Before the landmark Women’s Health Initiative (WHI) study in the 1990s, she pointed out, there was evidence in many observational studies that women who had longer exposure to estrogen – whether that was earlier age at first period and later age at menopause combined or women had taken hormone therapy at some point, had less risk for dementia.

Dr. Buckley said that in a secondary outcome of WHI, however, “there was increased risk for progression to dementia in women who were taking hormone therapy which essentially flipped the field on its ahead because until that point everybody thought that estrogen was a protective factor.”

She said although this study found no association with dementia, she still thinks HT has a role to play and that it may just need to be better tailored to individuals.

“If you think about it, we have our tailored cocktail of hormones in our body and who’s to say that my hormones are going to be the same as yours? Why should you and I be put on the same hormone therapy and assume that will give us the same outcome? I think we could do a lot better with customization and calibration of hormones to aid in women’s health.”
 

Lifetime approach to dementia

Ms. Gong says future dementia risk-reduction strategies should consider sex-specific risk, and consider the reproductive events that took place in women’s lifespans as well as their entire hormone history when assessing dementia risk, to ensure that the strategies are sex sensitive.

Dr. Buckley agrees: “I don’t think we should ever think about dementia in terms of 65 onwards. We know this disease is insidious and it starts very, very early.”

Regarding limitations, the authors noted that it was a retrospective study that included self-reported measures of reproductive factors, which may be inherently subject to recall bias.

A coauthor does consultant work for Amgen, Freeline, and Kirin outside the submitted work. There were no other relevant financial disclosures.

Certain reproductive factors are associated with greater or lower risk of dementia, according to researchers who conducted a large population-based study with UK Biobank data.

Jessica Gong, a PhD candidate at the George Institute for Global Health at University of New South Wales in Australia, and coauthors found a greater dementia risk in women with early and late menarche, women who were younger when they first gave birth, and those who had had a hysterectomy, especially those who had a hysterectomy without concomitant oophorectomy or with a previous oophorectomy.

After controlling for key confounders, the researchers found lower risk of all-cause dementia if women had ever been pregnant, ever had an abortion, had a longer reproductive span, or had later menopause.

Use of oral contraceptive pills was associated with a lower dementia risk, they found.

In this study, there was no evidence that hormone therapy (HT) was associated with dementia risk (hazard ratio, 0.99, 95% confidence interval [0.90-1.09], P =.0828).

The analysis, published online April 5 in PLOS Medicine, comprised 273,240 women and 228,957 men without prevalent dementia.

The authors noted that dementia rates are increasing. Globally, 50 million people live with dementia, and the number is expected to triple by 2050, according to Alzheimer’s Disease International.

“Our study identified certain reproductive factors related to shorter exposure to endogenous estrogen were associated with increased risk of dementia, highlighting the susceptibility in dementia risk pertaining to women,” Ms. Gong told this publication.
 

Risk comparison of men and women

Men were included in this study to compare the association between number of children fathered and the risk of all-cause dementia, with the association in their female counterparts.

The U-shaped associations between the number of children and dementia risk were similar for both sexes, suggesting that the risk difference in women may not be associated with factors associated with childbearing

“It may be more related to social and behavioral factors in parenthood, rather than biological factors involved in childbearing,” Ms. Gong said.

Compared with those with two children, for those without children, the multiple adjusted HR (95% CI) was 1.18 (1.04, 1.33) (P = .027) for women and 1.10 (0.98-1.23) P = .164) for men.

For those with four or more children, the HR was 1.14 (0.98, 1.33) (P = .132) for women and 1.26 (1.10-1.45) (P = .003) for men.

Rachel Buckley, PhD, assistant professor of neurology with a dual appointment at Brigham and Women’s and Massachusetts General hospitals in Boston, told this publication she found the comparison of dementia risk with number of children in men and women “fascinating.”

She said the argument usually is that if women have had more births, then they have had more estrogen through their body because women get a huge injection of hormones in pregnancy.

“The idea is that the more pregnancies you have the more protected you are. But this study put that on its head, because if men and women are showing increased [dementia] risk in the number of children they have, it suggests there must be something about having the children – not necessarily the circulating hormones – that might be having an impact,” Dr. Buckley said.

