Jake Remaly

Tooth decay can be easy to overlook – particularly for pediatricians and family physicians, who may be neglecting a crucial aspect of childhood health.

Left untreated, it can lead to serious and even fatal medical problems. The incorporation of preventive oral health care services like the application of fluoride varnish into primary care may be helping protect kids’ smiles and improving their overall physical well-being, according to doctors and a recent government report.
 

‘We don’t deal with that in pediatrics’

Physicians historically were not trained to examine teeth. That was the dentist’s job.

But dental caries is one of the most common chronic diseases in children, and many children do not regularly see a dentist.

“I stumbled across the statistic that oral health problems in children are five times as common as asthma,” said Susan A. Fisher-Owens, MD, MPH, professor of pediatrics at the University of California, San Francisco. “And I said to myself, ‘Well, that can’t be. We don’t deal with that in pediatrics.’ And then I realized, ‘Oh my goodness, we don’t deal with that in pediatrics!’ ”

Children should see a dentist, of course. Physicians should refer families to a dentist by age 1 for routine care, Dr. Fisher-Owens said. The sooner kids are seen, the more likely they are to stay healthy and avoid the need for costlier care, she said.

But the receipt of dental care has gaps.

“About half of all American children do not receive regular dental care because of social, economic, and geographic obstacles,” according to a 2021 fact sheet from the National Institute of Dental and Craniofacial Research. “Integrating dental care within family and pediatric medical care settings is improving children’s oral health.”

Many children do not start to see a dentist when they are supposed to, acknowledged Kami Hoss, DDS, MS, founder of a large dental practice in California and the author of a new book, “If Your Mouth Could Talk,” that examines links between oral health and physical disease.

Although the American Academy of Pediatric Dentistry says every child should see a pediatric dentist by the time their first baby teeth come in, usually at around 6 months or no later than age 1 year, that does not always happen.

Indeed, only about 16% of children adhere to that guidance, Dr. Hoss said, “which means 84% of parents rely on their pediatricians for oral health advice.”

At older ages, oral health problems like gum disease are linked to almost every chronic disease, Dr. Hoss said.

“We love to bridge the gap, to build bridges between medicine and dentistry,” he said. “After all, your mouth is part of your body.”

A 2021 NIDCR report similarly describes the stakes: “Although caries is largely preventable, if untreated it can lead to pain, inflammation, and the spread of infection to bone and soft tissue. Children may suffer from difficulty eating, poor nutrition, delayed physical development, and poor self-image and socialization. Even academic performance can be affected.”

In November, the World Health Organization published a report showing that about 45% of the world’s population – 3.5 billion people – have oral diseases, including 2.5 billion people with untreated dental caries.

Oral health care is often neglected in public health research, and often entails high out-of-pocket costs for families, the organization notes.
 

‘Strep tooth’

Dental cavities are caused by bacteria – mainly Streptococcus mutans – that eat sugars or carbohydrates in the mouth. That process causes acid, which can erode teeth. In that way, the development of caries is a fully preventable infectious disease process, Dr. Fisher-Owens said.

“I think if people looked at this disease as ‘strep tooth,’ it would get a lot more people interested,” she said.

Bacteria that cause caries can spread from caregiver to child, such as when a parent tries to clean a dropped pacifier in their own mouth, or from child to child.

Caries can be prevented with proper diet and oral hygiene: toothbrushing and then applying fluoride to strengthen teeth or restrengthen teeth that have been weakened by the disease process, Dr. Fisher-Owens said.

The biggest risk factor for having cavities in adult teeth is having them in primary teeth, she said. “There is a common misconception that it doesn’t matter what happens with baby teeth. They’ll fall out,” she said. “But actually it does because it puts you on a trajectory of having cavities in the adult teeth and worse outcomes with other adult conditions, such as diabetes.”

At the 2022 annual meeting of the American Academy of Pediatrics in Anaheim in October, Dr. Fisher-Owens and Jean Calvo, DDS, MPH, also with the University of California, San Francisco, trained colleagues to apply fluoride varnish to primary teeth – so-called baby teeth – in the doctor’s office. This session is a regular feature at these conferences.

Since 2014, the U.S. Preventive Services Task Force has recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children.

Many pediatricians may not do this regularly, however.

Researchers recently reported that, despite insurance coverage, less than 5% of well-child visits for privately insured young children between 2016 and 2018 included the service.

Nevertheless, the practice may be helping, according to the NIDCR report.

Since 2000, untreated tooth decay in primary teeth among children younger than 12 years has fallen from 23% to 15%, according to the report. For children aged 2-5 years, untreated tooth decay decreased from at least 19% to 10%. For children aged 6-11 years, the prevalence of dental cavities in permanent teeth fell from 25% to 18%, the report states.

“Fluoridated water, toothpastes, and varnish – as well as dental sealants – can work together to dramatically reduce the incidence of caries,” according to the NIDCR. “Integrating dental care within family and pediatric medical care settings has been another important advancement. The delivery of preventive oral health services, such as fluoride varnish, during well-child visits in medical offices is showing promise in reducing dental caries among preschool-age children.”

Integrating oral health care with medical primary care has met challenges, however, including “resistance by providers, lack of training, and the need for insurance reimbursement for services,” the report notes.

Clinicians can already bill for the application of fluoride varnish using Current Procedural Terminology (CPT) code 99188, and additional oral health care procedures may be on the horizon.

The American Medical Association this fall established a new Category III CPT code for the application of silver diamine fluoride to dental cavities.

Silver diamine fluoride is a newer product that was approved as a desensitizing agent by the Food and Drug Administration in 2014. It has antimicrobial and remineralizing properties, and researchers have found that it can stop the progression of early tooth decay and is more effective than fluoride varnish in preventing cavities.

Several dental groups supported the creation of this new code, which is expected to be made available by electronic health records vendors in July.

Some dentists have reservations, however. The Academy of General Dentistry in October expressed concerns that allowing “nondental health care workers to administer silver diamine fluoride is a temporary solution to a growing oral health crisis.”

Silver diamine fluoride may stop about 80% of cavities. Although the CPT code for silver diamine fluoride has been established, whether insurers will reimburse health care professionals for the service is another matter, said Richard Niederman, DMD, professor and chair of epidemiology and health promotion at New York University College of Dentistry.
 

Fatal consequences

Disparities in oral health in children may be greater than with almost any other disease process. The rate of caries in children who are poor is about twice that for children who are not poor, Dr. Fisher-Owens said. Disparities by race or ethnicity compound these differences.

In 2007, 12-year-old Deamonte Driver died after bacteria from a dental abscess spread to his brain. He had needed a tooth extraction, but his family lacked insurance and had had trouble finding dentists that accepted Medicaid near where they lived in Maryland.

After two emergency brain surgeries, 2 weeks in a hospital, and another 6 weeks in a hospital for rehabilitation, Deamonte died from the infection. The case sparked calls to fix the dental health system.

Physicians may notice more oral health problems in their patients, including dental abscesses, once they start looking for them, Dr. Fisher-Owens said.

She recalled one instance where a child with an underlying seizure disorder was hospitalized at an academic center because they appeared to be having more seizures.

“They eventually discharged the kid because they looked at all of the things related to seizures. None of them were there,” she said.

When Dr. Fisher-Owens saw the child for a discharge exam, she looked in the mouth and saw a whopping dental abscess.

“I realized that this kid wasn’t seizing but was actually rigoring in pain,” she said. No one else on the medical team had seen the true problem despite multiple examinations. The child started antibiotics, was referred to a dentist to have the abscess drained, and had a good outcome.

Suzanne C. Boulter, MD, adjunct clinical professor of pediatrics and community health at the Geisel School of Medicine at Dartmouth, Hanover, N.H., had noticed that many of her poorer patients had oral health problems, but many pediatric dentists were not able or willing to see them to provide treatment.

“Taking it one step further, you really want to prevent early childhood caries,” Dr. Boulter said. She started speaking up about oral health at pediatric meetings and became an early adopter of preventive interventions, including the use of fluoride varnish.

“Fluoride varnish is a sticky substance that has a very high concentration of fluoride in it,and it’s a very powerful reducer of oral childhood caries, by maybe 35%,” Dr. Boulter said.

Applying the varnish is fairly simple, but it had never been part of the well-child exam. Dr. Boulter started using it around 2005.

Initially, convincing other pediatricians to adopt this procedure – when visits are already time-constrained – was not always easy, she said.

Now that fluoride varnish is recommended for all children and is part of Bright Futures recommendations and is covered in the Affordable Care Act, “it became more the norm,” Dr. Boulter said. But there is room for improvement.

“There is still not a high enough percentage of pediatricians and family physicians who actually have incorporated application of fluoride varnish into their practice,” she said.
 

Brush, book, bed

Clinicians can take other steps to counsel parents about protecting their child’s teeth, like making sure that their teeth get brushed before bed, encouraging kids to drink tap water, especially if it’s fluoridated, and avoiding juice. The AAP has a program called Brush, Book, Bed to promote oral health, along with reading and good sleep habits.

Dr. Hoss noted that parents, and even dentists, may have misconceptions about optimal oral hygiene. “For example, you’re supposed to brush your teeth before breakfast, not after breakfast. But I’ve seen dentists even tell their patients, brush after breakfast,” he said.

In addition, people should brush gently but thoroughly using high-quality toothbrushes with soft bristles – “not scrubbing the teeth away with a coarse toothbrush,” he said.

Dr. Niederman has studied ways to prevent caries in underserved communities and is co-CEO of CariedAway, an organization that brings free cavity-prevention programs to schools.

In an average classroom of 24 students, about 6 children would be expected to have untreated tooth decay, Dr. Niederman said. And about 10% of the children with untreated tooth decay experience a toothache. So in two classrooms, at least one child would be expected to be experiencing pain, while the other students with caries might feel a lesser degree of discomfort. “That reduces presenteeism in the classroom and certainly presenteeism for the kid with a toothache,” Dr. Niederman said.

In communities with less access to dental care, including rural areas, the number of students with tooth decay might be double.

The new WHO report shows that the prevalence of caries in permanent teeth in various countries has remained at roughly 30%, regardless of a country’s income level, and despite efforts to bolster the dental workforce, said Dr. Niederman.

“The dental system is similar globally and focused on drilling and filling rather than prevention,” he said.

A 2019 Lancet series on oral health called for radical change in dental care, Dr. Niederman noted. “One of those radical changes would be primary care physicians or their offices participating in outreach programs to deliver care in schools,” he said.

Dr. Fisher-Owens is on a data and safety monitoring board for research by Colgate. Dr. Boulter serves on the editorial advisory board of Pediatric News. Dr. Hoss is the author of “If Your Mouth Could Talk” and the founder and CEO of SuperMouth, which markets children’s oral care products. Dr. Niederman’s research has used toothbrushes, toothpaste, and fluoride varnish donated by Colgate; silver diamine fluoride provided by Elevate Oral Health; and glass ionomer provided by GC America.

Tooth decay can be easy to overlook – particularly for pediatricians and family physicians, who may be neglecting a crucial aspect of childhood health.

Left untreated, it can lead to serious and even fatal medical problems. The incorporation of preventive oral health care services like the application of fluoride varnish into primary care may be helping protect kids’ smiles and improving their overall physical well-being, according to doctors and a recent government report.
 

‘We don’t deal with that in pediatrics’

Physicians historically were not trained to examine teeth. That was the dentist’s job.

But dental caries is one of the most common chronic diseases in children, and many children do not regularly see a dentist.

“I stumbled across the statistic that oral health problems in children are five times as common as asthma,” said Susan A. Fisher-Owens, MD, MPH, professor of pediatrics at the University of California, San Francisco. “And I said to myself, ‘Well, that can’t be. We don’t deal with that in pediatrics.’ And then I realized, ‘Oh my goodness, we don’t deal with that in pediatrics!’ ”

Children should see a dentist, of course. Physicians should refer families to a dentist by age 1 for routine care, Dr. Fisher-Owens said. The sooner kids are seen, the more likely they are to stay healthy and avoid the need for costlier care, she said.

But the receipt of dental care has gaps.

“About half of all American children do not receive regular dental care because of social, economic, and geographic obstacles,” according to a 2021 fact sheet from the National Institute of Dental and Craniofacial Research. “Integrating dental care within family and pediatric medical care settings is improving children’s oral health.”

Many children do not start to see a dentist when they are supposed to, acknowledged Kami Hoss, DDS, MS, founder of a large dental practice in California and the author of a new book, “If Your Mouth Could Talk,” that examines links between oral health and physical disease.

Although the American Academy of Pediatric Dentistry says every child should see a pediatric dentist by the time their first baby teeth come in, usually at around 6 months or no later than age 1 year, that does not always happen.

Indeed, only about 16% of children adhere to that guidance, Dr. Hoss said, “which means 84% of parents rely on their pediatricians for oral health advice.”

At older ages, oral health problems like gum disease are linked to almost every chronic disease, Dr. Hoss said.

“We love to bridge the gap, to build bridges between medicine and dentistry,” he said. “After all, your mouth is part of your body.”

A 2021 NIDCR report similarly describes the stakes: “Although caries is largely preventable, if untreated it can lead to pain, inflammation, and the spread of infection to bone and soft tissue. Children may suffer from difficulty eating, poor nutrition, delayed physical development, and poor self-image and socialization. Even academic performance can be affected.”

In November, the World Health Organization published a report showing that about 45% of the world’s population – 3.5 billion people – have oral diseases, including 2.5 billion people with untreated dental caries.

Oral health care is often neglected in public health research, and often entails high out-of-pocket costs for families, the organization notes.
 

‘Strep tooth’

Dental cavities are caused by bacteria – mainly Streptococcus mutans – that eat sugars or carbohydrates in the mouth. That process causes acid, which can erode teeth. In that way, the development of caries is a fully preventable infectious disease process, Dr. Fisher-Owens said.

“I think if people looked at this disease as ‘strep tooth,’ it would get a lot more people interested,” she said.

Bacteria that cause caries can spread from caregiver to child, such as when a parent tries to clean a dropped pacifier in their own mouth, or from child to child.

Caries can be prevented with proper diet and oral hygiene: toothbrushing and then applying fluoride to strengthen teeth or restrengthen teeth that have been weakened by the disease process, Dr. Fisher-Owens said.

The biggest risk factor for having cavities in adult teeth is having them in primary teeth, she said. “There is a common misconception that it doesn’t matter what happens with baby teeth. They’ll fall out,” she said. “But actually it does because it puts you on a trajectory of having cavities in the adult teeth and worse outcomes with other adult conditions, such as diabetes.”

At the 2022 annual meeting of the American Academy of Pediatrics in Anaheim in October, Dr. Fisher-Owens and Jean Calvo, DDS, MPH, also with the University of California, San Francisco, trained colleagues to apply fluoride varnish to primary teeth – so-called baby teeth – in the doctor’s office. This session is a regular feature at these conferences.

Since 2014, the U.S. Preventive Services Task Force has recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children.

Many pediatricians may not do this regularly, however.

Researchers recently reported that, despite insurance coverage, less than 5% of well-child visits for privately insured young children between 2016 and 2018 included the service.

Nevertheless, the practice may be helping, according to the NIDCR report.

Since 2000, untreated tooth decay in primary teeth among children younger than 12 years has fallen from 23% to 15%, according to the report. For children aged 2-5 years, untreated tooth decay decreased from at least 19% to 10%. For children aged 6-11 years, the prevalence of dental cavities in permanent teeth fell from 25% to 18%, the report states.

“Fluoridated water, toothpastes, and varnish – as well as dental sealants – can work together to dramatically reduce the incidence of caries,” according to the NIDCR. “Integrating dental care within family and pediatric medical care settings has been another important advancement. The delivery of preventive oral health services, such as fluoride varnish, during well-child visits in medical offices is showing promise in reducing dental caries among preschool-age children.”

Integrating oral health care with medical primary care has met challenges, however, including “resistance by providers, lack of training, and the need for insurance reimbursement for services,” the report notes.

Clinicians can already bill for the application of fluoride varnish using Current Procedural Terminology (CPT) code 99188, and additional oral health care procedures may be on the horizon.

The American Medical Association this fall established a new Category III CPT code for the application of silver diamine fluoride to dental cavities.

Silver diamine fluoride is a newer product that was approved as a desensitizing agent by the Food and Drug Administration in 2014. It has antimicrobial and remineralizing properties, and researchers have found that it can stop the progression of early tooth decay and is more effective than fluoride varnish in preventing cavities.

Several dental groups supported the creation of this new code, which is expected to be made available by electronic health records vendors in July.

Some dentists have reservations, however. The Academy of General Dentistry in October expressed concerns that allowing “nondental health care workers to administer silver diamine fluoride is a temporary solution to a growing oral health crisis.”

Silver diamine fluoride may stop about 80% of cavities. Although the CPT code for silver diamine fluoride has been established, whether insurers will reimburse health care professionals for the service is another matter, said Richard Niederman, DMD, professor and chair of epidemiology and health promotion at New York University College of Dentistry.
 

Fatal consequences

Disparities in oral health in children may be greater than with almost any other disease process. The rate of caries in children who are poor is about twice that for children who are not poor, Dr. Fisher-Owens said. Disparities by race or ethnicity compound these differences.

In 2007, 12-year-old Deamonte Driver died after bacteria from a dental abscess spread to his brain. He had needed a tooth extraction, but his family lacked insurance and had had trouble finding dentists that accepted Medicaid near where they lived in Maryland.

After two emergency brain surgeries, 2 weeks in a hospital, and another 6 weeks in a hospital for rehabilitation, Deamonte died from the infection. The case sparked calls to fix the dental health system.

Physicians may notice more oral health problems in their patients, including dental abscesses, once they start looking for them, Dr. Fisher-Owens said.

She recalled one instance where a child with an underlying seizure disorder was hospitalized at an academic center because they appeared to be having more seizures.

“They eventually discharged the kid because they looked at all of the things related to seizures. None of them were there,” she said.

When Dr. Fisher-Owens saw the child for a discharge exam, she looked in the mouth and saw a whopping dental abscess.

“I realized that this kid wasn’t seizing but was actually rigoring in pain,” she said. No one else on the medical team had seen the true problem despite multiple examinations. The child started antibiotics, was referred to a dentist to have the abscess drained, and had a good outcome.

Suzanne C. Boulter, MD, adjunct clinical professor of pediatrics and community health at the Geisel School of Medicine at Dartmouth, Hanover, N.H., had noticed that many of her poorer patients had oral health problems, but many pediatric dentists were not able or willing to see them to provide treatment.

“Taking it one step further, you really want to prevent early childhood caries,” Dr. Boulter said. She started speaking up about oral health at pediatric meetings and became an early adopter of preventive interventions, including the use of fluoride varnish.

“Fluoride varnish is a sticky substance that has a very high concentration of fluoride in it,and it’s a very powerful reducer of oral childhood caries, by maybe 35%,” Dr. Boulter said.

Applying the varnish is fairly simple, but it had never been part of the well-child exam. Dr. Boulter started using it around 2005.

Initially, convincing other pediatricians to adopt this procedure – when visits are already time-constrained – was not always easy, she said.

Now that fluoride varnish is recommended for all children and is part of Bright Futures recommendations and is covered in the Affordable Care Act, “it became more the norm,” Dr. Boulter said. But there is room for improvement.

“There is still not a high enough percentage of pediatricians and family physicians who actually have incorporated application of fluoride varnish into their practice,” she said.
 

Brush, book, bed

Clinicians can take other steps to counsel parents about protecting their child’s teeth, like making sure that their teeth get brushed before bed, encouraging kids to drink tap water, especially if it’s fluoridated, and avoiding juice. The AAP has a program called Brush, Book, Bed to promote oral health, along with reading and good sleep habits.

Dr. Hoss noted that parents, and even dentists, may have misconceptions about optimal oral hygiene. “For example, you’re supposed to brush your teeth before breakfast, not after breakfast. But I’ve seen dentists even tell their patients, brush after breakfast,” he said.

In addition, people should brush gently but thoroughly using high-quality toothbrushes with soft bristles – “not scrubbing the teeth away with a coarse toothbrush,” he said.

Dr. Niederman has studied ways to prevent caries in underserved communities and is co-CEO of CariedAway, an organization that brings free cavity-prevention programs to schools.

In an average classroom of 24 students, about 6 children would be expected to have untreated tooth decay, Dr. Niederman said. And about 10% of the children with untreated tooth decay experience a toothache. So in two classrooms, at least one child would be expected to be experiencing pain, while the other students with caries might feel a lesser degree of discomfort. “That reduces presenteeism in the classroom and certainly presenteeism for the kid with a toothache,” Dr. Niederman said.

In communities with less access to dental care, including rural areas, the number of students with tooth decay might be double.

The new WHO report shows that the prevalence of caries in permanent teeth in various countries has remained at roughly 30%, regardless of a country’s income level, and despite efforts to bolster the dental workforce, said Dr. Niederman.

“The dental system is similar globally and focused on drilling and filling rather than prevention,” he said.

