Pertussis vaccination of infants reduces death, hospitalization risk

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Pertussis vaccination of infants reduces death, hospitalization risk

Receiving the first dose of the pertussis vaccine significantly reduces the risk of death, hospitalization, and pneumonia among infants who contract the illness, a recent study found.

“Health professionals should ensure on-time first-dose pertussis vaccination as early as 6 weeks of age during pertussis outbreaks and provide early recommended antibiotic treatment,” said Dr. Tejpratap S.P. Tiwari and colleagues at the Centers for Disease Control and Prevention, Atlanta. “Infants who are age-ineligible for vaccination will benefit from strengthening strategies that provide immunity to newborns and prevent exposure to [Bordetella] pertussis,” they wrote (Pediatrics 2015 (doi:10.1542/peds.2014-2291).

©Micah Young/istockphoto.com

Dr. Tiwari’s team reviewed all cases of pertussis in infants under age 1 year that had been reported to the National Notifiable Diseases Surveillance System (NNDSS) and the Centers for Disease Control and Prevention between 1991 and 2008. Among 45,404 reported cases, 258 deaths (0.57%) occurred.

All of the children who died had contracted pertussis before age 34 weeks, and 64% of the deaths occurred in children younger than 6 weeks. Overall, 90% of nonfatal cases occurred in infants younger than 34 weeks. The older children were, the less likely they were to die from the disease: the case fatality rate dropped from 2.36% at age 1 week to 0.28% at age 12 weeks. No significant differences in sex were observed.

Infants at least 42 days old who had received at least one dose of DTaP were 72% less likely to die from the illness after adjusting for onset age, race, and antibiotic treatment (adjusted odds ratio, 0.28). They were also 31% less likely to be hospitalized and 20% less likely to develop pneumonia (aOR, 0.69 and 0.80, respectively). Babies who received the recommended antibiotics were 72% less likely to die than those who didn’t receive the drugs (aOR, 0.28).

Hispanic infants with pertussis were more than twice as likely to die than were non-Hispanic infants with the illness, with a case fatality rate of 1.26% for Hispanic infants and 0.75% for non-Hispanic infants (aOR, 2.28, compared with white infants). American Indian/Alaska Native infants had a more than five times greater odds of death and a case fatality rate of 1.85% (aOR, 5.15).

The researchers calculated that on-time vaccination could have prevented 72% of the deaths occurring after 8 weeks, resulting in a 16% reduced fatality rate.

The research was funded by the CDC. The authors reported no relevant financial disclosures.

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Receiving the first dose of the pertussis vaccine significantly reduces the risk of death, hospitalization, and pneumonia among infants who contract the illness, a recent study found.

“Health professionals should ensure on-time first-dose pertussis vaccination as early as 6 weeks of age during pertussis outbreaks and provide early recommended antibiotic treatment,” said Dr. Tejpratap S.P. Tiwari and colleagues at the Centers for Disease Control and Prevention, Atlanta. “Infants who are age-ineligible for vaccination will benefit from strengthening strategies that provide immunity to newborns and prevent exposure to [Bordetella] pertussis,” they wrote (Pediatrics 2015 (doi:10.1542/peds.2014-2291).

©Micah Young/istockphoto.com

Dr. Tiwari’s team reviewed all cases of pertussis in infants under age 1 year that had been reported to the National Notifiable Diseases Surveillance System (NNDSS) and the Centers for Disease Control and Prevention between 1991 and 2008. Among 45,404 reported cases, 258 deaths (0.57%) occurred.

All of the children who died had contracted pertussis before age 34 weeks, and 64% of the deaths occurred in children younger than 6 weeks. Overall, 90% of nonfatal cases occurred in infants younger than 34 weeks. The older children were, the less likely they were to die from the disease: the case fatality rate dropped from 2.36% at age 1 week to 0.28% at age 12 weeks. No significant differences in sex were observed.

Infants at least 42 days old who had received at least one dose of DTaP were 72% less likely to die from the illness after adjusting for onset age, race, and antibiotic treatment (adjusted odds ratio, 0.28). They were also 31% less likely to be hospitalized and 20% less likely to develop pneumonia (aOR, 0.69 and 0.80, respectively). Babies who received the recommended antibiotics were 72% less likely to die than those who didn’t receive the drugs (aOR, 0.28).

Hispanic infants with pertussis were more than twice as likely to die than were non-Hispanic infants with the illness, with a case fatality rate of 1.26% for Hispanic infants and 0.75% for non-Hispanic infants (aOR, 2.28, compared with white infants). American Indian/Alaska Native infants had a more than five times greater odds of death and a case fatality rate of 1.85% (aOR, 5.15).

The researchers calculated that on-time vaccination could have prevented 72% of the deaths occurring after 8 weeks, resulting in a 16% reduced fatality rate.

The research was funded by the CDC. The authors reported no relevant financial disclosures.

Receiving the first dose of the pertussis vaccine significantly reduces the risk of death, hospitalization, and pneumonia among infants who contract the illness, a recent study found.

“Health professionals should ensure on-time first-dose pertussis vaccination as early as 6 weeks of age during pertussis outbreaks and provide early recommended antibiotic treatment,” said Dr. Tejpratap S.P. Tiwari and colleagues at the Centers for Disease Control and Prevention, Atlanta. “Infants who are age-ineligible for vaccination will benefit from strengthening strategies that provide immunity to newborns and prevent exposure to [Bordetella] pertussis,” they wrote (Pediatrics 2015 (doi:10.1542/peds.2014-2291).

©Micah Young/istockphoto.com

Dr. Tiwari’s team reviewed all cases of pertussis in infants under age 1 year that had been reported to the National Notifiable Diseases Surveillance System (NNDSS) and the Centers for Disease Control and Prevention between 1991 and 2008. Among 45,404 reported cases, 258 deaths (0.57%) occurred.

All of the children who died had contracted pertussis before age 34 weeks, and 64% of the deaths occurred in children younger than 6 weeks. Overall, 90% of nonfatal cases occurred in infants younger than 34 weeks. The older children were, the less likely they were to die from the disease: the case fatality rate dropped from 2.36% at age 1 week to 0.28% at age 12 weeks. No significant differences in sex were observed.

Infants at least 42 days old who had received at least one dose of DTaP were 72% less likely to die from the illness after adjusting for onset age, race, and antibiotic treatment (adjusted odds ratio, 0.28). They were also 31% less likely to be hospitalized and 20% less likely to develop pneumonia (aOR, 0.69 and 0.80, respectively). Babies who received the recommended antibiotics were 72% less likely to die than those who didn’t receive the drugs (aOR, 0.28).

Hispanic infants with pertussis were more than twice as likely to die than were non-Hispanic infants with the illness, with a case fatality rate of 1.26% for Hispanic infants and 0.75% for non-Hispanic infants (aOR, 2.28, compared with white infants). American Indian/Alaska Native infants had a more than five times greater odds of death and a case fatality rate of 1.85% (aOR, 5.15).

The researchers calculated that on-time vaccination could have prevented 72% of the deaths occurring after 8 weeks, resulting in a 16% reduced fatality rate.

The research was funded by the CDC. The authors reported no relevant financial disclosures.

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Pertussis vaccination of infants reduces death, hospitalization risk
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Key clinical point: Pertussis vaccination reduces death, hospitalization, and pneumonia in infected infants.

Major finding: Vaccinated infants with pertussis had 72% lower odds of dying, 31% lower odds of hospitalization, and 20% lower odds of pneumonia than unvaccinated infants with pertussis.

Data source: Retrospective analysis of all 45,404 confirmed or probable cases of pertussis in infants under age 1 year reported to the National Notifiable Diseases Surveillance System and the Centers for Disease Control and Prevention between 1991 and 2008.

Disclosures: The research was funded by the CDC. The authors reported no relevant financial disclosures.

Teens’ Tdap Booster Dose Begins to Wane After 2 Years

Tdap waning shows importance of prenatal vaccination
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Teens’ Tdap Booster Dose Begins to Wane After 2 Years

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

References

Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

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Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

Title
Tdap waning shows importance of prenatal vaccination
Tdap waning shows importance of prenatal vaccination

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

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Teens’ Tdap Booster Dose Begins to Wane After 2 Years
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Teens’ Tdap booster dose begins to wane after 2 years

Tdap waning shows importance of prenatal vaccination
Article Type
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Display Headline
Teens’ Tdap booster dose begins to wane after 2 years

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

References

Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

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Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

Body

In the study by Acosta et al., the duration of Tdap effectiveness is disappointing, particularly because case-control studies tend to inflate efficacy. The resurgence of pertussis is often attributed to the switch from whole-cell pertussis vaccines to acellular products. However, the increase in reported pertussis began 14 years before the universal use of diphtheria-tetanus-acellular pertussis (DTaP) vaccines in childhood commenced. The two greatest contributors to the resurgence of pertussis are greater awareness and more sensitive diagnosis (routine use of polymerase chain reaction).

In the pre-DTaP and pre-Tdap eras, the pertussis attack rate in nonepidemic periods in largely whole-cell pertussis vaccine–primed adolescents and adults was 370 to 500 per 100,000 per year. These rates are underestimates because of clear evidence of “observer bias” in both studies. In this present Washington State study, the attack rate during the epidemic was only 182.3 per 100,000 for the one-half-year study period.

Factors that I think are most important relating to DTaP vaccine failure are as follows: decay in antibody over time; a T helper (Th) 1/Th2 versus a Th1, Th17 cellular response; incomplete antigen package; incorrect balance of antigens in the vaccine; linked-epitope suppression; and the occurrence of pertactin-deficient B. pertussis strains. Some, but not all, of these factors also may relate to Tdap failure over time.

Although adequate data are not available, it can be assumed that adolescents and adults who were primed in infancy by infection or DTP will have a Th1, Th17 response to Tdap. In contrast, those who were primed by DTaP will have a Th1/Th2 response. In line with the results of these two recent Tdap effectiveness studies, we should examine our present Tdap immunization recommendations. It is my opinion that we should continue with our present Tdap schedules. Of most importance is to see that all pregnant women receive Tdap with each pregnancy. This alone can prevent virtually all pertussis deaths in young infants.

James D. Cherry, M.D., is professor of pediatrics at the University of California, Los Angeles. These comments are excerpted from an editorial (Pediatrics 2015 [doi:10.1542/peds.2014-4118]) accompanying Dr. Acosta’s study. Dr. Cherry is a member of the Sanofi Pasteur speakers bureau and of the Global Pertussis Initiative, supported by Sanofi Pastuer. He receives royalties from Elsevier for “Feigin and Cherry’s Textbook of Pediatric Infectious Diseases.”

Title
Tdap waning shows importance of prenatal vaccination
Tdap waning shows importance of prenatal vaccination

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

A sixth dose of Tdap is initially effective in preventing pertussis in teens, but its effectiveness declines by half within 4 years after the booster, a recent study found.

“This waning is likely contributing to the increase in pertussis among adolescents,” reported Dr. Anna M. Acosta of the Centers for Disease Control and Prevention, Atlanta, and her associates (Pediatrics 2015 [doi: 10.1542/peds.2014-3358]).

“Advances in our understanding of the immunology and bacteriology of Bordetella pertussis are essential to optimize future prevention and control measures,” they wrote. “However, novel pertussis vaccines that effectively limit infection and transmission are also likely needed to reduce the burden of pertussis disease in the United States.”

©shvili/thinkstockphotos.com

The researchers matched three controls by birth year and primary provider practice (total 2,322 controls) to each of 836 cases of pertussis in seven counties of Washington during the 2012 pertussis epidemic. Cases were more likely than were controls to be non-Hispanic and white, but there was a lack of race/ethnicity data.

Receipt of the five childhood series doses was similar among cases (74%) and controls (75%), but a smaller proportion of both (60% cases, 58% controls) were on schedule. Among more than 84% of participants who received Tdap between ages 11 and 12, 81% of the cases and 90% of the controls received the sixth dose.

Among the 450 cases and 1,246 controls who received all acellular vaccines for the primary series, Tdap effectiveness was 63.9% overall. Stratified by time since Tdap vaccination, however, it was 73.1% within 12 months, 54.9% within 12-23 months, and 34.2% within 24-47 months.

