Monday, February 28, 2011

Refusing to Vaccinate Affects Other Kids, Too

From WebMD Health News

Daniel J. DeNoon

March 24, 2010 — A CDC investigation shows a measles outbreak in San Diego was fueled by kids whose parents refused to vaccinate them, thus endangering children too young to be vaccinated.

Measles is one of the world's most highly contagious viral diseases. Thanks to high vaccination rates, the dangerous disease stopped circulating in the U.S. But now there are ominous signs it may come back.

The reason: Pockets of parents who believe the measles/mumps/rubella (MMR) vaccine is more dangerous than the diseases. Such beliefs led to a drop-off in MMR vaccination in England -- and the subsequent return of measles.

Could it happen in the U.S.? Yes, suggests an in-depth study of the 2008 measles outbreak in San Diego.

San Diego Measles Outbreak

The outbreak began in January 2008 when a 7-year-old boy whose parents refused to vaccinate him returned to the U.S. from Switzerland. Before symptoms appeared, he infected his 3-year-old brother and 9-year-old sister. Neither was vaccinated.

Neither were 11% of the boy's classmates, whose parents shared similar beliefs that a healthy lifestyle protected against disease while vaccines were riskier than the illnesses they prevented.

In the end, 839 people were exposed to measles. Eleven were infected, and 48 exposed kids too young to be vaccinated were quarantined -- forbidden to leave their homes -- for 21 days. Jane Seward, MBBS, MPH, was the CDC's senior investigator for the outbreak.

"Even with the very high vaccine coverage that we saw in San Diego, if you have a community of vaccine refusers you can get an outbreak," Seward tells WebMD.
"Had the local health department not been extremely aggressive in quarantining everyone who came in contact with a case who did not have immunity, the outbreak would have broadened."

Fortunately, nobody died or suffered neurological damage. But there was one very close call.

Megan Campbell's 10-month-old son was in the pediatrician's waiting room when the boy who'd been infected in Switzerland came in. The infant got very, very sick -- so sick that Campbell and her family thought he was going to die.

"There were moments I was worried he wouldn't make it because this fever just wasn't letting up. This 106-degree fever, and this rash that made my son look like an alien almost, and I wondered if he was going to be the same boy he was a week before," Campbell told interviewer Susan Burton on the radio program This American Life.

The infant spent three days in the hospital. He dropped from 18 to 12 pounds in five days. He was sick for weeks; Campbell and her husband had to take a month off of work. Fortunately, the boy recovered fully.

"I just wondered how this family who had brought this into San Diego, what were they thinking?" Campbell said on the radio program. "Were they thinking they were part of something that put that child there? Did they feel for us at all? Did they feel bad about it?"

Many Parents Question Vaccine Safety

Part of the CDC and San Diego County investigation involved outreach to parents in the affected community who believe vaccines pose a greater risk to children than the diseases they prevent.

These parents told the researchers that they were skeptical of vaccine safety and efficacy claims by the government, the pharmaceutical industry, and the medical community. They felt there was a very low risk of getting a vaccine-preventable disease, and that such diseases were better prevented by "natural lifestyles" including prolonged breastfeeding and organic foods. Most felt vaccines could damage a child's immune system and cause neurologic complications such as autism.

"I really don't think many of them changed their minds," study investigator and CDC researcher Albert E. Barskey, MPH, tells WebMD. "They were pretty set in their ways. In fact, when given the choice of vaccinating their children after exposure so they could go back to school, most chose instead to keep them quarantined at home for three weeks."

Even so, when faced with the fact that their children had been exposed to measles, about 40% of the parents did chose vaccination over quarantine.

Vaccine Debate Rages On

Despite the extraordinary efforts of health workers, what really ended the San Diego outbreak wasn't quarantine or post-exposure vaccination. It was the high vaccination rate in the rest of the community that kept the outbreak from becoming an epidemic.

Christopher Harrison, MD, director of the infectious diseases research laboratory at Children's Mercy Hospitals & Clinic in Kansas City, Mo., says parents who don't vaccinate may think they are avoiding making a decision that could harm their child.

