The FDA has revised its guidance on fish consumption

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Tue, 07/09/2019 - 13:53

 

The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.



“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

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The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.



“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

 

The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.



“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

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Self-harm with bupropion linked to greater risk compared to SSRIs

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Changed
Tue, 07/23/2019 - 19:31

Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.

In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.

Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.

Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.

“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.

The study investigators reported that there were no conflicts of interest.

SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.

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Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.

In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.

Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.

Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.

“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.

The study investigators reported that there were no conflicts of interest.

SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.

Adolescents who attempt self-harm using bupropion are at a significantly higher risk of serious morbidity and poor outcomes, compared with those who attempt self-harm with selective serotonin reuptake inhibitors (SSRIs), according to Adam Overberg, PharmD, of the Indiana Poison Center in Indianapolis and associates.

In a study published in Pediatrics, the researchers analyzed 30,026 cases that were coded as “suspected suicide” and were reported to the National Poison Data System between June 2013 and December 2017. All cases were in adolescents aged 10-19 years. A total of 3,504 cases were exposures to bupropion; the rest were exposures to SSRIs.

Cases involving SSRIs were significantly more likely to result in either minor or no outcomes, compared with bupropion (68.0% vs 33.2%); cases resulting in moderate or major outcomes were much more likely to involve bupropion, compared with SSRIs (58.1% vs 19.0%). Among the 10 most common effects in cases with a moderate or major outcome, bupropion was more likely to cause tachycardia (83.7% vs. 59.9%), vomiting (24.8% vs. 20.6%), cardiac conduction disturbances (20.0% vs. 17.1%), agitation (20.2% vs. 11.7%), seizures (27.0% vs. 8.5%), and hallucinations (28.6% vs. 4.3%). Cases involving SSRIs were more likely to cause hypertension (25.3% vs. 17.6%). Eight deaths were reported in the study population; all were caused by bupropion ingestion.

Medical therapies that were more common with bupropion overdose included intubation (4.9% vs. 0.3%), vasopressor use (1.1% vs. 0.2%), benzodiazepine administration (34.2% vs. 5.4%), supplemental oxygen requirement (8.2% vs. 0.8%), and CPR (0.5% vs. 0.01%); three patients in the bupropion group required extracorporeal membrane oxygenation, compared with none in the SSRI group.

“Suicidal ingestions are increasing steadily, as are the numbers of adolescents treated with medication for depression. In light of bupropion’s disproportionately significant morbidity and mortality risk, it would be prudent for practitioners to avoid the use of this medication in adolescents that are at risk for self-harm,” the investigators concluded.

The study investigators reported that there were no conflicts of interest.

SOURCE: Overberg A et al. Pediatrics. 2019 Jul 5. doi: 10.1542/peds.2018-3295.

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Legislative, educational interventions influenced vaccine status of California kindergartners

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Tue, 07/02/2019 - 13:57

After California lawmakers implemented policies to limit and eventually eliminate nonmedical exemptions for childhood vaccinations, the proportion of kindergartners who were not up to date for recommended vaccinations fell from 10% in 2013 to 5% in 2017.

Choreograp/Getty Images

At the same time, the percentage chance for within-school contact among California kindergartners without up-to-date vaccination status decreased from 26% in 2014 to 5% in 2017.

The findings come from an observational study that used cross-sectional school-entry data from 2000 to 2017 to calculate the rates of kindergartners attending California schools who were not up to date on required vaccinations.

“Large-scale vaccination programs that included school-entry mandates have been essential to maintaining high levels of immunization coverage and low rates of vaccine-preventable diseases,” researchers led by S. Cassandra Pingali, MPH, MS, wrote in JAMA. “However, an increasing number of parents are not vaccinating their children over concerns about potential adverse effects. These parental actions threaten the herd immunity established by decades of high vaccine uptake and increase the potential for disease outbreaks.”

Ms. Pingali, of the department of epidemiology at Emory University, Atlanta, and colleagues conducted an observational analysis of California kindergartners who were not up to date on one or more of the required vaccinations during the course of three interventions implemented in the state. The first was Assembly Bill 2109 (AB 2109), which was passed in 2014. It required parents to show proof they had discussed the risks of not vaccinating their children with a health care practitioner before they obtained a personal belief exemption. The second intervention was a campaign carried out in 2015 by the California Department of Public Health and local health departments, designed to educate school staff on the proper application of the conditional admission criteria, which allowed students additional time to catch up on vaccination. The third intervention was the implementation of Senate bill 277 (SB 277), which banned all personal belief exemptions.

Between 2000 and 2017, the researchers reported that the yearly mean kindergarten enrollment in California was 517,962 and the mean number of schools was 7,278. Over this time, the yearly rate of students without up-to-date vaccination status rose from 8% during 2000 to 10% during 2013, before decreasing to 5% during 2017. Ms. Pingali and associates also found that average percentage chance of any within-school contact for a student without up-to-date vaccination status with another student with the same status was 19% during 2000, and increased steadily to 26% during 2014, the first year of AB 2109. The values decreased to 3% (the first year of SB 277), before increasing slightly to 5% during 2017.

“Across the interventions, the percentage of kindergartners attending schools with an up-to-date vaccination status percentage that was greater than the herd immunity threshold also increased for various vaccine-preventable diseases,” the researchers wrote. “Overall, the results suggest that the risk of disease outbreak via potential contact among susceptible children decreased over the course of the interventions.”

The way Matthew M. Davis, MD and Seema K. Shah, JD, see it, the current outbreak of measles in the United States is rooted in the failure of parents to vaccinate their children against the disease based on their beliefs rather than medical contraindications.

“The public health implications of such decisions are amplified because parents who share belief systems about childhood vaccinations tend to congregate socially and residentially, thereby forming clusters of unvaccinated children who are at elevated health risks when exposed to vaccine-preventable diseases,” the authors wrote in an accompanying editorial.

While the study reported by Pingali et al. did not measure actual outbreaks of disease, “reductions in children’s risk of contracting measles are a promising outcome in California resulting from policy changes,” wrote Dr. Davis and Ms. Shah, both of Northwestern University, Chicago (JAMA. 2019;322[1]:33-4). “Yet, because of the ease of domestic and international travel, the mobile nature of young families, and the inability of all states to implement this approach, changes made in each state for nonmedical exemptions may not ensure sufficiently high protection against measles for children across all jurisdictions in the United States. Although states have historically made their own decisions about vaccination exemptions linked to day care or school entry because states exercise primary authority over educational matters, childhood vaccination is a national matter in many respects.”

The best way to remedy the current system failure regarding measles vaccination, they continued, may be to adopt a unified national approach to prohibit nonmedical exemptions. They pointed to the fact that the United States previously achieved virtual eradication of measles as recently as 2000. “Following that achievement, state-level policy changes relaxed immunization requirements and set the stage for progressively larger outbreaks in the United States in recent years. Such system failures result when the products, processes, and people (including the public) that comprise systems do not function or behave in ways that protect health optimally.”

The study was supported by a grant from the National Institutes of Health. One coauthor reported having received consulting fees from Merck and grants from Pfizer and Walgreens. Another reported receiving grants from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science, Dynavax, and MedImmune. The remaining coauthors reported no relevant financial disclosures.

The editorialists reported having no financial disclosures.

SOURCE: Pingali SC et al. JAMA. 2019 Jul 2. doi: 10.1001/jama.2019.7924.

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After California lawmakers implemented policies to limit and eventually eliminate nonmedical exemptions for childhood vaccinations, the proportion of kindergartners who were not up to date for recommended vaccinations fell from 10% in 2013 to 5% in 2017.

Choreograp/Getty Images

At the same time, the percentage chance for within-school contact among California kindergartners without up-to-date vaccination status decreased from 26% in 2014 to 5% in 2017.

