Pediatric News

Scarlet fever, commonly described in young children and adolescents, is characterized by a papular, blanching rash that may be described as having a “sandpaper” texture. This condition typically presents in the setting of Streptococcus pyogenes pharyngitis, or strep throat, and is spread via mucosal transfer in close proximity such as classrooms and nurseries. The dermatologic symptoms are a result of the endotoxin produced by S. pyogenes, which is part of the group A Strep bacteria. Clinically, the presentation can be differentiated from an allergic eruption by its relation to acute pharyngitis, insidious onset, and lack of confluence of the lesions. Diagnosis is supported by a throat culture and rapid strep test, although a rapid test lacks reliability in older patients who are less commonly affected and likely to be carriers. First-line treatment is penicillin or amoxicillin, but first-generation cephalosporins, clindamycin, or erythromycin are sufficient if the patient is allergic to penicillins. Prognosis worsens as time between onset and treatment increases, but is overall excellent now with the introduction of antibiotics and improved hygiene.

Scarlet fever is among a list of many common childhood rashes, and it can be difficult to differentiate between these pathologies on clinical presentation. A few notable childhood dermatologic eruptions include erythema infectiosum (fifth disease), roseola (exanthema subitum or sixth disease), and measles. These cases can be distinguished clinically by the age of the patient, distribution, and quality of the symptoms. Laboratory testing may be used to confirm the diagnosis.

Erythema infectiosum is known as fifth disease or slapped-cheek rash because it commonly presents on the cheeks as a pink, maculopapular rash in a reticular pattern. The disease is caused by parvovirus B19 and is accompanied by low fever, malaise, headache, sore throat, and nausea, which precedes the erythematous rash. The facial rash appears first and is followed by patchy eruptions on the extremities. Appearance of the rash typically indicates the patient is no longer contagious, and patients are treated symptomatically with NSAIDs and antihistamines for associated pruritus.

Roseola infantum is commonly caused by human herpesvirus 6 and is usually found in children 3 years and younger. The defining symptom is a high fever, which is paired with a mild cough, runny nose, and diarrhea. A maculopapular rash appears after the fever subsides, starting centrally and spreading outward to the extremities. Although this rash is similar to measles, they can be differentiated by the order of onset. The rash caused by measles begins on the face and mouth (Koplik spots) and moves downward. Additionally, the patient appears generally healthy and the disease is self-limiting in roseola, while patients with measles will appear more ill and require further attention. Measles is caused by the measles virus of the genus Morbillivirus and is highly contagious. It is spread via respiratory route presenting with fever, cough, coryza, and conjunctivitis followed by the rash. Fortunately, the measles vaccine is in widespread use, so cases have declined over the years.

Our patient had a positive strep test. Influenza and coronavirus tests were negative. She was started on daily amoxicillin and the rash resolved within 2 days of taking the antibiotics.

This case and photo were submitted by Lucas Shapiro, BS, Nova Southeastern University, Tampa, and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Allmon A et al.. Am Fam Physician. 2015 Aug 1;92(3):211-6.

Moss WJ. Lancet. 2017 Dec 2;390(10111):2490-502.

Mullins TB and Krishnamurthy K. Roseola Infantum, in “StatPearls.” Treasure Islan, Fla.: StatPearls Publishing, 2022.

Pardo S and Perera TB. Scarlet Fever, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2022.
 

Scarlet fever, commonly described in young children and adolescents, is characterized by a papular, blanching rash that may be described as having a “sandpaper” texture. This condition typically presents in the setting of Streptococcus pyogenes pharyngitis, or strep throat, and is spread via mucosal transfer in close proximity such as classrooms and nurseries. The dermatologic symptoms are a result of the endotoxin produced by S. pyogenes, which is part of the group A Strep bacteria. Clinically, the presentation can be differentiated from an allergic eruption by its relation to acute pharyngitis, insidious onset, and lack of confluence of the lesions. Diagnosis is supported by a throat culture and rapid strep test, although a rapid test lacks reliability in older patients who are less commonly affected and likely to be carriers. First-line treatment is penicillin or amoxicillin, but first-generation cephalosporins, clindamycin, or erythromycin are sufficient if the patient is allergic to penicillins. Prognosis worsens as time between onset and treatment increases, but is overall excellent now with the introduction of antibiotics and improved hygiene.

Scarlet fever is among a list of many common childhood rashes, and it can be difficult to differentiate between these pathologies on clinical presentation. A few notable childhood dermatologic eruptions include erythema infectiosum (fifth disease), roseola (exanthema subitum or sixth disease), and measles. These cases can be distinguished clinically by the age of the patient, distribution, and quality of the symptoms. Laboratory testing may be used to confirm the diagnosis.

Erythema infectiosum is known as fifth disease or slapped-cheek rash because it commonly presents on the cheeks as a pink, maculopapular rash in a reticular pattern. The disease is caused by parvovirus B19 and is accompanied by low fever, malaise, headache, sore throat, and nausea, which precedes the erythematous rash. The facial rash appears first and is followed by patchy eruptions on the extremities. Appearance of the rash typically indicates the patient is no longer contagious, and patients are treated symptomatically with NSAIDs and antihistamines for associated pruritus.

Roseola infantum is commonly caused by human herpesvirus 6 and is usually found in children 3 years and younger. The defining symptom is a high fever, which is paired with a mild cough, runny nose, and diarrhea. A maculopapular rash appears after the fever subsides, starting centrally and spreading outward to the extremities. Although this rash is similar to measles, they can be differentiated by the order of onset. The rash caused by measles begins on the face and mouth (Koplik spots) and moves downward. Additionally, the patient appears generally healthy and the disease is self-limiting in roseola, while patients with measles will appear more ill and require further attention. Measles is caused by the measles virus of the genus Morbillivirus and is highly contagious. It is spread via respiratory route presenting with fever, cough, coryza, and conjunctivitis followed by the rash. Fortunately, the measles vaccine is in widespread use, so cases have declined over the years.

Our patient had a positive strep test. Influenza and coronavirus tests were negative. She was started on daily amoxicillin and the rash resolved within 2 days of taking the antibiotics.

This case and photo were submitted by Lucas Shapiro, BS, Nova Southeastern University, Tampa, and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Allmon A et al.. Am Fam Physician. 2015 Aug 1;92(3):211-6.

Moss WJ. Lancet. 2017 Dec 2;390(10111):2490-502.

Mullins TB and Krishnamurthy K. Roseola Infantum, in “StatPearls.” Treasure Islan, Fla.: StatPearls Publishing, 2022.

Pardo S and Perera TB. Scarlet Fever, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2022.
 

