From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

From chemical sunscreen to the measles outbreak and drug approvals to product recalls, dermatology experienced its share of firsts and controversies in 2019.

Chemical Sunscreen Controversies

Controversial concerns about the effects of chemical sunscreen on coral reefs took an unprecedented turn in the United States this last year. On February 5, 2019, an ordinance was passed in Key West, Florida, prohibiting the sale of sunscreen containing the organic UV filters oxybenzone and/or octinoxate within city limits.¹ On June 25, 2019, a similar law that also included octocrylene was passed in the US Virgin Islands.² In so doing, these areas joined Hawaii, the Republic of Palau, and parts of Mexico in restricting chemical sunscreen sales.¹ Although the Key West ordinance is set to take effect in January 2021, opponents, including dermatologists who believe it will discourage sunscreen use, currently are trying to overturn the ban.³ In the US Virgin Islands, part of the ban went into effect in September 2019, with the rest of the ban set to start in March 2020.² Companies have started to follow suit. On August 1, 2019, CVS Pharmacy announced that, by the end of 2020, it will remove oxybenzone and octinoxate from some of its store-brand chemical sunscreens.⁴

On February 26, 2019, the US Food and Drug Administration (FDA) proposed that there are insufficient data to determine if 12 organic UV filters—including the aforementioned oxybenzone, octinoxate, and octocrylene—are generally recognized as safe and effective (GRASE).⁵ Although these ingredients were listed as GRASE by the FDA in 2011, the rise in sunscreen use since then, as well as changes in sunscreen formulations, prompted the FDA to ask manufacturers to perform additional studies on safety parameters such as systemic absorption.^5,6 One study conducted by the FDA itself was published in May 2019 and showed that maximal use of 4 sunscreens resulted in systemic absorption of 4 organic UV filters above 0.5 ng/mL, the FDA’s threshold for requiring nonclinical toxicology assessment. The study authors concluded that “further studies [are needed] to determine the clinical significance of these findings. [But] These results do not indicate that individuals should refrain from the use of sunscreen.”⁷ Some in the industry have suggested it may take at least 5 years to generate all the data the FDA has requested.⁶

End of the New York City Measles Outbreak

On September 3, 2019, New York City’s largest measles outbreak in nearly 30 years was declared over. This announcement reflected the fact that 2 incubation periods for measles—42 days—had passed since the last measles patient was considered contagious. In total, there were 654 cases of measles and 52 associated hospitalizations, including 16 admissions to the intensive care unit. Most patients were younger than 18 years and unvaccinated.⁸

The outbreak began in October 2018 after Orthodox Jewish children from Brooklyn became infected while visiting Israel and imported the measles virus upon their return home.^8,9 All 5 boroughs in New York City were ultimately affected, although 4 zip codes in Williamsburg, a neighborhood in Brooklyn with an undervaccinated Orthodox Jewish community, accounted for 72% of cases.^8,10 As part of a $6 million effort to stop the outbreak, an emergency order was placed on these 4 zip codes, posing potential fines on people living or working there if they were unvaccinated.⁸ In addition, a bill was passed and signed into law in New York State that eliminated religious exemptions for immunizations.¹¹ In collaboration with Jewish leaders, these efforts increased the administration of measles-mumps-rubella vaccines by 41% compared with the year before in Williamsburg and Borough Park, another heavily Orthodox Jewish neighborhood in Brooklyn.⁸

Drug Approvals for Pediatric Dermatology

On March 11, 2019, the IL-4/IL-13 inhibitor dupilumab became the third biologic with a pediatric dermatology indication when the FDA extended its approval to adolescents for the treatment of atopic dermatitis.¹² The FDA approval was based on a randomized, double-blind, placebo-controlled trial in which 42% (34/82) of adolescents treated with dupilumab monotherapy every other week achieved 75% or more improvement in the Eczema Area and Severity Index at week 16 compared with 8% (7/85) in the placebo group (P<.001).¹³

In October 2019, trifarotene cream and minocycline foam were approved by the FDA for the treatment of acne in patients 9 years and older.^14,15 As such, both became the first acne therapies to include patients as young as 9 years in their studies and indication—a milestone, considering the fact that children have historically been excluded from clinical trials.¹⁶ The 2 topical treatments also are noteworthy for being first in class: trifarotene cream is the only topical retinoid to selectively target the retinoic acid receptor γ and to have been studied specifically for both facial and truncal acne,^14,17 and minocycline foam is the first topical tetracycline.¹⁵

Drug Approvals for Rare Dermatologic Diseases

On July 19, 2019, apremilast, a phosphodiesterase 4 inhibitor, became the first medication approved by the FDA for the treatment of adults with oral ulcers due to Behçet disease, a rare multisystem inflammatory disease.¹⁸ The FDA approval was based on a double-blind, randomized, placebo-controlled trial in which 53% (55/104) of patients receiving apremilast monotherapy were ulcer free at week 12 compared to 22% (23/103) receiving placebo (P<.0001)(ClinicalTrials.gov Identifier NCT02307513).¹⁹

On October 8, 2019, afamelanotide was approved by the FDA to increase pain-free light exposure in adults with erythropoietic protoporphyria, a rare metabolic disorder associated with photosensitivity.²⁰ A melanocortin receptor agonist, afamelanotide is believed to confer photoprotection by increasing the production of eumelanin in the epidermis. The FDA approval was based on 2 randomized, double-blind, placebo-controlled trials, both of which found that patients given afamelanotide spent significantly more time in direct sunlight without pain compared to patients in the placebo group (P=.005 and P=.04).²¹