The findings come from an observational study that used cross-sectional school-entry data from 2000 to 2017 to calculate the rates of kindergartners attending California schools who were not up to date on required vaccinations.

“Large-scale vaccination programs that included school-entry mandates have been essential to maintaining high levels of immunization coverage and low rates of vaccine-preventable diseases,” researchers led by S. Cassandra Pingali, MPH, MS, wrote in JAMA. “However, an increasing number of parents are not vaccinating their children over concerns about potential adverse effects. These parental actions threaten the herd immunity established by decades of high vaccine uptake and increase the potential for disease outbreaks.”

Ms. Pingali, of the department of epidemiology at Emory University, Atlanta, and colleagues conducted an observational analysis of California kindergartners who were not up to date on one or more of the required vaccinations during the course of three interventions implemented in the state. The first was Assembly Bill 2109 (AB 2109), which was passed in 2014. It required parents to show proof they had discussed the risks of not vaccinating their children with a health care practitioner before they obtained a personal belief exemption. The second intervention was a campaign carried out in 2015 by the California Department of Public Health and local health departments, designed to educate school staff on the proper application of the conditional admission criteria, which allowed students additional time to catch up on vaccination. The third intervention was the implementation of Senate bill 277 (SB 277), which banned all personal belief exemptions.

Between 2000 and 2017, the researchers reported that the yearly mean kindergarten enrollment in California was 517,962 and the mean number of schools was 7,278. Over this time, the yearly rate of students without up-to-date vaccination status rose from 8% during 2000 to 10% during 2013, before decreasing to 5% during 2017. Ms. Pingali and associates also found that average percentage chance of any within-school contact for a student without up-to-date vaccination status with another student with the same status was 19% during 2000, and increased steadily to 26% during 2014, the first year of AB 2109. The values decreased to 3% (the first year of SB 277), before increasing slightly to 5% during 2017.

“Across the interventions, the percentage of kindergartners attending schools with an up-to-date vaccination status percentage that was greater than the herd immunity threshold also increased for various vaccine-preventable diseases,” the researchers wrote. “Overall, the results suggest that the risk of disease outbreak via potential contact among susceptible children decreased over the course of the interventions.”

The way Matthew M. Davis, MD and Seema K. Shah, JD, see it, the current outbreak of measles in the United States is rooted in the failure of parents to vaccinate their children against the disease based on their beliefs rather than medical contraindications.

“The public health implications of such decisions are amplified because parents who share belief systems about childhood vaccinations tend to congregate socially and residentially, thereby forming clusters of unvaccinated children who are at elevated health risks when exposed to vaccine-preventable diseases,” the authors wrote in an accompanying editorial.

While the study reported by Pingali et al. did not measure actual outbreaks of disease, “reductions in children’s risk of contracting measles are a promising outcome in California resulting from policy changes,” wrote Dr. Davis and Ms. Shah, both of Northwestern University, Chicago (JAMA. 2019;322[1]:33-4). “Yet, because of the ease of domestic and international travel, the mobile nature of young families, and the inability of all states to implement this approach, changes made in each state for nonmedical exemptions may not ensure sufficiently high protection against measles for children across all jurisdictions in the United States. Although states have historically made their own decisions about vaccination exemptions linked to day care or school entry because states exercise primary authority over educational matters, childhood vaccination is a national matter in many respects.”

The best way to remedy the current system failure regarding measles vaccination, they continued, may be to adopt a unified national approach to prohibit nonmedical exemptions. They pointed to the fact that the United States previously achieved virtual eradication of measles as recently as 2000. “Following that achievement, state-level policy changes relaxed immunization requirements and set the stage for progressively larger outbreaks in the United States in recent years. Such system failures result when the products, processes, and people (including the public) that comprise systems do not function or behave in ways that protect health optimally.”

The study was supported by a grant from the National Institutes of Health. One coauthor reported having received consulting fees from Merck and grants from Pfizer and Walgreens. Another reported receiving grants from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science, Dynavax, and MedImmune. The remaining coauthors reported no relevant financial disclosures.

The editorialists reported having no financial disclosures.

SOURCE: Pingali SC et al. JAMA. 2019 Jul 2. doi: 10.1001/jama.2019.7924.

After California lawmakers implemented policies to limit and eventually eliminate nonmedical exemptions for childhood vaccinations, the proportion of kindergartners who were not up to date for recommended vaccinations fell from 10% in 2013 to 5% in 2017.

Choreograp/Getty Images

At the same time, the percentage chance for within-school contact among California kindergartners without up-to-date vaccination status decreased from 26% in 2014 to 5% in 2017.

The findings come from an observational study that used cross-sectional school-entry data from 2000 to 2017 to calculate the rates of kindergartners attending California schools who were not up to date on required vaccinations.

“Large-scale vaccination programs that included school-entry mandates have been essential to maintaining high levels of immunization coverage and low rates of vaccine-preventable diseases,” researchers led by S. Cassandra Pingali, MPH, MS, wrote in JAMA. “However, an increasing number of parents are not vaccinating their children over concerns about potential adverse effects. These parental actions threaten the herd immunity established by decades of high vaccine uptake and increase the potential for disease outbreaks.”

Ms. Pingali, of the department of epidemiology at Emory University, Atlanta, and colleagues conducted an observational analysis of California kindergartners who were not up to date on one or more of the required vaccinations during the course of three interventions implemented in the state. The first was Assembly Bill 2109 (AB 2109), which was passed in 2014. It required parents to show proof they had discussed the risks of not vaccinating their children with a health care practitioner before they obtained a personal belief exemption. The second intervention was a campaign carried out in 2015 by the California Department of Public Health and local health departments, designed to educate school staff on the proper application of the conditional admission criteria, which allowed students additional time to catch up on vaccination. The third intervention was the implementation of Senate bill 277 (SB 277), which banned all personal belief exemptions.

Between 2000 and 2017, the researchers reported that the yearly mean kindergarten enrollment in California was 517,962 and the mean number of schools was 7,278. Over this time, the yearly rate of students without up-to-date vaccination status rose from 8% during 2000 to 10% during 2013, before decreasing to 5% during 2017. Ms. Pingali and associates also found that average percentage chance of any within-school contact for a student without up-to-date vaccination status with another student with the same status was 19% during 2000, and increased steadily to 26% during 2014, the first year of AB 2109. The values decreased to 3% (the first year of SB 277), before increasing slightly to 5% during 2017.

“Across the interventions, the percentage of kindergartners attending schools with an up-to-date vaccination status percentage that was greater than the herd immunity threshold also increased for various vaccine-preventable diseases,” the researchers wrote. “Overall, the results suggest that the risk of disease outbreak via potential contact among susceptible children decreased over the course of the interventions.”

The way Matthew M. Davis, MD and Seema K. Shah, JD, see it, the current outbreak of measles in the United States is rooted in the failure of parents to vaccinate their children against the disease based on their beliefs rather than medical contraindications.

“The public health implications of such decisions are amplified because parents who share belief systems about childhood vaccinations tend to congregate socially and residentially, thereby forming clusters of unvaccinated children who are at elevated health risks when exposed to vaccine-preventable diseases,” the authors wrote in an accompanying editorial.

While the study reported by Pingali et al. did not measure actual outbreaks of disease, “reductions in children’s risk of contracting measles are a promising outcome in California resulting from policy changes,” wrote Dr. Davis and Ms. Shah, both of Northwestern University, Chicago (JAMA. 2019;322[1]:33-4). “Yet, because of the ease of domestic and international travel, the mobile nature of young families, and the inability of all states to implement this approach, changes made in each state for nonmedical exemptions may not ensure sufficiently high protection against measles for children across all jurisdictions in the United States. Although states have historically made their own decisions about vaccination exemptions linked to day care or school entry because states exercise primary authority over educational matters, childhood vaccination is a national matter in many respects.”