A 2019 Lancet series on oral health called for radical change in dental care, Dr. Niederman noted. “One of those radical changes would be primary care physicians or their offices participating in outreach programs to deliver care in schools,” he said.

Dr. Fisher-Owens is on a data and safety monitoring board for research by Colgate. Dr. Boulter serves on the editorial advisory board of Pediatric News. Dr. Hoss is the author of “If Your Mouth Could Talk” and the founder and CEO of SuperMouth, which markets children’s oral care products. Dr. Niederman’s research has used toothbrushes, toothpaste, and fluoride varnish donated by Colgate; silver diamine fluoride provided by Elevate Oral Health; and glass ionomer provided by GC America.

Tooth decay can be easy to overlook – particularly for pediatricians and family physicians, who may be neglecting a crucial aspect of childhood health.

Left untreated, it can lead to serious and even fatal medical problems. The incorporation of preventive oral health care services like the application of fluoride varnish into primary care may be helping protect kids’ smiles and improving their overall physical well-being, according to doctors and a recent government report.
 

‘We don’t deal with that in pediatrics’

Physicians historically were not trained to examine teeth. That was the dentist’s job.

But dental caries is one of the most common chronic diseases in children, and many children do not regularly see a dentist.

“I stumbled across the statistic that oral health problems in children are five times as common as asthma,” said Susan A. Fisher-Owens, MD, MPH, professor of pediatrics at the University of California, San Francisco. “And I said to myself, ‘Well, that can’t be. We don’t deal with that in pediatrics.’ And then I realized, ‘Oh my goodness, we don’t deal with that in pediatrics!’ ”

Children should see a dentist, of course. Physicians should refer families to a dentist by age 1 for routine care, Dr. Fisher-Owens said. The sooner kids are seen, the more likely they are to stay healthy and avoid the need for costlier care, she said.

But the receipt of dental care has gaps.

“About half of all American children do not receive regular dental care because of social, economic, and geographic obstacles,” according to a 2021 fact sheet from the National Institute of Dental and Craniofacial Research. “Integrating dental care within family and pediatric medical care settings is improving children’s oral health.”

Many children do not start to see a dentist when they are supposed to, acknowledged Kami Hoss, DDS, MS, founder of a large dental practice in California and the author of a new book, “If Your Mouth Could Talk,” that examines links between oral health and physical disease.

Although the American Academy of Pediatric Dentistry says every child should see a pediatric dentist by the time their first baby teeth come in, usually at around 6 months or no later than age 1 year, that does not always happen.

Indeed, only about 16% of children adhere to that guidance, Dr. Hoss said, “which means 84% of parents rely on their pediatricians for oral health advice.”

At older ages, oral health problems like gum disease are linked to almost every chronic disease, Dr. Hoss said.

“We love to bridge the gap, to build bridges between medicine and dentistry,” he said. “After all, your mouth is part of your body.”

A 2021 NIDCR report similarly describes the stakes: “Although caries is largely preventable, if untreated it can lead to pain, inflammation, and the spread of infection to bone and soft tissue. Children may suffer from difficulty eating, poor nutrition, delayed physical development, and poor self-image and socialization. Even academic performance can be affected.”

In November, the World Health Organization published a report showing that about 45% of the world’s population – 3.5 billion people – have oral diseases, including 2.5 billion people with untreated dental caries.

Oral health care is often neglected in public health research, and often entails high out-of-pocket costs for families, the organization notes.
 

‘Strep tooth’

Dental cavities are caused by bacteria – mainly Streptococcus mutans – that eat sugars or carbohydrates in the mouth. That process causes acid, which can erode teeth. In that way, the development of caries is a fully preventable infectious disease process, Dr. Fisher-Owens said.

“I think if people looked at this disease as ‘strep tooth,’ it would get a lot more people interested,” she said.

Bacteria that cause caries can spread from caregiver to child, such as when a parent tries to clean a dropped pacifier in their own mouth, or from child to child.

Caries can be prevented with proper diet and oral hygiene: toothbrushing and then applying fluoride to strengthen teeth or restrengthen teeth that have been weakened by the disease process, Dr. Fisher-Owens said.

The biggest risk factor for having cavities in adult teeth is having them in primary teeth, she said. “There is a common misconception that it doesn’t matter what happens with baby teeth. They’ll fall out,” she said. “But actually it does because it puts you on a trajectory of having cavities in the adult teeth and worse outcomes with other adult conditions, such as diabetes.”

At the 2022 annual meeting of the American Academy of Pediatrics in Anaheim in October, Dr. Fisher-Owens and Jean Calvo, DDS, MPH, also with the University of California, San Francisco, trained colleagues to apply fluoride varnish to primary teeth – so-called baby teeth – in the doctor’s office. This session is a regular feature at these conferences.

Since 2014, the U.S. Preventive Services Task Force has recommended that primary care clinicians apply fluoride varnish to the primary teeth of all infants and children.

Many pediatricians may not do this regularly, however.

Researchers recently reported that, despite insurance coverage, less than 5% of well-child visits for privately insured young children between 2016 and 2018 included the service.

Nevertheless, the practice may be helping, according to the NIDCR report.

Since 2000, untreated tooth decay in primary teeth among children younger than 12 years has fallen from 23% to 15%, according to the report. For children aged 2-5 years, untreated tooth decay decreased from at least 19% to 10%. For children aged 6-11 years, the prevalence of dental cavities in permanent teeth fell from 25% to 18%, the report states.

“Fluoridated water, toothpastes, and varnish – as well as dental sealants – can work together to dramatically reduce the incidence of caries,” according to the NIDCR. “Integrating dental care within family and pediatric medical care settings has been another important advancement. The delivery of preventive oral health services, such as fluoride varnish, during well-child visits in medical offices is showing promise in reducing dental caries among preschool-age children.”

Integrating oral health care with medical primary care has met challenges, however, including “resistance by providers, lack of training, and the need for insurance reimbursement for services,” the report notes.

Clinicians can already bill for the application of fluoride varnish using Current Procedural Terminology (CPT) code 99188, and additional oral health care procedures may be on the horizon.

The American Medical Association this fall established a new Category III CPT code for the application of silver diamine fluoride to dental cavities.

Silver diamine fluoride is a newer product that was approved as a desensitizing agent by the Food and Drug Administration in 2014. It has antimicrobial and remineralizing properties, and researchers have found that it can stop the progression of early tooth decay and is more effective than fluoride varnish in preventing cavities.

Several dental groups supported the creation of this new code, which is expected to be made available by electronic health records vendors in July.

Some dentists have reservations, however. The Academy of General Dentistry in October expressed concerns that allowing “nondental health care workers to administer silver diamine fluoride is a temporary solution to a growing oral health crisis.”

Silver diamine fluoride may stop about 80% of cavities. Although the CPT code for silver diamine fluoride has been established, whether insurers will reimburse health care professionals for the service is another matter, said Richard Niederman, DMD, professor and chair of epidemiology and health promotion at New York University College of Dentistry.
 

Fatal consequences

Disparities in oral health in children may be greater than with almost any other disease process. The rate of caries in children who are poor is about twice that for children who are not poor, Dr. Fisher-Owens said. Disparities by race or ethnicity compound these differences.

In 2007, 12-year-old Deamonte Driver died after bacteria from a dental abscess spread to his brain. He had needed a tooth extraction, but his family lacked insurance and had had trouble finding dentists that accepted Medicaid near where they lived in Maryland.

After two emergency brain surgeries, 2 weeks in a hospital, and another 6 weeks in a hospital for rehabilitation, Deamonte died from the infection. The case sparked calls to fix the dental health system.

Physicians may notice more oral health problems in their patients, including dental abscesses, once they start looking for them, Dr. Fisher-Owens said.

She recalled one instance where a child with an underlying seizure disorder was hospitalized at an academic center because they appeared to be having more seizures.

“They eventually discharged the kid because they looked at all of the things related to seizures. None of them were there,” she said.

When Dr. Fisher-Owens saw the child for a discharge exam, she looked in the mouth and saw a whopping dental abscess.

“I realized that this kid wasn’t seizing but was actually rigoring in pain,” she said. No one else on the medical team had seen the true problem despite multiple examinations. The child started antibiotics, was referred to a dentist to have the abscess drained, and had a good outcome.

Suzanne C. Boulter, MD, adjunct clinical professor of pediatrics and community health at the Geisel School of Medicine at Dartmouth, Hanover, N.H., had noticed that many of her poorer patients had oral health problems, but many pediatric dentists were not able or willing to see them to provide treatment.

“Taking it one step further, you really want to prevent early childhood caries,” Dr. Boulter said. She started speaking up about oral health at pediatric meetings and became an early adopter of preventive interventions, including the use of fluoride varnish.

“Fluoride varnish is a sticky substance that has a very high concentration of fluoride in it,and it’s a very powerful reducer of oral childhood caries, by maybe 35%,” Dr. Boulter said.

Applying the varnish is fairly simple, but it had never been part of the well-child exam. Dr. Boulter started using it around 2005.

Initially, convincing other pediatricians to adopt this procedure – when visits are already time-constrained – was not always easy, she said.

Now that fluoride varnish is recommended for all children and is part of Bright Futures recommendations and is covered in the Affordable Care Act, “it became more the norm,” Dr. Boulter said. But there is room for improvement.

“There is still not a high enough percentage of pediatricians and family physicians who actually have incorporated application of fluoride varnish into their practice,” she said.
 

Brush, book, bed

Clinicians can take other steps to counsel parents about protecting their child’s teeth, like making sure that their teeth get brushed before bed, encouraging kids to drink tap water, especially if it’s fluoridated, and avoiding juice. The AAP has a program called Brush, Book, Bed to promote oral health, along with reading and good sleep habits.

Dr. Hoss noted that parents, and even dentists, may have misconceptions about optimal oral hygiene. “For example, you’re supposed to brush your teeth before breakfast, not after breakfast. But I’ve seen dentists even tell their patients, brush after breakfast,” he said.

In addition, people should brush gently but thoroughly using high-quality toothbrushes with soft bristles – “not scrubbing the teeth away with a coarse toothbrush,” he said.

Dr. Niederman has studied ways to prevent caries in underserved communities and is co-CEO of CariedAway, an organization that brings free cavity-prevention programs to schools.

In an average classroom of 24 students, about 6 children would be expected to have untreated tooth decay, Dr. Niederman said. And about 10% of the children with untreated tooth decay experience a toothache. So in two classrooms, at least one child would be expected to be experiencing pain, while the other students with caries might feel a lesser degree of discomfort. “That reduces presenteeism in the classroom and certainly presenteeism for the kid with a toothache,” Dr. Niederman said.

In communities with less access to dental care, including rural areas, the number of students with tooth decay might be double.

The new WHO report shows that the prevalence of caries in permanent teeth in various countries has remained at roughly 30%, regardless of a country’s income level, and despite efforts to bolster the dental workforce, said Dr. Niederman.

“The dental system is similar globally and focused on drilling and filling rather than prevention,” he said.

A 2019 Lancet series on oral health called for radical change in dental care, Dr. Niederman noted. “One of those radical changes would be primary care physicians or their offices participating in outreach programs to deliver care in schools,” he said.

Dr. Fisher-Owens is on a data and safety monitoring board for research by Colgate. Dr. Boulter serves on the editorial advisory board of Pediatric News. Dr. Hoss is the author of “If Your Mouth Could Talk” and the founder and CEO of SuperMouth, which markets children’s oral care products. Dr. Niederman’s research has used toothbrushes, toothpaste, and fluoride varnish donated by Colgate; silver diamine fluoride provided by Elevate Oral Health; and glass ionomer provided by GC America.

Some experts are encouraging clinicians to see the amoxicillin shortage through pink-colored glasses.

The ongoing shortage, which was first reported in October and was prompted by a surge in demand linked in part to influenza and respiratory syncytial virus (RSV), could be an opportunity for clinicians to refine their prescribing practices and avoid unnecessary and potentially harmful orders for the medication, they say.

Antibiotics are often prescribed to patients who do not need them. In many cases, patients’ symptoms are caused by viral infections, not bacteria, so antibiotics do not help.

Even when symptoms resolve after a patient takes an antibiotic, the drug may have had nothing to do with their improvement.

“Seems like a good time to remind people that the vast majority of respiratory infections are caused by viruses and that antibiotics like amoxicillin do absolutely nothing for them except give people diarrhea. Time to double-down on assessment; use antibiotics only when needed,” Jason Gallagher, PharmD, of Temple University School of Pharmacy in Philadelphia, posted on Twitter.

When antibiotics are not helping, they still may cause harm. Treatment with antibiotics entails risks for antibiotic resistance, infection with Clostridioides difficile, and side effects, such as rashes and – as Dr. Gallagher noted – diarrhea.

“They say ‘never let a good shortage go to waste,’ ” Michael Cosimini, MD, a pediatrician at Oregon Health & Science University, Portland, tweeted about the lack of amoxicillin in October.

Dr. Cosimini offered his thoughts about “improving our amoxicillin prescribing patterns” in pediatrics and encouraged colleagues to do so.

For example, he highlighted guidelines that state that antimicrobial therapy is not routinely required for preschool-aged children with community-acquired pneumonia (CAP) because most cases are caused by viral pathogens.

And trials show that when antibiotics are used for CAP, a shorter treatment duration, such as 5 days, rather than the standard 7-10 days, can be sufficient.

“As physicians, a shortage like this is an opportunity to do our best in the short term, as well as reflect on our current practice and make changes for the better in the long run,” Dr. Cosimini told this news organization.

Amoxicillin is the most commonly prescribed antibiotic in the outpatient setting and is the first choice among antimicrobial agents for common infections, such as otitis media, strep throat, and pneumonia, he said. “We use it frequently, so even small changes could go a long way to improve our prescribing practice,” Dr. Cosimini said.
 

Inappropriate antibiotic prescribing may be common

A 2021 statement on antibiotic stewardship from the American Academy of Pediatrics (AAP) declared that while antibiotics have saved countless lives, they can also cause harm and are frequently used inappropriately.

“One in five pediatric ambulatory visits result in an antibiotic prescription, accounting for nearly 50 million antibiotic prescriptions annually in the United States, at least half of which are considered inappropriate. [Acute respiratory tract infections] account for more than two-thirds of antibiotic prescriptions for children, at least one-third of which are unnecessary,” according to the society.

Outpatient antibiotic stewardship efforts could focus on clinical encounters in which the medications could be avoided altogether, the AAP suggested.

“Examples include antibiotic prescribing for nonspecific upper respiratory infection, bronchiolitis, acute bronchitis, asthma exacerbation, or conjunctivitis,” the group said.

Given the epidemiology of bacterial infections seen in ambulatory care settings that warrant antibiotic therapy, researchers conservatively estimate “that antibiotic prescribing could be safely reduced by 30%,” the statement noted.

That said, treatment decisions are not always clear cut.

“Certain infections in children, such as ear infections and lung infections, can be caused by viruses, bacteria, or both at the same time,” Dr. Cosimini said. “As such, it is very difficult to know which children benefit from which antibiotics.”
 

Watching, waiting, vaccinating

Pediatricians know that many children with ear infections will get better without antibiotics. “Parents should know that their doctor may suggest watching an ear infection without antibiotics, as is the recommendation from the AAP,” Dr. Cosimini said.

Data indicate that doctors are not following this practice as often as they could be, he said.

When antibiotic treatment is needed during the shortage, agents other than amoxicillin suspension can be used.

“Even though amoxicillin suspension is our go-to antibiotic for many infections, there are effective alternative options,” Dr. Cosimini said. “Children’s Hospital of Philadelphia has a good list for doctors looking for alternatives.”

Another approach to reducing the use of antibiotics in the future involves preventing infections through vaccination.

Research shows that routine childhood vaccines may have averted millions of respiratory and ear infections. And because bacterial infections can follow viral infections, the annual flu vaccine and COVID-19 vaccines “are also great tools to reduce antibiotic use,” Dr. Cosimini said.
 

A turn to more toxic options?

The shortage of amoxicillin oral powder for suspension was reported by the Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) in October.

On Nov. 4, the Society of Infectious Diseases Pharmacists (SIDP) issued a statement on the amoxicillin shortage, noting that increased demand for the drug coincided with a surge in respiratory viral infections, including RSV and influenza, among children.

“Though supportive care is the mainstay of treatment for viral infections, antibiotics may be indicated for the treatment of superimposed bacterial infections, including pneumonia and acute otitis media,” the SIDP statement said. “While alternative antibiotics may be available depending on the indication, many have a broader spectrum of activity, increased toxicity, and excess cost relative to amoxicillin. Furthermore, it is anticipated alternatives may soon become in short supply as well, given increased usage.”

SIDP “encourages the judicious use of antibiotics” and supports watch-and-wait strategies and the use of the shortest effective duration of therapy when appropriate.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, monitors around 250 drug shortages at any given time.

The amoxicillin shortage, while not “overly worrisome,” stands out because of how widely the drug is used and the fact that the shortage appears to have been sparked by an increase in demand rather than supply chain or manufacturing quality problems that more typically lead to shortages, he said.

Unlike some other shortages, the amoxicillin shortfall largely does not involve disrupting a medication regimen that someone was already receiving, and substitutions should be available.

“That said, it’s very, very disruptive to parents or a caregiver when you have a sick child who needs an antibiotic and it’s not available,” Dr. Ganio said.
 

Can a poster change practice?

In an unrelated move, the U.S. Agency for Healthcare Research and Quality published new resources and strategies to reduce inappropriate antibiotic use in ambulatory care settings.

One of the tools is a poster that doctors can print and hang in their offices. It states: “We commit to only prescribing antibiotics when they will help you. Taking antibiotics when you do not need them will NOT make you better. You will still feel sick, and the antibiotic may give you a skin rash, diarrhea, or a yeast infection.”

Jeffrey A. Linder, MD, MPH, a general internist and researcher at Northwestern University in Chicago, helped develop some of the approaches to improve prescribing practices in primary care.

Dr. Linder explained on a recent episode of the Freakonomics, M.D. podcast that the poster can be key.

One reason clinicians may prescribe antibiotics inappropriately is because they assume – perhaps erroneously – that patients want and expect them. By addressing the issue up front by displaying the poster, they may be able to “short-circuit” that type of thinking.

A minority of patients do expect antibiotics. “But the vast majority of patients are thinking, ‘I don’t feel well, I want to know what’s going on, and I want to know how to feel better and what’s going to happen.’ ”

For their part, patients can tell their doctors that they want an antibiotic only if they really need it, Dr. Linder said.

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

Some experts are encouraging clinicians to see the amoxicillin shortage through pink-colored glasses.

The ongoing shortage, which was first reported in October and was prompted by a surge in demand linked in part to influenza and respiratory syncytial virus (RSV), could be an opportunity for clinicians to refine their prescribing practices and avoid unnecessary and potentially harmful orders for the medication, they say.

Antibiotics are often prescribed to patients who do not need them. In many cases, patients’ symptoms are caused by viral infections, not bacteria, so antibiotics do not help.

Even when symptoms resolve after a patient takes an antibiotic, the drug may have had nothing to do with their improvement.

“Seems like a good time to remind people that the vast majority of respiratory infections are caused by viruses and that antibiotics like amoxicillin do absolutely nothing for them except give people diarrhea. Time to double-down on assessment; use antibiotics only when needed,” Jason Gallagher, PharmD, of Temple University School of Pharmacy in Philadelphia, posted on Twitter.

When antibiotics are not helping, they still may cause harm. Treatment with antibiotics entails risks for antibiotic resistance, infection with Clostridioides difficile, and side effects, such as rashes and – as Dr. Gallagher noted – diarrhea.

“They say ‘never let a good shortage go to waste,’ ” Michael Cosimini, MD, a pediatrician at Oregon Health & Science University, Portland, tweeted about the lack of amoxicillin in October.

Dr. Cosimini offered his thoughts about “improving our amoxicillin prescribing patterns” in pediatrics and encouraged colleagues to do so.

For example, he highlighted guidelines that state that antimicrobial therapy is not routinely required for preschool-aged children with community-acquired pneumonia (CAP) because most cases are caused by viral pathogens.

And trials show that when antibiotics are used for CAP, a shorter treatment duration, such as 5 days, rather than the standard 7-10 days, can be sufficient.

“As physicians, a shortage like this is an opportunity to do our best in the short term, as well as reflect on our current practice and make changes for the better in the long run,” Dr. Cosimini told this news organization.

Amoxicillin is the most commonly prescribed antibiotic in the outpatient setting and is the first choice among antimicrobial agents for common infections, such as otitis media, strep throat, and pneumonia, he said. “We use it frequently, so even small changes could go a long way to improve our prescribing practice,” Dr. Cosimini said.
 

Inappropriate antibiotic prescribing may be common

A 2021 statement on antibiotic stewardship from the American Academy of Pediatrics (AAP) declared that while antibiotics have saved countless lives, they can also cause harm and are frequently used inappropriately.

“One in five pediatric ambulatory visits result in an antibiotic prescription, accounting for nearly 50 million antibiotic prescriptions annually in the United States, at least half of which are considered inappropriate. [Acute respiratory tract infections] account for more than two-thirds of antibiotic prescriptions for children, at least one-third of which are unnecessary,” according to the society.

