Conference Coverage

There has been an increase in the incidence and prevalence of myasthenia gravis in the United States, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.

Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.

Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.

In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained. 
 

Claims-based analysis

To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.

They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.

Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.

Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.

For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.

When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.

In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).

Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.

The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.

These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.

A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
 

Underestimated burden

Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”

“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”

“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.

“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added. 

Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.

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

There has been an increase in the incidence and prevalence of myasthenia gravis in the United States, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.

Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.

Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.

In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained. 
 

Claims-based analysis

To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.

They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.

Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.

Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.

For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.

When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.

In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).

Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.

The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.

These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.

A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
 

Underestimated burden

Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”

“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”

“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.

“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added. 

Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.

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

There has been an increase in the incidence and prevalence of myasthenia gravis in the United States, an analysis of new claims data shows. Investigators speculate the rise of this rare disorder may be due to “increased diagnosis and more awareness of the disease over time, which has been shown in several studies,” study investigator Ema Rodrigues, DSc, MPH, with Alexion Pharmaceuticals, Boston.

Dr. Rodrigues presented her research at the 2023 annual meeting of the American Academy of Neurology.

Myasthenia gravis is a rare neuromuscular disease characterized by muscle weakness and fatigue caused by the binding of autoantibodies at the neuromuscular junction. It affects the voluntary muscles of the body, especially those that control the eyes, mouth, throat, and limbs.

In Europe, the incidence and prevalence of myasthenia gravis has increased for the past several decades. In the United States, increasing prevalence has also been observed, but recent estimates are lacking, making it tough to gauge the true burden of disease, Dr. Rodrigues explained. 
 

Claims-based analysis

To investigate, Dr. Rodrigues and colleagues analyzed claims data (commercial, Medicare, and Medicaid) and electronic health records representing over 300 million patients in the United States from 2011 to present.

They calculated sex- and age-specific incidence and prevalence of myasthenia gravis for the year 2021 using U.S. Census data.

Prevalent patients were identified as having one or more myasthenia gravis records in 2021 and two or more myasthenia gravis records, at least 30 days apart, from 2016 to 2021. This cohort had 78,225 patients.

Incident patients were identified as those with a myasthenia gravis record in 2021 and no previous myasthenia gravis record from 2019 to 2020. This cohort had 4,214 patients.

For both the prevalent and incident cohort, the distribution of male and female patients was roughly 50/50, with a slightly higher proportion of females in the incident cohort, Dr. Rodrigues reported.

When looking at age groups, there were “very few pediatric patients,” she noted, with less than 1% of the patients under the age of 12. The highest proportion of patients were 65 years or older. The mean age was 67 in the prevalent cohort and 68 in the incident cohort.

In 2021, the overall incidence of myasthenia gravis was 3.2 per 100,000 with similar estimates for males and females (3.2 vs. 3.1 per 100,000, respectively).

Total prevalence was estimated to be 37.0 per 100,000 with sex-specific estimates being comparable at 37.3 and 36.7 per 100,000 for males and females, respectively.

The incidence and prevalence of myasthenia gravis increased with age, ranging from 0.3 and 0.4 per 100,000, respectively, in children younger than age 2 years, to 10.2 and 116.8 per 100,000, respectively, in people 65 and older.

These estimates are “significantly higher” than those from a prior U.S. analysis from 2003, Dr. Rodrigues told attendees, but they are quite similar to the estimates that were reported in Sweden in 2020.

A limitation of the analysis is that patients who do not seek care regularly may have not been identified due to inclusion criteria, potentially leading to underestimates. Also, no information was available on the myasthenia gravis subtype (ocular vs. generalized).
 

Underestimated burden

Reached for comment, Richard J. Nowak, MD, MS, director of the Yale Myasthenia Gravis Clinic, Yale School of Medicine, New Haven, Conn., noted that the new report, “albeit limited as a claims-based analysis, presents modern data on incidence and prevalence of myasthenia gravis in the United States.”

“It suggests that the current estimates of myasthenia gravis in the United States are too low and that the true impact/burden of myasthenia gravis is greater. While we are unable to verify the accuracy of the diagnosis, the total myasthenia gravis population is likely to be about 100,000, which is higher than prior estimates.”

“This, in fact, might be driven by greater disease awareness and increased diagnosis along with decreased mortality and longer life expectancy,” Dr. Nowak said.

“Anecdotally, we are most certainly seeing patients with new-onset myasthenia gravis in their 70s, 80s, and even 90s in recent years. The EXPLORE-MG registry published data from a tertiary center on age of onset breakdown showing myasthenia gravis can present at any age,” Dr. Nowak added. 

Funding for the study was provided by Alexion, AstraZeneca Rare Disease. Dr. Rodrigues receives compensation and owns stock as an employee of Alexion, AstraZeneca Rare Diseases. Dr. Nowak has no relevant disclosures.

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

Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO_2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO_2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

Higher step counts and cardiorespiratory fitness in adolescents were associated with a lower heart rate at rest – confirming an association long identified in adults, according to a study presented at the Pediatric Academic Societies annual meeting.

The new findings provide a new means for pediatricians to measure physical fitness, the researchers said.

“It really changes the way we evaluate kids’ fitness and gives us a new method of judging physical fitness other than body mass index,” said Susan Gasparino, MD, an instructor in pediatrics at the University of Rochester (N.Y.) Medical Center, who led the study.

Using data from the 2005 to 2006 National Health and Nutrition Examination Survey, Dr. Gasparino and her colleagues examined the association between resting heart rate (RHR) and step count among 899 children and 1,640 adolescents aged 6-19 years.

In the adolescent group, the mean RHR was 74.9 among those who walked more than 10,000 steps per day (n = 414) and 79.3 for those whose step counts fell below that cutoff (n = 1,226) (P < .001). For each additional 1,000 steps per day, RHR decreased by an average of 0.7 beats per minute in this group (P < .001).

In the younger age group, mean RHR was 85.3 among children who took more than 10,000 steps per day (n = 447) and 86.3 among those who did not reach that threshold (n = 452) (P = .29). For each additional 1,000 steps per day, RHR decreased by an average of 0.3 bpm in this group (P = .02)

Dr. Gasparino said next steps in research could include controlling for confounders, such as baseline anxiety and medications that could blunt the heart rate.
 

Broader implications

If similar results bear out in future studies, monitoring RHR could be incorporated into fitness programs for children and adolescents. Doing so could obviate “the need for intensive treadmill assessments using VO_2max, time-consuming and emotionally fraught school-based physical fitness tests, and the fear and potential shame of the scale,” the researchers said.

Dr. Gasparino said measuring RHR during a 3-minute step test could help organizations and governments determine whether fitness programs are improving cardiovascular and overall health and could help them direct “funding and resources to the programs that are effective.” Such a test could also be incorporated into pediatrician wellness checks, she noted.

“It’s an exciting development, and [RHR measurement] holds a lot of promise as a clinical tool that can be applicable in a lot of settings,” said Nicholas M. Edwards, MD, MPH, a sports medicine pediatrician and an associate professor of orthopedics at the University of Minnesota in Minneapolis.

Dr. Edwards said that, because measurement of fitness in clinical settings is difficult, finding ways to “assess fitness in the office with the equipment already at hand would be a superb development.”

If use of RHR to measure fitness “is validated in a clinical setting,” Dr. Edwards said, “I think adoption would be a natural next step.”

Dr. Edwards has disclosed no relevant financial relationships.

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

BOSTON – When it comes to relieving migraine, triptans, ergots, and antiemetics are the most effective classes of medications, a new real-world analysis of data on more than 3 million migraine attacks shows.

The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

The power of big data

Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.

“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.

The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.

They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).

The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.

The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.

Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).

Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).

This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
 

End of trial-and-error?

Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”

“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.

“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.

The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.

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

BOSTON – When it comes to relieving migraine, triptans, ergots, and antiemetics are the most effective classes of medications, a new real-world analysis of data on more than 3 million migraine attacks shows.

The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

The power of big data

Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.

“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.

The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.

They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).

The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.

The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.

Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).

Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).

This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
 

End of trial-and-error?

Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”

“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.

“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.

The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.