The best way to remedy the current system failure regarding measles vaccination, they continued, may be to adopt a unified national approach to prohibit nonmedical exemptions. They pointed to the fact that the United States previously achieved virtual eradication of measles as recently as 2000. “Following that achievement, state-level policy changes relaxed immunization requirements and set the stage for progressively larger outbreaks in the United States in recent years. Such system failures result when the products, processes, and people (including the public) that comprise systems do not function or behave in ways that protect health optimally.”

The study was supported by a grant from the National Institutes of Health. One coauthor reported having received consulting fees from Merck and grants from Pfizer and Walgreens. Another reported receiving grants from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science, Dynavax, and MedImmune. The remaining coauthors reported no relevant financial disclosures.

The editorialists reported having no financial disclosures.

SOURCE: Pingali SC et al. JAMA. 2019 Jul 2. doi: 10.1001/jama.2019.7924.

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‘Tis the season … for fireworks injuries

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Changed
Tue, 07/02/2019 - 11:59

In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

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In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

In 2018, almost two-thirds of all fireworks-related injuries in the United States occurred in a 1-month period surrounding the Fourth of July, according to the Consumer Product Safety Commission.

Of the estimated 9,100 fireworks-related injuries treated in emergency departments last year, 5,600 (62%) occurred between June 22 and July 22, 2018. That works out to a rate of 1.7 ED-treated injuries per 100,000 people for that 1 month and a rate of 2.8 per 100,000 for the entire year, the CPSC said in its 2018 Fireworks Annual Report.

Children had higher injury rates than adults in the Fourth of July window, and those aged 10-14 years had the highest rate of all, 5.2 injuries per 100,000 population. They were followed by teens aged 15-19 years (3.1 per 100,000) and children aged 5-9 (2.7 per 100,000), the CPSC investigators said based on data from the National Electronic Injury Surveillance System.

A deeper dive into the data pool shows that firecrackers caused more injuries – 19% of the total for the month – than any other type of firework device (reloadable shells were second at 12%). Burns were the most common type of injury, making up 44% of the total, and hands and fingers were the body parts most often injured (28% of the total), they reported.

There were five fireworks-related deaths last year – below the average of 7.6 per year since 2003 – but the total for 2018 may go up because reporting for the year is not yet complete. In one of the 2018 cases, an 18-year-old taped a tube to a football helmet and tried to launch a mortar shell while wearing the helmet. The first one worked, but the second shell got stuck and exploded in the tube, the CPSC said.

“CPSC works year-round to help prevent deaths and injuries from fireworks, by verifying fireworks meet safety regulations in our ports, marketplace, and on the road,” acting CPSC Chairman Ann Marie Buerkle said in a written statement. “Beyond CPSC’s efforts, we want to make sure everyone takes simple safety steps to celebrate safely with their family and friends.”

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New research in otitis media

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Mon, 07/01/2019 - 12:49

 

New research was presented at the International Society for Otitis Media meeting in June 2019, which I attended. I would like to share a selection of new findings from the many presentations.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Transtympanic antibiotic delivery

Topical therapy has been used to treat only otitis externa and acute otitis media (AOM) with ear discharge. Giving antibiotics through the tympanic membrane could mitigate many of the concerns about antibiotic use driving antibiotic resistance of bacteria among children. Up to now, using antibiotics in the ear canal to treat AOM has not been considered because the tympanic membrane is highly impermeable to the transtympanic diffusion of any drugs. However, in recent years, a number of different drug delivery systems have been developed, and in some cases, animal studies have shown that noninvasive transtympanic delivery is possible so that drugs can reach high concentrations in the middle ear without damage. Nanovesicles and nanoliposomes that contain antibiotics and are small enough to pass through the eardrum have been developed and tested in animal models; these show promise. Ototopical administration of a drug called vinpocetine that was repurposed has been tested in mice and shown to reduce inflammation and mucus production in the middle ear during otitis media.

Biofilms

Antibiotic treatment failure can occur in AOM for several reasons. The treatment of choice, amoxicillin, for example may fail to achieve an adequate concentration because of poor absorption in the gastrointestinal tract or poor penetration into the middle ear. Or, the antibiotic chosen may not be effective because of resistance of the strain causing the infection. Another explanation, especially in recurrent AOM and chronic AOM, could be the presence of biofilms. Biofilms are multicellular bacterial communities incorporated in a polymeric, plasticlike matrix in which pathogens are protected from antibiotic activity. The biofilm provides a physical barrier to antibiotic penetration, and bacteria can persist in the middle ear and periodically cause a new AOM. If AOM persists or becomes a more chronic otitis media with effusion, the “glue ear” causes an environment in the middle ear that is low in oxygen. A low-oxygen environment is favorable to biofilms. Also one might expect that middle ear pus would have a low pH, but actual measurements show the pH is highly alkaline. Species of Haemophilus influenzae have been identified as more virulent when in an alkaline pH or the alkaline pH makes the H. influenzae persist better in the middle ear, perhaps in a biofilm. To eliminate biofilms and improve antibiotic efficacy, a vaccine against a protein expressed by H. influenzae has been developed. Antibodies against this protein have been shown to disrupt and prevent the formation of biofilms in an animal model.

Probiotics

The normal bacteria that live in the nasopharynx of children with recurrent AOM is now known to differ from that of children who experience infrequent AOM or remain AOM-free throughout childhood. The use of oral pre- and probiotics for AOM prophylaxis remains debated because the results of studies are conflicting and frequently show no effect. So the idea of using prebiotics or probiotics to create a favorable “microbiome” of the nose is under investigation. Two species of bacteria that are gathering the most attention are Corynebacterium species (a few types in particular) and a bacteria called Dolosigranulum pigrum. Delivery of the commensal species would be as a nose spray.

 

 

Vaccines

The use of pneumococcal conjugate vaccines (PCVs) has reduced the frequency of AOM caused by Streptococcus pneumoniae. PCVs are not as effective against AOM as they are against invasive pneumococcal disease, but they still help a lot. However, because there are now at least 96 different serotypes of the pneumococcus based on different capsular types, we see a pattern of replacement of disease-causing strains by new strains within a few years of introduction of a new formulation. We started with 7 serotypes (Prevnar 7) in year 2000, and it was replaced by the current formulation with 13 serotypes (Prevnar 13) in 2010. Replacements have occurred again so vaccine companies are making new formulations for the future that include more serotypes, up to 20 serotypes. But, technically and feasibility-wise there is a limit to making such vaccines. A vaccine based on killed unencapsulated bacteria has been tested for safety and immunogenicity in young children. There is no test so far for prevention of AOM. Another type of vaccine based on proteins expressed by the pneumococcus that could be vaccine targets was tested in American Navajo children, and it failed to be as efficacious as hoped.

Dr. Michael E. Pichichero

Biomarkers.

Due to recurrent AOM or persistent otitis media with effusion, about 15% of children in the United States receive tympanostomy tubes. Among those who receive tubes, about 20% go on to receive a second set of tubes, often with adenotonsillectomy. To find a biomarker that could identify children likely to require a second set of tubes, the fluid in the middle ear was tested when a first set of tubes were inserted. If bacteria were detected by polymerase chain reaction (PCR) testing or if a profile of specific inflammatory cytokines was measured, those results could be used to predict a high likelihood for a second set of tubes.

