Pediatrics

MINNEAPOLIS – Whether a young female patient has a refractory flare of inflammatory acne, or has a condition that can predispose to androgen excess, using a hormonal approach can be an effective management tool for controlling adolescent acne.

During a presentation at the annual meeting of the Society for Pediatric Dermatology, Dr. Diane Thiboutot outlined tips and tricks for optimizing hormonal therapy for acne in teens, and referred to the new acne treatment guidelines from the American Academy of Dermatology, which clarify when to treat with hormones, which to choose, and when further testing might be indicated.

The full range of hormonal therapy options for acne can include oral contraceptives, which block ovarian hormone production; antiandrogens such as spironolactone, and the less commonly used flutamide, which blocks the effects of androgen on the skin; and glucocorticoids, which block adrenal production.

The 2016 guidelines recommend oral contraceptives as an effective treatment for inflammatory acne in females (J Am Acad Dermatol. 2016 May;74[5]; 945-973.e33). Combined oral contraceptives (COCs) reduce serum androgens, and reduce free testosterone by increasing sex hormone binding globulin production, thus reducing sebum production. “The only things that really decrease sebum are oral contraceptives in women, and isotretinoin,” said Dr. Thiboutot, professor of dermatology at Penn State University, Hershey.

For most female adolescents with acne, hormonal testing is not indicated. The AAD guidelines recommend laboratory evaluation for younger patients with acne who have clinical signs of androgen excess, such as early onset body odor and axillary and/or pubic hair, accelerated growth, advanced bone age, or early genital maturation. Just obtaining a hand film for bone age and mapping growth against a growth chart can be a good initial screening tool when considering whether to perform hormonal testing, she noted.

For postpubertal females in whom polycystic ovary syndrome (PCOS) or other hyperandrogenic states are suspected, hormonal testing is indicated in the presence of the clinical signs of infrequent menses and infertility, hirsutism, truncal obesity, androgenetic alopecia, polycystic ovaries, or clitoromegaly.

In searching for an endocrine disorder, Dr. Thiboutot recommends checking total and free testosterone, luteinizing hormone/follicle stimulating hormone ratio, 17-hydroxyprogesterone levels, and dehydroepiandrosterone (DHEA-S) levels. These tests should be performed at least 6 weeks after the patient has been off hormonal contraception, and should be done during the menstrual period, or during the week prior to menses, in order to avoid ovulation-related hormonal changes.

Lab findings consistent with congenital adrenal hyperplasia include elevated serum DHEA-S, together with elevated 17-hydroxyprogesterone or testosterone. A PCOS diagnosis can be made in adolescent females if there is clinical or laboratory evidence of hyperandrogenism with concomitant persistent oligomenorrhea.

Acne related to hyperandrogenism may respond well to oral contraceptives, but COCs can also be an effective alternative to repeated courses of isotretinoin and antibiotics, as well as an effective adjunct to topical therapy, Dr. Thiboutot said.

When beginning a patient on oral contraceptives, it’s not necessary to perform a pelvic exam or obtain a Pap smear before initiating the COC, but it is important to obtain a thorough medical history and an accurate blood pressure measurement at the outset, she noted. The World Health Organization (WHO) has established recommendations outlining contraindications to COC use, also identifying populations in whom COCs should be used with caution, and who should be monitored.

Headaches are a condition frequently seen among healthy teens and young women, and one for which the WHO advises caution. There are concerns that women with migraines may be at increased risk of stroke if they take COCs, but the overall risk is low, and the American College of Obstetricians and Gynecologists (ACOG) advises that COCs can be considered for women younger than 35 with migraines if they have no focal neurologic signs, are nonsmokers, and are otherwise healthy, Dr. Thiboutot added.

A large Food and Drug Administration–sponsored retrospective cohort study examined the risk of venous thromboembolism in contraceptive users. In April 2012, the FDA concluded that though the risk of blood clots may be higher for those on hormonal contraception methods than for those who are not using them, the risk of blood clots during pregnancy and the postpartum period is higher than the thromboembolism risk for contraceptive users.

Regarding the potential for antibiotics to reduce contraceptive efficacy, Dr. Thiboutot said,“it’s okay to use oral contraceptives with antibiotics. There’s a lot of misunderstanding about antibiotics and combined oral contraceptives.” She cited an ACOG practice bulletin that reported that only rifampin has been shown to reduce serum steroid levels when taken with oral contraceptives (Obstet Gynecol. 2006 Jun;107[6]:1453-72).

According to the 2016 AAD guidelines, the use of oral glucocorticoids may be appropriate over the short term when initiating therapy for severe inflammatory acne. “Pharmacokinetic studies have not demonstrated decreased oral contraceptive levels with common antibiotics,” Dr. Thiboutot said.

Spironolactone, according to the new guidelines, is useful for acne in select females. Spironolactone is an androgen receptor and 5a-reductase blocker, and its antiandrogen effects can improve acne. Many patients do well with 25-50 mg twice daily, though breast tenderness and menstrual irregularities are commonly seen side effects, she noted. If a woman taking spironolactone becomes pregnant, there’s a risk of hypospadias for a male fetus.

Though spironolactone carries a boxed warning because of tumorigenicity observed in animal studies, Dr. Thiboutot said that a large Danish study searched for any association between breast, uterine, or ovarian cancers and spironolactone use. Among the 2.3 million women studied, no increased association was seen (Cancer Epidemiol. 2013 Dec;37:870-5).

She also noted that there’s “low usefulness in monitoring potassium levels in young healthy women on spironolactone.” She cited a study that compared 974 healthy young women taking spironolactone with 1,165 women who were not on spironolactone, which found that the hyperkalemia rate of 0.72% among those on spironolactone was equivalent to the 0.76% baseline rate of hyperkalemia in the young, healthy female population (JAMA Dermatol. 2015;151[9];941-944).

Oral corticosteroids for acne, Dr. Thiboutot said, should be reserved to quiet a severe bout of inflammatory acne while standard therapies are being initiated.

She reported being an investigator or a consultant for a number of pharmaceutical companies.

koakes@frontlinemedcom.com

On Twitter @karioakes

MINNEAPOLIS – Whether a young female patient has a refractory flare of inflammatory acne, or has a condition that can predispose to androgen excess, using a hormonal approach can be an effective management tool for controlling adolescent acne.

During a presentation at the annual meeting of the Society for Pediatric Dermatology, Dr. Diane Thiboutot outlined tips and tricks for optimizing hormonal therapy for acne in teens, and referred to the new acne treatment guidelines from the American Academy of Dermatology, which clarify when to treat with hormones, which to choose, and when further testing might be indicated.

The full range of hormonal therapy options for acne can include oral contraceptives, which block ovarian hormone production; antiandrogens such as spironolactone, and the less commonly used flutamide, which blocks the effects of androgen on the skin; and glucocorticoids, which block adrenal production.

The 2016 guidelines recommend oral contraceptives as an effective treatment for inflammatory acne in females (J Am Acad Dermatol. 2016 May;74[5]; 945-973.e33). Combined oral contraceptives (COCs) reduce serum androgens, and reduce free testosterone by increasing sex hormone binding globulin production, thus reducing sebum production. “The only things that really decrease sebum are oral contraceptives in women, and isotretinoin,” said Dr. Thiboutot, professor of dermatology at Penn State University, Hershey.

For most female adolescents with acne, hormonal testing is not indicated. The AAD guidelines recommend laboratory evaluation for younger patients with acne who have clinical signs of androgen excess, such as early onset body odor and axillary and/or pubic hair, accelerated growth, advanced bone age, or early genital maturation. Just obtaining a hand film for bone age and mapping growth against a growth chart can be a good initial screening tool when considering whether to perform hormonal testing, she noted.

For postpubertal females in whom polycystic ovary syndrome (PCOS) or other hyperandrogenic states are suspected, hormonal testing is indicated in the presence of the clinical signs of infrequent menses and infertility, hirsutism, truncal obesity, androgenetic alopecia, polycystic ovaries, or clitoromegaly.

In searching for an endocrine disorder, Dr. Thiboutot recommends checking total and free testosterone, luteinizing hormone/follicle stimulating hormone ratio, 17-hydroxyprogesterone levels, and dehydroepiandrosterone (DHEA-S) levels. These tests should be performed at least 6 weeks after the patient has been off hormonal contraception, and should be done during the menstrual period, or during the week prior to menses, in order to avoid ovulation-related hormonal changes.

Lab findings consistent with congenital adrenal hyperplasia include elevated serum DHEA-S, together with elevated 17-hydroxyprogesterone or testosterone. A PCOS diagnosis can be made in adolescent females if there is clinical or laboratory evidence of hyperandrogenism with concomitant persistent oligomenorrhea.

Acne related to hyperandrogenism may respond well to oral contraceptives, but COCs can also be an effective alternative to repeated courses of isotretinoin and antibiotics, as well as an effective adjunct to topical therapy, Dr. Thiboutot said.

When beginning a patient on oral contraceptives, it’s not necessary to perform a pelvic exam or obtain a Pap smear before initiating the COC, but it is important to obtain a thorough medical history and an accurate blood pressure measurement at the outset, she noted. The World Health Organization (WHO) has established recommendations outlining contraindications to COC use, also identifying populations in whom COCs should be used with caution, and who should be monitored.

Headaches are a condition frequently seen among healthy teens and young women, and one for which the WHO advises caution. There are concerns that women with migraines may be at increased risk of stroke if they take COCs, but the overall risk is low, and the American College of Obstetricians and Gynecologists (ACOG) advises that COCs can be considered for women younger than 35 with migraines if they have no focal neurologic signs, are nonsmokers, and are otherwise healthy, Dr. Thiboutot added.

