From Medscape Medical News
Neil Osterweil
February 25, 2011 — Meet the new influenza vaccine: it's the same as the old one. The trivalent vaccine for the 2011-2012 influenza season in the Northern Hemisphere will probably be essentially a clone of the current season’s vaccine, ruled members of the Vaccine and Related Biologic Products Advisory Committee (VRBPAC) to the US Food and Drug Administration today.
In 3 separate votes, the committee elected to retain the current formulation of the vaccine, containing the following components:
* Influenza A (H1N1) strain A/California/7/2009 (H1N1)-like virus (the pandemic 2009 strain that was distributed in a monovalent vaccine in the United States in 2009);
* Influenza A (H3N2) strain A/Perth/16/2009 (H3N2)-like virus; and
* Influenza B/Brisbane 60/2008-like virus (R/Victoria lineage; this will be third season in which this strain of influenza B has been included in the trivalent vaccine)
The strains are the same as those recommended by the World Health Organization earlier this week.
After considering the best possible information from worldwide surveillance, the committee chose the strains most likely to provide broad coverage of the population at large, but some committee members confessed to being uneasy about the choice.
"In addition to the sleepless night last night worrying about [influenza] B, I’m going to have another one tonight" said temporary voting member Pamela McInnes, DDS, MSc, director of the Division of Extramural Research at the National Institute of Dental and Craniofacial Research in Bethesda, Maryland.
"We make the decision we do with the data we have on the table, but I think for the record there is obvious discomfort and concern about this every year," she added.
She said the inclusion of the influenza B/Brisbane 60/2008-like virus for the third consecutive year is of concern because the current birth cohort may be exposed to other emerging strains not covered in the proposed formulation, such as the influenza B/Yamagata/16/88 lineage, which is less well covered by the current vaccine.
She urged investigators to continue working with new isolates and reagents to help develop a rapid response should new influenza B strains become problematic in the near future.
Resistance to Adamantanes
Slightly more than half (54%) of all influenza viruses antigenically characterized at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, since the beginning of October 2010 are influenza A (H3N2) isolates, 99% of which were the strain included in the current vaccine, reported Lisa Grohskopf, MD, MPH, a captain in the US Public Health Service, who is also in the Influenza Division of the Epidemiology and Prevention Branch of the CDC.
One third of the isolates (33%) were influenza B, of which 94% were of the Victoria lineage, primarily the B/Brisbane/60/2008-like type covered in the current vaccine. The remaining 6% were of the Yamagata lineage.
Of the 85 influenza A (H1N1) viruses tested (13% of all viruses tested), all were of the strain covered in the current vaccine, Dr. Grohskopf said.
There is high-level resistance to adamantanes (amantadine, rimantadine) among circulating influenza A isolates, but the A(H1N1), A(H3N2), and B virus isolates tested remained susceptible to the neuraminidase inhibitors (oseltamivir [Tamiflu] and zanamivir [Relenza]), she said.
Military Data Suggest Coverage Problems
Data from the global laboratory-based influenza surveillance system maintained by the US Department of Defense (DoD) indicate that there is good agreement between the current vaccine components and the circulating influenza strains, reported Kevin Russell, MD, a captain in the US Navy, director of the DoD’s Global Emerging Infectious Surveillance and Response System, and deputy director of the Armed Forces Health Surveillance Center in Silver Spring, Maryland.
But there is also evidence from a study of 132 active-duty military and dependents suggesting that overall vaccine effectiveness in this group was only 59.7% (95% confidence interval, 51.3% - 68.1%), Dr. Russell said.
In addition, evidence from sentinel surveillance studies suggests poor vaccine protection against A/H1 strains, particularly among those who received the live attenuated influenza vaccine (LAIV) compared with the inactivated vaccine (TIV).
An analysis of data from 36 people with influenza-like illness showed an odds ratio of 2.70 for an illness with flu-like symptoms among those vaccinated with LAIV compared with TIV, Dr. Russell said.
Febrile Seizures
Children younger than 2 years who received both influenza vaccine by Sanofi Pasteur (Fluzone) and the new pneumococcal conjugate vaccine by Wyeth (Prevnar 13), had a slightly elevated risk for febrile seizures, reported David Martin, MD, MPH, an electrophysiologist in the Department of Cardiovascular Medicine at the Cleveland Clinic in Ohio.
Data from the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink system suggested a small risk in children age 12 to 23 months, but not in the larger cohort of children age 6 to 23 months or those older than 23 months, Dr. Martin said.
Vaccine safety investigators will continue with case ascertainment until the end of the current flu season. They will review charts of all cases that received one or both vaccines, Dr. Martin said.
Monday, February 28, 2011
Coadministration of Flu, Pneumococcal Vaccines Linked to Febrile Seizures
From Medscape Medical News
Emma Hitt, PhD
February 25, 2011 — Trivalent inactivated flu vaccine (TIV) administered concurrently with the 13-valent pneumococcal conjugate vaccine (PCV13) appears to be associated with an increased risk for febrile seizure in children age 6 months to 23 months, according to the US Centers for Disease Control and Prevention (CDC).
Frank DeStefano, MD, MPH, from the CDC's Immunization Safety Office, and Grace M. Lee, MD, MPH, from Harvard Medical School, in Boston, Massachusetts, presented data and discussed the issue at the Advisory Committee on Immunization Practices (ACIP) meeting held here in Atlanta, Georgia, on Wednesday and Thursday this week.
According to Dr. DeStefano, fever after vaccination is a common event and can potentially increase the risk for febrile seizures.
Vaccines associated with febrile seizures include whole-cell pertussis vaccines, measles-containing vaccines, and the 2010 TIV for the southern hemisphere, specifically the brand manufactured by CSL Biotherapies (Fluvax and Fluvax Juniors, used in Australia and New Zealand only).
Preliminary results from the Vaccine Safety Datalink suggest that the 2010/2011 TIV used in the United States is not associated with an increased risk for febrile seizure in children 6 months to 23 months of age, unless administered at the same time as PCV13.
Dr. DeStefano estimates that TIV and PCV13 coadministration may account for about 60 seizures per 100,000 children and that such seizures typically occur the day after vaccination.
