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Home Insulin Pumps Safe for In-Hospital Pediatric Care
TOPLINE:
METHODOLOGY:
- Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
- The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
- Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
- Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
- Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.
TAKEAWAY:
The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).
At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).
The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).
No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.
IN PRACTICE:
“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.
SOURCE:
The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.
LIMITATIONS:
The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.
DISCLOSURES:
The study did not disclose any source of funding. The authors did not report any conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
- The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
- Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
- Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
- Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.
TAKEAWAY:
The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).
At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).
The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).
No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.
IN PRACTICE:
“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.
SOURCE:
The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.
LIMITATIONS:
The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.
DISCLOSURES:
The study did not disclose any source of funding. The authors did not report any conflicts of interest.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Clinical guidelines support the use of home insulin pumps in adults hospitalized for noncritical illnesses, but it has been unclear if adult safety data translate to pediatric inpatients.
- The study evaluated if insulin can be safely and precisely delivered using home insulin pumps managed by patients or caregivers in 2738 patients (0.5-25 years old; median age about 16) with insulin-dependent diabetes admitted to non–intensive care units of a tertiary children’s hospital between January 2016 and December 2021.
- Insulin was delivered either using home insulin pumps managed by patients or caregivers or using hospital insulin pumps or subcutaneous injections managed by hospital staff.
- Safety was measured by hyperglycemia (glucose level > 250 mg/dL), hypoglycemia (moderate: glucose level, 45-59 mg/dL or severe: glucose level, < 45 mg/dL), glucose variability, and the incidence of diabetic ketoacidosis for each delivery method.
- Results were calculated by the number of days a patient had one or more glucose levels meeting the definition of hyperglycemia or hypoglycemia and divided by the number of days a patient receive any insulin dose.
TAKEAWAY:
The number of hyperglycemic days was lower in patients using a hospital (15.7%) or a home (27.0%) insulin pump than in those receiving subcutaneous insulin injections (45.2%; P < .001).
At least one moderate hypoglycemic day was noted in patients receiving insulin through subcutaneous injections (5.1%) compared with those receiving it through hospital (3.1%) or home insulin pumps (4.5%; P = .02).
The proportion of days within the desired blood glucose range and glucose variability were similar in patients using hospital or home insulin pumps and worse in patients managed with injections (P < .001).
No patients using home or hospital pumps developed diabetic ketoacidosis, but two cases of diabetic ketoacidosis were noted among patients using injections.
IN PRACTICE:
“Safety is not sacrificed when patients or caregivers use home pumps during pediatric non–intensive care unit admissions,” the authors wrote.
SOURCE:
The investigation, led by Jodi Owens, MSN, RN, Division of Endocrinology, Cincinnati Children’s Hospital Medical Center, was published along with an invited commentary in JAMA Network Open.
LIMITATIONS:
The strategies employed for insulin safety and awareness by the institution may have led to improved rates of hypoglycemia and hyperglycemia. Moreover, the study did not assess changes in glycemic levels during transition in the insulin delivery method. The study was limited to non–intensive care units and hence cannot be generalized to intensive care unit settings or in patients with diabetic ketoacidosis. The study did not include patients using hybrid-closed loop insulin pumps.
DISCLOSURES:
The study did not disclose any source of funding. The authors did not report any conflicts of interest.
A version of this article appeared on Medscape.com.
Pfizer Antibody-Drug Conjugate Picks Up Pediatric ALL Indication
The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition.
Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m2 per cycle and the rest with an initial dose of 1.8 mg/m2 per cycle for a median of two cycles and a range of one to four cycles.
Premedications included methylprednisolone plus an antipyretic and antihistamine.
Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months.
All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.
Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.
The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.
The initial recommended dose is 1.8 mg/m2 per cycle, divided into 0.8 mg/m2 on day 1, followed by 0.5 mg/m2 on day 9 and 0.5 mg/m2 on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities.
According to drugs.com, 0.9 mg costs $23,423.47.
A version of this article appeared on Medscape.com.
The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition.
Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m2 per cycle and the rest with an initial dose of 1.8 mg/m2 per cycle for a median of two cycles and a range of one to four cycles.
Premedications included methylprednisolone plus an antipyretic and antihistamine.
Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months.
All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.
Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.
The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.
The initial recommended dose is 1.8 mg/m2 per cycle, divided into 0.8 mg/m2 on day 1, followed by 0.5 mg/m2 on day 9 and 0.5 mg/m2 on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities.
According to drugs.com, 0.9 mg costs $23,423.47.
A version of this article appeared on Medscape.com.