A large Food and Drug Administration–sponsored retrospective cohort study examined the risk of venous thromboembolism in contraceptive users. In April 2012, the FDA concluded that though the risk of blood clots may be higher for those on hormonal contraception methods than for those who are not using them, the risk of blood clots during pregnancy and the postpartum period is higher than the thromboembolism risk for contraceptive users.

Regarding the potential for antibiotics to reduce contraceptive efficacy, Dr. Thiboutot said,“it’s okay to use oral contraceptives with antibiotics. There’s a lot of misunderstanding about antibiotics and combined oral contraceptives.” She cited an ACOG practice bulletin that reported that only rifampin has been shown to reduce serum steroid levels when taken with oral contraceptives (Obstet Gynecol. 2006 Jun;107[6]:1453-72).

According to the 2016 AAD guidelines, the use of oral glucocorticoids may be appropriate over the short term when initiating therapy for severe inflammatory acne. “Pharmacokinetic studies have not demonstrated decreased oral contraceptive levels with common antibiotics,” Dr. Thiboutot said.

Spironolactone, according to the new guidelines, is useful for acne in select females. Spironolactone is an androgen receptor and 5a-reductase blocker, and its antiandrogen effects can improve acne. Many patients do well with 25-50 mg twice daily, though breast tenderness and menstrual irregularities are commonly seen side effects, she noted. If a woman taking spironolactone becomes pregnant, there’s a risk of hypospadias for a male fetus.

Though spironolactone carries a boxed warning because of tumorigenicity observed in animal studies, Dr. Thiboutot said that a large Danish study searched for any association between breast, uterine, or ovarian cancers and spironolactone use. Among the 2.3 million women studied, no increased association was seen (Cancer Epidemiol. 2013 Dec;37:870-5).

She also noted that there’s “low usefulness in monitoring potassium levels in young healthy women on spironolactone.” She cited a study that compared 974 healthy young women taking spironolactone with 1,165 women who were not on spironolactone, which found that the hyperkalemia rate of 0.72% among those on spironolactone was equivalent to the 0.76% baseline rate of hyperkalemia in the young, healthy female population (JAMA Dermatol. 2015;151[9];941-944).

Oral corticosteroids for acne, Dr. Thiboutot said, should be reserved to quiet a severe bout of inflammatory acne while standard therapies are being initiated.

She reported being an investigator or a consultant for a number of pharmaceutical companies.

koakes@frontlinemedcom.com

On Twitter @karioakes

MINNEAPOLIS – Whether a young female patient has a refractory flare of inflammatory acne, or has a condition that can predispose to androgen excess, using a hormonal approach can be an effective management tool for controlling adolescent acne.

During a presentation at the annual meeting of the Society for Pediatric Dermatology, Dr. Diane Thiboutot outlined tips and tricks for optimizing hormonal therapy for acne in teens, and referred to the new acne treatment guidelines from the American Academy of Dermatology, which clarify when to treat with hormones, which to choose, and when further testing might be indicated.

The full range of hormonal therapy options for acne can include oral contraceptives, which block ovarian hormone production; antiandrogens such as spironolactone, and the less commonly used flutamide, which blocks the effects of androgen on the skin; and glucocorticoids, which block adrenal production.

The 2016 guidelines recommend oral contraceptives as an effective treatment for inflammatory acne in females (J Am Acad Dermatol. 2016 May;74[5]; 945-973.e33). Combined oral contraceptives (COCs) reduce serum androgens, and reduce free testosterone by increasing sex hormone binding globulin production, thus reducing sebum production. “The only things that really decrease sebum are oral contraceptives in women, and isotretinoin,” said Dr. Thiboutot, professor of dermatology at Penn State University, Hershey.

For most female adolescents with acne, hormonal testing is not indicated. The AAD guidelines recommend laboratory evaluation for younger patients with acne who have clinical signs of androgen excess, such as early onset body odor and axillary and/or pubic hair, accelerated growth, advanced bone age, or early genital maturation. Just obtaining a hand film for bone age and mapping growth against a growth chart can be a good initial screening tool when considering whether to perform hormonal testing, she noted.

For postpubertal females in whom polycystic ovary syndrome (PCOS) or other hyperandrogenic states are suspected, hormonal testing is indicated in the presence of the clinical signs of infrequent menses and infertility, hirsutism, truncal obesity, androgenetic alopecia, polycystic ovaries, or clitoromegaly.

In searching for an endocrine disorder, Dr. Thiboutot recommends checking total and free testosterone, luteinizing hormone/follicle stimulating hormone ratio, 17-hydroxyprogesterone levels, and dehydroepiandrosterone (DHEA-S) levels. These tests should be performed at least 6 weeks after the patient has been off hormonal contraception, and should be done during the menstrual period, or during the week prior to menses, in order to avoid ovulation-related hormonal changes.

Lab findings consistent with congenital adrenal hyperplasia include elevated serum DHEA-S, together with elevated 17-hydroxyprogesterone or testosterone. A PCOS diagnosis can be made in adolescent females if there is clinical or laboratory evidence of hyperandrogenism with concomitant persistent oligomenorrhea.

Acne related to hyperandrogenism may respond well to oral contraceptives, but COCs can also be an effective alternative to repeated courses of isotretinoin and antibiotics, as well as an effective adjunct to topical therapy, Dr. Thiboutot said.

When beginning a patient on oral contraceptives, it’s not necessary to perform a pelvic exam or obtain a Pap smear before initiating the COC, but it is important to obtain a thorough medical history and an accurate blood pressure measurement at the outset, she noted. The World Health Organization (WHO) has established recommendations outlining contraindications to COC use, also identifying populations in whom COCs should be used with caution, and who should be monitored.

Headaches are a condition frequently seen among healthy teens and young women, and one for which the WHO advises caution. There are concerns that women with migraines may be at increased risk of stroke if they take COCs, but the overall risk is low, and the American College of Obstetricians and Gynecologists (ACOG) advises that COCs can be considered for women younger than 35 with migraines if they have no focal neurologic signs, are nonsmokers, and are otherwise healthy, Dr. Thiboutot added.

A large Food and Drug Administration–sponsored retrospective cohort study examined the risk of venous thromboembolism in contraceptive users. In April 2012, the FDA concluded that though the risk of blood clots may be higher for those on hormonal contraception methods than for those who are not using them, the risk of blood clots during pregnancy and the postpartum period is higher than the thromboembolism risk for contraceptive users.

Regarding the potential for antibiotics to reduce contraceptive efficacy, Dr. Thiboutot said,“it’s okay to use oral contraceptives with antibiotics. There’s a lot of misunderstanding about antibiotics and combined oral contraceptives.” She cited an ACOG practice bulletin that reported that only rifampin has been shown to reduce serum steroid levels when taken with oral contraceptives (Obstet Gynecol. 2006 Jun;107[6]:1453-72).

According to the 2016 AAD guidelines, the use of oral glucocorticoids may be appropriate over the short term when initiating therapy for severe inflammatory acne. “Pharmacokinetic studies have not demonstrated decreased oral contraceptive levels with common antibiotics,” Dr. Thiboutot said.

Spironolactone, according to the new guidelines, is useful for acne in select females. Spironolactone is an androgen receptor and 5a-reductase blocker, and its antiandrogen effects can improve acne. Many patients do well with 25-50 mg twice daily, though breast tenderness and menstrual irregularities are commonly seen side effects, she noted. If a woman taking spironolactone becomes pregnant, there’s a risk of hypospadias for a male fetus.

Though spironolactone carries a boxed warning because of tumorigenicity observed in animal studies, Dr. Thiboutot said that a large Danish study searched for any association between breast, uterine, or ovarian cancers and spironolactone use. Among the 2.3 million women studied, no increased association was seen (Cancer Epidemiol. 2013 Dec;37:870-5).

She also noted that there’s “low usefulness in monitoring potassium levels in young healthy women on spironolactone.” She cited a study that compared 974 healthy young women taking spironolactone with 1,165 women who were not on spironolactone, which found that the hyperkalemia rate of 0.72% among those on spironolactone was equivalent to the 0.76% baseline rate of hyperkalemia in the young, healthy female population (JAMA Dermatol. 2015;151[9];941-944).

Oral corticosteroids for acne, Dr. Thiboutot said, should be reserved to quiet a severe bout of inflammatory acne while standard therapies are being initiated.

She reported being an investigator or a consultant for a number of pharmaceutical companies.

koakes@frontlinemedcom.com

On Twitter @karioakes

Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.

In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).

©s-c-s/Thinkstock

Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.

The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.

“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”

Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).

llaubach@frontlinemedcom.com

Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.

In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).

©s-c-s/Thinkstock

Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.

The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.

“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”

Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).

llaubach@frontlinemedcom.com

Sport-related concussion (SRC) recovery time can be reduced if athletes are removed from game participation, according to R.J. Elbin, PhD, of the University of Arkansas, Fayetteville, and his associates.

In the prospective study, 95 athletes sought care for an SRC at a concussion specialty clinic between Sept. 1 and Dec. 1, 2014. The athletes were divided into two groups: those who continued to play after experiencing signs and symptoms of an SRC and those who were immediately removed from play. The played group took longer to recover (44 days) than did the removed group (22 days) (P = .003).

©s-c-s/Thinkstock

Post hoc analyses revealed that the played group demonstrated significantly worse verbal and visual memory, processing speed, and reaction time, and higher symptoms (all P less than or equal to .001), compared with the removed group at 1-7 days. From 8 to 30 days post injury, the played group demonstrated worse verbal memory (P = .009), visual memory (P less than or equal to .001), processing speed (P = .001), and greater symptoms (P = .001), compared with the removed group.

The study also showed that athletes in the played group were 8.80 times more likely to experience a protracted recovery, compared with athletes in the removed group (21 days or longer) (P less than .001). Athletes participated in a variety of sports including football, soccer, ice hockey, volleyball, field hockey, rugby, basketball, and wrestling.