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

BOSTON – When it comes to relieving migraine, triptans, ergots, and antiemetics are the most effective classes of medications, a new real-world analysis of data on more than 3 million migraine attacks shows.

The findings “align with results of clinical trials and recommendations from clinical treatment guidelines” and provide insights to complement clinical practice, said study investigator Chia-Chun Chiang, MD, a neurologist with Mayo Clinic, Rochester, Minn.

The findings were presented at the 2023 annual meeting of the American Academy of Neurology.
 

The power of big data

Despite a wide variety of acute migraine medications that are available, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking, Dr. Chiang explained.

“To the best of our knowledge, this is the first study that simultaneously compared multiple acute migraine medications using a Big Data analysis approach based on real-world patient-provided data,” she said.

The researchers extracted more than 10 million self-reported migraine attack records from a migraine smartphone app called Migraine Buddy, where users can document whether a treatment was helpful, somewhat helpful, unsure, or unhelpful.

They analyzed 25 acute medications among seven classes: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, combination analgesics (acetaminophen/aspirin/caffeine), ergots, antiemetics, and opioids. The newer gepants and ditan medication classes of medications were not included because of the relatively lower numbers of usage when data was extracted (2014-2020).

The researchers employed a two-level nested logistic regression model to analyze the odds of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user.

The final analysis included more than 3.1 million migraine attacks among 278,000 users globally.

Using ibuprofen as the reference, triptans, ergots, and antiemetics had the highest efficacy with mean odds ratios of 4.8, 3.02, and 2.67, respectively, followed by opioids (OR, 2.49), NSAIDs (OR, 1.94), combination analgesics (OR, 1.69), others (OR, 1.49), and acetaminophen (OR, 0.83).

Individual medications with the highest patient-reported effectiveness were eletriptan (Relpax; OR, 6.1), zolmitriptan (Zomig; OR, 5.7) and sumatriptan (Zecuity; OR, 5.2).

This migraine medication comparative effectiveness analysis, based on patient-reported outcomes, “supports and complements the treatment recommendations from national headache societies based on randomized controlled trials and meta-analyses and strongly supports the use of triptans,” Dr. Chiang said.
 

End of trial-and-error?

Commenting on this research, Shaheen Lakhan, MD, PhD, a neurologist and researcher in Boston, said “This is a great study of Big Data in that it shows the power of the smartphone to collect real-world data and smart researchers like at Mayo Clinic to analyze them.”

“The study sheds light on how different therapeutics compare with each other. The next iteration of this line of research, I would hope, would be to determine if particular medications are effective for a particular migraine population, and even down to individuals with migraine,” said Dr. Lakhan, who wasn’t involved in the study.

“Once those models are appropriately built, long gone will be the era of trial-and-error medicine,” Dr. Lakhan added.

The study had no specific funding. Dr. Chiang has served as a consultant for Satsuma. Dr. Lakhan reports no relevant financial relationships.

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

BOSTON – Results of a phase 2 study demonstrate potential Alzheimer’s disease–modifying effects of an investigational oral antiamyloid agent, represented by positive changes in plasma and imaging biomarkers of Alzheimer’s disease pathology.

Use of the drug, ALZ-801 (Alzheon), led to a significant reduction of plasma phosphorylated–tau 181 (p-tau₁₈₁) , a marker of amyloid-induced neuronal injury in Alzheimer’s disease, as well as slowing of hippocampal atrophy and stabilization of cognition.

“The 12-month results of our phase 2 trial support the finding that ALZ-801 blocks misfolding of amyloid monomers and subsequent formation of neurotoxic amyloid oligomers, the key initial step in the amyloid aggregation cascade, which leads to a rapid and sustained reduction of brain neurodegeneration as measured by plasma p-tau₁₈₁,” John Hey, PhD, Alzheon’s chief scientific officer, said in a statement.

“The severalfold greater reduction on the p-tau₁₈₁ biomarker in plasma compared to plaque-clearing antiamyloid antibodies, combined with preservation of brain hippocampal volume and their positive correlations with cognitive benefits, further validate the disease-modifying effects of ALZ-801 in Alzheimer’s patients,” Dr. Hey added.

The results were presented at the 2023 annual meeting of the American Academy of Neurology.
 

ALZ-801 is an optimized prodrug of tramiprosate that has been shown to inhibit amyloid-beta 42 aggregation into toxic oligomers.

The ongoing phase 2 study is evaluating the effects of oral ALZ-801 (265 mg twice daily) on biomarkers of Alzheimer’s disease pathology for 84 adults with early Alzheimer’s disease who have either the APOE4/4 or APOE3/4 genotype. These genotypes represent the majority of patients with Alzheimer’s disease.

The mean age of the cohort was 69 years, and 51% are women; 70% had mild cognitive impairment, and 30% had mild Alzheimer’s disease. The mean Mini-Mental State Examination score for the cohort was 26.0. Roughly half were taking a cholinesterase inhibitor.

Significant plasma p-tau₁₈₁ reduction was observed at 13 weeks. Levels were reduced by 41% by 52 weeks (P = .016). There was also a significant 5% reduction in plasma amyloid-beta 42 and 40 at 52 weeks (P = .002 and P = .005, respectively), Dr. Hey reported.

After 12 months of treatment, hippocampal atrophy was reduced by about 23%, and expansion of ventricular volume was reduced by about 15%, both in comparison with matched controls from the Alzheimer’s Disease Neuroimaging Initiative.

Composite cognitive z-score improved significantly at 13 and 26 weeks and remained above baseline at 52 weeks in comparison with matched ADNI controls. “These are very promising data,” Dr. Hey told conference attendees.

He noted that the safety profile of ALZ-801 remains favorable and consistent with prior safety data. Common adverse events were mild nausea and SARS-CoV-2 infection. There were no drug-related serious events or amyloid-related imaging abnormalities–edema (ARIA-E).

The phase 3 APOLLOE4 study of ALZ-801 is underway. This double-blind, randomized study is comparing oral ALZ-801 with placebo over 78 weeks for roughly 300 adults with early Alzheimer’s disease who have the APOE4/4 genotype. APOLLOE4 is expected to be completed in mid 2024.

The APOLLOE4 study is supported by a $47 million grant from the National Institute on Aging. The U.S. Food and Drug Administration has granted ALZ-801 fast-track designation.
 

More accessible option?

Reached for comment, Percy Griffin, PhD, Alzheimer’s Association director of scientific engagement, noted that the “biggest difference between this drug and others is that it is taken orally, rather than delivered through an infusion. This is important and valuable for reducing patient and caregiver burden and increasing ease of use and access.”

It’s also noteworthy that ALZ-801 was not associated with ARIA-E, “which has been reported in other antiamyloid trials and can occasionally be serious,” Dr. Griffin said.

Overall, he said the results are “encouraging, but more work is needed. If studies results continue to be positive, this treatment may provide a more accessible option for people who are at higher risk of ARIA,” Dr. Griffin said.

The study was funded by Alzheon. Dr. Hey is an employee of Alzheon and holds stock in the company. Dr. Griffin has disclosed no relevant financial relationships.

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

BOSTON – Results of a phase 2 study demonstrate potential Alzheimer’s disease–modifying effects of an investigational oral antiamyloid agent, represented by positive changes in plasma and imaging biomarkers of Alzheimer’s disease pathology.

Use of the drug, ALZ-801 (Alzheon), led to a significant reduction of plasma phosphorylated–tau 181 (p-tau₁₈₁) , a marker of amyloid-induced neuronal injury in Alzheimer’s disease, as well as slowing of hippocampal atrophy and stabilization of cognition.

“The 12-month results of our phase 2 trial support the finding that ALZ-801 blocks misfolding of amyloid monomers and subsequent formation of neurotoxic amyloid oligomers, the key initial step in the amyloid aggregation cascade, which leads to a rapid and sustained reduction of brain neurodegeneration as measured by plasma p-tau₁₈₁,” John Hey, PhD, Alzheon’s chief scientific officer, said in a statement.

“The severalfold greater reduction on the p-tau₁₈₁ biomarker in plasma compared to plaque-clearing antiamyloid antibodies, combined with preservation of brain hippocampal volume and their positive correlations with cognitive benefits, further validate the disease-modifying effects of ALZ-801 in Alzheimer’s patients,” Dr. Hey added.

