Pediatrics

As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.

The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.¹ But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.²

Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.^3,4

I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.

© Catherine Yeulet/ iStockphoto

The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics ^at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.

References

1. Interact J Med Res. 2015 Jun 22;4(2):e12.

2. “Google Sharpens Search Results for ‘Skin Rash,’ ‘Tummy Ache’ and Other Symptoms,” Wall Street Journal, by Nathan Olivarez-Giles, June 20, 2016.

3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.

4. Ann Pharmacother. 2011 Oct;45(10):1302-4.

Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.

The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.¹ But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.²

Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.^3,4

I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.

© Catherine Yeulet/ iStockphoto

The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics ^at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.

References

1. Interact J Med Res. 2015 Jun 22;4(2):e12.

2. “Google Sharpens Search Results for ‘Skin Rash,’ ‘Tummy Ache’ and Other Symptoms,” Wall Street Journal, by Nathan Olivarez-Giles, June 20, 2016.

3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.

4. Ann Pharmacother. 2011 Oct;45(10):1302-4.

Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

As physicians, we have a responsibility to stay abreast of the medical literature to provide state of the art pediatric care. We have at our disposal reliable resources to stay current, from professional organizations that provide us with updated practice guidelines, to scientific publications with cutting-edge medical research and clinical databases that offer support for medical decision making.

The greater public, however, does not have the luxury of a guide to navigate the health information ocean. In addition to traditional news outlets, such as television and the printed press, the advent of the Internet and social media have placed unprecedented amounts of medical information at everyone’s fingertips.¹ But not all health information is created equal, and even “Dr. Google” has admitted its symptoms search engine has not been very helpful.²

Many websites, despite authoritarian-sounding domain names, are not impartial providers of medical information. The power of the media to shape public perception is perhaps nowhere more poignantly felt than in the pediatric community, where the now thoroughly debunked study by Dr. Andrew Wakefield that linked the MMR vaccine to autism continues to have lingering effects on vaccination rates.^3,4

I recently completed an internship in medical journalism with ABC News in New York City to better understand how the news media provides health and medical information to millions of Americans. Lay medical journalists have the complicated task of reviewing new research, weighing its newsworthiness, and distilling complex concepts down to easy-to-digest sound bites. Working with medical correspondents and the editorial team, I reviewed new scientific studies, dissected their impact, and pondered their potential for a catchy headline. I also wrote content for medical segments and participated in educational Twitter chats. What made the headlines wasn’t always what I thought should make the headlines, and translating the results of a randomized, controlled trial into a 60-second script for television felt near impossible. Dipping my toes into medical journalism gave me a new appreciation of my role as a physician educator – avoiding health information overload and promoting meaningful health literacy for my patients.

© Catherine Yeulet/ iStockphoto

The 24/7 medical news cycle is here to stay. Our patients will continue to use various media platforms for medical information whether we like it or not. It is our responsibility as pediatricians to help families get the most relevant and current medical information. By directing them to trustworthy sources, such as the American Academy of Pediatrics ^at healthychildren.org or the National Library of Medicine at www.nlm.nih.gov/medlineplus, we can strengthen our therapeutic alliance while promoting health literacy.

References

1. Interact J Med Res. 2015 Jun 22;4(2):e12.

2. “Google Sharpens Search Results for ‘Skin Rash,’ ‘Tummy Ache’ and Other Symptoms,” Wall Street Journal, by Nathan Olivarez-Giles, June 20, 2016.

3. “A Discredited Vaccine Study’s Continuing Impact on Public Health,” by Clyde Haberman, Feb. 1, 2015.

4. Ann Pharmacother. 2011 Oct;45(10):1302-4.

Dr. Talbot is a third-year resident at Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tenn. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

SCOTTSDALE, ARIZ. – Children with severe atopic dermatitis were significantly more likely to log at least 5 hours of screen time a day, and were significantly less likely to exercise than were nonatopic controls, said the lead investigator of a large national study.

“Atopic dermatitis overall was not associated with sedentary behavior. It was severe disease only,” said Mark Strom of the department of dermatology, Northwestern University, Chicago, during an oral presentation at the annual meeting of the Society for Investigative Dermatology. Patients tended to be even more sedentary if they suffered from disturbed sleep in addition to severe eczema, he added.

Heat and sweat worsen the intense itch of atopic dermatitis. Hypothesizing that this would deter affected children from physical activity, Mr. Strom and his associates analyzed data for 131,783 respondents aged 18 and under from the National Survey of Children’s Health. The survey assesses physical activity by asking how many days a week the respondent sweated and breathed hard for at least 20 minutes. Screen time is measured by asking about daily hours spent watching television and playing video games, and sleep quality is assessed by asking how many nights a week the child slept the normal amount for his or her age.

Simply having atopic dermatitis was linked with only a slight increase in the chance of having a sedentary lifestyle after controlling for demographic factors, insurance status, geographic location, and educational level, according to Mr. Strom. Specifically, eczema was significantly associated with a 12% lower odds of having exercised on at least 3 days of the previous week (odds ratio, 0.88). However, severe atopic dermatitis significantly reduced the odds that a child exercised at least one day a week by 61% (OR, 0.39). Furthermore, severe atopic dermatitis was associated with more than double the odds of having at least 5 hours of daily screen time (OR, 2.62). And having either moderate or severe eczema was tied to a significant decrease in the odds of having participated in sports in the past year, Mr. Strom said.

“Atopic dermatitis and sleep disturbance each contribute to sedentary behavior,” he reported. Nonatopic children who did not sleep enough on most nights had nearly double the odds of heavy television and video game use, compared with children who slept more, a significant difference. When poor sleepers also had atopic dermatitis, their odds of heavy screen use more than tripled. Poor sleepers were also significantly less likely to join sports teams, even when they did not have eczema, Mr. Strom said.