The CD22-directed antibody and cytotoxic drug conjugate was previously approved only for adults with the condition.
Pediatric approval was based on a single-arm study of 53 children, of whom 12 were treated with an initial dose of 1.4 mg/m2 per cycle and the rest with an initial dose of 1.8 mg/m2 per cycle for a median of two cycles and a range of one to four cycles.
Premedications included methylprednisolone plus an antipyretic and antihistamine.
Overall, 22 children (42%) had a complete remission, defined as < 5% blasts in the bone marrow, no leukemia blasts in peripheral blood, full recovery of peripheral blood counts, and resolution of extramedullary disease. The median duration of complete remission was 8.2 months.
All but one child who went into complete remission (95.5%) had no minimal residual disease (MRD) by flow cytometry, and 19 (86.4%) were MRD negative by real-time quantitative polymerase chain reaction.
Adverse events in ≥ 20% of participants included thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.
The antibody-drug conjugate carries a black box warning of hepatotoxicity, including hepatic veno-occlusive and post-hematopoietic stem cell transplant mortality.
The initial recommended dose is 1.8 mg/m2 per cycle, divided into 0.8 mg/m2 on day 1, followed by 0.5 mg/m2 on day 9 and 0.5 mg/m2 on day 15. The initial 3-week cycle can be extended to 4 weeks for patients who have a complete remission or a complete remission with incomplete hematologic recovery and/or to recover from toxicities.
According to drugs.com, 0.9 mg costs $23,423.47.
A version of this article appeared on Medscape.com.
Is Atopic Dermatitis Linked to Cognitive Impairment Symptoms in Children?
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
It remains unknown whether subpopulations of children with atopic dermatitis face a greater risk for cognitive impairment or not.
To determine the association, researchers drew from a weighted sample of 69,732,807 children with atopic dermatitis in the 2021 US National Health Interview Survey.
Main outcomes of interest were difficulty in learning or memory (cognitive impairment symptoms) as reported by the child’s caregiver.
The researchers performed logistic regression to compare the odds of learning or memory difficulties between 60,509,794 children without atopic dermatitis and 9,223,013 children with atopic dermatitis.
TAKEAWAY:
Children with versus without atopic dermatitis were more likely to experience difficulties with learning (10.8% [95% CI, 7.8%-15.8%] vs 5.9% [95% CI, 5.1%-6.9%]; P < .001) and difficulties with memory (11.1% [95% CI, 8.0%-15.9%] vs 5.8% [95% CI, 4.9%-6.9%]; P < .001).
On multivariable logistic regression adjusted for sociodemographic factors, asthma, food allergies, and seasonal allergies or hay fever, researchers found that having atopic dermatitis was associated with increased odds of difficulties in learning (adjusted odds ratio [aOR], 1.77; 95% CI, 1.28-2.45) and memory (aOR, 1.69; 95% CI, 1.19-2.41).
When stratified by neurodevelopmental comorbidities, having atopic dermatitis was associated with a 2- to 3-fold greater odds of memory difficulties among children with any neurodevelopmental disorder (aOR, 2.26; 95% CI, 1.43-3.57), which included ADHD (aOR, 2.90; 95% CI, 1.60-5.24) or learning disabilities (aOR, 2.04; 95% CI, 1.04-4.00).
Having atopic dermatitis was not associated with learning or memory difficulties among children without neurodevelopmental conditions.
IN PRACTICE:
“These findings may improve the risk stratification of children with atopic dermatitis for cognitive impairment and suggest that evaluation for cognitive impairment should be prioritized among children with atopic dermatitis and comorbid ADHD or learning disability,” the authors wrote.
SOURCE:
Corresponding author Joy Wan, MD, of the department of dermatology at Johns Hopkins University School of Medicine, Baltimore, and colleagues conducted the research, which was published on March 6, 2024, in JAMA Dermatology.
LIMITATIONS:
The study’s limitations were its cross-sectional design, reliance on caregiver reports, and the fact that National Health Interview Survey data do not include information on factors such as atopic dermatitis severity, age at atopic dermatitis diagnosis, and sleep.
DISCLOSURES:
The study was supported by a grant from the National Institutes of Health. Dr. Wan reported receiving a grant from Pfizer and personal fees from Sun Pharmaceutical Industries and Janssen Pharmaceuticals outside the submitted work. No other study authors had disclosures to report.
A version of this article appeared on Medscape.com.
Move Over Sealants, Silver Diamine Fluoride Might Take Your Place
TOPLINE:
Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics
METHODOLOGY:
- School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
- Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
- The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
- Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
- Researchers compared the rates of new cavities and fillings between the two groups over time.