Scarlet fever, commonly described in young children and adolescents, is characterized by a papular, blanching rash that may be described as having a “sandpaper” texture. This condition typically presents in the setting of Streptococcus pyogenes pharyngitis, or strep throat, and is spread via mucosal transfer in close proximity such as classrooms and nurseries. The dermatologic symptoms are a result of the endotoxin produced by S. pyogenes, which is part of the group A Strep bacteria. Clinically, the presentation can be differentiated from an allergic eruption by its relation to acute pharyngitis, insidious onset, and lack of confluence of the lesions. Diagnosis is supported by a throat culture and rapid strep test, although a rapid test lacks reliability in older patients who are less commonly affected and likely to be carriers. First-line treatment is penicillin or amoxicillin, but first-generation cephalosporins, clindamycin, or erythromycin are sufficient if the patient is allergic to penicillins. Prognosis worsens as time between onset and treatment increases, but is overall excellent now with the introduction of antibiotics and improved hygiene.

Scarlet fever is among a list of many common childhood rashes, and it can be difficult to differentiate between these pathologies on clinical presentation. A few notable childhood dermatologic eruptions include erythema infectiosum (fifth disease), roseola (exanthema subitum or sixth disease), and measles. These cases can be distinguished clinically by the age of the patient, distribution, and quality of the symptoms. Laboratory testing may be used to confirm the diagnosis.

Erythema infectiosum is known as fifth disease or slapped-cheek rash because it commonly presents on the cheeks as a pink, maculopapular rash in a reticular pattern. The disease is caused by parvovirus B19 and is accompanied by low fever, malaise, headache, sore throat, and nausea, which precedes the erythematous rash. The facial rash appears first and is followed by patchy eruptions on the extremities. Appearance of the rash typically indicates the patient is no longer contagious, and patients are treated symptomatically with NSAIDs and antihistamines for associated pruritus.

Roseola infantum is commonly caused by human herpesvirus 6 and is usually found in children 3 years and younger. The defining symptom is a high fever, which is paired with a mild cough, runny nose, and diarrhea. A maculopapular rash appears after the fever subsides, starting centrally and spreading outward to the extremities. Although this rash is similar to measles, they can be differentiated by the order of onset. The rash caused by measles begins on the face and mouth (Koplik spots) and moves downward. Additionally, the patient appears generally healthy and the disease is self-limiting in roseola, while patients with measles will appear more ill and require further attention. Measles is caused by the measles virus of the genus Morbillivirus and is highly contagious. It is spread via respiratory route presenting with fever, cough, coryza, and conjunctivitis followed by the rash. Fortunately, the measles vaccine is in widespread use, so cases have declined over the years.

Our patient had a positive strep test. Influenza and coronavirus tests were negative. She was started on daily amoxicillin and the rash resolved within 2 days of taking the antibiotics.

This case and photo were submitted by Lucas Shapiro, BS, Nova Southeastern University, Tampa, and Dr. Bilu Martin.

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

Allmon A et al.. Am Fam Physician. 2015 Aug 1;92(3):211-6.

Moss WJ. Lancet. 2017 Dec 2;390(10111):2490-502.

Mullins TB and Krishnamurthy K. Roseola Infantum, in “StatPearls.” Treasure Islan, Fla.: StatPearls Publishing, 2022.

Pardo S and Perera TB. Scarlet Fever, in “StatPearls.” Treasure Island, Fla.: StatPearls Publishing, 2022.
 

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.

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

A new meta-analysis of 884 studies evaluating 27 different types of antioxidant supplements has suggested that some of these micronutrients – including omega-3 fatty acids, folic acid, and coenzyme Q10 – may produce significant cardiovascular benefits.

Other antioxidant supplements that showed some evidence of reducing cardiovascular risk were omega-6 fatty acids, L-arginine, L-citrulline, magnesium, zinc, alpha-lipoic acid, melatonin, catechin, curcumin, flavanol, genistein, and quercetin.

No effect was seen with vitamin C, vitamin D, vitamin E, or selenium, and beta-carotene supplementation was linked to an increase in all-cause mortality in the analysis.

The study is published in the Journal of the American College of Cardiology and was also published online.

“Our systematic assessment and quantification of multiple differential effects of a wide variety of micronutrients and phytochemicals on cardiometabolic health indicate that an optimal nutritional strategy to promote cardiometabolic health will likely involve personalized combinations of these nutrients,” the authors, led by Peng An, PhD, China Agricultural University, Beijing, conclude.

“Identifying the optimal mixture of micronutrients is important, as not all are beneficial, and some may even have harmful effects,” senior author Simin Liu, MD, professor of epidemiology and medicine at Brown University, Providence, R.I., said in an American College of Cardiology press release.

“The micronutrients identified require further validation in large, high-quality interventional trials to establish clinical efficacy to determine their long-term balance of risks and benefits,” the authors add.
 

Experts cautious

Experts in the field of cardiovascular risk and preventative medicine have urged caution in interpreting these results.

JoAnn Manson, MD, chief of the division of preventive medicine at Brigham and Women’s Hospital, Boston, told this news organization that she has concerns that some of the results in the meta-analysis may be inflated by publication bias and some are chance findings that haven’t been well replicated.

“Although this meta-analysis of micronutrients and cardiometabolic health was based on randomized clinical trials, the quality of randomized trials on this subject varies widely,” she noted.

“The study is informative, but the conclusions are only as good as the quality of the evidence. Some of the trials are limited by short duration, and included trials have a wide range of quality, dosing, inclusion criteria, imperfect blinding, and few of them focus on hard clinical events,” Dr. Manson said. “Also, with trials of this nature, the potential for publication bias warrants consideration, because many of the smaller trials with unfavorable or neutral results may remain unpublished or not even be submitted for publication.”   

However, she added, “despite these limitations, this is an important contribution to the literature on micronutrients and health – and goes a long way in separating the wheat from the chaff.”

Steve Nissen, MD, chief academic officer of the Heart Vascular and Thoracic Institute at the Cleveland Clinic, was more critical of the meta-analysis.

“This study does not make sense. Some of the ‘micronutrients’ in this meta-analysis have undergone thorough testing in large randomized clinical trials that showed different results. I am skeptical whether any of the purported benefits of these supplements would be confirmed in a high-quality randomized controlled trial,” he said.

Dr. Nissen added that many of the included studies are low in quality. “I must quote [renowned cardiologist, Dr.] Franz Messerli: ‘A meta-analysis is like making bouillabaisse. ... One rotten fish can spoil the broth.’ This type of analysis does not override high-quality large, randomized trials.”

In the JACC paper, the study investigators note that the American Heart Association now recommends dietary patterns, including the Mediterranean diet and DASH (the Dietary Approach to Stop Hypertension), as preventive or treatment approaches for cardiovascular disease. A common feature of these dietary patterns is that they are low in saturated fat and sodium and rich in micronutrients such as phytochemicals, unsaturated fatty acids, antioxidant vitamins, and minerals.

“To personalize cardiometabolic preventive and therapeutic dietary practices, it is of critical importance to have a comprehensive and in-depth understanding of the balance of benefits and risks associated with constituent micronutrients in diverse dietary patterns,” they note.