“Children with more severe atopic dermatitis may have more profound exacerbations of activity-related symptoms, which would lead to these findings,” he concluded. Future studies should explore whether better symptom control can help improve sedentary behaviors, he added.

The study was sponsored by the Maternal and Child Health Bureau of the U.S. Department of Health and Human Services. Mr. Strom had no disclosures.

MINNEAPOLIS, MINN. – For a select subset of pediatric dermatology patients, home phototherapy may represent a safe, effective, and even affordable alternative to office visits. Some families whose children are in treatment for vitiligo, psoriasis, and atopic dermatitis may find that the expense and learning curve of administering treatment at home are worthwhile, but dermatologists must select those families carefully.

Leslie Castelo-Soccio, MD, PhD, professor of pediatric dermatology at the Children’s Hospital of Philadelphia, gave an overview of medical phototherapy for childhood skin diseases at the annual meeting of the Society for Pediatric Dermatology.

For vitiligo, narrow-band UVB’s (NBUVB) effectiveness is maximized if treatment is begun relatively early, and if results are going to happen, they’ll show up fairly quickly. “If there’s no response after six months, stop the therapy,” Dr. Castelo-Soccio said.

Although the literature shows NBUVB to be effective in treating atopic dermatitis, Dr. Castelo-Soccio noted that most pediatric atopic dermatitis studies have been small and retrospective and conducted in a population with severe disease.

Regarding psoriasis in children, the literature shows “higher numbers of patients with near-complete or complete response,” she said.

The experience of NBUVB for pediatric dermatologic conditions at the Children’s Hospital of Philadelphia supports the idea that “the best responses are seen after at least 40 treatments,” and that 6 months is enough time to see whether a patient will respond. The best responders at her institution are children with facial vitiligo. “Of course, you get a better response with compliance,” she noted.

The experience of her patients falls in line with the data about side effects, in which the most common adverse events are reactivation of HSV and burning.

Families ask about cancer risk, but “there are no published data on the risk of skin cancer in long-term phototherapy in children,” she said. At this point, the best pediatric dermatologists can do is to extrapolate risk from data on phototherapy for neonatal jaundice, but even those data are inconclusive, she said.

Dr. Castelo-Soccio noted that it’s pretty common for families to request home treatment: “When you start talking to patients about phototherapy, the thing I always get questions about is, ‘Why can’t I do it at home?’ ” She prefers to initiate treatment in the clinic and then assess suitability for home therapy after a relationship has been established.

The ideal patient, said Dr. Castelo-Soccio, is one whose family has been diligent about coming to appointments and who otherwise demonstrates excellent compliance.

At first blush, the cost of acquiring a home device – often in the $2,000 range – might seem prohibitive for many families. The upfront cost may be worth it for some, since office visits involve copayments and lost time from school and work for multiple treatments weekly over a period of months. A big commute to the doctor’s office for treatment may further tip the scales toward home treatment. “I wouldn’t hesitate to offer this option to the right family,” she said.

Dr. Castelo-Soccio said she’s had some limited success getting insurance reimbursement for home phototherapy, especially if success has already been seen with office-based treatment.

NBUVB therapy has limitations, though. Some that have particular relevance for the pediatric population involve the challenges of safe delivery, including using appropriate eye wear and ensuring lack of movement. Each of these problems can be even more of a challenge at home, reinforcing the need to select appropriate patients for home phototherapy, she added.

Dr. Castelo-Soccio said she provides information about all of the various phototherapy devices to her patients and their parents, letting them make the choice. “All of the companies are really good about helping with paperwork” to apply for insurance reimbursement, she said. Options range from the bulkiest and most expensive – a full phototherapy box – to three-panel arrays, single panels, hand-foot devices, and even hand-held devices. The latter can be had for less than $1,000 and may be best suited for targeting smaller areas.

Features to look for in home phototherapy devices include a dosimeter accuracy sensor, which adjusts the treatment time to deliver the same dose, even if dust or aging lamps reduce output. User-friendly timers also are helpful for families, said Dr. Castelo-Soccio. A safety lock-out will allow only a certain number of treatments before the unit must be reset by the physician and is a reassuring feature. Each activation counts as a treatment, however, so families and physicians must be aware that if a hand-held unit is used to treat multiple small lesions in different body areas, a single treatment session will involve many device activations, each of which will be registered as a treatment.

Dr. Castelo-Soccio had no relevant financial disclosures.

koakes@frontlinemedcom.com

On Twitter @karioakes

MINNEAPOLIS, MINN. – For a select subset of pediatric dermatology patients, home phototherapy may represent a safe, effective, and even affordable alternative to office visits. Some families whose children are in treatment for vitiligo, psoriasis, and atopic dermatitis may find that the expense and learning curve of administering treatment at home are worthwhile, but dermatologists must select those families carefully.

Leslie Castelo-Soccio, MD, PhD, professor of pediatric dermatology at the Children’s Hospital of Philadelphia, gave an overview of medical phototherapy for childhood skin diseases at the annual meeting of the Society for Pediatric Dermatology.

For vitiligo, narrow-band UVB’s (NBUVB) effectiveness is maximized if treatment is begun relatively early, and if results are going to happen, they’ll show up fairly quickly. “If there’s no response after six months, stop the therapy,” Dr. Castelo-Soccio said.

Although the literature shows NBUVB to be effective in treating atopic dermatitis, Dr. Castelo-Soccio noted that most pediatric atopic dermatitis studies have been small and retrospective and conducted in a population with severe disease.

