State e-cigarette laws linked to reduced youth use

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Several state regulations governing the sales or use of e-cigarettes and related products were associated with lower proportions of youth trying or regularly using vaping products, a new study found.

Restricting sales of electronic vapor products to minors, however, was not linked to a lower risk of vaping among teens.

Dr. Sarah A. Keim
“It may be too soon to tell if the state level restrictions are having an impact,” said lead author Sarah A. Keim, PhD, of Nationwide Children’s Hospital in Columbus, Ohio, in an interview. “However, it was reassuring to see these early indicators that they may be having an effect so early on, and so these findings were not surprising.”

Dr. Keim and her associates investigated possible associations between various state laws related to vaping products, all passed before 2015, and youth use of the products. They relied on 2015 data from 35 state-specific surveys of youth regarding use of vaping products and from the Youth Risk Behavior Survey from the Centers for Disease Control and Prevention, a nationally representative, biannual survey of students in grades 9-12. The Tobacco Control Laws Database of the American Nonsmokers’ Rights Foundation provided information on state laws related to electronic vapor products.

Among the 200,513 teens whose responses were included in the study, 44% had ever used any kind of electronic vapor product. Rates were similar between girls and boys for ever having tried one or currently using one, Dr. Keim reported at the Pediatric Academic Societies annual meeting.

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Experimentation began young for most: 35% of respondents tried an e-cigarette before age 14 years, and 18% under age 14 currently use vaping products. By age 17, half of all kids had tried an e-cigarette or related product, and a quarter were currently using them.

The researchers looked at associations with each of the following types of laws:

• Statewide prohibition of vaping products on school property or in workplaces, which includes Arizona, New Hampshire, Vermont, and Virginia for schools and North Dakota for workplaces.

• Prohibition of sales to minors under age 18 years, present in 24 states.

• Prohibition or restriction of sales of e-cigarette products from vending machines, present in 17 states.

• Prohibition or restriction of self-service displays of vaping products, present in 11 states.

• Prohibition or restriction of sampling of electronic vapor products, present in Arizona, Delaware, Kentucky, Maryland, New Hampshire, North Carolina, Oklahoma, and South Carolina.

 

 

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This report highlights how much we need to learn about e-cigarettes and consequences for all at-risk groups, including teens. Plus, we need to learn it FAST!
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This report highlights how much we need to learn about e-cigarettes and consequences for all at-risk groups, including teens. Plus, we need to learn it FAST!
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Dr. Susan Millard
This report highlights how much we need to learn about e-cigarettes and consequences for all at-risk groups, including teens. Plus, we need to learn it FAST!
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Comment by Dr. Susan Millard, MD, FCCP
Comment by Dr. Susan Millard, MD, FCCP

 

Several state regulations governing the sales or use of e-cigarettes and related products were associated with lower proportions of youth trying or regularly using vaping products, a new study found.

Restricting sales of electronic vapor products to minors, however, was not linked to a lower risk of vaping among teens.

Dr. Sarah A. Keim
“It may be too soon to tell if the state level restrictions are having an impact,” said lead author Sarah A. Keim, PhD, of Nationwide Children’s Hospital in Columbus, Ohio, in an interview. “However, it was reassuring to see these early indicators that they may be having an effect so early on, and so these findings were not surprising.”

Dr. Keim and her associates investigated possible associations between various state laws related to vaping products, all passed before 2015, and youth use of the products. They relied on 2015 data from 35 state-specific surveys of youth regarding use of vaping products and from the Youth Risk Behavior Survey from the Centers for Disease Control and Prevention, a nationally representative, biannual survey of students in grades 9-12. The Tobacco Control Laws Database of the American Nonsmokers’ Rights Foundation provided information on state laws related to electronic vapor products.

Among the 200,513 teens whose responses were included in the study, 44% had ever used any kind of electronic vapor product. Rates were similar between girls and boys for ever having tried one or currently using one, Dr. Keim reported at the Pediatric Academic Societies annual meeting.

Thinkstockphotos
Experimentation began young for most: 35% of respondents tried an e-cigarette before age 14 years, and 18% under age 14 currently use vaping products. By age 17, half of all kids had tried an e-cigarette or related product, and a quarter were currently using them.

The researchers looked at associations with each of the following types of laws:

• Statewide prohibition of vaping products on school property or in workplaces, which includes Arizona, New Hampshire, Vermont, and Virginia for schools and North Dakota for workplaces.

• Prohibition of sales to minors under age 18 years, present in 24 states.

• Prohibition or restriction of sales of e-cigarette products from vending machines, present in 17 states.

• Prohibition or restriction of self-service displays of vaping products, present in 11 states.

• Prohibition or restriction of sampling of electronic vapor products, present in Arizona, Delaware, Kentucky, Maryland, New Hampshire, North Carolina, Oklahoma, and South Carolina.

 

 

 

Several state regulations governing the sales or use of e-cigarettes and related products were associated with lower proportions of youth trying or regularly using vaping products, a new study found.

Restricting sales of electronic vapor products to minors, however, was not linked to a lower risk of vaping among teens.

Dr. Sarah A. Keim
“It may be too soon to tell if the state level restrictions are having an impact,” said lead author Sarah A. Keim, PhD, of Nationwide Children’s Hospital in Columbus, Ohio, in an interview. “However, it was reassuring to see these early indicators that they may be having an effect so early on, and so these findings were not surprising.”

Dr. Keim and her associates investigated possible associations between various state laws related to vaping products, all passed before 2015, and youth use of the products. They relied on 2015 data from 35 state-specific surveys of youth regarding use of vaping products and from the Youth Risk Behavior Survey from the Centers for Disease Control and Prevention, a nationally representative, biannual survey of students in grades 9-12. The Tobacco Control Laws Database of the American Nonsmokers’ Rights Foundation provided information on state laws related to electronic vapor products.

Among the 200,513 teens whose responses were included in the study, 44% had ever used any kind of electronic vapor product. Rates were similar between girls and boys for ever having tried one or currently using one, Dr. Keim reported at the Pediatric Academic Societies annual meeting.

Thinkstockphotos
Experimentation began young for most: 35% of respondents tried an e-cigarette before age 14 years, and 18% under age 14 currently use vaping products. By age 17, half of all kids had tried an e-cigarette or related product, and a quarter were currently using them.

The researchers looked at associations with each of the following types of laws:

• Statewide prohibition of vaping products on school property or in workplaces, which includes Arizona, New Hampshire, Vermont, and Virginia for schools and North Dakota for workplaces.

• Prohibition of sales to minors under age 18 years, present in 24 states.

• Prohibition or restriction of sales of e-cigarette products from vending machines, present in 17 states.

• Prohibition or restriction of self-service displays of vaping products, present in 11 states.

• Prohibition or restriction of sampling of electronic vapor products, present in Arizona, Delaware, Kentucky, Maryland, New Hampshire, North Carolina, Oklahoma, and South Carolina.

 

 

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Key clinical point: The two state laws associated with lower risks of teens trying or currently using e-cigarette products were prohibiting their use at school or work and prohibiting or restricting self-service displays.

Major finding: Reduced risk of trying or currently using vaping products among youth ranged from 5% to 13% in states with one or more laws related to vaping, depending on the law.

Data source: The findings are based on an analysis of 200,513 high school students’ use of electronic vapor products and their states’ laws regarding vaping use, marketing, or sales.

Disclosures: The research did not use any external funding, and Dr. Keim had no relevant financial disclosures.

Microneedle pretreatment shortened ALA incubation time

Microneedles poised to become increasingly valuable clinically
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Pretreatment with microneedles provided a faster, less painful, way to treat facial actinic keratoses (AKs) with photodynamic therapy, with similar clearance rates as would be expected with traditional therapy, in a study of 33 patients.

This approach reduced the incubation time of aminolevulinic acid (ALA) to 20 minutes, with comparable results to one-hour ALA incubation times. “Interestingly, the secondary outcome of pain associated with blue light exposure during photodynamic therapy was nominal and not significantly different from the sham side,” reported Tatyana A. Petukhova, MD, and her associates in the department of dermatology at the University of California, Davis (JAMA Dermatol. 2017 May 17. doi: 10.1001/jamadermatol.2017.0849).

“Pain associated with PDT is the most severe adverse effect and may lead to interruption or discontinuation of treatment, resulting in refusal to repeat the process at a future date owing to unbearable discomfort,” they wrote. Patients also reported little to no swelling or pain after treatment and minimal erythema and peeling.

The randomized, split-face, single-blinded controlled trial enrolled 33 patients, with at least eight AKs on their faces, from a university dermatology outpatient clinic from 2015 to 2016. They were randomized to receive either 10 minutes or 20 minutes incubation time with ALA, and 32 completed the study. Those in the 20-minute group had a mean of 25 grade II facial AKs, and those in the 10-minute group had an average of 31 grade II facial AKs.

Before administration of ALA, each patient received pretreatment with a microneedle roller on one side of their face and a sham roller on the other side. On each half of their faces, the microneedle device (a single-use sterile array of microneedles measuring 200 mcm) or sham roller was rolled forward and backward eight times in four directions.