“This study is the first to show that athletes who continue to play with an SRC experience a longer recovery and more time away from the sport,” researchers concluded. “These findings should be incorporated into SRC education and awareness programs for athletes, coaches, parents, and medical professionals.”

Find the full study in Pediatrics (doi: 10.1542/peds.2016-0910).

llaubach@frontlinemedcom.com

A genetic modification of the plasminogen activator inhibitor-1 gene in conjunction with lower respiratory infections during early life was associated with increased risk of asthma, morbidities, and reduced lung function, according to Seong H. Cho, MD, and his associates.

A history of respiratory syncytial virus (RSV) and a history of other lower respiratory infections (LRIs) before the age of 2 were independently associated with asthma in Latino people aged 8-21, with odd ratios of 9.9 and 9.1, respectively, while PAI-1 was not independently associated. In combination, the OR for PAI-1/RSV increased to 17.7, and the OR for PAI-1/other LRIs increased to 11.7.

©SilverV/Thinkstock

Lung function was also adversely affected by the joint effect of PAI-1 and early life infection. In patients with PAI-1/LRI, forced expiratory volume in 1 second (FEV₁₎ percent predicted and FEV₁/forced vital capacity (FVC) percent predicted were significantly less than in the control group. Similar but less significant results were seen in the PAI-1/RSV group. Recurring hospitalizations were also significantly more likely in the PAI-1/RSV group, with an OR of 3.1.

“Further prospective studies are needed to replicate our RSV-genotype findings in other non-Latino populations, and determine if PAI-1 variants may serve as a biomarker of risk, which may provide impetus for clinical trials of primary prevention of asthma. In the interim, PAI-1 genotype in combination with significant LRI identifies individuals at increased risk of developing asthma,” the investigators wrote.

Find the full study in PLoS One (doi: 10.1371/journal.pone.0157848).

lfranki@frontlinemedcom.com

A genetic modification of the plasminogen activator inhibitor-1 gene in conjunction with lower respiratory infections during early life was associated with increased risk of asthma, morbidities, and reduced lung function, according to Seong H. Cho, MD, and his associates.

A history of respiratory syncytial virus (RSV) and a history of other lower respiratory infections (LRIs) before the age of 2 were independently associated with asthma in Latino people aged 8-21, with odd ratios of 9.9 and 9.1, respectively, while PAI-1 was not independently associated. In combination, the OR for PAI-1/RSV increased to 17.7, and the OR for PAI-1/other LRIs increased to 11.7.

©SilverV/Thinkstock

Lung function was also adversely affected by the joint effect of PAI-1 and early life infection. In patients with PAI-1/LRI, forced expiratory volume in 1 second (FEV₁₎ percent predicted and FEV₁/forced vital capacity (FVC) percent predicted were significantly less than in the control group. Similar but less significant results were seen in the PAI-1/RSV group. Recurring hospitalizations were also significantly more likely in the PAI-1/RSV group, with an OR of 3.1.

“Further prospective studies are needed to replicate our RSV-genotype findings in other non-Latino populations, and determine if PAI-1 variants may serve as a biomarker of risk, which may provide impetus for clinical trials of primary prevention of asthma. In the interim, PAI-1 genotype in combination with significant LRI identifies individuals at increased risk of developing asthma,” the investigators wrote.

Find the full study in PLoS One (doi: 10.1371/journal.pone.0157848).

lfranki@frontlinemedcom.com

A genetic modification of the plasminogen activator inhibitor-1 gene in conjunction with lower respiratory infections during early life was associated with increased risk of asthma, morbidities, and reduced lung function, according to Seong H. Cho, MD, and his associates.

A history of respiratory syncytial virus (RSV) and a history of other lower respiratory infections (LRIs) before the age of 2 were independently associated with asthma in Latino people aged 8-21, with odd ratios of 9.9 and 9.1, respectively, while PAI-1 was not independently associated. In combination, the OR for PAI-1/RSV increased to 17.7, and the OR for PAI-1/other LRIs increased to 11.7.

©SilverV/Thinkstock

Lung function was also adversely affected by the joint effect of PAI-1 and early life infection. In patients with PAI-1/LRI, forced expiratory volume in 1 second (FEV₁₎ percent predicted and FEV₁/forced vital capacity (FVC) percent predicted were significantly less than in the control group. Similar but less significant results were seen in the PAI-1/RSV group. Recurring hospitalizations were also significantly more likely in the PAI-1/RSV group, with an OR of 3.1.

“Further prospective studies are needed to replicate our RSV-genotype findings in other non-Latino populations, and determine if PAI-1 variants may serve as a biomarker of risk, which may provide impetus for clinical trials of primary prevention of asthma. In the interim, PAI-1 genotype in combination with significant LRI identifies individuals at increased risk of developing asthma,” the investigators wrote.

Find the full study in PLoS One (doi: 10.1371/journal.pone.0157848).

lfranki@frontlinemedcom.com

Red blood cell culture showing

Staphylococcus infection

Photo by Bill Branson

Ambulatory bloodstream infections (BSIs) can be costly in young cancer patients and recipients of hematopoietic stem cell transplants, according to research published in Pediatric Blood & Cancer.

Among the 61 patients studied, the median cost for an ambulatory BSI was $40,852, and the median length of hospital stay was 7 days.

For patients who were hospitalized for BSI and other medical issues, the cost and length of stay were much higher.

“This issue has resonance beyond the pediatric stem cell transplant and oncology patient population,” said study author Amy Billett, MD, of the Dana–Farber Cancer Institute and Boston Children’s Hospital in Massachusetts.

“At a time when many aspects of care are being shifted to the home and of heightened attention to safety and cost, this is the new frontier. What we learn about preventing outpatient bloodstream infections in these patients could have broad relevance.”

To determine the economic and hospitalization impact of ambulatory BSIs, Dr Billet and her colleagues retrospectively analyzed data on outpatient BSIs at Dana-Farber/Boston Children’s that occurred between January 1, 2012, and December 31, 2013, and resulted in hospitalization.

The team identified 74 BSIs in 61 patients. Sixty-nine percent of these infections were classified as central-line-associated bloodstream infections.

In 43% of BSIs, the patient’s central line had to be surgically removed. In 15% of cases, the child was transferred to the intensive care unit. Four patients died during hospitalization, and 3 of these deaths were associated with the infections.

Most of the hospitalizations analyzed—62—were due solely to BSIs. The remainder involved at least 1 other medical issue.

The median total cost of BSIs was $40,852, and the median length of hospital stay was 7 days.

The median cost was $36,611 among patients who were hospitalized for BSIs alone (n=62) and $89,935 for patients who were hospitalized for other medical issues as well. The median lengths of hospital stay were 6 days and 15 days, respectively.

The top 3 drivers of cost for all BSIs were room and board (43%), non-chemotherapy medications (22%), and procedures (11%).

Room and board accounted for 42% of charges among patients who were hospitalized for BSIs alone and 44% among the other patients. Non-chemotherapy medications accounted for 20% and 25%, respectively. And procedures accounted for 11% and 10%, respectively.

“Behind these metrics are real and serious risks to patients’ health,” said study author Chris Wong, MD, of Dana-Farber/Boston Children’s.

“The bottom line is that the dollar cost and lengthy hospital stays signal complications that could become life-threatening or delay treatment of the children’s cancer. Reducing these infections is important both for cost containment and quality of care.”

Red blood cell culture showing

Staphylococcus infection

Photo by Bill Branson

Ambulatory bloodstream infections (BSIs) can be costly in young cancer patients and recipients of hematopoietic stem cell transplants, according to research published in Pediatric Blood & Cancer.

Among the 61 patients studied, the median cost for an ambulatory BSI was $40,852, and the median length of hospital stay was 7 days.

For patients who were hospitalized for BSI and other medical issues, the cost and length of stay were much higher.

“This issue has resonance beyond the pediatric stem cell transplant and oncology patient population,” said study author Amy Billett, MD, of the Dana–Farber Cancer Institute and Boston Children’s Hospital in Massachusetts.

“At a time when many aspects of care are being shifted to the home and of heightened attention to safety and cost, this is the new frontier. What we learn about preventing outpatient bloodstream infections in these patients could have broad relevance.”

To determine the economic and hospitalization impact of ambulatory BSIs, Dr Billet and her colleagues retrospectively analyzed data on outpatient BSIs at Dana-Farber/Boston Children’s that occurred between January 1, 2012, and December 31, 2013, and resulted in hospitalization.

The team identified 74 BSIs in 61 patients. Sixty-nine percent of these infections were classified as central-line-associated bloodstream infections.

In 43% of BSIs, the patient’s central line had to be surgically removed. In 15% of cases, the child was transferred to the intensive care unit. Four patients died during hospitalization, and 3 of these deaths were associated with the infections.

Most of the hospitalizations analyzed—62—were due solely to BSIs. The remainder involved at least 1 other medical issue.

The median total cost of BSIs was $40,852, and the median length of hospital stay was 7 days.

The median cost was $36,611 among patients who were hospitalized for BSIs alone (n=62) and $89,935 for patients who were hospitalized for other medical issues as well. The median lengths of hospital stay were 6 days and 15 days, respectively.

The top 3 drivers of cost for all BSIs were room and board (43%), non-chemotherapy medications (22%), and procedures (11%).

Room and board accounted for 42% of charges among patients who were hospitalized for BSIs alone and 44% among the other patients. Non-chemotherapy medications accounted for 20% and 25%, respectively. And procedures accounted for 11% and 10%, respectively.

“Behind these metrics are real and serious risks to patients’ health,” said study author Chris Wong, MD, of Dana-Farber/Boston Children’s.

“The bottom line is that the dollar cost and lengthy hospital stays signal complications that could become life-threatening or delay treatment of the children’s cancer. Reducing these infections is important both for cost containment and quality of care.”

