Pediatrics

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

Defensive medicine exists. The question is how often it happens and how large a role it plays in making medical care in the United States so costly. When Dr. Tom Price was a congressman, he was quoted as saying that defensive medicine is responsible for more than 25% of every dollar this country spends on health care. (“A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests” Margot Sanger-Katz, New York Times, July 23, 2018). Neither I nor anyone else had any data to support or refute Dr. Price’s claim in 2010, but based on 50 years of practicing and observing medicine, I don’t find his claim completely unreasonable.

iStock

Defensive medicine has been going on for so many generations of physicians that most doctors practicing today don’t realize they are doing it. A physician may order a full battery of chemistries on a patient presenting with mild anemia when only a CBC is necessary because that’s the way he was trained.

However, the evidence to support my suspicion that defensive medicine is a significant financial drain on our economy has been difficult to tease out of the tangled web of confounders that is woven into our patchwork health care system. A recent study by two economists provides a glimpse into the role of defensive medicine in the cost of health care (“Defensive Medicine: Evidence from Military Immunity” Michael D. Frakes and Jonathan Gruber, National Bureau of Economic Research, July 2018). Using the unusual combination of circumstances in which military personnel and their dependents can or cannot sue depending on where they are receiving care, the investigators found that “liability immunity reduces inpatient spending by 5% with no measurable negative effect on patient outcomes.” While that may not be as high as Dr. Price or I think it may be, 5% of three trillion dollars is serious money.

The bigger problem is that defensive medicine is ugly, artless, and intellectually unsatisfying. While the patient may not view your diagnosis of his chronic debilitating or terminal illness as a work of art, there are such things as beautiful diagnoses. One may be beautiful in its simplicity and its ability to unify a variety of previously unexplained symptoms. Another diagnosis may be the intellectually stimulating result of a carefully thought out branching decision tree to solve a puzzling array of complaints using a minimum of costly studies.

Defensive medicine decisions are made primarily to avoid mistakes and omissions. Physicians often behave as though we believe our errors will always be fatal. That may be somewhat true for surgeons, but for the rest of us errors can be an important part of learning. The unfortunate outcome of an error, particularly one of omission, can usually be avoided by following the patient closely, remaining available ... and continuing to exude an aura of caring.

With close and thoughtful follow-up, you are going to discover pretty quickly when you have missed the target. Patients understand that we aren’t going to get the correct diagnosis or prescribe the best treatment on the first try every time. What patients don’t understand and what may prompt them to sue is feeling that they are being ignored.

While practicing defensive medicine isn’t usually listed as one of the cardinal symptoms of physician burnout, it probably deserves more attention. With some introspection and a bit of courage, recasting what you do in terms of its artistry and intellectual integrity could add a new and positive dimension to how you practice medicine. How many of your decisions are being made to avoid an error? Wouldn’t it be more fun to be making beautiful diagnoses you can be proud of?

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “Is My Child Overtired?: The Sleep Solution for Raising Happier, Healthier Children.” Email him at pdnews@mdedge.com.

ATLANTA – Childhood obesity increases the risk of severe dental infections, according to a review presented at the Pediatric Hospital Medicine meeting.

M. Alexander Otto/MDedge News

Among 171 children admitted to Rady Children’s Hospital, San Diego, for infected cavities, obese children were almost four times more likely than others to require surgery, and five times more likely to have a tooth pulled.

The average cost for obese children was $13,000/day, versus $10,000/day for nonobese children, probably because of the greater need for surgery. Average length of stay was the same between the two groups, just under 2 days. The findings were statistically significant.

Obesity turns out to be “an important risk factor for invasive interventions for pediatric dental infections,” concluded study leader Michelle Edmunds, MD, a pediatric hospital medicine fellow at Rady.

Childhood obesity has been associated with cavities before, but it’s new information that it increases the severity of dental infections. The finding is something for pediatricians to be aware of and to use to encourage regular dental care. “Even if you are obese, if you are getting routine care, you should be able to have cavities fixed” before they get out of hand. “Unfortunately, a lot of the kids we see don’t get routine care,” Dr. Edmunds said.

The investigators couldn’t assess the role of diet because there wasn’t enough information about it in the medical records. It certainly must play a role, because soda and other junk foods increase the risk of both obesity and cavities.

Other factors also are likely at play. Obesity might affect the oral flora, and perhaps the balance of pathogens. It also seems to reduce healing and infection-fighting ability, so “there might be some immunocompromise that’s playing a role here,” Dr. Edmunds said.

The team compared 25 children up to 18 years old who were at or above the 95th percentile for body mass index – the study definition of obesity – to 146 children who were below that mark. They had all been admitted through the ED between July 2011 and June 2016 with dental abscesses, facial cellulitis, or other dental-associated infections. Eighty percent of the children were on Medicaid, which has, itself, been associated with less frequent visits to the dentist.

About 50% of the children were discharged home without a dental procedure. Among the rest, a quarter had incision and drainage, and a quarter had tooth extractions. Overall 72% (18) of obese children had surgery, usually extractions, versus 43% (62) of nonobese children.

There’s perhaps around 200,000 pediatric ED visits a year in the United States for dental problems. “We’ve had toddlers and kids who have never seen a dentist before; all of their teeth were rotten and had to be pulled out, every single tooth,” Dr. Edmunds said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The mean age in the study was about 8 years. Nearly 60% of the subjects were boys, and a bit over 60% Hispanic. There were no statistical difference in demographics, prior antibiotic use, or cavity history between obese and nonobese children. Obese children were more likely to be on Medicaid, but not significantly so.

There was no industry funding for the work, and Dr. Edmunds didn’t have any disclosures.
 

aotto@mdedge.com

ATLANTA – Childhood obesity increases the risk of severe dental infections, according to a review presented at the Pediatric Hospital Medicine meeting.

M. Alexander Otto/MDedge News

Among 171 children admitted to Rady Children’s Hospital, San Diego, for infected cavities, obese children were almost four times more likely than others to require surgery, and five times more likely to have a tooth pulled.

The average cost for obese children was $13,000/day, versus $10,000/day for nonobese children, probably because of the greater need for surgery. Average length of stay was the same between the two groups, just under 2 days. The findings were statistically significant.

Obesity turns out to be “an important risk factor for invasive interventions for pediatric dental infections,” concluded study leader Michelle Edmunds, MD, a pediatric hospital medicine fellow at Rady.

Childhood obesity has been associated with cavities before, but it’s new information that it increases the severity of dental infections. The finding is something for pediatricians to be aware of and to use to encourage regular dental care. “Even if you are obese, if you are getting routine care, you should be able to have cavities fixed” before they get out of hand. “Unfortunately, a lot of the kids we see don’t get routine care,” Dr. Edmunds said.