“I had never thought to compare the number of children in men. I do find that very interesting,” she said.

As for the lack of a link between HT and dementia risk, in this study she said, she wouldn’t shut the door on that discussion just yet.

She noted the long history of controversy in the field about whether there is a protective factor against dementia for estrogen or whether exposure to estrogen leads to increased risk.

Before the landmark Women’s Health Initiative (WHI) study in the 1990s, she pointed out, there was evidence in many observational studies that women who had longer exposure to estrogen – whether that was earlier age at first period and later age at menopause combined or women had taken hormone therapy at some point, had less risk for dementia.

Dr. Buckley said that in a secondary outcome of WHI, however, “there was increased risk for progression to dementia in women who were taking hormone therapy which essentially flipped the field on its ahead because until that point everybody thought that estrogen was a protective factor.”

She said although this study found no association with dementia, she still thinks HT has a role to play and that it may just need to be better tailored to individuals.

“If you think about it, we have our tailored cocktail of hormones in our body and who’s to say that my hormones are going to be the same as yours? Why should you and I be put on the same hormone therapy and assume that will give us the same outcome? I think we could do a lot better with customization and calibration of hormones to aid in women’s health.”
 

Lifetime approach to dementia

Ms. Gong says future dementia risk-reduction strategies should consider sex-specific risk, and consider the reproductive events that took place in women’s lifespans as well as their entire hormone history when assessing dementia risk, to ensure that the strategies are sex sensitive.

Dr. Buckley agrees: “I don’t think we should ever think about dementia in terms of 65 onwards. We know this disease is insidious and it starts very, very early.”

Regarding limitations, the authors noted that it was a retrospective study that included self-reported measures of reproductive factors, which may be inherently subject to recall bias.

A coauthor does consultant work for Amgen, Freeline, and Kirin outside the submitted work. There were no other relevant financial disclosures.

A new score to gauge histologic remission in ulcerative colitis (UC), based simply on the presence or absence of neutrophils, is effective and easier to use than other indices, according to authors of a study published online in Gut.
 

Researchers, led by Xianyong Gui, MD, a surgical pathologist at the University of Washington, Seattle, developed the index, called the Paddington International Virtual Chromoendoscopy Score (PICaSSO) Histologic Remission Index (PHRI). They wrote that, when the index was plugged into an artificial intelligence (AI) model, the algorithm accurately determined histologic remission.

“Our preliminary AI algorithm differentiated active from quiescent UC with 78% sensitivity, 91.7% specificity, and 86% accuracy,” the authors noted.

Histologic remission has been previously proposed as a treatment target for UC and many indices have been developed to score disease activity, but they haven’t been widely used because of their complexity, the authors wrote. They believe this index can be applied easily and efficiently in clinical practice. “Since a pathologist needs only to identify neutrophils, which is a part of routine in reading biopsy slides as clinical histopathological evaluation, one can have the PHRI score immediately without making additional effort and spending extra time. Thus, the PHRI score can also be easily included into the pathology reports.”

The researchers found that the index correlates strongly with endoscopic activity and predicts UC clinical outcomes, including hospitalization, colectomy, and initiation or changes in treatment caused by UC flare-up.

Dr. Gui’s team developed the index using 614 biopsies from 307 patients with UC from 11 centers in Europe and North America who were prospectively enrolled in the PICaSSO study.

The index was a collaboration between pathologists and endoscopists who wanted a histologic score that would align with the endoscopic score and go beyond endoscopic evaluation. It eliminates consideration of ulceration/erosion, often a factor in other indices because variability can be high without contributing much to accuracy.
 

Keen interest in histologic remission

David T. Rubin, MD, chief of gastroenterology, hepatology and nutrition and the codirector of the Digestive Diseases Center at the University of Chicago, noted continued interest in whether histologic findings (biopsies) of the mucosa are a clinically important and reachable treatment goal with UC.

“It’s important to acknowledge that it is not yet a target of treatment, in part because of a variety of challenges and unknowns related to it,” he said.

