Obesity negatively affects axial spondyloarthritis disease activity

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Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Dr. Augusta Ortolan

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).



Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

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

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

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Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Dr. Augusta Ortolan

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).



Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

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

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Dr. Augusta Ortolan

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).



Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

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

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

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Send kids to school safely if possible, supplement virtually

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Tue, 02/14/2023 - 13:00

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

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The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

Dr. Howard Smart

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

 

 

It’s not just about education

Dr. Nathaniel Savio Beers

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

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Quality improvement program expands early childhood screening

Article Type
Changed
Sat, 08/22/2020 - 16:15

Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

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Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

Primary care screening in several key areas including maternal depression and developmental delay increased significantly after practices implemented a quality improvement (QI) program, according to data from 19 pediatric primary care practices in 12 states.

FatCamera/Getty Images

Screening for developmental delay, maternal depression, and autism spectrum disorder are recommended by the American Academy of Pediatrics; screening for social-emotional problems and social determinants of health also are recommended. However, “Practices face challenges in implementing recommended screenings simultaneously,” wrote Kori B. Flower, MD, MPH, of the University of North Carolina at Chapel Hill, and colleagues in Pediatrics.

To support practices in screening, the researchers developed a national QI collaborative. “Aims were to improve screening processes, including screening, discussion, referral, and follow-up,” the researchers wrote.

In the study published in Pediatrics, the researchers reviewed data from 19 pediatric practices in 12 states, including independent, academic, hospital-affiliated, and multispecialty group practices and community health centers for diversity in type, size, location, and patient population.

The improvement program included two full-day sessions of in-person learning, separated by a 9-month action period that included virtual learning through webinars and online resources, monthly data collection to assess progress, and coaching. “Coaches used reports to guide virtual learning content and provide individual feedback to practices,” the researchers said.

Overall, after a year, the largest screening increases from baseline occurred for maternal depression (from 27% to 87%) and social determinants of health (from 26% to 76%). Screening also increased significantly for developmental delays (from 60% to 93%), and autism spectrum disorder (from 74% to 95%).

Statistically significant increases in discussion of screening results occurred for all screening areas: developmental delays (from 63% to 97%), autism spectrum disorder (from 51% to 93%), maternal depression (from 46% to 90%), and social determinants of health (from 19% to 73%).

In addition, significant increases in referrals were seen for development (from 53% to 86%) and maternal depression (from 23% to 100%).
 

EHR packages deficiencies seen as barrier

“Standard EHR packages often lack features for documenting and tracking screenings, and this was a persistent barrier to screening improvement,” Dr. Flower and associates noted. However, the percentage of practices citing EHR challenges as a barrier to screening decreased from 41% at baseline to 24% after the intervention.

Parents also reported increased discussion of screening and referrals, but “[o]n overall rating of care, the percentage of parents rating care as above average or best did not change,” but parents were not asked reasons for their care rating, the researchers wrote.

The study findings were limited by several factors including limited data quality control and insufficient data to assess the effects of screening interventions on other preventive services or other office-based factors such as revenue, the researchers noted. However, the results suggest that shared learning can help primary care practices increase screening.

“Careful attention to integrating screenings in visit flow and emphasizing their potential impact on child health can make implementation possible in multiple screening areas,” Dr. Flower and colleagues concluded.

 

 

Making measurable, meaningful practice change

Dr. Barbara J. Howard

Barbara J. Howard, MD, commented: “It is clear that using validated tools to screen have benefits in accuracy, equity, efficiency, and income. Increasingly, practices are being judged and paid based on ‘value,’ which is especially difficult to measure in pediatrics with its low rates of serious chronic conditions to assess. We pediatricians will be judged on use of proven methods instead, and screening is a major criterion and also, fortunately, one that is within our power to change.

“However, as this study shows, a great deal of effort and teamwork is needed to shift office workflows to incorporate screening, discussions, referral, and follow-up – all necessary processes for screening to be of value. It is broadly recognized in all industries, not just health care, that use of QI processes is a major force in facilitating change in standard practices. The American Board of Pediatrics, as well as the American Academy of Pediatrics, recognizes this need and has been assisting as well as requiring use of QI methods.

“This study specifically selected a range of practices characteristic of U.S. providers to demonstrate that both screening for multiple child health risk factors simultaneously and use of methods of QI can be feasible and effective for measurable and meaningful practice change. This should give all pediatricians encouragement to move forward in implementing changes in screening,” Dr. Howard, of Johns Hopkins University, Baltimore, said in an interview.

This study not only showed the effectiveness of change management, but also detailed the effort it required, including:

  • Use of monthly team meetings.
  • Collecting data from patients and team members.
  • Soliciting parent feedback.
  • Implementing new templates for care.
  • Use of tool translations or translator support.
  • Involving colocated professionals, residents, and students.
  • Assembling resources.
  • Attempting to invoke change in EHR vendor.

“There were expert coaches involved of national prominence and extensive QI experience. Even with all this support and effort, it should be noted that 74% of practices had participated in QI efforts previously, which should have made this project easier, and even then it took 6-7 months before measurable change in practice could be documented. In spite of the fact that actually getting help for problems identified is the goal, referrals were only marginally improved, and the tracking of referrals was not significantly improved even with all this effort,” Dr. Howard noted.

“Of note, the practices reported at the end of the project that fewer practices reported lack of time or resources for screening and referral. As a result of this publication, a slimmed down set of practice report measures might be chosen to make future QI efforts work and be measurable in meaningful ways. Instead of paper chart reviews, data from electronic screening could be automatically collected in the course of care. Referral processes could likewise be made electronic and automated, including tracking their success, not just those through a local EHR. Integration of Software as a Service with EHRs could make this data collection – that is essential to both QI and actual good care – seamless. Templates and checklists, as well as more incidental knowledge gained from this and other QI projects in pediatric practices, should be shared. While each practice operates somewhat differently, the differences are not that great and, in some cases, traditional ways of doing things would be fruitfully discarded,” suggested Dr. Howard, who was not involved in the study.