TAKEAWAY:
- Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
- The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
- The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
- Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).
IN PRACTICE:
“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”
SOURCE:
The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.
LIMITATIONS:
The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition.
DISCLOSURES:
Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics
METHODOLOGY:
- School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
- Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
- The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
- Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
- Researchers compared the rates of new cavities and fillings between the two groups over time.
TAKEAWAY:
- Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
- The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
- The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
- Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).
IN PRACTICE:
“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”
SOURCE:
The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.
LIMITATIONS:
The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition.
DISCLOSURES:
Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.
A version of this article appeared on Medscape.com.
TOPLINE:
Children treated with silver diamine fluoride (SDF) had outcomes similar to those who received sealants and atraumatic restoration (ART), according to findings from a new study published in JAMA Pediatrics
METHODOLOGY:
- School programs for dental sealants were first proposed as a way to reduce health inequities, but the technique is too expensive to be widely used.
- Silver diamine fluoride has antimicrobial properties that remineralize the teeth and is a cost-effective alternative to dental sealants.
- The trial included 4100 children from low-income and/or minority groups in New York City, who were aged between 5 to 13 years.
- Between 2018 and 2023, students exhibiting early tooth decay were randomized to receive either SDF or sealants and ART.
- Researchers compared the rates of new cavities and fillings between the two groups over time.
TAKEAWAY:
- Overall, the odds of developing dental cavities decreased by around 20% in both treatment groups.
- The prevalence of cavities among children treated with SDF was 10.2 per 1000 tooth-years compared with 9.8 per 1000 in the sealant and ART group.
- The difference in students who had no new cavities or fillings between the two groups was minimal, ranging from −0.001 to 0.031.
- Children who received SDF from a nurse had outcomes similar to those who were treated by a dental hygienist (odds ratio, 0.89; 95% CI, 0.67-1.19).
IN PRACTICE:
“Research indicates that treatment of early childhood caries using SDF by physicians in primary care settings is both feasible and acceptable…we conclude that SDF is an effective alternative for community-based prevention that may help address these existing barriers.”
SOURCE:
The study was funded by the Patient-Centered Outcomes Research Institute (PCORI). It was led by Ryan Richard Ruff, PhD, MPH, associate professor in the Department of Epidemiology & Health Promotion at New York University College of Dentistry, New York.
LIMITATIONS:
The authors reported that youth may have received dental care outside of the study, which could have influenced the results. To account for that risk, they identified students who received outside care. In addition, > 3000 students were not included in the final analysis due to attrition.
DISCLOSURES:
Authors reported receiving grants from the National Institute on Minority Health and Health Disparities, the PCORI, and the National Institutes of Health. Richard Niederman, DMD, reported nonfinancial support from Colgate, GC America, and Elevate Oral Care and consulting fees from Delta Dental Washington outside the submitted work.
A version of this article appeared on Medscape.com.
Psilocybin Poison Control Calls Spike in Teens, Young Adults
Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.
METHODOLOGY:
- Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
- Researchers focused on calls about individuals between the ages of 13 and 25 years.
- Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.
TAKEAWAY:
- During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
- Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
- The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).
IN PRACTICE:
The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.
SOURCE:
Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.
LIMITATIONS:
NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.
DISCLOSURES:
Funding source was not disclosed. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.
METHODOLOGY:
- Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
- Researchers focused on calls about individuals between the ages of 13 and 25 years.
- Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.
TAKEAWAY:
- During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
- Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
- The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).
IN PRACTICE:
The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.
SOURCE:
Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.
LIMITATIONS:
NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.
DISCLOSURES:
Funding source was not disclosed. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Calls to US poison centers related to psilocybin more than tripled among teens and more than doubled in young adults between 2019 and 2022, new research suggests. Investigators say the increase may be linked to decriminalization efforts in US cities and states.
METHODOLOGY:
- Investigators used data from the National Poison Data System (NPDS) to identify calls involving psilocybin between January 2013 and December 2022.
- Researchers focused on calls about individuals between the ages of 13 and 25 years.
- Exposures to psilocybin were examined based on demographics, clinical effects, level of care, and medical outcome.
TAKEAWAY:
- During the entire 10-year study period, 4055 psilocybin-involved exposures were reported in the age groups studied, with 66% being single-substance exposures and close to three quarters receiving medical attention.
- Psilocybin’s most common effects were hallucinations or delusions (37% of calls), agitation (28%), tachycardia (20%), and confusion (16%).