Recalls of Popular Skin Products

On July 5, 2019, Neutrogena recalled its cult-favorite Light Therapy Acne Mask. The recall was driven by rare reports of transient visual side effects due to insufficient eye protection from the mask’s light-emitting diodes.^22,23 Reported in association with 0.02% of masks sold at the time of the recall, these side effects included eye pain, irritation, tearing, blurry vision, seeing spots, and changes in color vision.²⁴ In addition, a risk for potentially irreversible eye injury from the mask was cited in people taking photosensitizing medications, such as doxycycline, and people with certain underlying eye conditions, such as retinitis pigmentosa and ocular albinism.^22,24,25

Following decades of asbestos-related controversy, 1 lot of the iconic Johnson’s Baby Powder was recalled for the first time on October 18, 2019, after the FDA found subtrace levels of asbestos in 1 of the lot’s bottles.²⁶ After the recall, Johnson & Johnson reported that 2 third-party laboratories did not ultimately find asbestos when they tested the bottle of interest as well as other bottles from the recalled lot. Three of 5 samples prepared in 1 room by the third-party laboratories initially did test positive for asbestos, but this result was attributed to the room’s air conditioner, which was found to be contaminated with asbestos. When the same samples were prepared in another room, no asbestos was detected.²⁷ The FDA maintained there was “no indication of cross-contamination” when they originally tested the implicated bottle.²⁸

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

egreb@mdedge.com

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

egreb@mdedge.com

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

Antiepileptic drug (AED) exposure resulting from breastfeeding in infants is low, compared with exposure in mothers who took AEDs during pregnancy, according to a study published online ahead of print Dec. 30, 2019, in JAMA Neurology. The results may explain why previous research failed to find adverse neurodevelopmental effects of breastfeeding in infants whose mothers are undergoing AED treatment, said the authors.

“The results of this study add support to the general safety of breastfeeding by mothers with epilepsy who take AEDs,” wrote Angela K. Birnbaum, PhD, professor of experimental and clinical pharmacology at the University of Minnesota in Minneapolis, and colleagues.
 

Investigators measured infants’ blood AED concentrations

To date, medical consensus about the safety of breastfeeding while the mother is taking AEDs has been elusive. Researchers have investigated breast milk concentrations of AEDs as surrogate markers of AED concentrations in children. Breast milk concentrations, however, do not account for differences in infant pharmacokinetic processes and thus could misrepresent AED exposure in children through breastfeeding.

Dr. Birnbaum and colleagues sought to measure blood concentrations of AEDs in mothers with epilepsy and the infants that they breastfed to achieve an objective measure of AED exposure through breastfeeding. They examined data collected from December 2012 to October 2016 in the prospective Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) study. Eligible participants were pregnant women with epilepsy between the ages of 14 and 45 years whose pregnancies had progressed to fewer than 20 weeks’ gestational age and who had IQ scores greater than 70 points. Participants were followed up throughout pregnancy and for 9 months post partum. Children were enrolled at birth.

The investigators collected blood samples from mothers and infants who were breastfed at the same visit, which occurred at between 5 and 20 weeks after birth. The volume of ingested breast milk delivered through graduated feeding bottles each day and the total duration of all daily breastfeeding sessions were recorded. For infants, blood samples were collected from the plantar surface of the heel and stored as dried blood spots on filter paper. The study’s primary endpoint was the percentage of infant-to-mother concentration of AEDs. Concentrations of AEDs in infants at less than the lower limit of quantification were assessed as half of the lower limit.
 

Exposure in utero may be greater than exposure through breast milk

In all, the researchers enrolled 351 pregnant women with epilepsy into the study and collected data on 345 infants. Two hundred twenty-two (64.3%) of the infants were breastfed, and 146 (42.3%) had AED concentrations available. After excluding outliers and mothers with missing concentration data, Dr. Birnbaum and colleagues included 164 matching infant-mother concentration pairs in their analysis (i.e., of 135 mothers and 138 infants). Approximately 52% of the infants were female, and their median age at blood collection was 13 weeks. The mothers’ median age was 32 years. About 82% of mothers were receiving monotherapy. The investigators found no demographic differences between groups of mothers taking various AEDs.

Sixty-eight infants (49.3%) had AED concentrations that were less than the lower limit of quantification. AED concentration was not greater than the lower limit of quantification for any infants breastfed by mothers taking carbamazepine, oxcarbazepine, valproic acid, or topiramate. Most levetiracetam (71.4%) and zonisamide (60.0%) concentrations in infants were less than the lower limit of quantification. Most lamotrigine concentrations in infants (88.6%) were greater than the lower limit of quantification.

The median percentage of infant-to-mother concentration was 28.9% for lamotrigine, 5.3% for levetiracetam, 44.2% for zonisamide, 5.7% for carbamazepine, 5.4% for carbamazepine epoxide, 0.3% for oxcarbazepine, 17.2% for topiramate, and 21.4% for valproic acid. Multiple linear regression models indicated that maternal concentration was significantly associated with lamotrigine concentration in infants, but not levetiracetam concentration in infants.