They therefore conducted the current systematic review and meta-analyses of all available randomized controlled trials investigating the effect of micronutrients with antioxidant properties on cardiovascular risk factors and events in diverse populations.

The meta-analysis included a total of 884 randomized trials evaluating 27 types of micronutrients among 883,627 participants.

Results showed that supplementation with n-3 fatty acids, n-6 fatty acids, L-arginine, L-citrulline, folic acid, magnesium, zinc, alpha-lipoic acid, coenzyme Q10, melatonin, catechin, curcumin, flavanol, genistein, and quercetin had “moderate-to high-quality evidence” for reducing cardiovascular risk factors.

Specifically, n-3 fatty acid supplementation was linked to reduced rates of cardiovascular mortality (relative risk, 0.93), myocardial infarction (RR, 0.85), and coronary heart disease events (RR, 0.86). Folic acid supplementation was linked to a decreased stroke risk (RR, 0.84) and coenzyme Q10 was associated with a lower rate of all-cause mortality (RR, 0.68).

“The current study represents the first attempt in providing a comprehensive and most up-to-date evidence map that systematically assessed the quality and quantity of all randomized trials linking the effects of a wide variety of micronutrients on cardiovascular risk factors,” the authors say.

“The comprehensive evidence map presented here highlights the importance of micronutrient diversity and the balance of benefits and risks in the design of whole food–based dietary patterns to promote cardiometabolic health, which may require cultural adaptations to apply globally,” they conclude.

Commenting on some of the specific beneficial findings, Dr. Manson said: “I do believe that the marine omega-3s confer heart benefits, but results are not consistent and vary by dose and formulation.”

However, she pointed out that, regarding folic acid, a previous meta-analysis including eight large randomized trials in more than 37,000 participants found no reduction in coronary events, stroke, or major cardiovascular events with folic acid supplementation, compared with placebo, “so the reported stroke benefit would need further confirmation.”

In an accompanying editorial, Juan Gormaz, PhD, University of Chile, and Rodrigo Carrasco, MD, Chilean Society of Cardiology and Cardiovascular Surgery, both in Santiago, state: “Given that the compounds with more pleiotropic properties produced the better outcomes, the antioxidant paradigm on cardiovascular prevention can be challenged. For example, inasmuch as n-3 fatty acids have antiplatelet and anti-inflammatory properties, they are too complex to enable attribution of the observed benefits solely to their antioxidant capacity.”

The editorialists note that from a research point of view, “although the current information opens interesting perspectives for future consolidation of some antioxidants in preventive cardiology, there is still a long way to go in terms of generating evidence.”

They add that the challenge now for some compounds is to begin establishing consensus in definitions of dose and combinations, as well as continue strengthening the evidence of effectiveness.

“Regarding routine clinical practice, these results begin to open spaces for the integration of new tools into the therapeutic arsenal aimed at cardiovascular prevention in selected populations, which could be easily accessible and, with specific exceptions, would present a low frequency of adverse effects,” they conclude.

This work was partly supported by the United States’ Fulbright Program and by the Beijing Advanced Innovation Center for Food Nutrition and Human Health, the National Natural Science Foundation of China, the Chinese Universities Scientific Fund, and the Beijing Municipal Natural Science Foundation.

Dr. Liu has received honoraria for scientific presentations or reviews at Johns Hopkins University, Fred Hutchinson Cancer Center, Harvard University, University of Buffalo, Guangdong General Hospital, Fuwai Hospital, Chinese Academy of Medical Sciences, and the National Institutes of Health; he is a member of the Data Safety and Monitoring Board for several trials, including the SELECT (Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity) trial sponsored by Novo Nordisk and a trial of pulmonary hypertension in diabetes patients sponsored by Massachusetts General Hospital; he has received royalties from UpToDate and has received an honorarium from the American Society for Nutrition for his duties as Associate Editor. Co-author Jeffrey Mechanick, MD, has received honoraria from Abbott Nutrition for lectures and serves on the advisory boards of Aveta.Life, L-Nutra, and Twin Health. The other authors report no relevant financial relationships.

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

A new type of wound dressing might change burn care for the better with one amazing property: dissolvability. Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.

“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”

Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
 

A better bandage

Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.

Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.

“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.

The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.

“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.

The solution dissolves the hydrogel in 4-6 minutes.
 

Hybrid gels

Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.

“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.

The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.

The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.

And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.

When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.

“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.

The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.

This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.

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

A new type of wound dressing might change burn care for the better with one amazing property: dissolvability. Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.

“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”

Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
 

A better bandage

Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.

Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.

“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.

The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.

“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.

The solution dissolves the hydrogel in 4-6 minutes.
 

Hybrid gels

Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.

“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.

The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.

The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.

And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.

When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.

“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.

The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.

This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.

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

A new type of wound dressing might change burn care for the better with one amazing property: dissolvability. Surgically debriding burn wounds can be tedious for doctors and excruciating for patients. To change that, bioengineers have created a new hydrogel formula that dissolves rapidly from wound sites, melting off in 6 minutes or less.

“The removal of dressings, with the current standard of care, is very hard and time-consuming. It becomes very painful for the patient. People are screaming, or they’re given a lot of opioids,” said senior author O. Berk Usta, PhD, of the Center for Engineering in Medicine and Surgery at Massachusetts General Hospital, Boston. “Those are the things we wanted to minimize: the pain and the time.”

Although beneficial for all patients, a short, painless bandage change would be a particular boon for younger patients. At the pediatric burns care center at Shriners Hospitals for Children (an MGH partner), researchers “observe a lot of children who go through therapy or treatment after burns,” said Dr. Usta. The team at MGH collaborated with scientists at Tufts University, Boston, with those patients in mind, setting out to create a new hydrogel that would transform burn wound care.
 

A better bandage

Hydrogels provide cooling relief to burn wounds and maintain a moist environment that can speed healing. There are currently hydrogel sheets and hydrogel-infused dressings, as well as gel that is applied directly to burn wounds before being covered with protective material. These dressings must be replaced frequently to prevent infections, but that can be unbearably painful and drawn out, as dressings often stick to wounds.

Mechanical debridement can be especially difficult for second-degree burn patients, whose wounds may still retain nerve endings. Debridement tends to also remove some healthy tissue and can damage newly formed tissue, slowing down healing.

“It can take up to 2, 3 hours, and it requires multiple people working on it,” said Dr. Usta.

The new hydrogel treatment can be applied directly to a wound and it forms a protective barrier around the site in 15 seconds. The hydrogel is then covered by a protective dressing until it needs to be changed.

“After you take off the protective covering, you add another solution, which dissolves the [hydrogel] dressing, so that it can be easily removed from the burn site,” Dr. Usta said.

The solution dissolves the hydrogel in 4-6 minutes.
 

Hybrid gels

Many hydrogels currently used for burn wounds feature physically cross-linked molecules. This makes them strong and capable of retaining moisture, but also difficult to dissolve. The researchers used a different approach.