Outpatient antibiotic stewardship efforts could focus on clinical encounters in which the medications could be avoided altogether, the AAP suggested.

“Examples include antibiotic prescribing for nonspecific upper respiratory infection, bronchiolitis, acute bronchitis, asthma exacerbation, or conjunctivitis,” the group said.

Given the epidemiology of bacterial infections seen in ambulatory care settings that warrant antibiotic therapy, researchers conservatively estimate “that antibiotic prescribing could be safely reduced by 30%,” the statement noted.

That said, treatment decisions are not always clear cut.

“Certain infections in children, such as ear infections and lung infections, can be caused by viruses, bacteria, or both at the same time,” Dr. Cosimini said. “As such, it is very difficult to know which children benefit from which antibiotics.”
 

Watching, waiting, vaccinating

Pediatricians know that many children with ear infections will get better without antibiotics. “Parents should know that their doctor may suggest watching an ear infection without antibiotics, as is the recommendation from the AAP,” Dr. Cosimini said.

Data indicate that doctors are not following this practice as often as they could be, he said.

When antibiotic treatment is needed during the shortage, agents other than amoxicillin suspension can be used.

“Even though amoxicillin suspension is our go-to antibiotic for many infections, there are effective alternative options,” Dr. Cosimini said. “Children’s Hospital of Philadelphia has a good list for doctors looking for alternatives.”

Another approach to reducing the use of antibiotics in the future involves preventing infections through vaccination.

Research shows that routine childhood vaccines may have averted millions of respiratory and ear infections. And because bacterial infections can follow viral infections, the annual flu vaccine and COVID-19 vaccines “are also great tools to reduce antibiotic use,” Dr. Cosimini said.
 

A turn to more toxic options?

The shortage of amoxicillin oral powder for suspension was reported by the Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) in October.

On Nov. 4, the Society of Infectious Diseases Pharmacists (SIDP) issued a statement on the amoxicillin shortage, noting that increased demand for the drug coincided with a surge in respiratory viral infections, including RSV and influenza, among children.

“Though supportive care is the mainstay of treatment for viral infections, antibiotics may be indicated for the treatment of superimposed bacterial infections, including pneumonia and acute otitis media,” the SIDP statement said. “While alternative antibiotics may be available depending on the indication, many have a broader spectrum of activity, increased toxicity, and excess cost relative to amoxicillin. Furthermore, it is anticipated alternatives may soon become in short supply as well, given increased usage.”

SIDP “encourages the judicious use of antibiotics” and supports watch-and-wait strategies and the use of the shortest effective duration of therapy when appropriate.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, monitors around 250 drug shortages at any given time.

The amoxicillin shortage, while not “overly worrisome,” stands out because of how widely the drug is used and the fact that the shortage appears to have been sparked by an increase in demand rather than supply chain or manufacturing quality problems that more typically lead to shortages, he said.

Unlike some other shortages, the amoxicillin shortfall largely does not involve disrupting a medication regimen that someone was already receiving, and substitutions should be available.

“That said, it’s very, very disruptive to parents or a caregiver when you have a sick child who needs an antibiotic and it’s not available,” Dr. Ganio said.
 

Can a poster change practice?

In an unrelated move, the U.S. Agency for Healthcare Research and Quality published new resources and strategies to reduce inappropriate antibiotic use in ambulatory care settings.

One of the tools is a poster that doctors can print and hang in their offices. It states: “We commit to only prescribing antibiotics when they will help you. Taking antibiotics when you do not need them will NOT make you better. You will still feel sick, and the antibiotic may give you a skin rash, diarrhea, or a yeast infection.”

Jeffrey A. Linder, MD, MPH, a general internist and researcher at Northwestern University in Chicago, helped develop some of the approaches to improve prescribing practices in primary care.

Dr. Linder explained on a recent episode of the Freakonomics, M.D. podcast that the poster can be key.

One reason clinicians may prescribe antibiotics inappropriately is because they assume – perhaps erroneously – that patients want and expect them. By addressing the issue up front by displaying the poster, they may be able to “short-circuit” that type of thinking.

A minority of patients do expect antibiotics. “But the vast majority of patients are thinking, ‘I don’t feel well, I want to know what’s going on, and I want to know how to feel better and what’s going to happen.’ ”

For their part, patients can tell their doctors that they want an antibiotic only if they really need it, Dr. Linder said.

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

Some experts are encouraging clinicians to see the amoxicillin shortage through pink-colored glasses.

The ongoing shortage, which was first reported in October and was prompted by a surge in demand linked in part to influenza and respiratory syncytial virus (RSV), could be an opportunity for clinicians to refine their prescribing practices and avoid unnecessary and potentially harmful orders for the medication, they say.

Antibiotics are often prescribed to patients who do not need them. In many cases, patients’ symptoms are caused by viral infections, not bacteria, so antibiotics do not help.

Even when symptoms resolve after a patient takes an antibiotic, the drug may have had nothing to do with their improvement.

“Seems like a good time to remind people that the vast majority of respiratory infections are caused by viruses and that antibiotics like amoxicillin do absolutely nothing for them except give people diarrhea. Time to double-down on assessment; use antibiotics only when needed,” Jason Gallagher, PharmD, of Temple University School of Pharmacy in Philadelphia, posted on Twitter.

When antibiotics are not helping, they still may cause harm. Treatment with antibiotics entails risks for antibiotic resistance, infection with Clostridioides difficile, and side effects, such as rashes and – as Dr. Gallagher noted – diarrhea.

“They say ‘never let a good shortage go to waste,’ ” Michael Cosimini, MD, a pediatrician at Oregon Health & Science University, Portland, tweeted about the lack of amoxicillin in October.

Dr. Cosimini offered his thoughts about “improving our amoxicillin prescribing patterns” in pediatrics and encouraged colleagues to do so.

For example, he highlighted guidelines that state that antimicrobial therapy is not routinely required for preschool-aged children with community-acquired pneumonia (CAP) because most cases are caused by viral pathogens.

And trials show that when antibiotics are used for CAP, a shorter treatment duration, such as 5 days, rather than the standard 7-10 days, can be sufficient.

“As physicians, a shortage like this is an opportunity to do our best in the short term, as well as reflect on our current practice and make changes for the better in the long run,” Dr. Cosimini told this news organization.

Amoxicillin is the most commonly prescribed antibiotic in the outpatient setting and is the first choice among antimicrobial agents for common infections, such as otitis media, strep throat, and pneumonia, he said. “We use it frequently, so even small changes could go a long way to improve our prescribing practice,” Dr. Cosimini said.
 

Inappropriate antibiotic prescribing may be common

A 2021 statement on antibiotic stewardship from the American Academy of Pediatrics (AAP) declared that while antibiotics have saved countless lives, they can also cause harm and are frequently used inappropriately.

“One in five pediatric ambulatory visits result in an antibiotic prescription, accounting for nearly 50 million antibiotic prescriptions annually in the United States, at least half of which are considered inappropriate. [Acute respiratory tract infections] account for more than two-thirds of antibiotic prescriptions for children, at least one-third of which are unnecessary,” according to the society.

Outpatient antibiotic stewardship efforts could focus on clinical encounters in which the medications could be avoided altogether, the AAP suggested.

“Examples include antibiotic prescribing for nonspecific upper respiratory infection, bronchiolitis, acute bronchitis, asthma exacerbation, or conjunctivitis,” the group said.

Given the epidemiology of bacterial infections seen in ambulatory care settings that warrant antibiotic therapy, researchers conservatively estimate “that antibiotic prescribing could be safely reduced by 30%,” the statement noted.

That said, treatment decisions are not always clear cut.

“Certain infections in children, such as ear infections and lung infections, can be caused by viruses, bacteria, or both at the same time,” Dr. Cosimini said. “As such, it is very difficult to know which children benefit from which antibiotics.”
 

Watching, waiting, vaccinating

Pediatricians know that many children with ear infections will get better without antibiotics. “Parents should know that their doctor may suggest watching an ear infection without antibiotics, as is the recommendation from the AAP,” Dr. Cosimini said.

Data indicate that doctors are not following this practice as often as they could be, he said.

When antibiotic treatment is needed during the shortage, agents other than amoxicillin suspension can be used.

“Even though amoxicillin suspension is our go-to antibiotic for many infections, there are effective alternative options,” Dr. Cosimini said. “Children’s Hospital of Philadelphia has a good list for doctors looking for alternatives.”

Another approach to reducing the use of antibiotics in the future involves preventing infections through vaccination.

Research shows that routine childhood vaccines may have averted millions of respiratory and ear infections. And because bacterial infections can follow viral infections, the annual flu vaccine and COVID-19 vaccines “are also great tools to reduce antibiotic use,” Dr. Cosimini said.
 

A turn to more toxic options?

The shortage of amoxicillin oral powder for suspension was reported by the Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) in October.

On Nov. 4, the Society of Infectious Diseases Pharmacists (SIDP) issued a statement on the amoxicillin shortage, noting that increased demand for the drug coincided with a surge in respiratory viral infections, including RSV and influenza, among children.

“Though supportive care is the mainstay of treatment for viral infections, antibiotics may be indicated for the treatment of superimposed bacterial infections, including pneumonia and acute otitis media,” the SIDP statement said. “While alternative antibiotics may be available depending on the indication, many have a broader spectrum of activity, increased toxicity, and excess cost relative to amoxicillin. Furthermore, it is anticipated alternatives may soon become in short supply as well, given increased usage.”

SIDP “encourages the judicious use of antibiotics” and supports watch-and-wait strategies and the use of the shortest effective duration of therapy when appropriate.

Michael Ganio, PharmD, senior director of pharmacy practice and quality for ASHP, monitors around 250 drug shortages at any given time.

The amoxicillin shortage, while not “overly worrisome,” stands out because of how widely the drug is used and the fact that the shortage appears to have been sparked by an increase in demand rather than supply chain or manufacturing quality problems that more typically lead to shortages, he said.

Unlike some other shortages, the amoxicillin shortfall largely does not involve disrupting a medication regimen that someone was already receiving, and substitutions should be available.

“That said, it’s very, very disruptive to parents or a caregiver when you have a sick child who needs an antibiotic and it’s not available,” Dr. Ganio said.
 

Can a poster change practice?

In an unrelated move, the U.S. Agency for Healthcare Research and Quality published new resources and strategies to reduce inappropriate antibiotic use in ambulatory care settings.

One of the tools is a poster that doctors can print and hang in their offices. It states: “We commit to only prescribing antibiotics when they will help you. Taking antibiotics when you do not need them will NOT make you better. You will still feel sick, and the antibiotic may give you a skin rash, diarrhea, or a yeast infection.”

Jeffrey A. Linder, MD, MPH, a general internist and researcher at Northwestern University in Chicago, helped develop some of the approaches to improve prescribing practices in primary care.

Dr. Linder explained on a recent episode of the Freakonomics, M.D. podcast that the poster can be key.

One reason clinicians may prescribe antibiotics inappropriately is because they assume – perhaps erroneously – that patients want and expect them. By addressing the issue up front by displaying the poster, they may be able to “short-circuit” that type of thinking.

A minority of patients do expect antibiotics. “But the vast majority of patients are thinking, ‘I don’t feel well, I want to know what’s going on, and I want to know how to feel better and what’s going to happen.’ ”

For their part, patients can tell their doctors that they want an antibiotic only if they really need it, Dr. Linder said.

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

The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.

A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.

The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.

“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”

Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.

Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.

The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.

Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.

The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.

Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.

She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.

The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.

Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.

The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.

Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.

Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.

The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.

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

The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.

A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.

The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.

“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”

Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.

Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.

The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.

Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.

The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.

Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.

She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.

The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.

Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.

The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.

Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.

Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.

The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.

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

The successful treatment of Pompe disease in utero for the first time may be the start of a new chapter for fetal therapy, researchers said.

A report published online in the New England Journal of Medicine describes in utero enzyme-replacement therapy (ERT) for infantile-onset Pompe disease.

The patient, now a toddler, is thriving, according to the researchers. Her parents previously had children with the same disorder who died.

“This treatment expands the repertoire of fetal therapies in a new direction,” Tippi MacKenzie, MD, a pediatric surgeon with University of California, San Francisco, Benioff Children’s Hospitals and a coauthor of the report, said in a news release. “As new treatments become available for children with genetic conditions, we are developing protocols to apply them before birth.”

Dr. MacKenzie codirects the University of California, San Francisco’s center for maternal-fetal precision medicine and directs the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research.

Pompe disease is caused by mutations in a gene that makes acid alpha-glucosidase. With limited amounts of this enzyme, dangerous amounts of glycogen accumulate in the body. Babies with infantile-onset disease typically have enlarged hearts and die by age 2 years.

The condition, which occurs in an estimated 1 in 40,000 births, is one of several early-onset lysosomal storage disorders. Patients with these diseases “are ideal candidates for prenatal therapy because organ damage starts in utero,” the researchers said.

Newborn screening can lead to early initiation of treatment with recombinant enzymes, “but this strategy does not completely prevent irreversible organ damage,” the authors said.

The patient in the new report received six prenatal ERT treatments at the Ottawa Hospital and is receiving postnatal enzyme therapy at CHEO, a pediatric hospital and research center in Ottawa.

Investigators administered alglucosidase alfa through the umbilical vein. They delivered the first infusion to the fetus at 24 weeks 5 days of gestation. They continued providing infusions at 2-week intervals through 34 weeks 5 days of gestation.

She is doing well at age 16 months, with normal cardiac and motor function, and is meeting developmental milestones, according to the news release.

The successful treatment involved collaboration among the University of California, San Francisco, where researchers are conducting a clinical trial of this treatment approach; CHEO and the Ottawa Hospital; and Duke University, Durham, N.C.

Under normal circumstances, the patient’s family would have traveled to Benioff Children’s Hospitals fetal treatment center to participate in the clinical trial, but COVID-19 restrictions led the researchers to deliver the therapy to Ottawa as part of the trial.

The University of California, San Francisco, has received U.S. Food and Drug Administration approval to treat Pompe disease and several other lysosomal storage disorders in utero as part of a phase 1 clinical trial with 10 patients. The other diseases are mucopolysaccharidosis types 1, 2, 4a, 6, and 7; Gaucher disease types 2 and 3; and Wolman disease.

Patients with Pompe disease might typically be diagnosed clinically at age 3-6 months, said study coauthor Paul Harmatz, MD, with the University of California, San Francisco. With newborn screening, the disease might be diagnosed at 1 week. But intervening before birth may be optimal, Dr. Harmatz said.

Fetal treatment appears to be “revolutionary at this point,” Dr. Harmatz said.

The research was supported by a grant from the National Institutes of Health. Sanofi Genzyme provided the enzyme for the patient.

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

Knee and hip replacements can improve how well patients get around and can significantly increase their quality of life. But if a bone near the new joint breaks, the injury can be a major setback for the patient’s mobility, and the consequences can be life-threatening.

The proportion of patients who experience a periprosthetic fracture within 5 years of total hip arthroplasty is 0.9%. After total knee arthroplasty (TKA), the proportion is 0.6%, research shows.

Those rates might seem low. But given that more than a million of these joint replacement surgeries are performed each year in the United States – they are the most common inpatient surgical procedures among people aged 65 and older – thousands of revision surgeries due to periprosthetic fractures occur each year.

Primary care physicians, surgeons, and researchers are trying to identify risk factors, medication regimens, and nondrug approaches to avoid these complications. Primary care clinicians who make their patients’ bone health a priority early on – years before surgery, ideally – may help patients enjoy the benefits of new joints long term.

At the 2022 annual Santa Fe Bone Symposium this summer, Susan V. Bukata, MD, professor and chair of orthopedics at the University of California, San Diego, showed an image of “what we’re trying to avoid” – a patient with a broken bone and infection. Unfortunately, Dr. Bukata said, the patient’s clinicians had not adequately addressed her skeletal health before the injury.

“This is a complete disaster for this person who went in having a total hip to improve their function and now will probably never walk normally on that leg,” Dr. Bukata said at the meeting.

The patient eventually underwent total femur replacement. Five surgeries were required to clear the infection.

Medical and surgical advances have allowed more people – including older patients and those with other medical conditions – to undergo joint replacement surgery, including replacement of knees, hips, and shoulders.

The surgeries often are performed for adults whose bones are thinning. Sometimes surgeons don’t realize just how thin a patient’s bone is until they are operating.
 

Prioritizing bone health

In patients with osteoporosis, the bone surrounding the new joint is weaker than the metal of the prosthesis, and the metal can rip out of the bone, Dr. Bukata told this news organization. A periprosthetic fracture should be recognized as an osteoporotic fracture, too, although these fractures have not typically been categorized that way, she said.

People live with total joints in place for as long as 40 years, and fractures around the implants are “one of the fastest growing injuries that we are seeing in older patients,” Dr. Bukata said. “People don’t think of those as osteoporotic fractures. But a 90-year-old who falls and breaks next to their total knee, if they didn’t have that total knee in place, everybody would be, like, ‘Oh, that’s an osteoporotic fracture.’ ”

Periprosthetic fractures tend not to occur right after surgery but rather after the bone continues to lose density as the patient ages, Dr. Bukata said.
 

Missed chances

One approach to preventing periprosthetic fractures could involve prioritizing bone health earlier in life and diagnosing and treating osteoporosis well before a patient is scheduled for surgery.

A patient’s initial visit to their primary care doctor because of joint pain is an opportunity to check on and promote their bone health, given that they might be a candidate for surgery in the future, Dr. Bukata said.

Ahead of a scheduled surgery, patients can see endocrinologists or rheumatologists to receive medication to try to strengthen bones. Doctors may be limited in how much of a difference they can make in a matter of several weeks or months with these drugs, however. These patients still likely will need to be treated as if they have osteoporosis, Dr. Bukata said.

When surgeons realize that a patient has weaker bones while they are in the middle of an operation, they should emphasize the importance of bone health after the procedure, Dr. Bukata said.

Strengthening, maintaining, and protecting bone should be seen as a long-term investment in the patient’s success after a joint replacement. That said, “There is no clear evidence or protocol for us to follow,” she said. “The mantra at UCSD now is, let’s keep it simple. Get the patient on track. And then we can always refine things as we continue to treat the patient.”

Health systems should establish routines in which bone health is discussed before surgery in the way patient education programs address smoking cessation, nutrition, and weight management, Dr. Bukata said. Another step in the right direction could involve setting electronic medical records to automatically order assessments of bone health when a surgeon books a case.

Linda A. Russell, MD, rheumatologist and director of perioperative medicine at the Hospital for Special Surgery in New York, said periprosthetic fractures are a “complication we fear.”

“It’s a big deal to try to repair it,” Dr. Russell said. “Sometimes you need to revise the joint, or sometimes you need to put lots more hardware in.” Surgeons increasingly appreciate the need to pay attention to the quality of the bone before they operate, she said.

Nevertheless, Dr. Russell does not necessarily say that such cases call for alarm or particularly aggressive treatment regimens – just regular bone health evaluations before and after surgery to see whether patients have osteoporosis and are candidates for treatment.
 

Lifelong effort

In some ways, to address bone health at the time of surgery may be too late.

Bone health “is not something that you can have as an afterthought when you’re 75 years old,” said Elizabeth Matzkin, MD, chief of women’s sports medicine at Brigham and Women’s Hospital, in Boston.

The chance of being able to rebuild bone mass at that age is slim. If patients maximize bone density when they are young, they can afford to lose some bone mass each year as they age.

To that end, a healthy diet, exercise, not smoking, and cutting back on alcohol can help, she said.

For Dr. Matzkin, a fragility fracture is a red flag that the patient’s bone density is probably not optimal. In such cases, she prepares for various scenarios during surgery, such as a screw not holding in a low-density bone.

Recently published research reflects that prior fragility fractures are a significant risk factor for complications after surgery, including periprosthetic fractures.

Edward J. Testa, MD, of Brown University, Providence, R.I., and colleagues analyzed insurance claims to compare outcomes for 24,398 patients who had experienced a fragility fracture – that is, a break caused by low-velocity trauma such as a fall – during the 3 years before their TKA procedure and a matched group of patients who were similar in many respects but who had not had a fragility fracture in the 3 years before surgery.

Dr. Testa’s group found that a history of fragility fracture was associated with higher rates of complications in the year after surgery, including hospital readmissions (hazard ratio = 1.30; 95% CI, 1.22-1.38), periprosthetic fractures (odds ratio = 2.72; 95% CI, 1.89-3.99), and secondary fragility fractures (OR = 4.62; 95% CI, 4.19-5.12). Patients who had previously experienced fragility fractures also experienced dislocated prostheses (OR = 1.76; 95% CI, 1.22-2.56) and periprosthetic infections (OR = 1.49; 95% CI, 1.29-1.71) at higher rates.

The rates of complications were similar regardless of whether patients had filled a prescription for medications used to treat osteoporosis, including bisphosphonates, vitamin D replacement, raloxifene, and denosumab, the researchers reported.

The lack of a clear association between these treatments and patient outcomes could be related to an insufficient duration of pharmacotherapy before or after TKA, poor medication adherence, or small sample sizes, Dr. Testa said.