They were exposed to blue light for 1,000 seconds at an average wavelength of 478 nm, an overall fluence of 10 J/cm2, and advised to avoid sun exposure for 36 hours after treatment.

At follow-up one month later, among the patients with a 20-minute ALA incubation time, the mean AK clearance rate was 76% on the side with microneedle pretreatment, compared with 58% on the sham side (P less than .01). This included three patients with complete clearance. The efficacy of microneedle pretreatment with a 20-minute incubation time is similar to that of 1-hour incubation times with ALA. PDT typically uses 1-4 hours of incubation time.

Among the patients who received a 10-minute ALA incubation time, a mean of 43% of AKs on the microneedle side and 38% on the sham side cleared, a difference that was not statistically significant. Participants did not rate the pain as significantly different between each side of their face and both groups reported low levels of pain overall.

One limitation of the study was the short follow-up time. “Because actinic damage is cumulative, there is potential for thicker AKs to recur or for new lesions to develop during a longer follow-up period,” the authors noted.

The research was partly funded by an author’s University of California, Davis, Medical Student Research Fellowship. The authors reported having no disclosures.

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The effectiveness of photodynamic therapy (PDT) as a field therapy option for actinic keratoses (AKs) has been well documented. However, treatment is limited by poor or variable transepidermal absorption owing to the hydrophilic nature of aminolevulinic acid (ALA).

To overcome the problem of transepidermal delivery, patients wait for hours at a time between ALA application and the light treatment. These prolonged incubation times limit usefulness. Petukhova et al. hypothesized that microneedles would enhance penetration and decrease incubation period without compromising safety and efficacy. The results suggest that an effective and safe PDT treatment can be achieved by using microneedles as means to expedite drug penetration. These results also suggest that further reduction of incubation time will not be achieved by better transepidermal penetration.

As envisioned in 1971, microneedles can have an important clinical role and can be an important tool in the dermatologist’s armamentarium. Microneedles are painless when compared with hypodermic needles, do not require specific training, minimize risk of needlestick injuries, can potentially reduce cost, and improve patient compliance and access. Therefore, microneedle-based devices can potentially be used at home by patients in a safe manner. Mostly in preclinical trials, as well as in some clinical trials, microneedles have been successfully used to deliver various drugs and vaccines.

Importantly, dermatologists are uniquely positioned to research this novel drug delivery method because they routinely treat cutaneous disease. This can be leveraged by dermatologists to use microneedles not only for dermal rejuvenation purposes but also to enhance drug delivery for dermatological indications. Therefore, the study by Petukhova et al. not only provides practical information for treatment of AKs with PDT but can also be viewed as a call for action to all dermatologists to lead innovation in the field and revolutionize dermatological drug delivery.

These comments are adapted from an accompanying editorial by Hadar Lev-Tov, MD, of the University of Florida, Miami. He reported having no disclosures.

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The effectiveness of photodynamic therapy (PDT) as a field therapy option for actinic keratoses (AKs) has been well documented. However, treatment is limited by poor or variable transepidermal absorption owing to the hydrophilic nature of aminolevulinic acid (ALA).

To overcome the problem of transepidermal delivery, patients wait for hours at a time between ALA application and the light treatment. These prolonged incubation times limit usefulness. Petukhova et al. hypothesized that microneedles would enhance penetration and decrease incubation period without compromising safety and efficacy. The results suggest that an effective and safe PDT treatment can be achieved by using microneedles as means to expedite drug penetration. These results also suggest that further reduction of incubation time will not be achieved by better transepidermal penetration.

As envisioned in 1971, microneedles can have an important clinical role and can be an important tool in the dermatologist’s armamentarium. Microneedles are painless when compared with hypodermic needles, do not require specific training, minimize risk of needlestick injuries, can potentially reduce cost, and improve patient compliance and access. Therefore, microneedle-based devices can potentially be used at home by patients in a safe manner. Mostly in preclinical trials, as well as in some clinical trials, microneedles have been successfully used to deliver various drugs and vaccines.

Importantly, dermatologists are uniquely positioned to research this novel drug delivery method because they routinely treat cutaneous disease. This can be leveraged by dermatologists to use microneedles not only for dermal rejuvenation purposes but also to enhance drug delivery for dermatological indications. Therefore, the study by Petukhova et al. not only provides practical information for treatment of AKs with PDT but can also be viewed as a call for action to all dermatologists to lead innovation in the field and revolutionize dermatological drug delivery.

These comments are adapted from an accompanying editorial by Hadar Lev-Tov, MD, of the University of Florida, Miami. He reported having no disclosures.

Body

 

The effectiveness of photodynamic therapy (PDT) as a field therapy option for actinic keratoses (AKs) has been well documented. However, treatment is limited by poor or variable transepidermal absorption owing to the hydrophilic nature of aminolevulinic acid (ALA).

To overcome the problem of transepidermal delivery, patients wait for hours at a time between ALA application and the light treatment. These prolonged incubation times limit usefulness. Petukhova et al. hypothesized that microneedles would enhance penetration and decrease incubation period without compromising safety and efficacy. The results suggest that an effective and safe PDT treatment can be achieved by using microneedles as means to expedite drug penetration. These results also suggest that further reduction of incubation time will not be achieved by better transepidermal penetration.

As envisioned in 1971, microneedles can have an important clinical role and can be an important tool in the dermatologist’s armamentarium. Microneedles are painless when compared with hypodermic needles, do not require specific training, minimize risk of needlestick injuries, can potentially reduce cost, and improve patient compliance and access. Therefore, microneedle-based devices can potentially be used at home by patients in a safe manner. Mostly in preclinical trials, as well as in some clinical trials, microneedles have been successfully used to deliver various drugs and vaccines.

Importantly, dermatologists are uniquely positioned to research this novel drug delivery method because they routinely treat cutaneous disease. This can be leveraged by dermatologists to use microneedles not only for dermal rejuvenation purposes but also to enhance drug delivery for dermatological indications. Therefore, the study by Petukhova et al. not only provides practical information for treatment of AKs with PDT but can also be viewed as a call for action to all dermatologists to lead innovation in the field and revolutionize dermatological drug delivery.

These comments are adapted from an accompanying editorial by Hadar Lev-Tov, MD, of the University of Florida, Miami. He reported having no disclosures.

Title
Microneedles poised to become increasingly valuable clinically
Microneedles poised to become increasingly valuable clinically

 

Pretreatment with microneedles provided a faster, less painful, way to treat facial actinic keratoses (AKs) with photodynamic therapy, with similar clearance rates as would be expected with traditional therapy, in a study of 33 patients.

This approach reduced the incubation time of aminolevulinic acid (ALA) to 20 minutes, with comparable results to one-hour ALA incubation times. “Interestingly, the secondary outcome of pain associated with blue light exposure during photodynamic therapy was nominal and not significantly different from the sham side,” reported Tatyana A. Petukhova, MD, and her associates in the department of dermatology at the University of California, Davis (JAMA Dermatol. 2017 May 17. doi: 10.1001/jamadermatol.2017.0849).

“Pain associated with PDT is the most severe adverse effect and may lead to interruption or discontinuation of treatment, resulting in refusal to repeat the process at a future date owing to unbearable discomfort,” they wrote. Patients also reported little to no swelling or pain after treatment and minimal erythema and peeling.

The randomized, split-face, single-blinded controlled trial enrolled 33 patients, with at least eight AKs on their faces, from a university dermatology outpatient clinic from 2015 to 2016. They were randomized to receive either 10 minutes or 20 minutes incubation time with ALA, and 32 completed the study. Those in the 20-minute group had a mean of 25 grade II facial AKs, and those in the 10-minute group had an average of 31 grade II facial AKs.

Before administration of ALA, each patient received pretreatment with a microneedle roller on one side of their face and a sham roller on the other side. On each half of their faces, the microneedle device (a single-use sterile array of microneedles measuring 200 mcm) or sham roller was rolled forward and backward eight times in four directions.

They were exposed to blue light for 1,000 seconds at an average wavelength of 478 nm, an overall fluence of 10 J/cm2, and advised to avoid sun exposure for 36 hours after treatment.

At follow-up one month later, among the patients with a 20-minute ALA incubation time, the mean AK clearance rate was 76% on the side with microneedle pretreatment, compared with 58% on the sham side (P less than .01). This included three patients with complete clearance. The efficacy of microneedle pretreatment with a 20-minute incubation time is similar to that of 1-hour incubation times with ALA. PDT typically uses 1-4 hours of incubation time.

Among the patients who received a 10-minute ALA incubation time, a mean of 43% of AKs on the microneedle side and 38% on the sham side cleared, a difference that was not statistically significant. Participants did not rate the pain as significantly different between each side of their face and both groups reported low levels of pain overall.

One limitation of the study was the short follow-up time. “Because actinic damage is cumulative, there is potential for thicker AKs to recur or for new lesions to develop during a longer follow-up period,” the authors noted.

The research was partly funded by an author’s University of California, Davis, Medical Student Research Fellowship. The authors reported having no disclosures.

 

Pretreatment with microneedles provided a faster, less painful, way to treat facial actinic keratoses (AKs) with photodynamic therapy, with similar clearance rates as would be expected with traditional therapy, in a study of 33 patients.