“This is not physical cross-linking like the traditional approaches, but rather, softer covalent bonds between the different molecules. And that’s why, when you bring in another solution, the hydrogel dissolves away,” Dr. Usta said.

The new hydrogels rely on a supramolecular assembly: a network of synthetic polymers whose connections can be reversed more easily, meaning they can be dissolved quickly. Another standout feature of the new hydrogels is their hybrid composition, displaying characteristics of both liquids and solids. The polymers are knitted together into a mesh-like network that enables water retention, with the goal of maintaining the moist environment needed for wound healing.

The supramolecular assembly is also greener, Dr. Usta explained; traditional cross-linking approaches produce a lot of toxic by-products that could harm the environment.

And whereas traditional hydrogels can require a dozen chemistry steps to produce, the new hydrogels are ready after mixing two solutions, Dr. Usta explained. This makes them easy to prepare at bedside, ideal for treating large wounds in the ER or even on battlefields.

When tested in vitro, using skin cells, and in vivo, on mice, the new hydrogels were shown to be safe to use on wounds. Additional studies on mice, as well as large animals, will focus on safety and efficacy, and may be followed by human clinical trials, said Dr. Usta.

“The next phase of the project will be to look at whether these dressings will help wound healing by creating a moist environment,” said Dr. Usta.

The researchers are also exploring how to manufacture individual prewrapped hydrogels that could be applied in a clinical setting – or even in people’s homes. The consumer market is “another possibility,” said Dr. Usta, particularly among patients with “smaller, more superficial burns” or patients whose large burn wounds are still healing once they leave the hospital.

This research was supported by the National Institutes of Health, National Science Foundation, Massachusetts General Hospital Executive Committee on Research Interim Support Fund, and Shriners Hospitals.

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

Respiratory syncytial virus (RSV) and influenza cases are surging to record numbers this winter in the wake of the COVID-19 pandemic when children were sheltering in the home, receiving virtual education, masking, and hand sanitizing, and when other precautionary health measures were in place.

RSV and flu illness in children now have hospital emergency rooms and pediatric ICUs and wards over capacity. As these respiratory infections increase and variants of SARS-CoV-2 come to dominate, we may expect the full impact of a tripledemic (RSV + flu + SARS-CoV-2).

It has been estimated that RSV causes 33 million lower respiratory infections and 3.6 million hospitalizations annually worldwide in children younger than 5 years old (Lancet. 2022 May 19. doi: 10.1016/S0140-6736(22)00478-0). RSV is typically a seasonal respiratory infection occurring in late fall through early winter, when it gives way to dominance by flu. Thus, we have experienced an out-of-season surge in RSV since it began in early fall 2022, and it persists. A likely explanation for the early and persisting surge in RSV is immunity debt (Infect Dis Now. 2021 Aug. doi: 10.1016/j.idnow.2021.05.004).

Immunity debt is an unintended consequence of prevention of infections that occurred because of public health measures to prevent spread of SARS-CoV-2 infections. The COVID-19 lockdown undoubtedly saved many lives. However, while we were sheltering from SARS-CoV-2 infections, we also were avoiding other infections, especially other respiratory infections such as RSV and flu.

Our group studied this in community-based pediatric practices in Rochester, N.Y. Physician-diagnosed, medically attended infectious disease illness visits were assessed in two child cohorts, age 6-36 months from March 15 to Dec. 31, 2020 (the pandemic period), compared with the same months in 2019 (prepandemic). One hundred forty-four children were included in the pandemic cohort and 215 in the prepandemic cohort. Visits for bronchiolitis were 7.4-fold lower (P = .04), acute otitis media 3.7-fold lower (P < .0001), viral upper respiratory infections (URI) 3.8-fold lower (P < .0001), and croup 27.5-fold lower (P < .0001) in the pandemic than the prepandemic cohort (Front Pediatr. 2021 Sep 13. doi: 10.3389/fped.2021.72248).

The significant reduction in respiratory illness during the COVID-19 epidemic we and others observed resulted in a large pool of children who did not experience RSV or flu infections for an entire year or more. Herd immunity dropped. The susceptible child population increased, including children older than typically seen. We had an immunity debt that had to be repaid, and the repayment is occurring now.

As a consequence of the surge in RSV, interest in prevention has gained more attention. In 1966, tragically, two infant deaths and hospitalization of 80% of the participating infants occurred during a clinical trial of an experimental candidate RSV vaccine, which contained an inactivated version of the entire virus. The severe side effect was later found to be caused by both an antibody and a T-cell problem. The antibody produced in response to the inactivated whole virus didn’t have very good functional activity at blocking or neutralizing the virus. That led to deposition of immune complexes and activation of complement that damaged the airways. The vaccine also triggered a T-cell response with inflammatory cytokine release that added to airway obstruction and lack of clearance of the virus. RSV vaccine development was halted and the bar for further studies was raised very high to ensure safety of any future RSV vaccines. Now, 55 years later, two RSV vaccines and a new preventive monoclonal antibody are nearing licensure.

GlaxoSmithKline (GSK) and Pfizer are in phase 3 clinical trials of a safer RSV vaccine that contains only the RSV surface protein known as protein F. Protein F changes its structure when the virus infects and fuses with human respiratory epithelial cells. The GSK and Pfizer vaccines use a molecular strategy developed at the National Institutes of Health to lock protein F into its original, prefusion configuration. A similar strategy was used by Pfizer/BioNTech and Moderna in their design of mRNA vaccines to the SARS-CoV-2 spike surface protein.

A vaccine with the F protein in its prefusion form takes care of the antibody problem that caused the severe side-effects from the 1966 version of inactivated whole virus vaccine because it induces very high-efficiency, high-potency antibodies that neutralize the RSV. The T-cell response is not as well understood and that is why studies are being done in adults first and then moving to young infants.

The new RSV vaccines are being developed for use in adults over age 60, adults with comorbidities, maternal immunization, and infants. Encouraging results were recently reported by GSK and Pfizer from adult trials. In an interim analysis, Pfizer also recently reported that maternal immunization in the late second or third trimester with their vaccine had an efficacy of 82% within a newborn’s first 90 days of life against severe lower respiratory tract illness. At age 6 months, the efficacy was sustained at 69%. So far, both the GSK and Pfizer RSV vaccines have shown a favorable safety profile.

Another strategy in the RSV prevention field has been a monoclonal antibody. Palivizumab (Synagis, AstraZeneca) is used to prevent severe RSV infections in prematurely born and other infants who are at higher risk of mortality and severe morbidity. Soon there will likely be another monoclonal antibody, called nirsevimab (Beyfortus, AstraZeneca and Sanofi). It is approved in Europe but not yet approved in the United States as I prepare this column. Nirsevimab may be even better than palivizumab – based on phase 3 trial data – and a single injection lasts through an entire normal RSV season while palivizumab requires monthly injections.