Overdiagnosis

Diagnosis of AOM is challenging in young children, in whom it most frequently occurs. The ear canal is typically about 3 mm wide, the child struggles during the examination, and diagnostic skills are not taught in training, resulting in a high overdiagnosis rate. I presented data that suggest too many children who are not truly otitis prone have been classified as otitis prone based on incorrect clinical diagnosis. My colleagues and I found that 30% of children reach the threshold of three episodes of AOM in 6 months or four within a year when diagnosed by community pediatricians, similar to many other studies. Validated otoscopists (trained by experts with diagnosis definitively proven as at least 85% accurate using tympanocentesis) classify 15% of children as otitis prone – half as many. If tympanocentesis is used to prove middle ear fluid has bacterial pathogens (about 95% yield a bacterial otopathogen using culture and PCR), then about 10% of children are classified as otitis prone – one-third as many. This suggests that children clinically diagnosed by community-based pediatricians are overdiagnosed with AOM, perhaps three times more often than true. And that leads to overuse of antibiotics and referrals for tympanostomy tube surgery more often than should occur. So we need to improve diagnostic methods beyond otoscopy. New types of imaging for the eardrum and middle ear using novel technologies are in early clinical trials.

 

 

Immunity

The notion that young children get AOM because of Eustachian tube dysfunction in their early years of life (horizontal anatomy) may be true, but there is more to the story. After 10 years of work, the scientists in my research group have shown that children in the first 3 years of life can have an immune system that is suppressed – it is poorly responsive to pathogens and routine pediatric vaccines. Many features resemble a neonatal immune system, beginning life with a suppressed immune system or being in cytokine storm from birth. We introduced the term “prolonged neonatal-like immune profile (PNIP)” to give a general description of the immune responses we have found in otitis-prone children. They outgrow this. So the immune maturation is delayed but not permanent. It is mostly resolved by age 3 years. We found problems in both innate and adaptive immunity. It may be that the main explanation for recurrent AOM in the first years of life is PNIP. Scientists from Australia also reported immunity problems in Aboriginal children and they are very otitis prone, often progressing to chronic suppurative otitis media. Animal model studies of AOM show inadequate innate and adaptive immunity importantly contribute to the infection as well.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts to declare. Email him at [email protected].

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New research was presented at the International Society for Otitis Media meeting in June 2019, which I attended. I would like to share a selection of new findings from the many presentations.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Transtympanic antibiotic delivery

Topical therapy has been used to treat only otitis externa and acute otitis media (AOM) with ear discharge. Giving antibiotics through the tympanic membrane could mitigate many of the concerns about antibiotic use driving antibiotic resistance of bacteria among children. Up to now, using antibiotics in the ear canal to treat AOM has not been considered because the tympanic membrane is highly impermeable to the transtympanic diffusion of any drugs. However, in recent years, a number of different drug delivery systems have been developed, and in some cases, animal studies have shown that noninvasive transtympanic delivery is possible so that drugs can reach high concentrations in the middle ear without damage. Nanovesicles and nanoliposomes that contain antibiotics and are small enough to pass through the eardrum have been developed and tested in animal models; these show promise. Ototopical administration of a drug called vinpocetine that was repurposed has been tested in mice and shown to reduce inflammation and mucus production in the middle ear during otitis media.

Biofilms

Antibiotic treatment failure can occur in AOM for several reasons. The treatment of choice, amoxicillin, for example may fail to achieve an adequate concentration because of poor absorption in the gastrointestinal tract or poor penetration into the middle ear. Or, the antibiotic chosen may not be effective because of resistance of the strain causing the infection. Another explanation, especially in recurrent AOM and chronic AOM, could be the presence of biofilms. Biofilms are multicellular bacterial communities incorporated in a polymeric, plasticlike matrix in which pathogens are protected from antibiotic activity. The biofilm provides a physical barrier to antibiotic penetration, and bacteria can persist in the middle ear and periodically cause a new AOM. If AOM persists or becomes a more chronic otitis media with effusion, the “glue ear” causes an environment in the middle ear that is low in oxygen. A low-oxygen environment is favorable to biofilms. Also one might expect that middle ear pus would have a low pH, but actual measurements show the pH is highly alkaline. Species of Haemophilus influenzae have been identified as more virulent when in an alkaline pH or the alkaline pH makes the H. influenzae persist better in the middle ear, perhaps in a biofilm. To eliminate biofilms and improve antibiotic efficacy, a vaccine against a protein expressed by H. influenzae has been developed. Antibodies against this protein have been shown to disrupt and prevent the formation of biofilms in an animal model.

Probiotics

The normal bacteria that live in the nasopharynx of children with recurrent AOM is now known to differ from that of children who experience infrequent AOM or remain AOM-free throughout childhood. The use of oral pre- and probiotics for AOM prophylaxis remains debated because the results of studies are conflicting and frequently show no effect. So the idea of using prebiotics or probiotics to create a favorable “microbiome” of the nose is under investigation. Two species of bacteria that are gathering the most attention are Corynebacterium species (a few types in particular) and a bacteria called Dolosigranulum pigrum. Delivery of the commensal species would be as a nose spray.

 

 

Vaccines

The use of pneumococcal conjugate vaccines (PCVs) has reduced the frequency of AOM caused by Streptococcus pneumoniae. PCVs are not as effective against AOM as they are against invasive pneumococcal disease, but they still help a lot. However, because there are now at least 96 different serotypes of the pneumococcus based on different capsular types, we see a pattern of replacement of disease-causing strains by new strains within a few years of introduction of a new formulation. We started with 7 serotypes (Prevnar 7) in year 2000, and it was replaced by the current formulation with 13 serotypes (Prevnar 13) in 2010. Replacements have occurred again so vaccine companies are making new formulations for the future that include more serotypes, up to 20 serotypes. But, technically and feasibility-wise there is a limit to making such vaccines. A vaccine based on killed unencapsulated bacteria has been tested for safety and immunogenicity in young children. There is no test so far for prevention of AOM. Another type of vaccine based on proteins expressed by the pneumococcus that could be vaccine targets was tested in American Navajo children, and it failed to be as efficacious as hoped.

Dr. Michael E. Pichichero

Biomarkers.

Due to recurrent AOM or persistent otitis media with effusion, about 15% of children in the United States receive tympanostomy tubes. Among those who receive tubes, about 20% go on to receive a second set of tubes, often with adenotonsillectomy. To find a biomarker that could identify children likely to require a second set of tubes, the fluid in the middle ear was tested when a first set of tubes were inserted. If bacteria were detected by polymerase chain reaction (PCR) testing or if a profile of specific inflammatory cytokines was measured, those results could be used to predict a high likelihood for a second set of tubes.

Overdiagnosis

Diagnosis of AOM is challenging in young children, in whom it most frequently occurs. The ear canal is typically about 3 mm wide, the child struggles during the examination, and diagnostic skills are not taught in training, resulting in a high overdiagnosis rate. I presented data that suggest too many children who are not truly otitis prone have been classified as otitis prone based on incorrect clinical diagnosis. My colleagues and I found that 30% of children reach the threshold of three episodes of AOM in 6 months or four within a year when diagnosed by community pediatricians, similar to many other studies. Validated otoscopists (trained by experts with diagnosis definitively proven as at least 85% accurate using tympanocentesis) classify 15% of children as otitis prone – half as many. If tympanocentesis is used to prove middle ear fluid has bacterial pathogens (about 95% yield a bacterial otopathogen using culture and PCR), then about 10% of children are classified as otitis prone – one-third as many. This suggests that children clinically diagnosed by community-based pediatricians are overdiagnosed with AOM, perhaps three times more often than true. And that leads to overuse of antibiotics and referrals for tympanostomy tube surgery more often than should occur. So we need to improve diagnostic methods beyond otoscopy. New types of imaging for the eardrum and middle ear using novel technologies are in early clinical trials.