"They think that if they do nothing it is not their fault; that if they give their child a vaccine and something seems to go wrong, they are going to feel guilt," Harrison tells WebMD. "But not making a decision is really making a decision, and that decision is to leave your child unprotected. By not vaccinating, you have really put your child at risk."

Tamara R. Kuittenen, MD, director of medical education at New York's Lenox Hill Hospital, says she often encounters parents' "real fear" that the MMR vaccine somehow causes autism.

"I am a mother of three, age 3 and under, and I see all these mothers blogging about MMR vaccine refusal," she tells WebMD. "This is a story that needs to be told: Measles is still a threat and the vaccine is very effective. Not vaccinating your children puts them at risk of a lot of complications."

The CDC/San Diego Health Department study appears in the April issue of Pediatrics.

FDA Panel Keeps Same Formulation for 2011-12 Influenza Vaccine

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.

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.

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.

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.

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.

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

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

Study Calls Pediatric Antibiotic-Asthma Link Into Question

From Reuters Health Information

By Amy Norton

NEW YORK (Reuters Health) Feb 03 - While some studies have suggested that giving babies antibiotics might boost their risk of asthma later on, a new analysis concludes that much of that evidence is flawed.

The new analysis, of 21 studies conducted since 2002, found that the majority had limitations that could have biased them toward finding a link between infant antibiotic use and asthma risk.

According to the researchers, several studies were hampered by reverse causation. In other words, the babies' wheezing symptoms could have prompted the antibiotic prescriptions, rather than antibiotics causing wheezing and asthma to develop later on.

A couple of studies in the current review could not rule out the possibility of reverse causation. In a few others, there was initially a connection between early antibiotic use and asthma, but it disappeared after the researchers controlled for reverse causation.

In other studies, the issue was "confounding by indication," that is, the infection for which the antibiotic was prescribed could be the real risk factor for wheezing and asthma.

One study found babies with "chest" infections with symptoms of wheezing were twice as likely to be prescribed antibiotics as babies with upper respiratory infections, like colds. And it was the chest infections, rather than the antibiotics, that appeared to account for the increased risk of asthma symptoms before the age of five.

Several other studies did not account for the possibility of confounding by indication.

"The overall conclusion of our meta-analysis was that after excluding the studies that were at high risk of bias due to reverse causation and confounding by indication, there was only a very small increased risk of wheeze/asthma in children exposed to antibiotics in infancy," said lead researcher Dr. John Penders, of Maastricht University Medical Center in The Netherlands.

Another issue, he told Reuters Health by e-mail, is that only three of the studies looked at asthma risk beyond the age of five or six.

Asthma is tricky to diagnose in children younger than six, both because wheezing can be caused by respiratory infections rather than asthma, and because young children usually cannot perform the lung function tests used to objectively diagnose asthma.

When Dr. Penders' team combined the results of the three studies that included older children, there was no clear association between early antibiotic use and later asthma risk.

The bottom line, the researchers said in a January 13th online paper in the European Respiratory Journal, is that there is still a need for more well-designed studies that follow children over a longer period.

In the meantime, though, it is important to give babies and young children antibiotics only when absolutely necessary, according to Dr. Penders.

"Studies have shown that up to 50% of antibiotic prescriptions for children given by primary care physicians are unnecessary," he said, adding that the rate does vary widely among countries.

Dr. Anita Kozyrskyj, an associate professor at the University of Alberta in Edmonton, Canada, agreed on the need for further, long-range studies.

In an e-mail to Reuters Health, she pointed out that her own 2007 study, which was included in the analysis, did find a link between antibiotic prescriptions for non-respiratory conditions -- like urinary tract infections -- and later asthma risk.

Further studies that zero in on the reasons for babies' antibiotic prescriptions would be helpful, Dr. Kozyrskyj said.

She also agreed on the need for judicious use of antibiotics in infants -- especially when it comes to broad-spectrum antibiotics.

What is worrisome, Dr. Kozyrskyj said, is that guidelines in both the U.S. and Canada now call for greater use of wide-spectrum antibiotics for kids' ear infections.

"In Sweden and Norway, basic penicillin remains the antibiotic of choice," she noted.

Middle-ear infections are among the most common reasons for antibiotic prescriptions in American toddlers. But about 80% of children would get better without antibiotics, according to the American Academy of Pediatrics.