“While the pediatricians participated in the QI sessions, it is clear that the QI processes depend on the entire practice team, and generally, the team members more critical to success are not the doctor but the front desk receptionist, medical assistants, and the practice managers – as these individuals conduct or oversee workflow activities. Future QI interventions might include reinforcement and acknowledgment of these team members through inclusion in parallel continuing education activities from the American Association of Medical Assistants and the Medical Group Management Association continuing education credits,” she said.

Dr. Howard continued, “Of note, these studies were completed prior to the pandemic-related workflow changes including telehealth visits and requirements to minimize waiting room time and activities for the safety of patients and staff. These disruptive forces and the likelihood that telehealth alternatives will persist in primary care suggest that the traditional paper waiting room questionnaires are likely to have to give way to electronic alternatives. Using all electronic [approaches] will be the best unified workflow.”

The study was supported by the JPB Foundation through support to the American Academy of Pediatrics. The researchers had no financial conflicts to disclose. Dr. Howard is a pediatric founder of CHADIS, an online screening, decision support, patient education, and referral/tracking system in use nationally and implemented using QI processes. CHADIS is distributed by Total Child Health, of which Dr. Howard is president. Use of CHADIS for Part 4 Maintenance of Certification QI programs is under the ABMS portfolio sponsorship of the nonprofit Center for Promotion of Child Development through Primary Care, directed by her husband, Raymond Sturner, MD.

SOURCE: Flower KB et al. Pediatrics. 2020 Aug 7. doi: 10.1542/peds.2019-2328.

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FDA clamps down on compliance for gluten-free products

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Fri, 08/14/2020 - 12:39

 

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

AGA offers guidance on a gluten free diet for patients with celiac disease in the AGA GI Patient Center at http://ow.ly/Wu8F30r4phT

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To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

AGA offers guidance on a gluten free diet for patients with celiac disease in the AGA GI Patient Center at http://ow.ly/Wu8F30r4phT

 

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

AGA offers guidance on a gluten free diet for patients with celiac disease in the AGA GI Patient Center at http://ow.ly/Wu8F30r4phT

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Determining cause of skin lesions in COVID-19 patients remains challenging

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Thu, 08/26/2021 - 16:02

Many COVID-19 treatments, in addition to the infection, may be associated with adverse skin reactions and should be considered in a differential diagnosis, according to a review published in the Journal of the American Academy of Dermatology.

SARS-CoV-2 infection has been associated with a range of skin conditions, wrote Antonio Martinez-Lopez, MD, of Virgen de las Nieves University Hospital, Granada, Spain, and colleagues, who provided an overview of the cutaneous side effects associated with drugs used to treat COVID-19 infection.

“Cutaneous manifestations have recently been described in patients with the new coronavirus infection, similar to cutaneous involvement occurring in common viral infections,” they said. Infected individuals have experienced maculopapular eruption, pseudo-chilblain lesions, urticaria, monomorphic disseminated vesicular lesions, acral vesicular-pustulous lesions, and livedo or necrosis, they noted.

Diagnosing skin manifestations in patients with COVID-19 remains a challenge, because it is unclear whether the skin lesions are related to the virus, the authors said. “Skin diseases not related to coronavirus, other seasonal viral infections, and drug reactions should be considered in the differential diagnosis, especially in those patients suffering from nonspecific manifestations such as urticaria or maculopapular eruptions,” they wrote.

However, “urticarial lesions and maculopapular eruptions in SARS-CoV-2 infections usually appear at the same time as the systemic symptoms, while drug adverse reactions are likely to arise hours to days after the start of the treatment,” they said.

The reviewers noted several cutaneous side effects associated with several of the often-prescribed drugs for COVID-19 infection. The antimalarials hydroxychloroquine and chloroquine had been authorized for COVID-19 treatment by the Food and Drug Administration, but this emergency authorization was rescinded in June. They noted that up to 11.5% of patients on these drugs may experience cutaneous adverse effects, including some that “can be mistaken for skin manifestations of SARS-CoV-2, especially those with maculopapular rash or exanthematous reactions.” Another side effect is exacerbation of psoriasis, which has been described in patients with COVID-19, the authors said.



The oral antiretroviral combination lopinavir/ritonavir, under investigation in clinical trials for COVID-19, has been associated with skin rashes in as many as 5% of adults in HIV studies. Usually appearing after treatment is started, the maculopapular pruritic rash is “usually well tolerated,” they said, although there have been reports of Stevens-Johnson syndrome. Alopecia areata is among the other side effects reported.

Remdesivir also has been authorized for emergency treatment of COVID-19, and the small amount of data available suggest that cutaneous manifestations may be infrequent, the reviewers said. In a recent study of 53 patients treated with remdesivir for 10 days, approximately 8% developed a rash, but the study did not include any information “about rash morphology, distribution, or timeline in relation to remdesivir that may help clinicians differentiate from cutaneous manifestations of COVID-19,” they said.

Other potential treatments for complications of COVID-19 include imatinib, tocilizumab, anakinra, immunoglobulins, corticosteroids, colchicine, and low molecular weight heparins; all have the potential for association with skin reactions, but data on skin manifestations associated with COVID-19 are limited, the authors wrote.

Notably, data on the use of systemic corticosteroids for COVID-19 patients are controversial, although preliminary data showed some reduced mortality in COVID-19 patients who were on respiratory support, they noted. “With regard to differential diagnosis of cutaneous manifestations of COVID-19, the vascular fragility associated with corticosteroid use, especially in elderly patients, may be similar to the thrombotic complications of COVID-19 infection.”

Knowledge about the virology of COVID-19 continues to evolve rapidly, and the number of drugs being studied as treatments continues to expand, the authors pointed out.

“By considering adverse drug reactions in the differential diagnosis, dermatologists can be useful in assisting in the care of these patients,” they wrote. Drugs, rather than the infection, may be the cause of skin reactions in some COVID-19 patients, and “management is often symptomatic, but it is sometimes necessary to modify or discontinue the treatment, and some conditions can even be life-threatening,” they concluded.