This approach reduced the incubation time of aminolevulinic acid (ALA) to 20 minutes, with comparable results to one-hour ALA incubation times. “Interestingly, the secondary outcome of pain associated with blue light exposure during photodynamic therapy was nominal and not significantly different from the sham side,” reported Tatyana A. Petukhova, MD, and her associates in the department of dermatology at the University of California, Davis (JAMA Dermatol. 2017 May 17. doi: 10.1001/jamadermatol.2017.0849).

“Pain associated with PDT is the most severe adverse effect and may lead to interruption or discontinuation of treatment, resulting in refusal to repeat the process at a future date owing to unbearable discomfort,” they wrote. Patients also reported little to no swelling or pain after treatment and minimal erythema and peeling.

The randomized, split-face, single-blinded controlled trial enrolled 33 patients, with at least eight AKs on their faces, from a university dermatology outpatient clinic from 2015 to 2016. They were randomized to receive either 10 minutes or 20 minutes incubation time with ALA, and 32 completed the study. Those in the 20-minute group had a mean of 25 grade II facial AKs, and those in the 10-minute group had an average of 31 grade II facial AKs.

Before administration of ALA, each patient received pretreatment with a microneedle roller on one side of their face and a sham roller on the other side. On each half of their faces, the microneedle device (a single-use sterile array of microneedles measuring 200 mcm) or sham roller was rolled forward and backward eight times in four directions.

They were exposed to blue light for 1,000 seconds at an average wavelength of 478 nm, an overall fluence of 10 J/cm2, and advised to avoid sun exposure for 36 hours after treatment.

At follow-up one month later, among the patients with a 20-minute ALA incubation time, the mean AK clearance rate was 76% on the side with microneedle pretreatment, compared with 58% on the sham side (P less than .01). This included three patients with complete clearance. The efficacy of microneedle pretreatment with a 20-minute incubation time is similar to that of 1-hour incubation times with ALA. PDT typically uses 1-4 hours of incubation time.

Among the patients who received a 10-minute ALA incubation time, a mean of 43% of AKs on the microneedle side and 38% on the sham side cleared, a difference that was not statistically significant. Participants did not rate the pain as significantly different between each side of their face and both groups reported low levels of pain overall.

One limitation of the study was the short follow-up time. “Because actinic damage is cumulative, there is potential for thicker AKs to recur or for new lesions to develop during a longer follow-up period,” the authors noted.

The research was partly funded by an author’s University of California, Davis, Medical Student Research Fellowship. The authors reported having no disclosures.

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Key clinical point: Pretreatment with microneedles before a 20-minute incubation of aminolevulinic acid (ALA) and photodynamic therapy effectively cleared most facial actinic keratoses.

Major finding: The mean facial AK clearance rate one month after microneedle pretreatment and 20 minutes incubation of ALA was 76%.

Data source: The findings are based on a randomized, controlled, single-blinded study of 33 outpatients with actinic keratoses.

Disclosures: The research was partly funded by an author’s University of California, Davis, Medical Student Research Fellowship. The authors reported having no disclosures.

Marijuana-related visits to Colorado ED steadily increasing

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SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.

Dr. George Sam Wang
An estimated 7% of adolescents aged 12-17 years used marijuana in the past month in 2015, according to data from the National Survey on Drug Use and Health. That figure has remained fairly stable from 2004 through 2015, suggesting no effect from state legalization on national prevalence of use.

However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.

Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).

During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.

A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.

The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.

Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.

Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.

“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.

Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.

The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
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SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.

Dr. George Sam Wang
An estimated 7% of adolescents aged 12-17 years used marijuana in the past month in 2015, according to data from the National Survey on Drug Use and Health. That figure has remained fairly stable from 2004 through 2015, suggesting no effect from state legalization on national prevalence of use.

However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.

Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).

During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.

A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.

The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.

Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.

Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.

“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.

Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.

The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.

 

SAN FRANCISCO – Visits to the emergency department and urgent care by adolescents using marijuana in Colorado increased from 2005 to 2015, a retrospective study showed.

Dr. George Sam Wang
An estimated 7% of adolescents aged 12-17 years used marijuana in the past month in 2015, according to data from the National Survey on Drug Use and Health. That figure has remained fairly stable from 2004 through 2015, suggesting no effect from state legalization on national prevalence of use.

However, only eight states have legalized recreational use, and federal data may not reflect the reality within states with legalization. In Colorado, 8% of youth in that age range have used marijuana in the past month.

Dr. Wang and his colleagues therefore conducted a retrospective review of adolescent and young adult visits to the Children’s Hospital Colorado ED or any of the system’s urgent care clinics between January 2005 and December 2015. They included all individuals 13-21 years old who had a positive urine drug screen for marijuana or whose visit was coded for marijuana use (ICD-9 codes of 305.20, 969.6, or E854.1).

During those 11 years, 3,844 visits occurred, and the rate of visits related to cannabis increased from 2/1,000 emergency department/urgent care visits in 2009 to 4/1,000 in 2015. A little over half (55%) of the patients were male, and the average age was 16 years.

A nearly linear steady increase in the number of visits occurred over the study period, from 146 visits in 2005 to 639 visits in 2015. Similarly, the number of annual psychiatry evaluations increased fivefold, from 75 in 2005 to 394 in 2015. Two-thirds of the patients overall (66%) underwent a psychiatric evaluation.

The most common ICD codes reported were for unspecified cannabis use (50% of visits), unspecified episodic mood disorder (20%), and alcohol abuse (15%). Urine drug screens for alcohol were positive in 70% of the patients, while amphetamines, benzodiazepines, opiates, and cocaine were each present in 4% of the patients. Less than 1% had positive drug screens for phencyclidine, barbiturates, oxycodone, and 3,4-methylenedioxy-methamphetamine.

Close behind unspecified alcohol abuse were codes for suicidal ideation and depressive disorder, both noted in 14% of visits. Additional codes, present in 9%-12% of visits, included educational circumstance, ADHD, unspecified anxiety, unspecified asthma, and tobacco use disorder.

Just over half of all patients (53%) were discharged home. Approximately one-quarter (27%) were admitted, and 10% were transferred to another facility. Information was not provided for the remaining 10%.

“Targeted education and prevention strategies for marijuana use are necessary in the adolescent population to reduce the public health impact,” Dr. Wang said, adding that the ED should initiate behavioral health screenings and/or interventions, such as referral to treatment, with adolescents using marijuana.

Because the study was conducted at a tertiary care hospital in a state with legalized recreational marijuana, the findings are not likely generalizable, and the researchers relied only on ICD codes and drug screens without conducting full chart reviews. The data set also began 5 years after medical marijuana was legalized, precluding the ability to make in-state comparisons to when marijuana was completely illegal.

The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.
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Key clinical point: Visits to the ED and urgent care have steadily increased among adolescents using marijuana in a state with legal recreational marijuana.

Major finding: Visits related to cannabis increased from 2/1,000 ED and urgent care visits in 2009 to 4/1,000 in 2015.

Data source: A retrospective study from 2005 to 2015 of 3,844 Colorado ED and urgent care visits involving adolescents who used marijuana.

Disclosures: The study had no external funding. Dr. Wang disclosed he has a Colorado department of public health and environment (CDPHE) grant evaluating pharmacokinetics of cannabidiol in pediatric epilepsy patients. He also serves on a CDPHE advisory committee on health effects and impact of cannabis on public health and is a contributing author on related topics for UpToDate.

Preterm infants at high risk for RSV morbidity without immunoprophylaxis

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SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.

Dr. John DeVincenzo


Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.

Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).

New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).

This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.

Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.

Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.

The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.

Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.

A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.

AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
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SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.

Dr. John DeVincenzo


Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.

Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).

New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).

This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.

Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.

Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.

The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.

Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.

A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.

AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.

 

SAN FRANCISCO – Preterm infants born at 29-35 weeks’ gestation and hospitalized for respiratory syncytial virus (RSV) can experience particularly severe morbidity if they have not received immunoprophylaxis, according to new industry-funded research.

Dr. John DeVincenzo


Previous research has shown that preterm infants born at 35 weeks or less gestation have a higher risk of RSV-related hospitalizations and subsequent morbidity, and that monthly immunoprophylaxis reduced RSV-related hospitalization in high-risk infants, including preterm infants.

Until 2014, the American Academy of Pediatrics recommended respiratory syncytial virus (RSV) immunoprophylaxis for all preterm infants under 32 weeks’ gestation and for infants between 32-35 weeks with additional risk factors, such as chronic lung disease or cyanotic heart disease (Pediatrics. 2003 Dec;112[6]:1442-6).

New recommendations in 2014 restricted immunoprophylaxis to preterm infants younger than 29 weeks’ gestational age unless they had additional risk factors such as chronic lung disease or hemodynamically significant heart disease (Pediatrics. 2014 Aug. doi: 10.1542/peds.2014-1665).

This study compared outcomes among all preterm infants born at 29-35 weeks’ gestation who were hospitalized during RSV season (October-April) for at least 24 hours with laboratory-confirmed RSV and who had not received RSV immunoprophylaxis within the 35 days before symptom onset. The 1,378 infants were younger than age 12 months when they were hospitalized at one of 43 sites during the 2014-2015 RSV season or one of 42 sites in the 2015-2016 season.