Regarding psoriasis in children, the literature shows “higher numbers of patients with near-complete or complete response,” she said.

The experience of NBUVB for pediatric dermatologic conditions at the Children’s Hospital of Philadelphia supports the idea that “the best responses are seen after at least 40 treatments,” and that 6 months is enough time to see whether a patient will respond. The best responders at her institution are children with facial vitiligo. “Of course, you get a better response with compliance,” she noted.

The experience of her patients falls in line with the data about side effects, in which the most common adverse events are reactivation of HSV and burning.

Families ask about cancer risk, but “there are no published data on the risk of skin cancer in long-term phototherapy in children,” she said. At this point, the best pediatric dermatologists can do is to extrapolate risk from data on phototherapy for neonatal jaundice, but even those data are inconclusive, she said.

Dr. Castelo-Soccio noted that it’s pretty common for families to request home treatment: “When you start talking to patients about phototherapy, the thing I always get questions about is, ‘Why can’t I do it at home?’ ” She prefers to initiate treatment in the clinic and then assess suitability for home therapy after a relationship has been established.

The ideal patient, said Dr. Castelo-Soccio, is one whose family has been diligent about coming to appointments and who otherwise demonstrates excellent compliance.

At first blush, the cost of acquiring a home device – often in the $2,000 range – might seem prohibitive for many families. The upfront cost may be worth it for some, since office visits involve copayments and lost time from school and work for multiple treatments weekly over a period of months. A big commute to the doctor’s office for treatment may further tip the scales toward home treatment. “I wouldn’t hesitate to offer this option to the right family,” she said.

Dr. Castelo-Soccio said she’s had some limited success getting insurance reimbursement for home phototherapy, especially if success has already been seen with office-based treatment.

NBUVB therapy has limitations, though. Some that have particular relevance for the pediatric population involve the challenges of safe delivery, including using appropriate eye wear and ensuring lack of movement. Each of these problems can be even more of a challenge at home, reinforcing the need to select appropriate patients for home phototherapy, she added.

Dr. Castelo-Soccio said she provides information about all of the various phototherapy devices to her patients and their parents, letting them make the choice. “All of the companies are really good about helping with paperwork” to apply for insurance reimbursement, she said. Options range from the bulkiest and most expensive – a full phototherapy box – to three-panel arrays, single panels, hand-foot devices, and even hand-held devices. The latter can be had for less than $1,000 and may be best suited for targeting smaller areas.

Features to look for in home phototherapy devices include a dosimeter accuracy sensor, which adjusts the treatment time to deliver the same dose, even if dust or aging lamps reduce output. User-friendly timers also are helpful for families, said Dr. Castelo-Soccio. A safety lock-out will allow only a certain number of treatments before the unit must be reset by the physician and is a reassuring feature. Each activation counts as a treatment, however, so families and physicians must be aware that if a hand-held unit is used to treat multiple small lesions in different body areas, a single treatment session will involve many device activations, each of which will be registered as a treatment.

Dr. Castelo-Soccio had no relevant financial disclosures.

koakes@frontlinemedcom.com

On Twitter @karioakes

MINNEAPOLIS, MINN. – For a select subset of pediatric dermatology patients, home phototherapy may represent a safe, effective, and even affordable alternative to office visits. Some families whose children are in treatment for vitiligo, psoriasis, and atopic dermatitis may find that the expense and learning curve of administering treatment at home are worthwhile, but dermatologists must select those families carefully.

Leslie Castelo-Soccio, MD, PhD, professor of pediatric dermatology at the Children’s Hospital of Philadelphia, gave an overview of medical phototherapy for childhood skin diseases at the annual meeting of the Society for Pediatric Dermatology.

For vitiligo, narrow-band UVB’s (NBUVB) effectiveness is maximized if treatment is begun relatively early, and if results are going to happen, they’ll show up fairly quickly. “If there’s no response after six months, stop the therapy,” Dr. Castelo-Soccio said.

Although the literature shows NBUVB to be effective in treating atopic dermatitis, Dr. Castelo-Soccio noted that most pediatric atopic dermatitis studies have been small and retrospective and conducted in a population with severe disease.

Regarding psoriasis in children, the literature shows “higher numbers of patients with near-complete or complete response,” she said.

The experience of NBUVB for pediatric dermatologic conditions at the Children’s Hospital of Philadelphia supports the idea that “the best responses are seen after at least 40 treatments,” and that 6 months is enough time to see whether a patient will respond. The best responders at her institution are children with facial vitiligo. “Of course, you get a better response with compliance,” she noted.

The experience of her patients falls in line with the data about side effects, in which the most common adverse events are reactivation of HSV and burning.

Families ask about cancer risk, but “there are no published data on the risk of skin cancer in long-term phototherapy in children,” she said. At this point, the best pediatric dermatologists can do is to extrapolate risk from data on phototherapy for neonatal jaundice, but even those data are inconclusive, she said.

Dr. Castelo-Soccio noted that it’s pretty common for families to request home treatment: “When you start talking to patients about phototherapy, the thing I always get questions about is, ‘Why can’t I do it at home?’ ” She prefers to initiate treatment in the clinic and then assess suitability for home therapy after a relationship has been established.

The ideal patient, said Dr. Castelo-Soccio, is one whose family has been diligent about coming to appointments and who otherwise demonstrates excellent compliance.

At first blush, the cost of acquiring a home device – often in the $2,000 range – might seem prohibitive for many families. The upfront cost may be worth it for some, since office visits involve copayments and lost time from school and work for multiple treatments weekly over a period of months. A big commute to the doctor’s office for treatment may further tip the scales toward home treatment. “I wouldn’t hesitate to offer this option to the right family,” she said.