Red blood cell culture showing

Staphylococcus infection

Photo by Bill Branson

Ambulatory bloodstream infections (BSIs) can be costly in young cancer patients and recipients of hematopoietic stem cell transplants, according to research published in Pediatric Blood & Cancer.

Among the 61 patients studied, the median cost for an ambulatory BSI was $40,852, and the median length of hospital stay was 7 days.

For patients who were hospitalized for BSI and other medical issues, the cost and length of stay were much higher.

“This issue has resonance beyond the pediatric stem cell transplant and oncology patient population,” said study author Amy Billett, MD, of the Dana–Farber Cancer Institute and Boston Children’s Hospital in Massachusetts.

“At a time when many aspects of care are being shifted to the home and of heightened attention to safety and cost, this is the new frontier. What we learn about preventing outpatient bloodstream infections in these patients could have broad relevance.”

To determine the economic and hospitalization impact of ambulatory BSIs, Dr Billet and her colleagues retrospectively analyzed data on outpatient BSIs at Dana-Farber/Boston Children’s that occurred between January 1, 2012, and December 31, 2013, and resulted in hospitalization.

The team identified 74 BSIs in 61 patients. Sixty-nine percent of these infections were classified as central-line-associated bloodstream infections.

In 43% of BSIs, the patient’s central line had to be surgically removed. In 15% of cases, the child was transferred to the intensive care unit. Four patients died during hospitalization, and 3 of these deaths were associated with the infections.

Most of the hospitalizations analyzed—62—were due solely to BSIs. The remainder involved at least 1 other medical issue.

The median total cost of BSIs was $40,852, and the median length of hospital stay was 7 days.

The median cost was $36,611 among patients who were hospitalized for BSIs alone (n=62) and $89,935 for patients who were hospitalized for other medical issues as well. The median lengths of hospital stay were 6 days and 15 days, respectively.

The top 3 drivers of cost for all BSIs were room and board (43%), non-chemotherapy medications (22%), and procedures (11%).

Room and board accounted for 42% of charges among patients who were hospitalized for BSIs alone and 44% among the other patients. Non-chemotherapy medications accounted for 20% and 25%, respectively. And procedures accounted for 11% and 10%, respectively.

“Behind these metrics are real and serious risks to patients’ health,” said study author Chris Wong, MD, of Dana-Farber/Boston Children’s.

“The bottom line is that the dollar cost and lengthy hospital stays signal complications that could become life-threatening or delay treatment of the children’s cancer. Reducing these infections is important both for cost containment and quality of care.”

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

jevans@frontlinemedcom.com

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

jevans@frontlinemedcom.com

A biosimilar of etanercept received clearance for marketing from the Food and Drug Administration on Aug. 30 for all of the inflammatory disease indications held by the reference originator etanercept product, Enbrel, according to an announcement from the agency.

Approval for all of Enbrel’s indications – rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis – was initially met with skepticism by members of the agency’s Arthritis Advisory Committee at a meeting in July because the biosimilar was compared against Enbrel in patients with plaque psoriasis only, but eventually all panel members voted to recommend approval.

The approval allows the biosimilar etanercept, called etanercept-szzs, to be marketed as a biosimilar only, not as an interchangeable product. The FDA has not yet developed guidance for manufacturers to follow to get approval for interchangeability, which means that a biosimilar “may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product,” according to the agency.

“We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s announcement.

Etanercept-szzs will be marketed by Sandoz as Erelzi. Erelzi’s prescribing information can be found here. The biosimilar is currently undergoing review with the European Medicines Agency.

jevans@frontlinemedcom.com

Unvaccinated newborns and infants 42 days old or younger had significantly fewer rotavirus infections after the introduction of a universal mass vaccination (UMV) program, based on a decade of surveillance data from 11 pediatric care facilities in Austria.

“The present study aimed to investigate the long-term effect of UMV on rotavirus (RV)–associated hospitalizations, with particular focus on neonates and infants less than 6 weeks of age, comparing surveillance data between the prevaccination and postvaccination periods,” wrote Martina Prelog, MD, of University Hospital Wuerzburg (Germany), and her colleagues.

CDC/Dr. Erskine Palmer

The data included 10,960 laboratory-confirmed cases of RV covering the periods before and after the initiation of the mass vaccination program.

Overall, hospitalizations for community-acquired RV infections dropped by almost 90% across all age groups. Among young infants, nosocomial RV infection rates were 28% prior to the vaccination program and 19% afterwards. However, overall nosocomial RV infection rates increased from 6% before the vaccination program to 13% after the program, and 6% of the cases were breakthrough infections, generally after incomplete RV vaccination.

“High numbers of documented cases and similar trends in all centers bolster the conclusion that UMV with RV vaccination may be associated with lower rates of RV hospitalization in unvaccinated neonates and young infants, supporting the beneficial role of UMV,” Dr. Prelog and her associates wrote.

Find the full study here in the Journal of Infectious Diseases (2016. doi: 10.1093/infdis/jiw186).

Unvaccinated newborns and infants 42 days old or younger had significantly fewer rotavirus infections after the introduction of a universal mass vaccination (UMV) program, based on a decade of surveillance data from 11 pediatric care facilities in Austria.

“The present study aimed to investigate the long-term effect of UMV on rotavirus (RV)–associated hospitalizations, with particular focus on neonates and infants less than 6 weeks of age, comparing surveillance data between the prevaccination and postvaccination periods,” wrote Martina Prelog, MD, of University Hospital Wuerzburg (Germany), and her colleagues.

CDC/Dr. Erskine Palmer

The data included 10,960 laboratory-confirmed cases of RV covering the periods before and after the initiation of the mass vaccination program.

Overall, hospitalizations for community-acquired RV infections dropped by almost 90% across all age groups. Among young infants, nosocomial RV infection rates were 28% prior to the vaccination program and 19% afterwards. However, overall nosocomial RV infection rates increased from 6% before the vaccination program to 13% after the program, and 6% of the cases were breakthrough infections, generally after incomplete RV vaccination.

“High numbers of documented cases and similar trends in all centers bolster the conclusion that UMV with RV vaccination may be associated with lower rates of RV hospitalization in unvaccinated neonates and young infants, supporting the beneficial role of UMV,” Dr. Prelog and her associates wrote.

Find the full study here in the Journal of Infectious Diseases (2016. doi: 10.1093/infdis/jiw186).

Unvaccinated newborns and infants 42 days old or younger had significantly fewer rotavirus infections after the introduction of a universal mass vaccination (UMV) program, based on a decade of surveillance data from 11 pediatric care facilities in Austria.

“The present study aimed to investigate the long-term effect of UMV on rotavirus (RV)–associated hospitalizations, with particular focus on neonates and infants less than 6 weeks of age, comparing surveillance data between the prevaccination and postvaccination periods,” wrote Martina Prelog, MD, of University Hospital Wuerzburg (Germany), and her colleagues.

CDC/Dr. Erskine Palmer

The data included 10,960 laboratory-confirmed cases of RV covering the periods before and after the initiation of the mass vaccination program.

Overall, hospitalizations for community-acquired RV infections dropped by almost 90% across all age groups. Among young infants, nosocomial RV infection rates were 28% prior to the vaccination program and 19% afterwards. However, overall nosocomial RV infection rates increased from 6% before the vaccination program to 13% after the program, and 6% of the cases were breakthrough infections, generally after incomplete RV vaccination.

“High numbers of documented cases and similar trends in all centers bolster the conclusion that UMV with RV vaccination may be associated with lower rates of RV hospitalization in unvaccinated neonates and young infants, supporting the beneficial role of UMV,” Dr. Prelog and her associates wrote.

Find the full study here in the Journal of Infectious Diseases (2016. doi: 10.1093/infdis/jiw186).

In an increasingly sleepless society inundated with caffeine drinks and social media, it is not surprising that 15%-30% of teens present with complaints of fatigue.¹ As fatigue can be a symptom of many disorders, a careful work-up is important.

Fewer than 8 hours’ sleep, large intake of caffeine, and several hours on social media each day are linked with fatigue. Poor eating habits are more likely than not; nearly 21% of teens are overweight.² Video games have also contributed to symptoms of fatigue by encouraging a sedentary life style.

The work-up for teens with fatigue requires a detailed history of present symptoms and a careful review of systems, which should specifically address weight gain or loss, menstrual change, palpitations, and respiratory changes. It is important to screen for signs of stress and depression.

The physical exam should identify systems that need further work-up, and a standard serum screen would include a complete blood cell count (CBC), complete metabolic panel (CMP), and a thyroid panel.

As many experienced physicians can attest, more often than not, this work-up results in normal findings. Suggesting that the basis for fatigue may be a psychiatric cause is usually not well received.

Another consideration is a diagnosis of chronic fatigue syndrome (CFS), a well-documented disorder with defined diagnostic criteria since 1994. Although CFS is more common in adults, research now reveals an annual incidence of 0.5% and a prevalence of 0.19%-1.29% in teens.³ The characteristics are severe and disabling new-onset fatigue lasting greater than 6 months and four of the following symptoms: impaired memory, sore throat, tender cervical and axillary lymph nodes, muscle pain, headaches, unrefreshing sleep, generalized malaise. Orthostatic intolerance has also been identified as a symptom.⁴

The cause of CFS is unknown, although its onset usually follows an illness.¹ The diagnosis is challenging, as there is no definitive test. If the criteria are met, however, a diagnosis of CFS should be given. This allows the patient to feel validated and can foster a better physician-patient relationship.