Those born from 1999 to 2000 were presumed to have received the DTaP in infancy, and those born from 1993 to 1997 were presumed to have received a mixture of the acellular and whole-cell (DTwP) vaccines. Among those with vaccine lot numbers recorded, all vaccines administered after 1998 were acellular. A direct comparison of Tdap effectiveness between those vaccinated with the acellular primary series and those vaccinated with a mixed primary series was not possible because of time differences in vaccination between the two groups.

The research did not receive external funding, and the authors reported no relevant financial disclosures.

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Teens’ Tdap booster dose begins to wane after 2 years
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Key clinical point: Tdap effectiveness for pertussis prevention wanes 2 years after the sixth dose in teens.

Major finding: Tdap booster effectiveness drops from 73% to 34% within 4 years of the sixth dose in teens.

Data source: A case-control study of 3,158 teens in seven counties during the 2012 pertussis epidemic in Washington State.

Disclosures: The research did not receive external funding, and the authors reported no relevant financial disclosures.

MenB vaccination campaign effectively stopped Princeton outbreak

Success story: public health response, immunization coverage
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MenB vaccination campaign effectively stopped Princeton outbreak

A targeted MenB vaccination campaign during a university outbreak of serogroup B meningococcal disease effectively prevented additional cases in those who received the vaccine, according to a recent study.

“The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future,” reported Lucy A. McNamara, Ph.D., of the Centers for Disease Control and Prevention, and her associates (Pediatrics 2015 April 27 [doi: 10.1542/peds.2014-4015]). Dr. McNamara’s team used a compilation of data sources for their report: case and population data, laboratory typing of meningococcal isolates, university staff interviews, and vaccination coverage data from the Investigational New Drug protocol.

©BVDC/Fotolia.com
"The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future," Dr. McNamara remarked.

Seven cases of the same strain of serogroup B meningococcal disease occurred among undergraduate students at Princeton (N.J.) University, between March and November 2013, plus an eighth case during that time in a high school student who stayed in the Princeton dorms. The subsequent vaccination campaign with a two-dose series of the 4CMenB vaccine Bexsero targeted the 5,241 undergraduates and 541 graduate students living in the dorms, plus 6 caregivers or spouses of these students living in the dorms and 11 other individuals at the university with a medical condition putting them at high risk.

The first vaccine dose was administered between Dec. 9 and 12, 2013, followed by the second between Feb. 17 and 20, 2014. By May 14, 94.9% of the target population had received at least one dose of the vaccine, and 89.1% had received both doses. Among undergraduates, 96.6% received the first dose and 91.4% received both. The only serious adverse event considered a possible effect of the vaccine was a single case of rhabdomyolysis occurring a day after the second dose. Since Feb. 1, 2015, no vaccinated individuals developed serogroup B meningococcal disease, but a ninth ultimately fatal case occurred in March 2014 in a student from a different university who had close contact with several mostly vaccinated Princeton undergraduates, indicating that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated, the authors wrote.

The research was funded by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists. Dr. Johnsen spoke at Pfizer conferences and at a National Meningitis Association conference; travel expenses were covered, but he received no honorarium or other reimbursement. No other authors reported any relevant financial disclosures.

References

Body

The study by Dr. McNamara and her associates evaluating the public health response to the meningitis B outbreak at Princeton University reveals that the vaccination campaign was highly effective in stamping out the mini-epidemic. It confirms that the vaccine, two-dose Bexsero, is highly efficacious and can be used in outbreak situations.

Dr. Stanley Block

These types of studies are important because they provide a real-time, in vivo opportunity to assess the effectiveness of the vaccine as well as public health officials’ success in communicating the risk of the disease to the target population. This study tells us that public health experts did a superb job of getting almost every candidate on this school campus – over 90% of all undergraduates – vaccinated and revaccinated with an additional booster dose over two 3-day intervals.

These results show what can be done in terrifying situations when we have to contain a horrific contagious bacteria like meningococcus. The public health response was incredible, especially since college students aged 18-22 years are typically resistant to receiving any vaccinations. The students must have been well informed about the alarming disease process that could maim them, cause brain damage, or even kill them.

It was quite a remarkable feat that the Food and Drug Administration and the Centers for Disease Control and Prevention, two large bureaucratic organizations, came together in such a timely matter to ensure that a non–FDA approved meningococcal B vaccine was quickly acquired from Europe to be used for an entire at-risk population of individuals in an epidemic situation. Thus, this paper also suggests that the new manufacturing process using “reverse lipoproteins” in vaccines will protect extremely well not only the recipients, but also that small percentage of the exposed population who did not receive the vaccine (i.e., providing some herd protection).

These comments were made during a phone interview by Dr. Stanley Block, a pediatrician in private practice in Bardstown, Ky. Dr. Block has received research grants from Novartis, Pfizer, and Sanofi Pasteur with regard to meningococcal vaccines. He has received other research grants from GlaxoSmithKline and has been on the speaker’s bureau for Novartis Vaccines meningococcal vaccine.

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Body

The study by Dr. McNamara and her associates evaluating the public health response to the meningitis B outbreak at Princeton University reveals that the vaccination campaign was highly effective in stamping out the mini-epidemic. It confirms that the vaccine, two-dose Bexsero, is highly efficacious and can be used in outbreak situations.

Dr. Stanley Block

These types of studies are important because they provide a real-time, in vivo opportunity to assess the effectiveness of the vaccine as well as public health officials’ success in communicating the risk of the disease to the target population. This study tells us that public health experts did a superb job of getting almost every candidate on this school campus – over 90% of all undergraduates – vaccinated and revaccinated with an additional booster dose over two 3-day intervals.

These results show what can be done in terrifying situations when we have to contain a horrific contagious bacteria like meningococcus. The public health response was incredible, especially since college students aged 18-22 years are typically resistant to receiving any vaccinations. The students must have been well informed about the alarming disease process that could maim them, cause brain damage, or even kill them.

It was quite a remarkable feat that the Food and Drug Administration and the Centers for Disease Control and Prevention, two large bureaucratic organizations, came together in such a timely matter to ensure that a non–FDA approved meningococcal B vaccine was quickly acquired from Europe to be used for an entire at-risk population of individuals in an epidemic situation. Thus, this paper also suggests that the new manufacturing process using “reverse lipoproteins” in vaccines will protect extremely well not only the recipients, but also that small percentage of the exposed population who did not receive the vaccine (i.e., providing some herd protection).

These comments were made during a phone interview by Dr. Stanley Block, a pediatrician in private practice in Bardstown, Ky. Dr. Block has received research grants from Novartis, Pfizer, and Sanofi Pasteur with regard to meningococcal vaccines. He has received other research grants from GlaxoSmithKline and has been on the speaker’s bureau for Novartis Vaccines meningococcal vaccine.

Body

The study by Dr. McNamara and her associates evaluating the public health response to the meningitis B outbreak at Princeton University reveals that the vaccination campaign was highly effective in stamping out the mini-epidemic. It confirms that the vaccine, two-dose Bexsero, is highly efficacious and can be used in outbreak situations.

Dr. Stanley Block

These types of studies are important because they provide a real-time, in vivo opportunity to assess the effectiveness of the vaccine as well as public health officials’ success in communicating the risk of the disease to the target population. This study tells us that public health experts did a superb job of getting almost every candidate on this school campus – over 90% of all undergraduates – vaccinated and revaccinated with an additional booster dose over two 3-day intervals.

These results show what can be done in terrifying situations when we have to contain a horrific contagious bacteria like meningococcus. The public health response was incredible, especially since college students aged 18-22 years are typically resistant to receiving any vaccinations. The students must have been well informed about the alarming disease process that could maim them, cause brain damage, or even kill them.

It was quite a remarkable feat that the Food and Drug Administration and the Centers for Disease Control and Prevention, two large bureaucratic organizations, came together in such a timely matter to ensure that a non–FDA approved meningococcal B vaccine was quickly acquired from Europe to be used for an entire at-risk population of individuals in an epidemic situation. Thus, this paper also suggests that the new manufacturing process using “reverse lipoproteins” in vaccines will protect extremely well not only the recipients, but also that small percentage of the exposed population who did not receive the vaccine (i.e., providing some herd protection).

These comments were made during a phone interview by Dr. Stanley Block, a pediatrician in private practice in Bardstown, Ky. Dr. Block has received research grants from Novartis, Pfizer, and Sanofi Pasteur with regard to meningococcal vaccines. He has received other research grants from GlaxoSmithKline and has been on the speaker’s bureau for Novartis Vaccines meningococcal vaccine.

Title
Success story: public health response, immunization coverage
Success story: public health response, immunization coverage

A targeted MenB vaccination campaign during a university outbreak of serogroup B meningococcal disease effectively prevented additional cases in those who received the vaccine, according to a recent study.

“The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future,” reported Lucy A. McNamara, Ph.D., of the Centers for Disease Control and Prevention, and her associates (Pediatrics 2015 April 27 [doi: 10.1542/peds.2014-4015]). Dr. McNamara’s team used a compilation of data sources for their report: case and population data, laboratory typing of meningococcal isolates, university staff interviews, and vaccination coverage data from the Investigational New Drug protocol.

©BVDC/Fotolia.com
"The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future," Dr. McNamara remarked.

Seven cases of the same strain of serogroup B meningococcal disease occurred among undergraduate students at Princeton (N.J.) University, between March and November 2013, plus an eighth case during that time in a high school student who stayed in the Princeton dorms. The subsequent vaccination campaign with a two-dose series of the 4CMenB vaccine Bexsero targeted the 5,241 undergraduates and 541 graduate students living in the dorms, plus 6 caregivers or spouses of these students living in the dorms and 11 other individuals at the university with a medical condition putting them at high risk.

The first vaccine dose was administered between Dec. 9 and 12, 2013, followed by the second between Feb. 17 and 20, 2014. By May 14, 94.9% of the target population had received at least one dose of the vaccine, and 89.1% had received both doses. Among undergraduates, 96.6% received the first dose and 91.4% received both. The only serious adverse event considered a possible effect of the vaccine was a single case of rhabdomyolysis occurring a day after the second dose. Since Feb. 1, 2015, no vaccinated individuals developed serogroup B meningococcal disease, but a ninth ultimately fatal case occurred in March 2014 in a student from a different university who had close contact with several mostly vaccinated Princeton undergraduates, indicating that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated, the authors wrote.

The research was funded by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists. Dr. Johnsen spoke at Pfizer conferences and at a National Meningitis Association conference; travel expenses were covered, but he received no honorarium or other reimbursement. No other authors reported any relevant financial disclosures.

A targeted MenB vaccination campaign during a university outbreak of serogroup B meningococcal disease effectively prevented additional cases in those who received the vaccine, according to a recent study.

“The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future,” reported Lucy A. McNamara, Ph.D., of the Centers for Disease Control and Prevention, and her associates (Pediatrics 2015 April 27 [doi: 10.1542/peds.2014-4015]). Dr. McNamara’s team used a compilation of data sources for their report: case and population data, laboratory typing of meningococcal isolates, university staff interviews, and vaccination coverage data from the Investigational New Drug protocol.

©BVDC/Fotolia.com
"The outbreak investigation and highly successful vaccination campaign described here can serve as a model for how to approach similar outbreaks in the future," Dr. McNamara remarked.

Seven cases of the same strain of serogroup B meningococcal disease occurred among undergraduate students at Princeton (N.J.) University, between March and November 2013, plus an eighth case during that time in a high school student who stayed in the Princeton dorms. The subsequent vaccination campaign with a two-dose series of the 4CMenB vaccine Bexsero targeted the 5,241 undergraduates and 541 graduate students living in the dorms, plus 6 caregivers or spouses of these students living in the dorms and 11 other individuals at the university with a medical condition putting them at high risk.

The first vaccine dose was administered between Dec. 9 and 12, 2013, followed by the second between Feb. 17 and 20, 2014. By May 14, 94.9% of the target population had received at least one dose of the vaccine, and 89.1% had received both doses. Among undergraduates, 96.6% received the first dose and 91.4% received both. The only serious adverse event considered a possible effect of the vaccine was a single case of rhabdomyolysis occurring a day after the second dose. Since Feb. 1, 2015, no vaccinated individuals developed serogroup B meningococcal disease, but a ninth ultimately fatal case occurred in March 2014 in a student from a different university who had close contact with several mostly vaccinated Princeton undergraduates, indicating that carriage of serogroup B Neisseria meningitidis among vaccinated persons was not eliminated, the authors wrote.