Dr. Castelo-Soccio said she’s had some limited success getting insurance reimbursement for home phototherapy, especially if success has already been seen with office-based treatment.

NBUVB therapy has limitations, though. Some that have particular relevance for the pediatric population involve the challenges of safe delivery, including using appropriate eye wear and ensuring lack of movement. Each of these problems can be even more of a challenge at home, reinforcing the need to select appropriate patients for home phototherapy, she added.

Dr. Castelo-Soccio said she provides information about all of the various phototherapy devices to her patients and their parents, letting them make the choice. “All of the companies are really good about helping with paperwork” to apply for insurance reimbursement, she said. Options range from the bulkiest and most expensive – a full phototherapy box – to three-panel arrays, single panels, hand-foot devices, and even hand-held devices. The latter can be had for less than $1,000 and may be best suited for targeting smaller areas.

Features to look for in home phototherapy devices include a dosimeter accuracy sensor, which adjusts the treatment time to deliver the same dose, even if dust or aging lamps reduce output. User-friendly timers also are helpful for families, said Dr. Castelo-Soccio. A safety lock-out will allow only a certain number of treatments before the unit must be reset by the physician and is a reassuring feature. Each activation counts as a treatment, however, so families and physicians must be aware that if a hand-held unit is used to treat multiple small lesions in different body areas, a single treatment session will involve many device activations, each of which will be registered as a treatment.

Dr. Castelo-Soccio had no relevant financial disclosures.

koakes@frontlinemedcom.com

On Twitter @karioakes

Acute kidney injury is a common complication after pediatric cardiac surgery, but measuring for a specific genetic protein immediately after cardiac surgery may improve cardiac surgeons’ ability to predict patients at higher risk of AKI, according to researchers from Brazil. The study results are in the July issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152-178-86).

“Plasma syndecan-1 levels measured early in the postoperative period were independently associated with severe acute kidney injury,” wrote Candice Torres de Melo Bezerra Cavalcante, MD, of Heart Hospital of Messejana and Federal University of Ceará.

Their prospective cohort study involved 289 pediatric patients who had cardiac surgery at their institution between September 2013 and December 2014.

©London_England/Thinkstock

Dr. Cavalcante and colleagues acknowledged that the traditional biomarker for renal function, serum creatinine, only increases appreciably after the glomerular filtration rate declines 50%, impairing physicians’ ability to detect AKI early enough to treat it. “This delay can explain, in part the, negative results in AKI therapeutic clinical trials,” they wrote.

They evaluated two different endothelial biomarkers in addition to syndecan-1 with regard to their capacity for predicting severe AKI: plasma ICAM-1, a marker of endothelial cell activation; and E-selectin, an endothelial cell adhesion molecule. Syndecan-1 works as a biomarker of injury to the glycocalyx protein that surrounds endothelial cell membranes that acts as a permeability barrier and prevents the cells from adhering to blood. They found that median syndecan-1 levels soon after surgery were higher in patients with severe AKI, 103.6 vs. 42.3 ng/mL.

“Although syndecan-1 is not a renal-specific biomarker, there has been recent increasing evidence that endothelial injury has an important role in AKI pathophysiology,” the researchers noted.

Study results showed the higher the level of syndecan-1, the greater the adjusted odds ratio (OR) for severe AKI. Levels of less than 17 ng/mL were considered normal; 17.1-46.7 ng/mL carried an adjusted OR of 1.42; 47.4-93.1 ng/mL had an adjusted OR of 2.05; and levels 96.3 or greater had an OR of 8.87.

“Maintenance of endothelial glycocalyx integrity can be a therapeutic target to reduce AKI in this setting,” the researchers wrote.

The authors acknowledged that the study was done at a single center that had dialysis and death rates three and five times higher, respectively, than those of developed countries; and it measured syndecan-1 at only one time point almost immediately after the operation.

“Adding postoperative syndecan-1, even when using a clinical model that already incorporates variables from renal angina index, results in significant improvement in the capacity to predict severe AKI,” Dr. Cavalcante and colleagues concluded.

They had no financial relationships to disclose.

cardnews@frontlinemedcom.com

Acute kidney injury is a common complication after pediatric cardiac surgery, but measuring for a specific genetic protein immediately after cardiac surgery may improve cardiac surgeons’ ability to predict patients at higher risk of AKI, according to researchers from Brazil. The study results are in the July issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152-178-86).

“Plasma syndecan-1 levels measured early in the postoperative period were independently associated with severe acute kidney injury,” wrote Candice Torres de Melo Bezerra Cavalcante, MD, of Heart Hospital of Messejana and Federal University of Ceará.

Their prospective cohort study involved 289 pediatric patients who had cardiac surgery at their institution between September 2013 and December 2014.

©London_England/Thinkstock

Dr. Cavalcante and colleagues acknowledged that the traditional biomarker for renal function, serum creatinine, only increases appreciably after the glomerular filtration rate declines 50%, impairing physicians’ ability to detect AKI early enough to treat it. “This delay can explain, in part the, negative results in AKI therapeutic clinical trials,” they wrote.

They evaluated two different endothelial biomarkers in addition to syndecan-1 with regard to their capacity for predicting severe AKI: plasma ICAM-1, a marker of endothelial cell activation; and E-selectin, an endothelial cell adhesion molecule. Syndecan-1 works as a biomarker of injury to the glycocalyx protein that surrounds endothelial cell membranes that acts as a permeability barrier and prevents the cells from adhering to blood. They found that median syndecan-1 levels soon after surgery were higher in patients with severe AKI, 103.6 vs. 42.3 ng/mL.