Treatment for CFS is symptomatic. The first step is good “sleep hygiene.” Reducing or eliminating caffeine and promoting exercise and a healthy diet all contribute to better sleep. Also, the blue light emitted by electronic devices suppresses melatonin and makes it more difficult to fall asleep.⁵

Resuming normal activity and improving school attendance is the goal achieved through graded exercises, behavioral therapy, and management of pain with acetaminophen and NSAIDs. Tricyclic antidepressants have been studied in CFS but their effectiveness has not been proven.¹ Significant improvements are seen in 50% of teens who are appropriately diagnosed and adhere to treatments.¹

CFS is a debilitating disorder that can be frustrating to treat. Acknowledging CFS as a legitimate syndrome can aid in treatment by fostering a good physician-patient relationship.

References

1. Findlay, SM. “The Tired Teen: A Review of the Assessment and Management of the Adolescent with Sleepiness and Fatigue” Paediatr Child Health. 2008 Jan;13(1):37-42. Print.

2. Prevalence of Childhood Obesity in the United States, 2011-2012, CDC.

3. Nijhof SL, et al. “Adolescent Chronic Fatigue Syndrome: Prevalence, Incidence, and Morbidity” Pediatrics. 2011 May;127(5):e1169-e1175.

4. Orthostatic intolerance in adolescent chronic fatigue syndrome. Stewart JM, et al. Pediatrics. 1999 Jan;103(1):116-21.

5. “The impact of light from computer monitors on melatonin levels in college students” Figueiro MG, et al. Neuro Endocrinol Lett. 2011;32(2):158-163.

In an increasingly sleepless society inundated with caffeine drinks and social media, it is not surprising that 15%-30% of teens present with complaints of fatigue.¹ As fatigue can be a symptom of many disorders, a careful work-up is important.

Fewer than 8 hours’ sleep, large intake of caffeine, and several hours on social media each day are linked with fatigue. Poor eating habits are more likely than not; nearly 21% of teens are overweight.² Video games have also contributed to symptoms of fatigue by encouraging a sedentary life style.

The work-up for teens with fatigue requires a detailed history of present symptoms and a careful review of systems, which should specifically address weight gain or loss, menstrual change, palpitations, and respiratory changes. It is important to screen for signs of stress and depression.

The physical exam should identify systems that need further work-up, and a standard serum screen would include a complete blood cell count (CBC), complete metabolic panel (CMP), and a thyroid panel.

As many experienced physicians can attest, more often than not, this work-up results in normal findings. Suggesting that the basis for fatigue may be a psychiatric cause is usually not well received.

Another consideration is a diagnosis of chronic fatigue syndrome (CFS), a well-documented disorder with defined diagnostic criteria since 1994. Although CFS is more common in adults, research now reveals an annual incidence of 0.5% and a prevalence of 0.19%-1.29% in teens.³ The characteristics are severe and disabling new-onset fatigue lasting greater than 6 months and four of the following symptoms: impaired memory, sore throat, tender cervical and axillary lymph nodes, muscle pain, headaches, unrefreshing sleep, generalized malaise. Orthostatic intolerance has also been identified as a symptom.⁴

The cause of CFS is unknown, although its onset usually follows an illness.¹ The diagnosis is challenging, as there is no definitive test. If the criteria are met, however, a diagnosis of CFS should be given. This allows the patient to feel validated and can foster a better physician-patient relationship.

Treatment for CFS is symptomatic. The first step is good “sleep hygiene.” Reducing or eliminating caffeine and promoting exercise and a healthy diet all contribute to better sleep. Also, the blue light emitted by electronic devices suppresses melatonin and makes it more difficult to fall asleep.⁵

Resuming normal activity and improving school attendance is the goal achieved through graded exercises, behavioral therapy, and management of pain with acetaminophen and NSAIDs. Tricyclic antidepressants have been studied in CFS but their effectiveness has not been proven.¹ Significant improvements are seen in 50% of teens who are appropriately diagnosed and adhere to treatments.¹

CFS is a debilitating disorder that can be frustrating to treat. Acknowledging CFS as a legitimate syndrome can aid in treatment by fostering a good physician-patient relationship.

References

1. Findlay, SM. “The Tired Teen: A Review of the Assessment and Management of the Adolescent with Sleepiness and Fatigue” Paediatr Child Health. 2008 Jan;13(1):37-42. Print.

2. Prevalence of Childhood Obesity in the United States, 2011-2012, CDC.

3. Nijhof SL, et al. “Adolescent Chronic Fatigue Syndrome: Prevalence, Incidence, and Morbidity” Pediatrics. 2011 May;127(5):e1169-e1175.

4. Orthostatic intolerance in adolescent chronic fatigue syndrome. Stewart JM, et al. Pediatrics. 1999 Jan;103(1):116-21.

5. “The impact of light from computer monitors on melatonin levels in college students” Figueiro MG, et al. Neuro Endocrinol Lett. 2011;32(2):158-163.

In an increasingly sleepless society inundated with caffeine drinks and social media, it is not surprising that 15%-30% of teens present with complaints of fatigue.¹ As fatigue can be a symptom of many disorders, a careful work-up is important.

Fewer than 8 hours’ sleep, large intake of caffeine, and several hours on social media each day are linked with fatigue. Poor eating habits are more likely than not; nearly 21% of teens are overweight.² Video games have also contributed to symptoms of fatigue by encouraging a sedentary life style.

The work-up for teens with fatigue requires a detailed history of present symptoms and a careful review of systems, which should specifically address weight gain or loss, menstrual change, palpitations, and respiratory changes. It is important to screen for signs of stress and depression.

The physical exam should identify systems that need further work-up, and a standard serum screen would include a complete blood cell count (CBC), complete metabolic panel (CMP), and a thyroid panel.

As many experienced physicians can attest, more often than not, this work-up results in normal findings. Suggesting that the basis for fatigue may be a psychiatric cause is usually not well received.

Another consideration is a diagnosis of chronic fatigue syndrome (CFS), a well-documented disorder with defined diagnostic criteria since 1994. Although CFS is more common in adults, research now reveals an annual incidence of 0.5% and a prevalence of 0.19%-1.29% in teens.³ The characteristics are severe and disabling new-onset fatigue lasting greater than 6 months and four of the following symptoms: impaired memory, sore throat, tender cervical and axillary lymph nodes, muscle pain, headaches, unrefreshing sleep, generalized malaise. Orthostatic intolerance has also been identified as a symptom.⁴

The cause of CFS is unknown, although its onset usually follows an illness.¹ The diagnosis is challenging, as there is no definitive test. If the criteria are met, however, a diagnosis of CFS should be given. This allows the patient to feel validated and can foster a better physician-patient relationship.

Treatment for CFS is symptomatic. The first step is good “sleep hygiene.” Reducing or eliminating caffeine and promoting exercise and a healthy diet all contribute to better sleep. Also, the blue light emitted by electronic devices suppresses melatonin and makes it more difficult to fall asleep.⁵

Resuming normal activity and improving school attendance is the goal achieved through graded exercises, behavioral therapy, and management of pain with acetaminophen and NSAIDs. Tricyclic antidepressants have been studied in CFS but their effectiveness has not been proven.¹ Significant improvements are seen in 50% of teens who are appropriately diagnosed and adhere to treatments.¹

CFS is a debilitating disorder that can be frustrating to treat. Acknowledging CFS as a legitimate syndrome can aid in treatment by fostering a good physician-patient relationship.

References

1. Findlay, SM. “The Tired Teen: A Review of the Assessment and Management of the Adolescent with Sleepiness and Fatigue” Paediatr Child Health. 2008 Jan;13(1):37-42. Print.

2. Prevalence of Childhood Obesity in the United States, 2011-2012, CDC.

3. Nijhof SL, et al. “Adolescent Chronic Fatigue Syndrome: Prevalence, Incidence, and Morbidity” Pediatrics. 2011 May;127(5):e1169-e1175.

4. Orthostatic intolerance in adolescent chronic fatigue syndrome. Stewart JM, et al. Pediatrics. 1999 Jan;103(1):116-21.

5. “The impact of light from computer monitors on melatonin levels in college students” Figueiro MG, et al. Neuro Endocrinol Lett. 2011;32(2):158-163.

Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

yktr/ThinkStock

The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG₄ production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

yktr/ThinkStock

The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG₄ production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

yktr/ThinkStock

The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG₄ production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

Congenital Zika virus infection may be associated with sensorineural hearing loss, according to the latest Morbidity and Mortality Weekly Report published by the CDC.

“In the majority of cases of hearing loss associated with congenital viral infection, the damage to the auditory system is within the cochlea,” wrote the authors of the MMWR, led by Mariana C. Leal, PhD of the Hospital Agamenon Magalhães in Recife, Brazil. “It is likely that similar lesions account for the hearing deficit in children with congenital Zika virus infection” (MMWR. 2016 Aug 30.65:1-4)

©Devonyu/Thinkstock

Full auditory function evaluations were performed on 70 children born with microcephaly, all of whom had confirmed laboratory evidence of congenital Zika virus. One child with bilateral profound sensorineural hearing loss was excluded because the child had already received treatment with amikacin (a known ototoxic antibiotic) prior to evaluation for this study. All children were ages 0-10 months; investigators defined Zika-associated microcephaly as head circumference of 32 cm or lower at birth. Gestational ages at birth ranged from 37 weeks to 1 day shy of 42 weeks.

Of the 69 children included for analysis, four (5.8%) were found to have sensorineural hearing loss with no other potential cause, which the investigators noted is “within the range (6%-65%) reported for other congenital viral infections.” The investigators also stated that the auditory issues were mainly evident in children whose mothers experienced a rash illness during the first trimester of their pregnancy.

“Children with evidence of congenital Zika virus infection who have normal initial screening tests should receive regular follow-up, because onset of hearing loss associated with other congenital viral infections can be delayed and the loss can be progressive,” the authors noted.

No disclosures or funding sources were reported.

dchitnis@frontlinemedcom.com

Congenital Zika virus infection may be associated with sensorineural hearing loss, according to the latest Morbidity and Mortality Weekly Report published by the CDC.