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

SOURCE: Martinez-Lopez A et al. J Am Acad Dermatol. 2020 doi: 10.1016/j.jaad.2020.08.006.

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Many COVID-19 treatments, in addition to the infection, may be associated with adverse skin reactions and should be considered in a differential diagnosis, according to a review published in the Journal of the American Academy of Dermatology.

SARS-CoV-2 infection has been associated with a range of skin conditions, wrote Antonio Martinez-Lopez, MD, of Virgen de las Nieves University Hospital, Granada, Spain, and colleagues, who provided an overview of the cutaneous side effects associated with drugs used to treat COVID-19 infection.

“Cutaneous manifestations have recently been described in patients with the new coronavirus infection, similar to cutaneous involvement occurring in common viral infections,” they said. Infected individuals have experienced maculopapular eruption, pseudo-chilblain lesions, urticaria, monomorphic disseminated vesicular lesions, acral vesicular-pustulous lesions, and livedo or necrosis, they noted.

Diagnosing skin manifestations in patients with COVID-19 remains a challenge, because it is unclear whether the skin lesions are related to the virus, the authors said. “Skin diseases not related to coronavirus, other seasonal viral infections, and drug reactions should be considered in the differential diagnosis, especially in those patients suffering from nonspecific manifestations such as urticaria or maculopapular eruptions,” they wrote.

However, “urticarial lesions and maculopapular eruptions in SARS-CoV-2 infections usually appear at the same time as the systemic symptoms, while drug adverse reactions are likely to arise hours to days after the start of the treatment,” they said.

The reviewers noted several cutaneous side effects associated with several of the often-prescribed drugs for COVID-19 infection. The antimalarials hydroxychloroquine and chloroquine had been authorized for COVID-19 treatment by the Food and Drug Administration, but this emergency authorization was rescinded in June. They noted that up to 11.5% of patients on these drugs may experience cutaneous adverse effects, including some that “can be mistaken for skin manifestations of SARS-CoV-2, especially those with maculopapular rash or exanthematous reactions.” Another side effect is exacerbation of psoriasis, which has been described in patients with COVID-19, the authors said.



The oral antiretroviral combination lopinavir/ritonavir, under investigation in clinical trials for COVID-19, has been associated with skin rashes in as many as 5% of adults in HIV studies. Usually appearing after treatment is started, the maculopapular pruritic rash is “usually well tolerated,” they said, although there have been reports of Stevens-Johnson syndrome. Alopecia areata is among the other side effects reported.

Remdesivir also has been authorized for emergency treatment of COVID-19, and the small amount of data available suggest that cutaneous manifestations may be infrequent, the reviewers said. In a recent study of 53 patients treated with remdesivir for 10 days, approximately 8% developed a rash, but the study did not include any information “about rash morphology, distribution, or timeline in relation to remdesivir that may help clinicians differentiate from cutaneous manifestations of COVID-19,” they said.

Other potential treatments for complications of COVID-19 include imatinib, tocilizumab, anakinra, immunoglobulins, corticosteroids, colchicine, and low molecular weight heparins; all have the potential for association with skin reactions, but data on skin manifestations associated with COVID-19 are limited, the authors wrote.

Notably, data on the use of systemic corticosteroids for COVID-19 patients are controversial, although preliminary data showed some reduced mortality in COVID-19 patients who were on respiratory support, they noted. “With regard to differential diagnosis of cutaneous manifestations of COVID-19, the vascular fragility associated with corticosteroid use, especially in elderly patients, may be similar to the thrombotic complications of COVID-19 infection.”

Knowledge about the virology of COVID-19 continues to evolve rapidly, and the number of drugs being studied as treatments continues to expand, the authors pointed out.

“By considering adverse drug reactions in the differential diagnosis, dermatologists can be useful in assisting in the care of these patients,” they wrote. Drugs, rather than the infection, may be the cause of skin reactions in some COVID-19 patients, and “management is often symptomatic, but it is sometimes necessary to modify or discontinue the treatment, and some conditions can even be life-threatening,” they concluded.

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

SOURCE: Martinez-Lopez A et al. J Am Acad Dermatol. 2020 doi: 10.1016/j.jaad.2020.08.006.

Many COVID-19 treatments, in addition to the infection, may be associated with adverse skin reactions and should be considered in a differential diagnosis, according to a review published in the Journal of the American Academy of Dermatology.

SARS-CoV-2 infection has been associated with a range of skin conditions, wrote Antonio Martinez-Lopez, MD, of Virgen de las Nieves University Hospital, Granada, Spain, and colleagues, who provided an overview of the cutaneous side effects associated with drugs used to treat COVID-19 infection.

“Cutaneous manifestations have recently been described in patients with the new coronavirus infection, similar to cutaneous involvement occurring in common viral infections,” they said. Infected individuals have experienced maculopapular eruption, pseudo-chilblain lesions, urticaria, monomorphic disseminated vesicular lesions, acral vesicular-pustulous lesions, and livedo or necrosis, they noted.

Diagnosing skin manifestations in patients with COVID-19 remains a challenge, because it is unclear whether the skin lesions are related to the virus, the authors said. “Skin diseases not related to coronavirus, other seasonal viral infections, and drug reactions should be considered in the differential diagnosis, especially in those patients suffering from nonspecific manifestations such as urticaria or maculopapular eruptions,” they wrote.

However, “urticarial lesions and maculopapular eruptions in SARS-CoV-2 infections usually appear at the same time as the systemic symptoms, while drug adverse reactions are likely to arise hours to days after the start of the treatment,” they said.

The reviewers noted several cutaneous side effects associated with several of the often-prescribed drugs for COVID-19 infection. The antimalarials hydroxychloroquine and chloroquine had been authorized for COVID-19 treatment by the Food and Drug Administration, but this emergency authorization was rescinded in June. They noted that up to 11.5% of patients on these drugs may experience cutaneous adverse effects, including some that “can be mistaken for skin manifestations of SARS-CoV-2, especially those with maculopapular rash or exanthematous reactions.” Another side effect is exacerbation of psoriasis, which has been described in patients with COVID-19, the authors said.