The current study addresses a major barrier to incorporation of histology in the clinical management of patients with UC: individual interpretation. “Development of this simplified novel scoring approach with artificial intelligence could be a major step forward. We are hopeful that this type of AI approach will eliminate some of the barriers to use of histology as a marker of treatment control. It is of interest to note that this novel score correlated to the endoscopic appearance, but didn’t necessarily demonstrate superiority to it. This is important, since we have hypothesized that histology may provide more information about outcomes than endoscopy alone,” Dr. Rubin said.

He added that PHRI will need broader validation and incorporation into meaningful interventions before it can be incorporated into clinical practice, but that “this type of technological innovation is what the field needs in order to move forward.”

The authors and Dr. Rubin declared no relevant financial conflicts. Two coauthors are funded by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham in the United Kingdom.

A new score to gauge histologic remission in ulcerative colitis (UC), based simply on the presence or absence of neutrophils, is effective and easier to use than other indices, according to authors of a study published online in Gut.
 

Researchers, led by Xianyong Gui, MD, a surgical pathologist at the University of Washington, Seattle, developed the index, called the Paddington International Virtual Chromoendoscopy Score (PICaSSO) Histologic Remission Index (PHRI). They wrote that, when the index was plugged into an artificial intelligence (AI) model, the algorithm accurately determined histologic remission.

“Our preliminary AI algorithm differentiated active from quiescent UC with 78% sensitivity, 91.7% specificity, and 86% accuracy,” the authors noted.

Histologic remission has been previously proposed as a treatment target for UC and many indices have been developed to score disease activity, but they haven’t been widely used because of their complexity, the authors wrote. They believe this index can be applied easily and efficiently in clinical practice. “Since a pathologist needs only to identify neutrophils, which is a part of routine in reading biopsy slides as clinical histopathological evaluation, one can have the PHRI score immediately without making additional effort and spending extra time. Thus, the PHRI score can also be easily included into the pathology reports.”

The researchers found that the index correlates strongly with endoscopic activity and predicts UC clinical outcomes, including hospitalization, colectomy, and initiation or changes in treatment caused by UC flare-up.

Dr. Gui’s team developed the index using 614 biopsies from 307 patients with UC from 11 centers in Europe and North America who were prospectively enrolled in the PICaSSO study.

The index was a collaboration between pathologists and endoscopists who wanted a histologic score that would align with the endoscopic score and go beyond endoscopic evaluation. It eliminates consideration of ulceration/erosion, often a factor in other indices because variability can be high without contributing much to accuracy.
 

Keen interest in histologic remission

David T. Rubin, MD, chief of gastroenterology, hepatology and nutrition and the codirector of the Digestive Diseases Center at the University of Chicago, noted continued interest in whether histologic findings (biopsies) of the mucosa are a clinically important and reachable treatment goal with UC.

“It’s important to acknowledge that it is not yet a target of treatment, in part because of a variety of challenges and unknowns related to it,” he said.

The current study addresses a major barrier to incorporation of histology in the clinical management of patients with UC: individual interpretation. “Development of this simplified novel scoring approach with artificial intelligence could be a major step forward. We are hopeful that this type of AI approach will eliminate some of the barriers to use of histology as a marker of treatment control. It is of interest to note that this novel score correlated to the endoscopic appearance, but didn’t necessarily demonstrate superiority to it. This is important, since we have hypothesized that histology may provide more information about outcomes than endoscopy alone,” Dr. Rubin said.

He added that PHRI will need broader validation and incorporation into meaningful interventions before it can be incorporated into clinical practice, but that “this type of technological innovation is what the field needs in order to move forward.”

The authors and Dr. Rubin declared no relevant financial conflicts. Two coauthors are funded by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham in the United Kingdom.

A new score to gauge histologic remission in ulcerative colitis (UC), based simply on the presence or absence of neutrophils, is effective and easier to use than other indices, according to authors of a study published online in Gut.
 

Researchers, led by Xianyong Gui, MD, a surgical pathologist at the University of Washington, Seattle, developed the index, called the Paddington International Virtual Chromoendoscopy Score (PICaSSO) Histologic Remission Index (PHRI). They wrote that, when the index was plugged into an artificial intelligence (AI) model, the algorithm accurately determined histologic remission.