The results were presented at the 2023 annual meeting of the American Academy of Neurology.
 

ALZ-801 is an optimized prodrug of tramiprosate that has been shown to inhibit amyloid-beta 42 aggregation into toxic oligomers.

The ongoing phase 2 study is evaluating the effects of oral ALZ-801 (265 mg twice daily) on biomarkers of Alzheimer’s disease pathology for 84 adults with early Alzheimer’s disease who have either the APOE4/4 or APOE3/4 genotype. These genotypes represent the majority of patients with Alzheimer’s disease.

The mean age of the cohort was 69 years, and 51% are women; 70% had mild cognitive impairment, and 30% had mild Alzheimer’s disease. The mean Mini-Mental State Examination score for the cohort was 26.0. Roughly half were taking a cholinesterase inhibitor.

Significant plasma p-tau₁₈₁ reduction was observed at 13 weeks. Levels were reduced by 41% by 52 weeks (P = .016). There was also a significant 5% reduction in plasma amyloid-beta 42 and 40 at 52 weeks (P = .002 and P = .005, respectively), Dr. Hey reported.

After 12 months of treatment, hippocampal atrophy was reduced by about 23%, and expansion of ventricular volume was reduced by about 15%, both in comparison with matched controls from the Alzheimer’s Disease Neuroimaging Initiative.

Composite cognitive z-score improved significantly at 13 and 26 weeks and remained above baseline at 52 weeks in comparison with matched ADNI controls. “These are very promising data,” Dr. Hey told conference attendees.

He noted that the safety profile of ALZ-801 remains favorable and consistent with prior safety data. Common adverse events were mild nausea and SARS-CoV-2 infection. There were no drug-related serious events or amyloid-related imaging abnormalities–edema (ARIA-E).

The phase 3 APOLLOE4 study of ALZ-801 is underway. This double-blind, randomized study is comparing oral ALZ-801 with placebo over 78 weeks for roughly 300 adults with early Alzheimer’s disease who have the APOE4/4 genotype. APOLLOE4 is expected to be completed in mid 2024.

The APOLLOE4 study is supported by a $47 million grant from the National Institute on Aging. The U.S. Food and Drug Administration has granted ALZ-801 fast-track designation.
 

More accessible option?

Reached for comment, Percy Griffin, PhD, Alzheimer’s Association director of scientific engagement, noted that the “biggest difference between this drug and others is that it is taken orally, rather than delivered through an infusion. This is important and valuable for reducing patient and caregiver burden and increasing ease of use and access.”

It’s also noteworthy that ALZ-801 was not associated with ARIA-E, “which has been reported in other antiamyloid trials and can occasionally be serious,” Dr. Griffin said.

Overall, he said the results are “encouraging, but more work is needed. If studies results continue to be positive, this treatment may provide a more accessible option for people who are at higher risk of ARIA,” Dr. Griffin said.

The study was funded by Alzheon. Dr. Hey is an employee of Alzheon and holds stock in the company. Dr. Griffin has disclosed no relevant financial relationships.

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

BOSTON – Results of a phase 2 study demonstrate potential Alzheimer’s disease–modifying effects of an investigational oral antiamyloid agent, represented by positive changes in plasma and imaging biomarkers of Alzheimer’s disease pathology.

Use of the drug, ALZ-801 (Alzheon), led to a significant reduction of plasma phosphorylated–tau 181 (p-tau₁₈₁) , a marker of amyloid-induced neuronal injury in Alzheimer’s disease, as well as slowing of hippocampal atrophy and stabilization of cognition.

“The 12-month results of our phase 2 trial support the finding that ALZ-801 blocks misfolding of amyloid monomers and subsequent formation of neurotoxic amyloid oligomers, the key initial step in the amyloid aggregation cascade, which leads to a rapid and sustained reduction of brain neurodegeneration as measured by plasma p-tau₁₈₁,” John Hey, PhD, Alzheon’s chief scientific officer, said in a statement.

“The severalfold greater reduction on the p-tau₁₈₁ biomarker in plasma compared to plaque-clearing antiamyloid antibodies, combined with preservation of brain hippocampal volume and their positive correlations with cognitive benefits, further validate the disease-modifying effects of ALZ-801 in Alzheimer’s patients,” Dr. Hey added.

The results were presented at the 2023 annual meeting of the American Academy of Neurology.
 

ALZ-801 is an optimized prodrug of tramiprosate that has been shown to inhibit amyloid-beta 42 aggregation into toxic oligomers.

The ongoing phase 2 study is evaluating the effects of oral ALZ-801 (265 mg twice daily) on biomarkers of Alzheimer’s disease pathology for 84 adults with early Alzheimer’s disease who have either the APOE4/4 or APOE3/4 genotype. These genotypes represent the majority of patients with Alzheimer’s disease.

The mean age of the cohort was 69 years, and 51% are women; 70% had mild cognitive impairment, and 30% had mild Alzheimer’s disease. The mean Mini-Mental State Examination score for the cohort was 26.0. Roughly half were taking a cholinesterase inhibitor.

Significant plasma p-tau₁₈₁ reduction was observed at 13 weeks. Levels were reduced by 41% by 52 weeks (P = .016). There was also a significant 5% reduction in plasma amyloid-beta 42 and 40 at 52 weeks (P = .002 and P = .005, respectively), Dr. Hey reported.

After 12 months of treatment, hippocampal atrophy was reduced by about 23%, and expansion of ventricular volume was reduced by about 15%, both in comparison with matched controls from the Alzheimer’s Disease Neuroimaging Initiative.

Composite cognitive z-score improved significantly at 13 and 26 weeks and remained above baseline at 52 weeks in comparison with matched ADNI controls. “These are very promising data,” Dr. Hey told conference attendees.

He noted that the safety profile of ALZ-801 remains favorable and consistent with prior safety data. Common adverse events were mild nausea and SARS-CoV-2 infection. There were no drug-related serious events or amyloid-related imaging abnormalities–edema (ARIA-E).

The phase 3 APOLLOE4 study of ALZ-801 is underway. This double-blind, randomized study is comparing oral ALZ-801 with placebo over 78 weeks for roughly 300 adults with early Alzheimer’s disease who have the APOE4/4 genotype. APOLLOE4 is expected to be completed in mid 2024.

The APOLLOE4 study is supported by a $47 million grant from the National Institute on Aging. The U.S. Food and Drug Administration has granted ALZ-801 fast-track designation.
 

More accessible option?

Reached for comment, Percy Griffin, PhD, Alzheimer’s Association director of scientific engagement, noted that the “biggest difference between this drug and others is that it is taken orally, rather than delivered through an infusion. This is important and valuable for reducing patient and caregiver burden and increasing ease of use and access.”

It’s also noteworthy that ALZ-801 was not associated with ARIA-E, “which has been reported in other antiamyloid trials and can occasionally be serious,” Dr. Griffin said.

Overall, he said the results are “encouraging, but more work is needed. If studies results continue to be positive, this treatment may provide a more accessible option for people who are at higher risk of ARIA,” Dr. Griffin said.

The study was funded by Alzheon. Dr. Hey is an employee of Alzheon and holds stock in the company. Dr. Griffin has disclosed no relevant financial relationships.

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

MANCHESTER, England – Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

MANCHESTER, England – Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

MANCHESTER, England – Data from the COVAD-2 e-survey suggest that people with a rheumatic disease are twice as likely as are those without to experience long-term effects after contracting COVID-19.

The prevalence of post–COVID-19 condition (PCC), the term the World Health Organization advocates for describing the widely popularized term long COVID, was 10.8% among people with autoimmune rheumatic diseases (AIRDs) vs. 5.3% among those with no autoimmune condition (designated as “healthy controls”). The odds ratio was 2.1, with a 95% confidence interval of 1.4-3.2 and a P-value of .002.

The prevalence in people with nonrheumatic autoimmune diseases was also higher than it was in the control participants but still lower, at 7.3%, than in those with AIRDs.

Sara Freeman/MDedge News

“Our findings highlight the importance of close monitoring for PCC,” Arvind Nune, MBBCh, MSc, said in a virtual poster presentation at the annual meeting of the British Society for Rheumatology.