The research was funded by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists. Dr. Johnsen spoke at Pfizer conferences and at a National Meningitis Association conference; travel expenses were covered, but he received no honorarium or other reimbursement. No other authors reported any relevant financial disclosures.

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Key clinical point: MenB vaccination of a high-risk population effectively stopped an outbreak.

Major finding: 89% of the target population received both doses of the vaccine; no additional cases in vaccinated individuals occurred.

Data source: The findings are based on a compilation of data sources: case and population data, laboratory typing of meningococcal isolates, university staff interviews and vaccination coverage data from the Investigational New Drug protocol.

Disclosures: The research was funded by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists. Dr. Johnsen spoke at Pfizer conferences and at a National Meningitis Association conference; travel expenses were covered, but he received no honorarium or other reimbursement. No other authors reported any relevant financial disclosures.

Gardasil vaccination reduces cervical dysplasia in teen years

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Gardasil vaccination reduces cervical dysplasia in teen years

Vaccination with Gardasil, the quadrivalent human papillomavirus (HPV) vaccine, can reduce cervical dysplasia and genital warts as early as 14-17 years old, a recent study found.

“The fact that these benefits were observed in such a young age group strengthens current recommendations that vaccination should occur at an early age,” reported Leah M. Smith of McGill University, Montreal, and her associates. “As such, policy makers and physicians can use these findings to substantiate arguments that delaying vaccination may result in missed opportunities for prevention,” they wrote (Pediatrics 2015 April 27 [doi:10.1542/peds.2014-2961]).

©Alex Raths/thinkstockphotos.com

In a population-based retrospective study in Ontario, Canada, the researchers compared the incidence of cervical dysplasia and anogenital warts between 131,781 girls in grade 8 during the 2005-2006 and 2006-2007 school years – before the HPV vaccination program was implemented – and 128,712 girls in grade 8 who were eligible for HPV vaccination in the 2007-2008 and 2008-2009 school years. Among those eligible for the vaccine, 75,848 received at least one dose, and 88% of these girls received all three doses.

Of the 2,436 cases of cervical dysplasia that occurred, 5.7 fewer girls per 1,000 developed cervical dysplasia if they had been vaccinated, compared with those not eligible for vaccination. The reduced risk for cervical dysplasia of 44% among vaccinated girls translated to 1 case prevented per 175 girls vaccinated. Simply being eligible for the vaccine also appeared to decrease risk of cervical dysplasia by 21%, or 2.32 fewer girls per 1,000.

Overall, 400 cases of genital warts occurred. Vaccinated girls had 43% lower risk for genital warts (0.83 fewer per 1,000), and eligibility for the vaccine reduced the risk by 19% (0.34 fewer girls per 1,000), but neither of these results reached statistical significance.

The research was funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health and Long-Term Care. The authors reported no disclosures.

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Vaccination with Gardasil, the quadrivalent human papillomavirus (HPV) vaccine, can reduce cervical dysplasia and genital warts as early as 14-17 years old, a recent study found.

“The fact that these benefits were observed in such a young age group strengthens current recommendations that vaccination should occur at an early age,” reported Leah M. Smith of McGill University, Montreal, and her associates. “As such, policy makers and physicians can use these findings to substantiate arguments that delaying vaccination may result in missed opportunities for prevention,” they wrote (Pediatrics 2015 April 27 [doi:10.1542/peds.2014-2961]).

©Alex Raths/thinkstockphotos.com

In a population-based retrospective study in Ontario, Canada, the researchers compared the incidence of cervical dysplasia and anogenital warts between 131,781 girls in grade 8 during the 2005-2006 and 2006-2007 school years – before the HPV vaccination program was implemented – and 128,712 girls in grade 8 who were eligible for HPV vaccination in the 2007-2008 and 2008-2009 school years. Among those eligible for the vaccine, 75,848 received at least one dose, and 88% of these girls received all three doses.

Of the 2,436 cases of cervical dysplasia that occurred, 5.7 fewer girls per 1,000 developed cervical dysplasia if they had been vaccinated, compared with those not eligible for vaccination. The reduced risk for cervical dysplasia of 44% among vaccinated girls translated to 1 case prevented per 175 girls vaccinated. Simply being eligible for the vaccine also appeared to decrease risk of cervical dysplasia by 21%, or 2.32 fewer girls per 1,000.

Overall, 400 cases of genital warts occurred. Vaccinated girls had 43% lower risk for genital warts (0.83 fewer per 1,000), and eligibility for the vaccine reduced the risk by 19% (0.34 fewer girls per 1,000), but neither of these results reached statistical significance.

The research was funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health and Long-Term Care. The authors reported no disclosures.

Vaccination with Gardasil, the quadrivalent human papillomavirus (HPV) vaccine, can reduce cervical dysplasia and genital warts as early as 14-17 years old, a recent study found.

“The fact that these benefits were observed in such a young age group strengthens current recommendations that vaccination should occur at an early age,” reported Leah M. Smith of McGill University, Montreal, and her associates. “As such, policy makers and physicians can use these findings to substantiate arguments that delaying vaccination may result in missed opportunities for prevention,” they wrote (Pediatrics 2015 April 27 [doi:10.1542/peds.2014-2961]).

©Alex Raths/thinkstockphotos.com

In a population-based retrospective study in Ontario, Canada, the researchers compared the incidence of cervical dysplasia and anogenital warts between 131,781 girls in grade 8 during the 2005-2006 and 2006-2007 school years – before the HPV vaccination program was implemented – and 128,712 girls in grade 8 who were eligible for HPV vaccination in the 2007-2008 and 2008-2009 school years. Among those eligible for the vaccine, 75,848 received at least one dose, and 88% of these girls received all three doses.

Of the 2,436 cases of cervical dysplasia that occurred, 5.7 fewer girls per 1,000 developed cervical dysplasia if they had been vaccinated, compared with those not eligible for vaccination. The reduced risk for cervical dysplasia of 44% among vaccinated girls translated to 1 case prevented per 175 girls vaccinated. Simply being eligible for the vaccine also appeared to decrease risk of cervical dysplasia by 21%, or 2.32 fewer girls per 1,000.

Overall, 400 cases of genital warts occurred. Vaccinated girls had 43% lower risk for genital warts (0.83 fewer per 1,000), and eligibility for the vaccine reduced the risk by 19% (0.34 fewer girls per 1,000), but neither of these results reached statistical significance.

The research was funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health and Long-Term Care. The authors reported no disclosures.

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Key clinical point: HPV vaccination effectively reduces cervical dysplasia in teens.

Major finding: For every 175 girls vaccinated, 1 case of cervical dysplasia was prevented, a 44% reduced risk.

Data source: The findings are based on a population-based retrospective cohort of 260,493 girls in grade 8 in Ontario, Canada.

Disclosures: The research was funded by the Canadian Institutes of Health Research and the Ontario Ministry of Health and Long-Term Care. The authors reported no relevant financial disclosures.

May 2015: Click for Credit

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May 2015: Click for Credit
Stay up to date on important developments in research and practice recommendations and earn CE/CME credit by reading the articles that follow. All posttests must be completed and submitted online.

Here are 5 articles in the May issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. Clindamycin, TMP-SMX Are Equally Effective for Skin Infections
To take the posttest, go to: http://bit.ly/1cVxR85

VITALS
Key clinical point:
Clindamycin and TMP-SMX had similar efficacy and adverse-effect profiles for treating uncomplicated skin infections, including both abscesses and cellulitis.
Major finding: At 7-10 days after therapy completion, the rates of cure in the evaluable population were 89.5% with clindamycin and 88.2% with TMP-SMX.
Data source: A prospective, multicenter, randomized, double-blind clinical trial involving 524 adults and children followed for 1 month after treatment.
Disclosures: This trial was supported by the National Institutes of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences (NCT00730028). Dr Miller reported receiving consulting fees from Cubist, Durata, and Pfizer; his associates reported ties to Cubist, Pfizer, EMMES, Theravance, AstraZeneca, Trius, Merck, and Cerexa.

2. Hormone Therapy 10 Years Postmenopause Increases Risks
To take the posttest, go to: http://bit.ly/1OBYcUe

VITALS
Key clinical point:
Hormone therapy in postmenopausal women increases stroke risk.
Major finding:
Stroke increased by 24%, venous thromboembolism by 92%, and pulmonary embolism by 81% in postmenopausal women receiving hormone therapy.
Data source:
A review and meta-analysis of 19 randomized controlled trials involving 40,140 postmenopausal women who received orally administered hormone therapy, placebo, or no treatment for prevention of cardiovascular disease.
Disclosures:
One study was funded by Wyeth-Ayerst. Two studies received partial funding from Novo-Nordisk Pharmaceutical, and one study was funded by the National Institutes of Health with support from Wyeth-Ayerst, Hoffman-La Roche, Pharmacia, and Upjohn. Eight other studies used medication provided by various pharmaceutical companies.

3. "Perfect storm" of Depression, Stress Raises Risk for MI, Death
To take the posttest, go to: http://bit.ly/1yM2HtF

VITALS
Key clinical point:
Concurrent depression and stress in coronary heart disease patients may increase early risk for MI and death. 
Major finding:
CHD patients with high depressive symptoms and high stress at baseline had an increased risk for MI and death early during follow-up (adjusted HR, 1.48).
Data source:
A prospective cohort study of 4,487 adults.
Disclosures:
The National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute supported the study. Dr Alcántara reported having no disclosures; two other authors received salary support from Amgen for research, and one served as a consultant for DiaDexus.

4. Type 2 Diabetes Lower in Familial Hypercholesterolemia
To take the posttest, go to: http://bit.ly/1bplTDc

VITALS
Key clinical point:
The prevalence of type 2 diabetes appears to be significantly lower in patients with familial hypercholesterolemia than in their unaffected relatives.
Major finding:
The prevalence of type 2 diabetes was 1.75% in 25,137 patients with familial hypercholesterolemia, compared with 2.93% in 38,183 of their unaffected relatives.
Data source:
An observational cross-sectional analysis of data for 63,320 people in the Dutch national registry of familial hypercholesterolemia.
Disclosures:
The study sponsor was not specified; the familial hypercholesterolemia registry is subsidized by the Dutch government. Dr Besseling reported having no financial disclosures; his associates reported ties to Aegerion, Amgen, AstraZeneca, Boehringer Ingelheim, Cerenis, Eli Lilly, Genzyme, JSiS, MSD, Novartis, Pfizer, Regeneron, Roche, and Sanofi.

5. Mongersen Induces 55%-65% Remission Rates in Crohn’s
To take the posttest, go to: http://bit.ly/1DctonL

VITALS
Key clinical point:
Mongersen, an oral SMAD7 antisense oligonucleotide, induced remission rates as high as 55%-65% in a small 2-week phase II clinical trial.
Major finding:
Rates of remission were 65% in the 43 participants who received 160 mg of mongersen, 55% in the 40 who received 40 mg, 12% in the 41 who received 10 mg, and 10% in the 42 who received placebo.
Data source:
A randomized, placebo-controlled, double-blind phase II clinical trial involving 166 adults at 17 medical centers in Italy and Germany.
Disclosures: This study was sponsored by Giuliani, acting under contract to Nogra Pharma. Dr Monteleone reported ties to Giuliani, Novo Nordisk, Teva, Sirtris, Lycera, Sofar, and Zambon, and holds a patent related to the use of SMAD7 antisense oligonucleotides in Crohn’s disease. His associates reported financial ties to numerous industry sources.

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Related Articles
Stay up to date on important developments in research and practice recommendations and earn CE/CME credit by reading the articles that follow. All posttests must be completed and submitted online.
Stay up to date on important developments in research and practice recommendations and earn CE/CME credit by reading the articles that follow. All posttests must be completed and submitted online.