“Although syndecan-1 is not a renal-specific biomarker, there has been recent increasing evidence that endothelial injury has an important role in AKI pathophysiology,” the researchers noted.

Study results showed the higher the level of syndecan-1, the greater the adjusted odds ratio (OR) for severe AKI. Levels of less than 17 ng/mL were considered normal; 17.1-46.7 ng/mL carried an adjusted OR of 1.42; 47.4-93.1 ng/mL had an adjusted OR of 2.05; and levels 96.3 or greater had an OR of 8.87.

“Maintenance of endothelial glycocalyx integrity can be a therapeutic target to reduce AKI in this setting,” the researchers wrote.

The authors acknowledged that the study was done at a single center that had dialysis and death rates three and five times higher, respectively, than those of developed countries; and it measured syndecan-1 at only one time point almost immediately after the operation.

“Adding postoperative syndecan-1, even when using a clinical model that already incorporates variables from renal angina index, results in significant improvement in the capacity to predict severe AKI,” Dr. Cavalcante and colleagues concluded.

They had no financial relationships to disclose.

cardnews@frontlinemedcom.com

Acute kidney injury is a common complication after pediatric cardiac surgery, but measuring for a specific genetic protein immediately after cardiac surgery may improve cardiac surgeons’ ability to predict patients at higher risk of AKI, according to researchers from Brazil. The study results are in the July issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152-178-86).

“Plasma syndecan-1 levels measured early in the postoperative period were independently associated with severe acute kidney injury,” wrote Candice Torres de Melo Bezerra Cavalcante, MD, of Heart Hospital of Messejana and Federal University of Ceará.

Their prospective cohort study involved 289 pediatric patients who had cardiac surgery at their institution between September 2013 and December 2014.

©London_England/Thinkstock

Dr. Cavalcante and colleagues acknowledged that the traditional biomarker for renal function, serum creatinine, only increases appreciably after the glomerular filtration rate declines 50%, impairing physicians’ ability to detect AKI early enough to treat it. “This delay can explain, in part the, negative results in AKI therapeutic clinical trials,” they wrote.

They evaluated two different endothelial biomarkers in addition to syndecan-1 with regard to their capacity for predicting severe AKI: plasma ICAM-1, a marker of endothelial cell activation; and E-selectin, an endothelial cell adhesion molecule. Syndecan-1 works as a biomarker of injury to the glycocalyx protein that surrounds endothelial cell membranes that acts as a permeability barrier and prevents the cells from adhering to blood. They found that median syndecan-1 levels soon after surgery were higher in patients with severe AKI, 103.6 vs. 42.3 ng/mL.

“Although syndecan-1 is not a renal-specific biomarker, there has been recent increasing evidence that endothelial injury has an important role in AKI pathophysiology,” the researchers noted.

Study results showed the higher the level of syndecan-1, the greater the adjusted odds ratio (OR) for severe AKI. Levels of less than 17 ng/mL were considered normal; 17.1-46.7 ng/mL carried an adjusted OR of 1.42; 47.4-93.1 ng/mL had an adjusted OR of 2.05; and levels 96.3 or greater had an OR of 8.87.

“Maintenance of endothelial glycocalyx integrity can be a therapeutic target to reduce AKI in this setting,” the researchers wrote.

The authors acknowledged that the study was done at a single center that had dialysis and death rates three and five times higher, respectively, than those of developed countries; and it measured syndecan-1 at only one time point almost immediately after the operation.

“Adding postoperative syndecan-1, even when using a clinical model that already incorporates variables from renal angina index, results in significant improvement in the capacity to predict severe AKI,” Dr. Cavalcante and colleagues concluded.

They had no financial relationships to disclose.

cardnews@frontlinemedcom.com

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

acruz@frontlinemedcom.com

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

acruz@frontlinemedcom.com

The 9-valent human papillomavirus vaccine was well tolerated in 16-26 year olds and had a safety profile comparable to that of the quadrivalent vaccine, according to an analysis of seven phase III trials.

“The demonstrated efficacy and favorable safety profile of the 9vHPV vaccine support widespread vaccination programs,” reported Dr. Edson D. Moreira Jr. and his associates in Pediatrics.

Vaccines were given in a three-dose regimen: 15,776 male and female patients received at least one dose of the 9-valent vaccine and 7,391 control subjects received at least one dose of the quadrivalent vaccine.

Frequencies of vaccine-related systemic adverse events such as headache and pyrexia were “generally similar” between the two vaccine groups, the investigators reported.

Compared with the quadrivalent vaccine, the 9-valent vaccine was associated with significantly more frequent adverse events at the injection site, including pain (84% vs. 90%), swelling (29% vs. 40%), and erythema (34% vs. 26%). Most of these reactions in both groups were mild to moderate in intensity, however.

Discontinuations and vaccine-related serious adverse events in the 9-valent vaccine group were rare (0.1% and less than 0.1%, respectively).

Read the full study here (doi:10.1542/peds.2015-4387).

acruz@frontlinemedcom.com

The U.S teen birth rate has dropped for another consecutive year, adding to the long-term decline in teen pregnancy, according to a federal report on trends in child health and well being.

©istock/Thinkstock.com

In 2014, the teen birth rate was 11 births per 1,000 girls’ aged 15-17 years, down from 12 per 1,000 in 2013. Racial and ethinic disparities in the teen birth rate have also dropped significantly since 1995 – with the difference between the highest and lowest rates dropping from 55 points in 1995 to 17 points in 2014. But substantial disparities persist.