The investigators couldn’t assess the role of diet because there wasn’t enough information about it in the medical records. It certainly must play a role, because soda and other junk foods increase the risk of both obesity and cavities.

Other factors also are likely at play. Obesity might affect the oral flora, and perhaps the balance of pathogens. It also seems to reduce healing and infection-fighting ability, so “there might be some immunocompromise that’s playing a role here,” Dr. Edmunds said.

The team compared 25 children up to 18 years old who were at or above the 95th percentile for body mass index – the study definition of obesity – to 146 children who were below that mark. They had all been admitted through the ED between July 2011 and June 2016 with dental abscesses, facial cellulitis, or other dental-associated infections. Eighty percent of the children were on Medicaid, which has, itself, been associated with less frequent visits to the dentist.

About 50% of the children were discharged home without a dental procedure. Among the rest, a quarter had incision and drainage, and a quarter had tooth extractions. Overall 72% (18) of obese children had surgery, usually extractions, versus 43% (62) of nonobese children.

There’s perhaps around 200,000 pediatric ED visits a year in the United States for dental problems. “We’ve had toddlers and kids who have never seen a dentist before; all of their teeth were rotten and had to be pulled out, every single tooth,” Dr. Edmunds said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The mean age in the study was about 8 years. Nearly 60% of the subjects were boys, and a bit over 60% Hispanic. There were no statistical difference in demographics, prior antibiotic use, or cavity history between obese and nonobese children. Obese children were more likely to be on Medicaid, but not significantly so.

There was no industry funding for the work, and Dr. Edmunds didn’t have any disclosures.
 

aotto@mdedge.com

ATLANTA – Childhood obesity increases the risk of severe dental infections, according to a review presented at the Pediatric Hospital Medicine meeting.

M. Alexander Otto/MDedge News

Among 171 children admitted to Rady Children’s Hospital, San Diego, for infected cavities, obese children were almost four times more likely than others to require surgery, and five times more likely to have a tooth pulled.

The average cost for obese children was $13,000/day, versus $10,000/day for nonobese children, probably because of the greater need for surgery. Average length of stay was the same between the two groups, just under 2 days. The findings were statistically significant.

Obesity turns out to be “an important risk factor for invasive interventions for pediatric dental infections,” concluded study leader Michelle Edmunds, MD, a pediatric hospital medicine fellow at Rady.

Childhood obesity has been associated with cavities before, but it’s new information that it increases the severity of dental infections. The finding is something for pediatricians to be aware of and to use to encourage regular dental care. “Even if you are obese, if you are getting routine care, you should be able to have cavities fixed” before they get out of hand. “Unfortunately, a lot of the kids we see don’t get routine care,” Dr. Edmunds said.

The investigators couldn’t assess the role of diet because there wasn’t enough information about it in the medical records. It certainly must play a role, because soda and other junk foods increase the risk of both obesity and cavities.

Other factors also are likely at play. Obesity might affect the oral flora, and perhaps the balance of pathogens. It also seems to reduce healing and infection-fighting ability, so “there might be some immunocompromise that’s playing a role here,” Dr. Edmunds said.

The team compared 25 children up to 18 years old who were at or above the 95th percentile for body mass index – the study definition of obesity – to 146 children who were below that mark. They had all been admitted through the ED between July 2011 and June 2016 with dental abscesses, facial cellulitis, or other dental-associated infections. Eighty percent of the children were on Medicaid, which has, itself, been associated with less frequent visits to the dentist.

About 50% of the children were discharged home without a dental procedure. Among the rest, a quarter had incision and drainage, and a quarter had tooth extractions. Overall 72% (18) of obese children had surgery, usually extractions, versus 43% (62) of nonobese children.

There’s perhaps around 200,000 pediatric ED visits a year in the United States for dental problems. “We’ve had toddlers and kids who have never seen a dentist before; all of their teeth were rotten and had to be pulled out, every single tooth,” Dr. Edmunds said at the meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.

The mean age in the study was about 8 years. Nearly 60% of the subjects were boys, and a bit over 60% Hispanic. There were no statistical difference in demographics, prior antibiotic use, or cavity history between obese and nonobese children. Obese children were more likely to be on Medicaid, but not significantly so.

There was no industry funding for the work, and Dr. Edmunds didn’t have any disclosures.
 

aotto@mdedge.com

Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.

The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.

With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.

The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).

In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A_1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.

Because the current method of using HbA_1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA_1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.

The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA_1c should be measured at 3-month intervals to assess glycemic control, with a target HbA_1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.

The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.

Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.

Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.

The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.

Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.

“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”

The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.

SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.

Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.

The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.

With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.

The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).

In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A_1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.

Because the current method of using HbA_1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA_1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.

The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA_1c should be measured at 3-month intervals to assess glycemic control, with a target HbA_1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.

The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.

Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.

Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.

The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.

Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.

“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”

The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.

SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.

Management of type 1 diabetes mellitus in children should include careful consideration of the unique features and challenges that differentiate it from T1DM in adults, according to a new position statement released by the American Diabetes Association.

The statement, published Aug. 10 in Diabetes Care, includes guidance on diagnosis, staging, screening, monitoring, treatment, nutrition, physical activity, and transition from pediatric to adult care.

With regard to diagnosis and staging, the recommendations emphasize the importance of distinguishing between T1DM, type 2 diabetes mellitus, and monogenic diabetes. It also asserts that a pediatric endocrinologist should be consulted before making a diagnosis when “isolated glycosuria or hyperglycemia is discovered in the setting of acute illness and in the absence of classic symptoms,” wrote Jane L. Chiang, MD, of McKinsey & Company and chief medical officer at Diasome Pharmaceuticals in Palo Alto, Calif., and coauthors.

The guidance also describes the three stages of type 1 diabetes development. Stage 1 is presymptomatic and features the presence of beta-cell autoimmunity. Stage 2, also presymptomatic, includes the presence of beta-cell autoimmunity with dysglycemia. Symptomatic disease from insulin deficiency begins in stage 3, and may include hyperglycemia, polyuria, polydipsia, weight loss, polyphagia, fatigue, and blurred vision. Perineal candidiasis is common in girls, and about one-third of cases present with diabetic ketoacidosis (DKA).

In patients with hyperglycemia symptoms, blood glucose, not hemoglobin A_1c, should be used to diagnose acute onset of disease. Delays in diagnosis and insulin replacement therapy should be avoided and a definitive diagnosis made quickly, the authors added.

Because the current method of using HbA_1c to diagnose diabetes was based on studies limited to adults, there is still debate over whether to use HbA_1c to diagnose T1DM in children and adolescents, Dr. Chiang and colleagues noted. Additionally, physicians must take care to distinguish between diabetes types because of increased numbers of overweight children with T1DM, as well as frequent misdiagnosis of monogenic diabetes as T1DM.

The position statement emphasizes the importance of insulin therapy as treatment for children with T1DM and recommends that most patients should be treated with either multiple injections of prandial and basal insulin, or with continuous subcutaneous insulin infusion. HbA_1c should be measured at 3-month intervals to assess glycemic control, with a target HbA_1c of less than 7.5%, the authors said. Also covered are recommendations for blood glucose monitoring, blood and urine ketone monitoring, and continuous glucose monitoring.

The importance of integrating an exercise and nutrition plan is also highlighted in the guidance. In addition to monitoring carbohydrate and caloric intake with the help of a dietitian, 60 minutes of moderate to vigorous activity daily are recommended as an exercise goal. Steps should also be taken to prevent hypoglycemia during and after exercise, the authors added.

Measures must also be taken to anticipate and address the unique behavioral and social challenges that accompany diabetes management in developing adolescents, the authors said. Social and family issues, peer relationships, and disordered eating should all be considered, and, starting at age 12 years, patients should be allowed time to speak in confidentiality with their health care provider, Dr. Chiang and colleagues said.

Additionally, as adolescents assert increased independence and autonomy, independent disease management should be facilitated, and issues such as depression and risky behaviors discussed.

The guidelines also discuss the importance of following the Centers for Disease Control and Prevention immunization schedule, and monitoring growth and weight gain. Patients with T1DM and their caregivers should also be sufficiently educated on comorbidities such as diabetic ketoacidosis, hypoglycemia, retinopathy, dyslipidemia, autoimmune diseases, and other complications.

Supportive environments such as diabetes camps, as well as technological advances, may be effective tools in encouraging diabetes self-management. Though there is no “optimal transition age” for the shift from pediatric to adult care, ADA recommends that providers begin transition preparation in the early adolescent years, and provide counseling on diabetes self-management.

“An ineffective transition from pediatric to adult diabetes care may contribute to fragmentation of health care and increased risk for adverse outcomes,” the authors said. “An individualized approach to transition timing is recommended, prioritizing the developmental needs and preferences of the patient.”

The authors reported relationships with Diasome Pharmaceuticals and numerous other companies.

SOURCE: Chiang J et al. Diabetes Care. 2018 Jul. doi: 10.2337/dci18-0023.

Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.

Herjua/Thinkstock

Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.

The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.

In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.

“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.

Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.

At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.

Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.

The authors had no relevant financial disclosures.

SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.

Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.

Herjua/Thinkstock

Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.

The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.

In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.

“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.

Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.

At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.

Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.

The authors had no relevant financial disclosures.

SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.

Lung ultrasound score (LUS) is an effective means of predicting whether extremely preterm neonates undergoing continuous positive airway pressure (CPAP) treatment for respiratory distress syndrome (RDS) require surfactant, according to results of study published in Pediatrics.

Herjua/Thinkstock

Lucia De Martino, MD, of the division of pediatrics and neonatal critical care at the A. Béclère Medical Centre of the South Paris University Hospital and her associates enrolled 133 neonates of 30 weeks’ gestation or less born between 2015 and 2016. They designed the prospective diagnostic accuracy cohort study, which was conducted in an academic tertiary care referral neonatal ICU.

The first dose of surfactant was administered at a mean 4 hours of life. Those that required further treatment received a second dose of surfactant at a mean 28 hours of life. Each patient received a single lung ultrasound lasting an average of 3 minutes. In each case, the procedure was well tolerated.

In particular, the study demonstrated that LUS is able to accurately predict the need for a first dose and “reveals fair accuracy when it comes to predicting surfactant retreatment,” they observed. The authors speculate that using LUS to predict retreatment is somewhat less reliable because of either the lower number of patients requiring retreatment or reasons related to the biology of surfactant.

“A LUS cutoff value between 6 and 8 provides optimal sensitivity and specificity for predicting the need for the first surfactant dose, whereas a cutoff value of 10 predicts the need for surfactant retreatment,” Dr. De Martino and her colleagues advised.

Of key importance was the finding that LUS is of greatest value to preterm infants less than 34 weeks’ gestation; the authors observed that LUS had significantly lower diagnostic accuracy in infants who were either late term or term. They offered that this outcome was likely attributable to the homogeneous nature of preterm neonates, who are commonly affected by RDS and tend to present with a variety of respiratory disorders and surfactant injury to differing degrees.

At present, international guidelines only recommend surfactant replacement in cases where CPAP has failed, but administering surfactant within the first 2-3 hours of life is key to reducing bronchopulmonary dysplasia as well as the risk of death, they said.

Current surfactant replacement is determined solely by fraction of inspired oxygen cutoff levels, which can result in delayed or even unnecessary treatment. Because neonates who are extremely preterm benefit the most from treatment, “both situations are potentially harmful because late surfactant replacement is less efficacious and giving surfactant when it is not needed may be invasive and seems to increase lung inflammation in animal models,” Dr. De Martino and her associates cautioned.

The authors had no relevant financial disclosures.

SOURCE: De Martino L et al. Pediatrics. 2018. doi: 10.1542/peds.2018-0463.

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

bjancin@mdedge.com

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

bjancin@mdedge.com

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

bjancin@mdedge.com

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

New comprehensive guidelines for pediatric use of chimeric antigen receptor (CAR) T-cell therapies emphasize the need for a flexible approach to detect early signs of serious complications for younger patients treated with this emerging class of medicines.

Researchers at the University of Texas MD Anderson Cancer Center, Houston, and the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) developed the guidelines, which were published in Nature Reviews Clinical Oncology. The recommendations build on the guidelines for more general use of these medicines from MD Anderson’s CARTOX Program, which Nature Reviews Clinical Oncology published in 2017.

Among the chief concerns with this new class of medicines are cytokine-release syndrome (CRS) and CAR T cell-related encephalopathy syndrome (CRES), according to Kris Michael Mahadeo, MD MPH, of the MD Anderson Cancer Center and his coauthors of the new paper.

Some of the tools used for older patients in screening for complications with CAR T drugs don’t work as well with younger ones, Dr. Mahadeo said in an interview. For instance, at MD Anderson, a handwriting sample is used to monitor patients for CAR T cell-related encephalopathy syndrome, which has symptoms of confusion and delirium. Patients provide a baseline handwriting sample of a single sentence that’s scanned into the medical record, and then they are asked to write this again during their time in the hospital, he said. But this tool may not work for children too young to write well.

The new guidelines suggest using the Cornell Assessment of Pediatric Delirium (CAPD) or to evaluate a child’s mental state, asking questions about eye contact, and level of awareness and mood, Dr. Mahadeo said. An alternative for patients aged 12 years and older with greater cognitive ability is the CARTOX-10 grading system.

“The nurses who spent most of the day with these patients will observe them over their shift and kind of get an idea of what was normal and answer a series of questions” through the CAPD tool, which is already used in ICUs, Dr. Mahadeo said. “It takes into consideration both the nurses’ perception and the parents, or whoever is at the bedside with the child. So that if they have a concern, it gives them a point that actually escalates things upward.”

The newly published recommendations also remind physicians and others caring for young patients to pay attention to these reports.

“Parent and/or caregiver concerns should be addressed because early signs or symptoms of CRS can be subtle and best recognized by those who know the child best,” Dr. Mahadeo and his colleagues wrote in a summary of key recommendations in the paper.

The recommendations also noted a need for close monitoring for complications such as hypotension, hypocalcemia, and catheter-related pain in young patients who require a leukapheresis catheter for cell collection. Infant and younger children “might not verbalize these symptoms,” according to the researchers.

Other recommendations include:

• Obtaining the child’s assent when appropriate, with psychological services often aiding in this goal. Dr. Mahadeo and his colleagues recommend considering “age-appropriate advance directives.”
• Maintaining high vigilance for sinus tachycardia as an early sign of CRS, using age-specific normal range or baseline values.
• Giving pediatric dosing of tocilizumab, with patients weighing less than 30 kg receiving 12 mg/kg, and those weighing 30 kg or greater receiving 8 mg/kg.
• Considering participation with a prospective collaboration with intensive-care registries that could allow accurate data entry of cell-therapy variables into the Center for International Blood and Marrow Transplant Research registry by cell-therapy programs.

The Food and Drug Administration approved the first two CAR T-cell therapies in the United States in 2017: Novartis’ tisagenlecleucel (Kymriah) for children and young adults with B-cell precursor acute lymphoblastic leukemia and later for adults with large B-cell lymphoma; and axicabtagene ciloleucel (Yescarta), sold by Gilead, for adults with large B-cell lymphoma. The therapies involve reengineering a patient’s T cells such that they recognize the threat of cancer, and then introducing them back into the body. The European Medicines Agency’s Committee for Medicinal Products for Human Use in June recommended granting marketing authorization to these drugs.

In the new pediatric guidelines, Dr. Mahadeo and his colleagues noted the use of CAR T-cell therapies for treatment of solid tumors and other malignancies in children already “is being explored.” “Moreover, consideration of earlier or upfront use of CAR T-cell therapy might spare patients the acute and long-term toxicities associated with traditional chemotherapy and/or radiation regimens,” they wrote.

There’s been great interest in learning how to most safely use the CAR T cell therapies, said Helen Heslop, MD, of Baylor College of Medicine.

She pointed to a 2014 publication in the journal Blood from Daniel W. Lee and his colleagues as an earlier example of this research. By now, cancer centers will have worked out their own procedures for pediatric use of CAR T therapies, hewing to standards set by the Foundation for the Accreditation of Cellular Therapy (FACT), Dr. Heslop said.

Dr. Heslop also stressed the role of the FDA in requiring risk evaluation and management strategy programs for these drugs. All of this, including the new guidelines from Dr. Mahadeo and his colleagues, is part of a growing body of research into safe use of CAR T therapies, Dr. Heslop said.

“It’s an active area of research,” she said. “Most centers will look at all of it and then develop what works best in their own individual center for providing the best care for the patients.”

The newly published guidelines could prove an “important contribution” to managing the risk of CAR T therapies, Phyllis I. Warkentin, MD, chief medical officer for FACT, said in an interview, while stressing that they were not more or less important than other similar efforts. Physicians learning how to use the CAR T therapies may welcome new input, as most of what’s been published has been about adults, she said.

“You don’t have the luxury of a lot of time to be learning on the job, so to speak,” with CAR T therapies, she said. “Many of the toxicities are fairly severe and fairly sudden.”

Dr. Heslop has been on advisory board for Gilead and Novartis. Dr. Warkentin and Dr. Mahadeo each reported having no financial disclosures. Other authors of the guidelines paper reported a patent with applications in the field of gene-modified T cell therapy for cancer, as well as financial ties to Cellectis, NexImmune, Torque Pharma, Kite Pharma (a Gilead company), Poseida Therapeutics, Celgene, Novartis, and Unum Therapeutics.

SOURCE: Mahadeo KM et al. Nat Rev Clin Oncol. 2018 Aug 6. doi: 10.1038/s41571-018-0075-2.

New comprehensive guidelines for pediatric use of chimeric antigen receptor (CAR) T-cell therapies emphasize the need for a flexible approach to detect early signs of serious complications for younger patients treated with this emerging class of medicines.

Researchers at the University of Texas MD Anderson Cancer Center, Houston, and the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) developed the guidelines, which were published in Nature Reviews Clinical Oncology. The recommendations build on the guidelines for more general use of these medicines from MD Anderson’s CARTOX Program, which Nature Reviews Clinical Oncology published in 2017.

Among the chief concerns with this new class of medicines are cytokine-release syndrome (CRS) and CAR T cell-related encephalopathy syndrome (CRES), according to Kris Michael Mahadeo, MD MPH, of the MD Anderson Cancer Center and his coauthors of the new paper.

Some of the tools used for older patients in screening for complications with CAR T drugs don’t work as well with younger ones, Dr. Mahadeo said in an interview. For instance, at MD Anderson, a handwriting sample is used to monitor patients for CAR T cell-related encephalopathy syndrome, which has symptoms of confusion and delirium. Patients provide a baseline handwriting sample of a single sentence that’s scanned into the medical record, and then they are asked to write this again during their time in the hospital, he said. But this tool may not work for children too young to write well.

The new guidelines suggest using the Cornell Assessment of Pediatric Delirium (CAPD) or to evaluate a child’s mental state, asking questions about eye contact, and level of awareness and mood, Dr. Mahadeo said. An alternative for patients aged 12 years and older with greater cognitive ability is the CARTOX-10 grading system.

“The nurses who spent most of the day with these patients will observe them over their shift and kind of get an idea of what was normal and answer a series of questions” through the CAPD tool, which is already used in ICUs, Dr. Mahadeo said. “It takes into consideration both the nurses’ perception and the parents, or whoever is at the bedside with the child. So that if they have a concern, it gives them a point that actually escalates things upward.”

The newly published recommendations also remind physicians and others caring for young patients to pay attention to these reports.

“Parent and/or caregiver concerns should be addressed because early signs or symptoms of CRS can be subtle and best recognized by those who know the child best,” Dr. Mahadeo and his colleagues wrote in a summary of key recommendations in the paper.

The recommendations also noted a need for close monitoring for complications such as hypotension, hypocalcemia, and catheter-related pain in young patients who require a leukapheresis catheter for cell collection. Infant and younger children “might not verbalize these symptoms,” according to the researchers.

Other recommendations include:

• Obtaining the child’s assent when appropriate, with psychological services often aiding in this goal. Dr. Mahadeo and his colleagues recommend considering “age-appropriate advance directives.”
• Maintaining high vigilance for sinus tachycardia as an early sign of CRS, using age-specific normal range or baseline values.
• Giving pediatric dosing of tocilizumab, with patients weighing less than 30 kg receiving 12 mg/kg, and those weighing 30 kg or greater receiving 8 mg/kg.
• Considering participation with a prospective collaboration with intensive-care registries that could allow accurate data entry of cell-therapy variables into the Center for International Blood and Marrow Transplant Research registry by cell-therapy programs.

The Food and Drug Administration approved the first two CAR T-cell therapies in the United States in 2017: Novartis’ tisagenlecleucel (Kymriah) for children and young adults with B-cell precursor acute lymphoblastic leukemia and later for adults with large B-cell lymphoma; and axicabtagene ciloleucel (Yescarta), sold by Gilead, for adults with large B-cell lymphoma. The therapies involve reengineering a patient’s T cells such that they recognize the threat of cancer, and then introducing them back into the body. The European Medicines Agency’s Committee for Medicinal Products for Human Use in June recommended granting marketing authorization to these drugs.

In the new pediatric guidelines, Dr. Mahadeo and his colleagues noted the use of CAR T-cell therapies for treatment of solid tumors and other malignancies in children already “is being explored.” “Moreover, consideration of earlier or upfront use of CAR T-cell therapy might spare patients the acute and long-term toxicities associated with traditional chemotherapy and/or radiation regimens,” they wrote.

There’s been great interest in learning how to most safely use the CAR T cell therapies, said Helen Heslop, MD, of Baylor College of Medicine.

She pointed to a 2014 publication in the journal Blood from Daniel W. Lee and his colleagues as an earlier example of this research. By now, cancer centers will have worked out their own procedures for pediatric use of CAR T therapies, hewing to standards set by the Foundation for the Accreditation of Cellular Therapy (FACT), Dr. Heslop said.

Dr. Heslop also stressed the role of the FDA in requiring risk evaluation and management strategy programs for these drugs. All of this, including the new guidelines from Dr. Mahadeo and his colleagues, is part of a growing body of research into safe use of CAR T therapies, Dr. Heslop said.

“It’s an active area of research,” she said. “Most centers will look at all of it and then develop what works best in their own individual center for providing the best care for the patients.”

The newly published guidelines could prove an “important contribution” to managing the risk of CAR T therapies, Phyllis I. Warkentin, MD, chief medical officer for FACT, said in an interview, while stressing that they were not more or less important than other similar efforts. Physicians learning how to use the CAR T therapies may welcome new input, as most of what’s been published has been about adults, she said.

“You don’t have the luxury of a lot of time to be learning on the job, so to speak,” with CAR T therapies, she said. “Many of the toxicities are fairly severe and fairly sudden.”

Dr. Heslop has been on advisory board for Gilead and Novartis. Dr. Warkentin and Dr. Mahadeo each reported having no financial disclosures. Other authors of the guidelines paper reported a patent with applications in the field of gene-modified T cell therapy for cancer, as well as financial ties to Cellectis, NexImmune, Torque Pharma, Kite Pharma (a Gilead company), Poseida Therapeutics, Celgene, Novartis, and Unum Therapeutics.

SOURCE: Mahadeo KM et al. Nat Rev Clin Oncol. 2018 Aug 6. doi: 10.1038/s41571-018-0075-2.

New comprehensive guidelines for pediatric use of chimeric antigen receptor (CAR) T-cell therapies emphasize the need for a flexible approach to detect early signs of serious complications for younger patients treated with this emerging class of medicines.

Researchers at the University of Texas MD Anderson Cancer Center, Houston, and the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) developed the guidelines, which were published in Nature Reviews Clinical Oncology. The recommendations build on the guidelines for more general use of these medicines from MD Anderson’s CARTOX Program, which Nature Reviews Clinical Oncology published in 2017.

Among the chief concerns with this new class of medicines are cytokine-release syndrome (CRS) and CAR T cell-related encephalopathy syndrome (CRES), according to Kris Michael Mahadeo, MD MPH, of the MD Anderson Cancer Center and his coauthors of the new paper.

Some of the tools used for older patients in screening for complications with CAR T drugs don’t work as well with younger ones, Dr. Mahadeo said in an interview. For instance, at MD Anderson, a handwriting sample is used to monitor patients for CAR T cell-related encephalopathy syndrome, which has symptoms of confusion and delirium. Patients provide a baseline handwriting sample of a single sentence that’s scanned into the medical record, and then they are asked to write this again during their time in the hospital, he said. But this tool may not work for children too young to write well.

The new guidelines suggest using the Cornell Assessment of Pediatric Delirium (CAPD) or to evaluate a child’s mental state, asking questions about eye contact, and level of awareness and mood, Dr. Mahadeo said. An alternative for patients aged 12 years and older with greater cognitive ability is the CARTOX-10 grading system.

“The nurses who spent most of the day with these patients will observe them over their shift and kind of get an idea of what was normal and answer a series of questions” through the CAPD tool, which is already used in ICUs, Dr. Mahadeo said. “It takes into consideration both the nurses’ perception and the parents, or whoever is at the bedside with the child. So that if they have a concern, it gives them a point that actually escalates things upward.”

The newly published recommendations also remind physicians and others caring for young patients to pay attention to these reports.

“Parent and/or caregiver concerns should be addressed because early signs or symptoms of CRS can be subtle and best recognized by those who know the child best,” Dr. Mahadeo and his colleagues wrote in a summary of key recommendations in the paper.

The recommendations also noted a need for close monitoring for complications such as hypotension, hypocalcemia, and catheter-related pain in young patients who require a leukapheresis catheter for cell collection. Infant and younger children “might not verbalize these symptoms,” according to the researchers.

Other recommendations include:

• Obtaining the child’s assent when appropriate, with psychological services often aiding in this goal. Dr. Mahadeo and his colleagues recommend considering “age-appropriate advance directives.”
• Maintaining high vigilance for sinus tachycardia as an early sign of CRS, using age-specific normal range or baseline values.
• Giving pediatric dosing of tocilizumab, with patients weighing less than 30 kg receiving 12 mg/kg, and those weighing 30 kg or greater receiving 8 mg/kg.
• Considering participation with a prospective collaboration with intensive-care registries that could allow accurate data entry of cell-therapy variables into the Center for International Blood and Marrow Transplant Research registry by cell-therapy programs.

The Food and Drug Administration approved the first two CAR T-cell therapies in the United States in 2017: Novartis’ tisagenlecleucel (Kymriah) for children and young adults with B-cell precursor acute lymphoblastic leukemia and later for adults with large B-cell lymphoma; and axicabtagene ciloleucel (Yescarta), sold by Gilead, for adults with large B-cell lymphoma. The therapies involve reengineering a patient’s T cells such that they recognize the threat of cancer, and then introducing them back into the body. The European Medicines Agency’s Committee for Medicinal Products for Human Use in June recommended granting marketing authorization to these drugs.

In the new pediatric guidelines, Dr. Mahadeo and his colleagues noted the use of CAR T-cell therapies for treatment of solid tumors and other malignancies in children already “is being explored.” “Moreover, consideration of earlier or upfront use of CAR T-cell therapy might spare patients the acute and long-term toxicities associated with traditional chemotherapy and/or radiation regimens,” they wrote.

There’s been great interest in learning how to most safely use the CAR T cell therapies, said Helen Heslop, MD, of Baylor College of Medicine.

She pointed to a 2014 publication in the journal Blood from Daniel W. Lee and his colleagues as an earlier example of this research. By now, cancer centers will have worked out their own procedures for pediatric use of CAR T therapies, hewing to standards set by the Foundation for the Accreditation of Cellular Therapy (FACT), Dr. Heslop said.

Dr. Heslop also stressed the role of the FDA in requiring risk evaluation and management strategy programs for these drugs. All of this, including the new guidelines from Dr. Mahadeo and his colleagues, is part of a growing body of research into safe use of CAR T therapies, Dr. Heslop said.

“It’s an active area of research,” she said. “Most centers will look at all of it and then develop what works best in their own individual center for providing the best care for the patients.”

The newly published guidelines could prove an “important contribution” to managing the risk of CAR T therapies, Phyllis I. Warkentin, MD, chief medical officer for FACT, said in an interview, while stressing that they were not more or less important than other similar efforts. Physicians learning how to use the CAR T therapies may welcome new input, as most of what’s been published has been about adults, she said.

“You don’t have the luxury of a lot of time to be learning on the job, so to speak,” with CAR T therapies, she said. “Many of the toxicities are fairly severe and fairly sudden.”

Dr. Heslop has been on advisory board for Gilead and Novartis. Dr. Warkentin and Dr. Mahadeo each reported having no financial disclosures. Other authors of the guidelines paper reported a patent with applications in the field of gene-modified T cell therapy for cancer, as well as financial ties to Cellectis, NexImmune, Torque Pharma, Kite Pharma (a Gilead company), Poseida Therapeutics, Celgene, Novartis, and Unum Therapeutics.

SOURCE: Mahadeo KM et al. Nat Rev Clin Oncol. 2018 Aug 6. doi: 10.1038/s41571-018-0075-2.

Teens who were exposed to any type of secondhand tobacco smoke were significantly more likely to visit emergency departments and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.

pmphoto/iStockphoto

Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.

In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.

Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.

In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).

The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.

The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.

The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.

Teens who were exposed to any type of secondhand tobacco smoke were significantly more likely to visit emergency departments and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.

pmphoto/iStockphoto

Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.

In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.

Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.

In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).

The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.

The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.

The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.

Teens who were exposed to any type of secondhand tobacco smoke were significantly more likely to visit emergency departments and to have more such visits, compared with unexposed controls, based on data from more than 7,000 adolescents.

pmphoto/iStockphoto

Approximately 35% of U.S. teens spent more than an hour exposed to secondhand smoke in a given week, wrote Ashley L. Merianos, PhD, of the University of Cincinnati and her colleagues.

In a study published in Pediatrics, the researchers conducted a secondary analysis of nonsmoking adolescents aged 12-17 years who had not been diagnosed with asthma and who were part of the PATH (Population Assessment of Tobacco and Health) study, a longitudinal cohort trial of tobacco use behavior and related health outcomes in adolescents and adults in the United States. The data were collected between Oct. 3, 2014, and Oct. 30, 2015. The researchers reviewed three main measures of tobacco smoke exposure (TSE): living with a smoker, being exposed to secondhand smoke at home, and being exposed to secondhand smoke for an hour or more in the past 7 days.

Overall, teens who lived with a smoker, had secondary exposure at home, or had at least 1 hour of TSE had significantly more emergency department and/or urgent care visits (mean ranged from 1.62 to 1.65), compared with unexposed peers (mean visits ranged from 1.42 to 1.48). Those who both lived with a smoker and had at least 1 hour of TSE exposure were significantly more likely to visit an ED or urgent care center.

In addition, teens who lived with a smoker, had secondary exposure at home, and had at least 1 hour of TSE were significantly more likely than were unexposed peers to report shortness of breath, difficulty exercising, wheezing during and after exercise, and a dry cough at night (P less than .001).

The researchers also assessed other health indicators, and found that teens with TSE exposure were significantly less likely than were unexposed peers to report very good or excellent health and were approximately 1.50 times more likely than unexposed peers to report missing school because of poor health.

The results were limited by several factors including the use of self-reports of TSE and parent reports of emergency or urgent care visits, and by the inclusion only of other public use variables in the PATH database, the researchers noted. But they adjusted for potentially confounding factors such as household income level, parent education, and health insurance status. However, “Because adolescents are high users of EDs and/or [urgent care] for primary care reasons, these venues are high-volume settings that should be used to offer interventions to adolescents with TSE and their families,” they said.

The researchers had no financial conflicts to disclose. The study was funded by the National Institutes of Health via the National Institute on Drug Abuse and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

SOURCE: Merianos AL et al. Pediatrics 2018 Aug 6. doi: org/10.1542/peds.2018-0266.

Children with Down syndrome (DS) have a nine times higher risk both of hospitalization and mortality associated with respiratory syncytial virus (RSV) infection, reported Andrea Beckhaus, MD, and Jose Castro-Rodriguez, MD, PhD, at the Pontificia Universidad Católica de Chile in Santiago.

Dr. Craig Lyerla/CDC

Because DS is the most common chromosomal disorder, affecting 1 in every 800 children born worldwide, and respiratory infections are the leading cause of hospitalization in children with DS, especially during the first year of life, the results of this study are important and have considerable consequences for public health, the authors observed.

The economic burden on families of children with DS and the health care systems that treat them is, not surprisingly, significantly higher given their sevenfold higher need for supplemental oxygen therapy, threefold likely increased risk of ICU admission, fivefold higher likely need for ventilator support, and average increased length of hospital stay by nearly 5 days.

In the 15 years from 1997 to 2012, RSV-related hospital charges for infants with DS increased by nearly 80% from $10,141 (US dollars) to $18,217, compared with charges for infants not at high risk, which increased by more than 60% from $6,983 to $11,273 during the same period, according to a study (PLoS One. 2016;11[4]:e0152208).

Dr. Beckhaus and Dr. Castro-Rodriguez conducted their systematic review and meta-analysis to evaluate RSV-associated morbidity in children with DS. Following a search of four electronic data bases, a total of 12 studies published between 2004 and 2017 across 10 different countries were identified, including six in Europe, three in Asia, two in the United States, and one in Latin America. Altogether, 3,662 children with DS and 1,145,509 without DS were included in the review.

“Any potential strategy to reduce RSV infection (e.g., prophylaxis with monoclonal antibodies or new vaccines) in children with DS could decrease their morbidity and mortality,” the authors noted. Specifically, they cited the humanized monoclonal antibody palivizumab, which is used for prophylaxis against RSV. Palivizumab is known to reduce hospitalizations in children at high risk from comorbid conditions, including chronic lung disease, hemodynamically significant congenital heart disease (CHD), neuromuscular disease, immunodeficiency, and prematurity. At present, palivizumab is not recommended by the American Academy of Pediatrics for routine use to prevent RSV infection in patients with DS who are not already qualified for other reasons because there are insufficient data to recommend routine prophylactic use of the drug in children with Down syndrome.

The authors cited recent studies in Canada and Japan that may warrant further reconsideration of the AAP’s recommendations, however. A fourfold lowering of RSV-related hospitalizations was observed during the first 2 years of life among 532 children with DS receiving palivizumab who were included in a recent prospective Canadian study. The drug also was found to be safe and effective for preventing lower respiratory tract infections caused by RSV in a recent Japanese multicenter postmarketing surveillance study that evaluated palivizumab prophylaxis for RSV infection in 138 children with DS who did not have hemodynamically significant CHD; only 2 of the children treated required hospitalization.

“More cost-utility studies used to determine the efficacy of RSV immunoprophylaxis in this specific high-risk patient population need to be done,” Dr. Beckhaus and Dr. Castro-Rodriguez recommended.

The review was not without limitations. Not all of the studies included subgroups of participants with DS with CHD and without CHD or other additional risk factors. However, when only those studies were considered that had data for participants with DS without other risk factors, almost all results were similar.

One key strength of the study concerned the study methodology. Using the Newcastle–Ottawa scale, the risk of bias among the 12 studies was generally low, the total number of participants was considerably high, and the outcomes selected had importance for the patients and also public health implications. “It is important to remark that the vast majority of the outcomes that were analyzed had no or unimportant bias,” they said.

Dr. Beckhaus and Dr. Castro-Rodriguez had no relevant disclosures to disclose.

SOURCE: Beckhaus A et al. J Pediatrics. 2018;142(3):e20180225.

Children with Down syndrome (DS) have a nine times higher risk both of hospitalization and mortality associated with respiratory syncytial virus (RSV) infection, reported Andrea Beckhaus, MD, and Jose Castro-Rodriguez, MD, PhD, at the Pontificia Universidad Católica de Chile in Santiago.

Dr. Craig Lyerla/CDC

Because DS is the most common chromosomal disorder, affecting 1 in every 800 children born worldwide, and respiratory infections are the leading cause of hospitalization in children with DS, especially during the first year of life, the results of this study are important and have considerable consequences for public health, the authors observed.

The economic burden on families of children with DS and the health care systems that treat them is, not surprisingly, significantly higher given their sevenfold higher need for supplemental oxygen therapy, threefold likely increased risk of ICU admission, fivefold higher likely need for ventilator support, and average increased length of hospital stay by nearly 5 days.

In the 15 years from 1997 to 2012, RSV-related hospital charges for infants with DS increased by nearly 80% from $10,141 (US dollars) to $18,217, compared with charges for infants not at high risk, which increased by more than 60% from $6,983 to $11,273 during the same period, according to a study (PLoS One. 2016;11[4]:e0152208).

Dr. Beckhaus and Dr. Castro-Rodriguez conducted their systematic review and meta-analysis to evaluate RSV-associated morbidity in children with DS. Following a search of four electronic data bases, a total of 12 studies published between 2004 and 2017 across 10 different countries were identified, including six in Europe, three in Asia, two in the United States, and one in Latin America. Altogether, 3,662 children with DS and 1,145,509 without DS were included in the review.

“Any potential strategy to reduce RSV infection (e.g., prophylaxis with monoclonal antibodies or new vaccines) in children with DS could decrease their morbidity and mortality,” the authors noted. Specifically, they cited the humanized monoclonal antibody palivizumab, which is used for prophylaxis against RSV. Palivizumab is known to reduce hospitalizations in children at high risk from comorbid conditions, including chronic lung disease, hemodynamically significant congenital heart disease (CHD), neuromuscular disease, immunodeficiency, and prematurity. At present, palivizumab is not recommended by the American Academy of Pediatrics for routine use to prevent RSV infection in patients with DS who are not already qualified for other reasons because there are insufficient data to recommend routine prophylactic use of the drug in children with Down syndrome.

The authors cited recent studies in Canada and Japan that may warrant further reconsideration of the AAP’s recommendations, however. A fourfold lowering of RSV-related hospitalizations was observed during the first 2 years of life among 532 children with DS receiving palivizumab who were included in a recent prospective Canadian study. The drug also was found to be safe and effective for preventing lower respiratory tract infections caused by RSV in a recent Japanese multicenter postmarketing surveillance study that evaluated palivizumab prophylaxis for RSV infection in 138 children with DS who did not have hemodynamically significant CHD; only 2 of the children treated required hospitalization.

“More cost-utility studies used to determine the efficacy of RSV immunoprophylaxis in this specific high-risk patient population need to be done,” Dr. Beckhaus and Dr. Castro-Rodriguez recommended.

The review was not without limitations. Not all of the studies included subgroups of participants with DS with CHD and without CHD or other additional risk factors. However, when only those studies were considered that had data for participants with DS without other risk factors, almost all results were similar.

One key strength of the study concerned the study methodology. Using the Newcastle–Ottawa scale, the risk of bias among the 12 studies was generally low, the total number of participants was considerably high, and the outcomes selected had importance for the patients and also public health implications. “It is important to remark that the vast majority of the outcomes that were analyzed had no or unimportant bias,” they said.