Given the findings, which were published online in the Journal of Arthroplasty, “patients with a history of fragility fracture should be identified and counseled appropriately for a possible increased risk of the aforementioned complications, and optimized when possible, prior to undergoing TKA,” Dr. Testa told this news organization. “Ultimately, the decision to move forward with surgery is far more complex than the identification of this sole, yet important, risk factor for certain postoperative, implant-related complications.”
 

Treatment gaps

Prior research has shown that women aged 70 years and older are at higher risk for periprosthetic fractures. Many women in this age group who could receive treatment for osteoporosis do not, and major treatment gaps exist worldwide, noted Neil Binkley, MD, with the University of Wisconsin–Madison, in a separate talk at the Santa Fe Bone Symposium.

Ensuring adequate protein intake and addressing the risk of falling are other measures that clinicians can take to promote healthy bones, apart from prescribing drugs, he said.

Unpublished data from one group show that nearly 90% of periprosthetic fractures may result from falls, while about 8% may be spontaneous. “We need to be thinking about falls,” Dr. Binkley said.

Dr. Bukata has consulted for Amgen, Radius, and Solarea Bio and has served on a speakers bureau for Radius. She also is a board member for the Orthopaedic Research Society and the American Academy of Orthopaedic Surgeons Board of Specialty Societies. Dr. Binkley has received research support from Radius and has consulted for Amgen.

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

Knee and hip replacements can improve how well patients get around and can significantly increase their quality of life. But if a bone near the new joint breaks, the injury can be a major setback for the patient’s mobility, and the consequences can be life-threatening.

The proportion of patients who experience a periprosthetic fracture within 5 years of total hip arthroplasty is 0.9%. After total knee arthroplasty (TKA), the proportion is 0.6%, research shows.

Those rates might seem low. But given that more than a million of these joint replacement surgeries are performed each year in the United States – they are the most common inpatient surgical procedures among people aged 65 and older – thousands of revision surgeries due to periprosthetic fractures occur each year.

Primary care physicians, surgeons, and researchers are trying to identify risk factors, medication regimens, and nondrug approaches to avoid these complications. Primary care clinicians who make their patients’ bone health a priority early on – years before surgery, ideally – may help patients enjoy the benefits of new joints long term.

At the 2022 annual Santa Fe Bone Symposium this summer, Susan V. Bukata, MD, professor and chair of orthopedics at the University of California, San Diego, showed an image of “what we’re trying to avoid” – a patient with a broken bone and infection. Unfortunately, Dr. Bukata said, the patient’s clinicians had not adequately addressed her skeletal health before the injury.

“This is a complete disaster for this person who went in having a total hip to improve their function and now will probably never walk normally on that leg,” Dr. Bukata said at the meeting.

The patient eventually underwent total femur replacement. Five surgeries were required to clear the infection.

Medical and surgical advances have allowed more people – including older patients and those with other medical conditions – to undergo joint replacement surgery, including replacement of knees, hips, and shoulders.

The surgeries often are performed for adults whose bones are thinning. Sometimes surgeons don’t realize just how thin a patient’s bone is until they are operating.
 

Prioritizing bone health

In patients with osteoporosis, the bone surrounding the new joint is weaker than the metal of the prosthesis, and the metal can rip out of the bone, Dr. Bukata told this news organization. A periprosthetic fracture should be recognized as an osteoporotic fracture, too, although these fractures have not typically been categorized that way, she said.

People live with total joints in place for as long as 40 years, and fractures around the implants are “one of the fastest growing injuries that we are seeing in older patients,” Dr. Bukata said. “People don’t think of those as osteoporotic fractures. But a 90-year-old who falls and breaks next to their total knee, if they didn’t have that total knee in place, everybody would be, like, ‘Oh, that’s an osteoporotic fracture.’ ”

Periprosthetic fractures tend not to occur right after surgery but rather after the bone continues to lose density as the patient ages, Dr. Bukata said.
 

Missed chances

One approach to preventing periprosthetic fractures could involve prioritizing bone health earlier in life and diagnosing and treating osteoporosis well before a patient is scheduled for surgery.

A patient’s initial visit to their primary care doctor because of joint pain is an opportunity to check on and promote their bone health, given that they might be a candidate for surgery in the future, Dr. Bukata said.

Ahead of a scheduled surgery, patients can see endocrinologists or rheumatologists to receive medication to try to strengthen bones. Doctors may be limited in how much of a difference they can make in a matter of several weeks or months with these drugs, however. These patients still likely will need to be treated as if they have osteoporosis, Dr. Bukata said.

When surgeons realize that a patient has weaker bones while they are in the middle of an operation, they should emphasize the importance of bone health after the procedure, Dr. Bukata said.

Strengthening, maintaining, and protecting bone should be seen as a long-term investment in the patient’s success after a joint replacement. That said, “There is no clear evidence or protocol for us to follow,” she said. “The mantra at UCSD now is, let’s keep it simple. Get the patient on track. And then we can always refine things as we continue to treat the patient.”

Health systems should establish routines in which bone health is discussed before surgery in the way patient education programs address smoking cessation, nutrition, and weight management, Dr. Bukata said. Another step in the right direction could involve setting electronic medical records to automatically order assessments of bone health when a surgeon books a case.

Linda A. Russell, MD, rheumatologist and director of perioperative medicine at the Hospital for Special Surgery in New York, said periprosthetic fractures are a “complication we fear.”

“It’s a big deal to try to repair it,” Dr. Russell said. “Sometimes you need to revise the joint, or sometimes you need to put lots more hardware in.” Surgeons increasingly appreciate the need to pay attention to the quality of the bone before they operate, she said.

Nevertheless, Dr. Russell does not necessarily say that such cases call for alarm or particularly aggressive treatment regimens – just regular bone health evaluations before and after surgery to see whether patients have osteoporosis and are candidates for treatment.
 

Lifelong effort

In some ways, to address bone health at the time of surgery may be too late.

Bone health “is not something that you can have as an afterthought when you’re 75 years old,” said Elizabeth Matzkin, MD, chief of women’s sports medicine at Brigham and Women’s Hospital, in Boston.

The chance of being able to rebuild bone mass at that age is slim. If patients maximize bone density when they are young, they can afford to lose some bone mass each year as they age.

To that end, a healthy diet, exercise, not smoking, and cutting back on alcohol can help, she said.

For Dr. Matzkin, a fragility fracture is a red flag that the patient’s bone density is probably not optimal. In such cases, she prepares for various scenarios during surgery, such as a screw not holding in a low-density bone.

Recently published research reflects that prior fragility fractures are a significant risk factor for complications after surgery, including periprosthetic fractures.

Edward J. Testa, MD, of Brown University, Providence, R.I., and colleagues analyzed insurance claims to compare outcomes for 24,398 patients who had experienced a fragility fracture – that is, a break caused by low-velocity trauma such as a fall – during the 3 years before their TKA procedure and a matched group of patients who were similar in many respects but who had not had a fragility fracture in the 3 years before surgery.

Dr. Testa’s group found that a history of fragility fracture was associated with higher rates of complications in the year after surgery, including hospital readmissions (hazard ratio = 1.30; 95% CI, 1.22-1.38), periprosthetic fractures (odds ratio = 2.72; 95% CI, 1.89-3.99), and secondary fragility fractures (OR = 4.62; 95% CI, 4.19-5.12). Patients who had previously experienced fragility fractures also experienced dislocated prostheses (OR = 1.76; 95% CI, 1.22-2.56) and periprosthetic infections (OR = 1.49; 95% CI, 1.29-1.71) at higher rates.

The rates of complications were similar regardless of whether patients had filled a prescription for medications used to treat osteoporosis, including bisphosphonates, vitamin D replacement, raloxifene, and denosumab, the researchers reported.

The lack of a clear association between these treatments and patient outcomes could be related to an insufficient duration of pharmacotherapy before or after TKA, poor medication adherence, or small sample sizes, Dr. Testa said.

Given the findings, which were published online in the Journal of Arthroplasty, “patients with a history of fragility fracture should be identified and counseled appropriately for a possible increased risk of the aforementioned complications, and optimized when possible, prior to undergoing TKA,” Dr. Testa told this news organization. “Ultimately, the decision to move forward with surgery is far more complex than the identification of this sole, yet important, risk factor for certain postoperative, implant-related complications.”
 

Treatment gaps

Prior research has shown that women aged 70 years and older are at higher risk for periprosthetic fractures. Many women in this age group who could receive treatment for osteoporosis do not, and major treatment gaps exist worldwide, noted Neil Binkley, MD, with the University of Wisconsin–Madison, in a separate talk at the Santa Fe Bone Symposium.

Ensuring adequate protein intake and addressing the risk of falling are other measures that clinicians can take to promote healthy bones, apart from prescribing drugs, he said.

Unpublished data from one group show that nearly 90% of periprosthetic fractures may result from falls, while about 8% may be spontaneous. “We need to be thinking about falls,” Dr. Binkley said.

Dr. Bukata has consulted for Amgen, Radius, and Solarea Bio and has served on a speakers bureau for Radius. She also is a board member for the Orthopaedic Research Society and the American Academy of Orthopaedic Surgeons Board of Specialty Societies. Dr. Binkley has received research support from Radius and has consulted for Amgen.

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

Knee and hip replacements can improve how well patients get around and can significantly increase their quality of life. But if a bone near the new joint breaks, the injury can be a major setback for the patient’s mobility, and the consequences can be life-threatening.

The proportion of patients who experience a periprosthetic fracture within 5 years of total hip arthroplasty is 0.9%. After total knee arthroplasty (TKA), the proportion is 0.6%, research shows.

Those rates might seem low. But given that more than a million of these joint replacement surgeries are performed each year in the United States – they are the most common inpatient surgical procedures among people aged 65 and older – thousands of revision surgeries due to periprosthetic fractures occur each year.

Primary care physicians, surgeons, and researchers are trying to identify risk factors, medication regimens, and nondrug approaches to avoid these complications. Primary care clinicians who make their patients’ bone health a priority early on – years before surgery, ideally – may help patients enjoy the benefits of new joints long term.

At the 2022 annual Santa Fe Bone Symposium this summer, Susan V. Bukata, MD, professor and chair of orthopedics at the University of California, San Diego, showed an image of “what we’re trying to avoid” – a patient with a broken bone and infection. Unfortunately, Dr. Bukata said, the patient’s clinicians had not adequately addressed her skeletal health before the injury.

“This is a complete disaster for this person who went in having a total hip to improve their function and now will probably never walk normally on that leg,” Dr. Bukata said at the meeting.

The patient eventually underwent total femur replacement. Five surgeries were required to clear the infection.

Medical and surgical advances have allowed more people – including older patients and those with other medical conditions – to undergo joint replacement surgery, including replacement of knees, hips, and shoulders.

The surgeries often are performed for adults whose bones are thinning. Sometimes surgeons don’t realize just how thin a patient’s bone is until they are operating.
 

Prioritizing bone health

In patients with osteoporosis, the bone surrounding the new joint is weaker than the metal of the prosthesis, and the metal can rip out of the bone, Dr. Bukata told this news organization. A periprosthetic fracture should be recognized as an osteoporotic fracture, too, although these fractures have not typically been categorized that way, she said.

People live with total joints in place for as long as 40 years, and fractures around the implants are “one of the fastest growing injuries that we are seeing in older patients,” Dr. Bukata said. “People don’t think of those as osteoporotic fractures. But a 90-year-old who falls and breaks next to their total knee, if they didn’t have that total knee in place, everybody would be, like, ‘Oh, that’s an osteoporotic fracture.’ ”

Periprosthetic fractures tend not to occur right after surgery but rather after the bone continues to lose density as the patient ages, Dr. Bukata said.
 

Missed chances

One approach to preventing periprosthetic fractures could involve prioritizing bone health earlier in life and diagnosing and treating osteoporosis well before a patient is scheduled for surgery.

A patient’s initial visit to their primary care doctor because of joint pain is an opportunity to check on and promote their bone health, given that they might be a candidate for surgery in the future, Dr. Bukata said.

Ahead of a scheduled surgery, patients can see endocrinologists or rheumatologists to receive medication to try to strengthen bones. Doctors may be limited in how much of a difference they can make in a matter of several weeks or months with these drugs, however. These patients still likely will need to be treated as if they have osteoporosis, Dr. Bukata said.

When surgeons realize that a patient has weaker bones while they are in the middle of an operation, they should emphasize the importance of bone health after the procedure, Dr. Bukata said.

Strengthening, maintaining, and protecting bone should be seen as a long-term investment in the patient’s success after a joint replacement. That said, “There is no clear evidence or protocol for us to follow,” she said. “The mantra at UCSD now is, let’s keep it simple. Get the patient on track. And then we can always refine things as we continue to treat the patient.”

Health systems should establish routines in which bone health is discussed before surgery in the way patient education programs address smoking cessation, nutrition, and weight management, Dr. Bukata said. Another step in the right direction could involve setting electronic medical records to automatically order assessments of bone health when a surgeon books a case.

Linda A. Russell, MD, rheumatologist and director of perioperative medicine at the Hospital for Special Surgery in New York, said periprosthetic fractures are a “complication we fear.”

“It’s a big deal to try to repair it,” Dr. Russell said. “Sometimes you need to revise the joint, or sometimes you need to put lots more hardware in.” Surgeons increasingly appreciate the need to pay attention to the quality of the bone before they operate, she said.

Nevertheless, Dr. Russell does not necessarily say that such cases call for alarm or particularly aggressive treatment regimens – just regular bone health evaluations before and after surgery to see whether patients have osteoporosis and are candidates for treatment.
 

Lifelong effort

In some ways, to address bone health at the time of surgery may be too late.

Bone health “is not something that you can have as an afterthought when you’re 75 years old,” said Elizabeth Matzkin, MD, chief of women’s sports medicine at Brigham and Women’s Hospital, in Boston.

The chance of being able to rebuild bone mass at that age is slim. If patients maximize bone density when they are young, they can afford to lose some bone mass each year as they age.

To that end, a healthy diet, exercise, not smoking, and cutting back on alcohol can help, she said.

For Dr. Matzkin, a fragility fracture is a red flag that the patient’s bone density is probably not optimal. In such cases, she prepares for various scenarios during surgery, such as a screw not holding in a low-density bone.

Recently published research reflects that prior fragility fractures are a significant risk factor for complications after surgery, including periprosthetic fractures.

Edward J. Testa, MD, of Brown University, Providence, R.I., and colleagues analyzed insurance claims to compare outcomes for 24,398 patients who had experienced a fragility fracture – that is, a break caused by low-velocity trauma such as a fall – during the 3 years before their TKA procedure and a matched group of patients who were similar in many respects but who had not had a fragility fracture in the 3 years before surgery.

Dr. Testa’s group found that a history of fragility fracture was associated with higher rates of complications in the year after surgery, including hospital readmissions (hazard ratio = 1.30; 95% CI, 1.22-1.38), periprosthetic fractures (odds ratio = 2.72; 95% CI, 1.89-3.99), and secondary fragility fractures (OR = 4.62; 95% CI, 4.19-5.12). Patients who had previously experienced fragility fractures also experienced dislocated prostheses (OR = 1.76; 95% CI, 1.22-2.56) and periprosthetic infections (OR = 1.49; 95% CI, 1.29-1.71) at higher rates.

The rates of complications were similar regardless of whether patients had filled a prescription for medications used to treat osteoporosis, including bisphosphonates, vitamin D replacement, raloxifene, and denosumab, the researchers reported.

The lack of a clear association between these treatments and patient outcomes could be related to an insufficient duration of pharmacotherapy before or after TKA, poor medication adherence, or small sample sizes, Dr. Testa said.

Given the findings, which were published online in the Journal of Arthroplasty, “patients with a history of fragility fracture should be identified and counseled appropriately for a possible increased risk of the aforementioned complications, and optimized when possible, prior to undergoing TKA,” Dr. Testa told this news organization. “Ultimately, the decision to move forward with surgery is far more complex than the identification of this sole, yet important, risk factor for certain postoperative, implant-related complications.”
 

Treatment gaps

Prior research has shown that women aged 70 years and older are at higher risk for periprosthetic fractures. Many women in this age group who could receive treatment for osteoporosis do not, and major treatment gaps exist worldwide, noted Neil Binkley, MD, with the University of Wisconsin–Madison, in a separate talk at the Santa Fe Bone Symposium.

Ensuring adequate protein intake and addressing the risk of falling are other measures that clinicians can take to promote healthy bones, apart from prescribing drugs, he said.

Unpublished data from one group show that nearly 90% of periprosthetic fractures may result from falls, while about 8% may be spontaneous. “We need to be thinking about falls,” Dr. Binkley said.

Dr. Bukata has consulted for Amgen, Radius, and Solarea Bio and has served on a speakers bureau for Radius. She also is a board member for the Orthopaedic Research Society and the American Academy of Orthopaedic Surgeons Board of Specialty Societies. Dr. Binkley has received research support from Radius and has consulted for Amgen.

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

People with a rare genetic condition that causes extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) may miss out on decades of treatment because of a lack of lipid screening in childhood, researchers reported at the annual meeting of the American Academy of Pediatrics.

The condition, homozygous familial hypercholesterolemia (FH), raises the risk for atherosclerotic cardiovascular disease (ASCVD) as early as the first decade of life.

Routine screening for FH is uncommon, however, the researchers said. Lack of familiarity with guidelines and limited access to lipid specialists have been cited as possible reasons for inconsistent screening practices.

“These findings and recent improvement in lipid lowering therapies make a compelling case for rigorous compliance with AAP’s guidelines on lipid screening for children with a family history of FH or ASCVD at age 2,” study coauthor Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, said in a statement about the new study.
 

Early consequences

To characterize patients with homozygous FH, Dr. McGowan and her colleagues examined data from 67 participants in the CASCADE-FH registry. The Family Heart Foundation created the registry in 2013, and 40 medical centers in the United States contribute data to the repository. The researchers had access to data about patients with homozygous FH from 20 centers in the registry.

Dr. McGowan’s group compared 16 patients with homozygous FH who enrolled in the registry when they were children and 51 patients who were adults at the time of their enrollment.

Patients enrolled as children had a median age at diagnosis of 2 years (interquartile range [IQR], 2-3.5), whereas patients enrolled as adults had a median age at diagnosis of 12.6 years (IQR, 4.1-26.5).

The median untreated level of LDL-C in those enrolled as children was 776 mg/dL (IQR, 704-892). Among those enrolled as adults, it was 533 mg/dL (IQR, 467-702).

Approximately 19% of those enrolled as children had evidence of aortic valve stenosis, and 43.8% had evidence of ASCVD. The median age at onset of ASCVD was 8.9 years. One child was diagnosed with ASCVD at age 2 years and underwent liver transplant at age 4 years. Another was diagnosed with the condition at age 3 years and underwent liver transplant at age 8 years. Two children underwent coronary artery bypass grafting at ages 6 years and 14 years. Five participants underwent liver transplant before age 18 years.

About 56% of participants who enrolled as children had xanthomas, or fat deposits in tendons, and none had corneal arcus — a gray-white line of fat deposits around the edge of the cornea, both of which can indicate homozygous FH in children.

Treatment reduced LDL-C substantially, but only 25% of children achieved goal levels of cholesterol, the researchers reported. Patients who received more lipid-lowering therapies had a better chance of reaching their target levels, they found.

The data raise “the possibility that only children with the most severe phenotypes are diagnosed before adulthood,” the researchers said.

Clinical diagnosis of homozygous FH can be based on LDL-C levels, family history, and the presence of xanthomas, the researchers noted. Many children do not have physical findings, however, and a lipid panel or genetic testing may be necessary.

“There is a clear need to implement universal screening” to identify all children with homozygous FH and heterozygous FH, a less severe and more common form of FH, Dr. McGowan said.
 

Possible missed cases

As many as 1 in 250 people may have heterozygous FH, and 1 in 300,000 people may have homozygous FH, according to estimates. Patients with homozygous FH have two FH genes, one from each parent. In patients with homozygous FH, levels of LDL-C levels typically range between 400 and 1,000 mg/dL without treatment, which is four to 10 times higher than normal concentrations of the blood fat, according to the Family Heart Foundation.

“This study adds to a growing body of literature – including our own work – demonstrating that recommended universal screening occurs in barely 1 in 5 children. This means some patients are not being recognized as having treatable diseases,” said Justin H. Berger, MD, PhD, a pediatric cardiologist at Children’s Hospital of Philadelphia.

Even among children who are at the highest risk for early onset adult-type heart disease, only a quarter to two-thirds receive recommended screening, said Dr. Berger, who was not a member of the study team.

While Dr. Berger advocates universal lipid screening, improving screening rates in practice probably isn’t as simple as telling clinicians to screen more, he said. “Increasing testing will increase health care spending and the burden on busy primary care providers without addressing who will subsequently evaluate and manage children with abnormal lipid screening results,” Dr. Berger said.

Instead, clinicians may want to focus on screening patients who are at risk, which “could have dramatic benefits for their life-long cardiovascular health,” he said.