Of the 702 preterm infants hospitalized in 2014-2015, 42% were admitted to intensive care, and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during the 2015-2016 season went to the ICU, and 19% required mechanical ventilation. One infant died of RSV in each season.

Throughout both seasons, more than three quarters (78%) of all RSV hospitalizations were infants younger than 6 months old. In 2014-2015, infants younger than 6 months accounted for 87% of all RSV admissions to the ICU and 92% of those needing mechanical ventilation. Similarly, young infants accounted for 81% of ICU admissions and 90% of RSV-related mechanical ventilation during the 2015-2016 season. Overall, preterm infants younger than 6 months old without immunoprophylaxis accounted for 84% of RSV-related ICU admissions and 91% of RSV-related mechanical ventilation.

The younger the infants were, the more likely they were to need ICU care and/or mechanical ventilation, the researchers found. Across both seasons, 56% of infants under 3 months old with RSV were admitted to the ICU, compared to 34% of those between 3 and 12 months old. Likewise, 29% of those under 3 months old and 10% of those between 3 and 12 months needed invasive mechanical ventilation.

Nearly half (46%) of all infants hospitalized for RSV had been discharged from their birth hospital within the previous 30 days, and 82% of all hospitalizations occurred within 2 months of birth discharge.

A cost analysis revealed that mean hospital charges for RSV-related hospitalizations of preterm infants ranged from $31,366 for 35-week gestation infants between ages 3-6 months to $122,301 for infants under 3 months old born between 29-32 weeks.

AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.
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Key clinical point: Preterm infants, particularly those younger than 3 months, can experience severe respiratory syncytial virus (RSV) illness without immunoprophylaxis.

Major finding: Of the 702 preterm infants hospitalized during 2014-2015, 42% went to the ICU and 20% needed invasive mechanical ventilation. Nearly half (48%) of the 676 infants admitted during 2015-2016 went to the ICU and 19% required mechanical ventilation.

Data source: An analysis of 1,378 preterm infants born at 29-35 weeks’ gestation and hospitalized at under 1 year for lab-confirmed RSV during the 2014-2015 and 2015-2016 RSV seasons.

Disclosures: AstraZeneca/MedImmune funded the study. Dr. DeVincenzo and a number of his colleagues have received grants/research support from AstraZeneca/MedImmune, and some of his colleagues are or were AstraZeneca employees.

HPV vaccine training video improved provider knowledge, confidence

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SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.

“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.

Dr. Maya Kumar
The video was completed before a two-dose schedule of the vaccine was approved for those under age 15 years by the Centers for Disease Control and Prevention, but it remains relevant to current providers. The video is publicly available on YouTube or can be viewed in nine shorter segments on the website of the American Academy of Pediatrics California Chapter 3.

Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.

“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.

She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.

The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.

The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.

Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.

Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).

Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).

The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.

Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).

Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.

Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
 

 

• Making a strong recommendation for the HPV vaccine.

• Discussing HPV vaccination again with a family who has previously declined it.

• Facilitating completion of a three-dose vaccine series once initiated.

• Presenting the HPV vaccine as a cancer-prevention vaccine.

• Addressing parental concerns about safety and side effects.

• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.

• Counseling about the need to routinely vaccinate boys against HPV.

• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.

“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.

She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.

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SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.

“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.

Dr. Maya Kumar
The video was completed before a two-dose schedule of the vaccine was approved for those under age 15 years by the Centers for Disease Control and Prevention, but it remains relevant to current providers. The video is publicly available on YouTube or can be viewed in nine shorter segments on the website of the American Academy of Pediatrics California Chapter 3.

Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.

“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.

She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.

The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.

The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.

Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.

Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).

Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).

The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.

Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).

Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.

Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
 

 

• Making a strong recommendation for the HPV vaccine.

• Discussing HPV vaccination again with a family who has previously declined it.

• Facilitating completion of a three-dose vaccine series once initiated.

• Presenting the HPV vaccine as a cancer-prevention vaccine.

• Addressing parental concerns about safety and side effects.

• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.

• Counseling about the need to routinely vaccinate boys against HPV.

• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.

“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.

She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.

 

SAN FRANCISCO – Showing pediatric providers a 22-minute online training video about the human papillomavirus (HPV) vaccine and how to counsel families on it improved the providers’ knowledge, attitudes, and confidence in recommending the vaccine, according to a study.

“This video may be a cost-effective way to train providers across the nation to strongly recommend the HPV vaccine, which may ultimately impact vaccination rates,” lead author Maya Kumar, MD, of the University of California, San Diego, said at the Pediatric Academic Societies meeting.

Dr. Maya Kumar
The video was completed before a two-dose schedule of the vaccine was approved for those under age 15 years by the Centers for Disease Control and Prevention, but it remains relevant to current providers. The video is publicly available on YouTube or can be viewed in nine shorter segments on the website of the American Academy of Pediatrics California Chapter 3.

Previous research has shown that one of the biggest obstacles to uptake of the HPV vaccine is the lack of a strong provider recommendation.

“Common reasons for this include inadequate knowledge of the impact of HPV-related disease, perceptions that the vaccine is less important for preteens or less important for boys, and discomfort with addressing parental concerns about the vaccine,” explained Dr. Kumar.

She therefore wanted to see whether a video addressing these concerns and knowledge gaps would improve providers’ knowledge, confidence, and their likelihood of strongly recommending the HPV vaccine to their clients.

The AAP California Chapter 3 created a 22-minute video that explains the burden of HPV-related disease, provides general information about the vaccine, and reviews common provider-related obstacles to vaccination (although not patient-related or systemic barriers). Then the video provides counseling strategies to help providers in improving HPV vaccine uptake at their clinic. Following the discussion of those strategies are eight clinical vignettes in which experienced pediatricians model those techniques with “patients” and “parents” played by actors.

The researchers then showed the video to 109 providers from four large pediatric practices in San Diego and the San Diego Immunization Coalition. The group included 47% of pediatricians and nurse practitioners, 25% of allied health professionals, 20% nurses and 7% of trainees.

Before viewing, the providers filled out a questionnaire assessing their knowledge and attitude toward the HPV vaccine and how they perceived their skill in recommending the vaccine. Then they filled out the same questionnaire after viewing the video.

Providers’ correct answers to questions on their knowledge about the vaccine all increased substantially after viewing the video. The biggest improvement was seen in response to the question about whether the vaccine’s efficacy changes with age. Before viewing the video, 49% of the providers knew that the immune response to the vaccine was stronger among younger recipients and that its efficacy dropped off as people reach their mid-20s. After seeing the video, 89% of providers correctly answered that question (P less than .01).

Another substantial improvement occurred for the question about HPV-related cancers’ prevalence in men. Before the video, 37% of providers answered correctly that a large proportion of these cancers do occur in men; after the video, 67% answered correctly (P less than .01).

The proportion of providers who correctly responded that HPV infects the majority of sexually active people increased from 85% to 90%. Similarly, those who knew HPV catch-up vaccination can be offered up until age 26 years increased from 88% to 96%, and those who knew HPV-related cancer is more prevalent than meningococcal disease increased from 91% to 97% (P less than .01 for all of these). The increase in providers who knew HPV infects the majority of sexually active people, from 85% to 97%, was the only one that didn’t reach statistical significance.

Similar improvements were seen in providers’ attitudes after viewing the video. On a Likert scale of 1 (strongly disagree) to 5 (strongly agree), statistically significant increases occurred for responding to whether it’s important to vaccinate girls against HPV (.07 increase) and the importance of the HPV vaccine for cancer protection rather than wart protection (.22 increase).

Likewise, statistically significant decreases occurred for whether it’s acceptable to delay the vaccine for a child before sexual debut (–0.38), whether it’s more important to give the Tdap and meningococcal vaccines than the HPV vaccines (–0.44), and whether the provider is concerned about short-term (–0.20) or long-term (–0.12) side effects of the vaccine.

Every one of the questions about providers’ skills improved statistically significantly, from increases of 0.19 to 0.66 points:
 

 

• Making a strong recommendation for the HPV vaccine.

• Discussing HPV vaccination again with a family who has previously declined it.

• Facilitating completion of a three-dose vaccine series once initiated.

• Presenting the HPV vaccine as a cancer-prevention vaccine.

• Addressing parental concerns about safety and side effects.

• Addressing parental concerns about HPV being sexually transmitted and the need to vaccinate before sexual debut.

• Counseling about the need to routinely vaccinate boys against HPV.

• Counseling about the rationale for routinely giving the HPV vaccine at age 11-12 years.

“There was positive feedback from the viewing providers, particularly about the use of clinical vignettes to model effective counseling strategies for recommending vaccination,” Dr. Kumar said.

She acknowledged that the results may not be generalizable to providers in other regions, and the study was unable to assess whether providers’ actual behavior or practice vaccination rates changed after viewing the video.

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Key clinical point: An online training video improved pediatric providers’ knowledge, attitudes, and confidence regarding the HPV vaccine.

Major finding: Statistically significant improvements occurred among providers for five questions on HPV vaccine knowledge, six questions about attitudes toward the vaccine, and all eight questions concerning self-assessed skills in counseling families about the vaccine.