- The number of psilocybin-related calls to poison control centers for youth were largely unchanged from 2013 to 2018 but more than tripled among adolescents (aged 13-19 years) from 2019 and 2022 and more than doubled among young adults (aged 20-25 years) between 2018 and 2022 (P < .0001).
IN PRACTICE:
The increase in poison center calls coincides with psilocybin decriminalization efforts in several states in 2019, the authors noted. However, because those efforts only legalized use in adults aged 21 years and older, the rise among younger people is concerning, they added. “As psilocybin may become more widely available, it is important for parents to be aware that psilocybin is also available in edible forms such as chocolate and gummies. And we learned from our experience with edible cannabis that young children can mistake edibles for candy,” lead author Rita Farah, PharmD, MPH, PhD, Blue Ridge Poison Center epidemiologist, said in a news release.
SOURCE:
Christopher Holstege, MD, director of UVA Health’s Blue Ridge Poison Center and chief of the Division of Medical Toxicology at the UVA School of Medicine was the senior and corresponding author of the study. It was published online on February 26 in the Journal of Adolescent Health.
LIMITATIONS:
NPDS data are not designed to assess potential risk factors leading to increases in psilocybin-related cases. Moreover, because reports to poison control centers are voluntary and don’t capture all exposures, NPDS data likely under-represent cases of hallucinogenic mushroom poisonings. Lastly, NPDS data are susceptible to reporting and misclassification biases.
DISCLOSURES:
Funding source was not disclosed. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Be Wary of TikTok Content on Infantile Hemangiomas: Study
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- New parents may turn to TikTok for information about IHs, but little is known about the quality of videos on the social media platform related to the topic.
- Using the search term “hemangioma,” researchers reviewed the top 50 English-language TikTok videos that resulted from the query in November 2022.
- The researchers analyzed the videos for their content source, accuracy, and purpose and used Infantile Hemangioma Referral Score criteria to determine if the lesions pictured on the videos met criteria for referral to a specialist or not.
TAKEAWAY:
- Combined, the 50 videos were viewed 25.1 million times, had 2.6 million likes, and received 17,600 comments.
- Only 36 were considered likely to be IH. Of those 36 videos, the researchers deemed 33 (92%) to be potentially problematic, meriting referral to a specialist. The remaining three lesions could not be classified because of insufficient information.
- Of the 50 videos, 45 were created by individuals personally affected by IH (parents of a child with IH or young adults living with residual impacts), and only three were created by physicians (two by plastic surgeons and one by a neonatologist).
- In terms of content, 2 of the 45 videos created by someone personally affected by IH contained inaccurate information, while all three of videos created by physicians contained inaccurate information, such as oversimplification of the prognosis or incorrect nomenclature.
IN PRACTICE:
“Providers should be aware that TikTok may be useful for promoting birthmark awareness, but that it should not be relied on for accurate information about IHs,” the authors wrote.
SOURCE:
First author Sonora Yun, a medical student at Columbia University College of Physicians and Surgeons, New York City, conducted the research with Maria C. Garzon, MD, and Kimberly D. Morel, MD, who are board-certified pediatric dermatologists at Columbia. The study was published in Pediatric Dermatology.
LIMITATIONS:
The authors noted no specific limitations to the study.
DISCLOSURES:
The researchers reported having no disclosures.
A version of this article appeared on Medscape.com.
Omalizumab for Food Allergies: What PCPs Should Know
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Sandra Hong, MD, chair of allergy and immunology and director of the Food Allergy Center of Excellence at Cleveland Clinic, in Ohio, sees firsthand how situations that feel ordinary to most people strike fear in the hearts of her patients with food allergies.
Not only do some experience reactions to milk when they eat a cheese pizza — they can’t be in the same room with someone enjoying a slice nearby. “That would be terrifying,” Dr. Hong said.
Omalizumab (Xolair), recently approved by the US Food and Drug Administration as monotherapy for the treatment of food allergies, may now bring peace of mind to these patients and their families by reducing their risk of dangerous allergic reactions to accidental exposure.
While the drug does not cure food allergies, a phase 3, placebo-controlled trial found that after 16 weeks of treatment, two thirds of participants were able to tolerate at least 600 mg of peanut protein — equal to about 2.5 peanuts — without experiencing moderate to severe reactions.
An open-label extension trial also found the monoclonal antibody reduced the likelihood of serious reactions to eggs by 67%, milk by 66%, and cashews by 42%. The results of the study were published in The New England Journal of Medicine.
The treatment is approved for children as young as the age of 1 year and is the only treatment approved for multiple food allergies. It does not treat anaphylaxis or other emergency situations.