Similar to the situation with RSV, the flu season started earlier than usual in fall 2022 and has been picking up steam, likely also because of immunity debt. The WHO estimates that annual epidemics of influenza cause 1 billion infections, 3 million to 5 million severe cases, and 300,000-500,000 deaths. Seasonal flu vaccines provide modest protection. Current flu vaccine formulations consist of the hemagglutinin (H) and neuraminidase (N) proteins but those proteins change sufficiently (called antigenic drift) such that production of the vaccines based on a best guess each year often is not correct for the influenza A or influenza B strains that circulate in a given year (antigenic mismatch).

Public health authorities have long worried about a major change in the composition of the H and N proteins of the influenza virus (called antigenic shift). Preparedness and response to the COVID-19 pandemic was based on preparedness and response to an anticipated influenza pandemic similar to the 1918 flu pandemic. For flu, new “universal” vaccines are in development. Among the candidate vaccines are mRNA vaccines, building on the success of the SARS-CoV-2 mRNA vaccines (Science. 2022 Nov 24. doi: 10.1126/science.abm0271).
 

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

Respiratory syncytial virus (RSV) and influenza cases are surging to record numbers this winter in the wake of the COVID-19 pandemic when children were sheltering in the home, receiving virtual education, masking, and hand sanitizing, and when other precautionary health measures were in place.

RSV and flu illness in children now have hospital emergency rooms and pediatric ICUs and wards over capacity. As these respiratory infections increase and variants of SARS-CoV-2 come to dominate, we may expect the full impact of a tripledemic (RSV + flu + SARS-CoV-2).

It has been estimated that RSV causes 33 million lower respiratory infections and 3.6 million hospitalizations annually worldwide in children younger than 5 years old (Lancet. 2022 May 19. doi: 10.1016/S0140-6736(22)00478-0). RSV is typically a seasonal respiratory infection occurring in late fall through early winter, when it gives way to dominance by flu. Thus, we have experienced an out-of-season surge in RSV since it began in early fall 2022, and it persists. A likely explanation for the early and persisting surge in RSV is immunity debt (Infect Dis Now. 2021 Aug. doi: 10.1016/j.idnow.2021.05.004).

Immunity debt is an unintended consequence of prevention of infections that occurred because of public health measures to prevent spread of SARS-CoV-2 infections. The COVID-19 lockdown undoubtedly saved many lives. However, while we were sheltering from SARS-CoV-2 infections, we also were avoiding other infections, especially other respiratory infections such as RSV and flu.

Our group studied this in community-based pediatric practices in Rochester, N.Y. Physician-diagnosed, medically attended infectious disease illness visits were assessed in two child cohorts, age 6-36 months from March 15 to Dec. 31, 2020 (the pandemic period), compared with the same months in 2019 (prepandemic). One hundred forty-four children were included in the pandemic cohort and 215 in the prepandemic cohort. Visits for bronchiolitis were 7.4-fold lower (P = .04), acute otitis media 3.7-fold lower (P < .0001), viral upper respiratory infections (URI) 3.8-fold lower (P < .0001), and croup 27.5-fold lower (P < .0001) in the pandemic than the prepandemic cohort (Front Pediatr. 2021 Sep 13. doi: 10.3389/fped.2021.72248).

The significant reduction in respiratory illness during the COVID-19 epidemic we and others observed resulted in a large pool of children who did not experience RSV or flu infections for an entire year or more. Herd immunity dropped. The susceptible child population increased, including children older than typically seen. We had an immunity debt that had to be repaid, and the repayment is occurring now.

As a consequence of the surge in RSV, interest in prevention has gained more attention. In 1966, tragically, two infant deaths and hospitalization of 80% of the participating infants occurred during a clinical trial of an experimental candidate RSV vaccine, which contained an inactivated version of the entire virus. The severe side effect was later found to be caused by both an antibody and a T-cell problem. The antibody produced in response to the inactivated whole virus didn’t have very good functional activity at blocking or neutralizing the virus. That led to deposition of immune complexes and activation of complement that damaged the airways. The vaccine also triggered a T-cell response with inflammatory cytokine release that added to airway obstruction and lack of clearance of the virus. RSV vaccine development was halted and the bar for further studies was raised very high to ensure safety of any future RSV vaccines. Now, 55 years later, two RSV vaccines and a new preventive monoclonal antibody are nearing licensure.

GlaxoSmithKline (GSK) and Pfizer are in phase 3 clinical trials of a safer RSV vaccine that contains only the RSV surface protein known as protein F. Protein F changes its structure when the virus infects and fuses with human respiratory epithelial cells. The GSK and Pfizer vaccines use a molecular strategy developed at the National Institutes of Health to lock protein F into its original, prefusion configuration. A similar strategy was used by Pfizer/BioNTech and Moderna in their design of mRNA vaccines to the SARS-CoV-2 spike surface protein.

A vaccine with the F protein in its prefusion form takes care of the antibody problem that caused the severe side-effects from the 1966 version of inactivated whole virus vaccine because it induces very high-efficiency, high-potency antibodies that neutralize the RSV. The T-cell response is not as well understood and that is why studies are being done in adults first and then moving to young infants.

The new RSV vaccines are being developed for use in adults over age 60, adults with comorbidities, maternal immunization, and infants. Encouraging results were recently reported by GSK and Pfizer from adult trials. In an interim analysis, Pfizer also recently reported that maternal immunization in the late second or third trimester with their vaccine had an efficacy of 82% within a newborn’s first 90 days of life against severe lower respiratory tract illness. At age 6 months, the efficacy was sustained at 69%. So far, both the GSK and Pfizer RSV vaccines have shown a favorable safety profile.

Another strategy in the RSV prevention field has been a monoclonal antibody. Palivizumab (Synagis, AstraZeneca) is used to prevent severe RSV infections in prematurely born and other infants who are at higher risk of mortality and severe morbidity. Soon there will likely be another monoclonal antibody, called nirsevimab (Beyfortus, AstraZeneca and Sanofi). It is approved in Europe but not yet approved in the United States as I prepare this column. Nirsevimab may be even better than palivizumab – based on phase 3 trial data – and a single injection lasts through an entire normal RSV season while palivizumab requires monthly injections.

Similar to the situation with RSV, the flu season started earlier than usual in fall 2022 and has been picking up steam, likely also because of immunity debt. The WHO estimates that annual epidemics of influenza cause 1 billion infections, 3 million to 5 million severe cases, and 300,000-500,000 deaths. Seasonal flu vaccines provide modest protection. Current flu vaccine formulations consist of the hemagglutinin (H) and neuraminidase (N) proteins but those proteins change sufficiently (called antigenic drift) such that production of the vaccines based on a best guess each year often is not correct for the influenza A or influenza B strains that circulate in a given year (antigenic mismatch).