Dr. McGowan disclosed ties to Abbott and Regeneron, and her coauthors disclosed ties to Esperion Therapeutics and research funding from Regeneron and REGENXBIO. Dr. Berger disclosed no relevant financial relationships.

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

People with a rare genetic condition that causes extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) may miss out on decades of treatment because of a lack of lipid screening in childhood, researchers reported at the annual meeting of the American Academy of Pediatrics.

The condition, homozygous familial hypercholesterolemia (FH), raises the risk for atherosclerotic cardiovascular disease (ASCVD) as early as the first decade of life.

Routine screening for FH is uncommon, however, the researchers said. Lack of familiarity with guidelines and limited access to lipid specialists have been cited as possible reasons for inconsistent screening practices.

“These findings and recent improvement in lipid lowering therapies make a compelling case for rigorous compliance with AAP’s guidelines on lipid screening for children with a family history of FH or ASCVD at age 2,” study coauthor Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, said in a statement about the new study.
 

Early consequences

To characterize patients with homozygous FH, Dr. McGowan and her colleagues examined data from 67 participants in the CASCADE-FH registry. The Family Heart Foundation created the registry in 2013, and 40 medical centers in the United States contribute data to the repository. The researchers had access to data about patients with homozygous FH from 20 centers in the registry.

Dr. McGowan’s group compared 16 patients with homozygous FH who enrolled in the registry when they were children and 51 patients who were adults at the time of their enrollment.

Patients enrolled as children had a median age at diagnosis of 2 years (interquartile range [IQR], 2-3.5), whereas patients enrolled as adults had a median age at diagnosis of 12.6 years (IQR, 4.1-26.5).

The median untreated level of LDL-C in those enrolled as children was 776 mg/dL (IQR, 704-892). Among those enrolled as adults, it was 533 mg/dL (IQR, 467-702).

Approximately 19% of those enrolled as children had evidence of aortic valve stenosis, and 43.8% had evidence of ASCVD. The median age at onset of ASCVD was 8.9 years. One child was diagnosed with ASCVD at age 2 years and underwent liver transplant at age 4 years. Another was diagnosed with the condition at age 3 years and underwent liver transplant at age 8 years. Two children underwent coronary artery bypass grafting at ages 6 years and 14 years. Five participants underwent liver transplant before age 18 years.

About 56% of participants who enrolled as children had xanthomas, or fat deposits in tendons, and none had corneal arcus — a gray-white line of fat deposits around the edge of the cornea, both of which can indicate homozygous FH in children.

Treatment reduced LDL-C substantially, but only 25% of children achieved goal levels of cholesterol, the researchers reported. Patients who received more lipid-lowering therapies had a better chance of reaching their target levels, they found.

The data raise “the possibility that only children with the most severe phenotypes are diagnosed before adulthood,” the researchers said.

Clinical diagnosis of homozygous FH can be based on LDL-C levels, family history, and the presence of xanthomas, the researchers noted. Many children do not have physical findings, however, and a lipid panel or genetic testing may be necessary.

“There is a clear need to implement universal screening” to identify all children with homozygous FH and heterozygous FH, a less severe and more common form of FH, Dr. McGowan said.
 

Possible missed cases

As many as 1 in 250 people may have heterozygous FH, and 1 in 300,000 people may have homozygous FH, according to estimates. Patients with homozygous FH have two FH genes, one from each parent. In patients with homozygous FH, levels of LDL-C levels typically range between 400 and 1,000 mg/dL without treatment, which is four to 10 times higher than normal concentrations of the blood fat, according to the Family Heart Foundation.

“This study adds to a growing body of literature – including our own work – demonstrating that recommended universal screening occurs in barely 1 in 5 children. This means some patients are not being recognized as having treatable diseases,” said Justin H. Berger, MD, PhD, a pediatric cardiologist at Children’s Hospital of Philadelphia.

Even among children who are at the highest risk for early onset adult-type heart disease, only a quarter to two-thirds receive recommended screening, said Dr. Berger, who was not a member of the study team.

While Dr. Berger advocates universal lipid screening, improving screening rates in practice probably isn’t as simple as telling clinicians to screen more, he said. “Increasing testing will increase health care spending and the burden on busy primary care providers without addressing who will subsequently evaluate and manage children with abnormal lipid screening results,” Dr. Berger said.

Instead, clinicians may want to focus on screening patients who are at risk, which “could have dramatic benefits for their life-long cardiovascular health,” he said.

Dr. McGowan disclosed ties to Abbott and Regeneron, and her coauthors disclosed ties to Esperion Therapeutics and research funding from Regeneron and REGENXBIO. Dr. Berger disclosed no relevant financial relationships.

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

People with a rare genetic condition that causes extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) may miss out on decades of treatment because of a lack of lipid screening in childhood, researchers reported at the annual meeting of the American Academy of Pediatrics.

The condition, homozygous familial hypercholesterolemia (FH), raises the risk for atherosclerotic cardiovascular disease (ASCVD) as early as the first decade of life.

Routine screening for FH is uncommon, however, the researchers said. Lack of familiarity with guidelines and limited access to lipid specialists have been cited as possible reasons for inconsistent screening practices.

“These findings and recent improvement in lipid lowering therapies make a compelling case for rigorous compliance with AAP’s guidelines on lipid screening for children with a family history of FH or ASCVD at age 2,” study coauthor Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, said in a statement about the new study.
 

Early consequences

To characterize patients with homozygous FH, Dr. McGowan and her colleagues examined data from 67 participants in the CASCADE-FH registry. The Family Heart Foundation created the registry in 2013, and 40 medical centers in the United States contribute data to the repository. The researchers had access to data about patients with homozygous FH from 20 centers in the registry.

Dr. McGowan’s group compared 16 patients with homozygous FH who enrolled in the registry when they were children and 51 patients who were adults at the time of their enrollment.

Patients enrolled as children had a median age at diagnosis of 2 years (interquartile range [IQR], 2-3.5), whereas patients enrolled as adults had a median age at diagnosis of 12.6 years (IQR, 4.1-26.5).

The median untreated level of LDL-C in those enrolled as children was 776 mg/dL (IQR, 704-892). Among those enrolled as adults, it was 533 mg/dL (IQR, 467-702).

Approximately 19% of those enrolled as children had evidence of aortic valve stenosis, and 43.8% had evidence of ASCVD. The median age at onset of ASCVD was 8.9 years. One child was diagnosed with ASCVD at age 2 years and underwent liver transplant at age 4 years. Another was diagnosed with the condition at age 3 years and underwent liver transplant at age 8 years. Two children underwent coronary artery bypass grafting at ages 6 years and 14 years. Five participants underwent liver transplant before age 18 years.

About 56% of participants who enrolled as children had xanthomas, or fat deposits in tendons, and none had corneal arcus — a gray-white line of fat deposits around the edge of the cornea, both of which can indicate homozygous FH in children.

Treatment reduced LDL-C substantially, but only 25% of children achieved goal levels of cholesterol, the researchers reported. Patients who received more lipid-lowering therapies had a better chance of reaching their target levels, they found.

The data raise “the possibility that only children with the most severe phenotypes are diagnosed before adulthood,” the researchers said.

Clinical diagnosis of homozygous FH can be based on LDL-C levels, family history, and the presence of xanthomas, the researchers noted. Many children do not have physical findings, however, and a lipid panel or genetic testing may be necessary.

“There is a clear need to implement universal screening” to identify all children with homozygous FH and heterozygous FH, a less severe and more common form of FH, Dr. McGowan said.
 

Possible missed cases

As many as 1 in 250 people may have heterozygous FH, and 1 in 300,000 people may have homozygous FH, according to estimates. Patients with homozygous FH have two FH genes, one from each parent. In patients with homozygous FH, levels of LDL-C levels typically range between 400 and 1,000 mg/dL without treatment, which is four to 10 times higher than normal concentrations of the blood fat, according to the Family Heart Foundation.

“This study adds to a growing body of literature – including our own work – demonstrating that recommended universal screening occurs in barely 1 in 5 children. This means some patients are not being recognized as having treatable diseases,” said Justin H. Berger, MD, PhD, a pediatric cardiologist at Children’s Hospital of Philadelphia.

Even among children who are at the highest risk for early onset adult-type heart disease, only a quarter to two-thirds receive recommended screening, said Dr. Berger, who was not a member of the study team.

While Dr. Berger advocates universal lipid screening, improving screening rates in practice probably isn’t as simple as telling clinicians to screen more, he said. “Increasing testing will increase health care spending and the burden on busy primary care providers without addressing who will subsequently evaluate and manage children with abnormal lipid screening results,” Dr. Berger said.

Instead, clinicians may want to focus on screening patients who are at risk, which “could have dramatic benefits for their life-long cardiovascular health,” he said.

Dr. McGowan disclosed ties to Abbott and Regeneron, and her coauthors disclosed ties to Esperion Therapeutics and research funding from Regeneron and REGENXBIO. Dr. Berger disclosed no relevant financial relationships.

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

The number of children and teens who die from gun violence in the United States on a given day could fill a typical high school classroom, according to the American Academy of Pediatrics.

Preventing firearm-related injuries and deaths in children and youth “demands a public safety approach like regulation of motor vehicles,” the group said.

The organization on Oct. 8 released an updated policy statement and technical report about gun violence and children at its 2022 annual meeting in Anaheim, Calif. The reports were published in the journal Pediatrics, and the authors plan to discuss them during the conference.

“Each day, 28 U.S. children and teens – the equivalent of a high school classroom – die from gun violence, making it the No. 1 killer of youth through age 24,” the AAP said in a statement about the reports. “The national death rate is significantly higher than all other high-income countries combined, largely due to an alarming increase in suicides and homicides that do not make national headlines.”

Firearms have become the leading cause of death among children in the United States. 

In 2020, guns caused 10,197 deaths of Americans younger than 24, according to the Society for Adolescent Health and Medicine.

In 2015, more than 7,200 American youth were killed by firearms. That same year in 28 other high-income countries – which combined would have had a population twice that of the United States – just 685 youth were killed by firearms, according to the AAP.

Separately at the AAP conference, physicians are presenting new research about gun violence and children. And on Oct. 10, a pediatrician who was at Uvalde Memorial Hospital in Texas after the deadly school shooting in May is scheduled to address attendees. The doctor, Roy Guerrero, MD, testified on Capitol Hill to advocate for gun control after the shooting at Robb Elementary School, which killed 19 children and two adults.

“This is not a simple problem, and it cannot be fixed with a simple solution,” Lois K. Lee, MD, MPH, said in the AAP news release. Dr. Lee chairs the AAP Council on Injury, Violence, and Poison Prevention that wrote the new reports. “Pediatricians as a start can offer families guidance and education on more safely storing guns. AAP also calls for supporting legislation that, much like the common-sense requirements for obtaining a driver’s license, would improve gun ownership safety.”
 

Many deaths occur at home

The rate of homicide from firearms in U.S. youth, especially those aged 15-24 years, increased by 14% during the past decade, and the rate of suicide from firearms increased by 39%, according to the AAP.  

Homicides account for 58% of youth firearm deaths, whereas suicides account for 37%. Another 2% of youth firearm deaths are unintentional, and 1% result from law enforcement actions, the group said.

Among children 12 years old and younger, about 85% of firearm deaths occur at home. Teen firearm deaths are about as likely to occur at home (39%) as on the street or sidewalk (38%), according to research based on 2014 data.

“School shootings represent a relatively new phenomenon over the last half-century, and the United States has the highest rate of school shootings in the world,” the AAP technical report noted. Between 1966 and 2008, according to the group, 44 such shootings occurred in the United States, or an average of about one per year. Fast forward a few years and the violence became dramatically worse: Between 2013 and 2015, officials counted 154 school shootings – or about one per week.

Still, school shootings are responsible for less than 1% of all firearm deaths among children 17 years or younger in the United States. While school shootings “receive a tremendous amount of attention,” the report stated, other child firearm deaths may be less likely to make national headlines.

“Many firearm tragedies escape public attention because they occur in a home, sometimes in a child’s own home or at a friend’s house, or their neighbor’s or grandparent’s residence,” Eric W. Fleegler, MD, MPH, Boston Children’s Hospital, a co-author of the new reports, said in a statement from AAP. “Research tells us that families tend to underestimate how children will behave when they encounter a gun and miscalculate the risks. Suicide risks are also a huge concern, especially in families where teens are struggling with their mental health.”

AAP-recommended actions include:

• Mental health screenings and safe gun storage education provided by clinicians as part of routine patient visits
• Increased funding for violence intervention programs in hospital and community settings
• Regulation of firearms like other consumer products, with national requirements that address training, licensing, insurance coverage, registration of individuals purchasing firearms, and safe storage
• The use of technology that allows only authorized users to pull the trigger
• Universal background checks that use federal databases and information from local police before all gun purchases
• Extreme risk protection order laws, or “red flag laws,” that prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm
• More funding for firearm injury and prevention research.

A noticeable increase in the ED

Irma Ugalde, MD, associate professor and director of pediatric emergency medicine research at McGovern Medical School at UTHealth Houston, noticed that firearm-related injuries in children at her hospital were more common during the COVID-19 pandemic, even as pediatric emergency department visits decreased overall.

She and her colleagues studied the trends and reported their findings at the AAP meeting.

“We saw a drop in pediatric admissions overall,” Dr. Ugalde said in a statement about the study. “But what was really noticeable was that trauma was still very prevalent – in fact probably more so – and we were seeing more firearm injuries.”

The researchers found that firearm injuries in children rose from 88 cases in 2019 to 118 in 2020. The number of incidents remained elevated in 2021, with 115 cases.

In addition, the researchers found an initial increase in injuries occurring at home where the shooter was a known family member or friend, and in cases involving firearms that were not properly stored.

By comparison, pediatric ED visits overall decreased by 34.2% from 2019 to 2020, and by 11.8% from 2019 to 2021.

The increase in firearm injuries coincided with an increase in gun sales in the United States, the researchers noted.

“National and statewide initiatives to mitigate the risk of firearm-related injury and death are necessary,” Dr. Ugalde’s group said. “We recommend that health care workers remain vigilant about screening for potential risk factors and safe storage of firearms.”
 

Accidental injuries

Daniel D. Guzman, MD, with Cook Children’s Health Care Center, Fort Worth, Tex., conducted a study focused on unintentional firearm injuries in children. Dr. Guzman’s group analyzed data from 204 patients younger than age 19 seen at Cook Children’s from January 2015 to June 2021.

Dr. Guzman and his colleagues examined outcomes for injuries caused by powder guns – shotguns, rifles, and handguns – and air-power guns that shoot BBs and pellets.

The researchers found that 29% of the unintentional firearm injuries occurred with powder guns and 71% with air-power weapons, often BB guns.

“It is important that all firearms, powdered and air-powered, be stored safely in a lock box or safe,” Dr. Guzman said in a statement. To that end, Cook Children’s has developed a program called Aim for Safety to teach children and parents about the dangers of unsupervised play with BB guns and pellet guns, as well as the importance of storing all firearms unloaded and in a locked safe.

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

The number of children and teens who die from gun violence in the United States on a given day could fill a typical high school classroom, according to the American Academy of Pediatrics.

Preventing firearm-related injuries and deaths in children and youth “demands a public safety approach like regulation of motor vehicles,” the group said.

The organization on Oct. 8 released an updated policy statement and technical report about gun violence and children at its 2022 annual meeting in Anaheim, Calif. The reports were published in the journal Pediatrics, and the authors plan to discuss them during the conference.

“Each day, 28 U.S. children and teens – the equivalent of a high school classroom – die from gun violence, making it the No. 1 killer of youth through age 24,” the AAP said in a statement about the reports. “The national death rate is significantly higher than all other high-income countries combined, largely due to an alarming increase in suicides and homicides that do not make national headlines.”

Firearms have become the leading cause of death among children in the United States. 

In 2020, guns caused 10,197 deaths of Americans younger than 24, according to the Society for Adolescent Health and Medicine.

In 2015, more than 7,200 American youth were killed by firearms. That same year in 28 other high-income countries – which combined would have had a population twice that of the United States – just 685 youth were killed by firearms, according to the AAP.

Separately at the AAP conference, physicians are presenting new research about gun violence and children. And on Oct. 10, a pediatrician who was at Uvalde Memorial Hospital in Texas after the deadly school shooting in May is scheduled to address attendees. The doctor, Roy Guerrero, MD, testified on Capitol Hill to advocate for gun control after the shooting at Robb Elementary School, which killed 19 children and two adults.

“This is not a simple problem, and it cannot be fixed with a simple solution,” Lois K. Lee, MD, MPH, said in the AAP news release. Dr. Lee chairs the AAP Council on Injury, Violence, and Poison Prevention that wrote the new reports. “Pediatricians as a start can offer families guidance and education on more safely storing guns. AAP also calls for supporting legislation that, much like the common-sense requirements for obtaining a driver’s license, would improve gun ownership safety.”
 

Many deaths occur at home

The rate of homicide from firearms in U.S. youth, especially those aged 15-24 years, increased by 14% during the past decade, and the rate of suicide from firearms increased by 39%, according to the AAP.  

Homicides account for 58% of youth firearm deaths, whereas suicides account for 37%. Another 2% of youth firearm deaths are unintentional, and 1% result from law enforcement actions, the group said.

Among children 12 years old and younger, about 85% of firearm deaths occur at home. Teen firearm deaths are about as likely to occur at home (39%) as on the street or sidewalk (38%), according to research based on 2014 data.

“School shootings represent a relatively new phenomenon over the last half-century, and the United States has the highest rate of school shootings in the world,” the AAP technical report noted. Between 1966 and 2008, according to the group, 44 such shootings occurred in the United States, or an average of about one per year. Fast forward a few years and the violence became dramatically worse: Between 2013 and 2015, officials counted 154 school shootings – or about one per week.

Still, school shootings are responsible for less than 1% of all firearm deaths among children 17 years or younger in the United States. While school shootings “receive a tremendous amount of attention,” the report stated, other child firearm deaths may be less likely to make national headlines.

“Many firearm tragedies escape public attention because they occur in a home, sometimes in a child’s own home or at a friend’s house, or their neighbor’s or grandparent’s residence,” Eric W. Fleegler, MD, MPH, Boston Children’s Hospital, a co-author of the new reports, said in a statement from AAP. “Research tells us that families tend to underestimate how children will behave when they encounter a gun and miscalculate the risks. Suicide risks are also a huge concern, especially in families where teens are struggling with their mental health.”

AAP-recommended actions include:

• Mental health screenings and safe gun storage education provided by clinicians as part of routine patient visits
• Increased funding for violence intervention programs in hospital and community settings
• Regulation of firearms like other consumer products, with national requirements that address training, licensing, insurance coverage, registration of individuals purchasing firearms, and safe storage
• The use of technology that allows only authorized users to pull the trigger
• Universal background checks that use federal databases and information from local police before all gun purchases
• Extreme risk protection order laws, or “red flag laws,” that prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm
• More funding for firearm injury and prevention research.

A noticeable increase in the ED

Irma Ugalde, MD, associate professor and director of pediatric emergency medicine research at McGovern Medical School at UTHealth Houston, noticed that firearm-related injuries in children at her hospital were more common during the COVID-19 pandemic, even as pediatric emergency department visits decreased overall.

She and her colleagues studied the trends and reported their findings at the AAP meeting.

“We saw a drop in pediatric admissions overall,” Dr. Ugalde said in a statement about the study. “But what was really noticeable was that trauma was still very prevalent – in fact probably more so – and we were seeing more firearm injuries.”

The researchers found that firearm injuries in children rose from 88 cases in 2019 to 118 in 2020. The number of incidents remained elevated in 2021, with 115 cases.

In addition, the researchers found an initial increase in injuries occurring at home where the shooter was a known family member or friend, and in cases involving firearms that were not properly stored.

By comparison, pediatric ED visits overall decreased by 34.2% from 2019 to 2020, and by 11.8% from 2019 to 2021.

The increase in firearm injuries coincided with an increase in gun sales in the United States, the researchers noted.

“National and statewide initiatives to mitigate the risk of firearm-related injury and death are necessary,” Dr. Ugalde’s group said. “We recommend that health care workers remain vigilant about screening for potential risk factors and safe storage of firearms.”
 

Accidental injuries

Daniel D. Guzman, MD, with Cook Children’s Health Care Center, Fort Worth, Tex., conducted a study focused on unintentional firearm injuries in children. Dr. Guzman’s group analyzed data from 204 patients younger than age 19 seen at Cook Children’s from January 2015 to June 2021.

Dr. Guzman and his colleagues examined outcomes for injuries caused by powder guns – shotguns, rifles, and handguns – and air-power guns that shoot BBs and pellets.

The researchers found that 29% of the unintentional firearm injuries occurred with powder guns and 71% with air-power weapons, often BB guns.

“It is important that all firearms, powdered and air-powered, be stored safely in a lock box or safe,” Dr. Guzman said in a statement. To that end, Cook Children’s has developed a program called Aim for Safety to teach children and parents about the dangers of unsupervised play with BB guns and pellet guns, as well as the importance of storing all firearms unloaded and in a locked safe.