They also show the need for “appropriate referral for optimized multidisciplinary care for patients with autoimmune rheumatic diseases during the recovery period following COVID-19,” added Dr. Nune, who works for Southport (England) and Ormskirk Hospital NHS Trust.

In an interview, he noted that it was patients who had a severe COVID-19 course or had other coexisting conditions that appeared to experience more long-term effects than did their less-affected counterparts.

Commenting on the study, Jeffrey A. Sparks, MD, MMSc, told this news organization: “This is one of the first studies to find that the prevalence of long COVID is higher among people with systemic rheumatic diseases than those without.”

Dr. Sparks, who is based at Brigham and Women’s Hospital and Harvard Medical School in Boston, added: “Since the symptoms of long COVID and rheumatic diseases can overlap substantially, more work will need to be done to determine whether COVID may have induced flares, new symptoms, or whether the finding is due to the presence of the chronic rheumatic disease.”
 

The COVAD study

Using an electronic survey platform, the COVAD study has been set up to look at the long-term efficacy and safety of COVID-19 vaccinations in patients with AIRDs. It’s now a large international effort involving more than 150 collaborating clinics in 106 countries.

A huge amount of data has been collected. “We collected demographics, details of autoimmune disease, including treatment, comorbidity, COVID infection, vaccination history and outcomes, date on flares, and validated patient-reported outcomes, including pain, fatigue, physical function, and quality of life,” Dr. Nune said in his presentation.

A total of 12,358 people who were invited to participate responded to the e-survey. Of them, 2,640 were confirmed to have COVID-19. Because the analysis aimed to look at PCC, anyone who had completed the survey less than 3 months after infection was excluded. This left 1,677 eligible respondents, of whom, an overall 8.7% (n = 136) were identified as having PCC.

“The [WHO] definition for PCC was employed, which is persistent signs or symptoms beyond 3 months of COVID-19 infection lasting at least 2 months,” Dr. Nune told this news organization.

“Symptoms could be anything from fatigue to breathlessness to arthralgias,” he added. However, the focus of the present analysis was to look at how many people were experiencing the condition rather than specific symptoms.

A higher risk for PCC was seen in women than in men (OR, 2.9; 95% CI, 1.1-7.7; P = .037) in the entire cohort.

In addition, those with comorbidities were found to have a greater chance of long-term sequelae from COVID-19 than were those without comorbid disease (OR, 2.8; 95% CI, 1.4-5.7; P = .005).

Patients who experienced more severe acute COVID-19, such as those who needed intensive care treatment, oxygen therapy, or advanced treatment for COVID-19 with monoclonal antibodies, were significantly more likely to later have PCC than were those who did not (OR, 3.8; 95% CI, 1.1-13.6; P = .039).

Having PCC was also associated with poorer patient-reported outcomes for physical function, compared with not having PCC. “However, no association with disease flares of underlying rheumatic diseases or immunosuppressive drugs used were noted,” Dr. Nune said.

These new findings from the COVAD study should be published soon. Dr. Nune suggested that the findings might be used to help identify patients early so that they can be referred to the appropriate services in good time.

The COVAD study was independently supported. Dr. Nune reports no relevant financial relationships. Dr. Sparks is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Sparks has received research support from Bristol-Myers Squibb and performed consultancy for AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer.
 

An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.

“At concentrations of less than 50%, nitrous oxide is classified as a minimal sedative, making it a promising option for many urologic outpatient procedures such as prostate biopsies,” said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.

Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.

In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).

A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.

Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.

“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.

This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.

Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.

“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.

Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.

In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”

He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.

“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.

“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.

Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.

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

An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.

“At concentrations of less than 50%, nitrous oxide is classified as a minimal sedative, making it a promising option for many urologic outpatient procedures such as prostate biopsies,” said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.

Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.

In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).

A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.

Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.

“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.

This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.

Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.

“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.

Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.

In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”

He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.

“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.

“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.

Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.

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

An old dog – nitrous oxide – can learn new tricks, managing pain in men undergoing transrectal biopsies, researchers reported at the annual meeting of the American Urological Association.

“At concentrations of less than 50%, nitrous oxide is classified as a minimal sedative, making it a promising option for many urologic outpatient procedures such as prostate biopsies,” said Heidi Rayala, MD, PhD, assistant professor of surgery at Harvard Medical School, Boston, who helped conduct the study.

Nitrous oxide is best known as a pain medication and anesthetic during dental procedures and childbirth, after trauma, and in end-of-life care.

In the new study, Dr. Rayala and her colleagues at Harvard and Beth Israel-Deaconess Medical Center, Boston, randomly assigned 128 men to self-administered nitrous oxide (SANO) or oxygen as a placebo. Patients in the SANO group had a smaller change in post-biopsy pain score (Visual Analog Scale for pain, 0.43 vs. 1.03; P = .03) and lower odds of experiencing pain during the procedure (odds ratio, 0.45; confidence interval, 0.21-0.97; P = .04).

A comparison of anxiety scores in the two groups failed to find a statistically significant difference between SANO and placebo. However, more men who received nitrous oxide said they tolerated the procedure “better than expected” (61% vs. 41%; P = 0.02), according to the researchers.

Dr. Rayala said that the researchers used the Nitrouseal system (Sedation Systems), in which the patient holds a mask to their face and works with staff to adjust the gas levels to the desired amount. The system is governed to max out at 50% nitrous oxide, ensuring “minimal sedation concentrations, so anesthesia personnel are not required,” she said.

“At levels of less than 50%, patients respond normally to verbal commands and maintain normal airway reflexes,” Dr. Rayala added. “This provides an advantage in that patients do not require the presence of anesthesia personnel.” And because the body eliminates the gas within about 5 minutes, patients do not require an escort home, she said.

This system is also self-scavenging to protect the operating urologist and other personnel from environmental exposure to nitrous oxide.

Dr. Rayala said that three patients (2.3%) found the mask uncomfortable, but in follow-up studies the clinicians have done a better job of preparing patients for the feeling of the mask, making a marked difference. Headaches and nausea are the most commonly reported complaints at concentrations above 50%.

“We did not have patients report headaches or nausea in new study (by the BIDMC group),” she said. This study has been submitted for publication.

Clinicians outside the United States have been quicker to embrace nitrous oxide for prostate procedures.

In a randomized controlled trial, researchers in Australia found no significant improvement in pain scores at 15 minutes from the use of nitrous oxide during transrectal biopsies; however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.

Stephen McCombie, MD, a consultant at Perth Urology Clinic, Australia, who has been adapting the nitrous oxide protocol for transrectal biopsies to transperineal procedures, said that the Beth Israel study “adds to the evidence to support adjunct use of mild inhalational anesthetics and analgesics during prostate biopsies to improve the patient experience of the procedure.”

He said that the role for these agents may grow with the global trend away from transrectal prostate biopsies and toward transperineal biopsies, largely driven by increasing rates of sepsis after transrectal biopsies.

“While transperineal biopsies can be more painful then transrectal biopsies when performed under local anesthesia, perhaps due to biopsies being taken through the highly sensate perineum as opposed to above the dentate line, optimization of the technique can significantly reduce the discomfort associated with the procedure, which may be further reduced with these agents,” Dr. McCombie said.

“Studies indicate that transperineal biopsies can be more painful than the traditional transrectal biopsies,” Dr. Rayala said. “We do offer transperineal biopsies at BIDMC, and we are gearing up to repeat the SANO study” for those patients.

Dr. Rayala and Dr. McCombie have disclosed no relevant financial relationships.

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

Although continuous positive airway pressure (CPAP) machines are the gold standard in the management of sleep apnea, several other treatments should be considered.

“Just because you have a hammer doesn’t mean everything is a nail,” Kimberly Hardin, MD, professor of clinical internal medicine at University of California, Davis, said at the annual meeting of the American College of Physicians.

“Sleep has been underestimated in the health arena for many, many years,” said Dr. Hardin, who likened sound sleep to the “sixth vital sign.” “We know that sleep plays an integral role in our health.”