“In the majority of cases of hearing loss associated with congenital viral infection, the damage to the auditory system is within the cochlea,” wrote the authors of the MMWR, led by Mariana C. Leal, PhD of the Hospital Agamenon Magalhães in Recife, Brazil. “It is likely that similar lesions account for the hearing deficit in children with congenital Zika virus infection” (MMWR. 2016 Aug 30.65:1-4)

©Devonyu/Thinkstock

Full auditory function evaluations were performed on 70 children born with microcephaly, all of whom had confirmed laboratory evidence of congenital Zika virus. One child with bilateral profound sensorineural hearing loss was excluded because the child had already received treatment with amikacin (a known ototoxic antibiotic) prior to evaluation for this study. All children were ages 0-10 months; investigators defined Zika-associated microcephaly as head circumference of 32 cm or lower at birth. Gestational ages at birth ranged from 37 weeks to 1 day shy of 42 weeks.

Of the 69 children included for analysis, four (5.8%) were found to have sensorineural hearing loss with no other potential cause, which the investigators noted is “within the range (6%-65%) reported for other congenital viral infections.” The investigators also stated that the auditory issues were mainly evident in children whose mothers experienced a rash illness during the first trimester of their pregnancy.

“Children with evidence of congenital Zika virus infection who have normal initial screening tests should receive regular follow-up, because onset of hearing loss associated with other congenital viral infections can be delayed and the loss can be progressive,” the authors noted.

No disclosures or funding sources were reported.

dchitnis@frontlinemedcom.com

Congenital Zika virus infection may be associated with sensorineural hearing loss, according to the latest Morbidity and Mortality Weekly Report published by the CDC.

“In the majority of cases of hearing loss associated with congenital viral infection, the damage to the auditory system is within the cochlea,” wrote the authors of the MMWR, led by Mariana C. Leal, PhD of the Hospital Agamenon Magalhães in Recife, Brazil. “It is likely that similar lesions account for the hearing deficit in children with congenital Zika virus infection” (MMWR. 2016 Aug 30.65:1-4)

©Devonyu/Thinkstock

Full auditory function evaluations were performed on 70 children born with microcephaly, all of whom had confirmed laboratory evidence of congenital Zika virus. One child with bilateral profound sensorineural hearing loss was excluded because the child had already received treatment with amikacin (a known ototoxic antibiotic) prior to evaluation for this study. All children were ages 0-10 months; investigators defined Zika-associated microcephaly as head circumference of 32 cm or lower at birth. Gestational ages at birth ranged from 37 weeks to 1 day shy of 42 weeks.

Of the 69 children included for analysis, four (5.8%) were found to have sensorineural hearing loss with no other potential cause, which the investigators noted is “within the range (6%-65%) reported for other congenital viral infections.” The investigators also stated that the auditory issues were mainly evident in children whose mothers experienced a rash illness during the first trimester of their pregnancy.

“Children with evidence of congenital Zika virus infection who have normal initial screening tests should receive regular follow-up, because onset of hearing loss associated with other congenital viral infections can be delayed and the loss can be progressive,” the authors noted.

No disclosures or funding sources were reported.

dchitnis@frontlinemedcom.com

For years, pediatricians have sought a blessing from the American Academy of Pediatrics that acknowledged it was valid for members to dismiss families from their practice if they refused to vaccinate despite all attempts to persuade them. Now, a new clinical report has essentially delivered just that.

The report does not represent an official policy change from the AAP, but it does for the first time acknowledge that “firing” patients who persistently refuse vaccination is “an acceptable option” (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-2146).

“A number of pediatricians feel so strongly that if they don’t agree on vaccines, which are so basic to the delivery of care and have made such a big difference in children’s lives, how will they agree on a number of other things they’ll need to discuss?” Kathryn M. Edwards, MD, director of the Vanderbilt Vaccine Research Program, Nashville, Tenn., and a coauthor of the report, explained in an interview.

The AAP has received pressure from its members over recent years as increasing numbers of pediatricians choose to dismiss some or all of their patients whose parents were resolved not vaccinate, coauthor Jesse M. Hackell, MD, a practicing pediatrician and managing partner at Pomona Pediatrics, an affiliate of Boston Children’s Health Physicians, said in an interview.

In fact, a new study has revealed that 12% of pediatricians reported dismissing vaccine-refusing families in 2013, up from 6% in 2006. At the same time, the proportion of families refusing vaccines has nearly doubled in the same time.

“There was a groundswell of opinion that enough is enough and we can’t provide quality care if we can’t provide something we know is so important,” Dr. Hackell said. “We felt the Academy needed to stop being so adamantly opposed to the possibility of dismissal – not to recommend dismissal but simply to state it is an acceptable option.”

The AAP responds to fellows’ concerns

While the AAP continues to recommend doctors attempt to persuade families as long as possible to vaccinate, the new report discusses dismissal as a viable option as long as it adheres to relevant state laws that prohibit abandonment of patients.

“The decision to dismiss a family who continues to refuse immunization is not one that should be made lightly, nor should it be made without considering and respecting the reasons for the parents’ point of view,” the report states. “Nevertheless, the individual pediatrician may consider dismissal of families who refuse vaccination as an acceptable option.”

The report does note that some practice settings, such as hospitals or large health care organizations, may not allow dismissal of patients, and that pediatricians “should carefully evaluate the availability of other qualified providers for the family” if they live in an area with limited access to pediatric care.

But the report finally acknowledges those pediatricians who are “just philosophically wired to not accept vaccine refusals,” Stuart A. Cohen, MD, an assistant professor of pediatrics at the University of California, San Diego, and chair of AAP District 9 in California, said in an interview.

“It really interferes with your physician-patient relationship,” Dr. Cohen said, who was not a coauthor of the report.

Now, if pediatricians feel it necessary to dismiss nonvaccinating patients, “then the Academy understands because of concerns for other patients, but it must be done in a way that’s respectful and tries to ensure patients understand the safety and necessity of vaccines,” Dr. Edwards said.

The report still includes the AAP recommendation that “pediatricians continue to engage with vaccine-hesitant parents, provide other health care services to their children, and attempt to modify their opposition to vaccines.” And a number of members of the AAP’s infectious diseases and bioethics committees were uncomfortable with dismissing patients, Dr. Edwards said, but “there were certain people who needed this, who needed some blessing that this was not inappropriate after all the other things the pediatrician had done.”

Vaccines undergo thorough testing for safety and effectiveness

But the report also aims to provide pediatricians with strategies for doing everything possible first.

“We needed to address enabling the clinician to have some very specific talking points to use and not get involved in a philosophical discussion that can take an hour,” Dr. Hackell said. “They need to make a clear statement that vaccines are important, and if you don’t get them, bad things like death can happen.”

The report therefore provides a comprehensive overview of vaccine development, from the initial identification of the need for a vaccine through the various phases of clinical testing and ongoing postlicensure monitoring. This background information can arm pediatricians with foundational knowledge that’s helpful in talking with patients.

“Vaccine development is a long and arduous process, often lasting many years and involving a combination of public and private partnerships,” the report states. “The current system for developing, testing and regulating vaccines requires that the vaccines demonstrate both safety and efficacy before licensure and that long-term safety is monitored.”

The report briefly explains the multiple mechanisms for continuing to track and study adverse events and other safety concerns:

• Vaccine Adverse Events Reporting System (VAERS). A voluntary passive reporting system used to identify potential safety signals.

• Vaccine Safety Datalink (VSD). A network of linked databases from health care systems across the United States involving millions of individuals

• Post-Licensure Rapid Immunization Safety Monitoring system (PRISM). A system which monitors vaccine safety using health insurance claims data from 107 million individuals .

• Clinical Immunization Safety Assessment Project (CISA). A system that answers individual health care providers’ specific questions on vaccine safety.

Vaccine hesitancy and vaccine exemptions

Opposition to vaccination is not new, the report states, describing it as dating back to Edward Jenner’s smallpox vaccine in the early 1800s.

“Although vaccine hesitancy is not a new phenomenon, it may have a greater effect on public health today,” the report states. “With the ease of global travel, vaccine-preventable diseases are spread more quickly and may unexpectedly appear in areas where health care professionals are unfamiliar with their clinical presentation.”

The historical presence of vaccination opposition has led to circumstances in the United States today in which parents can seek nonmedical exemptions from vaccines in 47 states, and their use has increased with their availability. Yet, the increase in use of exemptions and of “alternative” immunization schedules runs the risk of eroding the herd immunity that protects the community, the report notes.

“For these reasons, we believe the better approach is to work to eliminate all nonmedical exemptions for childhood vaccines,” the authors write. The American Medical Association and the Infectious Diseases Society of America espouse this position, and the AAP is developing a similar statement.

“Families should not have to fear going to school or the grocery store or a house of worship and worry about their kids getting sick,” said Dr. Cohen. “We now strongly say that we need to work with legislators, families, and other advocates for children at the state level to spread more laws like California’s SB 277 that would abolish philosophical exemptions.”

Dr. Cohen also emphasized the importance of communicating to parents that there are no valid “alternative schedules” for vaccination. There is the Centers for Disease Control and Prevention recommended schedule and anything else is a “nonrecommended vaccine schedule because it hasn’t been studied.” That change in terminology drives home the point that the CDC schedule is the only one fully tested for safety and effectiveness.

Meanwhile, however, pediatricians need the tools to address vaccine hesitancy, starting with understanding it. The report describes the pattern of disease incidence, vaccine uptake, disease reduction, adverse event increase and resulting vaccine hesitancy, punctuated by periodic outbreaks that restore eroded confidence in vaccines.

“When diseases are present, parents are worried and want a vaccine, and when they’re gone, they don’t,” Dr. Edwards said. “We need to remember that there is a dependence on the maintenance of herd immunity by immunization by your neighbors.”