Data source: The findings are based on a cohort of 109 California pediatric providers whose knowledge, attitudes, and self-reported skills were assessed before and after the intervention.

Disclosures: The study was funded by an American Academy of Pediatrics Adolescent Vaccinations and Wellness Education Grant, supported by Merck. Dr. Kumar had no relevant financial disclosures.

Asthma step-up therapy in children improves outcomes

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SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.

Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.

Dr. Dane Snyder
“In the setting of long-term medication nonadherence, strategies to step up pharmacotherapy, as opposed to working on medication adherence alone, may be beneficial in some patients,” Dr. Snyder told colleagues at the Pediatric Academic Societies meeting.

Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.

Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.

Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).

After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.

The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.

ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.

Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.

Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.

“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.

The research did not use external funding, and Dr. Snyder had no disclosures.
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SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.

Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.

Dr. Dane Snyder
“In the setting of long-term medication nonadherence, strategies to step up pharmacotherapy, as opposed to working on medication adherence alone, may be beneficial in some patients,” Dr. Snyder told colleagues at the Pediatric Academic Societies meeting.

Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.

Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.

Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).

After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.

The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.

ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.

Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.

Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.

“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.

The research did not use external funding, and Dr. Snyder had no disclosures.

 

SAN FRANCISCO – Stepping up pharmacotherapy in children with poorly controlled asthma resulted in fewer asthma-related emergency department (ED) visits and inpatient stays than maintaining current medication therapy, a study found.

Perhaps surprisingly, however, the patients with the worst outcomes were those who were told only to improve their medication adherence, said Dane Snyder, MD, a physician at Nationwide Children’s Hospital who is also in the department of pediatrics at Ohio State University, Columbus.

Dr. Dane Snyder
“In the setting of long-term medication nonadherence, strategies to step up pharmacotherapy, as opposed to working on medication adherence alone, may be beneficial in some patients,” Dr. Snyder told colleagues at the Pediatric Academic Societies meeting.

Asthma affects nearly 1 in 10 children, and national guidelines recommend step-up asthma pharmacotherapy in patients with poorly controlled asthma. The researchers assessed the impact of step-up therapy on inpatient care, and emergency and urgent care visits for children with poor asthma control in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio. More than 10,000 asthma patients are treated at the 12 clinics in the network, and the study was part of a quality improvement initiative starting in July 2015.

Between August and October 2015, researchers used documentation in a standard asthma note to identify 908 patients aged 2-18 years who had poor asthma control based on their Asthma Control Test (ACT) score and history. Of these patients, 463 with a mean ACT score of 15.8 were assigned to step-up pharmacotherapy, while 445 with a mean ACT of 16.2 were not. The two groups also were similar in their use of unscheduled health care utilization in the 12 months before the study period.

Over the next 12 months, 1.3% of patients receiving step-up therapy had inpatient stays, compared with 4% in the other group, translating to a 68% lower risk of admission with step-up therapy (relative risk, 0.316; P = .01). Those receiving step-up therapy also were 37% less likely to visit the ED for asthma, with 7.1% of ED visits for those with step-up therapy and 11.2% of visits for those without it (RR, 0.634; P = .032). Visits to urgent care, however, showed no significant difference between those receiving step-up therapy (10.8%) and those who had not (10.3%).

After comparing these findings, the researchers went back and manually reviewed all 463 charts of the group who received step-up therapy to determine whether the children actually did receive a step up in therapy. Nearly a quarter (23%) of the children in the intervention group simply resumed taking their previously prescribed mediation, and 8% took allergy medication. The remaining 69% had step-up therapy.

The researchers then reanalyzed the data among those who truly had step-up pharmacotherapy, those who did not, and those who resumed taking their prior medication. The difference in inpatient admissions remained the same because none of the children who had resumed medication were admitted.

ED visits showed a more gradual distribution: 7.3% of those receiving step-up therapy, 8.4% of those who resumed taking their medication, and 11% of those with no intervention went to the ED. But these differences did not reach statistical significance.

Similarly, the differences among the three groups in urgent care visits was not statistically significant, but 15% of those who resumed taking prior medication had urgent care visits, compared with 10.3% of those with step-up therapy and 9.2% of those in the control group.

Those findings suggest that “stepping up pharmacotherapy, even in the face of controller nonadherence, can improve outcomes,” Dr. Snyder told his colleagues.

“While challenging, management changes in a large primary care network are possible,” Dr. Snyder said. He also emphasized that manually auditing bulk data, as they did with the 463 records, can be important in assessing outcomes of quality improvement measures.

The research did not use external funding, and Dr. Snyder had no disclosures.
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Key clinical point: Stepping up asthma pharmacotherapy in children reduces inpatient admissions and ED visits.

Major finding: Children with poorly controlled asthma receiving step-up pharmacotherapy had a 68% lower risk of inpatient admission and 37% lower risk of emergency department visits for asthma (P less than .05).

Data source: The findings are based on a nonrandomized trial of 903 children, aged 2-18 years, tracked for 12 months in the Nationwide Children’s Hospital Primary Care Network in Columbus, Ohio.

Disclosures: The research did not use external funding, and Dr. Snyder had no disclosures.

Infants’ responses to multiple vaccines affected by maternal antibodies

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Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.

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The potential interference of prenatal vaccination programs with established infant immunization schedules suggests caution and a potential benefit in later-age immunization, the authors noted. But the clinical implications of these findings remain unclear given the complexity of developing and altering infant immunizations schedules.

“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.

Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).

Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.

“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.

The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.

The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.

All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.

Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.

“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”

For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.

The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.

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Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.

copyright itsmejust/Thinkstock
The potential interference of prenatal vaccination programs with established infant immunization schedules suggests caution and a potential benefit in later-age immunization, the authors noted. But the clinical implications of these findings remain unclear given the complexity of developing and altering infant immunizations schedules.

“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.

Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).

Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.

“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.

The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.

The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.

All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.

Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.

“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”

For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.

The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.

 

Maternal antibody concentrations continue to affect children’s immune response to their first and later vaccine doses as late as age 2 years, according to study findings.

copyright itsmejust/Thinkstock
The potential interference of prenatal vaccination programs with established infant immunization schedules suggests caution and a potential benefit in later-age immunization, the authors noted. But the clinical implications of these findings remain unclear given the complexity of developing and altering infant immunizations schedules.

“Our analysis comprehensively models the effects of maternal antibody inhibition and infant age at vaccination on the majority of vaccine antigens contained in current global infant immunization programs and reveals that, for almost all antigens, transplacental antibody inhibits the antibody response to priming vaccinations,” wrote Merryn Voysey of the University of Oxford (England), and her associates.

Booster doses do not diminish the effect, the authors add. “These analyses further reveal the benefit of infants being older when first immunized, an association that remains after adjusting for waning maternal antibody levels” (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0638).

Although the blunting from maternal antibodies has been long understood for the measles vaccine, this new study showed that even conjugate vaccines have this blunting in infancy, both due to “preexisting antibodies to the polysaccharide antigen [and] from antibodies associated with carrier proteins,” the authors wrote, referring to findings related to pneumococcal conjugate vaccines.

“Therefore, prenatal immunization programs containing multicomponent vaccines have the potential to interfere with the immunogenicity of current immunization programs,” Ms. Voysey and her colleagues wrote.

The authors requested and then analyzed deidentified participant data from GlaxoSmithKline vaccine immunogenicity clinical trials in which antibody concentration data were available before and after infants’ first vaccine dose. The analysis included 7,630 infants enrolled in 32 studies in 17 countries from Europe, Africa, Latin America, East Asia, Russia, and Australia. About half were boys, and infants’ mean age at baseline was 9 weeks.

The researchers found that infants’ antibody responses were blunted for 20 of 21 antigens due to maternal antibodies they still had. The inactivated polio vaccine was affected the most: a maternal antibody twice as high as other infants’ resulted in a 20% lower antibody geometric mean ratio for type 1 and a 28% lower antibody geometric mean ratio for type 2 after vaccination.

All three vaccines in the DTaP showed inhibited responses as well. Having twice as high a maternal antibody for acellular pertussis antigens resulted in an 11% reduction in infants’ antibody for both pertussis toxoid and filamentous hemagglutinin. Antibody for pertactin was 22% lower. Double the maternal antibody for tetanus translated to 13% lower response, and diphtheria antibody was similarly 24% lower.

Even at 12-24 months, children showed a blunted response due to maternal antibodies for the acellular pertussis, inactivated polio, and diphtheria vaccines. For each additional month of age children were when first immunized, their antibody response ranged from 10%-71% greater for 18 of 21 antigens, after accounting for the influence of maternal antibodies.

“In contrast to previous reports, the effects of maternal antibodies and the infant’s age when first immunized are not only seen in response to a priming series of vaccines, but continue to affect antibody responses to booster vaccinations at ages 12 to 24 months for many antigens,” the authors reported. “This finding suggests the importance of the quality of the immune response to the first dose of antigen, regardless of subsequent doses.”

For example, delaying administration of a first vaccine dose by 2-5 weeks resulted in offsetting a two- to fivefold greater concentration of maternal pertussis antibodies. To offset similarly higher maternal antibody concentrations for the other components of the DTaP would require a delay of 3-6 weeks for diphtheria and 2-4 weeks for tetanus.