The oral antiretroviral combination lopinavir/ritonavir, under investigation in clinical trials for COVID-19, has been associated with skin rashes in as many as 5% of adults in HIV studies. Usually appearing after treatment is started, the maculopapular pruritic rash is “usually well tolerated,” they said, although there have been reports of Stevens-Johnson syndrome. Alopecia areata is among the other side effects reported.

Remdesivir also has been authorized for emergency treatment of COVID-19, and the small amount of data available suggest that cutaneous manifestations may be infrequent, the reviewers said. In a recent study of 53 patients treated with remdesivir for 10 days, approximately 8% developed a rash, but the study did not include any information “about rash morphology, distribution, or timeline in relation to remdesivir that may help clinicians differentiate from cutaneous manifestations of COVID-19,” they said.

Other potential treatments for complications of COVID-19 include imatinib, tocilizumab, anakinra, immunoglobulins, corticosteroids, colchicine, and low molecular weight heparins; all have the potential for association with skin reactions, but data on skin manifestations associated with COVID-19 are limited, the authors wrote.

Notably, data on the use of systemic corticosteroids for COVID-19 patients are controversial, although preliminary data showed some reduced mortality in COVID-19 patients who were on respiratory support, they noted. “With regard to differential diagnosis of cutaneous manifestations of COVID-19, the vascular fragility associated with corticosteroid use, especially in elderly patients, may be similar to the thrombotic complications of COVID-19 infection.”

Knowledge about the virology of COVID-19 continues to evolve rapidly, and the number of drugs being studied as treatments continues to expand, the authors pointed out.

“By considering adverse drug reactions in the differential diagnosis, dermatologists can be useful in assisting in the care of these patients,” they wrote. Drugs, rather than the infection, may be the cause of skin reactions in some COVID-19 patients, and “management is often symptomatic, but it is sometimes necessary to modify or discontinue the treatment, and some conditions can even be life-threatening,” they concluded.

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

SOURCE: Martinez-Lopez A et al. J Am Acad Dermatol. 2020 doi: 10.1016/j.jaad.2020.08.006.

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FDA clamps down on compliance for gluten-free products

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Fri, 08/14/2020 - 13:04

 

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

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To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

 

To retain the label of “gluten free,” manufacturers of foods that are fermented and hydrolyzed, or that contain fermented or hydrolyzed ingredients, must make and keep detailed records of the manufacturing and production process, according to a final rule issued by the Food and Drug Administration.

In an announcement released on Aug. 12, the FDA stated that manufacturers must confirm that food products such as soy sauce, yogurt, sauerkraut, pickles, cheese, and green olives, as well as distilled foods such as vinegar, meet the definition of gluten free before the fermentation or hydrolysis process. In addition, the rule states that “the manufacturer has adequately evaluated the potential for cross-contact with gluten during the manufacturing process; and if necessary, measures are in place to prevent the introduction of gluten into the food during the manufacturing process,” according to the FDA.

Gluten breaks down during fermentation and hydrolysis, and the gluten-free status of products manufactured in this way can’t be confirmed after the process using currently available methods, according to the FDA.

The new rule is designed to ensure that products labeled as gluten-free meet the definition of gluten free, which remains unchanged from the FDA guidance in 2013.

“The FDA continues to work to protect people with celiac disease, which impacts at least 3 million Americans,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

“The agency has taken a number of steps on this front by first establishing a standardized definition of gluten free, and now by continuing to work to ensure manufacturers are keeping the products that are labeled with this claim gluten free,” he emphasized.

The final rule states that manufacturers will not need to keep such records if and when other analytical methods are developed, but in the meantime products that do not meet the definition will be deemed misbranded, according to the FDA.

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Cachexia affects more than half of lupus patients

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Mon, 08/17/2020 - 16:15

Cachexia developed in 56% of adults with systemic lupus erythematosus over a 5-year period, and 18% did not recover their weight, based on data from more than 2,000 patients.

Sara Freeman/MDedge News
Dr. George Stojan

Although weight loss is common in patients with systemic lupus erythematosus (SLE), cachexia, a disorder of involuntary weight loss, is largely undescribed in SLE patients, wrote George Stojan, MD, of Johns Hopkins University, Baltimore, and colleagues. Cachexia has been described in a range of disorders, including heart failure, renal disease, and rheumatoid arthritis, they said. “Cachexia has been shown to lead to progressive functional impairment, treatment-related complications, poor quality of life, and increased mortality,” they added.

In a study published in Arthritis Care & Research, the investigators reviewed data from the Hopkins Lupus Cohort, consisting of all SLE patients seen at a single center who are followed at least quarterly.

The study population included 2,452 SLE patients older than 18 years who had their weight assessed at each clinic visit. The average follow-up period was 7.75 years, and the average number of weight measurements per patient was nearly 24.

Cachexia was defined as a 5% stable weight loss in 6 months without starvation relative to the average weight in all prior cohort visits; and/or weight loss of more than 2% without starvation relative to the average weight in all prior cohort visits in addition to a body mass index less than 20 kg/m2.

Overall, the risk for cachexia within 5 years of entering the study was significantly higher in patients with a BMI less than 20, current steroid use, vasculitis, lupus nephritis, serositis, hematologic lupus, positive anti-double strand DNA (anti-dsDNA), anti-Smith (anti-Sm), and antiribonucleoprotein (anti-RNP), the researchers noted. After adjustment for prednisone use, cachexia remained significantly associated with lupus nephritis, vasculitis, serositis, and hematologic lupus.



Future organ damage including cataracts, retinal change or optic atrophy, cognitive impairment, cerebrovascular accidents, cranial or peripheral neuropathy, pulmonary hypertension, pleural fibrosis, angina or coronary bypass, bowel infarction or resection, osteoporosis, avascular necrosis, and premature gonadal failure were significantly more likely among patients with intermittent cachexia, compared with those with continuous or no cachexia. Patients with continuous cachexia were significantly more likely to experience an estimated glomerular filtration rate less than 50 mL/min/1.73 m2, proteinuria greater than 3.5 g/day, and end-stage renal disease.