Specific strategies to counter vaccine hesitancy

Just over half of physicians spend 10-19 minutes discussing vaccines with concerned parents, and 8% spend at least 20 minutes with such parents, found a study cited in the report. Other research has found these discussions take a toll on doctors’ job satisfaction.

Yet pediatricians remain the single biggest influence on parents’ vaccination decisions, cited by nearly 80% of parents in one large study.

“The pediatrician should appreciate that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns should be individually identified and addressed,” the report states. “Although many techniques for working with vaccine-hesitant parents have been suggested, scant data are available to determine the efficacy of these methods.”

It goes on to recommend that physicians should discuss the development and safety testing of vaccines “in a nonconfrontational dialogue with the parents while listening to and acknowledging their concerns.”

Pediatricians should not, however, delay vaccines or limit the number per visit – thereby deviating from the CDC recommended and AAP-endorsed schedule – unless it’s the only way a parent agrees to vaccinate.

Another strategy is the presumptive approach: Present all vaccine recommendations as required immunizations that the provider expects a parent to agree to, although pediatricians should consider their experience and relationship with a family since this approach may not work well for some parents.

The report also emphasizes the potential effectiveness of personalizing vaccine conversations by having doctors share their own experience, such as the fact that they vaccinated themselves, their children, and/or their grandchildren.

“Parents often are more likely to be persuaded by stories and anecdotes about the successes of vaccines,” the authors write. “Personal examples of children who were sick with vaccine-preventable illnesses can be much more effective than simply reading the numbers of children infected with a disease each year.”

The report also offers several suggestions for reducing the pain from administering vaccinations: administering vaccines quickly without aspirating; saving the most painful injection for last; holding the child upright; providing tactile stimulation; breastfeeding or providing sweet solutions and topical anesthetics after administration; and using distraction, such as deep breathing, pinwheels, or toys to decrease children’s pain and anxiety.

But the bottom line is that pediatricians have one key message they must communicate to parents, the report states: “The clear message parents should hear is that vaccines are safe and effective, and serious disease can occur if your child and family are not immunized.”

For years, pediatricians have sought a blessing from the American Academy of Pediatrics that acknowledged it was valid for members to dismiss families from their practice if they refused to vaccinate despite all attempts to persuade them. Now, a new clinical report has essentially delivered just that.

The report does not represent an official policy change from the AAP, but it does for the first time acknowledge that “firing” patients who persistently refuse vaccination is “an acceptable option” (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-2146).

“A number of pediatricians feel so strongly that if they don’t agree on vaccines, which are so basic to the delivery of care and have made such a big difference in children’s lives, how will they agree on a number of other things they’ll need to discuss?” Kathryn M. Edwards, MD, director of the Vanderbilt Vaccine Research Program, Nashville, Tenn., and a coauthor of the report, explained in an interview.

The AAP has received pressure from its members over recent years as increasing numbers of pediatricians choose to dismiss some or all of their patients whose parents were resolved not vaccinate, coauthor Jesse M. Hackell, MD, a practicing pediatrician and managing partner at Pomona Pediatrics, an affiliate of Boston Children’s Health Physicians, said in an interview.

In fact, a new study has revealed that 12% of pediatricians reported dismissing vaccine-refusing families in 2013, up from 6% in 2006. At the same time, the proportion of families refusing vaccines has nearly doubled in the same time.

“There was a groundswell of opinion that enough is enough and we can’t provide quality care if we can’t provide something we know is so important,” Dr. Hackell said. “We felt the Academy needed to stop being so adamantly opposed to the possibility of dismissal – not to recommend dismissal but simply to state it is an acceptable option.”

The AAP responds to fellows’ concerns

While the AAP continues to recommend doctors attempt to persuade families as long as possible to vaccinate, the new report discusses dismissal as a viable option as long as it adheres to relevant state laws that prohibit abandonment of patients.

“The decision to dismiss a family who continues to refuse immunization is not one that should be made lightly, nor should it be made without considering and respecting the reasons for the parents’ point of view,” the report states. “Nevertheless, the individual pediatrician may consider dismissal of families who refuse vaccination as an acceptable option.”

The report does note that some practice settings, such as hospitals or large health care organizations, may not allow dismissal of patients, and that pediatricians “should carefully evaluate the availability of other qualified providers for the family” if they live in an area with limited access to pediatric care.

But the report finally acknowledges those pediatricians who are “just philosophically wired to not accept vaccine refusals,” Stuart A. Cohen, MD, an assistant professor of pediatrics at the University of California, San Diego, and chair of AAP District 9 in California, said in an interview.

“It really interferes with your physician-patient relationship,” Dr. Cohen said, who was not a coauthor of the report.

Now, if pediatricians feel it necessary to dismiss nonvaccinating patients, “then the Academy understands because of concerns for other patients, but it must be done in a way that’s respectful and tries to ensure patients understand the safety and necessity of vaccines,” Dr. Edwards said.

The report still includes the AAP recommendation that “pediatricians continue to engage with vaccine-hesitant parents, provide other health care services to their children, and attempt to modify their opposition to vaccines.” And a number of members of the AAP’s infectious diseases and bioethics committees were uncomfortable with dismissing patients, Dr. Edwards said, but “there were certain people who needed this, who needed some blessing that this was not inappropriate after all the other things the pediatrician had done.”

Vaccines undergo thorough testing for safety and effectiveness

But the report also aims to provide pediatricians with strategies for doing everything possible first.

“We needed to address enabling the clinician to have some very specific talking points to use and not get involved in a philosophical discussion that can take an hour,” Dr. Hackell said. “They need to make a clear statement that vaccines are important, and if you don’t get them, bad things like death can happen.”

The report therefore provides a comprehensive overview of vaccine development, from the initial identification of the need for a vaccine through the various phases of clinical testing and ongoing postlicensure monitoring. This background information can arm pediatricians with foundational knowledge that’s helpful in talking with patients.

“Vaccine development is a long and arduous process, often lasting many years and involving a combination of public and private partnerships,” the report states. “The current system for developing, testing and regulating vaccines requires that the vaccines demonstrate both safety and efficacy before licensure and that long-term safety is monitored.”

The report briefly explains the multiple mechanisms for continuing to track and study adverse events and other safety concerns:

• Vaccine Adverse Events Reporting System (VAERS). A voluntary passive reporting system used to identify potential safety signals.

• Vaccine Safety Datalink (VSD). A network of linked databases from health care systems across the United States involving millions of individuals

• Post-Licensure Rapid Immunization Safety Monitoring system (PRISM). A system which monitors vaccine safety using health insurance claims data from 107 million individuals .

• Clinical Immunization Safety Assessment Project (CISA). A system that answers individual health care providers’ specific questions on vaccine safety.

Vaccine hesitancy and vaccine exemptions

Opposition to vaccination is not new, the report states, describing it as dating back to Edward Jenner’s smallpox vaccine in the early 1800s.

“Although vaccine hesitancy is not a new phenomenon, it may have a greater effect on public health today,” the report states. “With the ease of global travel, vaccine-preventable diseases are spread more quickly and may unexpectedly appear in areas where health care professionals are unfamiliar with their clinical presentation.”

The historical presence of vaccination opposition has led to circumstances in the United States today in which parents can seek nonmedical exemptions from vaccines in 47 states, and their use has increased with their availability. Yet, the increase in use of exemptions and of “alternative” immunization schedules runs the risk of eroding the herd immunity that protects the community, the report notes.

“For these reasons, we believe the better approach is to work to eliminate all nonmedical exemptions for childhood vaccines,” the authors write. The American Medical Association and the Infectious Diseases Society of America espouse this position, and the AAP is developing a similar statement.

“Families should not have to fear going to school or the grocery store or a house of worship and worry about their kids getting sick,” said Dr. Cohen. “We now strongly say that we need to work with legislators, families, and other advocates for children at the state level to spread more laws like California’s SB 277 that would abolish philosophical exemptions.”

Dr. Cohen also emphasized the importance of communicating to parents that there are no valid “alternative schedules” for vaccination. There is the Centers for Disease Control and Prevention recommended schedule and anything else is a “nonrecommended vaccine schedule because it hasn’t been studied.” That change in terminology drives home the point that the CDC schedule is the only one fully tested for safety and effectiveness.

Meanwhile, however, pediatricians need the tools to address vaccine hesitancy, starting with understanding it. The report describes the pattern of disease incidence, vaccine uptake, disease reduction, adverse event increase and resulting vaccine hesitancy, punctuated by periodic outbreaks that restore eroded confidence in vaccines.

“When diseases are present, parents are worried and want a vaccine, and when they’re gone, they don’t,” Dr. Edwards said. “We need to remember that there is a dependence on the maintenance of herd immunity by immunization by your neighbors.”

Specific strategies to counter vaccine hesitancy

Just over half of physicians spend 10-19 minutes discussing vaccines with concerned parents, and 8% spend at least 20 minutes with such parents, found a study cited in the report. Other research has found these discussions take a toll on doctors’ job satisfaction.

Yet pediatricians remain the single biggest influence on parents’ vaccination decisions, cited by nearly 80% of parents in one large study.

“The pediatrician should appreciate that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns should be individually identified and addressed,” the report states. “Although many techniques for working with vaccine-hesitant parents have been suggested, scant data are available to determine the efficacy of these methods.”

It goes on to recommend that physicians should discuss the development and safety testing of vaccines “in a nonconfrontational dialogue with the parents while listening to and acknowledging their concerns.”

Pediatricians should not, however, delay vaccines or limit the number per visit – thereby deviating from the CDC recommended and AAP-endorsed schedule – unless it’s the only way a parent agrees to vaccinate.

Another strategy is the presumptive approach: Present all vaccine recommendations as required immunizations that the provider expects a parent to agree to, although pediatricians should consider their experience and relationship with a family since this approach may not work well for some parents.