Dr. Hardin highlighted nasal and oral mandibular advancement devices and oral appliance therapy as alternatives to CPAP. Surgical options include nasal surgery and maxillomandibular advancement surgery, also known as double-jaw surgery. Such procedures should be considered only for patients who are unwilling or unable to use CPAP or other nonsurgical treatments.

Sleep apnea occurs in 4% of adult men and 2% of adult women aged 30-60. Most commonly, obstructive sleep apnea involves the cessation or significant decrease in airflow while sleeping. The Apnea Hypopnea Index (AHI) is the number of times a patient experiences apnea or hypopnea during one night divided by the hours of sleep. Normal sleep AHI is fewer than five events per hour on average; mild sleep apnea is five to 14 events; moderate, 15-29; and severe, at least 30 events.

To identify sleep apnea, physicians have several tools at their disposal, starting with preliminary questionnaires that query patients as to whether they are having trouble falling asleep, staying asleep, or are tired during the day. Additional assessment tools include sleep lab testing and at-home testing.

At-home testing has come to include more than the common devices that are worn around the chest and nose for a night.

“It’s not very fun looking,” Dr. Hardin said of the weighty, obtrusive monitoring devices. “So lots of folks have come up with some new ways of doing things.”

These new options incorporate headbands, wrist and finger devices, arterial tonometry, and sleep rings.

Studies show that U.S. adults do not get enough sleep, and poor-quality sleep is as inadequate as insufficient sleep. Barely a third of adults get the minimum 7 hours recommended by the Centers for Disease Control and Prevention. Non-Hispanic Black adults are less likely to report sleeping 7-9 hours and are more likely to report sleeping 6 or fewer hours than are non-Hispanic White and Hispanic adults.

Dr. Hardin said doctors can advise patients to keep their bedrooms quiet, dark, and cool with no TVs or electronics, to maintain regular wake and sleep times, and to stop consuming caffeine late in the day.

Insufficient or poor sleep can have wide-ranging implications on medical conditions such as diabetes, heart disease, obesity, immunodeficiency, cognitive function, mental health, and, ultimately, mortality, according to Dr. Hardin.

“Some people say, ‘Oh, never mind, I can sleep when I’m dead,’ “ Dr. Hardin said. But such a mentality can have a bearing on life expectancy.
 

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

Although continuous positive airway pressure (CPAP) machines are the gold standard in the management of sleep apnea, several other treatments should be considered.

“Just because you have a hammer doesn’t mean everything is a nail,” Kimberly Hardin, MD, professor of clinical internal medicine at University of California, Davis, said at the annual meeting of the American College of Physicians.

“Sleep has been underestimated in the health arena for many, many years,” said Dr. Hardin, who likened sound sleep to the “sixth vital sign.” “We know that sleep plays an integral role in our health.”

Dr. Hardin highlighted nasal and oral mandibular advancement devices and oral appliance therapy as alternatives to CPAP. Surgical options include nasal surgery and maxillomandibular advancement surgery, also known as double-jaw surgery. Such procedures should be considered only for patients who are unwilling or unable to use CPAP or other nonsurgical treatments.

Sleep apnea occurs in 4% of adult men and 2% of adult women aged 30-60. Most commonly, obstructive sleep apnea involves the cessation or significant decrease in airflow while sleeping. The Apnea Hypopnea Index (AHI) is the number of times a patient experiences apnea or hypopnea during one night divided by the hours of sleep. Normal sleep AHI is fewer than five events per hour on average; mild sleep apnea is five to 14 events; moderate, 15-29; and severe, at least 30 events.

To identify sleep apnea, physicians have several tools at their disposal, starting with preliminary questionnaires that query patients as to whether they are having trouble falling asleep, staying asleep, or are tired during the day. Additional assessment tools include sleep lab testing and at-home testing.

At-home testing has come to include more than the common devices that are worn around the chest and nose for a night.

“It’s not very fun looking,” Dr. Hardin said of the weighty, obtrusive monitoring devices. “So lots of folks have come up with some new ways of doing things.”

These new options incorporate headbands, wrist and finger devices, arterial tonometry, and sleep rings.

Studies show that U.S. adults do not get enough sleep, and poor-quality sleep is as inadequate as insufficient sleep. Barely a third of adults get the minimum 7 hours recommended by the Centers for Disease Control and Prevention. Non-Hispanic Black adults are less likely to report sleeping 7-9 hours and are more likely to report sleeping 6 or fewer hours than are non-Hispanic White and Hispanic adults.

Dr. Hardin said doctors can advise patients to keep their bedrooms quiet, dark, and cool with no TVs or electronics, to maintain regular wake and sleep times, and to stop consuming caffeine late in the day.

Insufficient or poor sleep can have wide-ranging implications on medical conditions such as diabetes, heart disease, obesity, immunodeficiency, cognitive function, mental health, and, ultimately, mortality, according to Dr. Hardin.

“Some people say, ‘Oh, never mind, I can sleep when I’m dead,’ “ Dr. Hardin said. But such a mentality can have a bearing on life expectancy.
 

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

Although continuous positive airway pressure (CPAP) machines are the gold standard in the management of sleep apnea, several other treatments should be considered.

“Just because you have a hammer doesn’t mean everything is a nail,” Kimberly Hardin, MD, professor of clinical internal medicine at University of California, Davis, said at the annual meeting of the American College of Physicians.

“Sleep has been underestimated in the health arena for many, many years,” said Dr. Hardin, who likened sound sleep to the “sixth vital sign.” “We know that sleep plays an integral role in our health.”

Dr. Hardin highlighted nasal and oral mandibular advancement devices and oral appliance therapy as alternatives to CPAP. Surgical options include nasal surgery and maxillomandibular advancement surgery, also known as double-jaw surgery. Such procedures should be considered only for patients who are unwilling or unable to use CPAP or other nonsurgical treatments.

Sleep apnea occurs in 4% of adult men and 2% of adult women aged 30-60. Most commonly, obstructive sleep apnea involves the cessation or significant decrease in airflow while sleeping. The Apnea Hypopnea Index (AHI) is the number of times a patient experiences apnea or hypopnea during one night divided by the hours of sleep. Normal sleep AHI is fewer than five events per hour on average; mild sleep apnea is five to 14 events; moderate, 15-29; and severe, at least 30 events.

To identify sleep apnea, physicians have several tools at their disposal, starting with preliminary questionnaires that query patients as to whether they are having trouble falling asleep, staying asleep, or are tired during the day. Additional assessment tools include sleep lab testing and at-home testing.

At-home testing has come to include more than the common devices that are worn around the chest and nose for a night.

“It’s not very fun looking,” Dr. Hardin said of the weighty, obtrusive monitoring devices. “So lots of folks have come up with some new ways of doing things.”

These new options incorporate headbands, wrist and finger devices, arterial tonometry, and sleep rings.

Studies show that U.S. adults do not get enough sleep, and poor-quality sleep is as inadequate as insufficient sleep. Barely a third of adults get the minimum 7 hours recommended by the Centers for Disease Control and Prevention. Non-Hispanic Black adults are less likely to report sleeping 7-9 hours and are more likely to report sleeping 6 or fewer hours than are non-Hispanic White and Hispanic adults.

Dr. Hardin said doctors can advise patients to keep their bedrooms quiet, dark, and cool with no TVs or electronics, to maintain regular wake and sleep times, and to stop consuming caffeine late in the day.

Insufficient or poor sleep can have wide-ranging implications on medical conditions such as diabetes, heart disease, obesity, immunodeficiency, cognitive function, mental health, and, ultimately, mortality, according to Dr. Hardin.

“Some people say, ‘Oh, never mind, I can sleep when I’m dead,’ “ Dr. Hardin said. But such a mentality can have a bearing on life expectancy.
 

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

CHICAGO – Wireless tibial neurostimulation devices that are implanted to treat urinary incontinence appear to be effective at reducing the urge to void, according to new findings presented at the 2023 annual meeting of the American Urological Association.

As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.

Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.

Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.

More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.

The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.

Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”

“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.

He said the device should be worn twice a day for about 20 minutes, with many patients using it less.

Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.

In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.

“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”

The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.

Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.

But regular stimulation is necessary to achieve and preserve efficacy, he said.

Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,

Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.