“Prior studies at delivery demonstrated that umbilical-cord concentrations were nearly equal to maternal concentrations, suggesting extensive placental passage to the fetus,” wrote Dr. Birnbaum and colleagues. “Therefore, the amount of AED exposure via breast milk is likely substantially lower than fetal exposure during pregnancy and appears unlikely to confer any additional risks beyond those that might be associated with exposure in pregnancy, especially given prior studies showing no adverse neurodevelopmental effects of breastfeeding while taking AEDs.”

The investigators acknowledged several limitations of their research, including the observational design of the MONEAD study. The amount of AED in participants’ breast milk is unknown, and the investigators could not calculate relative infant dosages. Only one blood sample was taken per infant, thus the results may not reflect infants’ total exposure over time.

The National Institute of Neurological Disorders and Stroke and the National Institute of Child Health and Development funded the research. The authors reported receiving research support from various pharmaceutical companies.

egreb@mdedge.com

SOURCE: Birnbaum AK et al. JAMA Neurol. 2019 Dec 30. doi: 10.1001/jamaneurol.2019.4443.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

mzoler@mdedge.com

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

mzoler@mdedge.com

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

PHILADELPHIA – The American Heart Association and American College of Cardiology took a big step toward facilitating widespread U.S. application of the hypertension management guideline that the societies issued in 2017 by releasing a set of performance and quality measures for adults with high blood pressure based on the 2017 guideline.

Mitchel L. Zoler/MDedge News

This guideline notably set a treatment target for patients diagnosed with hypertension of less than 130/80 mg/dL, and also lowered the threshold for diagnosing stage 1 hypertension to a blood pressure at or above 130/80 mm Hg, adding in a stroke about 31 million adults with hypertension to the U.S. total.

Having performance and quality measures based on the guideline is “critical, because how else would you know whether you’re having an effect on accurately diagnosing and properly controlling hypertension?” said Donald E. Casey Jr., MD, chair of the performance measures writing committee. The next step is field testing of the measures “to show they are reliable and effective,” as well as other steps to encourage widespread U.S. uptake of the performance and quality measures and the specifics of the 2017 guideline, Dr. Casey said during a presentation of the revised measures at the American Heart Association scientific sessions.

He especially highlighted the important role of Target: BP, an education, recognition, and quality improvement program run by the AHA and American Medical Association, as a tool that medical practices, health systems, and even payers and employers can use to begin to apply the new performance and quality measures (J Am Coll Cardiol. 2019 Nov 26;74[21]:2661-706) and better align with the recommendations of the 2017 high blood pressure guideline (J Am Coll Cardiol. 2018 May;71[19]:e127-248).

“We’re trying now to promote Target: BP; it’s something you can take off the shelf and get going if it’s embedded in a real-life delivery model. I think Target: BP is the secret sauce. It will be the way we’ll convince people to adopt this,” said Dr. Casey, principal and founder of IPO 4 Health, a Chicago-based health care consulting firm.

He also advised practices and health systems not to feel compelled to introduce all of the specific performance and quality measures at once. “We don’t believe everyone has the resources to do all of it at once; the point is to move toward this system of care. We understand that people don’t have the resources to get it all done” immediately, Dr. Casey said in an interview.

Mitchel L. Zoler/MDedge News

A report during another session at the meeting documented the potential impact that Target: BP can have on blood pressure control within a health system. The Trinity Health of New England medical group based in Springfield, Mass., a system with about 140,000 patients – including 20,000 adults diagnosed with hypertension – and served by 230 health care providers in 13 offices in western Massachusetts, began using Target: BP’s MAP improvement program in its practices in November 2018. (MAP stands for measure accurately, act rapidly, and partner with patients.) Just before the MAP program began, 72% of patients diagnosed with hypertension in the medical group were at their goal blood pressure. Less than a year later, in September 2019, the hypertension control rate had jumped to 84%, a 12 percentage point improvement in control in practices that already had been doing a relatively good job, said Daniel W. Weiswasser, MD, director of quality and clinical informatics at Trinity Health of New England. Based on this success, Trinity Health plans to next involve the remaining regions of Trinity Health of New England in Target: BP, followed by the other regions of Trinity’s national organization, which operates in 21 states with nearly 4,000 staff physicians and about half a million patients diagnosed with hypertension, Dr. Weiswasser said.

Mitchel L. Zoler/MDedge News

“If clinicians do the three steps of the MAP then we will see substantial drops in blood pressures. It will occur,” declared Brent M. Egan, MD, vice president for cardiovascular disease prevention of the AMA in Greenville, S.C.

The new report includes six performance measures based on the strongest guideline recommendations and designed to document adherence levels for the purposes of public reporting and pay-for-performance programs. It also includes 16 quality measures designed for local quality review purposes, with 6 process quality measures and 10 structural quality measures. The report spells out that the authors designed the performance measures for use by major national organizations such as the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance (NCQA), while the quality measures are designed to support quality improvement efforts in any care-delivery setting.

The authors said that the writing committee is sensitive to the fact that the 2019 performance measures for controlling high blood pressure developed by the NCQA for the Healthcare Effectiveness Data and Information Set and currently in use in 2019 by CMS also does not incorporate the 2017 Hypertension Clinical Practice Guidelines classification scheme. “It is well understood that these measures are already in widespread use, especially for quality-related payment programs promulgated by CMS, such as the Medicare Advantage ‘Stars’ ratings, the Medicare Shared Savings Program, and the Physician Quality Payment Program, as well as many other programs promoted by commercial health insurers. In particular, the widespread use of the 2017 Hypertension Clinical Practice Guidelines classification scheme will also help to guide decision making about when to prescribe antihypertensive medications in accordance with its current recommendations for the ACC/AHA “stages” of stage 1 and stage 2 hypertension and elevated blood pressure,” they added.