The report also found that the percentages of 10th and 12th-graders in all racial and ethnic groups who binge-drink were the lowest in 2015 since the report started in 1980. The percentage of uninsured children also declined, falling from 7% in 2013 to 5% in 2014. However, there was no improvement in the rate of childhood obesity. During 2011-2014, 19% of children aged 6-17 years were obese.

The annual report is published by the Federal Interagency Forum on Child and Family Statistics, a working group of 23 federal agencies that collect, analyze and report data on conditions and trends related to child and family well-being. The report tracks 41 health and social indicators.

Read the full 2016 America’s Children Report here.

llaubach@frontlinemedcom.com

The U.S teen birth rate has dropped for another consecutive year, adding to the long-term decline in teen pregnancy, according to a federal report on trends in child health and well being.

©istock/Thinkstock.com

In 2014, the teen birth rate was 11 births per 1,000 girls’ aged 15-17 years, down from 12 per 1,000 in 2013. Racial and ethinic disparities in the teen birth rate have also dropped significantly since 1995 – with the difference between the highest and lowest rates dropping from 55 points in 1995 to 17 points in 2014. But substantial disparities persist.

The report also found that the percentages of 10th and 12th-graders in all racial and ethnic groups who binge-drink were the lowest in 2015 since the report started in 1980. The percentage of uninsured children also declined, falling from 7% in 2013 to 5% in 2014. However, there was no improvement in the rate of childhood obesity. During 2011-2014, 19% of children aged 6-17 years were obese.

The annual report is published by the Federal Interagency Forum on Child and Family Statistics, a working group of 23 federal agencies that collect, analyze and report data on conditions and trends related to child and family well-being. The report tracks 41 health and social indicators.

Read the full 2016 America’s Children Report here.

llaubach@frontlinemedcom.com

The U.S teen birth rate has dropped for another consecutive year, adding to the long-term decline in teen pregnancy, according to a federal report on trends in child health and well being.

©istock/Thinkstock.com

In 2014, the teen birth rate was 11 births per 1,000 girls’ aged 15-17 years, down from 12 per 1,000 in 2013. Racial and ethinic disparities in the teen birth rate have also dropped significantly since 1995 – with the difference between the highest and lowest rates dropping from 55 points in 1995 to 17 points in 2014. But substantial disparities persist.

The report also found that the percentages of 10th and 12th-graders in all racial and ethnic groups who binge-drink were the lowest in 2015 since the report started in 1980. The percentage of uninsured children also declined, falling from 7% in 2013 to 5% in 2014. However, there was no improvement in the rate of childhood obesity. During 2011-2014, 19% of children aged 6-17 years were obese.

The annual report is published by the Federal Interagency Forum on Child and Family Statistics, a working group of 23 federal agencies that collect, analyze and report data on conditions and trends related to child and family well-being. The report tracks 41 health and social indicators.

Read the full 2016 America’s Children Report here.

llaubach@frontlinemedcom.com

The Food and Drug Administration’s Arthritis Advisory Committee, together with an added complement of dermatologists and gastroenterologists, unanimously recommended during meetings on July 12 and 13 that the agency license a biosimilar Humira (adalimumab) that is made by Amgen and a biosimilar Enbrel (etanercept) that is made by Sandoz for many of the same indications held by the reference drugs.

The FDA advisory panel that endorsed biosimilar Humira recommended the agent’s approval in a 26-0 vote for many, but not all of the indications currently assigned to Humira itself: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis in patients at least 4 years old, plaque psoriasis, adult Crohn’s disease, and adult ulcerative colitis.

A slightly different group of 20 advisory panel members (without any gastroenterologists) voted 20-0 in favor of the FDA granting biosimilar Enbrel all five of the indications now held by Enbrel: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and plaque psoriasis.

The biosimilar Humira and the biosimilar Enbrel are, respectively, the third and fourth candidate biosimilars to emerge from the FDA’s development program and receive advisory committee scrutiny and support. The first agent through the process, biosimilar filgrastim (Zarxio) received FDA approval in 2015 and is available in the United States. Although the second biosimilar through the process, the tumor necrosis factor inhibitor Inflectra that is biosimilar Remicade (infliximab), received FDA approval in April of this year, it has not yet become available for sale, although a spokeswoman for the company that will market it, Pfizer, said that the company expects to start U.S. sales of Inflectra before the end of 2016.

While the Arthritis Advisory Committee ended each of its daylong deliberations for each of the two candidate biosimilars with unanimous support, the panelists’ discussions among themselves and with FDA staffers reflected some uncertainty with the biosimilar concept, especially during the first day when they focused on biosimilar Humira. The major sticking point revolved around the regulatory pathway to approval first established by the Biologics Price Competition and Innovation Act of 2009 and subsequently refined by the FDA that allows a candidate biosimilar to establish its biosimilarity primarily though the results of analytical studies that establish that the candidate molecule is highly similar to the reference molecule. This approval scheme uses clinical trials in a confirmatory role to establish biosimilarity rather than as the linchpin of approval.

It also means that the FDA can grant clinical indications to the biosimilar drug based not on the results from clinical trials, but based entirely on what have already been demonstrated as safe and effective clinical applications for the reference drug. For example, the biosimilar Humira underwent testing in two clinical studies showing similar efficacy and safety as Humira in patients with rheumatoid arthritis and in patients with plaque psoriasis, but received endorsements based on extrapolations for an additional five indications. Biosimilar Enbrel was compared with Enbrel in patients with plaque psoriasis only and still received extrapolated indications for the additional four rheumatologic conditions.

“This is a new level of extrapolation, across indications,” noted Sarah E. Streett, MD, a gastroenterologist at Stanford (Calif.) University, one of several panelists who initially voiced uncertainty about the concept.