Here are 5 articles in the May issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. Clindamycin, TMP-SMX Are Equally Effective for Skin Infections
To take the posttest, go to: http://bit.ly/1cVxR85

VITALS
Key clinical point:
Clindamycin and TMP-SMX had similar efficacy and adverse-effect profiles for treating uncomplicated skin infections, including both abscesses and cellulitis.
Major finding: At 7-10 days after therapy completion, the rates of cure in the evaluable population were 89.5% with clindamycin and 88.2% with TMP-SMX.
Data source: A prospective, multicenter, randomized, double-blind clinical trial involving 524 adults and children followed for 1 month after treatment.
Disclosures: This trial was supported by the National Institutes of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences (NCT00730028). Dr Miller reported receiving consulting fees from Cubist, Durata, and Pfizer; his associates reported ties to Cubist, Pfizer, EMMES, Theravance, AstraZeneca, Trius, Merck, and Cerexa.

2. Hormone Therapy 10 Years Postmenopause Increases Risks
To take the posttest, go to: http://bit.ly/1OBYcUe

VITALS
Key clinical point:
Hormone therapy in postmenopausal women increases stroke risk.
Major finding:
Stroke increased by 24%, venous thromboembolism by 92%, and pulmonary embolism by 81% in postmenopausal women receiving hormone therapy.
Data source:
A review and meta-analysis of 19 randomized controlled trials involving 40,140 postmenopausal women who received orally administered hormone therapy, placebo, or no treatment for prevention of cardiovascular disease.
Disclosures:
One study was funded by Wyeth-Ayerst. Two studies received partial funding from Novo-Nordisk Pharmaceutical, and one study was funded by the National Institutes of Health with support from Wyeth-Ayerst, Hoffman-La Roche, Pharmacia, and Upjohn. Eight other studies used medication provided by various pharmaceutical companies.

3. "Perfect storm" of Depression, Stress Raises Risk for MI, Death
To take the posttest, go to: http://bit.ly/1yM2HtF

VITALS
Key clinical point:
Concurrent depression and stress in coronary heart disease patients may increase early risk for MI and death. 
Major finding:
CHD patients with high depressive symptoms and high stress at baseline had an increased risk for MI and death early during follow-up (adjusted HR, 1.48).
Data source:
A prospective cohort study of 4,487 adults.
Disclosures:
The National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute supported the study. Dr Alcántara reported having no disclosures; two other authors received salary support from Amgen for research, and one served as a consultant for DiaDexus.

4. Type 2 Diabetes Lower in Familial Hypercholesterolemia
To take the posttest, go to: http://bit.ly/1bplTDc

VITALS
Key clinical point:
The prevalence of type 2 diabetes appears to be significantly lower in patients with familial hypercholesterolemia than in their unaffected relatives.
Major finding:
The prevalence of type 2 diabetes was 1.75% in 25,137 patients with familial hypercholesterolemia, compared with 2.93% in 38,183 of their unaffected relatives.
Data source:
An observational cross-sectional analysis of data for 63,320 people in the Dutch national registry of familial hypercholesterolemia.
Disclosures:
The study sponsor was not specified; the familial hypercholesterolemia registry is subsidized by the Dutch government. Dr Besseling reported having no financial disclosures; his associates reported ties to Aegerion, Amgen, AstraZeneca, Boehringer Ingelheim, Cerenis, Eli Lilly, Genzyme, JSiS, MSD, Novartis, Pfizer, Regeneron, Roche, and Sanofi.

5. Mongersen Induces 55%-65% Remission Rates in Crohn’s
To take the posttest, go to: http://bit.ly/1DctonL

VITALS
Key clinical point:
Mongersen, an oral SMAD7 antisense oligonucleotide, induced remission rates as high as 55%-65% in a small 2-week phase II clinical trial.
Major finding:
Rates of remission were 65% in the 43 participants who received 160 mg of mongersen, 55% in the 40 who received 40 mg, 12% in the 41 who received 10 mg, and 10% in the 42 who received placebo.
Data source:
A randomized, placebo-controlled, double-blind phase II clinical trial involving 166 adults at 17 medical centers in Italy and Germany.
Disclosures: This study was sponsored by Giuliani, acting under contract to Nogra Pharma. Dr Monteleone reported ties to Giuliani, Novo Nordisk, Teva, Sirtris, Lycera, Sofar, and Zambon, and holds a patent related to the use of SMAD7 antisense oligonucleotides in Crohn’s disease. His associates reported financial ties to numerous industry sources.

Here are 5 articles in the May issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. Clindamycin, TMP-SMX Are Equally Effective for Skin Infections
To take the posttest, go to: http://bit.ly/1cVxR85

VITALS
Key clinical point:
Clindamycin and TMP-SMX had similar efficacy and adverse-effect profiles for treating uncomplicated skin infections, including both abscesses and cellulitis.
Major finding: At 7-10 days after therapy completion, the rates of cure in the evaluable population were 89.5% with clindamycin and 88.2% with TMP-SMX.
Data source: A prospective, multicenter, randomized, double-blind clinical trial involving 524 adults and children followed for 1 month after treatment.
Disclosures: This trial was supported by the National Institutes of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences (NCT00730028). Dr Miller reported receiving consulting fees from Cubist, Durata, and Pfizer; his associates reported ties to Cubist, Pfizer, EMMES, Theravance, AstraZeneca, Trius, Merck, and Cerexa.

2. Hormone Therapy 10 Years Postmenopause Increases Risks
To take the posttest, go to: http://bit.ly/1OBYcUe

VITALS
Key clinical point:
Hormone therapy in postmenopausal women increases stroke risk.
Major finding:
Stroke increased by 24%, venous thromboembolism by 92%, and pulmonary embolism by 81% in postmenopausal women receiving hormone therapy.
Data source:
A review and meta-analysis of 19 randomized controlled trials involving 40,140 postmenopausal women who received orally administered hormone therapy, placebo, or no treatment for prevention of cardiovascular disease.
Disclosures:
One study was funded by Wyeth-Ayerst. Two studies received partial funding from Novo-Nordisk Pharmaceutical, and one study was funded by the National Institutes of Health with support from Wyeth-Ayerst, Hoffman-La Roche, Pharmacia, and Upjohn. Eight other studies used medication provided by various pharmaceutical companies.

3. "Perfect storm" of Depression, Stress Raises Risk for MI, Death
To take the posttest, go to: http://bit.ly/1yM2HtF

VITALS
Key clinical point:
Concurrent depression and stress in coronary heart disease patients may increase early risk for MI and death. 
Major finding:
CHD patients with high depressive symptoms and high stress at baseline had an increased risk for MI and death early during follow-up (adjusted HR, 1.48).
Data source:
A prospective cohort study of 4,487 adults.
Disclosures:
The National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute supported the study. Dr Alcántara reported having no disclosures; two other authors received salary support from Amgen for research, and one served as a consultant for DiaDexus.

4. Type 2 Diabetes Lower in Familial Hypercholesterolemia
To take the posttest, go to: http://bit.ly/1bplTDc

VITALS
Key clinical point:
The prevalence of type 2 diabetes appears to be significantly lower in patients with familial hypercholesterolemia than in their unaffected relatives.
Major finding:
The prevalence of type 2 diabetes was 1.75% in 25,137 patients with familial hypercholesterolemia, compared with 2.93% in 38,183 of their unaffected relatives.
Data source:
An observational cross-sectional analysis of data for 63,320 people in the Dutch national registry of familial hypercholesterolemia.
Disclosures:
The study sponsor was not specified; the familial hypercholesterolemia registry is subsidized by the Dutch government. Dr Besseling reported having no financial disclosures; his associates reported ties to Aegerion, Amgen, AstraZeneca, Boehringer Ingelheim, Cerenis, Eli Lilly, Genzyme, JSiS, MSD, Novartis, Pfizer, Regeneron, Roche, and Sanofi.

5. Mongersen Induces 55%-65% Remission Rates in Crohn’s
To take the posttest, go to: http://bit.ly/1DctonL

VITALS
Key clinical point:
Mongersen, an oral SMAD7 antisense oligonucleotide, induced remission rates as high as 55%-65% in a small 2-week phase II clinical trial.
Major finding:
Rates of remission were 65% in the 43 participants who received 160 mg of mongersen, 55% in the 40 who received 40 mg, 12% in the 41 who received 10 mg, and 10% in the 42 who received placebo.
Data source:
A randomized, placebo-controlled, double-blind phase II clinical trial involving 166 adults at 17 medical centers in Italy and Germany.
Disclosures: This study was sponsored by Giuliani, acting under contract to Nogra Pharma. Dr Monteleone reported ties to Giuliani, Novo Nordisk, Teva, Sirtris, Lycera, Sofar, and Zambon, and holds a patent related to the use of SMAD7 antisense oligonucleotides in Crohn’s disease. His associates reported financial ties to numerous industry sources.

References

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Hepatitis B perinatal infection risk factors identified

Antiviral therapy for high risk may prevent perinatal HBV
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Hepatitis B perinatal infection risk factors identified

Hepatitis B vertical infections are rare, but they are more likely if any of several risk factors are present, according to the results of a study led by Dr. Sarah Schillie.

Dr. Schillie of the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and her associates analyzed prospectively collected data from 2007 to 2013 on 17,951 infant-mother pairs (including 15,938 mothers) in five U.S.-funded Perinatal Hepatitis B Prevention Programs in Florida, Michigan, Minnesota, New York, and most of Texas. The mothers had a median age of 30 years, and all tested positive for hepatitis B surface antigen (HBsAg).

CDC/Dr. Erskine Palmer
6.7% of infants with fewer than three doses of the vaccine developed an HBV infection vs. 1.1% of infants who received at least three doses.

Most infants born to mothers with active hepatitis B virus (HBV) received the vaccine plus immune globulin, but 1.1% acquired the infection perinatally (Pediatrics 2014 April 20 [doi:10.1542/peds.2014-3213]).

Newborns were more likely to acquire an infection if their mother was younger, was of Asian or Pacific Islander race, tested positive for hepatitis B antigens, tested negative for antibodies to hepatitis B antigens, or had a viral load of at least 2,000 IU/mL.

Further, 6.7% of infants with fewer than three doses of the vaccine developed an HBV infection, compared with 1.1% of infants who received at least three doses. Developing an infection was not linked to gestational age, birth weight, or timing of the vaccine or immune globulin (within or after 12 hours of birth).

“The identification of women with a higher risk of perinatal hepatitis B transmission in the context of optimal postexposure prophylaxis suggests that interventions such as maternal antiviral therapy might further decrease or eliminate perinatal hepatitis B infections,” Dr. Schillie and her associates reported.

Among 11,479 infants with information on HBV vaccine timing, 96.4% received the vaccine within 12 hours of birth; 95.5% of 11,633 newborns with timing data received hepatitis B immune globulin. Among 11,335 newborns with information available, 94.9% received both. HBsAg results were available for 51.5% of the total group (9,252 infants): 99.5% of these received at least three doses of the vaccine, and 1.1% (100 infants) acquired HBV perinatal infections.

The research was funded by the CDC and the U.S. Department of Energy. The authors reported no disclosures.

References

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Body

Much of the data [Dr. Schillie and her associates] share is good news. These results should cause us to stop and recognize the scope and success of the tremendous efforts of everyone involved in preventing HBV vertical transmission.

This article should also spur us to take the next step in HBV prevention. Some studies have shown that using antiviral agents, specifically tenofovir, to suppress HBV DNA in pregnant women with active disease in the third trimester can prevent vertical transmission when combined with standard of care. Many adult hepatologists already do this routinely for those women with chronic HBV infection with risk factors for vertical transmission prophylaxis failure when they become pregnant.

To find the women with previously unknown disease, we as a medical community need to broaden, standardize, and implement these practices so they can be used by everyone. Further studies are important because there are tangible downstream risks to using antiviral agents during pregnancy. Women in the “immune tolerant” phase of chronic HBV, with HBV e antigen–positive and high-level HBV DNA in the absence of symptoms or elevated liver enzymes, may transition to a more active phase of hepatitis when treatment is stopped post partum. Despite the published warning, there is likely little infant drug exposure if a woman breastfeeds while taking tenofovir, but fetal drug exposure before delivery could have some long-term effect that is not yet appreciated.