The patients who never developed cachexia were significantly less likely to develop malignancies, diabetes, valvular disease, or cardiomyopathy than were those who did have cachexia, the researchers said.

The mechanisms of action for cachexia in SLE remain unclear, but studies in cancer patients may provide some guidance, the researchers noted. “Tumors secrete a range of procachexia factors thought to be unique to cancer-related cachexia, and colloquially termed the ‘tumor secretome,’ ” they said. “Every single proinflammatory cytokine mentioned as part of the tumor secretome has a role in lupus pathogenesis,” suggesting a possible common pathway to cachexia across different diseases, they said.

The study findings were limited by several factors, mainly the use of BMI to measure weight “since BMI is a rather poor indicator of percent of body fat,” the researchers noted. “Ideally, cachexia would be defined as sarcopenia based on body composition evaluation with a dual x-ray absorptiometry,” they wrote.

The study was supported by the National Institutes of Health and the NIH Roadmap for Medical Research. The researchers had no financial conflicts to disclose.

SOURCE: Stojan G et al. Arthritis Care Res. 2020 Aug 2. doi: 10.1002/acr.24395.

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Cachexia developed in 56% of adults with systemic lupus erythematosus over a 5-year period, and 18% did not recover their weight, based on data from more than 2,000 patients.

Sara Freeman/MDedge News
Dr. George Stojan

Although weight loss is common in patients with systemic lupus erythematosus (SLE), cachexia, a disorder of involuntary weight loss, is largely undescribed in SLE patients, wrote George Stojan, MD, of Johns Hopkins University, Baltimore, and colleagues. Cachexia has been described in a range of disorders, including heart failure, renal disease, and rheumatoid arthritis, they said. “Cachexia has been shown to lead to progressive functional impairment, treatment-related complications, poor quality of life, and increased mortality,” they added.

In a study published in Arthritis Care & Research, the investigators reviewed data from the Hopkins Lupus Cohort, consisting of all SLE patients seen at a single center who are followed at least quarterly.

The study population included 2,452 SLE patients older than 18 years who had their weight assessed at each clinic visit. The average follow-up period was 7.75 years, and the average number of weight measurements per patient was nearly 24.

Cachexia was defined as a 5% stable weight loss in 6 months without starvation relative to the average weight in all prior cohort visits; and/or weight loss of more than 2% without starvation relative to the average weight in all prior cohort visits in addition to a body mass index less than 20 kg/m2.

Overall, the risk for cachexia within 5 years of entering the study was significantly higher in patients with a BMI less than 20, current steroid use, vasculitis, lupus nephritis, serositis, hematologic lupus, positive anti-double strand DNA (anti-dsDNA), anti-Smith (anti-Sm), and antiribonucleoprotein (anti-RNP), the researchers noted. After adjustment for prednisone use, cachexia remained significantly associated with lupus nephritis, vasculitis, serositis, and hematologic lupus.



Future organ damage including cataracts, retinal change or optic atrophy, cognitive impairment, cerebrovascular accidents, cranial or peripheral neuropathy, pulmonary hypertension, pleural fibrosis, angina or coronary bypass, bowel infarction or resection, osteoporosis, avascular necrosis, and premature gonadal failure were significantly more likely among patients with intermittent cachexia, compared with those with continuous or no cachexia. Patients with continuous cachexia were significantly more likely to experience an estimated glomerular filtration rate less than 50 mL/min/1.73 m2, proteinuria greater than 3.5 g/day, and end-stage renal disease.

The patients who never developed cachexia were significantly less likely to develop malignancies, diabetes, valvular disease, or cardiomyopathy than were those who did have cachexia, the researchers said.

The mechanisms of action for cachexia in SLE remain unclear, but studies in cancer patients may provide some guidance, the researchers noted. “Tumors secrete a range of procachexia factors thought to be unique to cancer-related cachexia, and colloquially termed the ‘tumor secretome,’ ” they said. “Every single proinflammatory cytokine mentioned as part of the tumor secretome has a role in lupus pathogenesis,” suggesting a possible common pathway to cachexia across different diseases, they said.

The study findings were limited by several factors, mainly the use of BMI to measure weight “since BMI is a rather poor indicator of percent of body fat,” the researchers noted. “Ideally, cachexia would be defined as sarcopenia based on body composition evaluation with a dual x-ray absorptiometry,” they wrote.

The study was supported by the National Institutes of Health and the NIH Roadmap for Medical Research. The researchers had no financial conflicts to disclose.

SOURCE: Stojan G et al. Arthritis Care Res. 2020 Aug 2. doi: 10.1002/acr.24395.

Cachexia developed in 56% of adults with systemic lupus erythematosus over a 5-year period, and 18% did not recover their weight, based on data from more than 2,000 patients.

Sara Freeman/MDedge News
Dr. George Stojan

Although weight loss is common in patients with systemic lupus erythematosus (SLE), cachexia, a disorder of involuntary weight loss, is largely undescribed in SLE patients, wrote George Stojan, MD, of Johns Hopkins University, Baltimore, and colleagues. Cachexia has been described in a range of disorders, including heart failure, renal disease, and rheumatoid arthritis, they said. “Cachexia has been shown to lead to progressive functional impairment, treatment-related complications, poor quality of life, and increased mortality,” they added.

In a study published in Arthritis Care & Research, the investigators reviewed data from the Hopkins Lupus Cohort, consisting of all SLE patients seen at a single center who are followed at least quarterly.

The study population included 2,452 SLE patients older than 18 years who had their weight assessed at each clinic visit. The average follow-up period was 7.75 years, and the average number of weight measurements per patient was nearly 24.

Cachexia was defined as a 5% stable weight loss in 6 months without starvation relative to the average weight in all prior cohort visits; and/or weight loss of more than 2% without starvation relative to the average weight in all prior cohort visits in addition to a body mass index less than 20 kg/m2.