But FDA staffer Nikolay P. Nikolov, MD, who led the agency’s presentation, assured the panelists that the concept of extrapolation was at the heart of biosimilar development and regulatory assessment.

“We have confidence from the data that the two molecules [the reference drug and biosimilar drug] are so similar that we can rely on the safety and efficacy of the reference product. The premise of our approach to biosimilars is that this is not a new molecule that we know nothing about.”

The other uncertainty about biosimilar Humira and biosimilar Enbrel that raised concerns of many panelists were the prospects for nonmedical switching once these drugs reach the market. Nonmedical switching refers to when an insurance company or pharmacy benefit manager substitutes a biosimilar for a reference drug without approval from or even the knowledge of the prescribing physician or the patient. Many of the people who spoke during the public forum period on both days of hearings voiced their concerns about this prospect.

“Nonmedical switching is a major concern of clinicians and policy makers, and we need greater clarification from the FDA,” said committee chair Daniel H. Solomon, MD, a rheumatologist and professor of medicine at Harvard Medical School in Boston.

“I see a remarkable disconnect between the public’s concerns [about nonmedical switching] and the charge to the committee. These are essential issues that need a forum to be aired out,” said panelist Steven F. Solga, MD, chief of gastroenterology at St. Luke’s Hospital in Bethlehem, Pa.

Dr. Nikolov assured committee members that the FDA recognized this concern and was working on it. “We appreciate the disconnect between the charge and the concerns of the community. I assure you that the issues brought up will be part of our discussions so we can get this [biosimilar pathway] implemented the right way.”

According to the FDA’s regulations, a biosimilar designation does not allow for nonmedical switching, something that could only happen under a related but distinct designation known as interchangeability. During the committee meeting on July 13, a FDA staffer said that the agency is currently developing guidance for an “interchangeable” designation and plans to have it available before then end of 2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The Food and Drug Administration’s Arthritis Advisory Committee, together with an added complement of dermatologists and gastroenterologists, unanimously recommended during meetings on July 12 and 13 that the agency license a biosimilar Humira (adalimumab) that is made by Amgen and a biosimilar Enbrel (etanercept) that is made by Sandoz for many of the same indications held by the reference drugs.

The FDA advisory panel that endorsed biosimilar Humira recommended the agent’s approval in a 26-0 vote for many, but not all of the indications currently assigned to Humira itself: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis in patients at least 4 years old, plaque psoriasis, adult Crohn’s disease, and adult ulcerative colitis.

A slightly different group of 20 advisory panel members (without any gastroenterologists) voted 20-0 in favor of the FDA granting biosimilar Enbrel all five of the indications now held by Enbrel: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and plaque psoriasis.

The biosimilar Humira and the biosimilar Enbrel are, respectively, the third and fourth candidate biosimilars to emerge from the FDA’s development program and receive advisory committee scrutiny and support. The first agent through the process, biosimilar filgrastim (Zarxio) received FDA approval in 2015 and is available in the United States. Although the second biosimilar through the process, the tumor necrosis factor inhibitor Inflectra that is biosimilar Remicade (infliximab), received FDA approval in April of this year, it has not yet become available for sale, although a spokeswoman for the company that will market it, Pfizer, said that the company expects to start U.S. sales of Inflectra before the end of 2016.

While the Arthritis Advisory Committee ended each of its daylong deliberations for each of the two candidate biosimilars with unanimous support, the panelists’ discussions among themselves and with FDA staffers reflected some uncertainty with the biosimilar concept, especially during the first day when they focused on biosimilar Humira. The major sticking point revolved around the regulatory pathway to approval first established by the Biologics Price Competition and Innovation Act of 2009 and subsequently refined by the FDA that allows a candidate biosimilar to establish its biosimilarity primarily though the results of analytical studies that establish that the candidate molecule is highly similar to the reference molecule. This approval scheme uses clinical trials in a confirmatory role to establish biosimilarity rather than as the linchpin of approval.

It also means that the FDA can grant clinical indications to the biosimilar drug based not on the results from clinical trials, but based entirely on what have already been demonstrated as safe and effective clinical applications for the reference drug. For example, the biosimilar Humira underwent testing in two clinical studies showing similar efficacy and safety as Humira in patients with rheumatoid arthritis and in patients with plaque psoriasis, but received endorsements based on extrapolations for an additional five indications. Biosimilar Enbrel was compared with Enbrel in patients with plaque psoriasis only and still received extrapolated indications for the additional four rheumatologic conditions.

“This is a new level of extrapolation, across indications,” noted Sarah E. Streett, MD, a gastroenterologist at Stanford (Calif.) University, one of several panelists who initially voiced uncertainty about the concept.

But FDA staffer Nikolay P. Nikolov, MD, who led the agency’s presentation, assured the panelists that the concept of extrapolation was at the heart of biosimilar development and regulatory assessment.

“We have confidence from the data that the two molecules [the reference drug and biosimilar drug] are so similar that we can rely on the safety and efficacy of the reference product. The premise of our approach to biosimilars is that this is not a new molecule that we know nothing about.”

The other uncertainty about biosimilar Humira and biosimilar Enbrel that raised concerns of many panelists were the prospects for nonmedical switching once these drugs reach the market. Nonmedical switching refers to when an insurance company or pharmacy benefit manager substitutes a biosimilar for a reference drug without approval from or even the knowledge of the prescribing physician or the patient. Many of the people who spoke during the public forum period on both days of hearings voiced their concerns about this prospect.