It is clear that we have come a long way in preventing HBV vertical transmission. It is also clear that it is time to take the next step. We have the tools available; we just need to have the will.

Dr. Ravi Jhaveri is a pediatric infectious diseases expert at the University of North Carolina at Chapel Hill. These comments were excerpted from an editorial accompanying Dr. Schillie’s study (Pediatrics 2015 [doi:10.1542/peds.2015-0360]). Dr. Jhaveri reported no relevant financial disclosures.

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Body

Much of the data [Dr. Schillie and her associates] share is good news. These results should cause us to stop and recognize the scope and success of the tremendous efforts of everyone involved in preventing HBV vertical transmission.

This article should also spur us to take the next step in HBV prevention. Some studies have shown that using antiviral agents, specifically tenofovir, to suppress HBV DNA in pregnant women with active disease in the third trimester can prevent vertical transmission when combined with standard of care. Many adult hepatologists already do this routinely for those women with chronic HBV infection with risk factors for vertical transmission prophylaxis failure when they become pregnant.

To find the women with previously unknown disease, we as a medical community need to broaden, standardize, and implement these practices so they can be used by everyone. Further studies are important because there are tangible downstream risks to using antiviral agents during pregnancy. Women in the “immune tolerant” phase of chronic HBV, with HBV e antigen–positive and high-level HBV DNA in the absence of symptoms or elevated liver enzymes, may transition to a more active phase of hepatitis when treatment is stopped post partum. Despite the published warning, there is likely little infant drug exposure if a woman breastfeeds while taking tenofovir, but fetal drug exposure before delivery could have some long-term effect that is not yet appreciated.

It is clear that we have come a long way in preventing HBV vertical transmission. It is also clear that it is time to take the next step. We have the tools available; we just need to have the will.

Dr. Ravi Jhaveri is a pediatric infectious diseases expert at the University of North Carolina at Chapel Hill. These comments were excerpted from an editorial accompanying Dr. Schillie’s study (Pediatrics 2015 [doi:10.1542/peds.2015-0360]). Dr. Jhaveri reported no relevant financial disclosures.

Body

Much of the data [Dr. Schillie and her associates] share is good news. These results should cause us to stop and recognize the scope and success of the tremendous efforts of everyone involved in preventing HBV vertical transmission.

This article should also spur us to take the next step in HBV prevention. Some studies have shown that using antiviral agents, specifically tenofovir, to suppress HBV DNA in pregnant women with active disease in the third trimester can prevent vertical transmission when combined with standard of care. Many adult hepatologists already do this routinely for those women with chronic HBV infection with risk factors for vertical transmission prophylaxis failure when they become pregnant.

To find the women with previously unknown disease, we as a medical community need to broaden, standardize, and implement these practices so they can be used by everyone. Further studies are important because there are tangible downstream risks to using antiviral agents during pregnancy. Women in the “immune tolerant” phase of chronic HBV, with HBV e antigen–positive and high-level HBV DNA in the absence of symptoms or elevated liver enzymes, may transition to a more active phase of hepatitis when treatment is stopped post partum. Despite the published warning, there is likely little infant drug exposure if a woman breastfeeds while taking tenofovir, but fetal drug exposure before delivery could have some long-term effect that is not yet appreciated.

It is clear that we have come a long way in preventing HBV vertical transmission. It is also clear that it is time to take the next step. We have the tools available; we just need to have the will.

Dr. Ravi Jhaveri is a pediatric infectious diseases expert at the University of North Carolina at Chapel Hill. These comments were excerpted from an editorial accompanying Dr. Schillie’s study (Pediatrics 2015 [doi:10.1542/peds.2015-0360]). Dr. Jhaveri reported no relevant financial disclosures.

Title
Antiviral therapy for high risk may prevent perinatal HBV
Antiviral therapy for high risk may prevent perinatal HBV

Hepatitis B vertical infections are rare, but they are more likely if any of several risk factors are present, according to the results of a study led by Dr. Sarah Schillie.

Dr. Schillie of the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and her associates analyzed prospectively collected data from 2007 to 2013 on 17,951 infant-mother pairs (including 15,938 mothers) in five U.S.-funded Perinatal Hepatitis B Prevention Programs in Florida, Michigan, Minnesota, New York, and most of Texas. The mothers had a median age of 30 years, and all tested positive for hepatitis B surface antigen (HBsAg).

CDC/Dr. Erskine Palmer
6.7% of infants with fewer than three doses of the vaccine developed an HBV infection vs. 1.1% of infants who received at least three doses.

Most infants born to mothers with active hepatitis B virus (HBV) received the vaccine plus immune globulin, but 1.1% acquired the infection perinatally (Pediatrics 2014 April 20 [doi:10.1542/peds.2014-3213]).

Newborns were more likely to acquire an infection if their mother was younger, was of Asian or Pacific Islander race, tested positive for hepatitis B antigens, tested negative for antibodies to hepatitis B antigens, or had a viral load of at least 2,000 IU/mL.

Further, 6.7% of infants with fewer than three doses of the vaccine developed an HBV infection, compared with 1.1% of infants who received at least three doses. Developing an infection was not linked to gestational age, birth weight, or timing of the vaccine or immune globulin (within or after 12 hours of birth).

“The identification of women with a higher risk of perinatal hepatitis B transmission in the context of optimal postexposure prophylaxis suggests that interventions such as maternal antiviral therapy might further decrease or eliminate perinatal hepatitis B infections,” Dr. Schillie and her associates reported.

Among 11,479 infants with information on HBV vaccine timing, 96.4% received the vaccine within 12 hours of birth; 95.5% of 11,633 newborns with timing data received hepatitis B immune globulin. Among 11,335 newborns with information available, 94.9% received both. HBsAg results were available for 51.5% of the total group (9,252 infants): 99.5% of these received at least three doses of the vaccine, and 1.1% (100 infants) acquired HBV perinatal infections.

The research was funded by the CDC and the U.S. Department of Energy. The authors reported no disclosures.

Hepatitis B vertical infections are rare, but they are more likely if any of several risk factors are present, according to the results of a study led by Dr. Sarah Schillie.

Dr. Schillie of the division of viral hepatitis at the Centers for Disease Control and Prevention, Atlanta, and her associates analyzed prospectively collected data from 2007 to 2013 on 17,951 infant-mother pairs (including 15,938 mothers) in five U.S.-funded Perinatal Hepatitis B Prevention Programs in Florida, Michigan, Minnesota, New York, and most of Texas. The mothers had a median age of 30 years, and all tested positive for hepatitis B surface antigen (HBsAg).

CDC/Dr. Erskine Palmer
6.7% of infants with fewer than three doses of the vaccine developed an HBV infection vs. 1.1% of infants who received at least three doses.

Most infants born to mothers with active hepatitis B virus (HBV) received the vaccine plus immune globulin, but 1.1% acquired the infection perinatally (Pediatrics 2014 April 20 [doi:10.1542/peds.2014-3213]).

Newborns were more likely to acquire an infection if their mother was younger, was of Asian or Pacific Islander race, tested positive for hepatitis B antigens, tested negative for antibodies to hepatitis B antigens, or had a viral load of at least 2,000 IU/mL.

Further, 6.7% of infants with fewer than three doses of the vaccine developed an HBV infection, compared with 1.1% of infants who received at least three doses. Developing an infection was not linked to gestational age, birth weight, or timing of the vaccine or immune globulin (within or after 12 hours of birth).

“The identification of women with a higher risk of perinatal hepatitis B transmission in the context of optimal postexposure prophylaxis suggests that interventions such as maternal antiviral therapy might further decrease or eliminate perinatal hepatitis B infections,” Dr. Schillie and her associates reported.

Among 11,479 infants with information on HBV vaccine timing, 96.4% received the vaccine within 12 hours of birth; 95.5% of 11,633 newborns with timing data received hepatitis B immune globulin. Among 11,335 newborns with information available, 94.9% received both. HBsAg results were available for 51.5% of the total group (9,252 infants): 99.5% of these received at least three doses of the vaccine, and 1.1% (100 infants) acquired HBV perinatal infections.

The research was funded by the CDC and the U.S. Department of Energy. The authors reported no disclosures.

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Hepatitis B perinatal infection risk factors identified
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Key clinical point: Several risk factors increase likelihood of hepatitis B perinatal transmission.

Major finding: Newborns were more likely to acquire an infection if their mother was younger, was of Asian or Pacific Islander race, tested positive for hepatitis B antigens, tested negative for antibodies to hepatitis B antigens, or had a viral load of at least 2,000 IU/mL.

Data source: The findings are based on an analysis of prospectively collected data on 17,951 mother-infant pairs at five U.S.-funded Perinatal Hepatitis B Prevention Programs in Florida, Michigan, Minnesota, New York, and Texas from 2007 to 2013.

Disclosures: The research was funded by the CDC and U.S. Department of Energy. The authors reported no disclosures.

Sexual abuse education interventions appear effective

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Sexual abuse education interventions appear effective

School-based educational programs to prevent sexual abuse appear to increase children’s knowledge, disclosure of abuse, and protective behaviors with no measurable harms, based on moderate evidence in an updated Cochrane systematic review.

These programs “seek to prevent child sexual abuse by providing students with knowledge and skills to recognize and avoid potentially sexually abusive situations, and with strategies to physically and verbally repel sexual approaches by offenders,” Kerryann Walsh of Queensland University of Technology in Brisbane, Australia, and her associates reported online. “Interventions aim to transfer the knowledge and skills learned by the child or adolescent in the classroom to real-life situations,” they wrote (Cochrane Database Syst. Rev. 2015 April 16 [doi:10.1001/14651858.CD004380.pub3]).

An estimated 10%-20% of female children and 5%-10% of male children have experienced some form of sexual abuse, ranging from unwanted touching to penetration, but two-thirds of individuals never report their abuse, and most cases are not reported to the authorities. Outcomes linked to sexual abuse include depression, posttraumatic stress disorder, suicidal behaviors, anti-social behaviors, eating disorders, substance abuse, sexual dysfunction, sexual revictimization, and parenting difficulties, as well as various chronic physical health problems.

Walsh’s team searched 14 databases and two trial registers for new randomized controlled trials to update the October 2013 review. This update excluded one previous trial and added 10 new trials through September 2014 to the 14 already included. The 24 total trials analyzed came from the United States, Canada, China, Germany, Spain, Taiwan, and Turkey, and included 5,802 elementary and high school students.

School-based programs increased children’s protective behaviors almost six times over children not receiving the intervention, based on two trials involving 102 children (odds ratio, 5.71).

Questionnaire-based knowledge about sexual abuse increased among children receiving education, based on analysis of 18 trials involving 4,657 children, although the trials differed significantly from one another. Similarly, children’s knowledge increased when assessed using vignettes across 11 trials, also highly heterogeneous, involving 1,688 children. The four trials assessing children’s knowledge over time found they retained their knowledge at least 6 months later.

Children who received the school-based intervention were 3.6 times more likely to disclose previous or current sexual abuse than children who did not receive the intervention (OR, 3.56).

The three trials that assessed harms found no increased or decreased anxiety or fear among the children receiving the intervention, but none of the trials assessed anxiety or fear among the children’s parents. The authors urged caution in interpreting the findings because high or unclear risk of selection bias, detection bias, and attrition bias, and too little information was available for the authors to conduct subgroup analyses. “Study quality was compromised in about half of the included studies due to suboptimal data collection methods for study outcomes and inappropriate data analysis,” the authors wrote.

Further, “studies have not yet adequately measured the long-term benefits of programs in terms of reducing the incidence or prevalence [or both] of child sexual abuse in program participants,” Dr. Walsh and her associates said.

The trials were heterogeneous, and the intervention programs lasted anywhere from a single 45-minute session to 20-minute sessions on each of 8 consecutive days. Common themes among the courses included teaching body ownership, safety rules, private parts of the body, who to tell, and telling apart types of touches and types of secrets. Videos, theatrical plays, and multimedia presentations, sometimes incorporating puppetry, comics, songs and coloring books, were used to deliver the programs. The teaching methods included “rehearsal, practice, role-playing, discussion, and feedback.”

Dr. Walsh received Australian Research Council Discovery Project Scheme funding for research about sexual abuse prevention programs in Australia conducted concurrently with this review. No other authors reported relevant disclosures.