The report also says that “the writing committee was sensitive to the fact that there is currently not complete consensus among other guidelines from the American College of Physicians and the American Academy of Family Physicians, and also the European Society of Cardiology and the European Society of Hypertension. Nonetheless, despite this ongoing debate, the writing committee felt strongly that it is now time to move the U.S. health care system ahead to reflect these differing points of view and expects that widespread use of this new measure set will help to achieve this goal.” The new report revises hypertension performance measures developed by the ACC and AHA in 2011 (J Am Coll Cardiol. 2011 Jul 12;58[3]: 316-36).

In short, the performance and quality measures give all the diverse components of the U.S. health care delivery system a road map for implementing the 2017 High Blood Pressure Guideline in a format that depends on those components electing to adopt and adhere to the 2017 guideline. (Although one of the new performance measures, 1a, harmonizes with an existing and widely applied performance measure.)

“Who is the audience for this, and how will they respond? These performance measures need to be appropriated” by health systems and by performance-assessment groups. “I hope the NCQA will adopt it,” said William C. Cushman, MD, professor of preventive medicine at the University of Tennessee Health Science Center in Memphis, and chief of preventive medicine at the Memphis Veterans Affairs Medical Center. “There are some negatives to performance measures, but on balance they have done good things and led to better care.” Dr. Cushman also approved of several specific performance and quality measures included in the report. “Most of what they emphasized is good,” particularly the importance of accurate pressure measurement, he said in an interview.

“Process drives outcomes” in hypertension management, and the new performance and quality measures “have some very good process metrics,” commented Dr. Egan. “I’d encourage health systems to select two or three measures that are key to what they do and make sense in their setting rather than try to implement it all at once,” he advised, echoing what Dr. Casey had suggested. “It’s ideal to do everything, but we know that if you give physicians a long list of performance measures they just get overwhelmed. The nice thing about hypertension is that we know that process drives outcomes. In the past, we’ve had some process metrics that did not drive outcomes. Getting these processes implemented will lead to better patient outcomes and save a ton of money.”

Mitchel L. Zoler/MDedge News

“We have introduced the 2017 guideline recommendations throughout Target: BP, but like any quality improvement program there is a question of how does it spread,” said Gregory Wozniak, PhD, director of outcomes analytics for the AMA in Chicago. “Our goal for Target: BP is to be impacting 20 million patients by 2021.”

Dr. Casey, Dr. Weiswasser, and Dr. Wozniak had no disclosures. Dr. Cushman has received honoraria as a speaker from Arbor and Sanofi-Aventis, and travel and research support from Eli Lilly. Dr. Egan has been a consultant to and speaker on behalf of Merck and a speaker for Emcure.

mzoler@mdedge.com

SOURCE: Casey DE et al. J Am Coll Cardiol. 2019 Nov 26;74[21]: 2661-706.

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

bjancin@mdedge.com

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

bjancin@mdedge.com

MADRID – A growing recognition that atopic dermatitis (AD) patients on dupilumab are prone to develop a paradoxical head and neck erythema that’s clinically and histologically distinct from their background skin disease emerged as a hot topic of discussion at a meeting of the European Task Force on Atopic Dermatitis held in conjunction with the annual congress of the European Academy of Dermatology and Venereology.

Bruce Jancin/MDedge News

“During treatment with dupilumab, we saw something that is really different from the classic eczema that patients experienced prior to dupilumab, with no or minimal scaling, itch, or burning sensation. We do not believe this is a delayed effect of dupilumab on that specific region. We think this is a dupilumab-induced entity that we’re looking at. You should take home, in my opinion, that this is a common side effect that’s underreported in daily practice at this moment, and it’s not reported in clinical trials at all,” said Linde de Wijs, MD, of the department of dermatology, Erasmus University Medical Center in Rotterdam, the Netherlands.

She presented a detailed case series of seven affected patients which included histologic examination of lesional skin biopsies. The biopsies were characterized by a perivascular lymphohistiocytic infiltrate, an increase in ectatic capillaries in the papillary dermis, and a notable dearth of spongiosis, eosinophils, and neutrophils. Four patients had bulbous elongated rete ridges evocative of a psoriasiform dermatitis. The overall histologic picture was suggestive of a drug-induced skin reaction.

A striking finding was that, even though AD patients typically place high importance on achieving total clearing of disease on the head and neck, these seven closely studied patients nonetheless rated their treatment satisfaction as 9 out of a possible 10 points. Dr. de Wijs interpreted this as testimony to dupilumab’s potent efficacy and comparatively acceptable safety profile, especially the apparent side effect’s absence of scaling and itch.

“Remember, these are patients with really severe atopic dermatitis who’ve been treated with a lot of immunosuppressants prior to dupilumab,” she said.

Once the investigators began to suspect the existence of a novel dupilumab-induced skin reaction, they conducted a retrospective chart review of more than 150 patients treated with dupilumab (Dupixent) and determined that roughly 30% had developed this distinctive sharply demarcated patchy erythema on the head and neck characterized by absence of itch. The sequence involved clearance of the AD in response to dupilumab, followed by gradual development of the head and neck erythema 10-39 weeks after the start of treatment.