“Our preliminary AI algorithm differentiated active from quiescent UC with 78% sensitivity, 91.7% specificity, and 86% accuracy,” the authors noted.

Histologic remission has been previously proposed as a treatment target for UC and many indices have been developed to score disease activity, but they haven’t been widely used because of their complexity, the authors wrote. They believe this index can be applied easily and efficiently in clinical practice. “Since a pathologist needs only to identify neutrophils, which is a part of routine in reading biopsy slides as clinical histopathological evaluation, one can have the PHRI score immediately without making additional effort and spending extra time. Thus, the PHRI score can also be easily included into the pathology reports.”

The researchers found that the index correlates strongly with endoscopic activity and predicts UC clinical outcomes, including hospitalization, colectomy, and initiation or changes in treatment caused by UC flare-up.

Dr. Gui’s team developed the index using 614 biopsies from 307 patients with UC from 11 centers in Europe and North America who were prospectively enrolled in the PICaSSO study.

The index was a collaboration between pathologists and endoscopists who wanted a histologic score that would align with the endoscopic score and go beyond endoscopic evaluation. It eliminates consideration of ulceration/erosion, often a factor in other indices because variability can be high without contributing much to accuracy.
 

Keen interest in histologic remission

David T. Rubin, MD, chief of gastroenterology, hepatology and nutrition and the codirector of the Digestive Diseases Center at the University of Chicago, noted continued interest in whether histologic findings (biopsies) of the mucosa are a clinically important and reachable treatment goal with UC.

“It’s important to acknowledge that it is not yet a target of treatment, in part because of a variety of challenges and unknowns related to it,” he said.

The current study addresses a major barrier to incorporation of histology in the clinical management of patients with UC: individual interpretation. “Development of this simplified novel scoring approach with artificial intelligence could be a major step forward. We are hopeful that this type of AI approach will eliminate some of the barriers to use of histology as a marker of treatment control. It is of interest to note that this novel score correlated to the endoscopic appearance, but didn’t necessarily demonstrate superiority to it. This is important, since we have hypothesized that histology may provide more information about outcomes than endoscopy alone,” Dr. Rubin said.

He added that PHRI will need broader validation and incorporation into meaningful interventions before it can be incorporated into clinical practice, but that “this type of technological innovation is what the field needs in order to move forward.”

The authors and Dr. Rubin declared no relevant financial conflicts. Two coauthors are funded by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham in the United Kingdom.

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Satisfaction ratings for virtual outpatient visits for pediatric orthopedic patients were similar to those for in-person office visits across most categories in an analysis of postencounter surveys completed by patients at the Cleveland Clinic.

Satisfaction ratings for both virtual and office visits were consistently higher than 85% across all measured parameters, according to the data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

Ahmed Emara, MD, a clinical research fellow in adult joint reconstruction at the Cleveland Clinic, led the study, which included data from all patients or guardians at the clinic who experienced such visits from March 2020 to March 2021.

A total of 1,686 responses were received, of which 226 (13.4%) involved virtual visits and 1,460 (86.6%) involved in-office visits. The primary endpoint was a patient-reported satisfaction score of good or excellent.

Analysis included ratings for access, care provider, telemedicine technology, and overall assessment/perception of satisfaction.
 

Target areas for improvement

In some areas, the virtual visits were less satisfactory than the in-office visits.

Patients had lower odds of reporting good/excellent satisfaction regarding their ability to schedule at a particularly convenient time (odds ratio, 0.1; 95% confidence interval, 0.08-0.18; P < .001). The study authors said scheduling more virtual time slots may help increase satisfaction in that area.

Satisfaction was also lower than with in-office visits with respect to providers’ explanations of patients’ conditions (OR, 0.4; 95% CI, 0.17-0.91; P = .03). Providers may need to find ways to better provide educational material in addition to the virtual consultation, the authors wrote.
 