 

 

Immunity

The notion that young children get AOM because of Eustachian tube dysfunction in their early years of life (horizontal anatomy) may be true, but there is more to the story. After 10 years of work, the scientists in my research group have shown that children in the first 3 years of life can have an immune system that is suppressed – it is poorly responsive to pathogens and routine pediatric vaccines. Many features resemble a neonatal immune system, beginning life with a suppressed immune system or being in cytokine storm from birth. We introduced the term “prolonged neonatal-like immune profile (PNIP)” to give a general description of the immune responses we have found in otitis-prone children. They outgrow this. So the immune maturation is delayed but not permanent. It is mostly resolved by age 3 years. We found problems in both innate and adaptive immunity. It may be that the main explanation for recurrent AOM in the first years of life is PNIP. Scientists from Australia also reported immunity problems in Aboriginal children and they are very otitis prone, often progressing to chronic suppurative otitis media. Animal model studies of AOM show inadequate innate and adaptive immunity importantly contribute to the infection as well.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts to declare. Email him at [email protected].

 

New research was presented at the International Society for Otitis Media meeting in June 2019, which I attended. I would like to share a selection of new findings from the many presentations.

Courtesy Wikimedia Commons/Mar10029/Creative Commons License

Transtympanic antibiotic delivery

Topical therapy has been used to treat only otitis externa and acute otitis media (AOM) with ear discharge. Giving antibiotics through the tympanic membrane could mitigate many of the concerns about antibiotic use driving antibiotic resistance of bacteria among children. Up to now, using antibiotics in the ear canal to treat AOM has not been considered because the tympanic membrane is highly impermeable to the transtympanic diffusion of any drugs. However, in recent years, a number of different drug delivery systems have been developed, and in some cases, animal studies have shown that noninvasive transtympanic delivery is possible so that drugs can reach high concentrations in the middle ear without damage. Nanovesicles and nanoliposomes that contain antibiotics and are small enough to pass through the eardrum have been developed and tested in animal models; these show promise. Ototopical administration of a drug called vinpocetine that was repurposed has been tested in mice and shown to reduce inflammation and mucus production in the middle ear during otitis media.

Biofilms

Antibiotic treatment failure can occur in AOM for several reasons. The treatment of choice, amoxicillin, for example may fail to achieve an adequate concentration because of poor absorption in the gastrointestinal tract or poor penetration into the middle ear. Or, the antibiotic chosen may not be effective because of resistance of the strain causing the infection. Another explanation, especially in recurrent AOM and chronic AOM, could be the presence of biofilms. Biofilms are multicellular bacterial communities incorporated in a polymeric, plasticlike matrix in which pathogens are protected from antibiotic activity. The biofilm provides a physical barrier to antibiotic penetration, and bacteria can persist in the middle ear and periodically cause a new AOM. If AOM persists or becomes a more chronic otitis media with effusion, the “glue ear” causes an environment in the middle ear that is low in oxygen. A low-oxygen environment is favorable to biofilms. Also one might expect that middle ear pus would have a low pH, but actual measurements show the pH is highly alkaline. Species of Haemophilus influenzae have been identified as more virulent when in an alkaline pH or the alkaline pH makes the H. influenzae persist better in the middle ear, perhaps in a biofilm. To eliminate biofilms and improve antibiotic efficacy, a vaccine against a protein expressed by H. influenzae has been developed. Antibodies against this protein have been shown to disrupt and prevent the formation of biofilms in an animal model.

Probiotics

The normal bacteria that live in the nasopharynx of children with recurrent AOM is now known to differ from that of children who experience infrequent AOM or remain AOM-free throughout childhood. The use of oral pre- and probiotics for AOM prophylaxis remains debated because the results of studies are conflicting and frequently show no effect. So the idea of using prebiotics or probiotics to create a favorable “microbiome” of the nose is under investigation. Two species of bacteria that are gathering the most attention are Corynebacterium species (a few types in particular) and a bacteria called Dolosigranulum pigrum. Delivery of the commensal species would be as a nose spray.

 

 

Vaccines

The use of pneumococcal conjugate vaccines (PCVs) has reduced the frequency of AOM caused by Streptococcus pneumoniae. PCVs are not as effective against AOM as they are against invasive pneumococcal disease, but they still help a lot. However, because there are now at least 96 different serotypes of the pneumococcus based on different capsular types, we see a pattern of replacement of disease-causing strains by new strains within a few years of introduction of a new formulation. We started with 7 serotypes (Prevnar 7) in year 2000, and it was replaced by the current formulation with 13 serotypes (Prevnar 13) in 2010. Replacements have occurred again so vaccine companies are making new formulations for the future that include more serotypes, up to 20 serotypes. But, technically and feasibility-wise there is a limit to making such vaccines. A vaccine based on killed unencapsulated bacteria has been tested for safety and immunogenicity in young children. There is no test so far for prevention of AOM. Another type of vaccine based on proteins expressed by the pneumococcus that could be vaccine targets was tested in American Navajo children, and it failed to be as efficacious as hoped.

Dr. Michael E. Pichichero

Biomarkers.

Due to recurrent AOM or persistent otitis media with effusion, about 15% of children in the United States receive tympanostomy tubes. Among those who receive tubes, about 20% go on to receive a second set of tubes, often with adenotonsillectomy. To find a biomarker that could identify children likely to require a second set of tubes, the fluid in the middle ear was tested when a first set of tubes were inserted. If bacteria were detected by polymerase chain reaction (PCR) testing or if a profile of specific inflammatory cytokines was measured, those results could be used to predict a high likelihood for a second set of tubes.

Overdiagnosis

Diagnosis of AOM is challenging in young children, in whom it most frequently occurs. The ear canal is typically about 3 mm wide, the child struggles during the examination, and diagnostic skills are not taught in training, resulting in a high overdiagnosis rate. I presented data that suggest too many children who are not truly otitis prone have been classified as otitis prone based on incorrect clinical diagnosis. My colleagues and I found that 30% of children reach the threshold of three episodes of AOM in 6 months or four within a year when diagnosed by community pediatricians, similar to many other studies. Validated otoscopists (trained by experts with diagnosis definitively proven as at least 85% accurate using tympanocentesis) classify 15% of children as otitis prone – half as many. If tympanocentesis is used to prove middle ear fluid has bacterial pathogens (about 95% yield a bacterial otopathogen using culture and PCR), then about 10% of children are classified as otitis prone – one-third as many. This suggests that children clinically diagnosed by community-based pediatricians are overdiagnosed with AOM, perhaps three times more often than true. And that leads to overuse of antibiotics and referrals for tympanostomy tube surgery more often than should occur. So we need to improve diagnostic methods beyond otoscopy. New types of imaging for the eardrum and middle ear using novel technologies are in early clinical trials.

 

 

Immunity

The notion that young children get AOM because of Eustachian tube dysfunction in their early years of life (horizontal anatomy) may be true, but there is more to the story. After 10 years of work, the scientists in my research group have shown that children in the first 3 years of life can have an immune system that is suppressed – it is poorly responsive to pathogens and routine pediatric vaccines. Many features resemble a neonatal immune system, beginning life with a suppressed immune system or being in cytokine storm from birth. We introduced the term “prolonged neonatal-like immune profile (PNIP)” to give a general description of the immune responses we have found in otitis-prone children. They outgrow this. So the immune maturation is delayed but not permanent. It is mostly resolved by age 3 years. We found problems in both innate and adaptive immunity. It may be that the main explanation for recurrent AOM in the first years of life is PNIP. Scientists from Australia also reported immunity problems in Aboriginal children and they are very otitis prone, often progressing to chronic suppurative otitis media. Animal model studies of AOM show inadequate innate and adaptive immunity importantly contribute to the infection as well.

Dr. Pichichero is a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital. He has no conflicts to declare. Email him at [email protected].