"Febrile seizures associated with vaccine administration are associated with a good prognosis, although they can scare parents and caregivers," he said.
ACIP also cast a final vote regarding the use of a booster vaccine against Japanese encephalitis virus. A purified, inactivated vaccine derived from an attenuated strain of Japanese encephalitis virus vaccine, Ixiaro, was licensed for use as a booster in October 2010 after its initial approval in 2009.
The vaccine requires a 2-dose series, but guidelines for a booster dose had not been established; ACIP voted that a booster dose before potential exposure to the virus should be given if the primary series of Ixiaro was administered more than a year ago.
The vaccine is recommended for travelers who may be exposed to endemic Japanese encephalitis virus for more than a month as well as laboratory workers.
Emma Hitt, PhD
February 25, 2011 — Trivalent inactivated flu vaccine (TIV) administered concurrently with the 13-valent pneumococcal conjugate vaccine (PCV13) appears to be associated with an increased risk for febrile seizure in children age 6 months to 23 months, according to the US Centers for Disease Control and Prevention (CDC).
Frank DeStefano, MD, MPH, from the CDC's Immunization Safety Office, and Grace M. Lee, MD, MPH, from Harvard Medical School, in Boston, Massachusetts, presented data and discussed the issue at the Advisory Committee on Immunization Practices (ACIP) meeting held here in Atlanta, Georgia, on Wednesday and Thursday this week.
According to Dr. DeStefano, fever after vaccination is a common event and can potentially increase the risk for febrile seizures.
Vaccines associated with febrile seizures include whole-cell pertussis vaccines, measles-containing vaccines, and the 2010 TIV for the southern hemisphere, specifically the brand manufactured by CSL Biotherapies (Fluvax and Fluvax Juniors, used in Australia and New Zealand only).
Preliminary results from the Vaccine Safety Datalink suggest that the 2010/2011 TIV used in the United States is not associated with an increased risk for febrile seizure in children 6 months to 23 months of age, unless administered at the same time as PCV13.
Dr. DeStefano estimates that TIV and PCV13 coadministration may account for about 60 seizures per 100,000 children and that such seizures typically occur the day after vaccination.
"Febrile seizures associated with vaccine administration are associated with a good prognosis, although they can scare parents and caregivers," he said.
ACIP also cast a final vote regarding the use of a booster vaccine against Japanese encephalitis virus. A purified, inactivated vaccine derived from an attenuated strain of Japanese encephalitis virus vaccine, Ixiaro, was licensed for use as a booster in October 2010 after its initial approval in 2009.
The vaccine requires a 2-dose series, but guidelines for a booster dose had not been established; ACIP voted that a booster dose before potential exposure to the virus should be given if the primary series of Ixiaro was administered more than a year ago.
The vaccine is recommended for travelers who may be exposed to endemic Japanese encephalitis virus for more than a month as well as laboratory workers.
Tuesday, February 15, 2011
Recommendations on Use of Meningococcal Conjugate Vaccines Updated
From Medscape Education Clinical Briefs
News Author: Laurie Barclay, MD
Penny Murata, MD
February 3, 2011 — The Advisory Committee on Immunization Practices (ACIP) has updated its recommendations for use of meningococcal conjugate vaccines and published the new guidelines in the January 28 issue of the MMWR Morbidity and Mortality Weekly Report.
Medscape Medical News previously reported on this recommendation in October 2010.
"On October 27, 2010, the ...ACIP approved updated recommendations for the use of quadrivalent (serogroups A, C, Y, and W-135) meningococcal conjugate vaccines (Menveo, Novartis; and Menactra, Sanofi Pasteur) in adolescents and persons at high risk for meningococcal disease," the ACIP writes.
"This report summarizes two new recommendations approved by ACIP:
1) routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years and
2) a 2-dose primary series administered 2 months apart for persons aged 2 through 54 years with persistent complement component deficiency (e.g., C5–C9, properidin, factor H, or factor D) and functional or anatomic asplenia, and for adolescents with human immunodeficiency virus (HIV) infection. CDC [US Centers for Disease Control and Prevention] guidance for vaccine providers regarding these updated recommendations also is included."
On the basis of immunogenicity and safety data, meningococcal conjugate vaccines were licensed in 2005.
However, postlicensure data regarding persistence of bactericidal antibody levels, US trends in meningococcal disease epidemiology, and vaccine efficacy suggested that many adolescents could lose protective immunity after 5 years.
Children immunized at ages 11 through 12 years could therefore have reduced protective immunity by ages 16 to 21 years.
Because the risk for meningococcal disease is greatest in this age range, adolescents 16 to 18 years old should receive either the first dose or a booster dose of meningococcal conjugate vaccine.
Recommendations by Risk Group
Specific recommendations for meningococcal conjugate vaccine by risk group are as follows:
* For persons 11 to 18 years old, the primary series should be 1 dose, preferably at age 11 or 12 years. The booster dose should be at age 16 years if the primary dose was at age 11 or 12 years, and at ages 16 to 18 years if the primary dose was at ages 13 to 15 years. If the primary dose was on or after age 16 years, no booster is needed.
* For HIV-infected persons 11 to 18 years old, the primary series should be 2 doses, 2 months apart. The booster dose should be at age 16 years if the primary dose was at age 11 or 12 years, and at ages 16 to 18 years if the primary dose was at ages 13 to 15 years. If the primary dose was on or after age 16 years, no booster is needed.
* For persons 2 to 55 years old with persistent complement component deficiency or functional or anatomic asplenia, the primary series should be 2 doses, 2 months apart, and the booster dose every 5 years. If a 1-dose primary series was administered, the booster dose should be given at the earliest opportunity, then at every 5 years.
* For persons 2 to 55 years old with a prolonged increased risk for exposure, the primary series should be 1 dose. The booster dose should be given after 3 years for persons 2 to 6 years old, and after 5 years for persons 7 years or older, if the person remains at increased risk.