“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”

BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
 

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

CHICAGO – Wireless tibial neurostimulation devices that are implanted to treat urinary incontinence appear to be effective at reducing the urge to void, according to new findings presented at the 2023 annual meeting of the American Urological Association.

As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.

Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.

Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.

More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.

The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.

Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”

“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.

He said the device should be worn twice a day for about 20 minutes, with many patients using it less.

Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.

In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.

“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”

The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.

Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.

But regular stimulation is necessary to achieve and preserve efficacy, he said.

Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,

Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.

“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”

BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
 

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

CHICAGO – Wireless tibial neurostimulation devices that are implanted to treat urinary incontinence appear to be effective at reducing the urge to void, according to new findings presented at the 2023 annual meeting of the American Urological Association.

As many as half of women in the United States aged 60 and older will experience urinary incontinence. Of those, roughly one in four experience urge urinary incontinence, marked by a sudden need to void that cannot be fully suppressed.

Researchers studied the benefits of the RENOVA iStim (BlueWind Medical) implantable tibial neuromodulation system for the treatment of overactive bladder in the OASIS trial.

Study investigator Roger R. Dmochowski, MD, MMHC, professor of urology and surgery and associate surgeon-in-chief at Vanderbilt University Medical Center, Nashville, Tenn., said the first-line treatment of urinary incontinence is lifestyle changes to retrain the bladder or physical therapy, including pelvic floor and Kegel exercises, per AUA guidelines. He said the success rate is about 30% and is not sustained. Second-line treatments include medications, which most (60%) patients stop taking by 6 months.

More than three-quarters of the 151 women who received the device responded to therapy at 1 year, and 84.6% of the patients showed improvement, according to Dr. Dmochowski.

The participants (mean age, 58.8) demonstrated a mean baseline of 4.8 urge incidents per day (standard deviation, 2.9) and 10 voids/day (SD, 3.3). No device or procedure-related serious adverse events were reported at 12 months. Half of the women no longer had symptoms on three consecutive days, Dr. Dmochowski said.

Because urge urinary incontinence is a chronic condition, “treatment with the BlueWind System will be ongoing, with frequency determined based on the patient’s response,” Dr. Dmochowski said. “The patient is then empowered to control when and where they perform therapy.”

“The device is activated by the external wearable. It’s like an on-off switch. It has a receiver within it that basically has the capacity to be turned on and off by the wearable, which is the control device. The device is in an off-position until the wearable is applied,” he said.

He said the device should be worn twice a day for about 20 minutes, with many patients using it less.

Only one implanted tibial neuromodulation device has been approved by the Food and Drug Administration – eCOIN (Valencia Technologies). The RENOVA iStim is an investigational device under review by the FDA, Dr. Dmochowski said.

In installing the device, Dr. Dmochowski said urologists use a subfascial technique to enable direct visualization of the tibial nerve and suture fixation that increases the possibility of a predictable placement. Patients use an external wearable, which activates the implant, without concern for battery longevity or replacement.

“This therapy is not associated with any adverse effects and may be beneficial for patients who do not respond to other treatments for OAB such as medications or Botox,” said Carol E. Bretschneider, MD, a urogynecologic and pelvic surgeon at Northwestern Medicine Central DuPage Hospital, outside Chicago. “Neurostimulators can be a great advanced therapy option for patients who do not respond to more conservative treatments or cannot take or tolerate a medication.”

The devices do not stimulate or strengthen muscles but act by modulating the reflexes that influence the bladder, sphincter, and pelvic floor, added Dr. Bretschneider, who was not involved in the study.

Other treatments for urge incontinence can include acupuncture, or percutaneous tibial nerve stimulation, to target the posterior tibial nerve in the ankle, which shares the same nerve root that controls the bladder, according to Aron Liaw, MD, a reconstructive urologist and assistant professor of urology at Wayne State University in Detroit. This treatment has been shown to be at least as effective as available medications, but with fewer side effects, he said.

But regular stimulation is necessary to achieve and preserve efficacy, he said.

Dr. Liaw, who was not involved in the neuromodulation study, said the benefits of a device like Renova iStim are that implantation is relatively easy and can be performed in office settings, and patients can then treat themselves at home. However, because the new study did not compare the device to other treatments or a placebo device, its relative benefits are unclear, he said,

Other treatments for urge urinary incontinence, such as bladder Botox and sacral neuromodulation, also are minimally invasive and have proven benefit, “so a device like this could well be less effective with little other advantage,” he said.

“Lifestyle changes can make a big difference, but making big lifestyle changes is not always easy,” added Dr. Liaw. “I have found neuromodulation [to be] very effective, especially in conjunction with lifestyle changes.”

BlueWind Medical funds the OASIS trial. Dr. Dmochowski reported he received no grants nor has any relevant financial relationships. Dr. Bretschneider and Dr. Liaw report no relevant financial relationships.
 

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

WASHINGTON – Concerns about negative judgment and lack of inclusive facilities topped the list of barriers to physical activity reported by gender-diverse teens in a poster presented at the Pediatric Academic Societies annual meeting. Other barriers included body dissatisfaction and discomfort or pain from binding or tucking, based on data from 160 individuals.

Previous studies suggest that gender-diverse teens have lower levels of physical activity than cisgender teens, but data on the specific barriers to physical activity reported by gender-diverse adolescents are lacking, according to Karishma Desai, BA, a medical student at Northwestern University, Chicago, and colleagues.

The researchers reviewed data from adolescents aged 13-18 years who identified as transgender or nonbinary and lived in the United States. Participants were recruited through flyers, wallet cards, email, and social media. They completed an online survey that included questions on preferred types of physical activity and potential barriers to physical activity. Major barriers were defined as items that “almost always” or “always” got in the way of physical activity.

Overall, 51% of the participants identified as female/transfeminine, 31% as male/transmasculine, 9% as genderqueer or agender, 8% as nonbinary, and 1% as unsure. A total of 86 participants were assigned male at birth, 73 were assigned female, and 1 was assigned intersex or other. Nearly all of the participants (96%) had begun social transition; approximately half (48%) reported using a chest binder, and 75% had been or were currently taking gender-affirming hormones.

Potential negative judgment from others was the top barrier to physical activity (cited by 39% of participants), followed by body dissatisfaction from gender dysphoria (38%) and discomfort with the available options for locker rooms or changing rooms (38%). Approximately one-third (36%) of respondents reported physical discomfort or pain from binding or tucking as a barrier to physical activity, and 34% cited discomfort with requirements for a physical activity uniform or athletic clothing at school. Other gender-diverse specific barriers to physical activity included bullying related to being transgender (31%) and the inability to participate in a group of choice because of gender identity (24%).

In addition, participants cited general barriers to physical activity including bullying related to weight (33%), dissatisfaction with weight or size (31%), and bullying in general or for reasons other than gender status (29%).

However, more than 50% of respondents said they were comfortable or very comfortable (4 or 5 on a 5-point Likert Scale) with physical activity in the settings of coed or all-gender teams (61%) or engaging in individual activities (71%). By contrast, 36% were comfortable or very comfortable with a team, group, or class that aligned with sex assignment at birth.

The majority of participants (81%) were comfortable or very comfortable with their homes or a private location as a setting for physical activity, 54% with a public space such as a park, and 43% with a school setting.

Increasing gender congruence was the biggest facilitator of physical activity, reported by 53% of participants, the researchers noted. Other facilitators of physical activity included increasing body satisfaction (43%), staying healthy to avoid long-term health problems in the future (43%), and staying healthy to prepare for gender-related surgery in the future (18%).

The study findings were limited by the use of self-reports and the use of a convenience sample, as well as the lack of data on race, the researchers noted. However, the results suggest that access to all-gender teams, standardizing physical activity clothing, and increasing inclusive facilities may promote greater physical activity participation by gender-diverse adolescents, and offering private or individual options may increase comfort with physical activity, they concluded.
 

Study provides teens’ perspectives

The current study is especially timely given the recent passage by the U.S. House of Representatives of the anti-trans sports bill preventing transgender women and girls from playing on sports teams “consistent with their gender identity,” said Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, in an interview. Ms. Thew was not involved in the current study.