The erythema proved treatment refractory. Dr. de Wijs and her colleagues tried topical corticosteroids, including potent ones, as well as topical tacrolimus, antifungals, antibiotics, emollients, oral steroids, and antihistamines, to no avail. Patch testing to investigate allergic contact dermatitis as a possible etiology was unremarkable.

She hypothesized that, since dupilumab blocks the key signaling pathways for Th2 T-cell differentiation by targeting the interleukin-4 receptor alpha, it’s possible that the biologic promotes a shift towards activation of the Th17 pathway, which might explain the observed histologic findings.

The fact that this erythema wasn’t reported in the major randomized clinical trials of dupilumab underscores the enormous value of clinical practice registries, she said.

“We are not the only ones observing this phenomenon,” noted Dr. de Wijs, citing recently published reports by other investigators (J Am Acad Dermatol. 2020 Jan;82[1]:230-2; JAMA Dermatol. 2019 Jul 1;155[7]:850-2).

Indeed, her talk was immediately followed by a presentation by Sebastien Barbarot, MD, PhD, who reported on a French national retrospective study of head and neck dermatitis arising in patients on dupilumab that was conducted by the French Atopic Dermatitis Network using the organization’s GREAT database. Among 1,000 adult patients with AD treated with the biologic at 29 French centers, 10 developed a de novo head and neck dermatitis, and 32 others experienced more than 50% worsening of eczema signs on the head and neck from baseline beginning about 2 months after starting on dupilumab.

This 4.2% incidence is probably an underestimate, since dermatologists weren’t aware of the phenomenon and didn’t specifically ask patients about it, observed Dr. Barbarot, a dermatologist at the University of Nantes (France).

Among the key findings: No differences in clinical characteristics were found between the de novo and exacerbation groups, nearly half of affected patients had concomitant conjunctivitis, and seven patients discontinued dupilumab because of an intolerable burning sensation on the head/neck.

“I think this condition is quite different from rosacea,” Dr. Barbarot emphasized.

French dermatologists generally turned to topical corticosteroids or topical tacrolimus to treat the face and neck dermatitis, with mixed results; 22 of the 42 patients showed improvement and 8 worsened.

Bruce Jancin/MDedge News

bjancin@mdedge.com

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.

Fall prevention strategies for hospitalized older adults include environmental factors such as adequate room lighting and patient-specific factors such as medications. In 2008, the Centers for Medicare & Medicaid Services (CMS) implemented a regulatory “shining of the light” on hospital-acquired falls by eliminating hospital payment for fall-related injuries. Shorr et al. found that implementation of the CMS Hospital-Acquired Conditions Initiative was associated with only a modest decline in falls and injurious falls over the first seven years, with the greatest reduction occurring in urban, teaching hospitals.¹ These disappointing findings were mitigated only by the finding that the prevalence of physical restraints decreased over the seven years of observation from 1.6% to 0.6%, suggesting that the modest reductions in falls did not occur at the expense of further restricting the mobility of hospitalized older adults. Shorr et al. concluded that falls may be largely attributable to individual patient risk and may not be prevented through health system quality and safety programs such as those that have achieved successes in never-events, including wrong-side surgery and catheter-associated blood stream infections.² The authors expressed concern that hospital leaders remain in the dark regarding proven fall prevention strategies. They question whether hospital-acquired falls are preventable without restricting the mobility of older adults most at risk for falls.

Hoff et al. found in their 2011 literature review of the first three years following implementation of the 2008 CMS hospital payment polices limited evidence-based approaches to address falls as a spotlighted avoidable hospital-acquired condition.³ Swartzell et al. reported that at some level, every patient admitted to an acute care hospital is at risk for falls. “Patients sick enough to be in the hospital have underlying disease, are receiving physiologically altering medications and treatments, and are likely experiencing pain, fatigue, anxiety, sleep disturbance, and other symptoms that interfere with cognitive and physical functioning. The key to preventing falls among hospitalized patients may lie in addressing how the hospital environment creates risk.”⁴

In 2017, Avanecean et al. published a systematic review of randomized control trials on fall prevention in hospitals.⁵ Three of five studies demonstrated 20%-30% reductions in fall rates, whereas two studies showed no difference in fall rates among control and intervention groups. In the three studies that demonstrated reduced fall rates, standardized fall risk assessments were used to identify patient-specific risks for falls. Individualized care plans addressed gait and balance disorders, delirium and cognitive deficits, vision and hearing impairments, and toileting needs. For example, physical therapists provided instruction on the safe use of walkers for those with gait and balance disorders. Patients with delirium and cognitive deficits received some form of staff alert of unsupervised transfers out of bed, ranging from bed alarms to customized rubber socks that contained pressure alarms. All three successful intervention studies included patient-centered care plans for toileting.