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Water safety: Drowning isn’t the only concern

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Tue, 07/23/2019 - 14:16
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Water safety: Drowning isn’t the only concern

References

1. CDC Childhood Injury Report: Patterns of Unintentional Injuries among 0-19 Year Olds in the United States, 2000-2006.  Centers for Disease Control and Prevention Web site. https://www.cdc.gov/safechild/pdf/cdc-childhoodinjury.pdf. Accessed June 26, 2019.
2. World Health Organization. Global Report on Drowning: Preventing a Leading Killer. https://apps.who.int/iris/bitstream/handle/10665/143893/9789241564786_eng.pdf;jsessionid=0B51AAEB51E29A603A0CABB41FCD96B5?sequence=1. Accessed June 26, 2019.
3. Vanden Esschert K, Haileyesus T, Tarrier AL, et al. Pool chemical injuries in public and residential settings—United States, 2008–2017, and New York, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:433–438.
4. Healthy Swimming. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/healthywater/swimming/index.html. Accessed June 26, 2019.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

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Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

Author and Disclosure Information

Doug Campos-Outcalt, MD, MPA, is a member of the US Community Preventive Services Task Force, a clinical professor at the University of Arizona College of Medicine, and a senior lecturer with the University of Arizona College of Public Health. He’s also an assistant editor at The Journal of Family Practice.

The speaker reported no potential conflicts of interest relevant to this audiocast.

References

1. CDC Childhood Injury Report: Patterns of Unintentional Injuries among 0-19 Year Olds in the United States, 2000-2006.  Centers for Disease Control and Prevention Web site. https://www.cdc.gov/safechild/pdf/cdc-childhoodinjury.pdf. Accessed June 26, 2019.
2. World Health Organization. Global Report on Drowning: Preventing a Leading Killer. https://apps.who.int/iris/bitstream/handle/10665/143893/9789241564786_eng.pdf;jsessionid=0B51AAEB51E29A603A0CABB41FCD96B5?sequence=1. Accessed June 26, 2019.
3. Vanden Esschert K, Haileyesus T, Tarrier AL, et al. Pool chemical injuries in public and residential settings—United States, 2008–2017, and New York, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:433–438.
4. Healthy Swimming. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/healthywater/swimming/index.html. Accessed June 26, 2019.

References

1. CDC Childhood Injury Report: Patterns of Unintentional Injuries among 0-19 Year Olds in the United States, 2000-2006.  Centers for Disease Control and Prevention Web site. https://www.cdc.gov/safechild/pdf/cdc-childhoodinjury.pdf. Accessed June 26, 2019.
2. World Health Organization. Global Report on Drowning: Preventing a Leading Killer. https://apps.who.int/iris/bitstream/handle/10665/143893/9789241564786_eng.pdf;jsessionid=0B51AAEB51E29A603A0CABB41FCD96B5?sequence=1. Accessed June 26, 2019.
3. Vanden Esschert K, Haileyesus T, Tarrier AL, et al. Pool chemical injuries in public and residential settings—United States, 2008–2017, and New York, 2018. MMWR Morb Mortal Wkly Rep. 2019;68:433–438.
4. Healthy Swimming. Centers for Disease Control and Prevention Web site. https://www.cdc.gov/healthywater/swimming/index.html. Accessed June 26, 2019.

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Treatment for pediatric low-grade glioma is associated with poor cognitive and socioeconomic outcomes

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Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

Dr. M. Douglas Ris

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

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Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

Dr. M. Douglas Ris

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

Decades after undergoing surgery and radiotherapy, survivors of a pediatric CNS tumor may have worse neuropsychologic and socioeconomic outcomes, compared with their unaffected siblings. Children who underwent surgery alone had better neuropsychologic and socioeconomic outcomes than those who also underwent radiotherapy, but their outcomes were worse than those of unaffected siblings. These findings were published online June 24 in Cancer.

Dr. M. Douglas Ris

“Late effects in adulthood are evident even for children with the least malignant types of brain tumors who were treated with the least toxic therapies available at the time,” said M. Douglas Ris, PhD, professor of pediatrics and psychology at Baylor College of Medicine in Houston, in a press release. “As pediatric brain tumors become more survivable with continued advances in treatments, we need to improve surveillance of these populations so that survivors continue to receive the best interventions during their transition to adulthood and well beyond.”

Clinicians generally have assumed that children with low-grade CNS tumors who receive less toxic treatment will have fewer long-term effects than survivors of more malignant tumors who undergo neurotoxic therapies. Yet research has indicated that the former patients can have lasting neurobehavioral or functional morbidity.

Dr. Ris and colleagues invited survivors of pediatric low-grade gliomas participating in the Childhood Cancer Survivor Study (CCSS) and a sibling comparison group to undergo a direct, comprehensive neurocognitive assessment. Of 495 eligible survivors, 257 participated. Seventy-six patients did not travel to a study site, but completed a questionnaire, and the researchers did not include data for this group in their analysis. Dr. Ris and colleagues obtained information about surgery and radiotherapy from participants’ medical records. Patients underwent standardized, age-normed neuropsychologic tests. The primary neuropsychologic outcomes were the Composite Neuropsychological Index (CNI) and estimated IQ. To evaluate socioeconomic outcomes, Dr. Ris and colleagues measured participants’ educational attainment, income, and occupational prestige.

After the researchers adjusted the data for age and sex, they found that siblings had higher mean scores than survivors treated with surgery plus radiotherapy or surgery alone on all neuropsychologic outcomes, including the CNI (siblings, 106.8; surgery only, 95.6; surgery plus radiotherapy, 88.3) and estimated IQ. Survivors who had been diagnosed at younger ages had low scores for all outcomes except for attention/processing speed.

Furthermore, surgery plus radiotherapy was associated with a 7.7-fold higher risk of having an occupation in the lowest sibling quartile, compared with siblings. Survivors who underwent surgery alone had a 2.8-fold higher risk than siblings of having an occupation in the lowest quartile. Surgery plus radiotherapy was associated with a 2.6-fold increased risk of a low occupation score, compared with survivors who underwent surgery alone.

Compared with siblings, surgery plus radiotherapy was associated with a 4.5-fold risk of an annual income of less than $20,000, while the risk for survivors who underwent surgery alone did not differ significantly from that for siblings. Surgery plus radiotherapy was associated with a 2.6-fold higher risk than surgery alone. Surgery plus radiotherapy was also associated with a significantly increased risk for an education level lower than a bachelor’s degree, compared with siblings, but surgery alone was not.

The National Cancer Institute supported the study. The authors had no disclosures.

SOURCE: Ris MD et al. Cancer. 2019 Jun 24. doi: 10.1002/cncr.32186.

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ACIP approves meningococcal booster for persons at increased risk

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A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Choreograph/Thinkstock

The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

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A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Choreograph/Thinkstock

The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

 

A booster dose of meningococcal B (MenB) vaccine is necessary to sustain protection for persons aged 10 years and older at increased risk, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Choreograph/Thinkstock

The committee voted unanimously in favor of a booster dose of MenB vaccine 1 year after completion of the primary series, with additional boosters every 2-3 years “for as long as risk remains” for high-risk persons, including microbiologists and persons with complement deficiency, complement inhibitor use, or asplenia.

The committee also voted unanimously in favor of a one-time MenB booster for individuals aged 10 years and older who are at least a year beyond completion of a MenB primary series and deemed at increased risk by public health officials in an outbreak situation.

In addition, “a booster dose interval of 6 months or more may be considered by public health officials depending on the specific outbreak, vaccine strategy, and projected duration of elevated risk” according to the language, which was included in the unanimously approved statement “Meningococcal Vaccination: Recommendations of The Advisory Committee on Immunization Practices.”