The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.

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Key clinical point: Maternal antibodies influence infant response to immunizations for up to 24 months.

Major finding: Infants’ antibody concentrations after vaccination were inhibited for 20 of 21 antigens after a first dose and for 18 of 21 antigens up to 24 months later.

Data source: The findings are based on an analysis of pre- and postimmunization antibody concentrations to 21 vaccine antigens in 7,630 infants enrolled in 32 immunogenicity clinical studies in 17 countries.

Disclosures: The research funding came from the National Institute for Health Research via a fellowship of one author and salary support of another. Ms. Voysey had no relevant financial disclosures. Most of her colleagues received research grants or other assistance from pharmaceutical companies.

BMI z scores less accurate for teen obesity than new measure

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A different measurement tool than body mass index (BMI) z scores was more accurate in assessing adolescents’ body fat percentage than BMI z scores, a study found.

Michail_Petrov-96/Thinkstock
“TMI requires only a single threshold for each sex, instead of the multiple complicated age- and sex-specific thresholds needed for BMI to work in adolescents,” reported Courtney M. Peterson, PhD, of the University of Alabama at Birmingham, and her associates.

They suggest that TMI therefore may be superior to BMI or BMI z scores in assessing adolescents’ weight at least among non-Hispanic whites, although further studies would need to assess TMI as an assessment tool in other racial/ethnic groups.

The standard formula for adult BMI – weight in kilograms divided by height in meters squared – has been known to be inappropriate for children and teens for more than a century because their proportions change with age. The currently established alternative of using youth’s BMI percentiles for their age in the BMI z system, however, “fails to take into account that both body proportions and body fat levels change during adolescent growth in a way that is inconsistent with BMI,” the authors wrote (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0460).

They therefore explored other methods of assessing appropriate weight ranges for adolescents and compared them with BMI, using dual-energy x-ray absorptiometry findings and anthropometric data collected from 4,398 non-Hispanic white participants, aged 8-29 years, in U.S. National Health and Nutrition Examination Surveys (NHANES) from 1999 to 2006.

Dr. Peterson’s team first evaluated the value of using BMI by looking at the following:

• How percent body fat influences the timing of the adolescent growth spurt in height.

• How percent body fat varies by age.

• How body proportions scale during adolescence.

Then they explored changing the exponent in the weight-to-height formula to see which alternatives might result in a measurement that’s more stable with an individuals’ age, more accurate in estimating body fat percentage, and more accurate in identifying which youths are overweight.

“In girls and women, percent body fat increased with age and reached a plateau by age 18 years, rising from a mean of 31.2% at age 8-9 years to 36.4% at ages 25-29 years (P less than .001),” the authors wrote. “By contrast, in boys and men, percent body fat decreased from a mean of 27.8%-23.0% between ages 12-13 years and 14-15 years (P less than .001) before stabilizing at approximately 25%-26% for ages 20 years and older.”

Because variations in body fat percentage occurred with both age and height in adolescence, Dr. Peterson and her associates concluded that the usual BMI weight-to-height formula is not ideal for assessing body fat in youth. The better alternative, they found, uses the formula of weight divided by height cubed (instead of squared), called triponderal mass index (TMI).

The threshold for overweight status with TMI was 16.0 kg/m3 for boys and 16.8 kg/m3 for girls. For obesity, the threshold was 18.8 kg/m3 for boys and 19.7 kg/m3 for girls. Using TMI instead of BMI resulted in improved stability with age and estimated percent body fat for those aged 8-17 years.

In addition, using BMI z scores misclassified 19.4% of adolescents as overweight instead of a healthy weight whereas TMI only misclassified 8.4% of youth as such in the same data set. BMI z scores also classified more youth as obese (11.3%), compared with TMI (8%).

The research was funded by the National Center for Advancing Translational Sciences and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. One investigator serves on the medical advisory boards for Medifast and Rice Lake Weighing System, unrelated to this study. Another investigator helped develop a trademarked smartphone weight loss intervention app called SmartLoss, whose licensing could benefit that investigator and Montclair State University.

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A different measurement tool than body mass index (BMI) z scores was more accurate in assessing adolescents’ body fat percentage than BMI z scores, a study found.

Michail_Petrov-96/Thinkstock
“TMI requires only a single threshold for each sex, instead of the multiple complicated age- and sex-specific thresholds needed for BMI to work in adolescents,” reported Courtney M. Peterson, PhD, of the University of Alabama at Birmingham, and her associates.

They suggest that TMI therefore may be superior to BMI or BMI z scores in assessing adolescents’ weight at least among non-Hispanic whites, although further studies would need to assess TMI as an assessment tool in other racial/ethnic groups.

The standard formula for adult BMI – weight in kilograms divided by height in meters squared – has been known to be inappropriate for children and teens for more than a century because their proportions change with age. The currently established alternative of using youth’s BMI percentiles for their age in the BMI z system, however, “fails to take into account that both body proportions and body fat levels change during adolescent growth in a way that is inconsistent with BMI,” the authors wrote (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0460).

They therefore explored other methods of assessing appropriate weight ranges for adolescents and compared them with BMI, using dual-energy x-ray absorptiometry findings and anthropometric data collected from 4,398 non-Hispanic white participants, aged 8-29 years, in U.S. National Health and Nutrition Examination Surveys (NHANES) from 1999 to 2006.

Dr. Peterson’s team first evaluated the value of using BMI by looking at the following:

• How percent body fat influences the timing of the adolescent growth spurt in height.

• How percent body fat varies by age.

• How body proportions scale during adolescence.

Then they explored changing the exponent in the weight-to-height formula to see which alternatives might result in a measurement that’s more stable with an individuals’ age, more accurate in estimating body fat percentage, and more accurate in identifying which youths are overweight.

“In girls and women, percent body fat increased with age and reached a plateau by age 18 years, rising from a mean of 31.2% at age 8-9 years to 36.4% at ages 25-29 years (P less than .001),” the authors wrote. “By contrast, in boys and men, percent body fat decreased from a mean of 27.8%-23.0% between ages 12-13 years and 14-15 years (P less than .001) before stabilizing at approximately 25%-26% for ages 20 years and older.”

Because variations in body fat percentage occurred with both age and height in adolescence, Dr. Peterson and her associates concluded that the usual BMI weight-to-height formula is not ideal for assessing body fat in youth. The better alternative, they found, uses the formula of weight divided by height cubed (instead of squared), called triponderal mass index (TMI).

The threshold for overweight status with TMI was 16.0 kg/m3 for boys and 16.8 kg/m3 for girls. For obesity, the threshold was 18.8 kg/m3 for boys and 19.7 kg/m3 for girls. Using TMI instead of BMI resulted in improved stability with age and estimated percent body fat for those aged 8-17 years.

In addition, using BMI z scores misclassified 19.4% of adolescents as overweight instead of a healthy weight whereas TMI only misclassified 8.4% of youth as such in the same data set. BMI z scores also classified more youth as obese (11.3%), compared with TMI (8%).

The research was funded by the National Center for Advancing Translational Sciences and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. One investigator serves on the medical advisory boards for Medifast and Rice Lake Weighing System, unrelated to this study. Another investigator helped develop a trademarked smartphone weight loss intervention app called SmartLoss, whose licensing could benefit that investigator and Montclair State University.

 

A different measurement tool than body mass index (BMI) z scores was more accurate in assessing adolescents’ body fat percentage than BMI z scores, a study found.

Michail_Petrov-96/Thinkstock
“TMI requires only a single threshold for each sex, instead of the multiple complicated age- and sex-specific thresholds needed for BMI to work in adolescents,” reported Courtney M. Peterson, PhD, of the University of Alabama at Birmingham, and her associates.

They suggest that TMI therefore may be superior to BMI or BMI z scores in assessing adolescents’ weight at least among non-Hispanic whites, although further studies would need to assess TMI as an assessment tool in other racial/ethnic groups.

The standard formula for adult BMI – weight in kilograms divided by height in meters squared – has been known to be inappropriate for children and teens for more than a century because their proportions change with age. The currently established alternative of using youth’s BMI percentiles for their age in the BMI z system, however, “fails to take into account that both body proportions and body fat levels change during adolescent growth in a way that is inconsistent with BMI,” the authors wrote (JAMA Pediatrics. 2017 May 15. doi: 10.1001/jamapediatrics.2017.0460).

They therefore explored other methods of assessing appropriate weight ranges for adolescents and compared them with BMI, using dual-energy x-ray absorptiometry findings and anthropometric data collected from 4,398 non-Hispanic white participants, aged 8-29 years, in U.S. National Health and Nutrition Examination Surveys (NHANES) from 1999 to 2006.

Dr. Peterson’s team first evaluated the value of using BMI by looking at the following:

• How percent body fat influences the timing of the adolescent growth spurt in height.

• How percent body fat varies by age.

• How body proportions scale during adolescence.

Then they explored changing the exponent in the weight-to-height formula to see which alternatives might result in a measurement that’s more stable with an individuals’ age, more accurate in estimating body fat percentage, and more accurate in identifying which youths are overweight.