No significant differences in categories of satisfaction

The researchers accounted for age, sex, traumatic etiology, and anatomic location of the complaint in multivariate regression analysis and found no significant differences between the two types of visits in the odds of getting a good/excellent rating for the following areas: patient inclusion in treatment decision (P = .562), discussion of proposed treatment (P = .222), concern by the provider (P = .189), degree of care for the patient as a person (P = .208), adequacy of teamwork in care provision (P = .053), likelihood of recommending the practice to others (P = .108), ease of receiving care at a particular practice (P = .109), ease of contacting the clinic (P = .177), and likelihood of recommending a particular provider (P = .218).

Anna Dimitriovna Vergun, MD, a pediatric orthopedist at the University of North Carolina at Chapel Hill, who was not involved in the study, said in an interview she had been conducting virtual visits even before the pandemic, when she worked for several years at a Shriner’s children’s hospital in Los Angeles, before coming to UNC. The virtual visits were necessary because the hospital offered charity care and covered an area that included several states.

She said that during the height of the pandemic, 80% of her visits at UNC were virtual; it is down to about 5% now.

Some consultations don’t need physical visits at all, Dr. Vergun noted. For example, UNC is starting a clinic for prenatal counseling in cases in which ultrasound detects a limb deformity. Without a virtual option, she said, pregnant mothers in all parts of the state may have to drive long distances when no physical exam is necessary.

And sometimes, a visit simply involves checking in with families to see whether pain is being controlled, which is done well virtually.

“Those are particularly useful for telemedicine,” Dr. Vergun said. “There’s a lot of space for this to be useful. You sometimes don’t realize it until you start doing it and getting feedback from the families that they like it.”

Other exams may be better suited to office visits, she said. These include spine and hip exams and exams in which providers need to check reflexes.

She said she sees many cases of club feet, for which an in-person exam is needed to determine flexibility.
 

Expert says virtual misses nuances

Ryan Fitzgerald, MD, an orthopedic expert with Children’s Orthopaedic and Scoliosis Surgery Associates in St. Petersburg, Fla., who also was not involved in the study, said in an interview he doesn’t offer the virtual option now because he thinks those visits usually miss too much.

COSSA is a private practice that provides orthopedic services for Johns Hopkins All Children’s Hospital.

“I think physicians’ perspective versus the families’ perspective may be quite a bit different,” he said.

While families like the convenience, “a lot of what we do is watching the patient walk, looking at their hip range of motion, and virtually, that’s a really difficult thing to do,” he said.

You can instruct a family on how to turn a camera on the patient, but “it doesn’t always translate,” he said.

He said virtual visits also highlight disparities in access, because many families don’t own the hardware needed for such visits, and internet connections can be spotty or images pixelated.

Dr. Fitzgerald said virtual visits were helpful during the pandemic and would be beneficial for yearly checkups “if you know [the patient] well and it’s a fairly run-of-the-mill thing.”

However, he said, “everything we do is about human interaction, and I think that’s a downfall of the virtual platform right now. While it is helpful in situations like COVID and where it is a very basic follow-up, it still has a ways to go.”

Dr. Fitzgerald is a consultant for OrthoPediatrics, Medtronic, and Depuy Synthes. Dr. Vergun disclosed no relevant financial relationships.

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

CHICAGO – Satisfaction ratings for virtual outpatient visits for pediatric orthopedic patients were similar to those for in-person office visits across most categories in an analysis of postencounter surveys completed by patients at the Cleveland Clinic.

Satisfaction ratings for both virtual and office visits were consistently higher than 85% across all measured parameters, according to the data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

Ahmed Emara, MD, a clinical research fellow in adult joint reconstruction at the Cleveland Clinic, led the study, which included data from all patients or guardians at the clinic who experienced such visits from March 2020 to March 2021.

A total of 1,686 responses were received, of which 226 (13.4%) involved virtual visits and 1,460 (86.6%) involved in-office visits. The primary endpoint was a patient-reported satisfaction score of good or excellent.

Analysis included ratings for access, care provider, telemedicine technology, and overall assessment/perception of satisfaction.
 

Target areas for improvement

In some areas, the virtual visits were less satisfactory than the in-office visits.

Patients had lower odds of reporting good/excellent satisfaction regarding their ability to schedule at a particularly convenient time (odds ratio, 0.1; 95% confidence interval, 0.08-0.18; P < .001). The study authors said scheduling more virtual time slots may help increase satisfaction in that area.