The updated statement on meningococcal vaccination was developed in 2019 “to consolidate all existing ACIP recommendations for MenACWY and MenB vaccines in a single document,” said Sarah Mbaeyi, MD, of the CDC’s National Center for Immunization and Respiratory Diseases, who presented immunogenicity data and the proposed recommendations.

The statement includes the recommendation of a MenB primary series for individuals aged 16-23 years based on shared clinical decision making. Kelly Moore, MD, of Vanderbilt University, Nashville, Tenn., noted the importance of ongoing data collection, and said clinicians must make clear to patients that, “if they want protection, they need the booster.”

Approximately 7% of serogroup B cases in the United States are related to disease outbreaks, mainly among college students, Dr. Mbaeyi said. All 13 universities that experienced outbreaks between 2013 and 2019 have implemented a MenB primary series, and one university has implemented an off-label booster program.

The work group concluded that a MenB booster dose is necessary to sustain protection against serogroup B disease in persons at increased risk during an outbreak, and that the potential benefits outweighed the harms given the seriousness of meningococcal disease.

Paul Hunter, MD, of the City of Milwaukee Health Department, noted that “the booster recommendation gives more flexibility” in an outbreak response.

The committee also voted unanimously to approve the Vaccines for Children resolution for the meningococcal vaccine that updates language to align with the new recommendations.

The ACIP members had no financial conflicts to disclose.

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Cryptosporidiosis infections spike during summer swim season

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Fri, 06/28/2019 - 10:39

 

Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.

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Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.

 

Outbreaks of cryptosporidiosis increased in the United States by an average of 13% each year between 2009 and 2017, based on data from the Centers for Disease Control and Prevention.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, researchers reviewed data from 444 reported outbreaks submitted to the CDC’s National Outbreak Reporting System totaling 7,465 cases, including 287 hospitalizations and one death.

The outbreaks during this period were most commonly associated with pools and water parks (35%), exposure to cattle (15%), and child care settings (13%). Another 3% of outbreaks were associated with drinking unpasteurized milk or apple cider. An outbreak was defined as two or more cases linked to a common source.

The profuse, watery diarrhea associated with infection from the cryptosporidium parasite can last for 3 weeks in healthy individuals and can cause life-threatening malnutrition in the immunocompromised, wrote Radhika Gharpure, DVM, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, and colleagues.

The overall number of outbreaks peaked during July and August each year; the number associated with pools and water parks peaked between June and August, the number associated with cattle peaked between March and May, and the number associated with child care settings peaked between July and September.

The results were limited by several factors including likely underestimation of the number of outbreaks, the use of multipathogen testing panels that could have inflated the number of outbreaks, and the variation in the ability of jurisdictions to detect, investigate, and report outbreaks, the researchers noted. CryptoNet, a molecularly-based surveillance system, has shown potential to track disease transmission, they said.

However, primary prevention is important to prevent the spread of disease, and strategies include refraining from swimming when one has diarrhea and for 2 weeks after resolution of diarrhea, not sending children to child care when they have diarrhea, and washing hands thoroughly after contact with animals, the researchers said.

“If a cryptosporidiosis outbreak occurs, substantial decontamination measures are needed, including hyperchlorinating public treated recreational water venues (e.g., swimming pools at a hotel, apartment complex, or water park) and using hydrogen peroxide to disinfect surfaces in child care settings to inactivate Cryptosporidium oocysts,” they emphasized.

The researchers had no financial conflicts to disclose.

SOURCE: Gharpure R et al. MMWR. 2019 June 28. 68:568-72.

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Key risk factors of pediatric cervical spinal injury identified

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Thu, 06/27/2019 - 14:09

Risk factors that have good test accuracy in recognizing pediatric cervical spinal injury (CSI) exist, and they can be incorporated into a clinical prediction rule that has the potential to greatly lower the need for cervical spine imaging during trauma evaluation, Julie C Leonard, MD, MPH, and associates reported in Pediatrics.

Fuse/thinkstockphotos.com

Though rare, cervical spine injuries in children lead to significant morbidity and mortality, and the vast majority of these children screened radiographically have no injury at all, which makes the inherent lifetime risk of malignancy from unnecessary radiation exposure troubling to many.

In their 2014-2016 prospective observational study in which 4,091 children aged 0-17 years were evaluated for blunt trauma in one of four U.S. tertiary care children’s hospitals, 2% had CSIs.

The mean age in the cohort was 9 years; the mean age of CSI patients was 11 years. Fully 39% of patients were under 8 years of age and 23 (1%) had CSIs. Among those with CSIs, more were boys, white, and non-Hispanic. Motor vehicle crash and sports-related injuries were reported to be the most common route of injury in all children.

The main goal of the study was to “establish the infrastructure for conducting a larger cohort study,” said Dr. Leonard of Ohio State University Nationwide Children’s Hospital in Columbus, and associates. They were successful in confirming the existence of an association between CSI and head injury. Specifically, the greatest independent associations with pediatric CSI were substantial head injury, namely basilar skull fracture; signs of traumatic brain injury, such as altered mental status; respiratory failure and intubation; and head-first impacts.

The authors were careful to point out that risk factors identified in their study differed from other studies focused on adult injury, specifically with regard to neck findings. They speculated that the increased neck and spine tenderness that commonly increase following restrictive supine positioning in a cervical collar on a rigid long board could play a key role. They also speculated that ED clinicians may be more likely to “defer aspects of the neck examination” in cases where children present wearing cervical collars, which limits assessment to self reporting.

As with adult evaluation, in which adult CSI prediction rules for cervical imaging depend upon determining the extent of normal mental status after blunt trauma, successful identification of pediatric candidates will require a similar set of CSI prediction rules. “Future development of a robust pediatric CSI prediction rule should be focused on stratification based on mental status because it may be meaningful in determining which children to triage to CT scan,” the investigators advised.

Future research exploring how these risk factors can be used to build a clear, pediatric CSI prediction rule that is prospective and observational in nature is crucial to improving the timeliness and accuracy of CSI diagnosis, Dr. Leonard and associates said.

In an accompanying editorial, Mark I. Neuman, MD, MPH and Rebekah C. Mannix, MD, MPH, noted that evidence uncovered by Leonard et al. will, no doubt, provide the conceptual foundation for a future multicenter trial that can establish effective criteria needed to consider the use of imaging when evaluating CSI in children.

Previously, the National Emergency X-Ray Utilization Study (NEXUS) was the largest prospective study of CSI that also included children. The Leonard et al. study includes a much higher proportion of children, 39% of whom were younger than 8 years of age. Although the sensitivities of the models used in this latest study are lower than for those used in the NEXUS study, the specificity is much higher at 46%-50%, which has noteworthy implications for classifying children at risk of CSI. “If validated, these findings have the potential to spare imaging in over one-third of children,” said Dr. Neuman and Dr. Mannix, both of the division of emergency medicine at Boston Children’s Hospital, and the department of pediatrics at Harvard Medical School, Boston.

“The complex and varying nature of CSI in children, the result of differences in the intrinsic biomechanics of the pediatric cervical spine, mechanism of injury, and variable presentations between younger and older children pose challenges for the development of a universal, simple, and highly sensitive clinical prediction rule,” they concluded.

The National Institutes of Health funded the study, and Dr. Leonard received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors had no relevant disclosures. There was no external funding for the accompanying editorial and Dr. Neuman and Dr. Mannix said they had no relevant disclosures.

SOURCE: Leonard J et al. Pediatrics. 2019;144(1):e20183221; Neuman MI et al. Pediatrics. 2019;144(1):e20184052.

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Risk factors that have good test accuracy in recognizing pediatric cervical spinal injury (CSI) exist, and they can be incorporated into a clinical prediction rule that has the potential to greatly lower the need for cervical spine imaging during trauma evaluation, Julie C Leonard, MD, MPH, and associates reported in Pediatrics.