“The House bill seeks to amend federal law to require that sex shall be recognized based solely on a person’s reproductive biology and genetics at birth, for the purpose of determining compliance with Title IX in athletics,” Ms. Thew said.

“Despite political responses to sports participation for transgender adolescents, we have not heard the perspective of the teens themselves,” she emphasized. “It is imperative for parents, coaches, and clinicians to hear the adolescents’ concerns so they can advocate for the students and provide the needed support.” In addition, Ms. Thew noted, “these concerns may also provide overdue changes to the required uniforms described for specific sports.”

Ms. Thew said she was surprised by the finding of transgender teens’ comfort with coed teams and individual activities, both of which may be opportunities to promote physical activity for transgender adolescents.

However, she added that she was not surprised by some of the results. “Many transgender adolescents experience the discomfort and further body dysmorphia of being put into gender-conforming attire such as swimwear, spandex shorts for female volleyball players, or field hockey skirts, for example.”

Although many schools are establishing safe, comfortable places for all adolescents to change clothing prior to physical education and sports participation, “resources are limited, and students and parents need to advocate within the school system,” Ms. Thew noted.

“We as a society, including athletic clothing makers, need to hear the testimony of transgender adolescents on the discomfort from body modifications to better support and innovate attire to meet their needs,” she added.

“The take-home message for clinicians is twofold,” said Ms. Thew. “Clinicians need to advocate for transgender patients to have the same opportunities as all teens when it comes to sports participation and physical activity. Also, clinicians need to ask all adolescents about their comfort in participating in physical activity both on club/school teams and independently,” she said. “If barriers are identified, clinicians need to work to support the adolescent with alternative activities/attire that will promote healthy physical activities for overall health.”

The current study also suggests that transgender adolescents who may have interest in, but discomfort with, physical activity should be redirected to coed or individual sports available in their communities, Ms. Thew added.

More research is needed on innovative sports attire that would improve comfort for transgender adolescents and thereby encourage physical activity, Ms. Thew told this news organization. More data also are needed on which sports transgender adolescents participate in and why, and how these activities might be promoted, she said.

Finally, more research will be needed to examine the impact of the recent House bills on physical activity for transgender youth, Ms. Thew said.

The study was supported by the Potocsnak Family Division of Adolescent and Young Adult Medicine at Ann and Robert H. Lurie’s Children’s Hospital of Chicago. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose, but she serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Concerns about negative judgment and lack of inclusive facilities topped the list of barriers to physical activity reported by gender-diverse teens in a poster presented at the Pediatric Academic Societies annual meeting. Other barriers included body dissatisfaction and discomfort or pain from binding or tucking, based on data from 160 individuals.

Previous studies suggest that gender-diverse teens have lower levels of physical activity than cisgender teens, but data on the specific barriers to physical activity reported by gender-diverse adolescents are lacking, according to Karishma Desai, BA, a medical student at Northwestern University, Chicago, and colleagues.

The researchers reviewed data from adolescents aged 13-18 years who identified as transgender or nonbinary and lived in the United States. Participants were recruited through flyers, wallet cards, email, and social media. They completed an online survey that included questions on preferred types of physical activity and potential barriers to physical activity. Major barriers were defined as items that “almost always” or “always” got in the way of physical activity.

Overall, 51% of the participants identified as female/transfeminine, 31% as male/transmasculine, 9% as genderqueer or agender, 8% as nonbinary, and 1% as unsure. A total of 86 participants were assigned male at birth, 73 were assigned female, and 1 was assigned intersex or other. Nearly all of the participants (96%) had begun social transition; approximately half (48%) reported using a chest binder, and 75% had been or were currently taking gender-affirming hormones.

Potential negative judgment from others was the top barrier to physical activity (cited by 39% of participants), followed by body dissatisfaction from gender dysphoria (38%) and discomfort with the available options for locker rooms or changing rooms (38%). Approximately one-third (36%) of respondents reported physical discomfort or pain from binding or tucking as a barrier to physical activity, and 34% cited discomfort with requirements for a physical activity uniform or athletic clothing at school. Other gender-diverse specific barriers to physical activity included bullying related to being transgender (31%) and the inability to participate in a group of choice because of gender identity (24%).

In addition, participants cited general barriers to physical activity including bullying related to weight (33%), dissatisfaction with weight or size (31%), and bullying in general or for reasons other than gender status (29%).

However, more than 50% of respondents said they were comfortable or very comfortable (4 or 5 on a 5-point Likert Scale) with physical activity in the settings of coed or all-gender teams (61%) or engaging in individual activities (71%). By contrast, 36% were comfortable or very comfortable with a team, group, or class that aligned with sex assignment at birth.

The majority of participants (81%) were comfortable or very comfortable with their homes or a private location as a setting for physical activity, 54% with a public space such as a park, and 43% with a school setting.

Increasing gender congruence was the biggest facilitator of physical activity, reported by 53% of participants, the researchers noted. Other facilitators of physical activity included increasing body satisfaction (43%), staying healthy to avoid long-term health problems in the future (43%), and staying healthy to prepare for gender-related surgery in the future (18%).

The study findings were limited by the use of self-reports and the use of a convenience sample, as well as the lack of data on race, the researchers noted. However, the results suggest that access to all-gender teams, standardizing physical activity clothing, and increasing inclusive facilities may promote greater physical activity participation by gender-diverse adolescents, and offering private or individual options may increase comfort with physical activity, they concluded.
 

Study provides teens’ perspectives

The current study is especially timely given the recent passage by the U.S. House of Representatives of the anti-trans sports bill preventing transgender women and girls from playing on sports teams “consistent with their gender identity,” said Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, in an interview. Ms. Thew was not involved in the current study.

“The House bill seeks to amend federal law to require that sex shall be recognized based solely on a person’s reproductive biology and genetics at birth, for the purpose of determining compliance with Title IX in athletics,” Ms. Thew said.

“Despite political responses to sports participation for transgender adolescents, we have not heard the perspective of the teens themselves,” she emphasized. “It is imperative for parents, coaches, and clinicians to hear the adolescents’ concerns so they can advocate for the students and provide the needed support.” In addition, Ms. Thew noted, “these concerns may also provide overdue changes to the required uniforms described for specific sports.”

Ms. Thew said she was surprised by the finding of transgender teens’ comfort with coed teams and individual activities, both of which may be opportunities to promote physical activity for transgender adolescents.

However, she added that she was not surprised by some of the results. “Many transgender adolescents experience the discomfort and further body dysmorphia of being put into gender-conforming attire such as swimwear, spandex shorts for female volleyball players, or field hockey skirts, for example.”

Although many schools are establishing safe, comfortable places for all adolescents to change clothing prior to physical education and sports participation, “resources are limited, and students and parents need to advocate within the school system,” Ms. Thew noted.

“We as a society, including athletic clothing makers, need to hear the testimony of transgender adolescents on the discomfort from body modifications to better support and innovate attire to meet their needs,” she added.

“The take-home message for clinicians is twofold,” said Ms. Thew. “Clinicians need to advocate for transgender patients to have the same opportunities as all teens when it comes to sports participation and physical activity. Also, clinicians need to ask all adolescents about their comfort in participating in physical activity both on club/school teams and independently,” she said. “If barriers are identified, clinicians need to work to support the adolescent with alternative activities/attire that will promote healthy physical activities for overall health.”

The current study also suggests that transgender adolescents who may have interest in, but discomfort with, physical activity should be redirected to coed or individual sports available in their communities, Ms. Thew added.

More research is needed on innovative sports attire that would improve comfort for transgender adolescents and thereby encourage physical activity, Ms. Thew told this news organization. More data also are needed on which sports transgender adolescents participate in and why, and how these activities might be promoted, she said.

Finally, more research will be needed to examine the impact of the recent House bills on physical activity for transgender youth, Ms. Thew said.

The study was supported by the Potocsnak Family Division of Adolescent and Young Adult Medicine at Ann and Robert H. Lurie’s Children’s Hospital of Chicago. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose, but she serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Concerns about negative judgment and lack of inclusive facilities topped the list of barriers to physical activity reported by gender-diverse teens in a poster presented at the Pediatric Academic Societies annual meeting. Other barriers included body dissatisfaction and discomfort or pain from binding or tucking, based on data from 160 individuals.