Overall, the risk for cachexia within 5 years of entering the study was significantly higher in patients with a BMI less than 20, current steroid use, vasculitis, lupus nephritis, serositis, hematologic lupus, positive anti-double strand DNA (anti-dsDNA), anti-Smith (anti-Sm), and antiribonucleoprotein (anti-RNP), the researchers noted. After adjustment for prednisone use, cachexia remained significantly associated with lupus nephritis, vasculitis, serositis, and hematologic lupus.



Future organ damage including cataracts, retinal change or optic atrophy, cognitive impairment, cerebrovascular accidents, cranial or peripheral neuropathy, pulmonary hypertension, pleural fibrosis, angina or coronary bypass, bowel infarction or resection, osteoporosis, avascular necrosis, and premature gonadal failure were significantly more likely among patients with intermittent cachexia, compared with those with continuous or no cachexia. Patients with continuous cachexia were significantly more likely to experience an estimated glomerular filtration rate less than 50 mL/min/1.73 m2, proteinuria greater than 3.5 g/day, and end-stage renal disease.

The patients who never developed cachexia were significantly less likely to develop malignancies, diabetes, valvular disease, or cardiomyopathy than were those who did have cachexia, the researchers said.

The mechanisms of action for cachexia in SLE remain unclear, but studies in cancer patients may provide some guidance, the researchers noted. “Tumors secrete a range of procachexia factors thought to be unique to cancer-related cachexia, and colloquially termed the ‘tumor secretome,’ ” they said. “Every single proinflammatory cytokine mentioned as part of the tumor secretome has a role in lupus pathogenesis,” suggesting a possible common pathway to cachexia across different diseases, they said.

The study findings were limited by several factors, mainly the use of BMI to measure weight “since BMI is a rather poor indicator of percent of body fat,” the researchers noted. “Ideally, cachexia would be defined as sarcopenia based on body composition evaluation with a dual x-ray absorptiometry,” they wrote.

The study was supported by the National Institutes of Health and the NIH Roadmap for Medical Research. The researchers had no financial conflicts to disclose.

SOURCE: Stojan G et al. Arthritis Care Res. 2020 Aug 2. doi: 10.1002/acr.24395.

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Health disparities training falls short for internal medicine residents

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Thu, 10/29/2020 - 14:14

Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

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Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

Less than half of internal medicine residency program directors report formal curricula on the topic of health disparities, according to findings of a survey of medical directors and residents across the United States.

Despite recommendations from the Institute of Medicine going back to 2002 calling for increased education on the topic for health care providers, data from a 2012 survey showed that only 17% of internal medicine programs had a health disparities curriculum, wrote Denise M. Dupras, MD, of the Mayo Medical School, Rochester, Minn., and colleagues.

To describe internal medicine residency training programs’ curricula and educational experiences on health disparities and to determine residents’ perceptions of training, the researchers designed a cross-sectional survey study including 227 program directors and 22,723 internal medicine residents. The survey was conducted from August to November 2015.

Overall, 91 program directors (40%) reported a curriculum in health disparities, but only 16 of them described the quality of their education as very good or excellent. In 56% of the programs, outcomes of the curriculum were not measured.

A majority (90%) of the programs included racial/ethnic diversity and socioeconomic status in their curricula, 58% included information about limited English proficiency, and 53% included information about gender identity and sexual orientation.

Reported barriers to curriculum development in 132 programs that did not have a health disparities curriculum included lack of time in the current curriculum, insufficient faculty skill to teach the topic, lack of institutional support, and lack of faculty interest, the researchers noted.

A total of 13,251 residents (70%) reported receiving some training in caring for patients at risk for health disparities over 3 years of training, and 10,494 (80%) of these rated the quality as very good or excellent. “Residents who cared for a larger proportion of underserved patients perceived that they received health disparities training at a higher rate,” the researchers wrote. However, increased care of at-risk populations does not necessarily translate into increased knowledge and skills. “Our finding that residents’ rating of the quality of their training was not associated with the presence of a curriculum in health disparities in their program also raises a concern that perceptions may overestimate the acquisition of needed skills,” they added.

The major limitation of the study was “that residents were not asked directly if they were exposed to a curriculum in health disparities but rather if they received training in the care of patients who would be at risk, which raises the concern that we cannot distinguish between their recognition of a formal and informal curriculum,” the researchers noted. In addition, the survey could not confirm that program directors were aware of all training. “Furthermore, because the survey items were embedded in larger program director survey, we were limited in the ability to ask them to define more specifically the components of their health disparities curricula,” they wrote.

However, the results were strengthened by the large and comprehensive study population, and highlight not only the need for standardized health disparities curricula, but also the need for research to determine the most effective domains for such curricula in graduate medical education, they emphasized.

“There are opportunities to explore partnerships among residencies, institutional clinical practices, and communities for productive collaborations around disparities-related quality improvement projects to address gaps in health care that are specific to the populations they serve,” they concluded.

The surveys were conducted in 2015 and the comparative work in 2018, prior to the COVID-19 pandemic and the subsequent increased concerns about disparities in health care, Dr. Dupras said in an interview.

“We conducted the survey because we recognized that health disparities were still prevalent in our society despite calls to improve the education of our learners to address them. We wanted to determine what our programs were providing for educational curriculum and what our learners were experiencing,” she said.

“We did not know what the surveys would show, so I cannot say that we were surprised by the findings,” said Dr. Dupras. “One of the challenges in interpreting our results is inherent in studies that rely on surveys. We cannot know how those filling out the surveys interpret the questions.” The study results yield several messages.

“First, residency training programs have opportunities to do a better job in developing educational opportunities related to health disparities; second, residents learn in the context of care and we must optimize education around these experiences; third, every patient is different. It is time to move towards cultural humility, since the risk for disparities is not associated with one patient characteristic, but composed of multiple factors,” she said.

“Given that 5 years has passed since our original survey, it would be important to repeat the survey and consider expanding it to include other training programs that provide frontline care, such as family medicine and pediatrics,” Dr. Dupras noted.

Dr. Dupras and colleagues had no financial conflicts to disclose.