Public health authorities have long worried about a major change in the composition of the H and N proteins of the influenza virus (called antigenic shift). Preparedness and response to the COVID-19 pandemic was based on preparedness and response to an anticipated influenza pandemic similar to the 1918 flu pandemic. For flu, new “universal” vaccines are in development. Among the candidate vaccines are mRNA vaccines, building on the success of the SARS-CoV-2 mRNA vaccines (Science. 2022 Nov 24. doi: 10.1126/science.abm0271).
 

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

Respiratory syncytial virus (RSV) and influenza cases are surging to record numbers this winter in the wake of the COVID-19 pandemic when children were sheltering in the home, receiving virtual education, masking, and hand sanitizing, and when other precautionary health measures were in place.

RSV and flu illness in children now have hospital emergency rooms and pediatric ICUs and wards over capacity. As these respiratory infections increase and variants of SARS-CoV-2 come to dominate, we may expect the full impact of a tripledemic (RSV + flu + SARS-CoV-2).

It has been estimated that RSV causes 33 million lower respiratory infections and 3.6 million hospitalizations annually worldwide in children younger than 5 years old (Lancet. 2022 May 19. doi: 10.1016/S0140-6736(22)00478-0). RSV is typically a seasonal respiratory infection occurring in late fall through early winter, when it gives way to dominance by flu. Thus, we have experienced an out-of-season surge in RSV since it began in early fall 2022, and it persists. A likely explanation for the early and persisting surge in RSV is immunity debt (Infect Dis Now. 2021 Aug. doi: 10.1016/j.idnow.2021.05.004).

Immunity debt is an unintended consequence of prevention of infections that occurred because of public health measures to prevent spread of SARS-CoV-2 infections. The COVID-19 lockdown undoubtedly saved many lives. However, while we were sheltering from SARS-CoV-2 infections, we also were avoiding other infections, especially other respiratory infections such as RSV and flu.

Our group studied this in community-based pediatric practices in Rochester, N.Y. Physician-diagnosed, medically attended infectious disease illness visits were assessed in two child cohorts, age 6-36 months from March 15 to Dec. 31, 2020 (the pandemic period), compared with the same months in 2019 (prepandemic). One hundred forty-four children were included in the pandemic cohort and 215 in the prepandemic cohort. Visits for bronchiolitis were 7.4-fold lower (P = .04), acute otitis media 3.7-fold lower (P < .0001), viral upper respiratory infections (URI) 3.8-fold lower (P < .0001), and croup 27.5-fold lower (P < .0001) in the pandemic than the prepandemic cohort (Front Pediatr. 2021 Sep 13. doi: 10.3389/fped.2021.72248).

The significant reduction in respiratory illness during the COVID-19 epidemic we and others observed resulted in a large pool of children who did not experience RSV or flu infections for an entire year or more. Herd immunity dropped. The susceptible child population increased, including children older than typically seen. We had an immunity debt that had to be repaid, and the repayment is occurring now.

As a consequence of the surge in RSV, interest in prevention has gained more attention. In 1966, tragically, two infant deaths and hospitalization of 80% of the participating infants occurred during a clinical trial of an experimental candidate RSV vaccine, which contained an inactivated version of the entire virus. The severe side effect was later found to be caused by both an antibody and a T-cell problem. The antibody produced in response to the inactivated whole virus didn’t have very good functional activity at blocking or neutralizing the virus. That led to deposition of immune complexes and activation of complement that damaged the airways. The vaccine also triggered a T-cell response with inflammatory cytokine release that added to airway obstruction and lack of clearance of the virus. RSV vaccine development was halted and the bar for further studies was raised very high to ensure safety of any future RSV vaccines. Now, 55 years later, two RSV vaccines and a new preventive monoclonal antibody are nearing licensure.

GlaxoSmithKline (GSK) and Pfizer are in phase 3 clinical trials of a safer RSV vaccine that contains only the RSV surface protein known as protein F. Protein F changes its structure when the virus infects and fuses with human respiratory epithelial cells. The GSK and Pfizer vaccines use a molecular strategy developed at the National Institutes of Health to lock protein F into its original, prefusion configuration. A similar strategy was used by Pfizer/BioNTech and Moderna in their design of mRNA vaccines to the SARS-CoV-2 spike surface protein.

A vaccine with the F protein in its prefusion form takes care of the antibody problem that caused the severe side-effects from the 1966 version of inactivated whole virus vaccine because it induces very high-efficiency, high-potency antibodies that neutralize the RSV. The T-cell response is not as well understood and that is why studies are being done in adults first and then moving to young infants.

The new RSV vaccines are being developed for use in adults over age 60, adults with comorbidities, maternal immunization, and infants. Encouraging results were recently reported by GSK and Pfizer from adult trials. In an interim analysis, Pfizer also recently reported that maternal immunization in the late second or third trimester with their vaccine had an efficacy of 82% within a newborn’s first 90 days of life against severe lower respiratory tract illness. At age 6 months, the efficacy was sustained at 69%. So far, both the GSK and Pfizer RSV vaccines have shown a favorable safety profile.

Another strategy in the RSV prevention field has been a monoclonal antibody. Palivizumab (Synagis, AstraZeneca) is used to prevent severe RSV infections in prematurely born and other infants who are at higher risk of mortality and severe morbidity. Soon there will likely be another monoclonal antibody, called nirsevimab (Beyfortus, AstraZeneca and Sanofi). It is approved in Europe but not yet approved in the United States as I prepare this column. Nirsevimab may be even better than palivizumab – based on phase 3 trial data – and a single injection lasts through an entire normal RSV season while palivizumab requires monthly injections.

Similar to the situation with RSV, the flu season started earlier than usual in fall 2022 and has been picking up steam, likely also because of immunity debt. The WHO estimates that annual epidemics of influenza cause 1 billion infections, 3 million to 5 million severe cases, and 300,000-500,000 deaths. Seasonal flu vaccines provide modest protection. Current flu vaccine formulations consist of the hemagglutinin (H) and neuraminidase (N) proteins but those proteins change sufficiently (called antigenic drift) such that production of the vaccines based on a best guess each year often is not correct for the influenza A or influenza B strains that circulate in a given year (antigenic mismatch).

Public health authorities have long worried about a major change in the composition of the H and N proteins of the influenza virus (called antigenic shift). Preparedness and response to the COVID-19 pandemic was based on preparedness and response to an anticipated influenza pandemic similar to the 1918 flu pandemic. For flu, new “universal” vaccines are in development. Among the candidate vaccines are mRNA vaccines, building on the success of the SARS-CoV-2 mRNA vaccines (Science. 2022 Nov 24. doi: 10.1126/science.abm0271).
 

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

New cases of COVID-19 in children largely held steady over the Thanksgiving holiday, but hospital admissions are telling a somewhat different story.