Previous studies suggest that gender-diverse teens have lower levels of physical activity than cisgender teens, but data on the specific barriers to physical activity reported by gender-diverse adolescents are lacking, according to Karishma Desai, BA, a medical student at Northwestern University, Chicago, and colleagues.

The researchers reviewed data from adolescents aged 13-18 years who identified as transgender or nonbinary and lived in the United States. Participants were recruited through flyers, wallet cards, email, and social media. They completed an online survey that included questions on preferred types of physical activity and potential barriers to physical activity. Major barriers were defined as items that “almost always” or “always” got in the way of physical activity.

Overall, 51% of the participants identified as female/transfeminine, 31% as male/transmasculine, 9% as genderqueer or agender, 8% as nonbinary, and 1% as unsure. A total of 86 participants were assigned male at birth, 73 were assigned female, and 1 was assigned intersex or other. Nearly all of the participants (96%) had begun social transition; approximately half (48%) reported using a chest binder, and 75% had been or were currently taking gender-affirming hormones.

Potential negative judgment from others was the top barrier to physical activity (cited by 39% of participants), followed by body dissatisfaction from gender dysphoria (38%) and discomfort with the available options for locker rooms or changing rooms (38%). Approximately one-third (36%) of respondents reported physical discomfort or pain from binding or tucking as a barrier to physical activity, and 34% cited discomfort with requirements for a physical activity uniform or athletic clothing at school. Other gender-diverse specific barriers to physical activity included bullying related to being transgender (31%) and the inability to participate in a group of choice because of gender identity (24%).

In addition, participants cited general barriers to physical activity including bullying related to weight (33%), dissatisfaction with weight or size (31%), and bullying in general or for reasons other than gender status (29%).

However, more than 50% of respondents said they were comfortable or very comfortable (4 or 5 on a 5-point Likert Scale) with physical activity in the settings of coed or all-gender teams (61%) or engaging in individual activities (71%). By contrast, 36% were comfortable or very comfortable with a team, group, or class that aligned with sex assignment at birth.

The majority of participants (81%) were comfortable or very comfortable with their homes or a private location as a setting for physical activity, 54% with a public space such as a park, and 43% with a school setting.

Increasing gender congruence was the biggest facilitator of physical activity, reported by 53% of participants, the researchers noted. Other facilitators of physical activity included increasing body satisfaction (43%), staying healthy to avoid long-term health problems in the future (43%), and staying healthy to prepare for gender-related surgery in the future (18%).

The study findings were limited by the use of self-reports and the use of a convenience sample, as well as the lack of data on race, the researchers noted. However, the results suggest that access to all-gender teams, standardizing physical activity clothing, and increasing inclusive facilities may promote greater physical activity participation by gender-diverse adolescents, and offering private or individual options may increase comfort with physical activity, they concluded.
 

Study provides teens’ perspectives

The current study is especially timely given the recent passage by the U.S. House of Representatives of the anti-trans sports bill preventing transgender women and girls from playing on sports teams “consistent with their gender identity,” said Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin in Milwaukee, in an interview. Ms. Thew was not involved in the current study.

“The House bill seeks to amend federal law to require that sex shall be recognized based solely on a person’s reproductive biology and genetics at birth, for the purpose of determining compliance with Title IX in athletics,” Ms. Thew said.

“Despite political responses to sports participation for transgender adolescents, we have not heard the perspective of the teens themselves,” she emphasized. “It is imperative for parents, coaches, and clinicians to hear the adolescents’ concerns so they can advocate for the students and provide the needed support.” In addition, Ms. Thew noted, “these concerns may also provide overdue changes to the required uniforms described for specific sports.”

Ms. Thew said she was surprised by the finding of transgender teens’ comfort with coed teams and individual activities, both of which may be opportunities to promote physical activity for transgender adolescents.

However, she added that she was not surprised by some of the results. “Many transgender adolescents experience the discomfort and further body dysmorphia of being put into gender-conforming attire such as swimwear, spandex shorts for female volleyball players, or field hockey skirts, for example.”

Although many schools are establishing safe, comfortable places for all adolescents to change clothing prior to physical education and sports participation, “resources are limited, and students and parents need to advocate within the school system,” Ms. Thew noted.

“We as a society, including athletic clothing makers, need to hear the testimony of transgender adolescents on the discomfort from body modifications to better support and innovate attire to meet their needs,” she added.

“The take-home message for clinicians is twofold,” said Ms. Thew. “Clinicians need to advocate for transgender patients to have the same opportunities as all teens when it comes to sports participation and physical activity. Also, clinicians need to ask all adolescents about their comfort in participating in physical activity both on club/school teams and independently,” she said. “If barriers are identified, clinicians need to work to support the adolescent with alternative activities/attire that will promote healthy physical activities for overall health.”

The current study also suggests that transgender adolescents who may have interest in, but discomfort with, physical activity should be redirected to coed or individual sports available in their communities, Ms. Thew added.

More research is needed on innovative sports attire that would improve comfort for transgender adolescents and thereby encourage physical activity, Ms. Thew told this news organization. More data also are needed on which sports transgender adolescents participate in and why, and how these activities might be promoted, she said.

Finally, more research will be needed to examine the impact of the recent House bills on physical activity for transgender youth, Ms. Thew said.

The study was supported by the Potocsnak Family Division of Adolescent and Young Adult Medicine at Ann and Robert H. Lurie’s Children’s Hospital of Chicago. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose, but she serves on the Editorial Advisory Board of Pediatric News.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.

WASHINGTON – Approximately 70% of children with febrile urinary tract infections receive guideline-adherent follow-up imaging from primary care, based on data from 118 individuals.

“Timely imaging is recommended after febrile UTI (fUTI) in young children to identify treatable urologic conditions,” wrote Jonathan Hatoun, MD, of Boston Children’s Hospital, and colleagues in a poster presented at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics (AAP) currently recommends renal-bladder ultrasound (RBUS) after fUTI with voiding cystourethrogram (VCUG) after abnormal RBUS or second fUTI, but data on clinician adherence to these recommendations are limited, the researchers said.

To characterize practice patterns regarding fUTI, the researchers reviewed data from children younger than 24 months of age with fUTI who were treated at a primary care network in Massachusetts in 2019. The definition of fUTI was temperature of 38° C or higher, positive urinalysis, and more than 50,000 CFU on urine culture. The median age of the patients was 9 months; 84% were female.

In a multivariate analysis, post-UTI imaging followed the AAP guidelines in 82 cases (69.5%). The main reasons for nonadherence were lack of RBUS in 21 patients, VCUG despite normal RBUS in 9 patients, no VCUG after abnormal RBUS in 4 patients, and no VCUG after a second fUTI in 2 patients.

Overall, nonadherence was a result of not ordering a recommended study in 23% of cases (errors of omission) and ordering an unnecessary study in 8% of cases (errors of commission).

Commercial insurance, larger number of providers in practice, and younger provider age were significant independent predictors of adherence (odds ratios 2.82, 1.38, and 0.96, respectively).

The findings were limited by the use of data from a single center; however, the results suggest that targeted training may improve guideline adherence, the researchers wrote. Additional research and quality improvement studies are needed to understand and address the impact of insurance on guideline adherence for imaging after febrile UTIs, they noted.
 

Provider education is essential to continued quality of care

When it comes to febrile UTIs, “it is important to stay focused on the quality of care being provided, as opposed to the usual benchmark of quantity of care,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.

“This is a very simple but interesting study on provider compliance with practice guidelines,” said Dr. Joos, who was not involved in the study. “I was surprised that the providers did so well in ordering the correct imaging in 70% of the cases,” he said.

 Of particular interest, Dr. Joos noted, was that “the authors also showed that older providers and those working in smaller practices are less likely to comply with this particular imaging guideline. This can be summed up as the ‘I didn’t know the guideline’ effect.”

To improve quality of care, “more research and effort should be directed at updating providers when strong new evidence changes previous practices and guidelines,” Dr. Joos told this news organization.

The study received no outside funding. The researchers and Dr. Joos had no financial conflicts to disclose.