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

The number of children and teens who die from gun violence in the United States on a given day could fill a typical high school classroom, according to the American Academy of Pediatrics.

Preventing firearm-related injuries and deaths in children and youth “demands a public safety approach like regulation of motor vehicles,” the group said.

The organization on Oct. 8 released an updated policy statement and technical report about gun violence and children at its 2022 annual meeting in Anaheim, Calif. The reports were published in the journal Pediatrics, and the authors plan to discuss them during the conference.

“Each day, 28 U.S. children and teens – the equivalent of a high school classroom – die from gun violence, making it the No. 1 killer of youth through age 24,” the AAP said in a statement about the reports. “The national death rate is significantly higher than all other high-income countries combined, largely due to an alarming increase in suicides and homicides that do not make national headlines.”

Firearms have become the leading cause of death among children in the United States. 

In 2020, guns caused 10,197 deaths of Americans younger than 24, according to the Society for Adolescent Health and Medicine.

In 2015, more than 7,200 American youth were killed by firearms. That same year in 28 other high-income countries – which combined would have had a population twice that of the United States – just 685 youth were killed by firearms, according to the AAP.

Separately at the AAP conference, physicians are presenting new research about gun violence and children. And on Oct. 10, a pediatrician who was at Uvalde Memorial Hospital in Texas after the deadly school shooting in May is scheduled to address attendees. The doctor, Roy Guerrero, MD, testified on Capitol Hill to advocate for gun control after the shooting at Robb Elementary School, which killed 19 children and two adults.

“This is not a simple problem, and it cannot be fixed with a simple solution,” Lois K. Lee, MD, MPH, said in the AAP news release. Dr. Lee chairs the AAP Council on Injury, Violence, and Poison Prevention that wrote the new reports. “Pediatricians as a start can offer families guidance and education on more safely storing guns. AAP also calls for supporting legislation that, much like the common-sense requirements for obtaining a driver’s license, would improve gun ownership safety.”
 

Many deaths occur at home

The rate of homicide from firearms in U.S. youth, especially those aged 15-24 years, increased by 14% during the past decade, and the rate of suicide from firearms increased by 39%, according to the AAP.  

Homicides account for 58% of youth firearm deaths, whereas suicides account for 37%. Another 2% of youth firearm deaths are unintentional, and 1% result from law enforcement actions, the group said.

Among children 12 years old and younger, about 85% of firearm deaths occur at home. Teen firearm deaths are about as likely to occur at home (39%) as on the street or sidewalk (38%), according to research based on 2014 data.

“School shootings represent a relatively new phenomenon over the last half-century, and the United States has the highest rate of school shootings in the world,” the AAP technical report noted. Between 1966 and 2008, according to the group, 44 such shootings occurred in the United States, or an average of about one per year. Fast forward a few years and the violence became dramatically worse: Between 2013 and 2015, officials counted 154 school shootings – or about one per week.

Still, school shootings are responsible for less than 1% of all firearm deaths among children 17 years or younger in the United States. While school shootings “receive a tremendous amount of attention,” the report stated, other child firearm deaths may be less likely to make national headlines.

“Many firearm tragedies escape public attention because they occur in a home, sometimes in a child’s own home or at a friend’s house, or their neighbor’s or grandparent’s residence,” Eric W. Fleegler, MD, MPH, Boston Children’s Hospital, a co-author of the new reports, said in a statement from AAP. “Research tells us that families tend to underestimate how children will behave when they encounter a gun and miscalculate the risks. Suicide risks are also a huge concern, especially in families where teens are struggling with their mental health.”

AAP-recommended actions include:

• Mental health screenings and safe gun storage education provided by clinicians as part of routine patient visits
• Increased funding for violence intervention programs in hospital and community settings
• Regulation of firearms like other consumer products, with national requirements that address training, licensing, insurance coverage, registration of individuals purchasing firearms, and safe storage
• The use of technology that allows only authorized users to pull the trigger
• Universal background checks that use federal databases and information from local police before all gun purchases
• Extreme risk protection order laws, or “red flag laws,” that prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm
• More funding for firearm injury and prevention research.

A noticeable increase in the ED

Irma Ugalde, MD, associate professor and director of pediatric emergency medicine research at McGovern Medical School at UTHealth Houston, noticed that firearm-related injuries in children at her hospital were more common during the COVID-19 pandemic, even as pediatric emergency department visits decreased overall.

She and her colleagues studied the trends and reported their findings at the AAP meeting.

“We saw a drop in pediatric admissions overall,” Dr. Ugalde said in a statement about the study. “But what was really noticeable was that trauma was still very prevalent – in fact probably more so – and we were seeing more firearm injuries.”

The researchers found that firearm injuries in children rose from 88 cases in 2019 to 118 in 2020. The number of incidents remained elevated in 2021, with 115 cases.

In addition, the researchers found an initial increase in injuries occurring at home where the shooter was a known family member or friend, and in cases involving firearms that were not properly stored.

By comparison, pediatric ED visits overall decreased by 34.2% from 2019 to 2020, and by 11.8% from 2019 to 2021.

The increase in firearm injuries coincided with an increase in gun sales in the United States, the researchers noted.

“National and statewide initiatives to mitigate the risk of firearm-related injury and death are necessary,” Dr. Ugalde’s group said. “We recommend that health care workers remain vigilant about screening for potential risk factors and safe storage of firearms.”
 

Accidental injuries

Daniel D. Guzman, MD, with Cook Children’s Health Care Center, Fort Worth, Tex., conducted a study focused on unintentional firearm injuries in children. Dr. Guzman’s group analyzed data from 204 patients younger than age 19 seen at Cook Children’s from January 2015 to June 2021.

Dr. Guzman and his colleagues examined outcomes for injuries caused by powder guns – shotguns, rifles, and handguns – and air-power guns that shoot BBs and pellets.

The researchers found that 29% of the unintentional firearm injuries occurred with powder guns and 71% with air-power weapons, often BB guns.

“It is important that all firearms, powdered and air-powered, be stored safely in a lock box or safe,” Dr. Guzman said in a statement. To that end, Cook Children’s has developed a program called Aim for Safety to teach children and parents about the dangers of unsupervised play with BB guns and pellet guns, as well as the importance of storing all firearms unloaded and in a locked safe.

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

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

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

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

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

For some parents, resuming sexual intimacy after having a baby is a top priority. For others, not so much – and late-night feedings and diaper changes may not be the only hang-ups.

Dyspareunia – pain during sex – occurs in a substantial number of women after childbirth, and recent research sheds light on how psychological and biomedical factors relate to this condition.

Mode of delivery, for instance, may have less of an effect on sexual well-being than some people suspect.

Despite a perception that cesarean delivery might affect sexual function less than vaginal delivery does, how mothers delivered did not affect how often they had sex postpartum or the amount of enjoyment they got from it, according to research published in BJOG.

Eleven years after delivery, however, cesarean delivery was associated with a 74% increased likelihood of pain in the vagina during sex, compared with vaginal delivery, the researchers found (odds ratio, 1.74; 95% confidence interval, 1.46-2.08).

The results suggest that cesarean delivery “may not help protect against sexual dysfunction, as previously thought,” Flo Martin, a PhD student in epidemiology at the University of Bristol, United Kingdom, and lead author of the study, said in a news release.

For their study, Ms. Martin and her colleagues analyzed data from more than 10,300 participants in the Avon Longitudinal Study of Parents and Children, which recruited women in the United Kingdom who were pregnant in 1991 and 1992.

The researchers had data about pain during sex at 11 years. They had data about sexual enjoyment and frequency at 33  months, 5 years, 12 years, and 18 years after delivery.

If women experienced pain during sex years after cesarean delivery, uterine scarring might have been a cause, Ms. Martin and colleagues suggested. Alternatively, women with dyspareunia before delivery may be more likely to have cesarean surgery, which also could explain the association.

Other studies have likewise found that different modes of delivery generally lead to similar outcomes of sexual well-being after birth.

“Several of my own longitudinal studies have shown limited associations between mode of delivery and various aspects of sexual well-being, including sexual satisfaction, sexual function, and sexual desire,” said Natalie O. Rosen, PhD, director of the Couples and Sexual Health Laboratory at Dalhousie University, Halifax, N.S.

Nevertheless, other published studies have yielded conflicting results, so the question warrants further study, she said.
 

Pain catastrophizing

One study by Dr. Rosen’s group, published in Obstetrics & Gynecology, tracked sexual pain in 582 people from mid-pregnancy to 2 years postpartum.

About 21% of participants experienced moderate pain during sex, as determined by an average pain score greater than 4 on scale of 0-10 points. The rest were classified as having “minimal dyspareunia.”

Pain tended to peak at 3 months postpartum and then steadily decrease in both the moderate and minimal pain groups.

Mode of delivery did not affect the odds that a participant would have moderate dyspareunia. Neither did breastfeeding or prior chronic pain.

“But we did find one key thing to look out for: Those who reported a lot of negative thoughts and feelings about pain, something called pain catastrophizing, were more likely to experience moderate persistent pain during sex,” the researchers said in a video about their findings.

Pain catastrophizing 3 months after delivery was associated with significantly increased odds of following a moderate pain trajectory (odds ratio, 1.09; 95% confidence interval, 1.04-1.15).
 

Let’s talk about #postbabyhankypanky

Caring for a newborn while maintaining a romantic relationship can be challenging, and “there is a lack of evidence-based research aimed at helping couples prevent and navigate changes to their sexual well-being postpartum,” Dr. Rosen said.

During the 2-year study, a growing number of participants reported having sex less often over time. The percentage of women who had engaged in sexual activity in the past 4 weeks was 99% at baseline (20-24 weeks of gestation), 83.5% at 32 weeks of gestation, 73.9% at 3 months postpartum, and 69.6% at 2 years postpartum.

“One crucial way that couples sustain their connection is through their sexuality,” Dr. Rosen said. “Unfortunately, most new parents experience significant disruptions to their sexual function,” such as lower sexual desire or more pain during intercourse.

Dr. Rosen’s group has created a series of videos related to this topic dubbed #postbabyhankypanky to facilitate communication about sex postpartum. She encourages women with dyspareunia to talk with a health care provider because treatments such as cognitive-behavioral therapy, pelvic floor physical therapy, and topical medications can help manage pain.
 

‘Reassuring’ data

Veronica Gillispie-Bell, MD, MAS, director of quality for women’s services at the Ochsner Health System, New Orleans, said that she sees patients with postpartum sexual pain frequently.

Patients typically are instructed to have pelvic rest from delivery until 6 weeks after.

At the 6-week appointment, she tells patients to make sure that they are using lots of lubrication, because vaginal dryness related to hormonal changes during pregnancy and breastfeeding can make sex more painful, regardless of mode of delivery.

For many patients, she also recommends pelvic floor physical therapy.

As the medical director for the Louisiana Perinatal Quality Collaborative – a network of care providers, public health officials, and advocates that aims to improve outcomes for birthing persons, families, and newborns – Dr. Gillispie-Bell also is focused on reducing the rate of cesarean deliveries in the state. The BJOG study showing an increased risk for dyspareunia after a cesarean surgery serves as a reminder that there may be “long-term effects of having a C-section that may not be as obvious,” she said.

“C-sections are life-saving procedures, but they are not without risk,” Dr. Gillispie-Bell said.

Leila Frodsham, MBChB, a spokesperson for the Royal College of Obstetricians and Gynaecologists, told Medscape UK that it was “reassuring” to see “no difference in sexual enjoyment or sexual frequency at any time point postpartum between women who gave birth via cesarean section and those who delivered vaginally.”

“Women should be supported to make informed decisions about how they plan to give birth, and it is vital that health care professionals respect their preferences,” Dr. Frodsham added.

Clinicians should also remain aware that sexual pain is also common during periods of subfertility, perimenopause, and initiation of sexual activity.

Combinations of biological, psychological, and social factors can influence pain during sex, and there is an interpersonal element to keep in mind as well, Dr. Rosen noted.

“Pain during sex is typically elicited in the context of a partnered relationship,” Dr. Rosen said. “This means that this is an inherently interpersonal issue – let’s not forget about the partner who is both impacted by and can impact the pain through their own responses.”

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

New research shows that “polypills” can prevent a combination of cardiovascular events and cardiovascular deaths among patients who have recently experienced a myocardial infarction.

But results from the SECURE trial, published in the New England Journal of Medicine, also raise questions.

How do the polypills reduce cardiovascular problems? And will they ever be available in the United States?

Questions about how they work center on a mystery in the trial data: the polypill – containing aspirin, an angiotensin-converting enzyme (ACE) inhibitor, and a statin – apparently conferred substantial cardiovascular protection while producing average blood pressure and lipid levels that were virtually the same as with usual care.

As to when polypills will be available, the answer may hinge on whether companies, government agencies, or philanthropic foundations come to see making and paying for such treatments – combinations of typically inexpensive generic drugs in a single pill for the sake of convenience and greater adherence – as financially worthwhile.
 

A matter of adherence?

In the SECURE trial, presented late August at the annual congress of the European Society of Cardiology, Barcelona, investigators randomly assigned 2,499 patients with an MI in the previous 6 months to receive usual care or a polypill.

Patients in the usual-care group typically received the same types of treatments included the polypill, only taken separately. Different versions of the polypill were available to allow for titration to tolerated doses of the component medications: aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 mg or 40 mg).

Researchers used the Morisky Medication Adherence Scale to gauge participants’ adherence to their medication regimen and found the polypill group was more adherent. Patients who received the polypill were more likely to have a high level of adherence at 6 months (70.6% vs. 62.7%) and 24 months (74.1% vs. 63.2%), they reported. (The Morisky tool is the subject of some controversy because of aggressive licensing tactics of its creator.)

The primary endpoint of cardiovascular death, MI, stroke, or urgent revascularization was significantly less likely in the polypill group during a median of 3 years of follow-up (hazard ratio, 0.76; P = .02).

“A primary-outcome event occurred in 118 of 1,237 patients (9.5%) in the polypill group and in 156 of 1,229 (12.7%) in the usual-care group,” the researchers report.

“Probably, adherence is the most important reason of how this works,” Valentin Fuster, MD, physician-in-chief at Mount Sinai Hospital, New York, who led the study, said at ESC 2022.

Still, some clinicians were left scratching their heads by the lack of difference between treatment groups in average blood pressure and levels of low-density lipoprotein (LDL) cholesterol.

In the group that received the polypill, average systolic and diastolic blood pressure at 24 months were 135.2 mmHg and 74.8 mmHg, respectively. In the group that received usual care, those values were 135.5 mmHg and 74.9 mmHg, respectively.

Likewise, “no substantial differences were found in LDL-cholesterol levels over time between the groups, with a mean value at 24 months of 67.7 mg/dL in the polypill group and 67.2 mg/dL in the usual-care group,” according to the researchers.

One explanation for the findings is that greater adherence led to beneficial effects that were not reflected in lipid and blood pressure measurements, the investigators said. Alternatively, the open-label trial design could have led to different health behaviors between groups, they suggested.

Martha Gulati, MD, director of preventive cardiology at Cedars-Sinai Medical Center, Los Angeles, said she loves the idea of polypills. But she wonders about the lack of difference in blood pressure and lipids in SECURE.

Dr. Gulati said she sees in practice how medication adherence and measurements of blood pressure and lipids typically go hand in hand.

When a patient initially responds to a medication, but then their LDL cholesterol goes up later, “my first question is, ‘Are you still taking your medication or how frequently are you taking it?’” Dr. Gulati said in an interview. “And I get all kinds of answers.”

“If you are more adherent, why wouldn’t your LDL actually be lower, and why wouldn’t your blood pressure be lower?” she asked.
 

Can the results be replicated?

Ethan J. Weiss, MD, a cardiologist and volunteer associate clinical professor of medicine at the University of California, San Francisco, said the SECURE results are “spectacular,” but the seeming disconnect with the biomarker measurements “doesn’t make for a clean story.”

“It just seems like if you are making an argument that this is a way to improve compliance ... you would see some evidence of improved compliance objectively” in the biomarker readings, Dr. Weiss said.

Trying to understand how the polypill worked requires more imagination. “Or it makes you just say, ‘Who cares what the mechanism is?’ These people did a lot better, full stop, and that’s all that matters,” he said.

Dr. Weiss said he expects some degree of replication of the results may be needed before practice changes.

To Steven E. Nissen, MD, chief academic officer of the Heart and Vascular Institute at Cleveland Clinic, the results “don’t make any sense.”

“If they got the same results on the biomarkers that the pill was designed to intervene upon, why are the [primary outcome] results different? It’s completely unexplained,” Dr. Nissen said.

In general, Dr. Nissen has not been an advocate of the polypill approach in higher-income countries.

“Medicine is all about customization of therapy,” he said. “Not everybody needs blood pressure lowering. Not everybody needs the same intensity of LDL reduction. We spend much of our lives seeing patients and treating their blood pressure, and if it doesn’t come down adequately, giving them a higher dose or adding another agent.”

Polypills might be reasonable for primary prevention in countries where people have less access to health care resources, he added. In such settings, a low-cost, simple treatment strategy might have benefit.

But Dr. Nissen still doesn’t see a role for a polypill in secondary prevention.

“I think we have to take a step back, take a deep breath, and look very carefully at the science and try to understand whether this, in fact, is sensible,” he said. “We may need another study to see if this can be replicated.”

For Dhruv S. Kazi, MD, the results of the SECURE trial offer an opportunity to rekindle conversations about the use of polypills for cardiovascular protection. These conversations and studies have been taking place for nearly two decades.

Dr. Kazi, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center, Boston, has used models to study the expected cost-effectiveness of polypills in various countries.

Although polypills can improve patients’ adherence to their prescribed medications, Dr. Kazi and colleagues have found that treatment gaps are “often at the physician level,” with many patients not prescribed all of the medications from which they could benefit.

Availability of polypills could help address those gaps. At the same time, many patients, even those with higher incomes, may have a strong preference for taking a single pill.

Dr. Kazi’s research also shows that a polypill approach may be more economically attractive as countries develop because successful treatment averts cardiovascular events that are costlier to treat.

“In the United States, in order for this to work, we would need a polypill that is both available widely but also affordable,” Dr. Kazi said. “It is going to require a visionary mover” to make that happen.

That could include philanthropic foundations. But it could also be a business opportunity for a company like Barcelona-based Ferrer, which provided the polypills for the SECURE trial.

The clinical and economic evidence in support of polypills has been compelling, Dr. Kazi said: “We have to get on with the business of implementing something that is effective and has the potential to greatly improve population health at scale.” 

The SECURE trial was funded by the European Union Horizon 2020 program and coordinated by the Spanish National Center for Cardiovascular Research (CNIC). Ferrer International provided the polypill that was used in the trial. CNIC receives royalties for sales of the polypill from Ferrer. Dr. Weiss is starting a biotech company unrelated to this area of research.

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

New research shows that “polypills” can prevent a combination of cardiovascular events and cardiovascular deaths among patients who have recently experienced a myocardial infarction.

But results from the SECURE trial, published in the New England Journal of Medicine, also raise questions.

How do the polypills reduce cardiovascular problems? And will they ever be available in the United States?

Questions about how they work center on a mystery in the trial data: the polypill – containing aspirin, an angiotensin-converting enzyme (ACE) inhibitor, and a statin – apparently conferred substantial cardiovascular protection while producing average blood pressure and lipid levels that were virtually the same as with usual care.

As to when polypills will be available, the answer may hinge on whether companies, government agencies, or philanthropic foundations come to see making and paying for such treatments – combinations of typically inexpensive generic drugs in a single pill for the sake of convenience and greater adherence – as financially worthwhile.
 

A matter of adherence?

In the SECURE trial, presented late August at the annual congress of the European Society of Cardiology, Barcelona, investigators randomly assigned 2,499 patients with an MI in the previous 6 months to receive usual care or a polypill.

Patients in the usual-care group typically received the same types of treatments included the polypill, only taken separately. Different versions of the polypill were available to allow for titration to tolerated doses of the component medications: aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 mg or 40 mg).

Researchers used the Morisky Medication Adherence Scale to gauge participants’ adherence to their medication regimen and found the polypill group was more adherent. Patients who received the polypill were more likely to have a high level of adherence at 6 months (70.6% vs. 62.7%) and 24 months (74.1% vs. 63.2%), they reported. (The Morisky tool is the subject of some controversy because of aggressive licensing tactics of its creator.)

The primary endpoint of cardiovascular death, MI, stroke, or urgent revascularization was significantly less likely in the polypill group during a median of 3 years of follow-up (hazard ratio, 0.76; P = .02).

“A primary-outcome event occurred in 118 of 1,237 patients (9.5%) in the polypill group and in 156 of 1,229 (12.7%) in the usual-care group,” the researchers report.

“Probably, adherence is the most important reason of how this works,” Valentin Fuster, MD, physician-in-chief at Mount Sinai Hospital, New York, who led the study, said at ESC 2022.

Still, some clinicians were left scratching their heads by the lack of difference between treatment groups in average blood pressure and levels of low-density lipoprotein (LDL) cholesterol.