New pediatric COVID cases for the week ending on Thanksgiving (11/18-11/24) were up by 5.3% over the previous week, but in the most recent week (11/25-12/1) new cases dropped by 2.6%, according to state data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

In both weeks, though, the total case count stayed below 30,000 – a streak that has now lasted 8 weeks – so the actual number of weekly cases remained fairly low, the AAP/CHA weekly report indicates.

The nation’s emergency departments also experienced a small Thanksgiving bump, as the proportion of visits with diagnosed COVID went from 1.0% of all ED visits for children aged 0-11 years on Nov. 14 to 2.0% on Nov. 27, just 3 days after the official holiday, based on data from the Centers for Disease Control and Prevention. The rate was down to 1.5% on Dec. 1, and similar patterns can be seen for children aged 12-15 and 16-17 years.

New hospital admissions, on the other hand, seem to be following a different path, at least according to the CDC. The hospitalization rate for children aged 0-17 years bottomed out at 0.16 new admissions per 100,000 population back on Oct. 21 and has climbed fairly steadily since then. It was up to 0.20 per 100,000 by Nov. 14, had reached 0.22 per 100,000 on Thanksgiving day (11/24), and then continued to 0.26 per 100,000 by Dec. 2, the latest date for which CDC data are available.

The hospitalization story, however, offers yet another twist. The New York Times, using data from the U.S. Department of Health & Human Services, reports that new COVID-related admissions have held steady at 1.0 per 100,000 since Nov. 18. The rate is much higher than has been reported by the CDC, but no increase can be seen in recent weeks among children, which is not the case for Americans overall, Medscape recently reported.

New cases of COVID-19 in children largely held steady over the Thanksgiving holiday, but hospital admissions are telling a somewhat different story.

New pediatric COVID cases for the week ending on Thanksgiving (11/18-11/24) were up by 5.3% over the previous week, but in the most recent week (11/25-12/1) new cases dropped by 2.6%, according to state data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

In both weeks, though, the total case count stayed below 30,000 – a streak that has now lasted 8 weeks – so the actual number of weekly cases remained fairly low, the AAP/CHA weekly report indicates.

The nation’s emergency departments also experienced a small Thanksgiving bump, as the proportion of visits with diagnosed COVID went from 1.0% of all ED visits for children aged 0-11 years on Nov. 14 to 2.0% on Nov. 27, just 3 days after the official holiday, based on data from the Centers for Disease Control and Prevention. The rate was down to 1.5% on Dec. 1, and similar patterns can be seen for children aged 12-15 and 16-17 years.

New hospital admissions, on the other hand, seem to be following a different path, at least according to the CDC. The hospitalization rate for children aged 0-17 years bottomed out at 0.16 new admissions per 100,000 population back on Oct. 21 and has climbed fairly steadily since then. It was up to 0.20 per 100,000 by Nov. 14, had reached 0.22 per 100,000 on Thanksgiving day (11/24), and then continued to 0.26 per 100,000 by Dec. 2, the latest date for which CDC data are available.

The hospitalization story, however, offers yet another twist. The New York Times, using data from the U.S. Department of Health & Human Services, reports that new COVID-related admissions have held steady at 1.0 per 100,000 since Nov. 18. The rate is much higher than has been reported by the CDC, but no increase can be seen in recent weeks among children, which is not the case for Americans overall, Medscape recently reported.

New cases of COVID-19 in children largely held steady over the Thanksgiving holiday, but hospital admissions are telling a somewhat different story.

New pediatric COVID cases for the week ending on Thanksgiving (11/18-11/24) were up by 5.3% over the previous week, but in the most recent week (11/25-12/1) new cases dropped by 2.6%, according to state data collected by the American Academy of Pediatrics and the Children’s Hospital Association.

In both weeks, though, the total case count stayed below 30,000 – a streak that has now lasted 8 weeks – so the actual number of weekly cases remained fairly low, the AAP/CHA weekly report indicates.

The nation’s emergency departments also experienced a small Thanksgiving bump, as the proportion of visits with diagnosed COVID went from 1.0% of all ED visits for children aged 0-11 years on Nov. 14 to 2.0% on Nov. 27, just 3 days after the official holiday, based on data from the Centers for Disease Control and Prevention. The rate was down to 1.5% on Dec. 1, and similar patterns can be seen for children aged 12-15 and 16-17 years.

New hospital admissions, on the other hand, seem to be following a different path, at least according to the CDC. The hospitalization rate for children aged 0-17 years bottomed out at 0.16 new admissions per 100,000 population back on Oct. 21 and has climbed fairly steadily since then. It was up to 0.20 per 100,000 by Nov. 14, had reached 0.22 per 100,000 on Thanksgiving day (11/24), and then continued to 0.26 per 100,000 by Dec. 2, the latest date for which CDC data are available.

The hospitalization story, however, offers yet another twist. The New York Times, using data from the U.S. Department of Health & Human Services, reports that new COVID-related admissions have held steady at 1.0 per 100,000 since Nov. 18. The rate is much higher than has been reported by the CDC, but no increase can be seen in recent weeks among children, which is not the case for Americans overall, Medscape recently reported.

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

With youth obesity on the rise – an estimated 1 in 5 youths are impacted by obesity, according to the Centers for Disease Control and Prevention – conversations about healthy weight are becoming more commonplace, not only in the pediatrician’s office, but at home, too. But the language we use around this sensitive topic is important, as youths are acutely aware that words have a direct impact on their mental health.

Sixteen-year-old Avery DiCocco of Northbrook, Ill., knows how vulnerable teenagers feel. 

“I think it definitely matters the way that parents and doctors address weight,” she said. “You never know who may be insecure, and using negative words could go a lot further than they think with impacting self-esteem.” 

A new study published in Pediatrics brings light to the words that parents (and providers) use when speaking to youths (ages 10-17) about their weight.

Researchers from the University of Connecticut Rudd Center for Food Policy & Health, Hartford, led an online survey of youths and their parents. Those who took part were asked about 27  terms related to body weight. Parents were asked to comment on their use of these words, while youths commented on the emotional response. The researchers said 1,936 parents and 2,032 adolescents were surveyed between September and December 2021.

Although results skewed toward the use of more positive words, such as “healthy weight,” over terms like “obese,” “fat” or “large,” there was variation across ethnicity, sexual orientation, and weight status. For example, it was noted in the study, funded by WW International, that preference for the word “curvy” was higher among Hispanic/Latino youths, sexual minority youths, and those with a body mass index in the 95th percentile, compared with their White, heterosexual, and lower-weight peers.
 

Words matter

In 2017, the American Academy of Pediatrics came out with a policy statement on weight stigma and the need for doctors to use more neutral language and less stigmatizing terms in practice when discussing weight among youths.

But one of the reasons this new study is important, said Gregory Germain, MD, associate chief of pediatrics at Yale New Haven (Conn.) Children’s Hospital, is that this study focuses on parents who interact with their kids much more often than a pediatrician who sees them a few times a year.