None of the three studies that measured the secondary outcome of fall-related injuries demonstrated impact of interventions, although the rates of injurious falls were low in both the control and intervention groups (2%-5%).^3-5

Since the 2008 CMS policies eliminated hospital payments for complications of falls, patient-centered models of fall risk reduction were widely implemented. The Systems Addressing Frail Elder (SAFE) Care, designed by Ansryan et al. includes nursing, social work, pharmacist, and medical provider assessments.⁶ Team huddles occur daily to establish individualized care plans, although as Shorr et al. highlight, without report of outcomes.² Nurses Improving Care for Healthsystem Elders (NICHE) is an New York University-based nursing education and consultation program that has extended to 566 healthcare organizations.⁷ Factors that promote the adoption of organizational interventions such as NICHE have been identified.⁸ The findings that NICHE is adopted more in larger, urban healthcare systems are consistent with the findings reported by Shorr et al. that fall rate reductions were greater in such hospital settings. Patient-centered care, although time-consuming, may promote staff satisfaction and is associated with reductions in other hospital-acquired conditions such as delirium.⁹

Patient-engaged video surveillance systems are recent technological solutions to reduce falls. One staff monitors multiple patients for behaviors that risk falls such as unsupervised transfers out of bed. Staff can speak to a patient through the monitoring system to request the patient to wait for assistance, while the unit staff are alerted to the fall risk. Bedside caregivers can activate virtual privacy screens during personal patient care.

Shorr et al. appropriately call for studies to further illuminate strategies to reduce hospital-acquired falls. A multihospital report of fall rates before and after the implementation of SAFE Care and NICHE would have sufficient scale to address the impact of these patient-centered interventions on injurious falls. Similarly, patient-engaged video surveillance systems need validation from clinical trials.

The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.

The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.

Beyond practice advice, the investigators highlighted a research focus for the future.

“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”

For now, many of the treatment principles in the update depend upon histologic features.

For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.

During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.

If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.

Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.

The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.

“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”

Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.

The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.

SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.

The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.

The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.

Beyond practice advice, the investigators highlighted a research focus for the future.

“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”

For now, many of the treatment principles in the update depend upon histologic features.

For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.

During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.

If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.

Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.

The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.

“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”

Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.

The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.

SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.

The American Gastroenterological Association recently released a clinical practice update for endoscopic treatment of Barrett’s esophagus with dysplasia and/or early esophageal adenocarcinoma.

The update offers best practice advice for a range of clinical scenarios based on published evidence, including guidelines and recent systematic reviews, reported lead author Prateek Sharma, MD, of the University of Kansas, Kansas City. Dr. Sharma was accompanied on the authoring review team by three other expert gastroenterologists from the United States and the Netherlands.

Beyond practice advice, the investigators highlighted a research focus for the future.

“Given the expense and time required for careful and continual surveillance after Barrett’s endoscopic therapy, the future must define improved means of risk-stratifying patients for therapy who are at highest risk for cancer development and for risk of recurrence after complete eradication of intestinal metaplasia,” they wrote in Gastroenterology. “Potentially, we may use a panel of patient characteristics (such as the [Progression in Barrett’s] score), preablation tissue characteristics (e.g., baseline grade of dysplasia) and the posttherapy molecular makeup of the epithelium to help risk stratify our patients.”

For now, many of the treatment principles in the update depend upon histologic features.

For instance, either endoscopic therapy or continued surveillance are reasonable options for patients with Barrett’s esophagus who have confirmed and persistent low-grade dysplasia. In contrast, the update recommends that all patients with high-grade dysplasia or esophageal adenocarcinoma (T1a) undergo endoscopic therapy, highlighting that this method is preferred over esophagectomy for patients with T1a cancer. Along the same lines, the investigators noted that endoscopic therapy is a “reasonable alternative” to esophagectomy in cases of T1b esophageal adenocarcinoma in the presence of minimal invasion and good to moderate differentiation, particularly in patients who are poor candidates for surgery.

During the decision-making process, patients with dysplasia should be advised that not undergoing endoscopic therapy may increase cancer risk, the investigators wrote, adding that patients should also be informed about endoscopic therapy–related risks of bleeding and perforation, which occur in less than 1% of patients, and the risk of postprocedural stricture formation, which occurs in approximately 6% of patients.

If endoscopic therapy is elected, the update suggests that the procedure be done by experts who perform at least 10 new cases per year.

Concerning specifics of therapy, the investigators advised that mucosal ablation be applied to all visible esophageal columnar mucosa, 5-10 mm proximal to the squamocolumnar junction, and 5-10 mm distal to the gastroesophageal junction. Ablation should only be performed in cases of flat Barrett’s esophagus in which no visible abnormalities or signs of inflammation are present, the review team wrote.

The investigators went on to lay out some “practical ground rules” for endoscopic therapy, including a potential pitfall.

“Ablation therapy may consist of multiple 2-3 monthly ablation sessions that may extend over a period of more than a year,” the investigators wrote. “The worst adverse outcome during the treatment period is failing to recognize and treat an invasive cancer while continuing the ablation sessions. This occurrence may place the patient outside of the window of opportunity for curative endoscopic treatment. Therefore, every ablation session starts with careful endoscopic inspection using [high-definition white-light endoscopy] and preferably optical chromoendoscopy to exclude the presence of visible abnormalities that require an endoscopic resection instead of the scheduled ablation. Routine biopsies of flat Barrett’s esophagus are not necessary or recommended prior to ablation at these sessions, as the blood may inhibit optimal energy transfer to the tissue.”

Following successfully achieved complete endoscopic and histologic eradication of intestinal metaplasia, the update calls for surveillance endoscopy with biopsies at intervals of 1 and 3 years for cases of low-grade dysplasia and at intervals of 3, 6, and 12 months for high-grade dysplasia or esophageal adenocarcinoma, followed by annual checks thereafter.

The investigators disclosed relationships with Olympus, Ironwood, Erbe, and others.

SOURCE: Sharma P et al. Gastroenterology. 2019 Nov 12. doi: 10.1053/j.gastro.2019.09.051.