In the group that received the polypill, average systolic and diastolic blood pressure at 24 months were 135.2 mmHg and 74.8 mmHg, respectively. In the group that received usual care, those values were 135.5 mmHg and 74.9 mmHg, respectively.

Likewise, “no substantial differences were found in LDL-cholesterol levels over time between the groups, with a mean value at 24 months of 67.7 mg/dL in the polypill group and 67.2 mg/dL in the usual-care group,” according to the researchers.

One explanation for the findings is that greater adherence led to beneficial effects that were not reflected in lipid and blood pressure measurements, the investigators said. Alternatively, the open-label trial design could have led to different health behaviors between groups, they suggested.

Martha Gulati, MD, director of preventive cardiology at Cedars-Sinai Medical Center, Los Angeles, said she loves the idea of polypills. But she wonders about the lack of difference in blood pressure and lipids in SECURE.

Dr. Gulati said she sees in practice how medication adherence and measurements of blood pressure and lipids typically go hand in hand.

When a patient initially responds to a medication, but then their LDL cholesterol goes up later, “my first question is, ‘Are you still taking your medication or how frequently are you taking it?’” Dr. Gulati said in an interview. “And I get all kinds of answers.”

“If you are more adherent, why wouldn’t your LDL actually be lower, and why wouldn’t your blood pressure be lower?” she asked.
 

Can the results be replicated?

Ethan J. Weiss, MD, a cardiologist and volunteer associate clinical professor of medicine at the University of California, San Francisco, said the SECURE results are “spectacular,” but the seeming disconnect with the biomarker measurements “doesn’t make for a clean story.”

“It just seems like if you are making an argument that this is a way to improve compliance ... you would see some evidence of improved compliance objectively” in the biomarker readings, Dr. Weiss said.

Trying to understand how the polypill worked requires more imagination. “Or it makes you just say, ‘Who cares what the mechanism is?’ These people did a lot better, full stop, and that’s all that matters,” he said.

Dr. Weiss said he expects some degree of replication of the results may be needed before practice changes.

To Steven E. Nissen, MD, chief academic officer of the Heart and Vascular Institute at Cleveland Clinic, the results “don’t make any sense.”

“If they got the same results on the biomarkers that the pill was designed to intervene upon, why are the [primary outcome] results different? It’s completely unexplained,” Dr. Nissen said.

In general, Dr. Nissen has not been an advocate of the polypill approach in higher-income countries.

“Medicine is all about customization of therapy,” he said. “Not everybody needs blood pressure lowering. Not everybody needs the same intensity of LDL reduction. We spend much of our lives seeing patients and treating their blood pressure, and if it doesn’t come down adequately, giving them a higher dose or adding another agent.”

Polypills might be reasonable for primary prevention in countries where people have less access to health care resources, he added. In such settings, a low-cost, simple treatment strategy might have benefit.

But Dr. Nissen still doesn’t see a role for a polypill in secondary prevention.

“I think we have to take a step back, take a deep breath, and look very carefully at the science and try to understand whether this, in fact, is sensible,” he said. “We may need another study to see if this can be replicated.”

For Dhruv S. Kazi, MD, the results of the SECURE trial offer an opportunity to rekindle conversations about the use of polypills for cardiovascular protection. These conversations and studies have been taking place for nearly two decades.

Dr. Kazi, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center, Boston, has used models to study the expected cost-effectiveness of polypills in various countries.

Although polypills can improve patients’ adherence to their prescribed medications, Dr. Kazi and colleagues have found that treatment gaps are “often at the physician level,” with many patients not prescribed all of the medications from which they could benefit.

Availability of polypills could help address those gaps. At the same time, many patients, even those with higher incomes, may have a strong preference for taking a single pill.

Dr. Kazi’s research also shows that a polypill approach may be more economically attractive as countries develop because successful treatment averts cardiovascular events that are costlier to treat.

“In the United States, in order for this to work, we would need a polypill that is both available widely but also affordable,” Dr. Kazi said. “It is going to require a visionary mover” to make that happen.

That could include philanthropic foundations. But it could also be a business opportunity for a company like Barcelona-based Ferrer, which provided the polypills for the SECURE trial.

The clinical and economic evidence in support of polypills has been compelling, Dr. Kazi said: “We have to get on with the business of implementing something that is effective and has the potential to greatly improve population health at scale.” 

The SECURE trial was funded by the European Union Horizon 2020 program and coordinated by the Spanish National Center for Cardiovascular Research (CNIC). Ferrer International provided the polypill that was used in the trial. CNIC receives royalties for sales of the polypill from Ferrer. Dr. Weiss is starting a biotech company unrelated to this area of research.

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

New research shows that “polypills” can prevent a combination of cardiovascular events and cardiovascular deaths among patients who have recently experienced a myocardial infarction.

But results from the SECURE trial, published in the New England Journal of Medicine, also raise questions.

How do the polypills reduce cardiovascular problems? And will they ever be available in the United States?

Questions about how they work center on a mystery in the trial data: the polypill – containing aspirin, an angiotensin-converting enzyme (ACE) inhibitor, and a statin – apparently conferred substantial cardiovascular protection while producing average blood pressure and lipid levels that were virtually the same as with usual care.

As to when polypills will be available, the answer may hinge on whether companies, government agencies, or philanthropic foundations come to see making and paying for such treatments – combinations of typically inexpensive generic drugs in a single pill for the sake of convenience and greater adherence – as financially worthwhile.
 

A matter of adherence?

In the SECURE trial, presented late August at the annual congress of the European Society of Cardiology, Barcelona, investigators randomly assigned 2,499 patients with an MI in the previous 6 months to receive usual care or a polypill.

Patients in the usual-care group typically received the same types of treatments included the polypill, only taken separately. Different versions of the polypill were available to allow for titration to tolerated doses of the component medications: aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 mg or 40 mg).

Researchers used the Morisky Medication Adherence Scale to gauge participants’ adherence to their medication regimen and found the polypill group was more adherent. Patients who received the polypill were more likely to have a high level of adherence at 6 months (70.6% vs. 62.7%) and 24 months (74.1% vs. 63.2%), they reported. (The Morisky tool is the subject of some controversy because of aggressive licensing tactics of its creator.)

The primary endpoint of cardiovascular death, MI, stroke, or urgent revascularization was significantly less likely in the polypill group during a median of 3 years of follow-up (hazard ratio, 0.76; P = .02).

“A primary-outcome event occurred in 118 of 1,237 patients (9.5%) in the polypill group and in 156 of 1,229 (12.7%) in the usual-care group,” the researchers report.

“Probably, adherence is the most important reason of how this works,” Valentin Fuster, MD, physician-in-chief at Mount Sinai Hospital, New York, who led the study, said at ESC 2022.

Still, some clinicians were left scratching their heads by the lack of difference between treatment groups in average blood pressure and levels of low-density lipoprotein (LDL) cholesterol.

In the group that received the polypill, average systolic and diastolic blood pressure at 24 months were 135.2 mmHg and 74.8 mmHg, respectively. In the group that received usual care, those values were 135.5 mmHg and 74.9 mmHg, respectively.

Likewise, “no substantial differences were found in LDL-cholesterol levels over time between the groups, with a mean value at 24 months of 67.7 mg/dL in the polypill group and 67.2 mg/dL in the usual-care group,” according to the researchers.

One explanation for the findings is that greater adherence led to beneficial effects that were not reflected in lipid and blood pressure measurements, the investigators said. Alternatively, the open-label trial design could have led to different health behaviors between groups, they suggested.

Martha Gulati, MD, director of preventive cardiology at Cedars-Sinai Medical Center, Los Angeles, said she loves the idea of polypills. But she wonders about the lack of difference in blood pressure and lipids in SECURE.

Dr. Gulati said she sees in practice how medication adherence and measurements of blood pressure and lipids typically go hand in hand.

When a patient initially responds to a medication, but then their LDL cholesterol goes up later, “my first question is, ‘Are you still taking your medication or how frequently are you taking it?’” Dr. Gulati said in an interview. “And I get all kinds of answers.”

“If you are more adherent, why wouldn’t your LDL actually be lower, and why wouldn’t your blood pressure be lower?” she asked.
 

Can the results be replicated?

Ethan J. Weiss, MD, a cardiologist and volunteer associate clinical professor of medicine at the University of California, San Francisco, said the SECURE results are “spectacular,” but the seeming disconnect with the biomarker measurements “doesn’t make for a clean story.”

“It just seems like if you are making an argument that this is a way to improve compliance ... you would see some evidence of improved compliance objectively” in the biomarker readings, Dr. Weiss said.

Trying to understand how the polypill worked requires more imagination. “Or it makes you just say, ‘Who cares what the mechanism is?’ These people did a lot better, full stop, and that’s all that matters,” he said.

Dr. Weiss said he expects some degree of replication of the results may be needed before practice changes.

To Steven E. Nissen, MD, chief academic officer of the Heart and Vascular Institute at Cleveland Clinic, the results “don’t make any sense.”

“If they got the same results on the biomarkers that the pill was designed to intervene upon, why are the [primary outcome] results different? It’s completely unexplained,” Dr. Nissen said.

In general, Dr. Nissen has not been an advocate of the polypill approach in higher-income countries.

“Medicine is all about customization of therapy,” he said. “Not everybody needs blood pressure lowering. Not everybody needs the same intensity of LDL reduction. We spend much of our lives seeing patients and treating their blood pressure, and if it doesn’t come down adequately, giving them a higher dose or adding another agent.”

Polypills might be reasonable for primary prevention in countries where people have less access to health care resources, he added. In such settings, a low-cost, simple treatment strategy might have benefit.

But Dr. Nissen still doesn’t see a role for a polypill in secondary prevention.

“I think we have to take a step back, take a deep breath, and look very carefully at the science and try to understand whether this, in fact, is sensible,” he said. “We may need another study to see if this can be replicated.”

For Dhruv S. Kazi, MD, the results of the SECURE trial offer an opportunity to rekindle conversations about the use of polypills for cardiovascular protection. These conversations and studies have been taking place for nearly two decades.

Dr. Kazi, associate director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center, Boston, has used models to study the expected cost-effectiveness of polypills in various countries.

Although polypills can improve patients’ adherence to their prescribed medications, Dr. Kazi and colleagues have found that treatment gaps are “often at the physician level,” with many patients not prescribed all of the medications from which they could benefit.

Availability of polypills could help address those gaps. At the same time, many patients, even those with higher incomes, may have a strong preference for taking a single pill.

Dr. Kazi’s research also shows that a polypill approach may be more economically attractive as countries develop because successful treatment averts cardiovascular events that are costlier to treat.

“In the United States, in order for this to work, we would need a polypill that is both available widely but also affordable,” Dr. Kazi said. “It is going to require a visionary mover” to make that happen.

That could include philanthropic foundations. But it could also be a business opportunity for a company like Barcelona-based Ferrer, which provided the polypills for the SECURE trial.

The clinical and economic evidence in support of polypills has been compelling, Dr. Kazi said: “We have to get on with the business of implementing something that is effective and has the potential to greatly improve population health at scale.” 

The SECURE trial was funded by the European Union Horizon 2020 program and coordinated by the Spanish National Center for Cardiovascular Research (CNIC). Ferrer International provided the polypill that was used in the trial. CNIC receives royalties for sales of the polypill from Ferrer. Dr. Weiss is starting a biotech company unrelated to this area of research.

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

Children who do not get enough sleep for one night can be cranky, groggy, or meltdown prone the next day.

Over time, though, insufficient sleep may impair neurodevelopment in ways that can be measured on brain scans and tests long term, a new study shows.

Research published in The Lancet Child & Adolescent Health found that 9- and 10-year-olds who do not get at least 9 hours of sleep most nights tend to have less gray matter and smaller areas of the brain responsible for attention, memory, and inhibition control, relative to children who do get enough sleep.

The researchers also found a relationship between insufficient sleep and disrupted connections between the basal ganglia and cortical regions of the brain. These disruptions appeared to be linked to depression, thought problems, and impairments in crystallized intelligence, a type of intelligence that depends on memory.

The overall patterns persisted 2 years later, even as those who got enough sleep at baseline gradually slept less over time, while those who were not getting enough sleep to begin with continued to sleep about the same amount, the researchers reported.

The results bolster the case for delaying school start times, as California recently did, according one researcher who was not involved in the study.
 

The ABCD Study

To examine how insufficient sleep affects children’s mental health, cognition, brain function, and brain structure over 2 years, Ze Wang, PhD, professor of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, and colleagues analyzed data from the ongoing Adolescent Brain Cognitive Development (ABCD) Study. The ABCD Study is tracking the biologic and behavioral development of more than 11,000 children in the United States who were recruited for the study when they were 9 or 10 years old.

For their new analysis, Dr. Wang’s group focused on 6,042 participants: 3,021 children with insufficient sleep who were matched with an equal number of participants who were similar in many respects, including sex, socioeconomic status, and puberty status, except they got at least 9 hours of sleep. They also looked at outcomes 2 years later from 749 of the matched pairs who had results available.

The investigators determined sleep duration based on how parents answered the question: “How many hours of sleep does your child get on most nights in the past 6 months?” Possible answers included at least 9 hours, 8-9 hours, 7-8 hours, 5-7 hours, or less than 5 hours. They also looked at functional and structural MRI scans, test results, and responses to questionnaires.

Negative effects of inadequate sleep were spread over “several different domains including brain structure, function, cognition, behavior, and mental health,” Dr. Wang said.

The strength of the relationship between sleep duration and the various outcomes was “modest” and based on group averages, he said. So, a given child who does not sleep for 9 hours most nights won’t necessarily perform worse than a child who gets enough sleep.

Still, modest effects may accumulate and have lasting consequences, Dr. Wang said.
 

Crystallized intelligence

The researchers looked at 42 behavioral outcomes, 32 of which were significantly different between the groups. Four outcomes in particular – depression, thought problems, performance on a picture-vocabulary test, and crystallized intelligence – were areas where insufficient sleep seemed to have a larger negative effect.

Sleep duration’s relationship with crystallized intelligence was twice that for fluid intelligence, which does not depend on memory.

“Sleep affects memory,” Dr. Wang said. “Crystallized intelligence depends on learned skills and knowledge, which are memory. In this sense, sleep is related to crystallized intelligence.”

One limitation of the study is that some parents may not accurately report how much sleep their child gets, Dr. Wang acknowledged. Children may be awake when parents think they are asleep, for example.

And although the results show getting 9 hours of sleep may help neurocognitive development, it’s also possible that excessive amounts of sleep could be problematic, the study authors wrote.

Further experiments are needed to prove that insufficient sleep – and not some other, unaccounted for factor – causes the observed impairments in neurodevelopment.

To promote healthy sleep, parents should keep a strict routine for their children, such as a regular bedtime and no electronic devices in the bedroom, Dr. Wang suggested. More physical activity during the day also should help.

If children have high levels of stress and depression, “finding the source is critical,” he said. Likewise, clinicians should consider how mental health can affect their patients’ sleep.
 

More to healthy sleep than duration

“This study both aligns with and advances existing research on the importance of sufficient sleep for child well-being,” said Ariel A. Williamson, PhD, DBSM, a psychologist and pediatric sleep expert in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia and assistant professor of psychiatry and pediatrics at University of Pennsylvania, also in Philadelphia.

The researchers used rigorous propensity score matching, longitudinal data, and brain imaging, which are “innovative methods that provide more evidence on potential mechanisms linking insufficient sleep and child outcomes,” said Dr. Williamson, who was not involved in the study.

While the investigators focused on sleep duration, child sleep health is multidimensional and includes other elements like timing and perception of sleep quality, Dr. Williamson noted. “For example, some research shows that having a sleep schedule that varies night to night is linked to poor child outcomes.”

Dr. Williamson tells families and clinicians that “sleep is a pillar of health,” equal to diet and exercise. That said, sleep recommendations need to fit within a family’s life – taking into account after school activities and late-night homework sessions. But extending sleep by just “20-30 minutes can make a meaningful difference for daytime functioning,” Dr. Williamson said.
 

Start school later?

Researchers have only relatively recently begun to understand how insufficient sleep affects adolescent neurocognitive development long term, and this study provides “crucial evidence” about the consequences, Lydia Gabriela Speyer, PhD, said in an editorial published with the study. Dr. Speyer is affiliated with the department of psychology at the University of Cambridge (England).

“Given the novel finding that insufficient sleep is associated with changes in brain structure and connectivity that are long-lasting, early intervention is crucial because such neural changes are probably not reversible and might consequently affect adolescents’ development into adulthood,” Dr. Speyer wrote.

Delaying school start times could be one way to help kids get more sleep. The American Academy of Pediatrics and the American Academy of Sleep Medicine recommend that middle schools and high schools start no earlier than 8:30 a.m. to better align with students’ circadian rhythm, Dr. Speyer noted.

As it is in the United States, most schools start closer to 8 a.m. In California, though, a law that went into effect on July 1 prohibits high schools from starting before 8:30 a.m. Other states are weighing similar legislation.

The research was supported by the National Institutes of Health. Dr. Wang and his coauthors and Dr. Speyer had no conflict of interest disclosures. Dr. Williamson is a sleep expert for the Pediatric Sleep Council (www.babysleep.com), which provides free information about early childhood sleep, but she does not receive compensation for this role.
 

Children who do not get enough sleep for one night can be cranky, groggy, or meltdown prone the next day.

Over time, though, insufficient sleep may impair neurodevelopment in ways that can be measured on brain scans and tests long term, a new study shows.

Research published in The Lancet Child & Adolescent Health found that 9- and 10-year-olds who do not get at least 9 hours of sleep most nights tend to have less gray matter and smaller areas of the brain responsible for attention, memory, and inhibition control, relative to children who do get enough sleep.

The researchers also found a relationship between insufficient sleep and disrupted connections between the basal ganglia and cortical regions of the brain. These disruptions appeared to be linked to depression, thought problems, and impairments in crystallized intelligence, a type of intelligence that depends on memory.

The overall patterns persisted 2 years later, even as those who got enough sleep at baseline gradually slept less over time, while those who were not getting enough sleep to begin with continued to sleep about the same amount, the researchers reported.

The results bolster the case for delaying school start times, as California recently did, according one researcher who was not involved in the study.
 

The ABCD Study

To examine how insufficient sleep affects children’s mental health, cognition, brain function, and brain structure over 2 years, Ze Wang, PhD, professor of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, and colleagues analyzed data from the ongoing Adolescent Brain Cognitive Development (ABCD) Study. The ABCD Study is tracking the biologic and behavioral development of more than 11,000 children in the United States who were recruited for the study when they were 9 or 10 years old.

For their new analysis, Dr. Wang’s group focused on 6,042 participants: 3,021 children with insufficient sleep who were matched with an equal number of participants who were similar in many respects, including sex, socioeconomic status, and puberty status, except they got at least 9 hours of sleep. They also looked at outcomes 2 years later from 749 of the matched pairs who had results available.

The investigators determined sleep duration based on how parents answered the question: “How many hours of sleep does your child get on most nights in the past 6 months?” Possible answers included at least 9 hours, 8-9 hours, 7-8 hours, 5-7 hours, or less than 5 hours. They also looked at functional and structural MRI scans, test results, and responses to questionnaires.

Negative effects of inadequate sleep were spread over “several different domains including brain structure, function, cognition, behavior, and mental health,” Dr. Wang said.

The strength of the relationship between sleep duration and the various outcomes was “modest” and based on group averages, he said. So, a given child who does not sleep for 9 hours most nights won’t necessarily perform worse than a child who gets enough sleep.

Still, modest effects may accumulate and have lasting consequences, Dr. Wang said.
 

Crystallized intelligence

The researchers looked at 42 behavioral outcomes, 32 of which were significantly different between the groups. Four outcomes in particular – depression, thought problems, performance on a picture-vocabulary test, and crystallized intelligence – were areas where insufficient sleep seemed to have a larger negative effect.

Sleep duration’s relationship with crystallized intelligence was twice that for fluid intelligence, which does not depend on memory.

“Sleep affects memory,” Dr. Wang said. “Crystallized intelligence depends on learned skills and knowledge, which are memory. In this sense, sleep is related to crystallized intelligence.”

One limitation of the study is that some parents may not accurately report how much sleep their child gets, Dr. Wang acknowledged. Children may be awake when parents think they are asleep, for example.

And although the results show getting 9 hours of sleep may help neurocognitive development, it’s also possible that excessive amounts of sleep could be problematic, the study authors wrote.

Further experiments are needed to prove that insufficient sleep – and not some other, unaccounted for factor – causes the observed impairments in neurodevelopment.

To promote healthy sleep, parents should keep a strict routine for their children, such as a regular bedtime and no electronic devices in the bedroom, Dr. Wang suggested. More physical activity during the day also should help.

If children have high levels of stress and depression, “finding the source is critical,” he said. Likewise, clinicians should consider how mental health can affect their patients’ sleep.
 

More to healthy sleep than duration

“This study both aligns with and advances existing research on the importance of sufficient sleep for child well-being,” said Ariel A. Williamson, PhD, DBSM, a psychologist and pediatric sleep expert in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia and assistant professor of psychiatry and pediatrics at University of Pennsylvania, also in Philadelphia.