“In girls and women, percent body fat increased with age and reached a plateau by age 18 years, rising from a mean of 31.2% at age 8-9 years to 36.4% at ages 25-29 years (P less than .001),” the authors wrote. “By contrast, in boys and men, percent body fat decreased from a mean of 27.8%-23.0% between ages 12-13 years and 14-15 years (P less than .001) before stabilizing at approximately 25%-26% for ages 20 years and older.”

Because variations in body fat percentage occurred with both age and height in adolescence, Dr. Peterson and her associates concluded that the usual BMI weight-to-height formula is not ideal for assessing body fat in youth. The better alternative, they found, uses the formula of weight divided by height cubed (instead of squared), called triponderal mass index (TMI).

The threshold for overweight status with TMI was 16.0 kg/m3 for boys and 16.8 kg/m3 for girls. For obesity, the threshold was 18.8 kg/m3 for boys and 19.7 kg/m3 for girls. Using TMI instead of BMI resulted in improved stability with age and estimated percent body fat for those aged 8-17 years.

In addition, using BMI z scores misclassified 19.4% of adolescents as overweight instead of a healthy weight whereas TMI only misclassified 8.4% of youth as such in the same data set. BMI z scores also classified more youth as obese (11.3%), compared with TMI (8%).

The research was funded by the National Center for Advancing Translational Sciences and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. One investigator serves on the medical advisory boards for Medifast and Rice Lake Weighing System, unrelated to this study. Another investigator helped develop a trademarked smartphone weight loss intervention app called SmartLoss, whose licensing could benefit that investigator and Montclair State University.

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Key clinical point: TMI is more accurate at assessing adolescents’ body fat percentage than body mass index z scores in non-Hispanic whites.

Major finding: 19.4% of youth aged 8-17 were misclassified as overweight using BMI, compared with 8.4% using TMI.

Data source: The findings are based on an analysis of data on 4,398 non-Hispanic white participants, aged 8-29 years, surveyed in the U.S. National Health and Nutrition Examination Surveys from 1999 to 2006.

Disclosures: The research was funded by the National Center for Advancing Translational Sciences and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. One investigator serves on the medical advisory boards for Medifast and Rice Lake Weighing System, unrelated to this study. Another investigator helped develop a trademarked smartphone weight loss intervention app called SmartLoss, whose licensing could benefit that investigator and Montclair State University.

Children’s asthma risk reduced with prenatal vitamin D supplementation

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SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.

At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.

Dr. Augusto Litonjua
Previous research already has suggested that vitamin D deficiency, particularly during pregnancy, may contribute to increasing incidence of asthma through a variety of potential mechanisms, explained lead author Augusto Litonjua, MD, of the Harvard Medical School and Brigham and Women’s Hospital in Boston. These mechanisms include possible effects from insufficient vitamin D on lung growth, the microbiome, and immune cell development and regulations.

However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.

The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.

The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.

Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.

Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.

At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).

“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.

The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.

“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.

The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
 

 

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SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.

At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.

Dr. Augusto Litonjua
Previous research already has suggested that vitamin D deficiency, particularly during pregnancy, may contribute to increasing incidence of asthma through a variety of potential mechanisms, explained lead author Augusto Litonjua, MD, of the Harvard Medical School and Brigham and Women’s Hospital in Boston. These mechanisms include possible effects from insufficient vitamin D on lung growth, the microbiome, and immune cell development and regulations.

However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.

The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.

The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.

Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.

Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.

At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).

“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.

The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.

“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.

The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
 

 

 

SAN FRANCISCO – Vitamin D supplementation during pregnancy may reduce the incidence of asthma or allergies in children at high risk for atopic disease, a study showed.

At age 3 years, asthma or recurrent wheeze occurred in 24% of children born to mothers with substantial vitamin D3 supplementation in pregnancy, compared with 30% of children whose mothers took a placebo during pregnancy.

Dr. Augusto Litonjua
Previous research already has suggested that vitamin D deficiency, particularly during pregnancy, may contribute to increasing incidence of asthma through a variety of potential mechanisms, explained lead author Augusto Litonjua, MD, of the Harvard Medical School and Brigham and Women’s Hospital in Boston. These mechanisms include possible effects from insufficient vitamin D on lung growth, the microbiome, and immune cell development and regulations.

However, observational study findings on vitamin D deficiency in pregnancy and asthma risk have been mixed, with no effect seen in research using measurements of 25OHD levels, despite protective effects seen in studies estimating vitamin D intake based on diet. Dr. Litonjua, therefore, led a randomized, controlled trial at three clinical centers to test whether vitamin D supplementation in pregnancy could prevent children at high risk of asthma from developing the condition. High-risk status was based on the presence of maternal and/or paternal asthma, allergic rhinitis, or eczema.

The 881 initial participants, enrolled between October 2009 and January 2015, were randomized to receive either 4,000 IU daily of vitamin D3 (440 women) or a placebo daily (436 women). Both groups took a multivitamin that contained 400 IU of vitamin D3. The participants included 43% black women, 26% white women, 14% Hispanic women, and 17% of other races/ethnicities.

The researchers collected maternal blood at the start of the study, between 32 and 38 weeks’ post partum, and at 1-year post partum. They collected cord blood at birth and then children’s blood at 1, 3, and 6 years old. At the third trimester, 87% of the women in the intervention group and 72% of the control group women had at least 50 nmol/L of 25OHD. Levels of at least 75 nmol/L were present in 75% of the intervention group and 35% of the control group in the third trimester.

Primary follow-up occurred at 3 years old with continuing follow-up through 6 years old, but data also were collected every 3 months regarding asthma and allergy symptoms and environmental exposures and diet. Stool was collected for microbiome analysis at 6 months, 1 year, and 3 years, and then annually after age 3 years. Children’s lung function was assessed with impulse oscillometry annually starting at age 4 years, with spirometry annually starting at age 5 years, and with bronchodilator response at age 6 years, Dr. Litonjua reported at the Pediatric Academic Societies meeting.

Just over one-quarter (27%) of the 806 children included in the final analysis had parental report of either an asthma diagnosis or recurrent wheeze, defined using any of five criteria involving multiple wheeze reports and/or use of an asthma controller. Rates of asthma or wheeze were significantly lower in children of women supplemented with 4,400 IU of vitamin D than in those born to women in the control group.

At age 1 year, the rate of asthma or wheeze among children from the intervention group was 9 percentage points lower than that of children from the control group, a 36% reduction. By age 2 years, the rate difference was 7%, a 25% reduced risk for intervention children, compared with control children. Children from the intervention group had a 20% lower risk of asthma or wheeze at age 3 years than those from the control group, with a rate difference of 6% (P = .051).

“Both maternal baseline 25OHD levels and third-trimester 25OHD levels were inversely associated with asthma/recurrent wheeze by age 3 years,” Dr. Litonjua reported, and relative risk at age 3 years was identical in black and white children. Maternal levels of 25OHD in the first trimester, however, “modified the effects of supplementation such that children born to women with higher levels and [who] were in the treatment arm had lowest risks for asthma/recurrent wheeze,” he said.

The greater reduction among women with higher baseline levels and supplementation suggests that higher levels than 30 ng/mL may be necessary for the prevention of asthma or allergies, Dr. Litonjua said. Personalized dosing or earlier supplementation may, therefore, be needed, he said.

“One of the main findings from our trial was that there were no serious adverse effects,” he said. Other trials, however, have found concerns with vitamin D toxicity. One challenge in the study was very low adherence: Only about half the women regularly took their vitamin D supplements at first, Dr. Litonjua said, although they were eventually able to raise adherence to around 80%.

The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press and consultation fees from AstraZeneca.
 

 

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Key clinical point: Higher levels of vitamin D3 in pregnancy led to a reduced risk of asthma or allergies in subsequent children at high risk for the condition.

Major finding: Asthma/recurrent wheeze prevalence was 20% lower among 3-year-old children of mothers supplemented with D3 during pregnancy (P = .051).

Data source: A randomized controlled trial at three clinical centers from October 2009 through January 2015, involving 881 pregnant women whose children had a high risk of asthma or allergies and 806 subsequent children.

Disclosures: The research was funded by the National Heart, Lung, and Blood Institute. Dr. Litonjua reported royalties from UpToDate and Springer Humana Press, and consultation fees from AstraZeneca.

Antacid use in infants linked to increased fracture risk

A critical first step
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– Children were more likely to experience a fracture if they were prescribed antacids before age 1 year, according to a study of military families.

The large study revealed that use of proton pump inhibitors (PPIs) before age 1 year was linked to a 22% increased risk of fracture, compared with those not prescribed antacids. Similarly, children prescribed both PPIs and H2 blockers before age 1 year were 31% more likely to have a fracture compared to those not taking the drugs.