In its treatment guidelines, the academy says infants and children without severe symptoms can often wait 48 to 72 hours before starting antibiotics to see if the infection improves on its own.

Eur Resp J. Posted online January 13, 2011. Abstract

Tuesday, February 8, 2011

Added Sugar Intake in US Adolescents Linked to Cardiovascular Risk

From Medscape Education Clinical Briefs

News Author: Laurie Barclay, MD
CME Author: Hien T. Nghiem, MD



January 31, 2011 — Added sugar intake in US adolescents is linked to increased cardiovascular disease risk, according to the results of a cross-sectional study reported online January 10 in Circulation.

"Whereas increased carbohydrate and sugar consumption has been associated with higher cardiovascular disease risk among adults, little is known about the impact of high consumption of added sugars (caloric sweeteners) among US adolescents," write Jean A. Welsh, MPH, RN, from the Nutrition and Health Science Program, Emory University School of Medicine in Atlanta, Georgia, and colleagues.

Dietary data from one 24-hour recall of 2157 US adolescents enrolled in the National Health and Nutrition Examination Survey 1999 to 2004 were merged with added sugar content data from the US Department of Agriculture MyPyramid Equivalents databases. Measures of cardiovascular disease risk were estimated as a function of added sugar intake level (< 10%, 10% to < 15%, 15% to < 20%, 20% to < 25%, 25% to < 30%, and ≥ 30% of total energy). Multivariable means were weighted to be representative of US adolescents, and variances were adjusted to account for the complex sampling methods. Average daily intake of added sugars was 21.4% of total energy. Added sugar consumption correlated inversely with mean high-density lipoprotein (HDL) cholesterol levels (mmol/L). The lowest consumers had a mean HDL of 1.40 (95% confidence interval [CI], 1.36 - 1.44), and the highest consumers had a mean HDL of 1.28 (95% CI, 1.23 - 1.33; P for trend = .001). Added sugar intake correlated positively with geometric mean triglyceride levels (mmol/L), which were 0.81 (95% CI, 0.74 - 0.88) in the lowest consumers and 0.89 (95% CI, 0.83 - 0.96) in the highest consumers (P for trend = .05). Added sugar intake also correlated positively with low-density lipoprotein (LDL) cholesterol levels (mmol/L), which were 2.24 (95% CI, 2.12 - 2.37) in the lowest consumers and 2.44 (95% CI, 2.34 - 2.53) in the highest consumers (P for trend = .01). For adolescents who were overweight or obese, defined as a body mass index at or above the 85th percentile, added sugars correlated positively with the homeostasis model assessment of insulin resistance (HOMA-IR; P for linear trend = .004). "Consumption of added sugars among US adolescents is positively associated with multiple measures known to increase cardiovascular disease risk," the study authors write. Limitations of this study include cross-sectional design with exposures and outcomes measured at the same time, precluding determination of causality; use of a single 24-hour dietary recall; possible residual confounding; and lack of information on the validity of the process used to estimate added sugar content data in the US Department of Agriculture MyPyramid Equivalents databases. "Though long-term trials to study the effect of reducing the consumption of added sugars are needed, the results of this study suggest that future risk of CVD [cardiovascular disease] may be reduced by minimizing consumption of added sugars among adolescents," the study authors conclude. One of the study authors (Miriam B. Vos, MD, MSPH) is supported in part by a career award from the National Institutes of Diabetes and Digestive and Kidney Diseases and by the Children's Digestive Health and Nutrition Foundation. Dr. Vos is also the author of The No-Diet Obesity Solution for Kids, for which he receives royalties. The remaining study authors have disclosed no relevant financial relationships. Circulation. Published online January 10, 2011. Abstract Clinical Context In 1986, the Sugars Task Force of the US Food and Drug Administration concluded that there was no evidence of an association between sugar consumption and cardiovascular disease or its risk factors. Since then, several epidemiologic and experimental studies have demonstrated more evidence linking the intake of carbohydrates and sugars with an increased risk for cardiovascular disease. The Institute of Medicine suggests a limit of 25% total energy from added sugars to ensure adequate intake of important nutrients, the World Health Organization advises limiting added sugars to less than 10% total energy to prevent dental caries, and the American Heart Association advises that daily intake of added sugars be limited to less than 100 calories daily for women and 150 calories for men for the prevention of heart disease. Whereas increased carbohydrate and sugar consumption has been associated with higher cardiovascular disease risk among adults, little is known about the impact of high consumption of added sugars (caloric sweeteners) among US adolescents. The aim of this study was to determine if there is an association between the consumption of added sugars and indicators of cardiovascular disease risk among US adolescents and to determine if body weight modifies this association. Study Highlights * In a cross-sectional study of 2157 US adolescents in the National Health and Nutrition Examination Survey 1999 to 2004, dietary data from one 24-hour recall were merged with added sugar content data from the US Department of Agriculture MyPyramid Equivalents databases. * Exclusion criteria were adolescents with unreliable or implausible (< 600 or > 4500 kcal/day) dietary data, those who were pregnant, those with extreme triglyceride levels (> 300 mg/dL), those with previously diagnosed diabetes mellitus, and those with missing covariate data.
* Measures of cardiovascular disease risk were estimated by added sugar consumption level (< 10%, 10% to < 15%, 15% to < 20%, 20% to < 25%, 25% to < 30%, and ≥ 30% of total energy). * Biological indicators known to be associated with cardiovascular disease were measured, including lipids and glucose metabolism. * HOMA-IR was calculated. This is an estimate of insulin resistance derived from fasting glucose and insulin levels, with higher levels representing greater degrees of insulin resistance. * Multivariable means were weighted to be representative of US adolescents, and variances were adjusted for the complex sampling methods. * No significant differences were observed between the level of added sugars consumed and demographic factors, physical activity, or total energy intake. * Results demonstrated that daily consumption of added sugars averaged 21.4% of total energy. * Added sugar intake correlated inversely with mean HDL cholesterol levels (mmol/L), which were 1.40 (95% CI, 1.36 - 1.44) among the lowest consumers and 1.28 (95% CI, 1.23 - 1.33) among the highest consumers (P for trend = .001). * Added sugars correlated positively with LDL cholesterol levels (P for trend = .01) and geometric mean triglyceride levels (P for trend = .05). * Among the lowest and highest consumers, respectively, LDL cholesterol levels (mmol/L) were 2.24 (95% CI, 2.12 - 2.37) and 2.44 (95% CI, 2.34 - 2.53), and triglyceride levels (mmol/L) were 0.81 (95% CI, 0.74 - 0.88) and 0.89 (95% CI, 0.83 - 0.96). * Among overweight or obese adolescents (> 85th percentile of body mass index), added sugars correlated positively with HOMA-IR (P for linear trend = .004) and higher fasting insulin levels.
* No significant trends were observed between consumption of added sugars and fasting glucose levels, systolic or diastolic blood pressure, waist circumference, or body mass index.