The report also emphasizes the potential effectiveness of personalizing vaccine conversations by having doctors share their own experience, such as the fact that they vaccinated themselves, their children, and/or their grandchildren.

“Parents often are more likely to be persuaded by stories and anecdotes about the successes of vaccines,” the authors write. “Personal examples of children who were sick with vaccine-preventable illnesses can be much more effective than simply reading the numbers of children infected with a disease each year.”

The report also offers several suggestions for reducing the pain from administering vaccinations: administering vaccines quickly without aspirating; saving the most painful injection for last; holding the child upright; providing tactile stimulation; breastfeeding or providing sweet solutions and topical anesthetics after administration; and using distraction, such as deep breathing, pinwheels, or toys to decrease children’s pain and anxiety.

But the bottom line is that pediatricians have one key message they must communicate to parents, the report states: “The clear message parents should hear is that vaccines are safe and effective, and serious disease can occur if your child and family are not immunized.”

For years, pediatricians have sought a blessing from the American Academy of Pediatrics that acknowledged it was valid for members to dismiss families from their practice if they refused to vaccinate despite all attempts to persuade them. Now, a new clinical report has essentially delivered just that.

The report does not represent an official policy change from the AAP, but it does for the first time acknowledge that “firing” patients who persistently refuse vaccination is “an acceptable option” (Pediatrics. 2016 Aug. doi: 10.1542/peds.2016-2146).

“A number of pediatricians feel so strongly that if they don’t agree on vaccines, which are so basic to the delivery of care and have made such a big difference in children’s lives, how will they agree on a number of other things they’ll need to discuss?” Kathryn M. Edwards, MD, director of the Vanderbilt Vaccine Research Program, Nashville, Tenn., and a coauthor of the report, explained in an interview.

The AAP has received pressure from its members over recent years as increasing numbers of pediatricians choose to dismiss some or all of their patients whose parents were resolved not vaccinate, coauthor Jesse M. Hackell, MD, a practicing pediatrician and managing partner at Pomona Pediatrics, an affiliate of Boston Children’s Health Physicians, said in an interview.

In fact, a new study has revealed that 12% of pediatricians reported dismissing vaccine-refusing families in 2013, up from 6% in 2006. At the same time, the proportion of families refusing vaccines has nearly doubled in the same time.

“There was a groundswell of opinion that enough is enough and we can’t provide quality care if we can’t provide something we know is so important,” Dr. Hackell said. “We felt the Academy needed to stop being so adamantly opposed to the possibility of dismissal – not to recommend dismissal but simply to state it is an acceptable option.”

The AAP responds to fellows’ concerns

While the AAP continues to recommend doctors attempt to persuade families as long as possible to vaccinate, the new report discusses dismissal as a viable option as long as it adheres to relevant state laws that prohibit abandonment of patients.

“The decision to dismiss a family who continues to refuse immunization is not one that should be made lightly, nor should it be made without considering and respecting the reasons for the parents’ point of view,” the report states. “Nevertheless, the individual pediatrician may consider dismissal of families who refuse vaccination as an acceptable option.”

The report does note that some practice settings, such as hospitals or large health care organizations, may not allow dismissal of patients, and that pediatricians “should carefully evaluate the availability of other qualified providers for the family” if they live in an area with limited access to pediatric care.

But the report finally acknowledges those pediatricians who are “just philosophically wired to not accept vaccine refusals,” Stuart A. Cohen, MD, an assistant professor of pediatrics at the University of California, San Diego, and chair of AAP District 9 in California, said in an interview.

“It really interferes with your physician-patient relationship,” Dr. Cohen said, who was not a coauthor of the report.

Now, if pediatricians feel it necessary to dismiss nonvaccinating patients, “then the Academy understands because of concerns for other patients, but it must be done in a way that’s respectful and tries to ensure patients understand the safety and necessity of vaccines,” Dr. Edwards said.

The report still includes the AAP recommendation that “pediatricians continue to engage with vaccine-hesitant parents, provide other health care services to their children, and attempt to modify their opposition to vaccines.” And a number of members of the AAP’s infectious diseases and bioethics committees were uncomfortable with dismissing patients, Dr. Edwards said, but “there were certain people who needed this, who needed some blessing that this was not inappropriate after all the other things the pediatrician had done.”

Vaccines undergo thorough testing for safety and effectiveness

But the report also aims to provide pediatricians with strategies for doing everything possible first.

“We needed to address enabling the clinician to have some very specific talking points to use and not get involved in a philosophical discussion that can take an hour,” Dr. Hackell said. “They need to make a clear statement that vaccines are important, and if you don’t get them, bad things like death can happen.”

The report therefore provides a comprehensive overview of vaccine development, from the initial identification of the need for a vaccine through the various phases of clinical testing and ongoing postlicensure monitoring. This background information can arm pediatricians with foundational knowledge that’s helpful in talking with patients.

“Vaccine development is a long and arduous process, often lasting many years and involving a combination of public and private partnerships,” the report states. “The current system for developing, testing and regulating vaccines requires that the vaccines demonstrate both safety and efficacy before licensure and that long-term safety is monitored.”

The report briefly explains the multiple mechanisms for continuing to track and study adverse events and other safety concerns:

• Vaccine Adverse Events Reporting System (VAERS). A voluntary passive reporting system used to identify potential safety signals.

• Vaccine Safety Datalink (VSD). A network of linked databases from health care systems across the United States involving millions of individuals

• Post-Licensure Rapid Immunization Safety Monitoring system (PRISM). A system which monitors vaccine safety using health insurance claims data from 107 million individuals .

• Clinical Immunization Safety Assessment Project (CISA). A system that answers individual health care providers’ specific questions on vaccine safety.

Vaccine hesitancy and vaccine exemptions

Opposition to vaccination is not new, the report states, describing it as dating back to Edward Jenner’s smallpox vaccine in the early 1800s.

“Although vaccine hesitancy is not a new phenomenon, it may have a greater effect on public health today,” the report states. “With the ease of global travel, vaccine-preventable diseases are spread more quickly and may unexpectedly appear in areas where health care professionals are unfamiliar with their clinical presentation.”

The historical presence of vaccination opposition has led to circumstances in the United States today in which parents can seek nonmedical exemptions from vaccines in 47 states, and their use has increased with their availability. Yet, the increase in use of exemptions and of “alternative” immunization schedules runs the risk of eroding the herd immunity that protects the community, the report notes.

“For these reasons, we believe the better approach is to work to eliminate all nonmedical exemptions for childhood vaccines,” the authors write. The American Medical Association and the Infectious Diseases Society of America espouse this position, and the AAP is developing a similar statement.

“Families should not have to fear going to school or the grocery store or a house of worship and worry about their kids getting sick,” said Dr. Cohen. “We now strongly say that we need to work with legislators, families, and other advocates for children at the state level to spread more laws like California’s SB 277 that would abolish philosophical exemptions.”

Dr. Cohen also emphasized the importance of communicating to parents that there are no valid “alternative schedules” for vaccination. There is the Centers for Disease Control and Prevention recommended schedule and anything else is a “nonrecommended vaccine schedule because it hasn’t been studied.” That change in terminology drives home the point that the CDC schedule is the only one fully tested for safety and effectiveness.

Meanwhile, however, pediatricians need the tools to address vaccine hesitancy, starting with understanding it. The report describes the pattern of disease incidence, vaccine uptake, disease reduction, adverse event increase and resulting vaccine hesitancy, punctuated by periodic outbreaks that restore eroded confidence in vaccines.

“When diseases are present, parents are worried and want a vaccine, and when they’re gone, they don’t,” Dr. Edwards said. “We need to remember that there is a dependence on the maintenance of herd immunity by immunization by your neighbors.”

Specific strategies to counter vaccine hesitancy

Just over half of physicians spend 10-19 minutes discussing vaccines with concerned parents, and 8% spend at least 20 minutes with such parents, found a study cited in the report. Other research has found these discussions take a toll on doctors’ job satisfaction.

Yet pediatricians remain the single biggest influence on parents’ vaccination decisions, cited by nearly 80% of parents in one large study.

“The pediatrician should appreciate that vaccine-hesitant parents are a heterogeneous group and that specific parental vaccine concerns should be individually identified and addressed,” the report states. “Although many techniques for working with vaccine-hesitant parents have been suggested, scant data are available to determine the efficacy of these methods.”

It goes on to recommend that physicians should discuss the development and safety testing of vaccines “in a nonconfrontational dialogue with the parents while listening to and acknowledging their concerns.”

Pediatricians should not, however, delay vaccines or limit the number per visit – thereby deviating from the CDC recommended and AAP-endorsed schedule – unless it’s the only way a parent agrees to vaccinate.

Another strategy is the presumptive approach: Present all vaccine recommendations as required immunizations that the provider expects a parent to agree to, although pediatricians should consider their experience and relationship with a family since this approach may not work well for some parents.

The report also emphasizes the potential effectiveness of personalizing vaccine conversations by having doctors share their own experience, such as the fact that they vaccinated themselves, their children, and/or their grandchildren.

“Parents often are more likely to be persuaded by stories and anecdotes about the successes of vaccines,” the authors write. “Personal examples of children who were sick with vaccine-preventable illnesses can be much more effective than simply reading the numbers of children infected with a disease each year.”

The report also offers several suggestions for reducing the pain from administering vaccinations: administering vaccines quickly without aspirating; saving the most painful injection for last; holding the child upright; providing tactile stimulation; breastfeeding or providing sweet solutions and topical anesthetics after administration; and using distraction, such as deep breathing, pinwheels, or toys to decrease children’s pain and anxiety.

But the bottom line is that pediatricians have one key message they must communicate to parents, the report states: “The clear message parents should hear is that vaccines are safe and effective, and serious disease can occur if your child and family are not immunized.”