 

 

Body

Acid suppression is frequently prescribed in infants for the treatment of symptoms such as fussiness, arching, and poor feeding, despite randomized controlled trials showing no benefit for these symptoms over placebo. These medications are often prescribed because physicians think they are useful; families are frustrated, exhausted, and worried about the infant’s symptoms; and these medications are considered safe and well tolerated. Recent adult studies have raised the possibility that these medications may not be as safe as once thought, with case-controlled studies linking them to increased risk of infectious, renal, cardiac, neurologic, and orthopedic complications. While there are pediatric studies supporting an increased infectious risk from both PPI and H2 antagonist use, there are no pediatric studies that address other complications. In this study by Dr. Malchodi et al., acid suppression use in infants under the age of 1 year was associated with an increased risk of fractures over the duration of enrollment in the U.S. Military Health System. They also found a dose-dependent effect, which further strengthens the conclusions that acid suppression may predispose patients to fractures. This research is a critical first step in elucidating the relationship of acid suppression and fracture risk in infants.
As with all database studies, there are some limitations to this study. First, patients taking acid suppression often have more comorbidities than do patients who are not taking the medications; because these patients are sicker, they may have more risk factors including compromised nutritional status and malabsorption predisposing them to fractures. The authors controlled for some of these comorbidities, but future studies should address additional ones. Second, as with all case-control studies, proving causality, not just association, is difficult so any future prospective acid suppression trials should include an assessment of bone health. Third, because the dosing per kilogram is not included, it is difficult to determine if there is a safe level of acid suppression for those children who need it. Fourth, because this is a database review, it is not clear if patients actually took the prescribed medication.
Because of the safety concerns regarding acid suppression as well as the lack of benefit in reducing symptoms in infants, nonpharmacologic therapies should be considered as first-line therapy for the treatment of bothersome symptoms. In the fussy, arching, or irritable child, changing the frequency or volume of feeds, thickening feeds, or changing to partially hydrolyzed formulas or eliminating dairy from the maternal diet (for breastfed infants) should be considered before starting acid suppression therapy. Other diagnoses besides gastroesophageal reflux disease, such as colic and cow’s milk protein allergy, need to be considered as well to ensure that the therapy matches the diagnosis. For those patients in whom acid suppression is required, using the lowest dose possible for the shortest amount of time is critical. Finally, for patients on multiple medications that may impact fracture risk (such as acid suppression, steroids), extra vigilance is needed to stop unnecessary medications as soon as possible.  

Rachel Rosen, MD, is director of the Aerodigestive Center at Boston Children’s Hospital, and an associate professor of pediatrics at Harvard Medical School, Boston. She is a specialist in pediatric gastroenterology who was asked to comment on the study by Malchodi et al. She disclosed that she received funds from the National Institutes of Health.
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Acid suppression is frequently prescribed in infants for the treatment of symptoms such as fussiness, arching, and poor feeding, despite randomized controlled trials showing no benefit for these symptoms over placebo. These medications are often prescribed because physicians think they are useful; families are frustrated, exhausted, and worried about the infant’s symptoms; and these medications are considered safe and well tolerated. Recent adult studies have raised the possibility that these medications may not be as safe as once thought, with case-controlled studies linking them to increased risk of infectious, renal, cardiac, neurologic, and orthopedic complications. While there are pediatric studies supporting an increased infectious risk from both PPI and H2 antagonist use, there are no pediatric studies that address other complications. In this study by Dr. Malchodi et al., acid suppression use in infants under the age of 1 year was associated with an increased risk of fractures over the duration of enrollment in the U.S. Military Health System. They also found a dose-dependent effect, which further strengthens the conclusions that acid suppression may predispose patients to fractures. This research is a critical first step in elucidating the relationship of acid suppression and fracture risk in infants.
As with all database studies, there are some limitations to this study. First, patients taking acid suppression often have more comorbidities than do patients who are not taking the medications; because these patients are sicker, they may have more risk factors including compromised nutritional status and malabsorption predisposing them to fractures. The authors controlled for some of these comorbidities, but future studies should address additional ones. Second, as with all case-control studies, proving causality, not just association, is difficult so any future prospective acid suppression trials should include an assessment of bone health. Third, because the dosing per kilogram is not included, it is difficult to determine if there is a safe level of acid suppression for those children who need it. Fourth, because this is a database review, it is not clear if patients actually took the prescribed medication.
Because of the safety concerns regarding acid suppression as well as the lack of benefit in reducing symptoms in infants, nonpharmacologic therapies should be considered as first-line therapy for the treatment of bothersome symptoms. In the fussy, arching, or irritable child, changing the frequency or volume of feeds, thickening feeds, or changing to partially hydrolyzed formulas or eliminating dairy from the maternal diet (for breastfed infants) should be considered before starting acid suppression therapy. Other diagnoses besides gastroesophageal reflux disease, such as colic and cow’s milk protein allergy, need to be considered as well to ensure that the therapy matches the diagnosis. For those patients in whom acid suppression is required, using the lowest dose possible for the shortest amount of time is critical. Finally, for patients on multiple medications that may impact fracture risk (such as acid suppression, steroids), extra vigilance is needed to stop unnecessary medications as soon as possible.  

Rachel Rosen, MD, is director of the Aerodigestive Center at Boston Children’s Hospital, and an associate professor of pediatrics at Harvard Medical School, Boston. She is a specialist in pediatric gastroenterology who was asked to comment on the study by Malchodi et al. She disclosed that she received funds from the National Institutes of Health.
Body

Acid suppression is frequently prescribed in infants for the treatment of symptoms such as fussiness, arching, and poor feeding, despite randomized controlled trials showing no benefit for these symptoms over placebo. These medications are often prescribed because physicians think they are useful; families are frustrated, exhausted, and worried about the infant’s symptoms; and these medications are considered safe and well tolerated. Recent adult studies have raised the possibility that these medications may not be as safe as once thought, with case-controlled studies linking them to increased risk of infectious, renal, cardiac, neurologic, and orthopedic complications. While there are pediatric studies supporting an increased infectious risk from both PPI and H2 antagonist use, there are no pediatric studies that address other complications. In this study by Dr. Malchodi et al., acid suppression use in infants under the age of 1 year was associated with an increased risk of fractures over the duration of enrollment in the U.S. Military Health System. They also found a dose-dependent effect, which further strengthens the conclusions that acid suppression may predispose patients to fractures. This research is a critical first step in elucidating the relationship of acid suppression and fracture risk in infants.
As with all database studies, there are some limitations to this study. First, patients taking acid suppression often have more comorbidities than do patients who are not taking the medications; because these patients are sicker, they may have more risk factors including compromised nutritional status and malabsorption predisposing them to fractures. The authors controlled for some of these comorbidities, but future studies should address additional ones. Second, as with all case-control studies, proving causality, not just association, is difficult so any future prospective acid suppression trials should include an assessment of bone health. Third, because the dosing per kilogram is not included, it is difficult to determine if there is a safe level of acid suppression for those children who need it. Fourth, because this is a database review, it is not clear if patients actually took the prescribed medication.
Because of the safety concerns regarding acid suppression as well as the lack of benefit in reducing symptoms in infants, nonpharmacologic therapies should be considered as first-line therapy for the treatment of bothersome symptoms. In the fussy, arching, or irritable child, changing the frequency or volume of feeds, thickening feeds, or changing to partially hydrolyzed formulas or eliminating dairy from the maternal diet (for breastfed infants) should be considered before starting acid suppression therapy. Other diagnoses besides gastroesophageal reflux disease, such as colic and cow’s milk protein allergy, need to be considered as well to ensure that the therapy matches the diagnosis. For those patients in whom acid suppression is required, using the lowest dose possible for the shortest amount of time is critical. Finally, for patients on multiple medications that may impact fracture risk (such as acid suppression, steroids), extra vigilance is needed to stop unnecessary medications as soon as possible.  

Rachel Rosen, MD, is director of the Aerodigestive Center at Boston Children’s Hospital, and an associate professor of pediatrics at Harvard Medical School, Boston. She is a specialist in pediatric gastroenterology who was asked to comment on the study by Malchodi et al. She disclosed that she received funds from the National Institutes of Health.
Name
Rachel Rosen, MD
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Rachel Rosen, MD
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A critical first step
A critical first step

 

– Children were more likely to experience a fracture if they were prescribed antacids before age 1 year, according to a study of military families.

The large study revealed that use of proton pump inhibitors (PPIs) before age 1 year was linked to a 22% increased risk of fracture, compared with those not prescribed antacids. Similarly, children prescribed both PPIs and H2 blockers before age 1 year were 31% more likely to have a fracture compared to those not taking the drugs.

 

 

 

– Children were more likely to experience a fracture if they were prescribed antacids before age 1 year, according to a study of military families.

The large study revealed that use of proton pump inhibitors (PPIs) before age 1 year was linked to a 22% increased risk of fracture, compared with those not prescribed antacids. Similarly, children prescribed both PPIs and H2 blockers before age 1 year were 31% more likely to have a fracture compared to those not taking the drugs.

 

 

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Key clinical point: Proton pump inhibitor use before age 1 year was associated with an increased risk of fracture.

Major finding: Risk of fracture increased 22% among children who took proton pump inhibitors in their first year of life and increased 31% among children taking both PPIs and H2 blockers.

Data source: A retrospective cohort study of 874,447 children born between 2001 and 2013 and who were in the U.S. Military Health System for at least 2 years.

Disclosures: No external funding was used. Dr. Malchodi reported having no relevant financial disclosures.