“Nonmedical switching is a major concern of clinicians and policy makers, and we need greater clarification from the FDA,” said committee chair Daniel H. Solomon, MD, a rheumatologist and professor of medicine at Harvard Medical School in Boston.

“I see a remarkable disconnect between the public’s concerns [about nonmedical switching] and the charge to the committee. These are essential issues that need a forum to be aired out,” said panelist Steven F. Solga, MD, chief of gastroenterology at St. Luke’s Hospital in Bethlehem, Pa.

Dr. Nikolov assured committee members that the FDA recognized this concern and was working on it. “We appreciate the disconnect between the charge and the concerns of the community. I assure you that the issues brought up will be part of our discussions so we can get this [biosimilar pathway] implemented the right way.”

According to the FDA’s regulations, a biosimilar designation does not allow for nonmedical switching, something that could only happen under a related but distinct designation known as interchangeability. During the committee meeting on July 13, a FDA staffer said that the agency is currently developing guidance for an “interchangeable” designation and plans to have it available before then end of 2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

The Food and Drug Administration’s Arthritis Advisory Committee, together with an added complement of dermatologists and gastroenterologists, unanimously recommended during meetings on July 12 and 13 that the agency license a biosimilar Humira (adalimumab) that is made by Amgen and a biosimilar Enbrel (etanercept) that is made by Sandoz for many of the same indications held by the reference drugs.

The FDA advisory panel that endorsed biosimilar Humira recommended the agent’s approval in a 26-0 vote for many, but not all of the indications currently assigned to Humira itself: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis in patients at least 4 years old, plaque psoriasis, adult Crohn’s disease, and adult ulcerative colitis.

A slightly different group of 20 advisory panel members (without any gastroenterologists) voted 20-0 in favor of the FDA granting biosimilar Enbrel all five of the indications now held by Enbrel: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, and plaque psoriasis.

The biosimilar Humira and the biosimilar Enbrel are, respectively, the third and fourth candidate biosimilars to emerge from the FDA’s development program and receive advisory committee scrutiny and support. The first agent through the process, biosimilar filgrastim (Zarxio) received FDA approval in 2015 and is available in the United States. Although the second biosimilar through the process, the tumor necrosis factor inhibitor Inflectra that is biosimilar Remicade (infliximab), received FDA approval in April of this year, it has not yet become available for sale, although a spokeswoman for the company that will market it, Pfizer, said that the company expects to start U.S. sales of Inflectra before the end of 2016.

While the Arthritis Advisory Committee ended each of its daylong deliberations for each of the two candidate biosimilars with unanimous support, the panelists’ discussions among themselves and with FDA staffers reflected some uncertainty with the biosimilar concept, especially during the first day when they focused on biosimilar Humira. The major sticking point revolved around the regulatory pathway to approval first established by the Biologics Price Competition and Innovation Act of 2009 and subsequently refined by the FDA that allows a candidate biosimilar to establish its biosimilarity primarily though the results of analytical studies that establish that the candidate molecule is highly similar to the reference molecule. This approval scheme uses clinical trials in a confirmatory role to establish biosimilarity rather than as the linchpin of approval.

It also means that the FDA can grant clinical indications to the biosimilar drug based not on the results from clinical trials, but based entirely on what have already been demonstrated as safe and effective clinical applications for the reference drug. For example, the biosimilar Humira underwent testing in two clinical studies showing similar efficacy and safety as Humira in patients with rheumatoid arthritis and in patients with plaque psoriasis, but received endorsements based on extrapolations for an additional five indications. Biosimilar Enbrel was compared with Enbrel in patients with plaque psoriasis only and still received extrapolated indications for the additional four rheumatologic conditions.

“This is a new level of extrapolation, across indications,” noted Sarah E. Streett, MD, a gastroenterologist at Stanford (Calif.) University, one of several panelists who initially voiced uncertainty about the concept.

But FDA staffer Nikolay P. Nikolov, MD, who led the agency’s presentation, assured the panelists that the concept of extrapolation was at the heart of biosimilar development and regulatory assessment.

“We have confidence from the data that the two molecules [the reference drug and biosimilar drug] are so similar that we can rely on the safety and efficacy of the reference product. The premise of our approach to biosimilars is that this is not a new molecule that we know nothing about.”

The other uncertainty about biosimilar Humira and biosimilar Enbrel that raised concerns of many panelists were the prospects for nonmedical switching once these drugs reach the market. Nonmedical switching refers to when an insurance company or pharmacy benefit manager substitutes a biosimilar for a reference drug without approval from or even the knowledge of the prescribing physician or the patient. Many of the people who spoke during the public forum period on both days of hearings voiced their concerns about this prospect.

“Nonmedical switching is a major concern of clinicians and policy makers, and we need greater clarification from the FDA,” said committee chair Daniel H. Solomon, MD, a rheumatologist and professor of medicine at Harvard Medical School in Boston.

“I see a remarkable disconnect between the public’s concerns [about nonmedical switching] and the charge to the committee. These are essential issues that need a forum to be aired out,” said panelist Steven F. Solga, MD, chief of gastroenterology at St. Luke’s Hospital in Bethlehem, Pa.

Dr. Nikolov assured committee members that the FDA recognized this concern and was working on it. “We appreciate the disconnect between the charge and the concerns of the community. I assure you that the issues brought up will be part of our discussions so we can get this [biosimilar pathway] implemented the right way.”

According to the FDA’s regulations, a biosimilar designation does not allow for nonmedical switching, something that could only happen under a related but distinct designation known as interchangeability. During the committee meeting on July 13, a FDA staffer said that the agency is currently developing guidance for an “interchangeable” designation and plans to have it available before then end of 2016.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler