Meningitis

A health system serving three Midwest states must pay millions to the parents of a now 10-year-old boy whose meningitis was misdiagnosed at birth, according to a report in the Star Tribune, among other news outlets.

The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.

Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.

Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.

Events proceeded rapidly from this point.

Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.

In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.

But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.

Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”

These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.

“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”

In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
 

ED physician found not liable for embolism, jury finds

A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.

The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.

In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.

At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.

Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.

The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”

The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.

At press time, there was no word on whether the plaintiffs planned to appeal.

A version of this article first appeared on Medscape.com.

A health system serving three Midwest states must pay millions to the parents of a now 10-year-old boy whose meningitis was misdiagnosed at birth, according to a report in the Star Tribune, among other news outlets.

The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.

Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.

Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.

Events proceeded rapidly from this point.

Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.

In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.

But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.

Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”

These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.

“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”

In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
 

ED physician found not liable for embolism, jury finds

A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.

The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.

In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.

At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.

Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.

The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”

The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.

At press time, there was no word on whether the plaintiffs planned to appeal.

A version of this article first appeared on Medscape.com.

A health system serving three Midwest states must pay millions to the parents of a now 10-year-old boy whose meningitis was misdiagnosed at birth, according to a report in the Star Tribune, among other news outlets.

The story of the jury verdict begins in 2013, when the boy, Johnny Galligan, was just 8 days old.

Alarmed by the newborn’s crying, lack of appetite, and fever, his parents, Alina and Steve Galligan, brought him to Essentia-Health-Ashland Clinic, located in Memorial Medical Center, Ashland, Wisc. There, the baby was seen by Andrew D. Snider, MD, a family physician. Dr. Snider noted the baby’s extreme fussiness and irritability and was concerned that he was being overfed. Without ordering additional tests, the family physician sent the baby home but arranged for the Galligans to be visited by a county nurse the following day.

Her visit raised concerns, as court documents make clear. She contacted Dr. Snider’s office and explained that the baby needed to be seen immediately. After writing a script for reflux and constipation, Dr. Snider arranged for the baby to be taken to his office later that day.

Events proceeded rapidly from this point.

Following an x-ray, Johnny appeared lethargic and in respiratory distress. He was then taken down the hall to Memorial’s emergency department, where doctors suspected a critical bowel obstruction. Arrangements were made for him to be transported by helicopter to Essentia Health, Duluth, Minn. There, doctors saw that Johnny was acidotic and in respiratory failure. Once again, he was rerouted, this time to Children’s Hospital, Minneapolis, where physicians finally arrived at a definitive diagnosis: meningitis.

In 2020, the Galligans filed a medical malpractice claim against several parties, including Dr. Snider, Duluth Clinic (doing business as Essentia Health and Essentia Health–Ashland Clinic), and Memorial Hospital. In their suit, Johnny’s parents alleged that the collective failure to diagnose their son’s severe infection led directly to his permanent brain damage.

But a Bayfield County, Wisconsin, jury didn’t quite see things that way. After deliberating, it dismissed the claim against Dr. Snider and the other named defendants and found the staff of Duluth Clinic to be solely responsible for injuries to Johnny Galligan.

Duluth must pay $19 million to the Galligan family, of which the largest amount ($7,500,00) is to be directed to Johnny’s “future medical expenses and care needs.”

These expenses and costs are likely to be significant. Currently, at 10 years of age, Johnny can’t walk and is confined to a wheelchair. He has serious neurologic problems and is almost completely deaf and blind.

“He’s doing fairly well, which I attribute to his family providing care for him,” says the attorney who represented the Galligans. “They care for him 24/7. They take him swimming and on four-wheeler rides. He’s not bedridden. He has the best possible quality of life he could have, in my opinion.”

In a statement following the verdict, Essentia Health said that, while it felt “compassion for the family,” it stood by the care it had provided in 2013: “We are exploring our options regarding next steps and remain committed to delivering high-quality care to the patients and communities we are privileged to serve.”
 

ED physician found not liable for embolism, jury finds

A Missouri doctor accused of incorrectly treating a woman’s embolism has been found not liable for her death, reports a story in Missouri Lawyers Media.

The woman went to her local hospital’s ED complaining of pain and swelling in her leg. At the ED, an emergency physician examined her and discovered an extensive, visible thrombosis. No other symptoms were noted.

In the past, such a finding would have prompted immediate hospital admission. But the standard of care has evolved. Now, many doctors first prescribe enoxaparin sodium (Lovenox), an anticoagulant used to treat deep-vein thrombosis. This was the option chosen by the Missouri emergency physician to treat his patient. After administering a first dose of the drug, he wrote a script for additional doses; consulted with his patient’s primary care physician; and arranged for the patient to be seen by him, the ED physician, the following day.

At the drugstore, though, the woman became ill, and an emergency medical services crew was alerted. Despite its quick response, the woman died en route to the hospital. No autopsy was later performed, and it was generally presumed that she had died of a pulmonary embolism.

Following the woman’s death, her family sued the emergency physician, alleging that his failure to admit the woman to the hospital most likely delayed treatment that could have saved her life.

The defense pushed back, arguing that the ED physician had followed the standard of care. “Even if she [had] come into the ER with full-blown [pulmonary embolism],” says the attorney representing the emergency physician, “the first thing you do is give Lovenox. It is just one of those rare circumstances where you can do everything right, but the patient can still die.”

The trial jury agreed. After deliberating for more than an hour, it found that the emergency physician was not responsible for the patient’s death.

At press time, there was no word on whether the plaintiffs planned to appeal.

A version of this article first appeared on Medscape.com.

Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.

Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.

In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.

Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.

Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.

“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.

“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”

The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.

Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.

“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.

Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.

She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.

“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.

In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.

However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.

“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.

It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.

“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”

Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.

The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.

Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.

“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”

Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.

Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.

Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.

In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.

Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.

Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.

“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.

“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”

The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.

Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.

“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.

Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.

She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.

“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.

In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.

However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.

“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.

It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.

“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”

Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.

The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.

Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.

“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”

Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.

Most children with simple febrile seizures (SFSs) can be safely managed without lumbar puncture or other diagnostic tests without risking delayed diagnosis of bacterial meningitis, new data gathered from a 15-year span suggest.

Vidya R. Raghavan, MD, with the division of emergency medicine at Boston Children’s Hospital and Harvard Medical School, also in Boston, published their findings in Pediatrics.

In 2011, researchers published the American Academy of Pediatrics simple febrile seizure guideline, which recommends limiting lumbar puncture to non–low-risk patients. The guidelines also specified that neuroimaging and hematologic testing are not routinely recommended.

Dr. Raghavan and coauthors studied evaluation and management trends of the patients before and after the guidelines. They identified 142,121 children diagnosed with SFS who presented to 1 of 49 pediatric tertiary EDs and met other study criteria. Changes in management of SFS had started years before the guideline and positive effects continued after the guideline publication.

Researchers found a significant 95% decline in rates of lumbar puncture between 2005 and 2019 from 11.6% (95% confidence interval, 10.8%-12.4%) of children in 2005 to 0.6% (95% CI, 0.5%-0.8%; P < .001) in 2019. The most significant declines were among infants 6 months to 1 year.

“We found similar declines in rates of diagnostic laboratory and radiologic testing, intravenous antibiotic administration, hospitalization, and costs,” the authors wrote.

“Importantly,” they wrote, “the decrease in testing was not associated with a concurrent increase in delayed diagnoses of bacterial meningitis.”

The number of hospital admissions and total costs also dropped significantly over the 15-year span of the study. After adjusting for inflation, the authors wrote, costs dropped from an average $1,523 in 2005 to $605 (P < .001) in 2019.

Among first-time presentations for SFSs, 19.2% (95% CI, 18.3%-20.2%) resulted in admission in 2005. That rate dropped to 5.2% (95% CI, 4.8%-5.6%) in 2019 (P < .001), although the authors noted that trend largely plateaued after the guideline was published.

“Our findings are consistent with smaller studies published before 2011 in which researchers found declining rates of LP [lumbar puncture] in children presenting to the ED with their first SFS,” the authors wrote.

Mercedes Blackstone, MD, an emergency physician at the Children’s Hospital of Philadelphia, said in an interview that the paper offers reassurance for changed practice over the last decade.

She said there was substantial relief in pediatrics when the 2011 guidelines recognized formally that protocols were outdated, especially as bacterial meningitis had become increasingly rare with widespread use of pneumococcal and Haemophilus influenzae vaccines. Practitioners had already started to limit the spinal taps on their own.

“We were not really complying with the prior recommendation to do a spinal tap in all those children because it often felt like doing a pretty invasive procedure with a very low yield in what was often a very well child in front of you,” she said.

In 2007, the authors noted, a few years before the guidelines, rates of bacterial meningitis had decreased to 7 per 100,000 in children aged between 2 and 23 months and 0.56 per 100,000 in children aged between 2 and 10 years.

However, Dr. Blackstone said, there was still a worry among some practitioners that there could be missed cases of bacterial meningitis.

“It’s very helpful to see that in all those years, the guidelines have been very validated and there were really no missed cases,” said Dr. Blackstone, author of CHOP’s febrile seizures clinical pathway.

It was good to see the number of CT scans drop as well, she said. Dr. Raghavan’s team found they decreased from 10.6% to 1.6%; P < .001, over the study period.

“Earlier work had shown that there was still a fair amount of head CTs happening and that’s radiation to the young brain,” Dr. Blackstone noted. “This is great news.”

Dr. Blackstone said it was great to see so many children from so many children’s hospitals included in the study.

The paper confirmed that “we’ve reduced a lot of unnecessary testing, saved a lot of cost, and had no increased risk to the patients,” she said.

Dr. Blackstone pointed out that the authors include a limitation that many children are seen in nonpediatric centers in community adult ED and she said those settings tend to have more testing.

“Hopefully, these guidelines have penetrated into the whole community,” she said. “With this paper they should feel reassured that they can spare children some of these tests and procedures.”

Dr. Raghavan and Dr. Blackstone declared no relevant financial relationships.

A clinical prediction rule combining procalcitonin, absolute neutrophil count, and urinalysis effectively identified most febrile infants at low risk for serious bacterial infections, based on data from 702 individuals

The clinical prediction rule (CPR) described in 2019 in JAMA Pediatrics was developed by the Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN) to identify febrile infants at low risk for serious bacterial infections in order to reduce unnecessary procedures, antibiotics use, and hospitalization, according to April Clawson, MD, of Arkansas Children’s Hospital, Little Rock, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, the researchers conducted an external validation of the rule via a retrospective, observational study of febrile infants aged 60 days and younger who presented to an urban pediatric ED between October 2014 and June 2019. The study population included 702 infants with an average age of 36 days. Approximately 45% were female, and 60% were White. Fever was defined as 38° C or greater. Exclusion criteria were prematurity, receipt of antibiotics in the past 48 hours, presence of an indwelling medical device, and evidence of focal infection (not including otitis media); those who were critically ill at presentation or had a previous medical condition were excluded as well, the researchers said. A serious bacterial infection (SBI) was defined as a urinary tract infection (UTI), bacteremia, or bacterial meningitis.

Based on the CPR, a patient is considered low risk for an SBI if all the following criteria are met: normal urinalysis (defined as absence of leukocyte esterase, nitrite, and 5 or less white blood cells per high power field); an absolute neutrophil count of 4,090/mL or less; and procalcitonin of 1.71 ng/mL or less.

Overall, 62 infants (8.8%) were diagnosed with an SBI, similar to the 9.3% seen in the parent study of the CPR, Dr. Clawson said.

Of these, 42 had a UTI only (6%), 10 had bacteremia only (1.4%), and 1 had meningitis only (0.1%). Another five infants had UTI with bacteremia (0.7%), and four had bacteremia and meningitis (0.6%).

According to the CPR, 432 infants met criteria for low risk and 270 were considered high risk. A total of five infants who were classified as low risk had SBIs, including two with UTIs, two with bacteremia, and one with meningitis.

“The CPR derived and validated by Kupperman et al. had a decreased sensitivity for the patients in our study and missed some SBIs,” Dr. Clawson noted. “However, it had a strong negative predictive value, so it may still be a useful CPR.”

The sensitivity for the CPR in the parent study and the current study was 97.7 and 91.9, respectively; specificity was 60 and 66.7, respectively. The negative predictive values for the parent and current studies were 99.6 and 98.8, respectively, and the positive predictive values were 20.7 and 21.1.

The results support the potential of the CPR, but more external validation is needed, they said.
 

PECARN rule keeps it simple

“It has always been a challenge to identify infants with fever with serious bacterial infections when they are well-appearing,” Yashas Nathani, MD, of Oklahoma University, Oklahoma City, said in an interview. “The clinical prediction rule offers a simple, step-by-step approach for pediatricians and emergency medicine physicians to stratify infants in high or low risk categories for SBIs. However, as with everything, validation of protocols, guidelines and decision-making algorithms is extremely important, especially as more clinicians start to employ this CPR to their daily practice. This study objectively puts the CPR to the test and offers an independent external validation.

“Although this study had a lower sensitivity in identifying infants with SBI using the clinical prediction rule as compared to the original study, the robust validation of negative predictive value is extremely important and not surprising,” said Dr. Nathani. “The goal of this CPR is to identify infants with low-risk for SBI and the stated NPV helps clinicians in doing just that.”

Overall, “the clinical prediction rule is a fantastic resource for physicians to identify potentially sick infants with fever, especially the ones that appear well on initial evaluation,” said Dr. Nathani. However, “it is important to acknowledge that this is merely a guideline, and not an absolute rule. Clinicians also must remain cautious, as this rule does not incorporate the presence of viral pathogens as a factor.

“It is important to continue the scientific quest to refine our approach in identifying infants with serious bacterial infections when fever is the only presentation,” Dr. Nathani noted. “Additional research is needed to continue fine-tuning this CPR and the thresholds for procalcitonin and absolute neutrophil counts to improve the sensitivity and specificity.” Research also is needed to explore whether this CPR can be extended to incorporate viral testing, “as a large number of infants with fever have viral pathogens as the primary etiology,” he concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Nathani had no financial conflicts to disclose.

A clinical prediction rule combining procalcitonin, absolute neutrophil count, and urinalysis effectively identified most febrile infants at low risk for serious bacterial infections, based on data from 702 individuals

The clinical prediction rule (CPR) described in 2019 in JAMA Pediatrics was developed by the Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN) to identify febrile infants at low risk for serious bacterial infections in order to reduce unnecessary procedures, antibiotics use, and hospitalization, according to April Clawson, MD, of Arkansas Children’s Hospital, Little Rock, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, the researchers conducted an external validation of the rule via a retrospective, observational study of febrile infants aged 60 days and younger who presented to an urban pediatric ED between October 2014 and June 2019. The study population included 702 infants with an average age of 36 days. Approximately 45% were female, and 60% were White. Fever was defined as 38° C or greater. Exclusion criteria were prematurity, receipt of antibiotics in the past 48 hours, presence of an indwelling medical device, and evidence of focal infection (not including otitis media); those who were critically ill at presentation or had a previous medical condition were excluded as well, the researchers said. A serious bacterial infection (SBI) was defined as a urinary tract infection (UTI), bacteremia, or bacterial meningitis.

Based on the CPR, a patient is considered low risk for an SBI if all the following criteria are met: normal urinalysis (defined as absence of leukocyte esterase, nitrite, and 5 or less white blood cells per high power field); an absolute neutrophil count of 4,090/mL or less; and procalcitonin of 1.71 ng/mL or less.

Overall, 62 infants (8.8%) were diagnosed with an SBI, similar to the 9.3% seen in the parent study of the CPR, Dr. Clawson said.

Of these, 42 had a UTI only (6%), 10 had bacteremia only (1.4%), and 1 had meningitis only (0.1%). Another five infants had UTI with bacteremia (0.7%), and four had bacteremia and meningitis (0.6%).

According to the CPR, 432 infants met criteria for low risk and 270 were considered high risk. A total of five infants who were classified as low risk had SBIs, including two with UTIs, two with bacteremia, and one with meningitis.

“The CPR derived and validated by Kupperman et al. had a decreased sensitivity for the patients in our study and missed some SBIs,” Dr. Clawson noted. “However, it had a strong negative predictive value, so it may still be a useful CPR.”

The sensitivity for the CPR in the parent study and the current study was 97.7 and 91.9, respectively; specificity was 60 and 66.7, respectively. The negative predictive values for the parent and current studies were 99.6 and 98.8, respectively, and the positive predictive values were 20.7 and 21.1.

The results support the potential of the CPR, but more external validation is needed, they said.
 

PECARN rule keeps it simple

“It has always been a challenge to identify infants with fever with serious bacterial infections when they are well-appearing,” Yashas Nathani, MD, of Oklahoma University, Oklahoma City, said in an interview. “The clinical prediction rule offers a simple, step-by-step approach for pediatricians and emergency medicine physicians to stratify infants in high or low risk categories for SBIs. However, as with everything, validation of protocols, guidelines and decision-making algorithms is extremely important, especially as more clinicians start to employ this CPR to their daily practice. This study objectively puts the CPR to the test and offers an independent external validation.

“Although this study had a lower sensitivity in identifying infants with SBI using the clinical prediction rule as compared to the original study, the robust validation of negative predictive value is extremely important and not surprising,” said Dr. Nathani. “The goal of this CPR is to identify infants with low-risk for SBI and the stated NPV helps clinicians in doing just that.”

Overall, “the clinical prediction rule is a fantastic resource for physicians to identify potentially sick infants with fever, especially the ones that appear well on initial evaluation,” said Dr. Nathani. However, “it is important to acknowledge that this is merely a guideline, and not an absolute rule. Clinicians also must remain cautious, as this rule does not incorporate the presence of viral pathogens as a factor.

“It is important to continue the scientific quest to refine our approach in identifying infants with serious bacterial infections when fever is the only presentation,” Dr. Nathani noted. “Additional research is needed to continue fine-tuning this CPR and the thresholds for procalcitonin and absolute neutrophil counts to improve the sensitivity and specificity.” Research also is needed to explore whether this CPR can be extended to incorporate viral testing, “as a large number of infants with fever have viral pathogens as the primary etiology,” he concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Nathani had no financial conflicts to disclose.

A clinical prediction rule combining procalcitonin, absolute neutrophil count, and urinalysis effectively identified most febrile infants at low risk for serious bacterial infections, based on data from 702 individuals

The clinical prediction rule (CPR) described in 2019 in JAMA Pediatrics was developed by the Febrile Infant Working Group of the Pediatric Emergency Care Applied Research Network (PECARN) to identify febrile infants at low risk for serious bacterial infections in order to reduce unnecessary procedures, antibiotics use, and hospitalization, according to April Clawson, MD, of Arkansas Children’s Hospital, Little Rock, and colleagues.

In a poster presented at the Pediatric Academic Societies annual meeting, the researchers conducted an external validation of the rule via a retrospective, observational study of febrile infants aged 60 days and younger who presented to an urban pediatric ED between October 2014 and June 2019. The study population included 702 infants with an average age of 36 days. Approximately 45% were female, and 60% were White. Fever was defined as 38° C or greater. Exclusion criteria were prematurity, receipt of antibiotics in the past 48 hours, presence of an indwelling medical device, and evidence of focal infection (not including otitis media); those who were critically ill at presentation or had a previous medical condition were excluded as well, the researchers said. A serious bacterial infection (SBI) was defined as a urinary tract infection (UTI), bacteremia, or bacterial meningitis.

Based on the CPR, a patient is considered low risk for an SBI if all the following criteria are met: normal urinalysis (defined as absence of leukocyte esterase, nitrite, and 5 or less white blood cells per high power field); an absolute neutrophil count of 4,090/mL or less; and procalcitonin of 1.71 ng/mL or less.

Overall, 62 infants (8.8%) were diagnosed with an SBI, similar to the 9.3% seen in the parent study of the CPR, Dr. Clawson said.

Of these, 42 had a UTI only (6%), 10 had bacteremia only (1.4%), and 1 had meningitis only (0.1%). Another five infants had UTI with bacteremia (0.7%), and four had bacteremia and meningitis (0.6%).

According to the CPR, 432 infants met criteria for low risk and 270 were considered high risk. A total of five infants who were classified as low risk had SBIs, including two with UTIs, two with bacteremia, and one with meningitis.

“The CPR derived and validated by Kupperman et al. had a decreased sensitivity for the patients in our study and missed some SBIs,” Dr. Clawson noted. “However, it had a strong negative predictive value, so it may still be a useful CPR.”

The sensitivity for the CPR in the parent study and the current study was 97.7 and 91.9, respectively; specificity was 60 and 66.7, respectively. The negative predictive values for the parent and current studies were 99.6 and 98.8, respectively, and the positive predictive values were 20.7 and 21.1.

The results support the potential of the CPR, but more external validation is needed, they said.
 

PECARN rule keeps it simple

“It has always been a challenge to identify infants with fever with serious bacterial infections when they are well-appearing,” Yashas Nathani, MD, of Oklahoma University, Oklahoma City, said in an interview. “The clinical prediction rule offers a simple, step-by-step approach for pediatricians and emergency medicine physicians to stratify infants in high or low risk categories for SBIs. However, as with everything, validation of protocols, guidelines and decision-making algorithms is extremely important, especially as more clinicians start to employ this CPR to their daily practice. This study objectively puts the CPR to the test and offers an independent external validation.

“Although this study had a lower sensitivity in identifying infants with SBI using the clinical prediction rule as compared to the original study, the robust validation of negative predictive value is extremely important and not surprising,” said Dr. Nathani. “The goal of this CPR is to identify infants with low-risk for SBI and the stated NPV helps clinicians in doing just that.”

Overall, “the clinical prediction rule is a fantastic resource for physicians to identify potentially sick infants with fever, especially the ones that appear well on initial evaluation,” said Dr. Nathani. However, “it is important to acknowledge that this is merely a guideline, and not an absolute rule. Clinicians also must remain cautious, as this rule does not incorporate the presence of viral pathogens as a factor.

“It is important to continue the scientific quest to refine our approach in identifying infants with serious bacterial infections when fever is the only presentation,” Dr. Nathani noted. “Additional research is needed to continue fine-tuning this CPR and the thresholds for procalcitonin and absolute neutrophil counts to improve the sensitivity and specificity.” Research also is needed to explore whether this CPR can be extended to incorporate viral testing, “as a large number of infants with fever have viral pathogens as the primary etiology,” he concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Nathani had no financial conflicts to disclose.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

Among infants younger than 1 year of age, bacterial meningitis is associated with worse long-term mortality, even after recovery from the initial infection. Heightened mortality risk stretched out to 10 years, and was highest in the wake of infection from Streptococcus agalactiae, according to a retrospective analysis of children in the Netherlands.

“The adjusted hazard rates were high for the whole group of bacterial meningitis, especially within the first year after onset. (Staphylococcus agalactiae) meningitis has the highest mortality risk within one year of disease onset,” Linde Snoek said during her presentation of the study (abstract 913) at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Ms. Snoek is a PhD student at Amsterdam University Medical Center.

Over longer time periods, the mortality associations were different. “The adjusted hazard rates were highest for pneumococcal meningitis compared to the other pathogens. And this was the case for 1 year, 5 years, and 10 years after disease onset,” said Ms. Snoek.

The study appears to be the first to look at extended mortality following bacterial meningitis in this age group, according to Marie Rohr, MD, who comoderated the session where the research was presented.

“In a quick review of the literature I did not find any [equivalent] study concerning short- and long-term mortality after bacterial meningitis in under 1 year of age,” said Dr. Rohr, a fellow in pediatric infectious diseases at University Hospitals of Geneva. But the message to physicians is clear. “Children with history of bacterial meningitis have a higher long-term mortality than children without a history of bacterial meningitis,” said Dr. Rohr.

The study did have a key limitation: For matched controls, it relied on anonymous data from the Municipal Personal Records Database in Statistics Netherlands. “Important information like cause of death is lacking,” said Dr. Rohr.

Bacterial meningitis is associated with significant mortality and morbidity. Pathogens behind the infections vary with age group and geographic location, as well as immunization status.

To examine long-term mortality after bacterial meningitis, the researchers collected 1,646 records from an exposed cohort, with a date range of 1995 to 2018, from the Netherlands Reference Laboratory for Bacterial Meningitis. Included patients had a positive culture diagnosis of bacterial meningitis during the first year of life. Each exposed subject was compared to 10 controls matched by birth month, birth year, and sex, who had no exposure to bacterial meningitis.

Staphylococcus pneumoniae accounted for the most cases, at 32.0% (median age of onset, 180 days), followed by Neisseria meningitidis at 29.0% (median age of onset, 203 days). Other pathogens included S. agalactiae (19.7%, 10 days), Escherichia coli (8.8%, 13 days), and Haemophilus influenzae (5.4%, 231 days).

The mortality risk within 1 year of disease onset was higher for all pathogens (6.2% vs. 0.2% unexposed). The highest mortality risk was seen for S. agalactiae (8.7%), followed by E. coli (6.4%), N. meningitidis (4.9%), and H. influenzae (3.4%).

Hazard ratios (HR) for mortality were also higher, particularly in the first year after disease onset. For all pathogens, mortality rates were higher within 1 year (HR, 39.2), 5 years (HR, 28.7), and 10 years (HR, 24.1). The consistently highest mortality rates were associated with S. pneumoniae over 1-year, 5-year, and 10-year follow-up (HR, 42.8; HR, 45.6; HR, 40.6, respectively). Within 1 year, the highest mortality rate was associated with N. meningitidis (HR, 58.4).

Ms. Snoek and Dr. Rohr have no relevant financial disclosures.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

A new quadrivalent meningococcal conjugate vaccine has been added to the Vaccines for Children (VFC) Program for individuals aged 2 years and older.

No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.

The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.

Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.

Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”

The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.

ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.

Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.

The committee members and Dr. McNamara had no relevant financial conflicts to disclose.

While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.

Steve Mann/Thinkstock

In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.

The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.

In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.

“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.

The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.

lfranki@mdedge.com

SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.

While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.

Steve Mann/Thinkstock

In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.

The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.

In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.

“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.

The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.

lfranki@mdedge.com

SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.

While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.

Steve Mann/Thinkstock

In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.

The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.

In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.

“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.

The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.

lfranki@mdedge.com

SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

A new study, the first of its kind, provided support for guidelines suggesting that the capsular meningococcal B vaccine be given to children with three rare conditions that boost infection risk.

©Micah Young/istockphoto.com

SOURCE: Martinón-Torres F et al. Pediatrics. 2018 Aug 1. doi: 10.1542/peds.2017-4250.

Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock

cnellist@frontlinemedcom.com

Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock

cnellist@frontlinemedcom.com

Vaccination opportunities often are missed in adolescents with chronic medical conditions, said Annika M. Hofstetter, MD, PhD, of Columbia University, New York, and her associates.

The National Health Interview Survey on Disability in 1994-1995 estimated that chronic conditions of any type affected 15%-18% of U.S. children and adolescents. The Advisory Committee on Immunization Practices recommends that all adolescents, whether or not they have chronic medical condition, be vaccinated with human papillomavirus (HPV), Tdap, meningococcal, and flu vaccines.

Joseph Abbott/Thinkstock

cnellist@frontlinemedcom.com