Clinical Implications

* Recently, the American Heart Association released recommendations advising that daily intake of added sugars be limited to less than 100 calories daily for women and 150 calories for men for the prevention of heart disease.
* Higher consumption of added sugars among US adolescents is positively associated with multiple measures known to increase cardiovascular disease risk.

CME Test

Sunday, February 6, 2011

AAP Practice Guideline Stresses Cause in Children With Febrile Seizure

From Medscape Medical News

Nancy Fowler

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.

Friday, February 4, 2011

Elimination Diet May Improve ADHD Symptoms

From Medscape Medical News > Psychiatry
Investigators Suggest 'Diet Therapy" Should Be Considered in All Children With ADHD

Megan Brooks

February 4, 2011 — In a group of young children with attention-deficit/hyperactivity disorder (ADHD), nearly two-thirds who followed a restricted elimination diet experienced a significant reduction in ADHD symptoms and oppositional defiant behavior. Going off the diet led to relapse.

The findings, from the Impact of Nutrition on Children with ADHD (INCA) study, are published in the February 5 issue of The Lancet.

"We think that dietary intervention should be considered in all children with ADHD, provided parents are willing to follow a diagnostic restricted elimination diet for a 5-week period and provided expert supervision is available," Lidy M. Pelsser, PhD, of the ADHD Research Centre in Eindhoven, the Netherlands, and colleagues write.