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

lfranki@mdedge.com

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

lfranki@mdedge.com

The Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for dapagliflozin (Farxiga) for the reduction of risk of cardiovascular death or worsening of heart failure in adult patients with heart failure with reduced ejection fraction (HFrEF).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The application was based on results from the landmark, phase 3 DAPA-HF trial, published in September 2019 in the New England Journal of Medicine. The study showed that dapagliflozin plus standard care reduced the incidence of cardiovascular death and worsening of heart failure versus placebo in patients with HFrEF.

Dapagliflozin was granted Fast Track designation for heart failure by the FDA in September 2019. In August 2019, the FDA also granted Fast Track designation to dapagliflozin for the delayed progression of renal failure and prevention of cardiovascular and renal death in patients with chronic kidney disease.

The drug is currently indicated for the improvement of glycemic control in adults with type 2 diabetes as either monotherapy or in combination. The FDA approved dapagliflozin in October 2019 for the reduction of heart failure hospitalization risk in patients with type 2 diabetes and cardiovascular risk factors.

“Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure,” said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZeneca.

Find the full press release on the AstraZeneca website.

lfranki@mdedge.com

I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.

Joel Carillet/iStock Unreleased

I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.

Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.

Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.

Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.

Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.

Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?

Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. We should join with the global community to support the United Nations Sustainable Development Goals, especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
 

I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.

Joel Carillet/iStock Unreleased

I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.

Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.

Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.

Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.

Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.

Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?

Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. We should join with the global community to support the United Nations Sustainable Development Goals, especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
 

I was asked recently about the trauma of 9/11 by a teen patient who was too young to remember the terrorist attacks. I was surprised that even today I become teary eyed thinking about it. My son was in his first week of college at Georgetown, and in the early confusion about what was going on I was panicked at reports of bombings in Washington. Fortunately, for me and my family at least, none of us were physically harmed. But the mental trauma still is with us. It was a momentary panic for me, but it’s not so fleeting for many families around the world today.

Joel Carillet/iStock Unreleased

I can’t imagine what it is like today to be a parent in an armed conflict zone, or even in an area with very high levels of criminal violence. At a meeting of the International Society for Social Pediatrics (ISSOP), I learned that an estimated 1.5 billion residents of Earth, or about one in five inhabitants, lived in war zones or in areas of tremendous violence, according to the World Bank’s 2011 World Development Report. And I learned that children are disproportionately affected – physically, mentally, and developmentally – from Stella Tsitoura, MD, of the Network for Children’s Rights, Athens, and others at the ISSOP meeting in Beirut, Lebanon, where pediatricians from around the world gathered in Oct. 2019 to consider what we as a profession should be doing in the context of armed conflict’s impact on so many children. The meeting was held in the Middle East because it is an especially hot conflict area, but children in South Asia, central Africa, South America, Central America, even rough inner-city areas in the United States are also affected.

Child soldiers in some parts of the world particularly are affected, sometimes being forced to commit violence on neighbors and kin. One country that I worked in years ago, Yemen, is a horrifying example of the complex impact of war on children and families. In 2017, over 2,100 children had been recruited as soldiers during the 3-year conflict in Yemen, a UNICEF representative reported. The death toll in Yemen was over 17,500 by Nov. 2018, according to a Human Rights Watch report.

Samuel Perlo-Freeman, PhD, an expert on the economics of arms trade, noted at the ISSOP meeting that two-thirds of civilian casualties in Yemen are caused by Coalition air strikes, whose members include Bahrain, Egypt, Jordan, Kuwait, Saudi Arabia, Sudan, and United Arab Emirates. He also said rebel groups in Yemen and elsewhere acquire their arms by capture, by smuggling, or through the aid of foreign backers. Six countries – the United States, Russia, and several western European countries – account for the majority of war tools used in armed conflict zones. In June 2019, courts in Great Britain ruled that British arms sales to the parties involved in Yemen were illegal without an assessment as to whether any violation of internal humanitarian law had taken place.

Many of us feel impotent when facing the magnitude of this problem, and the lives of despair that affected children lead are sometimes too heart breaking to dwell on. ISSOP, the American Academy of Pediatrics, and the International Pediatric Association (IPA) are teaching us differently: Standing up for the human rights of children living in areas of conflict or refugees from those areas is our responsibility, both as individuals and as members of our pediatric associations. At a basic level we need to witness – we need to share what we see with our patients who have immigrated legally or illegally in our practices, our hospitals, and our communities. It’s important to be knowledgeable of current standards of clinical care outlined by both ISSOP and the AAP to ensure our patients affected by conflict and violence get appropriate treatment.

Some of the most lasting health impacts for children in conflict are their mental health needs; the World Health Organization prevalence estimates of mental disorders in conflict settings is 22%, according to a 2019 report in the Lancet (2019 Jun;394[10194]:240-8). Not only do mental health conditions last throughout a lifetime, the impact of war can affect generations through epigenetic forces.

Arms manufacturers should be held accountable as the courts are doing in Great Britain. Too often American-made armaments are falling into the wrong hands. More can be done to limit the sale of weapons that go into conflict zones. Chemical weapons, cluster bombs, and biologic weapons are banned by international agreement; shouldn’t we do the same with nuclear weapons?