SOURCE: Dupras DM et al. JAMA Netw Open. 2020 Aug 10. doi: 10.1001/jamanetworkopen.2020.12757.

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Educational intervention curbs use of antibiotics for respiratory infections

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Mon, 08/17/2020 - 16:15

A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

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A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

A clinician education program significantly reduced overall antibiotic prescribing during pediatric visits for acute respiratory tract infections, according to data from 57 clinicians who participated in an intervention.

sturti/Getty Images

In a study published in Pediatrics, Matthew P. Kronman, MD, of the University of Washington, Seattle, and associates randomized 57 clinicians at 19 pediatric practices to a stepped-wedge clinical trial. The study included visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infections (defined as ARTI visits) for children aged 6 months to less than 11 years, for a total of 72,723 ARTI visits by 29,762 patients. The primary outcome was overall antibiotic prescribing for ARTI visits.

For the intervention, known as the Dialogue Around Respiratory Illness Treatment (DART) quality improvement (QI) program, clinicians received three program modules containing online tutorials and webinars. These professionally-produced modules included a combination of evidence-based communication strategies and antibiotic prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months.

Overall, the probability of antibiotic prescribing for ARTI visits decreased by 7% (adjusted relative risk 0.93) from baseline to a 2- to 8-month postintervention in an adjusted intent-to-treat analysis.

Analysis of secondary outcomes revealed that prescribing any antibiotics for viral ARTI decreased by 40% during the postintervention period compared to baseline (aRR 0.60).

In addition, second-line antibiotic prescribing decreased from baseline by 34% for streptococcal pharyngitis (aRR 0.66), and by 41% for sinusitis (aRR 0.59); however there was no significant change in prescribing for acute otitis media, the researchers said.

The study findings were limited by several factors including the potential for biased results because of the randomization of clinicians from multiple practices and the potential for clinicians to change their prescribing habits after the start of the study, Dr. Kronman and colleagues noted.

In addition, the study did not include complete data on rapid streptococcal antigen testing, which might eliminate some children from the study population, and the relatively short postintervention period “may not represent the true long-term intervention durability may not represent the true long-term intervention durability,” they said.

However, the results support the potential of the DART program. “The 7% reduction in antibiotic prescribing for all ARTIs, if extrapolated to all ambulatory ARTI visits to pediatricians nationally, would represent 1.5 million fewer antibiotic prescriptions for children with ARTI annually,” they wrote.

“Providing online communication training and evidence-based antibiotic prescribing education in combination with individualized antibiotic prescribing feedback reports may help achieve national goals of reducing unnecessary outpatient antibiotic prescribing for children,” Dr. Kronman and associates concluded.

Combining interventions are key to reducing unnecessary antibiotics use in pediatric ambulatory care, Rana F. Hamdy, MD, MPH, of Children’s National Hospital, Washington, , and Sophie E. Katz, MD, of Vanderbilt University, Nashville, Tenn., wrote in an accompanying editorial (Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-012922).

The researchers in the current study “seem to recognize that clinicians are adult learners, and they combine interventions to implement these adult learning theory tenets to improve appropriate antibiotic prescribing,” they wrote. The DART intervention combined best practices training, communications training, and individualized antibiotic prescribing feedback reports to improve communication between providers and families “especially when faced with a situation in which a parent or guardian might expect an antibiotic prescription but the provider does not think one is necessary,” Dr. Hamdy and Dr. Katz said.

Overall, the findings suggest that the interventions work best in combination vs. being used alone, although the study did not evaluate the separate contributions of each intervention, the editorialists wrote.

“In the current study, nonengaged physicians had an increase in second-line antibiotic prescribing, whereas the engaged physicians had a decrease in second-line antibiotic prescribing,” they noted. “This suggests that the addition of communications training could mitigate the undesirable effects that may result from solely using feedback reports.”

“Each year, U.S. children are prescribed as many as 10 million unnecessary antibiotic courses for acute respiratory tract infections,” Kristina A. Bryant, MD, of the University of Louisville, Ky., said in an interview. “Some of these prescriptions result in side effects or allergic reactions, and they contribute to growing antibiotic resistance. We need effective interventions to reduce antibiotic prescribing.”

Although the DART modules are free and available online, busy clinicians might struggle to find time to view them consistently, said Dr. Bryant.

“One advantage of the study design was that information was pushed to clinicians along with communication booster videos,” she said. “We know that education and reinforcement over time works better than a one and done approach.

“Study participants also received feedback over time about their prescribing habits, which can be a powerful motivator for change, although not all clinicians may have easy access to these reports,” she noted.

To overcome some of the barriers to using the modules, clinicians who are “interested in improving their prescribing could work with their office managers to develop antibiotic prescribing reports and schedule reminders to review them,” said Dr. Bryant.

“An individual could commit to education and review of his or her own prescribing patterns, but support from one’s partners and shared accountability is likely to be even more effective,” she said. “Sharing data within a practice and exploring differences in prescribing patterns can drive improvement.

“Spaced education and regular feedback about prescribing patterns can improve antibiotic prescribing for pharyngitis and sinusitis, and reduce antibiotic prescriptions for ARTIs,” Dr. Bryant said. The take-home from the study is that it should prompt anyone who prescribes antibiotics for children to ask themselves how they can improve their own prescribing habits.

“In this study, prescribing for viral ARTIs was reduced but not eliminated. We need additional studies to further reduce unnecessary antibiotic use,” Dr. Bryant said.

In addition, areas for future research could include longer-term follow-up. “Study participants were followed for 2 to 8 months after the intervention ended in June 2018. It would be interesting to know about their prescribing practices now, and if the changes observed in the study were durable,” she concluded.

The study was supported by the National Institutes of Health, along with additional infrastructure funding from the American Academy of Pediatrics and the Health Resources and Services Administration of the Department of Health and Human Services. The researchers had no financial conflicts to disclose.

Dr. Hamdy and Dr. Katz had no financial conflicts to disclose, but Dr. Katz disclosed grant support through the Centers for Disease Control and Prevention as a recipient of the Leadership in Epidemiology, Antimicrobial Stewardship, and Public Health fellowship, sponsored by the Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, and Pediatric Infectious Diseases Society.