"Children who react favorably to this diet should be diagnosed with food-induced ADHD and should enter a challenge procedure to define which foods each child reacts to and to increase the feasibility and to minimize the burden of the diet," they advise.

But in comments to Medscape Medical News, Jaswinder Ghuman, MD, of the Division of Child and Adolescent Psychiatry at University of Arizona, Tuscon, author of a linked commentary, said further investigation is needed "to make recommendations for children who are more likely to benefit."

IgG Measurements Not Helpful

Hypersensitivity or intolerance to foods or food additives is thought to contribute to ADHD. The children in the INCA study were unselected for any food sensitivities, and the researchers found that performing blood tests to identify ADHD "trigger" foods was not helpful.
Blood tests assessing IgG levels against foods did not predict which foods might have a deleterious impact on a child's behavior.

"Total IgE levels were increased in only a few children, equally in (diet) responders and nonresponders, suggesting that the underlying mechanism of food sensitivity in ADHD (which could be related to genetic factors) is nonallergic," Dr Pelsser and colleagues report.

The INCA study was a 2-phase randomized trial involving 100 children aged 4 to 8 years with ADHD. During a baseline period (weeks 1 to 3), 50 control children continued their normal diet and their parents were given healthy food advice and kept a diary of their child's behavior.
The other 50 children started an open trial with a restricted elimination diet (mainly rice, meat vegetables, pears, and water, complemented with potatoes, fruits, and wheat).

By the end of week 2, 17 of 41 children in the diet group (41.5%) had no behavioral response to the diet, and their diet was further restricted to rice, meat, vegetables, pears, and water.

According to the investigators, by the end of phase 1 (weeks 4-9), symptoms of ADHD and oppositional defiant disorder were significantly improved in 64% of children in the diet group compared with no improvement in controls.

Between baseline and the end of phase 1, the difference between the diet group and the control group in the mean ADHD rating scale (ARS) total score was 23.7 (95% confidence interval [CI], 18.6 – 28.8; P < .0001). The between-group difference in the mean abbreviated Conners' scale between baseline and phase 1 end was 11.8 (95% CI, 9.2 – 14.5; P < .0001).

Children in the diet group who had a clinical response in phase 1, defined as at least a 40% improvement on ARS score, proceeded to phase 2, a 4-week, double-blind, crossover food challenge, in which high-IgG or low-IgG foods (selected based on individual total IgG levels to 270 different foods) were added to the diet.

After challenges with either high- or low-IgG foods, relapse of ADHD symptoms occurred in 19 of 30 children (63%), regardless of IgG blood test results.

Diet 'Complex and Challenging'

Dr. Pelsser's team concludes that a strictly supervised restricted elimination diet "is a valuable instrument to assess whether ADHD is induced by food, [but] the prescription of diets on the basis of IgG blood tests should be discouraged."

In her commentary, Dr. Ghuman notes restricted elimination diet studies are "complex and challenging." The INCA study was "well-designed and carefully done, showed a benefit with a supervised elimination diet, and provides an additional treatment option for some young children with ADHD.

"For interested parents," Dr. Ghuman told Medscape Medical News, "clinicians should encourage them to seek the advice of the child's primary care provider and a nutritionist for appropriate monitoring of the child's nutritional status and needs. The parents will need appropriate guidance and supervision for a structured protocol to determine any benefit and identify incriminated foods."

In her commentary, Dr. Ghuman says it's important to note that 36% of children either didn't respond to the elimination diet or didn’t stick to it in phase 1 and 16 children eligible children (and parents) were not motivated to participate in the study.

She also points out that the blinded assessments in the study were based on information provided by parents. However, parents and teachers were aware whether the children were on the elimination diet or not in phase 1.

They also knew that the children entering phase 2 received challenge foods but not whether the foods were high- or low-IgG foods. The beliefs and expectations of the parents and teachers about changes in the ADHD symptoms could have been influenced by this knowledge, Dr. Ghuman notes.

Lancet. 2011;377:446-448, 494-503.