Some pediatric health care facilities are impacted by the needs of traumatized children more than others. Countries at the front line of conflict – like Lebanon, Jordon, Turkey, Greece, Italy, and Mexico – should be supported in their efforts on behalf of child refugees. We need to share the burden and support entities such as Doctors Without Borders, Save the Children, and the Red Cross/Crescent as they present themselves in crisis zones. We recognize that the fundamental human rights of children are being ignored by warring parties. We should join with the global community to support the United Nations Sustainable Development Goals, especially Goal 16, which asks the world community to make real progress in promoting peace and justice by 2030. Pediatricians may not be experts in armed conflict, but we are experts in what warfare does to the health and well-being of young children. It’s time to speak out and act.
 

Receiving clinical care within 1 week of a concussion is associated with faster recovery times, compared with having an initial clinic visit more than 1 week after the injury, according to a study published Jan. 6 in JAMA Neurology.

In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.

“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”

Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.

The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.

The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.

Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.

In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).

“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”

The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.

Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.

jremaly@mdedge.com

SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.

Receiving clinical care within 1 week of a concussion is associated with faster recovery times, compared with having an initial clinic visit more than 1 week after the injury, according to a study published Jan. 6 in JAMA Neurology.

In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.

“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”

Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.

The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.

The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.

Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.

In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).

“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”

The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.

Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.

jremaly@mdedge.com

SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.

Receiving clinical care within 1 week of a concussion is associated with faster recovery times, compared with having an initial clinic visit more than 1 week after the injury, according to a study published Jan. 6 in JAMA Neurology.

In addition, more severe visual motion sensitivity symptoms are associated with longer recovery times, said lead author Anthony P. Kontos, PhD, and colleagues. Dr. Kontos is associate professor of orthopedic surgery at the University of Pittsburgh and the research director of the University of Pittsburgh Medical Center Sports Medicine Concussion Program.

“Without clinical guidance and behavioral management recommendations post injury, athletes may have been engaging in counterproductive recovery strategies, such as a strict rest or excessive physical activity,” the authors said. “This explanation is supported by the fact that athletes recovered in a similar amount of time after that first evaluation.”

Various factors may influence recovery after a concussion, including age, sex, and comorbidities. To examine the relationship between time since injury at the start of clinical care and recovery time, the investigators conducted a retrospective, cross-sectional study. They analyzed data from patients seen in a sports medicine clinic between August 2016 and March 2018. Eligible patients were aged 12-22 years and had a diagnosed, symptomatic, sport-related concussion. The researchers excluded patients with incomplete recovery data.

The investigators included 162 patients in their analyses; 98 of these patients were seen within 7 days of the injury, and 64 were seen 8-20 days after a concussion. Both groups had a mean age of 15 years and similar proportions of female patients (52% in the early-care group vs. 62.5% in the late-care group). At the first clinical visit, symptom severity and cognitive, ocular, and vestibular test results were similar in both groups.

The researchers defined recovery time as the number of days from injury until the date of clearance for a full return to play. Physicians cleared patients to return to play when they returned to preinjury levels of symptoms and preinjury performance on cognitive, ocular, and vestibular tests with no increase in symptoms after exertion.

Patients’ recovery times ranged from 9 to 299 days; the average recovery time was 57 days. Fifty-two percent of patients in the early-care group recovered in 30 days or fewer, compared with 19% of patients in late-care group. Patients in the early-care group had a mean recovery of 51.1 days, whereas patients in the late-care group had a mean recovery of 66 days.

In a logistic regression model, late care “was associated with a 5.8-times increased likelihood of a recovery longer than 30 days,” the researchers reported. Visual motion sensitivity symptoms also were associated with increased odds of protracted recovery (adjusted odds ratio, 4.5).

“Once care was established, time to recovery did not differ for athletes evaluated within the first week of injury compared with those evaluated 2-3 weeks post injury,” Dr. Kontos and colleagues concluded. “Education on injury and behavioral recommendations to optimize concussion recovery and earlier initiation of active rehabilitation strategies, including exertion and vestibular therapy, are plausible explanations for the association of a shorter recovery time with earlier care. However, future research should focus on the specific mechanisms by which earlier health care postconcussion promotes faster recovery and determine if these findings apply to other subpopulations, including military personnel.”

The researchers noted that they excluded from their analysis 254 patients who had incomplete recovery data but otherwise met inclusion criteria, which may have led to selection bias.

Dr. Kontos disclosed grants from the National Football League and personal fees from APA Books and University of Pittsburgh projects outside the scope of this study.

jremaly@mdedge.com

SOURCE: Kontos AP et al. JAMA Neurol. 2020 Jan 6. doi: 10.1001/jamaneurol.2019.4552.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.

Key clinical point: In patients with progressive MS, high-dose biotin was not found to offer clear improvement in disability.

Major finding: At 12 months, Expanded Disability Status Scale (EDSS) scores increased from 5.8 ± 1.3 before high-dose biotin initiation to 6.0 ± 1.3 at baseline. EDSS scores increased significantly under high-dose biotin (6.3 ± 1.3 at 12 months vs. 6.1 ± 1.3 at baseline; P less than .0001).

Study details: The data were obtained from a prospective study of 178 patients in routine clinical practice; 26 patients stopped treatment before 12 months and 152 continued for at least 12 months.

Disclosures: The study was supported by MedDay Pharma and by the ANTARES association. The corresponding author received honoraria from Biogen, Sanofi Genzyme, Teva, Roche, Merck, and MSD.

Citation: Couloume L et al. Mult Scler. 2019 Dec 17. doi: 10.1177/1352458519894713.