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School-based educational programs to prevent sexual abuse appear to increase children’s knowledge, disclosure of abuse, and protective behaviors with no measurable harms, based on moderate evidence in an updated Cochrane systematic review.

These programs “seek to prevent child sexual abuse by providing students with knowledge and skills to recognize and avoid potentially sexually abusive situations, and with strategies to physically and verbally repel sexual approaches by offenders,” Kerryann Walsh of Queensland University of Technology in Brisbane, Australia, and her associates reported online. “Interventions aim to transfer the knowledge and skills learned by the child or adolescent in the classroom to real-life situations,” they wrote (Cochrane Database Syst. Rev. 2015 April 16 [doi:10.1001/14651858.CD004380.pub3]).

An estimated 10%-20% of female children and 5%-10% of male children have experienced some form of sexual abuse, ranging from unwanted touching to penetration, but two-thirds of individuals never report their abuse, and most cases are not reported to the authorities. Outcomes linked to sexual abuse include depression, posttraumatic stress disorder, suicidal behaviors, anti-social behaviors, eating disorders, substance abuse, sexual dysfunction, sexual revictimization, and parenting difficulties, as well as various chronic physical health problems.

Walsh’s team searched 14 databases and two trial registers for new randomized controlled trials to update the October 2013 review. This update excluded one previous trial and added 10 new trials through September 2014 to the 14 already included. The 24 total trials analyzed came from the United States, Canada, China, Germany, Spain, Taiwan, and Turkey, and included 5,802 elementary and high school students.

School-based programs increased children’s protective behaviors almost six times over children not receiving the intervention, based on two trials involving 102 children (odds ratio, 5.71).

Questionnaire-based knowledge about sexual abuse increased among children receiving education, based on analysis of 18 trials involving 4,657 children, although the trials differed significantly from one another. Similarly, children’s knowledge increased when assessed using vignettes across 11 trials, also highly heterogeneous, involving 1,688 children. The four trials assessing children’s knowledge over time found they retained their knowledge at least 6 months later.

Children who received the school-based intervention were 3.6 times more likely to disclose previous or current sexual abuse than children who did not receive the intervention (OR, 3.56).

The three trials that assessed harms found no increased or decreased anxiety or fear among the children receiving the intervention, but none of the trials assessed anxiety or fear among the children’s parents. The authors urged caution in interpreting the findings because high or unclear risk of selection bias, detection bias, and attrition bias, and too little information was available for the authors to conduct subgroup analyses. “Study quality was compromised in about half of the included studies due to suboptimal data collection methods for study outcomes and inappropriate data analysis,” the authors wrote.

Further, “studies have not yet adequately measured the long-term benefits of programs in terms of reducing the incidence or prevalence [or both] of child sexual abuse in program participants,” Dr. Walsh and her associates said.

The trials were heterogeneous, and the intervention programs lasted anywhere from a single 45-minute session to 20-minute sessions on each of 8 consecutive days. Common themes among the courses included teaching body ownership, safety rules, private parts of the body, who to tell, and telling apart types of touches and types of secrets. Videos, theatrical plays, and multimedia presentations, sometimes incorporating puppetry, comics, songs and coloring books, were used to deliver the programs. The teaching methods included “rehearsal, practice, role-playing, discussion, and feedback.”

Dr. Walsh received Australian Research Council Discovery Project Scheme funding for research about sexual abuse prevention programs in Australia conducted concurrently with this review. No other authors reported relevant disclosures.

School-based educational programs to prevent sexual abuse appear to increase children’s knowledge, disclosure of abuse, and protective behaviors with no measurable harms, based on moderate evidence in an updated Cochrane systematic review.

These programs “seek to prevent child sexual abuse by providing students with knowledge and skills to recognize and avoid potentially sexually abusive situations, and with strategies to physically and verbally repel sexual approaches by offenders,” Kerryann Walsh of Queensland University of Technology in Brisbane, Australia, and her associates reported online. “Interventions aim to transfer the knowledge and skills learned by the child or adolescent in the classroom to real-life situations,” they wrote (Cochrane Database Syst. Rev. 2015 April 16 [doi:10.1001/14651858.CD004380.pub3]).

An estimated 10%-20% of female children and 5%-10% of male children have experienced some form of sexual abuse, ranging from unwanted touching to penetration, but two-thirds of individuals never report their abuse, and most cases are not reported to the authorities. Outcomes linked to sexual abuse include depression, posttraumatic stress disorder, suicidal behaviors, anti-social behaviors, eating disorders, substance abuse, sexual dysfunction, sexual revictimization, and parenting difficulties, as well as various chronic physical health problems.

Walsh’s team searched 14 databases and two trial registers for new randomized controlled trials to update the October 2013 review. This update excluded one previous trial and added 10 new trials through September 2014 to the 14 already included. The 24 total trials analyzed came from the United States, Canada, China, Germany, Spain, Taiwan, and Turkey, and included 5,802 elementary and high school students.

School-based programs increased children’s protective behaviors almost six times over children not receiving the intervention, based on two trials involving 102 children (odds ratio, 5.71).

Questionnaire-based knowledge about sexual abuse increased among children receiving education, based on analysis of 18 trials involving 4,657 children, although the trials differed significantly from one another. Similarly, children’s knowledge increased when assessed using vignettes across 11 trials, also highly heterogeneous, involving 1,688 children. The four trials assessing children’s knowledge over time found they retained their knowledge at least 6 months later.

Children who received the school-based intervention were 3.6 times more likely to disclose previous or current sexual abuse than children who did not receive the intervention (OR, 3.56).

The three trials that assessed harms found no increased or decreased anxiety or fear among the children receiving the intervention, but none of the trials assessed anxiety or fear among the children’s parents. The authors urged caution in interpreting the findings because high or unclear risk of selection bias, detection bias, and attrition bias, and too little information was available for the authors to conduct subgroup analyses. “Study quality was compromised in about half of the included studies due to suboptimal data collection methods for study outcomes and inappropriate data analysis,” the authors wrote.

Further, “studies have not yet adequately measured the long-term benefits of programs in terms of reducing the incidence or prevalence [or both] of child sexual abuse in program participants,” Dr. Walsh and her associates said.

The trials were heterogeneous, and the intervention programs lasted anywhere from a single 45-minute session to 20-minute sessions on each of 8 consecutive days. Common themes among the courses included teaching body ownership, safety rules, private parts of the body, who to tell, and telling apart types of touches and types of secrets. Videos, theatrical plays, and multimedia presentations, sometimes incorporating puppetry, comics, songs and coloring books, were used to deliver the programs. The teaching methods included “rehearsal, practice, role-playing, discussion, and feedback.”

Dr. Walsh received Australian Research Council Discovery Project Scheme funding for research about sexual abuse prevention programs in Australia conducted concurrently with this review. No other authors reported relevant disclosures.

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Key clinical point: School-based education programs to prevent sexual abuse appear effective.

Major finding: Interventions increased protective behaviors 5.7 times and abuse disclosures 3.6 times.

Data source: The findings are based on 24 randomized controlled trials with 5,802 elementary and high school students in seven countries.

Disclosures: Dr. Walsh received Australian Research Council Discovery Project Scheme funding for research about sexual abuse prevention programs in Australia conducted concurrently with this review. No other authors reported relevant disclosures.

Neonatal abstinence syndrome risk varies with modifiable factors

Time for routine screening
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Neonatal abstinence syndrome risk varies with modifiable factors

Infants born to women taking prescription opioids were more likely to have neonatal abstinence syndrome (NAS) if their mothers smoked tobacco or took selective serotonin reuptake inhibitors (SSRIs), according to a recent study. Cumulative opioid exposure and opioid type (maintenance and long-acting) also increased the risk of NAS.

“The American Academy of Pediatrics recommends that all opioid-exposed infants be observed in the hospital for 4 to 7 days after birth. However, our data suggest there was a wide variability in an infant’s risk of drug withdrawal based on opioid type, dose, SSRI use, and number of cigarettes smoked per day by the mother,” reported Dr. Stephen W. Patrick of Vanderbilt University, Nashville, Tenn. “Future studies should evaluate new care models for opioid-exposed infants at different risk levels of developing NAS,” wrote Dr. Patrick and his associates [Pediatrics 2015 April 13 [doi: 10.1542/peds.2014-3299]).

Dr. Patrick’s team analyzed prescription data and vital statistics of 112,029 pregnant women and their newborns who were enrolled in the Tennessee Medicaid program between 2009 and 2011. Of these, 28% of the women filled at least one prescription for opioids; these included 96.2% taking short-acting medications, 2.7% receiving maintenance treatment for substance use disorders and 0.6% taking long-acting medications.

Among women taking prescription opioids, 5.3% had depression, 4.3% had an anxiety disorder, 41.8% smoked, 4.3% had been prescribed SSRIs within 30 days before birth, 8.3% had headache or migraine, and 23.7% had musculoskeletal disease, compared to 2.7%, 1.6% and 25.8%, 1.9%, 2.0% and 5.8%, respectively, for mothers not taking opioids.

Nearly a third of women on maintenance therapy (29.3%) had infants with NAS while 14.7% of mothers taking long-acting opioids and 1.4% of women taking short-acting preparations had newborns with NAS. Newborns were twice as likely to develop NAS if their mothers took SSRIs (odds ratio, 2.08), and their risk of NAS increased in a dose-response fashion with the number of daily cigarettes their mothers smoked.

NAS rates nearly doubled during the course of the study, landing at 10.7 per 1,000 births in the final year. Among the 1,086 newborns diagnosed with NAS, 21.2% had low birth weight, 16.7% were preterm, 28.7% had respiratory diagnoses, 13.1% had feeding difficulties, 7.2% had sepsis, and 3.7% had seizures. Among those exposed to opioids who did not develop NAS, 11.8% had low birth weight, 11.6% were preterm, 10.1% had respiratory diagnoses, 2.6% had feeding difficulties, 2.3% had sepsis and 0.4% had seizures. Among unexposed newborns, 9.9% had low birth weight, 11% were preterm, 8.8% had respiratory diagnoses, 2.3% had feeding difficulties, 1.9% had sepsis, and 0.3% had seizures.

“Public health efforts should focus on limiting inappropriate [opioid pain relievers] and tobacco use in pregnancy,” the authors wrote. “Prescribing opioids in pregnancy should be done with caution because it can lead to significant complications for the neonate.”

The research was funded by the Tennessee Department of Health and the National Institutes of Health. The authors reported no disclosures.

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Neonatal abstinence syndrome is a rapidly growing problem, increasing 16-fold in Tennessee in 13 years. At a rate of 12 cases per 1,000 births in 2013, the incidence is now 10 times more likely than group B strep sepsis, congenital deafness, or dislocated hips, and many times more likely than a bilirubin of 20. So screening for it must become standard newborn care.

Although the American Academy of Pediatrics 2012 guidelines (Pediatrics 2012;129:e540-60) noted that 45-87 out of 1,000 mothers are using illicit drugs during pregnancy, this new study indicates that use of prescription opioids during pregnancy has been increasing and is associated with this rise in NAS. The use of any opioids during pregnancy (28%) now matches the rate of any alcohol (23.7%) and tobacco use (27.7%). Chronic users of opioids are fewer in number, but much more likely to yield withdrawal in the neonate.

The article identifies cofactors (cigarette and selective serotonin reuptake inhibitor use) that increase the likelihood of a given amount of maternal opiate use leading to clinical NAS. So the use of those substances should be solicited in history along with the types, frequency, and duration of any opioid use. It would be ideal if this information was collected during the obstetric admission process along with maternal blood type, group B strep status, hepatitis B, and other labs. Observation for signs of withdrawal deserves as much attention as that paid to getting the hearing screen done and the bilirubin checked. It is harming more newborns.

Kevin T. Powell, M.D., Ph.D., is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He said that he had no relevant financial disclosures.

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Neonatal abstinence syndrome is a rapidly growing problem, increasing 16-fold in Tennessee in 13 years. At a rate of 12 cases per 1,000 births in 2013, the incidence is now 10 times more likely than group B strep sepsis, congenital deafness, or dislocated hips, and many times more likely than a bilirubin of 20. So screening for it must become standard newborn care.