Patient Selection Key
While 8% of children and 10% of adults in the United States have a true food allergy, Brian Vickery, MD, chief of allergy and immunology and director of the Food Allergy Center at Children’s Healthcare of Atlanta, noted that a significantly higher proportion of the population restricts their diet based on perceived food intolerances.
“Most important for family doctors prior to prescribing the medication will be to be sure that the diagnosis is correct,” Kim said. “We know that allergy blood and skin testing is good but not perfect, and false positive results can occur,” said Edwin Kim, MD, chief of the Division of Pediatric Allergy and Immunology and director of the University of North Carolina Food Allergy Initiative at the University of North Carolina School of Medicine, Chapel Hill, who was a coauthor on the study in the New England Journal of Medicine. “ An allergist can conduct food challenges to confirm the diagnosis if results are unclear.”
Even for patients with confirmed IgE-mediated allergies, Dr. Hong said selecting patients who are good candidates for the therapy has “nuances.”
Patients must be willing and able to commit to injections every 2-4 weeks. Dosing depends on body weight and the total IgE levels of each patient. Patients with IgE levels > 1850 UI/mL likely will be disqualified from treatment since the clinical trial did not enroll patients with total IgE above this level and the appropriate dose in those patients is unknown.
“My recommendation for family physicians who are counseling food-allergic patients interested in omalizumab treatment is to partner with an allergist-immunologist, if at all possible,” Dr. Vickery said. He added that patients should have a comprehensive workup before beginning treatment because starting omalizumab would reduce reactivity and alter the outcome a diagnostic oral food challenge.
Two populations Dr. Hong thinks might particularly benefit from the therapy are college students and preschoolers, who may be unable to completely avoid allergens because of poor impulse control and food sharing in group settings.
“The concerns we have about this age group are whether or not there might be other factors involved that may impede their ability to make good decisions.”
Less control of the environment in dorms or other group living situations also could increase the risk of accidental exposure to a food allergen.
For the right patients, the treatment regimen has significant advantages over oral immunotherapy treatment (OIT), including the fact that it’s not a daily medication and it has the potential to treat allergic asthma at the same time.
“The biggest pro for omalizumab is that it can treat all of your food allergies, whether you have one or many, and do it all in one medication,” Dr. Kim said.
Managing Potential Harms
Omalizumab carries risks both primary care providers and patients must consider. First among them is that the drug carries a “black box” warning for an increased risk of anaphylaxis, Dr. Hong said.
Although patients with multiple food allergies typically already have prescriptions for epinephrine, primary care physicians (PCPs) considering offering omalizumab must be comfortable treating severe systemic reactions and their offices capable of post-dose monitoring, Dr. Hong said.
Anaphylaxis “can occur after the first dose or it can be delayed,” she said. “Typically, allergists will give these in our offices and we’ll actually have people wait for delayed amounts of time, for hours.”
The drug has been available since 2003 as a treatment for allergic asthma and urticaria. In addition to the warning for anaphylaxis, common reactions include joint pain and injection-site reactions. It also increases the risk for parasitic infection, and some studies show an increase in the risk for cancer.
Still, Dr. Kim said omalizumab’s safety profile is reassuring and noted it has advantages over OIT. “Since the patient is not exposing themselves to the food they are allergic to like in OIT, the safety is expected to be far better,” he said.
Lifelong Treatment
Dr. Vickery, Dr. Hong, and Dr. Kim all cautioned that patients should understand that, while omalizumab offers protection against accidental exposure and can meaningfully improve quality of life, it won’t allow them to loosen their allergen-avoidant diets.
Further, maintaining protection requires receiving injections every 2-4 weeks for life. For those without insurance, or whose insurance does not cover the treatment, costs could reach thousands of dollars each month, Dr. Hong said.
Omalizumab “has been well covered by insurance for asthma and chronic hives, but we will have to see what it looks like for food allergy. The range of plans and out-of-pocket deductibles available to patients will also play a big role,” Dr. Kim said.
Other novel approaches to food allergies are currently in clinical trials, and both Dr. Hong and Dr. Vickery are optimistic about potential options in the pipeline.
“We’re just on the brink of really exciting therapies coming forward in the future,” Dr. Hong said.
The study was supported by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, both part of the National Institutes of Health; the Claudia and Steve Stange Family Fund; Genentech; and Novartis. Dr. Hong, Dr. Kim, and Dr. Vickery reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
AAP Updates Guidance on Vaccine Communication and Hesitancy
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
The measles outbreak in Florida, occurring just as health officials announced an official end to Philadelphia’s measles outbreak and rising global cases, has cast attention once again on concerns about vaccine hesitancy. In the midst of Florida’s surgeon general avoiding measles vaccination recommendations for parents, the American Academy of Pediatrics has updated its clinical guidance on vaccine communication.