The researchers used rigorous propensity score matching, longitudinal data, and brain imaging, which are “innovative methods that provide more evidence on potential mechanisms linking insufficient sleep and child outcomes,” said Dr. Williamson, who was not involved in the study.

While the investigators focused on sleep duration, child sleep health is multidimensional and includes other elements like timing and perception of sleep quality, Dr. Williamson noted. “For example, some research shows that having a sleep schedule that varies night to night is linked to poor child outcomes.”

Dr. Williamson tells families and clinicians that “sleep is a pillar of health,” equal to diet and exercise. That said, sleep recommendations need to fit within a family’s life – taking into account after school activities and late-night homework sessions. But extending sleep by just “20-30 minutes can make a meaningful difference for daytime functioning,” Dr. Williamson said.
 

Start school later?

Researchers have only relatively recently begun to understand how insufficient sleep affects adolescent neurocognitive development long term, and this study provides “crucial evidence” about the consequences, Lydia Gabriela Speyer, PhD, said in an editorial published with the study. Dr. Speyer is affiliated with the department of psychology at the University of Cambridge (England).

“Given the novel finding that insufficient sleep is associated with changes in brain structure and connectivity that are long-lasting, early intervention is crucial because such neural changes are probably not reversible and might consequently affect adolescents’ development into adulthood,” Dr. Speyer wrote.

Delaying school start times could be one way to help kids get more sleep. The American Academy of Pediatrics and the American Academy of Sleep Medicine recommend that middle schools and high schools start no earlier than 8:30 a.m. to better align with students’ circadian rhythm, Dr. Speyer noted.

As it is in the United States, most schools start closer to 8 a.m. In California, though, a law that went into effect on July 1 prohibits high schools from starting before 8:30 a.m. Other states are weighing similar legislation.

The research was supported by the National Institutes of Health. Dr. Wang and his coauthors and Dr. Speyer had no conflict of interest disclosures. Dr. Williamson is a sleep expert for the Pediatric Sleep Council (www.babysleep.com), which provides free information about early childhood sleep, but she does not receive compensation for this role.
 

Children who do not get enough sleep for one night can be cranky, groggy, or meltdown prone the next day.

Over time, though, insufficient sleep may impair neurodevelopment in ways that can be measured on brain scans and tests long term, a new study shows.

Research published in The Lancet Child & Adolescent Health found that 9- and 10-year-olds who do not get at least 9 hours of sleep most nights tend to have less gray matter and smaller areas of the brain responsible for attention, memory, and inhibition control, relative to children who do get enough sleep.

The researchers also found a relationship between insufficient sleep and disrupted connections between the basal ganglia and cortical regions of the brain. These disruptions appeared to be linked to depression, thought problems, and impairments in crystallized intelligence, a type of intelligence that depends on memory.

The overall patterns persisted 2 years later, even as those who got enough sleep at baseline gradually slept less over time, while those who were not getting enough sleep to begin with continued to sleep about the same amount, the researchers reported.

The results bolster the case for delaying school start times, as California recently did, according one researcher who was not involved in the study.
 

The ABCD Study

To examine how insufficient sleep affects children’s mental health, cognition, brain function, and brain structure over 2 years, Ze Wang, PhD, professor of diagnostic radiology and nuclear medicine at the University of Maryland, Baltimore, and colleagues analyzed data from the ongoing Adolescent Brain Cognitive Development (ABCD) Study. The ABCD Study is tracking the biologic and behavioral development of more than 11,000 children in the United States who were recruited for the study when they were 9 or 10 years old.

For their new analysis, Dr. Wang’s group focused on 6,042 participants: 3,021 children with insufficient sleep who were matched with an equal number of participants who were similar in many respects, including sex, socioeconomic status, and puberty status, except they got at least 9 hours of sleep. They also looked at outcomes 2 years later from 749 of the matched pairs who had results available.

The investigators determined sleep duration based on how parents answered the question: “How many hours of sleep does your child get on most nights in the past 6 months?” Possible answers included at least 9 hours, 8-9 hours, 7-8 hours, 5-7 hours, or less than 5 hours. They also looked at functional and structural MRI scans, test results, and responses to questionnaires.

Negative effects of inadequate sleep were spread over “several different domains including brain structure, function, cognition, behavior, and mental health,” Dr. Wang said.

The strength of the relationship between sleep duration and the various outcomes was “modest” and based on group averages, he said. So, a given child who does not sleep for 9 hours most nights won’t necessarily perform worse than a child who gets enough sleep.

Still, modest effects may accumulate and have lasting consequences, Dr. Wang said.
 

Crystallized intelligence

The researchers looked at 42 behavioral outcomes, 32 of which were significantly different between the groups. Four outcomes in particular – depression, thought problems, performance on a picture-vocabulary test, and crystallized intelligence – were areas where insufficient sleep seemed to have a larger negative effect.

Sleep duration’s relationship with crystallized intelligence was twice that for fluid intelligence, which does not depend on memory.

“Sleep affects memory,” Dr. Wang said. “Crystallized intelligence depends on learned skills and knowledge, which are memory. In this sense, sleep is related to crystallized intelligence.”

One limitation of the study is that some parents may not accurately report how much sleep their child gets, Dr. Wang acknowledged. Children may be awake when parents think they are asleep, for example.

And although the results show getting 9 hours of sleep may help neurocognitive development, it’s also possible that excessive amounts of sleep could be problematic, the study authors wrote.

Further experiments are needed to prove that insufficient sleep – and not some other, unaccounted for factor – causes the observed impairments in neurodevelopment.

To promote healthy sleep, parents should keep a strict routine for their children, such as a regular bedtime and no electronic devices in the bedroom, Dr. Wang suggested. More physical activity during the day also should help.

If children have high levels of stress and depression, “finding the source is critical,” he said. Likewise, clinicians should consider how mental health can affect their patients’ sleep.
 

More to healthy sleep than duration

“This study both aligns with and advances existing research on the importance of sufficient sleep for child well-being,” said Ariel A. Williamson, PhD, DBSM, a psychologist and pediatric sleep expert in the department of child and adolescent psychiatry and behavioral sciences at Children’s Hospital of Philadelphia and assistant professor of psychiatry and pediatrics at University of Pennsylvania, also in Philadelphia.

The researchers used rigorous propensity score matching, longitudinal data, and brain imaging, which are “innovative methods that provide more evidence on potential mechanisms linking insufficient sleep and child outcomes,” said Dr. Williamson, who was not involved in the study.

While the investigators focused on sleep duration, child sleep health is multidimensional and includes other elements like timing and perception of sleep quality, Dr. Williamson noted. “For example, some research shows that having a sleep schedule that varies night to night is linked to poor child outcomes.”

Dr. Williamson tells families and clinicians that “sleep is a pillar of health,” equal to diet and exercise. That said, sleep recommendations need to fit within a family’s life – taking into account after school activities and late-night homework sessions. But extending sleep by just “20-30 minutes can make a meaningful difference for daytime functioning,” Dr. Williamson said.
 

Start school later?

Researchers have only relatively recently begun to understand how insufficient sleep affects adolescent neurocognitive development long term, and this study provides “crucial evidence” about the consequences, Lydia Gabriela Speyer, PhD, said in an editorial published with the study. Dr. Speyer is affiliated with the department of psychology at the University of Cambridge (England).

“Given the novel finding that insufficient sleep is associated with changes in brain structure and connectivity that are long-lasting, early intervention is crucial because such neural changes are probably not reversible and might consequently affect adolescents’ development into adulthood,” Dr. Speyer wrote.

Delaying school start times could be one way to help kids get more sleep. The American Academy of Pediatrics and the American Academy of Sleep Medicine recommend that middle schools and high schools start no earlier than 8:30 a.m. to better align with students’ circadian rhythm, Dr. Speyer noted.

As it is in the United States, most schools start closer to 8 a.m. In California, though, a law that went into effect on July 1 prohibits high schools from starting before 8:30 a.m. Other states are weighing similar legislation.

The research was supported by the National Institutes of Health. Dr. Wang and his coauthors and Dr. Speyer had no conflict of interest disclosures. Dr. Williamson is a sleep expert for the Pediatric Sleep Council (www.babysleep.com), which provides free information about early childhood sleep, but she does not receive compensation for this role.
 

Rural patients with early onset dementia are more likely than urban patients to rely solely on primary care physicians or nurse practitioners for the initial diagnosis and treatment of the disease, a new study has found.

Patients in rural areas are also less likely to see psychologists and undergo neuropsychological testing, according to the study, published in JAMA Network Open.

Patients who forgo such specialist visits and testing may be missing information about their condition that could help them prepare for changes in job responsibilities and future care decisions, said Wendy Yi Xu, PhD, of The Ohio State University, Columbus, who led the research.

“A lot of them are still in the workforce,” Dr. Xu said. Patients in the study were an average age of 56 years, well before the conventional age of retirement.
 

Location, location, location

To examine rural versus urban differences in the use of diagnostic tests and health care visits for early onset Alzheimer’s disease and related dementias, Dr. Xu and colleagues analyzed commercial claims data from 2012-2018. They identified more than 71,000 patients aged 40-64 years with those conditions and focused on health care use by 7,311 patients in urban areas and 1,119 in rural areas within 90 days of a new dementia diagnosis.

The proportion who received neuropsychological testing was 19% among urban patients and 16% among rural patients. Psychological assessments, which are less specialized and detailed than neuropsychological testing, and brain imaging occurred at similar rates in both groups. Similar proportions of rural and urban patients visited neurologists (17.7% and 17.96%, respectively) and psychiatrists (6.02% and 6.47%).

But more urban patients than rural patients visited a psychologist, at 19% versus 15%, according to the researchers.

Approximately 18% of patients in rural areas saw a primary care provider without visiting other specialists, compared with 13% in urban areas.

The researchers found that rural patients were significantly less likely to undergo neuropsychological testing (odds ratio, 0.83; 95% confidence interval, 0.70-0.98) or see a psychologist (OR, 0.72; 95% CI, 0.60-0.85).

Similarly, rural patients had significantly higher odds of having only primary care providers involved in the diagnosis of dementia and symptom management (OR, 1.40; 95% CI, 1.19-1.66).
 

Addressing workforce deficiencies

More primary care training in dementia care and collaboration with specialist colleagues could help address differences in care, Dr. Xu’s group writes. Such efforts are already underway.

In 2018, the Alzheimer’s Association launched telementoring programs focused on dementia care using the Project ECHO (Extension for Community Healthcare Outcomes) model. Researchers originally developed Project ECHO at the University of New Mexico in 2003 to teach primary care clinicians in remote settings how to treat patients infected with the hepatitis C virus.

With the Alzheimer’s and Dementia Care ECHO Program for Clinicians, primary care clinicians can participate in interactive case-based video conferencing sessions to better understand dementia and how to provide high-quality care in community settings, according to the association.

The program covers guidelines for diagnosis, disclosure, and follow-up; the initiation of care planning; managing disease-related challenges; and resources for patients and caregivers.

Since 2018, nearly 100 primary care practices in the United States have completed training in dementia care using Project ECHO, said Morgan Daven, vice president of health systems for the Alzheimer’s Association. Many cases featured in the program are challenging, he added.

“With primary care being on the front lines, it is really important that primary care physicians are equipped to do what they can to detect or diagnose and know when to refer,” Mr. Daven said.

The association has compiled other resources for clinicians as well.

A 2020 report from the association examined the role that primary care physicians play in dementia care. One survey found that 82% of primary care physicians consider themselves on the front lines of providing care for patients with dementia.

Meanwhile, about half say medical professionals are not prepared to meet rising demands associated with Alzheimer’s disease and dementia care.

Mr. Daven said the geographic disparities Dr. Xu and colleagues found are unsurprising. More than half of primary care physicians who care for people with Alzheimer’s disease say dementia specialists in their communities cannot meet demand. The problem is more urgent in rural areas. Roughly half of nonmetropolitan counties in the United States lack a practicing psychologist, according to a 2018 study published in the American Journal of Preventive Medicine.

“We really need to approach this on both sides – build the capacity in primary care, but we also need to address the dementia care specialty shortages,” Mr. Daven said.

The lack of obvious differences in access to neurologists in the new study “was surprising, given the more than fourfold difference between urban and rural areas in the supply of neurologists,” the researchers note. Health plans may maintain more access to neurologists than psychologists because of relatively higher reimbursement for neurologists, they observed.

One of the study coauthors disclosed ties to Aveanna Healthcare, a company that delivers home health and hospice care.

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

Rural patients with early onset dementia are more likely than urban patients to rely solely on primary care physicians or nurse practitioners for the initial diagnosis and treatment of the disease, a new study has found.

Patients in rural areas are also less likely to see psychologists and undergo neuropsychological testing, according to the study, published in JAMA Network Open.

Patients who forgo such specialist visits and testing may be missing information about their condition that could help them prepare for changes in job responsibilities and future care decisions, said Wendy Yi Xu, PhD, of The Ohio State University, Columbus, who led the research.

“A lot of them are still in the workforce,” Dr. Xu said. Patients in the study were an average age of 56 years, well before the conventional age of retirement.
 

Location, location, location

To examine rural versus urban differences in the use of diagnostic tests and health care visits for early onset Alzheimer’s disease and related dementias, Dr. Xu and colleagues analyzed commercial claims data from 2012-2018. They identified more than 71,000 patients aged 40-64 years with those conditions and focused on health care use by 7,311 patients in urban areas and 1,119 in rural areas within 90 days of a new dementia diagnosis.

The proportion who received neuropsychological testing was 19% among urban patients and 16% among rural patients. Psychological assessments, which are less specialized and detailed than neuropsychological testing, and brain imaging occurred at similar rates in both groups. Similar proportions of rural and urban patients visited neurologists (17.7% and 17.96%, respectively) and psychiatrists (6.02% and 6.47%).

But more urban patients than rural patients visited a psychologist, at 19% versus 15%, according to the researchers.

Approximately 18% of patients in rural areas saw a primary care provider without visiting other specialists, compared with 13% in urban areas.

The researchers found that rural patients were significantly less likely to undergo neuropsychological testing (odds ratio, 0.83; 95% confidence interval, 0.70-0.98) or see a psychologist (OR, 0.72; 95% CI, 0.60-0.85).

Similarly, rural patients had significantly higher odds of having only primary care providers involved in the diagnosis of dementia and symptom management (OR, 1.40; 95% CI, 1.19-1.66).
 

Addressing workforce deficiencies

More primary care training in dementia care and collaboration with specialist colleagues could help address differences in care, Dr. Xu’s group writes. Such efforts are already underway.

In 2018, the Alzheimer’s Association launched telementoring programs focused on dementia care using the Project ECHO (Extension for Community Healthcare Outcomes) model. Researchers originally developed Project ECHO at the University of New Mexico in 2003 to teach primary care clinicians in remote settings how to treat patients infected with the hepatitis C virus.

With the Alzheimer’s and Dementia Care ECHO Program for Clinicians, primary care clinicians can participate in interactive case-based video conferencing sessions to better understand dementia and how to provide high-quality care in community settings, according to the association.

The program covers guidelines for diagnosis, disclosure, and follow-up; the initiation of care planning; managing disease-related challenges; and resources for patients and caregivers.

Since 2018, nearly 100 primary care practices in the United States have completed training in dementia care using Project ECHO, said Morgan Daven, vice president of health systems for the Alzheimer’s Association. Many cases featured in the program are challenging, he added.

“With primary care being on the front lines, it is really important that primary care physicians are equipped to do what they can to detect or diagnose and know when to refer,” Mr. Daven said.

The association has compiled other resources for clinicians as well.

A 2020 report from the association examined the role that primary care physicians play in dementia care. One survey found that 82% of primary care physicians consider themselves on the front lines of providing care for patients with dementia.

Meanwhile, about half say medical professionals are not prepared to meet rising demands associated with Alzheimer’s disease and dementia care.

Mr. Daven said the geographic disparities Dr. Xu and colleagues found are unsurprising. More than half of primary care physicians who care for people with Alzheimer’s disease say dementia specialists in their communities cannot meet demand. The problem is more urgent in rural areas. Roughly half of nonmetropolitan counties in the United States lack a practicing psychologist, according to a 2018 study published in the American Journal of Preventive Medicine.

“We really need to approach this on both sides – build the capacity in primary care, but we also need to address the dementia care specialty shortages,” Mr. Daven said.

The lack of obvious differences in access to neurologists in the new study “was surprising, given the more than fourfold difference between urban and rural areas in the supply of neurologists,” the researchers note. Health plans may maintain more access to neurologists than psychologists because of relatively higher reimbursement for neurologists, they observed.

One of the study coauthors disclosed ties to Aveanna Healthcare, a company that delivers home health and hospice care.

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

Rural patients with early onset dementia are more likely than urban patients to rely solely on primary care physicians or nurse practitioners for the initial diagnosis and treatment of the disease, a new study has found.

Patients in rural areas are also less likely to see psychologists and undergo neuropsychological testing, according to the study, published in JAMA Network Open.

Patients who forgo such specialist visits and testing may be missing information about their condition that could help them prepare for changes in job responsibilities and future care decisions, said Wendy Yi Xu, PhD, of The Ohio State University, Columbus, who led the research.

“A lot of them are still in the workforce,” Dr. Xu said. Patients in the study were an average age of 56 years, well before the conventional age of retirement.
 

Location, location, location

To examine rural versus urban differences in the use of diagnostic tests and health care visits for early onset Alzheimer’s disease and related dementias, Dr. Xu and colleagues analyzed commercial claims data from 2012-2018. They identified more than 71,000 patients aged 40-64 years with those conditions and focused on health care use by 7,311 patients in urban areas and 1,119 in rural areas within 90 days of a new dementia diagnosis.

The proportion who received neuropsychological testing was 19% among urban patients and 16% among rural patients. Psychological assessments, which are less specialized and detailed than neuropsychological testing, and brain imaging occurred at similar rates in both groups. Similar proportions of rural and urban patients visited neurologists (17.7% and 17.96%, respectively) and psychiatrists (6.02% and 6.47%).

But more urban patients than rural patients visited a psychologist, at 19% versus 15%, according to the researchers.

Approximately 18% of patients in rural areas saw a primary care provider without visiting other specialists, compared with 13% in urban areas.

The researchers found that rural patients were significantly less likely to undergo neuropsychological testing (odds ratio, 0.83; 95% confidence interval, 0.70-0.98) or see a psychologist (OR, 0.72; 95% CI, 0.60-0.85).

Similarly, rural patients had significantly higher odds of having only primary care providers involved in the diagnosis of dementia and symptom management (OR, 1.40; 95% CI, 1.19-1.66).
 

Addressing workforce deficiencies

More primary care training in dementia care and collaboration with specialist colleagues could help address differences in care, Dr. Xu’s group writes. Such efforts are already underway.

In 2018, the Alzheimer’s Association launched telementoring programs focused on dementia care using the Project ECHO (Extension for Community Healthcare Outcomes) model. Researchers originally developed Project ECHO at the University of New Mexico in 2003 to teach primary care clinicians in remote settings how to treat patients infected with the hepatitis C virus.

With the Alzheimer’s and Dementia Care ECHO Program for Clinicians, primary care clinicians can participate in interactive case-based video conferencing sessions to better understand dementia and how to provide high-quality care in community settings, according to the association.

The program covers guidelines for diagnosis, disclosure, and follow-up; the initiation of care planning; managing disease-related challenges; and resources for patients and caregivers.

Since 2018, nearly 100 primary care practices in the United States have completed training in dementia care using Project ECHO, said Morgan Daven, vice president of health systems for the Alzheimer’s Association. Many cases featured in the program are challenging, he added.

“With primary care being on the front lines, it is really important that primary care physicians are equipped to do what they can to detect or diagnose and know when to refer,” Mr. Daven said.

The association has compiled other resources for clinicians as well.

A 2020 report from the association examined the role that primary care physicians play in dementia care. One survey found that 82% of primary care physicians consider themselves on the front lines of providing care for patients with dementia.

Meanwhile, about half say medical professionals are not prepared to meet rising demands associated with Alzheimer’s disease and dementia care.

Mr. Daven said the geographic disparities Dr. Xu and colleagues found are unsurprising. More than half of primary care physicians who care for people with Alzheimer’s disease say dementia specialists in their communities cannot meet demand. The problem is more urgent in rural areas. Roughly half of nonmetropolitan counties in the United States lack a practicing psychologist, according to a 2018 study published in the American Journal of Preventive Medicine.

“We really need to approach this on both sides – build the capacity in primary care, but we also need to address the dementia care specialty shortages,” Mr. Daven said.

The lack of obvious differences in access to neurologists in the new study “was surprising, given the more than fourfold difference between urban and rural areas in the supply of neurologists,” the researchers note. Health plans may maintain more access to neurologists than psychologists because of relatively higher reimbursement for neurologists, they observed.

One of the study coauthors disclosed ties to Aveanna Healthcare, a company that delivers home health and hospice care.

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