Satisfaction was also lower than with in-office visits with respect to providers’ explanations of patients’ conditions (OR, 0.4; 95% CI, 0.17-0.91; P = .03). Providers may need to find ways to better provide educational material in addition to the virtual consultation, the authors wrote.
 

No significant differences in categories of satisfaction

The researchers accounted for age, sex, traumatic etiology, and anatomic location of the complaint in multivariate regression analysis and found no significant differences between the two types of visits in the odds of getting a good/excellent rating for the following areas: patient inclusion in treatment decision (P = .562), discussion of proposed treatment (P = .222), concern by the provider (P = .189), degree of care for the patient as a person (P = .208), adequacy of teamwork in care provision (P = .053), likelihood of recommending the practice to others (P = .108), ease of receiving care at a particular practice (P = .109), ease of contacting the clinic (P = .177), and likelihood of recommending a particular provider (P = .218).

Anna Dimitriovna Vergun, MD, a pediatric orthopedist at the University of North Carolina at Chapel Hill, who was not involved in the study, said in an interview she had been conducting virtual visits even before the pandemic, when she worked for several years at a Shriner’s children’s hospital in Los Angeles, before coming to UNC. The virtual visits were necessary because the hospital offered charity care and covered an area that included several states.

She said that during the height of the pandemic, 80% of her visits at UNC were virtual; it is down to about 5% now.

Some consultations don’t need physical visits at all, Dr. Vergun noted. For example, UNC is starting a clinic for prenatal counseling in cases in which ultrasound detects a limb deformity. Without a virtual option, she said, pregnant mothers in all parts of the state may have to drive long distances when no physical exam is necessary.

And sometimes, a visit simply involves checking in with families to see whether pain is being controlled, which is done well virtually.

“Those are particularly useful for telemedicine,” Dr. Vergun said. “There’s a lot of space for this to be useful. You sometimes don’t realize it until you start doing it and getting feedback from the families that they like it.”

Other exams may be better suited to office visits, she said. These include spine and hip exams and exams in which providers need to check reflexes.

She said she sees many cases of club feet, for which an in-person exam is needed to determine flexibility.
 

Expert says virtual misses nuances

Ryan Fitzgerald, MD, an orthopedic expert with Children’s Orthopaedic and Scoliosis Surgery Associates in St. Petersburg, Fla., who also was not involved in the study, said in an interview he doesn’t offer the virtual option now because he thinks those visits usually miss too much.

COSSA is a private practice that provides orthopedic services for Johns Hopkins All Children’s Hospital.

“I think physicians’ perspective versus the families’ perspective may be quite a bit different,” he said.

While families like the convenience, “a lot of what we do is watching the patient walk, looking at their hip range of motion, and virtually, that’s a really difficult thing to do,” he said.

You can instruct a family on how to turn a camera on the patient, but “it doesn’t always translate,” he said.

He said virtual visits also highlight disparities in access, because many families don’t own the hardware needed for such visits, and internet connections can be spotty or images pixelated.

Dr. Fitzgerald said virtual visits were helpful during the pandemic and would be beneficial for yearly checkups “if you know [the patient] well and it’s a fairly run-of-the-mill thing.”

However, he said, “everything we do is about human interaction, and I think that’s a downfall of the virtual platform right now. While it is helpful in situations like COVID and where it is a very basic follow-up, it still has a ways to go.”

Dr. Fitzgerald is a consultant for OrthoPediatrics, Medtronic, and Depuy Synthes. Dr. Vergun disclosed no relevant financial relationships.

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

CHICAGO – Satisfaction ratings for virtual outpatient visits for pediatric orthopedic patients were similar to those for in-person office visits across most categories in an analysis of postencounter surveys completed by patients at the Cleveland Clinic.

Satisfaction ratings for both virtual and office visits were consistently higher than 85% across all measured parameters, according to the data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

Ahmed Emara, MD, a clinical research fellow in adult joint reconstruction at the Cleveland Clinic, led the study, which included data from all patients or guardians at the clinic who experienced such visits from March 2020 to March 2021.