Although the American Academy of Pediatrics 2012 guidelines (Pediatrics 2012;129:e540-60) noted that 45-87 out of 1,000 mothers are using illicit drugs during pregnancy, this new study indicates that use of prescription opioids during pregnancy has been increasing and is associated with this rise in NAS. The use of any opioids during pregnancy (28%) now matches the rate of any alcohol (23.7%) and tobacco use (27.7%). Chronic users of opioids are fewer in number, but much more likely to yield withdrawal in the neonate.

The article identifies cofactors (cigarette and selective serotonin reuptake inhibitor use) that increase the likelihood of a given amount of maternal opiate use leading to clinical NAS. So the use of those substances should be solicited in history along with the types, frequency, and duration of any opioid use. It would be ideal if this information was collected during the obstetric admission process along with maternal blood type, group B strep status, hepatitis B, and other labs. Observation for signs of withdrawal deserves as much attention as that paid to getting the hearing screen done and the bilirubin checked. It is harming more newborns.

Kevin T. Powell, M.D., Ph.D., is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He said that he had no relevant financial disclosures.

Body

Neonatal abstinence syndrome is a rapidly growing problem, increasing 16-fold in Tennessee in 13 years. At a rate of 12 cases per 1,000 births in 2013, the incidence is now 10 times more likely than group B strep sepsis, congenital deafness, or dislocated hips, and many times more likely than a bilirubin of 20. So screening for it must become standard newborn care.

Although the American Academy of Pediatrics 2012 guidelines (Pediatrics 2012;129:e540-60) noted that 45-87 out of 1,000 mothers are using illicit drugs during pregnancy, this new study indicates that use of prescription opioids during pregnancy has been increasing and is associated with this rise in NAS. The use of any opioids during pregnancy (28%) now matches the rate of any alcohol (23.7%) and tobacco use (27.7%). Chronic users of opioids are fewer in number, but much more likely to yield withdrawal in the neonate.

The article identifies cofactors (cigarette and selective serotonin reuptake inhibitor use) that increase the likelihood of a given amount of maternal opiate use leading to clinical NAS. So the use of those substances should be solicited in history along with the types, frequency, and duration of any opioid use. It would be ideal if this information was collected during the obstetric admission process along with maternal blood type, group B strep status, hepatitis B, and other labs. Observation for signs of withdrawal deserves as much attention as that paid to getting the hearing screen done and the bilirubin checked. It is harming more newborns.

Kevin T. Powell, M.D., Ph.D., is a pediatric hospitalist and clinical ethics consultant living in St. Louis. He said that he had no relevant financial disclosures.

Title
Time for routine screening
Time for routine screening

Infants born to women taking prescription opioids were more likely to have neonatal abstinence syndrome (NAS) if their mothers smoked tobacco or took selective serotonin reuptake inhibitors (SSRIs), according to a recent study. Cumulative opioid exposure and opioid type (maintenance and long-acting) also increased the risk of NAS.

“The American Academy of Pediatrics recommends that all opioid-exposed infants be observed in the hospital for 4 to 7 days after birth. However, our data suggest there was a wide variability in an infant’s risk of drug withdrawal based on opioid type, dose, SSRI use, and number of cigarettes smoked per day by the mother,” reported Dr. Stephen W. Patrick of Vanderbilt University, Nashville, Tenn. “Future studies should evaluate new care models for opioid-exposed infants at different risk levels of developing NAS,” wrote Dr. Patrick and his associates [Pediatrics 2015 April 13 [doi: 10.1542/peds.2014-3299]).

Dr. Patrick’s team analyzed prescription data and vital statistics of 112,029 pregnant women and their newborns who were enrolled in the Tennessee Medicaid program between 2009 and 2011. Of these, 28% of the women filled at least one prescription for opioids; these included 96.2% taking short-acting medications, 2.7% receiving maintenance treatment for substance use disorders and 0.6% taking long-acting medications.

Among women taking prescription opioids, 5.3% had depression, 4.3% had an anxiety disorder, 41.8% smoked, 4.3% had been prescribed SSRIs within 30 days before birth, 8.3% had headache or migraine, and 23.7% had musculoskeletal disease, compared to 2.7%, 1.6% and 25.8%, 1.9%, 2.0% and 5.8%, respectively, for mothers not taking opioids.

Nearly a third of women on maintenance therapy (29.3%) had infants with NAS while 14.7% of mothers taking long-acting opioids and 1.4% of women taking short-acting preparations had newborns with NAS. Newborns were twice as likely to develop NAS if their mothers took SSRIs (odds ratio, 2.08), and their risk of NAS increased in a dose-response fashion with the number of daily cigarettes their mothers smoked.

NAS rates nearly doubled during the course of the study, landing at 10.7 per 1,000 births in the final year. Among the 1,086 newborns diagnosed with NAS, 21.2% had low birth weight, 16.7% were preterm, 28.7% had respiratory diagnoses, 13.1% had feeding difficulties, 7.2% had sepsis, and 3.7% had seizures. Among those exposed to opioids who did not develop NAS, 11.8% had low birth weight, 11.6% were preterm, 10.1% had respiratory diagnoses, 2.6% had feeding difficulties, 2.3% had sepsis and 0.4% had seizures. Among unexposed newborns, 9.9% had low birth weight, 11% were preterm, 8.8% had respiratory diagnoses, 2.3% had feeding difficulties, 1.9% had sepsis, and 0.3% had seizures.

“Public health efforts should focus on limiting inappropriate [opioid pain relievers] and tobacco use in pregnancy,” the authors wrote. “Prescribing opioids in pregnancy should be done with caution because it can lead to significant complications for the neonate.”

The research was funded by the Tennessee Department of Health and the National Institutes of Health. The authors reported no disclosures.

Infants born to women taking prescription opioids were more likely to have neonatal abstinence syndrome (NAS) if their mothers smoked tobacco or took selective serotonin reuptake inhibitors (SSRIs), according to a recent study. Cumulative opioid exposure and opioid type (maintenance and long-acting) also increased the risk of NAS.

“The American Academy of Pediatrics recommends that all opioid-exposed infants be observed in the hospital for 4 to 7 days after birth. However, our data suggest there was a wide variability in an infant’s risk of drug withdrawal based on opioid type, dose, SSRI use, and number of cigarettes smoked per day by the mother,” reported Dr. Stephen W. Patrick of Vanderbilt University, Nashville, Tenn. “Future studies should evaluate new care models for opioid-exposed infants at different risk levels of developing NAS,” wrote Dr. Patrick and his associates [Pediatrics 2015 April 13 [doi: 10.1542/peds.2014-3299]).

Dr. Patrick’s team analyzed prescription data and vital statistics of 112,029 pregnant women and their newborns who were enrolled in the Tennessee Medicaid program between 2009 and 2011. Of these, 28% of the women filled at least one prescription for opioids; these included 96.2% taking short-acting medications, 2.7% receiving maintenance treatment for substance use disorders and 0.6% taking long-acting medications.

Among women taking prescription opioids, 5.3% had depression, 4.3% had an anxiety disorder, 41.8% smoked, 4.3% had been prescribed SSRIs within 30 days before birth, 8.3% had headache or migraine, and 23.7% had musculoskeletal disease, compared to 2.7%, 1.6% and 25.8%, 1.9%, 2.0% and 5.8%, respectively, for mothers not taking opioids.

Nearly a third of women on maintenance therapy (29.3%) had infants with NAS while 14.7% of mothers taking long-acting opioids and 1.4% of women taking short-acting preparations had newborns with NAS. Newborns were twice as likely to develop NAS if their mothers took SSRIs (odds ratio, 2.08), and their risk of NAS increased in a dose-response fashion with the number of daily cigarettes their mothers smoked.

NAS rates nearly doubled during the course of the study, landing at 10.7 per 1,000 births in the final year. Among the 1,086 newborns diagnosed with NAS, 21.2% had low birth weight, 16.7% were preterm, 28.7% had respiratory diagnoses, 13.1% had feeding difficulties, 7.2% had sepsis, and 3.7% had seizures. Among those exposed to opioids who did not develop NAS, 11.8% had low birth weight, 11.6% were preterm, 10.1% had respiratory diagnoses, 2.6% had feeding difficulties, 2.3% had sepsis and 0.4% had seizures. Among unexposed newborns, 9.9% had low birth weight, 11% were preterm, 8.8% had respiratory diagnoses, 2.3% had feeding difficulties, 1.9% had sepsis, and 0.3% had seizures.

“Public health efforts should focus on limiting inappropriate [opioid pain relievers] and tobacco use in pregnancy,” the authors wrote. “Prescribing opioids in pregnancy should be done with caution because it can lead to significant complications for the neonate.”

The research was funded by the Tennessee Department of Health and the National Institutes of Health. The authors reported no disclosures.

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Key clinical point: Maintenance and long-acting prescription opioid use have higher risk of neonatal abstinence syndrome (NAS).

Major finding: In all, 29.3% of women on maintenance therapy, 14.7% of women on long-acting opioids and 1.4% of women on short-acting opioids had newborns with NAS; maternal tobacco use and selective serotonin reuptake inhibitor exposure increased the risk of NAS.

Data source: A retrospective review of prescriptions and vital statistics for 112,029 pregnant women and their newborns enrolled in the Tennessee Medicaid program between 2009 and 2011.

Disclosures: The research was funded by the Tennessee Department of Health and the National Institutes of Health. The authors reported no disclosures.

Pediatric BMI improves with motivational interviewing

Findings raise questions, point to integrated approach
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Pediatric BMI improves with motivational interviewing

Using an empathetic family-centered communication strategy known as motivated interviewing while counseling parents of young children with obesity resulted in greater improvements in children’s weight status over 2 years, a study found.

“This is among the first counseling interventions using MI [motivational interviewing] and delivered in primary care to yield significant effects on adiposity,” reported Kenneth Resnicow, Ph.D., of the University of Michigan in Ann Arbor, and his associates.

“Research is needed to determine the clinical significance and persistence of the BMI effects observed. Given the relatively modest dose, the intervention appears to have considerable dissemination potential, which can be explored in future studies,” they wrote (Pediatrics 2015 March 30 [doi:10.1542/peds.2014-1880]).

The researchers randomly assigned 42 pediatric practices to either usual care (n = 198) or one of two interventions for treating patients aged 2-8 years with a BMI between the 85th and 97th percentile. Only children without diabetes, prior specialist weight loss treatment, or chronic medical conditions, disorders, or syndromes were included. Practices were compensated with reimbursement and incentives for their participation. They were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings Network, composed of 1,676 practitioners from 712 practices with nationally representative patient populations.

Both interventions included the primary care providers’ receiving 2 days of in-person training in motivational interviewing and behavior therapy and then scheduling four counseling sessions with children’s parents. These providers also received a DVD training system focused on pediatric obesity. The second intervention group (n = 235) included a registered dietitian trained in motivational interviewing who scheduled six counseling sessions, in person or by phone with the parents.

Average baseline BMI percentile across all participating children was 91.9, with 60% white, 22% Hispanic, 7% black, and 6% Asian ethnicities. The 2-year follow-up data available for 71% of the children showed, after adjustment for confounders, an average BMI percentile of 90.3 in the usual care group, 88.1 in the group with motivational interviewing from providers only, and 87.1 in the group with providers’ and dietitians’ motivational interviewing: Mean changes from baseline in BMI percentile were 1.8, 3.8, and 4.9 across groups 1, 2, and 3. However, only the difference between the group with dietitians and the usual care group was statistically significant, even though few dietitians succeeded in completing all six counseling sessions with families. Difficulties encountered by the dietitians included family scheduling challenges and inadequate integration into the practice’s care team.

“One somewhat surprising finding was the relatively large BMI reduction in the usual care group: 1.8 BMI units. Although the effects on BMI observed in group 2 [physicians only providing motivational interviewing] were slightly better than the usual care group, they were not statistically significant. Had the usual care group exhibited the degree of change we expected, then these effects would have achieved statistical significance,” the investigators said.

The National Heart, Lung and Blood Institute, the U.S. Health Resources and Services Administration Maternal and Child Health Bureau and the American Academy of Pediatrics funded the research. The authors reported no disclosures.