Dr. Beckhaus and Dr. Castro-Rodriguez had no relevant disclosures to disclose.

SOURCE: Beckhaus A et al. J Pediatrics. 2018;142(3):e20180225.

Children with Down syndrome (DS) have a nine times higher risk both of hospitalization and mortality associated with respiratory syncytial virus (RSV) infection, reported Andrea Beckhaus, MD, and Jose Castro-Rodriguez, MD, PhD, at the Pontificia Universidad Católica de Chile in Santiago.

Dr. Craig Lyerla/CDC

Because DS is the most common chromosomal disorder, affecting 1 in every 800 children born worldwide, and respiratory infections are the leading cause of hospitalization in children with DS, especially during the first year of life, the results of this study are important and have considerable consequences for public health, the authors observed.

The economic burden on families of children with DS and the health care systems that treat them is, not surprisingly, significantly higher given their sevenfold higher need for supplemental oxygen therapy, threefold likely increased risk of ICU admission, fivefold higher likely need for ventilator support, and average increased length of hospital stay by nearly 5 days.

In the 15 years from 1997 to 2012, RSV-related hospital charges for infants with DS increased by nearly 80% from $10,141 (US dollars) to $18,217, compared with charges for infants not at high risk, which increased by more than 60% from $6,983 to $11,273 during the same period, according to a study (PLoS One. 2016;11[4]:e0152208).

Dr. Beckhaus and Dr. Castro-Rodriguez conducted their systematic review and meta-analysis to evaluate RSV-associated morbidity in children with DS. Following a search of four electronic data bases, a total of 12 studies published between 2004 and 2017 across 10 different countries were identified, including six in Europe, three in Asia, two in the United States, and one in Latin America. Altogether, 3,662 children with DS and 1,145,509 without DS were included in the review.

“Any potential strategy to reduce RSV infection (e.g., prophylaxis with monoclonal antibodies or new vaccines) in children with DS could decrease their morbidity and mortality,” the authors noted. Specifically, they cited the humanized monoclonal antibody palivizumab, which is used for prophylaxis against RSV. Palivizumab is known to reduce hospitalizations in children at high risk from comorbid conditions, including chronic lung disease, hemodynamically significant congenital heart disease (CHD), neuromuscular disease, immunodeficiency, and prematurity. At present, palivizumab is not recommended by the American Academy of Pediatrics for routine use to prevent RSV infection in patients with DS who are not already qualified for other reasons because there are insufficient data to recommend routine prophylactic use of the drug in children with Down syndrome.

The authors cited recent studies in Canada and Japan that may warrant further reconsideration of the AAP’s recommendations, however. A fourfold lowering of RSV-related hospitalizations was observed during the first 2 years of life among 532 children with DS receiving palivizumab who were included in a recent prospective Canadian study. The drug also was found to be safe and effective for preventing lower respiratory tract infections caused by RSV in a recent Japanese multicenter postmarketing surveillance study that evaluated palivizumab prophylaxis for RSV infection in 138 children with DS who did not have hemodynamically significant CHD; only 2 of the children treated required hospitalization.

“More cost-utility studies used to determine the efficacy of RSV immunoprophylaxis in this specific high-risk patient population need to be done,” Dr. Beckhaus and Dr. Castro-Rodriguez recommended.

The review was not without limitations. Not all of the studies included subgroups of participants with DS with CHD and without CHD or other additional risk factors. However, when only those studies were considered that had data for participants with DS without other risk factors, almost all results were similar.

One key strength of the study concerned the study methodology. Using the Newcastle–Ottawa scale, the risk of bias among the 12 studies was generally low, the total number of participants was considerably high, and the outcomes selected had importance for the patients and also public health implications. “It is important to remark that the vast majority of the outcomes that were analyzed had no or unimportant bias,” they said.

Dr. Beckhaus and Dr. Castro-Rodriguez had no relevant disclosures to disclose.

SOURCE: Beckhaus A et al. J Pediatrics. 2018;142(3):e20180225.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

cpalmer@mdedge.com

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

cpalmer@mdedge.com

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.

Women who were obese and had diabetes before becoming pregnant were sixfold more likely to have children with psychiatric and neurodevelopmental disorders by age 11 years, as compared to women with normal body mass indexes (BMIs), based on results of a large, prospective, population-based, cohort study published in Pediatrics.

The risks to offspring whose mothers were obese and had pregestational diabetes mellitus (PGDM) were far greater than the risks seen when mothers had either condition alone or had gestational diabetes mellitus (GDM) in the study, reported Linghua Kong of the Karolinska Institute, Stockholm, and colleagues. The study is based on data from various national registries in Finland regarding 649,043 live births during 2004-2014 and data regarding psychiatric diagnoses from the Finnish Care Registers for Health Care.

Of the children in the cohort, 7.67% had mothers who were obese and 3.66% had mothers who were severely obese based on standard World Health Organization criteria; mothers had PGDM in 0.62% of the births and GDM in 15.7% of the births.

Overall, 5.4% of the children were diagnosed with a psychiatric disorder by age 11 years.

Compared with children born to mothers of normal weight (BMI less than 25 kg/m²), those born to mothers with severe maternal obesity alone (BMI greater than 35) had higher rates of developmental disorders or speech, language, motor, and scholastic skills (hazard ratio, 1.69; 95% confidence interval 1.54-1.86); ADHD and/or conduct disorder (HR, 1.88; 95% CI, 1.58-2.23); and psychosis and mood and anxiety disorders (HR, 1.67; 95% CI, 1.31-2.13). Increased risk of psychiatric disorders were only slightly statistically significant in the offspring of women with severe obesity and GDM.

The risks were significantly elevated, however, for children born to obese women who also had PGDM. The hazard ratio for autism spectrum disorder was 6.49 (95% CI, 3.08-13.69), and the HR for ADHD and/or conduct disorder was 6.03 (95% CI, 3.23-11.24). The risks were fourfold higher for mixed disorders of emotions and conduct, disorders of social function, and tics (HR, 4.29; 95% CI, 2.14-8.60).

Limitations of the study included basing results on shorter follow-up times for those born later in the study period, grouping of offspring’s disorder diagnoses, basing the definition of PGDM on insulin prescription, and using BMI measurements taken at only one time point during pregnancy.

The researchers were supported by the National Institute for Health and Welfare: Drugs and Pregnancy project, the Swedish Research Council, the regional agreement on medical training and clinical research between Stockholm County Council and Karolinska Institutet Stockholm County Council, the China Scholarship Council, and the Swedish Brain Foundation.

cpalmer@mdedge.com

SOURCE: Kong L et al. Pediatrics. 2018 Sep;142(3):1-11.