Fuse/thinkstockphotos.com

Though rare, cervical spine injuries in children lead to significant morbidity and mortality, and the vast majority of these children screened radiographically have no injury at all, which makes the inherent lifetime risk of malignancy from unnecessary radiation exposure troubling to many.

In their 2014-2016 prospective observational study in which 4,091 children aged 0-17 years were evaluated for blunt trauma in one of four U.S. tertiary care children’s hospitals, 2% had CSIs.

The mean age in the cohort was 9 years; the mean age of CSI patients was 11 years. Fully 39% of patients were under 8 years of age and 23 (1%) had CSIs. Among those with CSIs, more were boys, white, and non-Hispanic. Motor vehicle crash and sports-related injuries were reported to be the most common route of injury in all children.

The main goal of the study was to “establish the infrastructure for conducting a larger cohort study,” said Dr. Leonard of Ohio State University Nationwide Children’s Hospital in Columbus, and associates. They were successful in confirming the existence of an association between CSI and head injury. Specifically, the greatest independent associations with pediatric CSI were substantial head injury, namely basilar skull fracture; signs of traumatic brain injury, such as altered mental status; respiratory failure and intubation; and head-first impacts.

The authors were careful to point out that risk factors identified in their study differed from other studies focused on adult injury, specifically with regard to neck findings. They speculated that the increased neck and spine tenderness that commonly increase following restrictive supine positioning in a cervical collar on a rigid long board could play a key role. They also speculated that ED clinicians may be more likely to “defer aspects of the neck examination” in cases where children present wearing cervical collars, which limits assessment to self reporting.

As with adult evaluation, in which adult CSI prediction rules for cervical imaging depend upon determining the extent of normal mental status after blunt trauma, successful identification of pediatric candidates will require a similar set of CSI prediction rules. “Future development of a robust pediatric CSI prediction rule should be focused on stratification based on mental status because it may be meaningful in determining which children to triage to CT scan,” the investigators advised.

Future research exploring how these risk factors can be used to build a clear, pediatric CSI prediction rule that is prospective and observational in nature is crucial to improving the timeliness and accuracy of CSI diagnosis, Dr. Leonard and associates said.

In an accompanying editorial, Mark I. Neuman, MD, MPH and Rebekah C. Mannix, MD, MPH, noted that evidence uncovered by Leonard et al. will, no doubt, provide the conceptual foundation for a future multicenter trial that can establish effective criteria needed to consider the use of imaging when evaluating CSI in children.

Previously, the National Emergency X-Ray Utilization Study (NEXUS) was the largest prospective study of CSI that also included children. The Leonard et al. study includes a much higher proportion of children, 39% of whom were younger than 8 years of age. Although the sensitivities of the models used in this latest study are lower than for those used in the NEXUS study, the specificity is much higher at 46%-50%, which has noteworthy implications for classifying children at risk of CSI. “If validated, these findings have the potential to spare imaging in over one-third of children,” said Dr. Neuman and Dr. Mannix, both of the division of emergency medicine at Boston Children’s Hospital, and the department of pediatrics at Harvard Medical School, Boston.

“The complex and varying nature of CSI in children, the result of differences in the intrinsic biomechanics of the pediatric cervical spine, mechanism of injury, and variable presentations between younger and older children pose challenges for the development of a universal, simple, and highly sensitive clinical prediction rule,” they concluded.

The National Institutes of Health funded the study, and Dr. Leonard received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors had no relevant disclosures. There was no external funding for the accompanying editorial and Dr. Neuman and Dr. Mannix said they had no relevant disclosures.

SOURCE: Leonard J et al. Pediatrics. 2019;144(1):e20183221; Neuman MI et al. Pediatrics. 2019;144(1):e20184052.

Risk factors that have good test accuracy in recognizing pediatric cervical spinal injury (CSI) exist, and they can be incorporated into a clinical prediction rule that has the potential to greatly lower the need for cervical spine imaging during trauma evaluation, Julie C Leonard, MD, MPH, and associates reported in Pediatrics.

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Though rare, cervical spine injuries in children lead to significant morbidity and mortality, and the vast majority of these children screened radiographically have no injury at all, which makes the inherent lifetime risk of malignancy from unnecessary radiation exposure troubling to many.

In their 2014-2016 prospective observational study in which 4,091 children aged 0-17 years were evaluated for blunt trauma in one of four U.S. tertiary care children’s hospitals, 2% had CSIs.

The mean age in the cohort was 9 years; the mean age of CSI patients was 11 years. Fully 39% of patients were under 8 years of age and 23 (1%) had CSIs. Among those with CSIs, more were boys, white, and non-Hispanic. Motor vehicle crash and sports-related injuries were reported to be the most common route of injury in all children.

The main goal of the study was to “establish the infrastructure for conducting a larger cohort study,” said Dr. Leonard of Ohio State University Nationwide Children’s Hospital in Columbus, and associates. They were successful in confirming the existence of an association between CSI and head injury. Specifically, the greatest independent associations with pediatric CSI were substantial head injury, namely basilar skull fracture; signs of traumatic brain injury, such as altered mental status; respiratory failure and intubation; and head-first impacts.

The authors were careful to point out that risk factors identified in their study differed from other studies focused on adult injury, specifically with regard to neck findings. They speculated that the increased neck and spine tenderness that commonly increase following restrictive supine positioning in a cervical collar on a rigid long board could play a key role. They also speculated that ED clinicians may be more likely to “defer aspects of the neck examination” in cases where children present wearing cervical collars, which limits assessment to self reporting.

As with adult evaluation, in which adult CSI prediction rules for cervical imaging depend upon determining the extent of normal mental status after blunt trauma, successful identification of pediatric candidates will require a similar set of CSI prediction rules. “Future development of a robust pediatric CSI prediction rule should be focused on stratification based on mental status because it may be meaningful in determining which children to triage to CT scan,” the investigators advised.

Future research exploring how these risk factors can be used to build a clear, pediatric CSI prediction rule that is prospective and observational in nature is crucial to improving the timeliness and accuracy of CSI diagnosis, Dr. Leonard and associates said.

In an accompanying editorial, Mark I. Neuman, MD, MPH and Rebekah C. Mannix, MD, MPH, noted that evidence uncovered by Leonard et al. will, no doubt, provide the conceptual foundation for a future multicenter trial that can establish effective criteria needed to consider the use of imaging when evaluating CSI in children.

Previously, the National Emergency X-Ray Utilization Study (NEXUS) was the largest prospective study of CSI that also included children. The Leonard et al. study includes a much higher proportion of children, 39% of whom were younger than 8 years of age. Although the sensitivities of the models used in this latest study are lower than for those used in the NEXUS study, the specificity is much higher at 46%-50%, which has noteworthy implications for classifying children at risk of CSI. “If validated, these findings have the potential to spare imaging in over one-third of children,” said Dr. Neuman and Dr. Mannix, both of the division of emergency medicine at Boston Children’s Hospital, and the department of pediatrics at Harvard Medical School, Boston.

“The complex and varying nature of CSI in children, the result of differences in the intrinsic biomechanics of the pediatric cervical spine, mechanism of injury, and variable presentations between younger and older children pose challenges for the development of a universal, simple, and highly sensitive clinical prediction rule,” they concluded.

The National Institutes of Health funded the study, and Dr. Leonard received a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors had no relevant disclosures. There was no external funding for the accompanying editorial and Dr. Neuman and Dr. Mannix said they had no relevant disclosures.

SOURCE: Leonard J et al. Pediatrics. 2019;144(1):e20183221; Neuman MI et al. Pediatrics. 2019;144(1):e20184052.

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