“Parental motivation, discussion, interaction on a consistent basis – that dialogue is so critical in kids with obesity,” said Germain, who stresses that all adults, coaches, and educators should consider this study as well.

“When we think about those detrimental impacts on mental health when more stigmatizing language is used, just us being more mindful in how we are talking to youth can make such a profound impact,” said Rebecca Kamody, PhD, a clinical psychologist at Yale University, with a research and clinical focus on eating and weight disorders.

“In essence, this is a low-hanging fruit intervention,” she said. 

Dr. Kamody recommends we take a lesson from “cultural humility” in psychology to understand how to approach this with kids, calling for “the humbleness as parents or providers in asking someone what they want used to make it the safest place for a discussion with our youth.”
 

One piece of the puzzle 

Dr. Germain and Dr. Kamody agreed that language in discussing this topic is important but that we need to recognize that this topic in general is extremely tricky.

For one, “there are these very real metabolic complications of having high weight at a young age,” said Kamody, who stresses the need for balance to make real change.

Dr. Germain agreed. “Finding a fine line between discussing obesity and not kicking your kid into disordered eating is important.”

The researchers also recognize the limits of an online study, where self-reporting parents may not want to admit using negative weight terminology, but certainly believe it’s a start in identifying some of the undesirable patterns that may be occurring when it comes to weight.

“The overarching message is a positive one, that with our preteens and teenage kids, we need to watch our language, to create a nonjudgmental and safe environment to discuss weight and any issue involved with taking care of themselves,” said Dr. Germain.

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

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Headlines from earlier in the fall were grim: Thanks to the COVID-19 pandemic, life expectancy in the United States has fallen for 2 years running. Last year, according to health officials, the average American newborn could hope to reach 76.1 years, down from 79 years in 2019.

So far, so bad. But the headlines don’t tell the full story, which is much less dire. In fact, 2022 is the best year in human history for a child to arrive on Earth.

For a child born this year, in a developed country, into a family with access to good health care, the odds of living into the 22nd century are almost 50%. One in three will live to be 100. Those estimates reflect only incremental progress in medicine and public health, with COVID-19 baked in. They don’t account for biotechnologies beckoning to take control of the cell cycle and aging itself – which could make the outlook much brighter.

For some perspective, consider that a century ago, life expectancy for an American neonate was about 60 years. That 1922 figure was itself nothing short of miraculous, representing a 25% jump since 1901 – a leap that far outstrips the first 2 decades of the current century, during which life expectancy rose by just 2.5 years.

A gain of 2.5 years over 2 decades might not sound impressive, even without COVID-19 causing life expectancy in this country and abroad to sag. But during the pandemic, exciting new technologies that could drive gains in lifespan and healthspan, even bigger than those seen in the early 20th century, have moved closer to clinical reality. Think Star Trek-ish technologies like human hibernation, universal blood, mRNA therapy able to reprogram immune cells to hunt malignancies and fibrotic tissue, even head transplantation.

How long that last one will take to reach a clinic near you is hard to predict, but advances in the needed technology to anastomose cephalic and somatic portions of the spinal cord are mind-boggling. All this means that, from a medical standpoint, the future for babies born in the early 2020s looks dazzlingly bright.

Those sunny rays of optimism likely have failed to pierce the gloom of public discourse. Between “breakthrough infections,” “long COVID,” “Paxlovid rebound,” vaccine-induced myopericarditis, the current respiratory syncytial virus (RSV) outbreak, school shootings, climate change, and the youth mental health crisis, news headlines are undoubtedly frightful.
 

RSV: What’s old is new again

For the youngest children, the RSV outbreak is currently the scariest story. With social interactions returning toward a pre-COVID state, RSV has rebounded with a vengeance. In many places, pediatric wards are close to, at, or even beyond capacity. With no antiviral treatment for RSV, no licensed vaccine quite yet, and passive immunization (intravenous palivizumab) reserved for children at greatest risk (those under age 6 months and born preterm 35 weeks or earlier), the situation does have the feel of the first year of COVID-19, when treatments were similarly limited.

But let’s keep some perspective. RSV has always been a devastating infection. Prior to COVID-19, in the United States alone RSV killed 100-300 children below age 5 and 6,000-10,000 adults above age 65. The toll has always been worse on the international level. In 2019, 3.6 million people around the world were hospitalized for RSV infections, mostly the very old and the very young. Among causes of death below the age of 5, RSV ranks second only to malaria.

Postvaccine myopericarditis, a favorite concern of the vaccine hesitant, is a real phenomenon in young males. But generally, the condition has a subclinical to mild manifestation and fully resolves within 2 weeks.
 

Vaccines on the horizon

Monkeypox also was putting a damper on health news in recent months. Yet outreach efforts and selective vaccination and other precautions based on risk stratification appear to have calmed the outbreak. That’s good news, as is the fact that the struggle against malaria may be about to change. After decades of trying, we now have a malaria vaccine with what appears to be 80% efficacy against the infection. The same goes for RSV; finally, not one but two RSV vaccines are showing promise in late-stage clinical trials.

To be sure, for many young people, the times don’t seem so wonderful. The rate of teen suicide is alarming – yet it remains well below that seen in the 1990s. Are social media to blame, or is it something more complex?

If COVID-19 has taught us anything, it’s that development of vaccines and treatments need not take a decade or more. Operation Warp Speed may have seemed like a marketing gimmick and political grandstanding, but you can’t argue with the results.

Keep that perspective in mind to appreciate the moment – which I believe is coming soon – when the same type of intramuscular injection that we now use to trigger immunity against SARS-CoV-2 hits clinics, only this time as a way to cure cancer. Or when you read the stories of young victims of firearm violence who would have died but are rapidly cooled and kept hibernating for hours, so that their wounds can be repaired. And although you may not see that head transplant, one of these new babies might see it, or even might perform the procedure.
 

Dr. Warmflash is a freelance health and science writer living in Portland, Ore. His recent book, Moon: An Illustrated History: From Ancient Myths to the Colonies of Tomorrow, tells the story of the moon’s role in a plethora of historical events, from the origin of life to early calendar systems, the emergence of science and technology, and the dawn of the Space Age. He reported having no relevant financial disclosures. A version of this article first appeared on Medscape.com.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

Adding a clinical decision support system (CDSS) to team-based diabetes care only modestly improved patients’ cardiovascular risk factors over team-based care alone, a randomized trial in China showed.

The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.

Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.

They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.

Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.

“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
 

Small improvements

To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.

Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.

The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.

At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.

After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).

The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).

All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
 

Addressing social needs

Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.

However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.

Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”

On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.

Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”

“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.

Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”

She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
 

Another team approach

Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.

In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.

Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.

Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.

Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).

Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.

In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.

The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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

A randomized trial indicating that surgical masks are not inferior to N95 masks in protecting health care workers against COVID-19 has sparked international criticism.

The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.

Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”

The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.

This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.

A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.

In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”

Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”

“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”

“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”

“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.

“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”

The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.

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