MMWR Morb Mortal Wkly Rep. 2011;60:72-76. Full Text
Clinical Context
The ACIP previously made recommendations regarding meningococcal prevention in the May 27, 2005, issue of MMWR Recommendations and Reports and the September 25, 2009, issue of MMWR Morbidity and Mortality Weekly Report. Routine vaccination was recommended at age 11 or 12 years to protect adolescents through the period of greatest risk. The ACIP Meningococcal Vaccines Work Group reviewed data on immunogenicity in high-risk groups, antibody persistence after immunization, epidemiology, vaccine effectiveness, and cost-effectiveness. Updated recommendations for quadrivalent (serogroups A, C, Y, and W-135) meningococcal conjugate vaccine administration were approved on October 27, 2010.
This report describes the new recommendations from the ACIP regarding routine immunization schedule and schedule for immunocompromised persons.
News Author: Laurie Barclay, MD
Penny Murata, MD
February 3, 2011 — The Advisory Committee on Immunization Practices (ACIP) has updated its recommendations for use of meningococcal conjugate vaccines and published the new guidelines in the January 28 issue of the MMWR Morbidity and Mortality Weekly Report.
Medscape Medical News previously reported on this recommendation in October 2010.
"On October 27, 2010, the ...ACIP approved updated recommendations for the use of quadrivalent (serogroups A, C, Y, and W-135) meningococcal conjugate vaccines (Menveo, Novartis; and Menactra, Sanofi Pasteur) in adolescents and persons at high risk for meningococcal disease," the ACIP writes.
"This report summarizes two new recommendations approved by ACIP:
1) routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years and
2) a 2-dose primary series administered 2 months apart for persons aged 2 through 54 years with persistent complement component deficiency (e.g., C5–C9, properidin, factor H, or factor D) and functional or anatomic asplenia, and for adolescents with human immunodeficiency virus (HIV) infection. CDC [US Centers for Disease Control and Prevention] guidance for vaccine providers regarding these updated recommendations also is included."
On the basis of immunogenicity and safety data, meningococcal conjugate vaccines were licensed in 2005.
However, postlicensure data regarding persistence of bactericidal antibody levels, US trends in meningococcal disease epidemiology, and vaccine efficacy suggested that many adolescents could lose protective immunity after 5 years.
Children immunized at ages 11 through 12 years could therefore have reduced protective immunity by ages 16 to 21 years.
Because the risk for meningococcal disease is greatest in this age range, adolescents 16 to 18 years old should receive either the first dose or a booster dose of meningococcal conjugate vaccine.
Recommendations by Risk Group
Specific recommendations for meningococcal conjugate vaccine by risk group are as follows:
* For persons 11 to 18 years old, the primary series should be 1 dose, preferably at age 11 or 12 years. The booster dose should be at age 16 years if the primary dose was at age 11 or 12 years, and at ages 16 to 18 years if the primary dose was at ages 13 to 15 years. If the primary dose was on or after age 16 years, no booster is needed.
* For HIV-infected persons 11 to 18 years old, the primary series should be 2 doses, 2 months apart. The booster dose should be at age 16 years if the primary dose was at age 11 or 12 years, and at ages 16 to 18 years if the primary dose was at ages 13 to 15 years. If the primary dose was on or after age 16 years, no booster is needed.
* For persons 2 to 55 years old with persistent complement component deficiency or functional or anatomic asplenia, the primary series should be 2 doses, 2 months apart, and the booster dose every 5 years. If a 1-dose primary series was administered, the booster dose should be given at the earliest opportunity, then at every 5 years.
* For persons 2 to 55 years old with a prolonged increased risk for exposure, the primary series should be 1 dose. The booster dose should be given after 3 years for persons 2 to 6 years old, and after 5 years for persons 7 years or older, if the person remains at increased risk.
MMWR Morb Mortal Wkly Rep. 2011;60:72-76. Full Text
Clinical Context
The ACIP previously made recommendations regarding meningococcal prevention in the May 27, 2005, issue of MMWR Recommendations and Reports and the September 25, 2009, issue of MMWR Morbidity and Mortality Weekly Report. Routine vaccination was recommended at age 11 or 12 years to protect adolescents through the period of greatest risk. The ACIP Meningococcal Vaccines Work Group reviewed data on immunogenicity in high-risk groups, antibody persistence after immunization, epidemiology, vaccine effectiveness, and cost-effectiveness. Updated recommendations for quadrivalent (serogroups A, C, Y, and W-135) meningococcal conjugate vaccine administration were approved on October 27, 2010.
This report describes the new recommendations from the ACIP regarding routine immunization schedule and schedule for immunocompromised persons.
AAP Practice Guideline Stresses Cause in Children With Febrile Seizure
From Medscape Education Clinical Briefs
News Author: Nancy Fowler
CME Author: Charles P. Vega, MD
February 2, 2010 — Physicians examining infants and young children after simple febrile seizure should contemplate meningitis as a possible cause of fever, according to new American Academy of Pediatrics (AAP) practice guidelines published online January 31 in Pediatrics.
"Meningitis should be considered in the differential diagnosis for any febrile child, and lumbar puncture should be performed if there are clinical signs or symptoms of concern," write Patricia K. Duffner, MD, of the AAP's Subcommittee on Febrile Seizures, 2002-2010, and colleagues.
Febrile seizure occurs in 2% to 5% of all children ages 6 to 60 months. It is characterized by a fever, or a body temperature of at least 100.4°F or 38°C, taken by any method, in children with no central nervous system infection. Complex febrile seizure is focal (affecting only specific parts of the body), lasts 15 minutes or longer, and/or recurs within 24 hours.
Simple febrile seizure is generalized, lasts for less than 15 minutes, and does not return within 24 hours. In 1980, the National Institutes of Health designated simple febrile seizure as a benign event, with excellent patient prognosis.
The new guidelines, which replace 1996 practice standards, pertain to patients presenting within 12 hours of simple febrile seizure. They are not intended for children who have experienced complex febrile seizure or those with prior neurologic insults, abnormalities of the central nervous system, or a history of seizures not related to fever.
Signs and symptoms of meningitis include stiff neck, Kernig's sign (lower back or posterior thigh pain during knee extension while the patient's hip is flexed and he or she is lying supine), and Brudzinski's sign (knee and hip flexion with flexed neck while in supine position). Lumbar puncture, also known as spinal tap, is used to diagnose meningitis. It involves the removal and examination of cerebrospinal fluid that surrounds the brain and spinal cord.
Updated Guidelines Stem From Comprehensive Review
Before issuing the new guidelines, AAP investigators examined evidence-based literature made available from 1996 to February 2009. They gave preference to population-based studies. However, a dearth of such research necessitated inclusion of information from hospital-based studies and data gathered from various groups of young children with febrile and other illnesses.
The researchers reviewed 372 articles, 169 more than were evaluated for the 1996 guidelines. Key action statements resulting from their investigation, and all pertaining to children presenting with simple febrile seizure, are as follows:
* Children with meningeal signs, or young patients with a suggestion or history of meningitis or intracranial infection, should undergo lumbar puncture, without exception.
* Any infant between the ages of 6 and 12 months should have lumbar puncture as an option when Haemophilus influenzae type b or Streptococcus pneumoniae immunizations are not current, or are not known.
* A child who has been pretreated with antibiotics should have lumbar puncture as an option because antibiotics can mask meningitis.
* In neurologically healthy children, an electroencephalogram (EEG) should never be performed.
* In the quest to identify simple febrile seizure cause, diagnosticians should not perform the following tests: serum electrolytes, calcium, phosphorus, magnesium, or blood glucose measurements; or complete blood cell count.
* Routine evaluation of children with simple febrile seizure should not include neuroimaging.
"In general, a simple febrile seizure does not usually require further evaluation, specifically EEGs, blood studies, or neuroimaging," the authors of the guideline write.
Regarding parental input on the performance of lumbar puncture, the researchers acknowledge that the procedure is invasive, often painful, and frequently costly. However, they point out that observational data and clinical principles are the foundation of their guidelines and that in the instances that they recommend lumbar puncture, the benefits outweigh possible harm.
"Although parents may not wish to have their child undergo a lumbar puncture, health care providers should explain that if meningitis is not diagnosed and treated, it could be fatal," the guideline authors write.
The guideline authors have disclosed no relevant financial relationships.
Pediatrics. Published online January 31, 2011. Abstract
Related Link
A previously released AAP guideline entitled Febrile Seizures: Clinical Practice Guideline for the Long-term Management of the Child With Simple Febrile Seizures is available online.
Clinical Context
Febrile seizures among young children can provoke significant anxiety among parents, but they rarely result in serious health consequences for the child. The authors of the current review note that 2% to 5% of all children experience a febrile seizure, and simple febrile seizures are defined by duration less than 15 minutes and no recurrence within 24 hours.
Previous research has found that simple febrile seizures are not associated with a higher risk for mortality, hemiplegia, or mental retardation. These seizures are associated with only a modest increase in the risk for epilepsy, but approximately one third of children may experience a recurrence of febrile seizures after a simple febrile seizure.
The AAP last published guidelines regarding the evaluation of children with simple febrile seizures in 1996. The current practice parameter updates that document.
News Author: Nancy Fowler
CME Author: Charles P. Vega, MD
February 2, 2010 — Physicians examining infants and young children after simple febrile seizure should contemplate meningitis as a possible cause of fever, according to new American Academy of Pediatrics (AAP) practice guidelines published online January 31 in Pediatrics.
"Meningitis should be considered in the differential diagnosis for any febrile child, and lumbar puncture should be performed if there are clinical signs or symptoms of concern," write Patricia K. Duffner, MD, of the AAP's Subcommittee on Febrile Seizures, 2002-2010, and colleagues.
Febrile seizure occurs in 2% to 5% of all children ages 6 to 60 months. It is characterized by a fever, or a body temperature of at least 100.4°F or 38°C, taken by any method, in children with no central nervous system infection. Complex febrile seizure is focal (affecting only specific parts of the body), lasts 15 minutes or longer, and/or recurs within 24 hours.
Simple febrile seizure is generalized, lasts for less than 15 minutes, and does not return within 24 hours. In 1980, the National Institutes of Health designated simple febrile seizure as a benign event, with excellent patient prognosis.
The new guidelines, which replace 1996 practice standards, pertain to patients presenting within 12 hours of simple febrile seizure. They are not intended for children who have experienced complex febrile seizure or those with prior neurologic insults, abnormalities of the central nervous system, or a history of seizures not related to fever.
Signs and symptoms of meningitis include stiff neck, Kernig's sign (lower back or posterior thigh pain during knee extension while the patient's hip is flexed and he or she is lying supine), and Brudzinski's sign (knee and hip flexion with flexed neck while in supine position). Lumbar puncture, also known as spinal tap, is used to diagnose meningitis. It involves the removal and examination of cerebrospinal fluid that surrounds the brain and spinal cord.
Updated Guidelines Stem From Comprehensive Review
Before issuing the new guidelines, AAP investigators examined evidence-based literature made available from 1996 to February 2009. They gave preference to population-based studies. However, a dearth of such research necessitated inclusion of information from hospital-based studies and data gathered from various groups of young children with febrile and other illnesses.
The researchers reviewed 372 articles, 169 more than were evaluated for the 1996 guidelines. Key action statements resulting from their investigation, and all pertaining to children presenting with simple febrile seizure, are as follows:
* Children with meningeal signs, or young patients with a suggestion or history of meningitis or intracranial infection, should undergo lumbar puncture, without exception.
* Any infant between the ages of 6 and 12 months should have lumbar puncture as an option when Haemophilus influenzae type b or Streptococcus pneumoniae immunizations are not current, or are not known.
* A child who has been pretreated with antibiotics should have lumbar puncture as an option because antibiotics can mask meningitis.
* In neurologically healthy children, an electroencephalogram (EEG) should never be performed.
* In the quest to identify simple febrile seizure cause, diagnosticians should not perform the following tests: serum electrolytes, calcium, phosphorus, magnesium, or blood glucose measurements; or complete blood cell count.
* Routine evaluation of children with simple febrile seizure should not include neuroimaging.
"In general, a simple febrile seizure does not usually require further evaluation, specifically EEGs, blood studies, or neuroimaging," the authors of the guideline write.
Regarding parental input on the performance of lumbar puncture, the researchers acknowledge that the procedure is invasive, often painful, and frequently costly. However, they point out that observational data and clinical principles are the foundation of their guidelines and that in the instances that they recommend lumbar puncture, the benefits outweigh possible harm.
"Although parents may not wish to have their child undergo a lumbar puncture, health care providers should explain that if meningitis is not diagnosed and treated, it could be fatal," the guideline authors write.
The guideline authors have disclosed no relevant financial relationships.
Pediatrics. Published online January 31, 2011. Abstract
Related Link
A previously released AAP guideline entitled Febrile Seizures: Clinical Practice Guideline for the Long-term Management of the Child With Simple Febrile Seizures is available online.
Clinical Context
Febrile seizures among young children can provoke significant anxiety among parents, but they rarely result in serious health consequences for the child. The authors of the current review note that 2% to 5% of all children experience a febrile seizure, and simple febrile seizures are defined by duration less than 15 minutes and no recurrence within 24 hours.
Previous research has found that simple febrile seizures are not associated with a higher risk for mortality, hemiplegia, or mental retardation. These seizures are associated with only a modest increase in the risk for epilepsy, but approximately one third of children may experience a recurrence of febrile seizures after a simple febrile seizure.
The AAP last published guidelines regarding the evaluation of children with simple febrile seizures in 1996. The current practice parameter updates that document.
US Task Force Issues Updated Statement on Visual Screening in Young Children
From Medscape Education Clinical Briefs
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
February 2, 2011 — The 2004 US Preventive Services Task Force (USPSTF) statement about screening for visual impairment in children 1 to 5 years old has been updated and published online January 31 in Pediatrics.
"The USPSTF recommends vision screening for all children at least once between the ages of 3 and 5 years, to detect the presence of amblyopia or its risk factors (grade B recommendation)," write Mary Barton, MD, from the Agency for Healthcare Research and Quality, Center for Primary Care, Prevention, and Clinical Partnerships in Rockville, Maryland, and colleagues from the USPSTF.
"The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening for children <3 years of age
In developing its updated recommendations, the USPSTF considered evidence from a systematic review of the association of screening for visual impairment in children 1 to 5 years old with improved health outcomes, the accuracy of risk factor evaluation and screening tests, the efficacy of early detection and intervention, the potential harms of screening and treatment, and the net benefit of screening in this population. However, the USPSTF respects the need for clinical or policy decisions to be based on additional considerations. Therefore, they recommend that clinicians and policy makers tailor their decisions to the specific patient or situation.
"Approximately 2% to 4% of preschool-aged children have amblyopia, an alteration in the visual neural pathway in the developing brain that can lead to permanent vision loss in the affected eye," the statement authors write. "Amblyopia usually occurs unilaterally but can occur bilaterally.
Identification of vision impairment before school entry could help identify children who may benefit from early interventions to correct or to improve vision."
On the basis of the evidence, the USPSTF concluded with moderate certainty that screening for visual impairment in children ages 3 to 5 years had a moderate net benefit.
Screening tests that can be used in primary care to identify visual impairment in children include visual acuity tests, stereoacuity tests, the cover-uncover test, and the Hirschberg light reflex test (for ocular alignment/strabismus).
Also potentially useful are autorefractors, or automated optical instruments that detect refractive errors and photoscreeners, or instruments that detect amblyogenic risk factors and refractive errors.
Evidence was adequate that vision screening tools are reasonably accurate in the detection of visual impairment, including refractive errors, strabismus, and amblyopia, and that early treatment for amblyopia, including cycloplegic agents such as atropine or patching of the nonaffected eye, and eyeglasses, for children 3 to 5 years old is associated with improved visual outcomes.
For children younger than 3 years, however, evidence was inadequate that early treatment of amblyopia results in better visual outcomes.
Evidence was limited regarding psychosocial or other harms of screening for children at least 3 years old. False-positive screening results could result in overprescribing of corrective lenses or reversible loss of visual acuity because of patching of the nonaffected eye. For children younger than 3 years, evidence of the harms of screening and treatment was inadequate.
On the basis of the evidence, the USPSTF concluded with moderate certainty that screening for visual impairment in children ages 3 to 5 years had a moderate net benefit. For children younger than 3 years, however, the USPSTF concluded that the benefits of vision screening are uncertain and that the balance of benefits and harms cannot be determined for this age group. The USPSTF did not find adequate evidence to determine the optimal screening interval.
Review: Efficacy of Vision Screening Limited
An accompanying updated evidence-based review by Roger Chou, MD, from Oregon Evidence-Based Practice Center, Oregon Health & Science University in Portland, and colleagues aimed to evaluate the efficacy of screening preschool-aged children for impaired visual acuity on health outcomes. The reviewers searched MEDLINE from 1950 to July 2009 and the Cochrane Library through the third quarter of 2009, reviewed bibliographies of identified articles, and consulted experts.
They found that direct evidence was limited regarding the efficacy of preschool vision screening for improving visual acuity or other clinical outcomes and did not adequately resolve whether screening is more effective than no screening. Indirect evidence included the ability of several screening tests to detect vision problems in preschool-aged children.
Diagnostic accuracy was not clearly different in different age categories, but testability rates were generally lower in children 1 to 3 years old. Compared with no treatment, treatments of amblyopia or unilateral refractive error were associated with mild improvements in visual acuity, but no study to date assessed school performance or other functional outcomes.
"Although treatments for amblyopia or unilateral refractive error can improve vision in preschool-aged children and screening tests have utility for identifying vision problems, additional studies are needed to better understand the effects of screening compared with no screening," the review authors write.
Commentary: Newer Technology Praised
An accompanying commentary by Sean P. Donahue, MD, PhD, from Vanderbilt University School of Medicine in Nashville, Tennessee; and James B. Ruben, MD, from Northern California Permanente Medical Group in Roseville and University of California, Davis, commend the USPSTF recommendation for vision screening at least once for all children between the ages of 3 and 5 years.
"Newer technologies now allow the identification of amblyopia risk factors before strabismus and amblyopia develop and become entrenched, and evidence supports the effectiveness of treatment of children so identified," Drs. Donahue and Ruben write. "It should be emphasized that the I (inconclusive) rating given by the USPSTF for screening children younger than 3 years should not be misinterpreted as 'ineffective.' We welcome the USPSTF level B recommendation for at least 1 vision screening in the child aged 3 to 5 years and believe that there is now adequate evidence to support an earlier screening using photorefraction or autorefraction in younger children."
The USPSTF statement authors and review authors and Dr. Ruben have disclosed no relevant financial relationships. Dr. Donahue has had research and travel support from Plusoptix Inc and Welch Allyn, Inc, and is a consultant for Diopsys, Inc.
Pediatrics. Published online January 31, 2011. Abstract
Related Link
The complete guideline along with supporting documentation is available for download on the USPSTF Web site.
Clinical Context
Amblyopia is the leading cause of monocular vision impairment in US children. It affects 2% to 4% of children, and treatment has been shown to be successful. Vision screening in children consists of various methods, including visual acuity tests, stereoacuity tests, the cover-uncover test, and the Hirschberg light reflex test.
This is a summary of the USPSTF recommendations for screening in children aged 3 to 5 years and in children younger than 3 years, based on a literature review of the evidence. This summary is also an update of the 2004 statement on screening for visual impairment in children younger than 5 years.
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
February 2, 2011 — The 2004 US Preventive Services Task Force (USPSTF) statement about screening for visual impairment in children 1 to 5 years old has been updated and published online January 31 in Pediatrics.
"The USPSTF recommends vision screening for all children at least once between the ages of 3 and 5 years, to detect the presence of amblyopia or its risk factors (grade B recommendation)," write Mary Barton, MD, from the Agency for Healthcare Research and Quality, Center for Primary Care, Prevention, and Clinical Partnerships in Rockville, Maryland, and colleagues from the USPSTF.
"The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening for children <3 years of age
In developing its updated recommendations, the USPSTF considered evidence from a systematic review of the association of screening for visual impairment in children 1 to 5 years old with improved health outcomes, the accuracy of risk factor evaluation and screening tests, the efficacy of early detection and intervention, the potential harms of screening and treatment, and the net benefit of screening in this population. However, the USPSTF respects the need for clinical or policy decisions to be based on additional considerations. Therefore, they recommend that clinicians and policy makers tailor their decisions to the specific patient or situation.
"Approximately 2% to 4% of preschool-aged children have amblyopia, an alteration in the visual neural pathway in the developing brain that can lead to permanent vision loss in the affected eye," the statement authors write. "Amblyopia usually occurs unilaterally but can occur bilaterally.
Identification of vision impairment before school entry could help identify children who may benefit from early interventions to correct or to improve vision."
On the basis of the evidence, the USPSTF concluded with moderate certainty that screening for visual impairment in children ages 3 to 5 years had a moderate net benefit.
Screening tests that can be used in primary care to identify visual impairment in children include visual acuity tests, stereoacuity tests, the cover-uncover test, and the Hirschberg light reflex test (for ocular alignment/strabismus).
Also potentially useful are autorefractors, or automated optical instruments that detect refractive errors and photoscreeners, or instruments that detect amblyogenic risk factors and refractive errors.
Evidence was adequate that vision screening tools are reasonably accurate in the detection of visual impairment, including refractive errors, strabismus, and amblyopia, and that early treatment for amblyopia, including cycloplegic agents such as atropine or patching of the nonaffected eye, and eyeglasses, for children 3 to 5 years old is associated with improved visual outcomes.
For children younger than 3 years, however, evidence was inadequate that early treatment of amblyopia results in better visual outcomes.
Evidence was limited regarding psychosocial or other harms of screening for children at least 3 years old. False-positive screening results could result in overprescribing of corrective lenses or reversible loss of visual acuity because of patching of the nonaffected eye. For children younger than 3 years, evidence of the harms of screening and treatment was inadequate.
On the basis of the evidence, the USPSTF concluded with moderate certainty that screening for visual impairment in children ages 3 to 5 years had a moderate net benefit. For children younger than 3 years, however, the USPSTF concluded that the benefits of vision screening are uncertain and that the balance of benefits and harms cannot be determined for this age group. The USPSTF did not find adequate evidence to determine the optimal screening interval.
Review: Efficacy of Vision Screening Limited
An accompanying updated evidence-based review by Roger Chou, MD, from Oregon Evidence-Based Practice Center, Oregon Health & Science University in Portland, and colleagues aimed to evaluate the efficacy of screening preschool-aged children for impaired visual acuity on health outcomes. The reviewers searched MEDLINE from 1950 to July 2009 and the Cochrane Library through the third quarter of 2009, reviewed bibliographies of identified articles, and consulted experts.
They found that direct evidence was limited regarding the efficacy of preschool vision screening for improving visual acuity or other clinical outcomes and did not adequately resolve whether screening is more effective than no screening. Indirect evidence included the ability of several screening tests to detect vision problems in preschool-aged children.
Diagnostic accuracy was not clearly different in different age categories, but testability rates were generally lower in children 1 to 3 years old. Compared with no treatment, treatments of amblyopia or unilateral refractive error were associated with mild improvements in visual acuity, but no study to date assessed school performance or other functional outcomes.
"Although treatments for amblyopia or unilateral refractive error can improve vision in preschool-aged children and screening tests have utility for identifying vision problems, additional studies are needed to better understand the effects of screening compared with no screening," the review authors write.
Commentary: Newer Technology Praised
An accompanying commentary by Sean P. Donahue, MD, PhD, from Vanderbilt University School of Medicine in Nashville, Tennessee; and James B. Ruben, MD, from Northern California Permanente Medical Group in Roseville and University of California, Davis, commend the USPSTF recommendation for vision screening at least once for all children between the ages of 3 and 5 years.
"Newer technologies now allow the identification of amblyopia risk factors before strabismus and amblyopia develop and become entrenched, and evidence supports the effectiveness of treatment of children so identified," Drs. Donahue and Ruben write. "It should be emphasized that the I (inconclusive) rating given by the USPSTF for screening children younger than 3 years should not be misinterpreted as 'ineffective.' We welcome the USPSTF level B recommendation for at least 1 vision screening in the child aged 3 to 5 years and believe that there is now adequate evidence to support an earlier screening using photorefraction or autorefraction in younger children."
The USPSTF statement authors and review authors and Dr. Ruben have disclosed no relevant financial relationships. Dr. Donahue has had research and travel support from Plusoptix Inc and Welch Allyn, Inc, and is a consultant for Diopsys, Inc.
Pediatrics. Published online January 31, 2011. Abstract
Related Link
The complete guideline along with supporting documentation is available for download on the USPSTF Web site.
Clinical Context
Amblyopia is the leading cause of monocular vision impairment in US children. It affects 2% to 4% of children, and treatment has been shown to be successful. Vision screening in children consists of various methods, including visual acuity tests, stereoacuity tests, the cover-uncover test, and the Hirschberg light reflex test.
This is a summary of the USPSTF recommendations for screening in children aged 3 to 5 years and in children younger than 3 years, based on a literature review of the evidence. This summary is also an update of the 2004 statement on screening for visual impairment in children younger than 5 years.
Children Coinfected With Complicated Pneumonia and Influenza Have Worse Outcomes
From Medscape Medical News
Laurie Barclay, MD
February 14, 2011 — Children coinfected with complicated pneumonia and influenza have worse outcomes than those without documented influenza coinfection, according to the results of a retrospective cohort study reported online February 7 in the Archives of Pediatrics & Adolescent Medicine.
"[A]lthough the association between complicated bacterial pneumonia and influenza has been recognized, no studies to our knowledge have specifically examined the impact of influenza coinfection on disease severity for children with complicated bacterial pneumonia, a group potentially at extremely high risk for poor outcomes," write Derek J. Williams, MD, MPH, from the Division of Pediatric Hospital Medicine, Vanderbilt University School of Medicine and the Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, Tennessee, and colleagues.
"Thus, this study sought to address this issue through the use of a large retrospective cohort of children with complicated pneumonia from 40 children's hospitals nationwide. The primary objective was to determine whether influenza coinfection is independently associated with worse clinical outcomes."
The study cohort consisted of children with complicated pneumonia requiring a pleural drainage. These children were discharged between January 1, 2004, and June 30, 2009, from 40 children's hospitals contributing data to the Pediatric Health Information System. The chief exposure studied was influenza coinfection, and the primary study endpoints were intensive care unit (ICU) admission, use of mechanical ventilation, use of vasoactive infusions, use of blood product transfusions, in-hospital mortality, readmission within 14 days of hospital discharge, hospital length of stay, and hospitalization costs.
Of 9680 children with complicated pneumonia, 3382 underwent pleural fluid drainage, and 105 (3.1%) of these patients undergoing pleural drainage had influenza coinfection. A bacterial pathogen was identified in more than one third of cases (35.5%; n = 1201). In children with influenza coinfection, Staphylococcus aureus was the most frequently identified bacteria (in 22.9% of cases), whereas in children without coinfection, Streptococcus pneumoniae was most common (20.0% of cases).
Children coinfected with influenza were more likely than those without coinfection to have ICU admission; receipt of mechanical ventilation, vasoactive infusions, and blood product transfusions; higher costs; and a longer hospital stay. Although children coinfected with influenza were less likely to require readmission, they exhibited a trend toward higher odds of mortality. In the subgroups of children with S aureus and with no specified bacteria, coinfected children still had worse outcomes.
"Influenza coinfection occurred in 3.1% of children with complicated pneumonia," the study authors write. "Clinical outcomes for children with complicated pneumonia and influenza coinfection were more severe than for children without documented influenza coinfection."
Limitations of this study include lack of reliability of discharge diagnosis codes for specific diseases or pathogens, possible misclassification of bacterial pathogens, and possible failure to identify some patients with influenza coinfection because of miscoding or absence of influenza testing.
"These findings are consistent with other studies performed on a smaller scale and serve to alert the clinician that viral testing is an important consideration in children with complicated pneumonia, particularly in those with a more severe clinical course," the study authors conclude. "Moreover, our findings underscore the importance of routine influenza vaccination for children."
Arch Pediatr Adolesc Med. Published online February 7, 2011. Abstract
Laurie Barclay, MD
February 14, 2011 — Children coinfected with complicated pneumonia and influenza have worse outcomes than those without documented influenza coinfection, according to the results of a retrospective cohort study reported online February 7 in the Archives of Pediatrics & Adolescent Medicine.
"[A]lthough the association between complicated bacterial pneumonia and influenza has been recognized, no studies to our knowledge have specifically examined the impact of influenza coinfection on disease severity for children with complicated bacterial pneumonia, a group potentially at extremely high risk for poor outcomes," write Derek J. Williams, MD, MPH, from the Division of Pediatric Hospital Medicine, Vanderbilt University School of Medicine and the Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, Tennessee, and colleagues.
"Thus, this study sought to address this issue through the use of a large retrospective cohort of children with complicated pneumonia from 40 children's hospitals nationwide. The primary objective was to determine whether influenza coinfection is independently associated with worse clinical outcomes."
The study cohort consisted of children with complicated pneumonia requiring a pleural drainage. These children were discharged between January 1, 2004, and June 30, 2009, from 40 children's hospitals contributing data to the Pediatric Health Information System. The chief exposure studied was influenza coinfection, and the primary study endpoints were intensive care unit (ICU) admission, use of mechanical ventilation, use of vasoactive infusions, use of blood product transfusions, in-hospital mortality, readmission within 14 days of hospital discharge, hospital length of stay, and hospitalization costs.
Of 9680 children with complicated pneumonia, 3382 underwent pleural fluid drainage, and 105 (3.1%) of these patients undergoing pleural drainage had influenza coinfection. A bacterial pathogen was identified in more than one third of cases (35.5%; n = 1201). In children with influenza coinfection, Staphylococcus aureus was the most frequently identified bacteria (in 22.9% of cases), whereas in children without coinfection, Streptococcus pneumoniae was most common (20.0% of cases).
Children coinfected with influenza were more likely than those without coinfection to have ICU admission; receipt of mechanical ventilation, vasoactive infusions, and blood product transfusions; higher costs; and a longer hospital stay. Although children coinfected with influenza were less likely to require readmission, they exhibited a trend toward higher odds of mortality. In the subgroups of children with S aureus and with no specified bacteria, coinfected children still had worse outcomes.
"Influenza coinfection occurred in 3.1% of children with complicated pneumonia," the study authors write. "Clinical outcomes for children with complicated pneumonia and influenza coinfection were more severe than for children without documented influenza coinfection."
Limitations of this study include lack of reliability of discharge diagnosis codes for specific diseases or pathogens, possible misclassification of bacterial pathogens, and possible failure to identify some patients with influenza coinfection because of miscoding or absence of influenza testing.
"These findings are consistent with other studies performed on a smaller scale and serve to alert the clinician that viral testing is an important consideration in children with complicated pneumonia, particularly in those with a more severe clinical course," the study authors conclude. "Moreover, our findings underscore the importance of routine influenza vaccination for children."
Arch Pediatr Adolesc Med. Published online February 7, 2011. Abstract
Wednesday, February 9, 2011
Mild Asthma Is Well Controlled With Low-Dose Steroid Monotherapy
From Reuters Health Information
By Frederik Joelving
NEW YORK (Reuters Health) Feb 07 - For mild persistent asthma, fluticasone propionate with salmeterol cuts the risk of exacerbations more than ciclesonide, but both regimens effectively control daily symptoms.
The findings appear in the February issue of Chest, and are doubly reassuring according to one expert, who was not involved in the study.
"It does look like the current guidelines are on course in terms of mild persistent asthma needing just an inhaled corticosteroid," said Dr. Andy Nish of the Allergy and Asthma Care Center in Gainesville, Georgia.
"But it is interesting that the combination product -- while I'm certainly not advocating treating mild persistent asthma with a combination product -- performed at least as well," he added.
For the study, funded by Nycomed, which markets the glucocorticoid ciclesonide (Alvesco), researchers randomized 657 patients aged 12 to 75 years to ciclesonide 160 mcg once daily, fluticasone propionate/salmeterol (Advair) 100/50 mcg twice daily, or placebo. (The U.S. Food and Drug Administration approved Alvesco for asthma in 2006.)
Over one year, only the combination therapy prolonged the time to asthma exacerbation compared with placebo (p=.0002). The probabilities of not experiencing exacerbations were 82% for patients on combination therapy, 70% for monotherapy and 65% for placebo.
This finding contrasts with earlier results from the OPTIMA trial, note Dr. Dirkje S. Postma, of the University Medical Center Groningen in The Netherlands, and colleagues in Chest. In that trial, adding a long-acting beta-agonist (formoterol) to a corticosteroid (budesonide) didn't reduce the likelihood of exacerbations.
In the current study, both regimens cut asthma symptom scores and the number of poorly controlled asthma days, and they increased the number of symptom-free days by about a week.
The combination therapy also increased lung function significantly, whereas ciclesonide did not. Asthma quality-of-life scores were higher in both treatment groups, and the ciclesonide group saw a greater increase than the combination group (p<.0001).
"In conclusion, as a first-line approach in mild asthma, CIC160 monotherapy offered similar clinical benefits to FP200/S100 for a large number of measures of asthma control," the researchers write. "Combination therapy may be required in some patients to attain full benefits for reducing exacerbations."
Sixty-four percent of the patients on combination therapy reported adverse events, including asthma attacks and nasopharyngitis, compared to 73% in the ciclesonide group and 74% in the placebo group.
"It appears that the combination product in this group was both safe and effective," said Dr. Nish. "That is reassuring for those people who do merit being on the combination."
Still, he added, "unless there is a clear-cut and clinically significant improvement with the combination treatment over monotherapy, then in general monotherapy should be recommended."
Chest. 2011;139:311-318. Abstract
By Frederik Joelving
NEW YORK (Reuters Health) Feb 07 - For mild persistent asthma, fluticasone propionate with salmeterol cuts the risk of exacerbations more than ciclesonide, but both regimens effectively control daily symptoms.
The findings appear in the February issue of Chest, and are doubly reassuring according to one expert, who was not involved in the study.
"It does look like the current guidelines are on course in terms of mild persistent asthma needing just an inhaled corticosteroid," said Dr. Andy Nish of the Allergy and Asthma Care Center in Gainesville, Georgia.
"But it is interesting that the combination product -- while I'm certainly not advocating treating mild persistent asthma with a combination product -- performed at least as well," he added.
For the study, funded by Nycomed, which markets the glucocorticoid ciclesonide (Alvesco), researchers randomized 657 patients aged 12 to 75 years to ciclesonide 160 mcg once daily, fluticasone propionate/salmeterol (Advair) 100/50 mcg twice daily, or placebo. (The U.S. Food and Drug Administration approved Alvesco for asthma in 2006.)
Over one year, only the combination therapy prolonged the time to asthma exacerbation compared with placebo (p=.0002). The probabilities of not experiencing exacerbations were 82% for patients on combination therapy, 70% for monotherapy and 65% for placebo.
This finding contrasts with earlier results from the OPTIMA trial, note Dr. Dirkje S. Postma, of the University Medical Center Groningen in The Netherlands, and colleagues in Chest. In that trial, adding a long-acting beta-agonist (formoterol) to a corticosteroid (budesonide) didn't reduce the likelihood of exacerbations.
In the current study, both regimens cut asthma symptom scores and the number of poorly controlled asthma days, and they increased the number of symptom-free days by about a week.
The combination therapy also increased lung function significantly, whereas ciclesonide did not. Asthma quality-of-life scores were higher in both treatment groups, and the ciclesonide group saw a greater increase than the combination group (p<.0001).
"In conclusion, as a first-line approach in mild asthma, CIC160 monotherapy offered similar clinical benefits to FP200/S100 for a large number of measures of asthma control," the researchers write. "Combination therapy may be required in some patients to attain full benefits for reducing exacerbations."
Sixty-four percent of the patients on combination therapy reported adverse events, including asthma attacks and nasopharyngitis, compared to 73% in the ciclesonide group and 74% in the placebo group.
"It appears that the combination product in this group was both safe and effective," said Dr. Nish. "That is reassuring for those people who do merit being on the combination."
Still, he added, "unless there is a clear-cut and clinically significant improvement with the combination treatment over monotherapy, then in general monotherapy should be recommended."
Chest. 2011;139:311-318. Abstract
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