References

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Recommendations for preventing and treating pediatric obesity suggest a staged approach with escalating intensity of care. Outcomes of clinical interventions for pediatric obesity are variable. In primary care settings, some interventions promote changes in diet, physical activity or television viewing, but do not achieve reductions in BMI; others have favorable, albeit sometimes small, effects on BMI. Although effective for certain patients/families, weight management clinics often are not feasible because of barriers associated with accessibility, transportation, and cost. Clearly, novel approaches are necessary to enhance interventions in primary care settings. The trial reported by Resnicow et al. in this issue of Pediatrics provides impressive data on the effectiveness of motivational interviewing (MI) to reduce BMI in primary care.

Several components of the trial reported by Resnicow et al. provide impetus for asking important questions when developing integrated care models for treating pediatric obesity. What linkages can be established between primary care practices and weight management clinics to coordinate care with obesity specialists (psychologist, dietitian, physicians) when necessary? Linkages must extend beyond referrals and notes in electronic medical records to systems for training, ongoing consultation, and possible comanagement. How can PCPs facilitate access to specialty colleagues for collaboration? Emerging communication technology could support such enhanced access. How can we ensure adequate and efficient “handoffs” among members of a team in different settings? How can interaction with community partners be extended, beyond PCPs advising patients to use programs, to obtaining updates on progress of individual patients?

Clearly, answers to these questions require collaboration among numerous stakeholders. Substantial effort must be directed toward coordinating care across settings to integrate services centered on the comprehensive needs of patients/families and measuring performance of care-coordination activities.

Cara B. Ebbeling, Ph.D., of the New Balance Foundation Obesity Prevention Center, at Boston Children’s Hospital, and Richard C. Antonelli, M.D. of Boston Children’s Hospital. These comments are excerpted from an editorial accompanying Dr. Resnicow and associates’ study (Pediatrics 2015 March 30 [doi:10.1542/peds.2015-0495]). The editorial was supported by the New Balance Foundation, but the authors had no relevant financial disclosures.

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Recommendations for preventing and treating pediatric obesity suggest a staged approach with escalating intensity of care. Outcomes of clinical interventions for pediatric obesity are variable. In primary care settings, some interventions promote changes in diet, physical activity or television viewing, but do not achieve reductions in BMI; others have favorable, albeit sometimes small, effects on BMI. Although effective for certain patients/families, weight management clinics often are not feasible because of barriers associated with accessibility, transportation, and cost. Clearly, novel approaches are necessary to enhance interventions in primary care settings. The trial reported by Resnicow et al. in this issue of Pediatrics provides impressive data on the effectiveness of motivational interviewing (MI) to reduce BMI in primary care.

Several components of the trial reported by Resnicow et al. provide impetus for asking important questions when developing integrated care models for treating pediatric obesity. What linkages can be established between primary care practices and weight management clinics to coordinate care with obesity specialists (psychologist, dietitian, physicians) when necessary? Linkages must extend beyond referrals and notes in electronic medical records to systems for training, ongoing consultation, and possible comanagement. How can PCPs facilitate access to specialty colleagues for collaboration? Emerging communication technology could support such enhanced access. How can we ensure adequate and efficient “handoffs” among members of a team in different settings? How can interaction with community partners be extended, beyond PCPs advising patients to use programs, to obtaining updates on progress of individual patients?

Clearly, answers to these questions require collaboration among numerous stakeholders. Substantial effort must be directed toward coordinating care across settings to integrate services centered on the comprehensive needs of patients/families and measuring performance of care-coordination activities.

Cara B. Ebbeling, Ph.D., of the New Balance Foundation Obesity Prevention Center, at Boston Children’s Hospital, and Richard C. Antonelli, M.D. of Boston Children’s Hospital. These comments are excerpted from an editorial accompanying Dr. Resnicow and associates’ study (Pediatrics 2015 March 30 [doi:10.1542/peds.2015-0495]). The editorial was supported by the New Balance Foundation, but the authors had no relevant financial disclosures.

Body

Recommendations for preventing and treating pediatric obesity suggest a staged approach with escalating intensity of care. Outcomes of clinical interventions for pediatric obesity are variable. In primary care settings, some interventions promote changes in diet, physical activity or television viewing, but do not achieve reductions in BMI; others have favorable, albeit sometimes small, effects on BMI. Although effective for certain patients/families, weight management clinics often are not feasible because of barriers associated with accessibility, transportation, and cost. Clearly, novel approaches are necessary to enhance interventions in primary care settings. The trial reported by Resnicow et al. in this issue of Pediatrics provides impressive data on the effectiveness of motivational interviewing (MI) to reduce BMI in primary care.

Several components of the trial reported by Resnicow et al. provide impetus for asking important questions when developing integrated care models for treating pediatric obesity. What linkages can be established between primary care practices and weight management clinics to coordinate care with obesity specialists (psychologist, dietitian, physicians) when necessary? Linkages must extend beyond referrals and notes in electronic medical records to systems for training, ongoing consultation, and possible comanagement. How can PCPs facilitate access to specialty colleagues for collaboration? Emerging communication technology could support such enhanced access. How can we ensure adequate and efficient “handoffs” among members of a team in different settings? How can interaction with community partners be extended, beyond PCPs advising patients to use programs, to obtaining updates on progress of individual patients?

Clearly, answers to these questions require collaboration among numerous stakeholders. Substantial effort must be directed toward coordinating care across settings to integrate services centered on the comprehensive needs of patients/families and measuring performance of care-coordination activities.

Cara B. Ebbeling, Ph.D., of the New Balance Foundation Obesity Prevention Center, at Boston Children’s Hospital, and Richard C. Antonelli, M.D. of Boston Children’s Hospital. These comments are excerpted from an editorial accompanying Dr. Resnicow and associates’ study (Pediatrics 2015 March 30 [doi:10.1542/peds.2015-0495]). The editorial was supported by the New Balance Foundation, but the authors had no relevant financial disclosures.

Title
Findings raise questions, point to integrated approach
Findings raise questions, point to integrated approach

Using an empathetic family-centered communication strategy known as motivated interviewing while counseling parents of young children with obesity resulted in greater improvements in children’s weight status over 2 years, a study found.

“This is among the first counseling interventions using MI [motivational interviewing] and delivered in primary care to yield significant effects on adiposity,” reported Kenneth Resnicow, Ph.D., of the University of Michigan in Ann Arbor, and his associates.

“Research is needed to determine the clinical significance and persistence of the BMI effects observed. Given the relatively modest dose, the intervention appears to have considerable dissemination potential, which can be explored in future studies,” they wrote (Pediatrics 2015 March 30 [doi:10.1542/peds.2014-1880]).

The researchers randomly assigned 42 pediatric practices to either usual care (n = 198) or one of two interventions for treating patients aged 2-8 years with a BMI between the 85th and 97th percentile. Only children without diabetes, prior specialist weight loss treatment, or chronic medical conditions, disorders, or syndromes were included. Practices were compensated with reimbursement and incentives for their participation. They were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings Network, composed of 1,676 practitioners from 712 practices with nationally representative patient populations.

Both interventions included the primary care providers’ receiving 2 days of in-person training in motivational interviewing and behavior therapy and then scheduling four counseling sessions with children’s parents. These providers also received a DVD training system focused on pediatric obesity. The second intervention group (n = 235) included a registered dietitian trained in motivational interviewing who scheduled six counseling sessions, in person or by phone with the parents.

Average baseline BMI percentile across all participating children was 91.9, with 60% white, 22% Hispanic, 7% black, and 6% Asian ethnicities. The 2-year follow-up data available for 71% of the children showed, after adjustment for confounders, an average BMI percentile of 90.3 in the usual care group, 88.1 in the group with motivational interviewing from providers only, and 87.1 in the group with providers’ and dietitians’ motivational interviewing: Mean changes from baseline in BMI percentile were 1.8, 3.8, and 4.9 across groups 1, 2, and 3. However, only the difference between the group with dietitians and the usual care group was statistically significant, even though few dietitians succeeded in completing all six counseling sessions with families. Difficulties encountered by the dietitians included family scheduling challenges and inadequate integration into the practice’s care team.

“One somewhat surprising finding was the relatively large BMI reduction in the usual care group: 1.8 BMI units. Although the effects on BMI observed in group 2 [physicians only providing motivational interviewing] were slightly better than the usual care group, they were not statistically significant. Had the usual care group exhibited the degree of change we expected, then these effects would have achieved statistical significance,” the investigators said.

The National Heart, Lung and Blood Institute, the U.S. Health Resources and Services Administration Maternal and Child Health Bureau and the American Academy of Pediatrics funded the research. The authors reported no disclosures.

Using an empathetic family-centered communication strategy known as motivated interviewing while counseling parents of young children with obesity resulted in greater improvements in children’s weight status over 2 years, a study found.

“This is among the first counseling interventions using MI [motivational interviewing] and delivered in primary care to yield significant effects on adiposity,” reported Kenneth Resnicow, Ph.D., of the University of Michigan in Ann Arbor, and his associates.

“Research is needed to determine the clinical significance and persistence of the BMI effects observed. Given the relatively modest dose, the intervention appears to have considerable dissemination potential, which can be explored in future studies,” they wrote (Pediatrics 2015 March 30 [doi:10.1542/peds.2014-1880]).

The researchers randomly assigned 42 pediatric practices to either usual care (n = 198) or one of two interventions for treating patients aged 2-8 years with a BMI between the 85th and 97th percentile. Only children without diabetes, prior specialist weight loss treatment, or chronic medical conditions, disorders, or syndromes were included. Practices were compensated with reimbursement and incentives for their participation. They were part of the American Academy of Pediatrics’ Pediatric Research in Office Settings Network, composed of 1,676 practitioners from 712 practices with nationally representative patient populations.

Both interventions included the primary care providers’ receiving 2 days of in-person training in motivational interviewing and behavior therapy and then scheduling four counseling sessions with children’s parents. These providers also received a DVD training system focused on pediatric obesity. The second intervention group (n = 235) included a registered dietitian trained in motivational interviewing who scheduled six counseling sessions, in person or by phone with the parents.

Average baseline BMI percentile across all participating children was 91.9, with 60% white, 22% Hispanic, 7% black, and 6% Asian ethnicities. The 2-year follow-up data available for 71% of the children showed, after adjustment for confounders, an average BMI percentile of 90.3 in the usual care group, 88.1 in the group with motivational interviewing from providers only, and 87.1 in the group with providers’ and dietitians’ motivational interviewing: Mean changes from baseline in BMI percentile were 1.8, 3.8, and 4.9 across groups 1, 2, and 3. However, only the difference between the group with dietitians and the usual care group was statistically significant, even though few dietitians succeeded in completing all six counseling sessions with families. Difficulties encountered by the dietitians included family scheduling challenges and inadequate integration into the practice’s care team.

“One somewhat surprising finding was the relatively large BMI reduction in the usual care group: 1.8 BMI units. Although the effects on BMI observed in group 2 [physicians only providing motivational interviewing] were slightly better than the usual care group, they were not statistically significant. Had the usual care group exhibited the degree of change we expected, then these effects would have achieved statistical significance,” the investigators said.

The National Heart, Lung and Blood Institute, the U.S. Health Resources and Services Administration Maternal and Child Health Bureau and the American Academy of Pediatrics funded the research. The authors reported no disclosures.

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Pediatric BMI improves with motivational interviewing
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Pediatric BMI improves with motivational interviewing
Legacy Keywords
motivational interviewing, counseling, BMI, children, obesity, overweight
Legacy Keywords
motivational interviewing, counseling, BMI, children, obesity, overweight
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FROM PEDIATRICS

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Inside the Article

Vitals

Key clinical point: Counseling with motivational interviewing improved pediatric body mass index.

Major finding: BMI percentile dropped 3.8-4.9 points with motivational interviewing, compared with 1.8 points with usual care.

Data source: A 2-year randomized controlled trial involving 42 pediatric practices treating 645 children, aged 2-8, with BMIs between the 85th and 97th percentiles.

Disclosures: The National Heart, Lung and Blood Institute, the U.S. Health Resources and Services Administration Maternal and Child Health Bureau, and the American Academy of Pediatrics funded the research. The authors reported no relevant financial disclosures.