Dr. Bryant disclosed serving as an investigator on multicenter clinical vaccine trials funded by Pfizer (but not in the last year). She also serves as the current president of the Pediatric Infectious Diseases Society, but the opinions expressed here are her own and do not necessarily reflect the views of PIDS.

SOURCE: Kronman MP et al. Pediatrics. 2020 Aug 3. doi: 10.1542/peds.2020-0038.

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Many children with COVID-19 present without classic symptoms

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Tue, 02/14/2023 - 13:01

Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

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To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

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

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

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Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

Fuse/thinkstockphotos.com

To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

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

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

Most children who tested positive for SARS-CoV-2 had no respiratory illness, according to data from a retrospective study of 22 patients at a single center.

Fuse/thinkstockphotos.com

To date, children account for less than 5% of COVID-19 cases in the United States, but details of the clinical presentations in children are limited, wrote Rabia Agha, MD, and colleagues of Maimonides Children’s Hospital, Brooklyn, N.Y.

In a study published in Hospital Pediatrics, the researchers reviewed data from 22 children aged 0-18 years who tested positive for SARS-CoV-2 by polymerase chain reaction (PCR) and were admitted to a single hospital over a 4-week period from March 18, 2020, to April 15, 2020.

Overall, 9 patients (41%) presented with a respiratory illness, and 7 (32%) required respiratory support. Of four patients requiring mechanical ventilation, two had underlying pulmonary disease. The other two patients who required intubation were one with cerebral palsy and status epilepticus and one who presented in a state of cardiac arrest.

The study population ranged from 11 days to 18 years of age, but 45% were infants younger than 1 year. None of the children had a travel history that might increase their risk for SARS-CoV-2 infection; 27% had confirmed exposure to the virus.

Most of the children (82%) were hospitalized within 3 days of the onset of symptoms, and no deaths occurred during the study period. The most common symptom was fever without a source in five (23%) otherwise healthy infants aged 11-35 days. All five of these children underwent a sepsis evaluation, received empiric antibiotics, and were discharged home with negative bacterial cultures within 48-72 hours. Another 10 children had fever in combination with other symptoms.

Other presenting symptoms were respiratory (9), fatigue (6), seizures (2), and headache (1).

Most children with respiratory illness were treated with supportive therapy and antibiotics, but three of those on mechanical ventilation also were treated with remdesivir; all three were ultimately extubated.

Neurological abnormalities occurred in two patients: an 11-year-old otherwise healthy boy who presented with fever, headache, confusion, and seizure but ultimately improved without short-term sequelae; and a 12-year-old girl with cerebral palsy who developed new onset seizures and required mechanical ventilation, but ultimately improved to baseline.

Positive PCR results were identified in seven patients (32%) during the second half of the study period who were initially hospitalized for non-COVID related symptoms; four with bacterial infections, two with illnesses of unknown etiology, and one with cardiac arrest. Another two children were completely asymptomatic at the time of admission but then tested positive by PCR; one child had been admitted for routine chemotherapy and the other for social reasons, Dr. Agha and associates said.

The study findings contrast with early data from China in which respiratory illness of varying severity was the major presentation in children with COVID-19, but support a more recent meta-analysis of 551 cases, the researchers noted. The findings also highlight the value of universal testing for children.

“Our initial testing strategy was according to the federal and local guidelines that recommended PCR testing for the symptoms of fever, cough and shortness of breath, or travel to certain countries or close contact with a confirmed case,” Dr. Agha and colleagues said.

“With the implementation of our universal screening strategy of all admitted pediatric patients, we identified 9 (41%) patients with COVID-19 that would have been missed, as they did not meet the then-recommended criteria for testing,” they wrote.

The results suggest the need for broader guidelines to test pediatric patients because children presenting with other illnesses may be positive for SARS-CoV-2 as well, the researchers said.

“Testing of all hospitalized patients will not only identify cases early in the course of their admission process, but will also help prevent inadvertent exposure of other patients and health care workers, assist in cohorting infected patients, and aid in conservation of personal protective equipment,” Dr. Agha and associates concluded.

The current study is important as clinicians continue to learn about how infection with SARS-CoV-2 presents in different populations, Diana Lee, MD, of the Icahn School of Medicine at Mount Sinai, New York, said in an interview.

“Understanding how it can present in the pediatric population is important in identifying children who may have the infection and developing strategies for testing,” she said.

“I was not surprised by the finding that most children did not present with the classic symptoms of COVID-19 in adults based on other published studies and my personal clinical experience taking care of hospitalized children in New York City,” said Dr. Lee. “Studies from the U.S. and other countries have reported that fewer children experience fever, cough, and shortness of breath [compared with] adults, and that most children have a milder clinical course, though there is a small percentage of children who can have severe or critical illness,” she said.

“A multisystem inflammatory syndrome in children associated with COVID-19 has also emerged and appears to be a postinfectious process with a presentation that often differs from classic COVID-19 infection in adults,” she added.

The take-home message for clinicians is the reminder that SARS-CoV-2 infection often presents differently in children than in adults, said Dr. Lee.

“Children who present to the hospital with non-classic COVID-19 symptoms or with other diagnoses may be positive for SARS-CoV-2 on testing. Broadly testing hospitalized children for SARS-CoV-2 and instituting appropriate isolation precautions may help to protect other individuals from being exposed to the virus,” she said.  

“Further research is needed to understand which individuals are contagious and how to accurately distinguish those who are infectious versus those who are not,” said Dr. Lee. “There have been individuals who persistently test positive for SARS-CoV-2 RNA (the genetic material of the virus), but were not found to have virus in their bodies that can replicate and thereby infect others,” she emphasized. “Further study is needed regarding the likelihood of household exposures in children with SARS-CoV-2 infection given that this study was done early in the epidemic in New York City when testing and contact tracing was less established,” she said.

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

SOURCE: Agha R et al. Hosp Pediatr. 2020 July. doi: 10.1542/hpeds.2020-000257.

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