“Disruption to routine pediatric vaccination during the COVID-19 pandemic has left many children vulnerable to vaccine-preventable diseases and more locations susceptible to outbreaks in the United States and around the world,” Sean T. O’Leary, MD, MPH, a pediatric infectious diseases specialist and associate professor of pediatrics at the University of Colorado in Aurora, and his colleagues, wrote in the new report, published in the March issue of Pediatrics. “Geographic clustering of vaccine refusal further increases the risk of communicable disease outbreaks in certain communities even when vaccination rates at a state or national level remain high overall.”
The authors note that disease resurgence may bolster vaccine uptake, with media coverage of recent outbreaks linked to more pro-vaccine discussions and attitudes among parents. But the evidence on that remains inconclusive, and the authors point out the slow uptake in COVID-19 vaccination as parents navigate ongoing spread of both the disease and vaccine misinformation.
Conflicting Evidence on Postpandemic Attitudes
It remains unclear how parent attitudes toward vaccines have shifted, if at all, since the pandemic. A study published in Pediatrics from October 2023, which Dr. O’Leary also coauthored, analyzed data from an online survey of Colorado mothers between 2018 and 2021 and found no significant difference in vaccine hesitancy during the pandemic compared with pre-pandemic.
Among 3,553 respondents, 1 in 5 (20.4%) were vaccine hesitant overall. Though parents were twice as likely to feel uncertain in trusting vaccine information after the COVID-19 vaccines were authorized (adjusted odds ratio [aOR] 2.14), they were half as likely to be unsure about hesitancy toward childhood vaccines (aOR 0.48).
Another study in Pediatrics from October 2023 found that common concerns about COVID-19 vaccines among parents included infertility, long-term effects from the vaccines, and effects on preexisting medical conditions. But even then, participants in focus groups “expressed that they would listen to their doctor for information about COVID-19 vaccines,” wrote Aubree Honcoop, MPS, of the University of Nebraska Medical Center in Omaha, and her colleagues.
“I think what we’re seeing, very importantly, is that physicians seem to be the source people rely on,” said Walter Orenstein, MD, professor of medicine and associate director of the Emory Vaccine Center at Emory University in Atlanta. “But we need to give the physicians time and incentives to spend time with families,” such as a billing code for vaccine counseling, he said.
Dr. Orenstein was surprised to see the results from Colorado, but he noted they were from a small survey in a single state. He pointed to other findings, such as those from the University of Pennsylvania’s Annenberg Public Policy Center in November 2023, that found lower confidence overall among Americans toward vaccines.
Paul Offit, MD, director of the Vaccine Education Center and an attending infectious disease physician at Children’s Hospital of Philadelphia, where the city’s measles outbreak began, is similarly skeptical about the Colorado study’s findings that parent vaccine attitudes have changed little since the pandemic. At the AAP’s annual conference in October 2023, Dr. Offit asked pediatricians about their experiences while he signed books.
“I would ask, ‘So what’s it like out there? Are we winning or losing?’ ” he said. “I would say, to a person, everyone said they felt things were much worse now than they ever have been before.”
Clinical Guidance
The new report reviews previously published evidence on the spectrum of parental vaccine acceptance — from supporters and “go along to get along” parents to cautious acceptors and fence sitters to vaccine refusers — and the determinants that contribute to hesitancy. They also noted the social inequities that have played a role in vaccine uptake disparities.
“Distrust of health systems based on historic and ongoing discrimination and inequitable access to care are intertwined challenges that contribute to racial and ethnic disparities in vaccine uptake,” the authors wrote. “Although there has been progress in reducing racial, ethnic, and socioeconomic disparities in childhood vaccination coverage, the COVID-19 pandemic made clear how much work is yet to be done.”
The report also reviewed the societal, individual, payer and pediatric practice costs of vaccine refusal. The 1-year cost to taxpayers from the measles outbreak in New York City in 2018-2019, for example, was $8.4 million, excluding vaccination programs.
The report provides background information to equip pediatricians for conversations with parents about vaccines. Since safety is the top concern for vaccine hesitancy among parents, the authors advised pediatricians to be familiar with the process of vaccine testing, emergency use authorization, licensure, approval, recommendations, and safety monitoring, including the Vaccine Safety Datalink, the Vaccine Adverse Event Reporting System (VAERS), the FDA’s Biologics Effectiveness and Safety (BEST) system, and the CDC’s Clinical Immunization Safety Assessment Project (CISA).