A total of 1,686 responses were received, of which 226 (13.4%) involved virtual visits and 1,460 (86.6%) involved in-office visits. The primary endpoint was a patient-reported satisfaction score of good or excellent.

Analysis included ratings for access, care provider, telemedicine technology, and overall assessment/perception of satisfaction.
 

Target areas for improvement

In some areas, the virtual visits were less satisfactory than the in-office visits.

Patients had lower odds of reporting good/excellent satisfaction regarding their ability to schedule at a particularly convenient time (odds ratio, 0.1; 95% confidence interval, 0.08-0.18; P < .001). The study authors said scheduling more virtual time slots may help increase satisfaction in that area.

Satisfaction was also lower than with in-office visits with respect to providers’ explanations of patients’ conditions (OR, 0.4; 95% CI, 0.17-0.91; P = .03). Providers may need to find ways to better provide educational material in addition to the virtual consultation, the authors wrote.
 

No significant differences in categories of satisfaction

The researchers accounted for age, sex, traumatic etiology, and anatomic location of the complaint in multivariate regression analysis and found no significant differences between the two types of visits in the odds of getting a good/excellent rating for the following areas: patient inclusion in treatment decision (P = .562), discussion of proposed treatment (P = .222), concern by the provider (P = .189), degree of care for the patient as a person (P = .208), adequacy of teamwork in care provision (P = .053), likelihood of recommending the practice to others (P = .108), ease of receiving care at a particular practice (P = .109), ease of contacting the clinic (P = .177), and likelihood of recommending a particular provider (P = .218).

Anna Dimitriovna Vergun, MD, a pediatric orthopedist at the University of North Carolina at Chapel Hill, who was not involved in the study, said in an interview she had been conducting virtual visits even before the pandemic, when she worked for several years at a Shriner’s children’s hospital in Los Angeles, before coming to UNC. The virtual visits were necessary because the hospital offered charity care and covered an area that included several states.

She said that during the height of the pandemic, 80% of her visits at UNC were virtual; it is down to about 5% now.

Some consultations don’t need physical visits at all, Dr. Vergun noted. For example, UNC is starting a clinic for prenatal counseling in cases in which ultrasound detects a limb deformity. Without a virtual option, she said, pregnant mothers in all parts of the state may have to drive long distances when no physical exam is necessary.

And sometimes, a visit simply involves checking in with families to see whether pain is being controlled, which is done well virtually.

“Those are particularly useful for telemedicine,” Dr. Vergun said. “There’s a lot of space for this to be useful. You sometimes don’t realize it until you start doing it and getting feedback from the families that they like it.”

Other exams may be better suited to office visits, she said. These include spine and hip exams and exams in which providers need to check reflexes.

She said she sees many cases of club feet, for which an in-person exam is needed to determine flexibility.
 

Expert says virtual misses nuances

Ryan Fitzgerald, MD, an orthopedic expert with Children’s Orthopaedic and Scoliosis Surgery Associates in St. Petersburg, Fla., who also was not involved in the study, said in an interview he doesn’t offer the virtual option now because he thinks those visits usually miss too much.

COSSA is a private practice that provides orthopedic services for Johns Hopkins All Children’s Hospital.

“I think physicians’ perspective versus the families’ perspective may be quite a bit different,” he said.

While families like the convenience, “a lot of what we do is watching the patient walk, looking at their hip range of motion, and virtually, that’s a really difficult thing to do,” he said.

You can instruct a family on how to turn a camera on the patient, but “it doesn’t always translate,” he said.

He said virtual visits also highlight disparities in access, because many families don’t own the hardware needed for such visits, and internet connections can be spotty or images pixelated.

Dr. Fitzgerald said virtual visits were helpful during the pandemic and would be beneficial for yearly checkups “if you know [the patient] well and it’s a fairly run-of-the-mill thing.”

However, he said, “everything we do is about human interaction, and I think that’s a downfall of the virtual platform right now. While it is helpful in situations like COVID and where it is a very basic follow-up, it still has a ways to go.”

Dr. Fitzgerald is a consultant for OrthoPediatrics, Medtronic, and Depuy Synthes. Dr. Vergun disclosed no relevant financial relationships.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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