“Because vaccines are generally given to healthy individuals to prevent disease, they are held to a higher safety standard than other medications,” the authors wrote before providing a summary of the process for physicians to reference. The report also includes information on vaccine ingredients and a chart of common misconceptions about vaccines with the corresponding facts.
Overcoming Hesitancy
Evidence-based strategies for increasing childhood vaccine uptake begin with a strong vaccine recommendation using a presumptive rather than participatory approach, the authors wrote. “A presumptive format is one in which the clinician asserts a position regarding vaccines using a closed-ended statement, such as ‘Sara is due for several vaccines today’ or ‘Well, we have to do some shots,’ ” the authors wrote. “This strategy is in contrast to a participatory format, in which an open-ended question is used to more explicitly invite the parent to voice an opinion, such as ‘How do you feel about vaccines today?’ ” The presumptive format and a strong recommendation are both associated with greater uptake, evidence shows.
For parents who express hesitancy, the authors provide a summary of additional evidence-based communication strategies, starting with motivational interviewing. Two other strategies they highlight include using language to re-emphasize the importance of adhering to the CDC recommended schedule — “He really needs these shots” — and bundling discussion of all recommended vaccines for a visit at once.
“Finally, clinicians can emphasize their own experiences when discussing the need for vaccination, including personal experience with vaccine-preventable diseases and the fact that they and their families are vaccinated because of their confidence in the safety and efficacy of the vaccines,” the authors wrote.
For families who refuse or delay vaccines, the authors reviewed the “ethical arguments both in favor of and against dismissal policies,” noting that nearly all pediatricians who report dismissing families who refuse vaccination are in private practice, since large systems are often unable to dismiss patients. They also point out that fewer pediatricians dismiss families for spreading out vaccines than outright refusing all vaccines.
”Dismissal of child patients of vaccine-refusing parents can be a difficult decision arrived at after considering multiple factors and documented attempts to counsel vaccine-refusing families,” they wrote. “However, if repeated attempts to help understand and address parental values and vaccine concerns fails to engender trust, move parents toward vaccine acceptance, or strengthen the therapeutic alliance, dismissal can be an acceptable option.”
Finally, the authors reminded pediatricians “that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns need to be individually identified and addressed.” Working with families to discuss their questions and concerns is an opportunity to “build rapport and trust with a family,” they wrote, ”and, ultimately, protect their children from the scourge of vaccine-preventable diseases.”
The focus groups study was funded by the National Institutes of Health, and the authors reported having no disclosures. The Colorado attitudes study used no external funding, and the authors reported no disclosures. The new clinical report used no external funding, and the authors reported no disclosures. Dr. Orenstein is an uncompensated member of the Moderna Scientific Advisory Board. Dr. Offit codeveloped a licensed rotavirus vaccine, but he does not receive any royalties or own a patent for that.
FROM PEDIATRICS
Do Kids With an October Birthday Have Protection From Flu?
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
TOPLINE:
A new study shows young children with October birthdays may have better protection against flu.
METHODOLOGY:
- Researchers analyzed data from the MarketScan Research Database between 2011 and 2018.
- They focused on 819,223 children aged 2-5 years who were vaccinated against influenza between August 1 and January 31 and whose birthdays fell during that window.
TAKEAWAY:
- Children born in October had the lowest rate of influenza diagnosis, with an average diagnosis rate of 2.7%, whereas those born in August had a diagnosis rate of 3%.
- Compared with children born in August, the adjusted odds ratio for influenza diagnosis in children born in October was 0.88 (95% CI, 0.85-0.92).
IN PRACTICE:
“The findings support current recommendations that children be vaccinated in October preceding a typical influenza season,” the authors of the study wrote.
SOURCE:
Anupam B. Jena, MD, PhD, with Harvard Medical School and Massachusetts General Hospital in Boston, Massachusetts, was the corresponding author on the study. The research was published online in BMJ .
LIMITATIONS:
The availability of the influenza vaccine and the peak of seasonal flu infections vary by year and region.
DISCLOSURES:
Researchers disclosed consulting fees from pharmaceutical and healthcare companies unrelated to the study.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article appeared on Medscape.com.
FDA Removes Harmful Chemicals From Food Packaging
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.
Issued on February 28, 2024, “this means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags is being eliminated,” the FDA said in a statement.
In 2020, the FDA had secured commitments from manufacturers to stop selling products containing PFAS used in the food packaging for grease-proofing. “Today’s announcement marks the fulfillment of these voluntary commitments,” according to the agency.
PFAS, a class of thousands of chemicals also called “forever chemicals” are widely used in consumer and industrial products. People may be exposed via contaminated food packaging (although perhaps no longer in the United States) or occupationally. Studies have found that some PFAS disrupt hormones including estrogen and testosterone, whereas others may impair thyroid function.
Endocrine Society Report Sounds the Alarm About PFAS and Others
The FDA’s announcement came just 2 days after the Endocrine Society issued a new alarm about the human health dangers from environmental EDCs including PFAS in a report covering the latest science.
“Endocrine disrupting chemicals” are individual substances or mixtures that can interfere with natural hormonal function, leading to disease or even death. Many are ubiquitous in the modern environment and contribute to a wide range of human diseases.
The new report Endocrine Disrupting Chemicals: Threats to Human Health was issued jointly with the International Pollutants Elimination Network (IPEN), a global advocacy organization. It’s an update to the Endocrine Society’s 2015 report, providing new data on the endocrine-disrupting substances previously covered and adding four EDCs not discussed in that document: Pesticides, plastics, PFAS, and children’s products containing arsenic.
At a briefing held during the United Nations Environment Assembly meeting in Nairobi, Kenya, last week, the new report’s lead author Andrea C. Gore, PhD, of the University of Texas at Austin, noted, “A well-established body of scientific research indicates that endocrine-disrupting chemicals that are part of our daily lives are making us more susceptible to reproductive disorders, cancer, diabetes, obesity, heart disease, and other serious health conditions.”
Added Dr. Gore, who is also a member of the Endocrine Society’s Board of Directors, “These chemicals pose particularly serious risks to pregnant women and children. Now is the time for the UN Environment Assembly and other global policymakers to take action to address this threat to public health.”
While the science has been emerging rapidly, global and national chemical control policies haven’t kept up, the authors said. Of particular concern is that EDCs behave differently from other chemicals in many ways, including that even very low-dose exposures can pose health threats, but policies thus far haven’t dealt with that aspect.
Moreover, “the effects of low doses cannot be predicted by the effects observed at high doses. This means there may be no safe dose for exposure to EDCs,” according to the report.
Exposures can come from household products, including furniture, toys, and food packages, as well as electronics building materials and cosmetics. These chemicals are also in the outdoor environment, via pesticides, air pollution, and industrial waste.
“IPEN and the Endocrine Society call for chemical regulations based on the most modern scientific understanding of how hormones act and how EDCs can perturb these actions. We work to educate policy makers in global, regional, and national government assemblies and help ensure that regulations correlate with current scientific understanding,” they said in the report.
New Data on Four Classes of EDCs
Chapters of the report summarized the latest information about the science of EDCs and their links to endocrine disease and real-world exposure. It included a special section about “EDCs throughout the plastics life cycle” and a summary of the links between EDCs and climate change.
The report reviewed three pesticides, including the world’s most heavily applied herbicide, glycophosphate. Exposures can occur directly from the air, water, dust, and food residues. Recent data linked glycophosphate to adverse reproductive health outcomes.
Two toxic plastic chemicals, phthalates and bisphenols, are present in personal care products, among others. Emerging evidence links them with impaired neurodevelopment, leading to impaired cognitive function, learning, attention, and impulsivity.
Arsenic has long been linked to human health conditions including cancer, but more recent evidence finds it can disrupt multiple endocrine systems and lead to metabolic conditions including diabetes, reproductive dysfunction, and cardiovascular and neurocognitive conditions.
The special section about plastics noted that they are made from fossil fuels and chemicals, including many toxic substances that are known or suspected EDCs. People who live near plastic production facilities or waste dumps may be at greatest risk, but anyone can be exposed using any plastic product. Plastic waste disposal is increasingly problematic and often foisted on lower- and middle-income countries.
‘Additional Education and Awareness-Raising Among Stakeholders Remain Necessary’
Policies aimed at reducing human health risks from EDCs have included the 2022 Plastics Treaty, a resolution adopted by 175 countries at the United Nations Environmental Assembly that “may be a significant step toward global control of plastics and elimination of threats from exposures to EDCs in plastics,” the report said.
The authors added, “While significant progress has been made in recent years connecting scientific advances on EDCs with health-protective policies, additional education and awareness-raising among stakeholders remain necessary to achieve a safer and more sustainable environment that minimizes exposure to these harmful chemicals.”
The document was produced with financial contributions from the Government of Sweden, the Tides Foundation, Passport Foundation, and other donors.
A version of this article appeared on Medscape.com.