Tuesday, February 1, 2011

US Task Force Issues Updated Statement on Visual Screening in Young Children

From Medscape Medical News

Laurie Barclay, MD

January 31, 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 (I statement)."

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."

Pediatrics. Published online January 31, 2011. Abstract

AAP Issues Recommended Childhood and Teen Immunization Schedules

From Medscape Medical News

Laurie Barclay, MD

February 1, 2011 — The American Academy of Pediatrics (AAP) has issued 2011 immunization schedules recommended for childhood and adolescents and published a policy statement describing the new schedules online February 1 in Pediatrics.
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the American Academy of Family Physicians have also approved the new recommendations, which were written by the Committee on Infectious Diseases, chaired by Michael T. Brady, MD.

Highlights of the new schedules include guidance on hepatitis B vaccine administration to children who did not receive the recommended birth dose, and new recommendations on the use of 13-valent pneumococcal conjugate vaccine (PCV13), which replaced the 7-valent pneumococcal conjugate vaccine (PCV7).

Because of recent outbreaks of pertussis nationwide, the new recommendations offer guidance for a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in 7- to 10-year-old children who have not been adequately immunized against pertussis. The updated schedules now recommend a booster dose of the conjugated meningococcal vaccine to improve protection of adolescents throughout the greatest period of risk for meningococcal disease. Instructions on dosing of influenza vaccine are now based on a history of receiving monovalent 2009 H1N1 vaccine. The policy statement also offers guidance on administering human papillomavirus (HPV) vaccines to boys 9 to 18 years old to lower their risk of acquiring genital warts.

Specific Updated Changes

Specific changes in the 2011 schedules from last year include the following:

* For children who did not receive the recommended birth dose of hepatitis B vaccine, the new recommendations offer guidance for administering the hepatitis B vaccine series. The catch-up schedule now includes a minimal age for dose 3 of hepatitis B vaccine, so that the final (third or fourth) dose in the series should be given no sooner than age 24 weeks.
* New recommendations are included on the use of PCV13, so that a PCV series started with PCV7 should be completed with PCV13. All children 14 through 59 months old who received an age-appropriate series of PCV7 should receive a single supplemental dose of PCV13. All children 60 through 71 months old with underlying medical conditions who have received an age-appropriate series of PCV7 should receive a single supplemental dose of PCV13. The supplemental PCV13 dose should be given at least 8 weeks after the previous dose of PCV7. Children 6 through 18 years old with functional or anatomic asplenia, HIV infection or other immunocompromising conditions, cochlear implant, or cerebrospinal fluid leak may be given a single dose of PCV13. Children at least 2 years old who have certain underlying medical conditions should be given the pneumococcal polysaccharide vaccine (PPSV) no sooner than 8 weeks after the last dose of PCV. Children with functional or anatomic asplenia or an immunocompromising condition should receive a single revaccination with PPSV after 5 years.
* On the basis of the child's history of receiving monovalent 2009 H1N1 vaccine, the new recommendations offer guidance for administering 1 or 2 doses of influenza vaccine. Children 6 months through 8 years old who are receiving influenza vaccine for the first time or who were vaccinated for the first time during the previous influenza season but only received 1 dose at that time should receive 2 doses at least 4 weeks apart. Two doses of 2010-2011 seasonal influenza vaccine should be given to children 6 months through 8 years old who received no doses of monovalent 2009 H1N1 vaccine or in whom the dosing schedule is unknown.
* Adolescents should be routinely immunized with quadrivalent meningococcal conjugate vaccine (MCV4), preferably at ages 11 through 12 years, and the new recommendations call for a booster dose at age 16 years. Adolescents given their first dose at ages 13 through 15 years should receive a booster dose at ages 16 through 18 years. A 2-dose primary series should be given 2 months apart to people at ages 2 through 54 years who are at higher risk for meningococcal disease.
* A single dose of Tdap should be given to children 7 through 10 years old who are not fully immunized against pertussis, including those who were never vaccinated or those with unknown pertussis vaccination status. Children 7 through 10 years old should be vaccinated according to the catch-up schedule if further doses are needed for complete immunization against tetanus and diphtheria. If adolescents 13 through 18 years old have not received the Tdap vaccine, they should receive a dose followed by a tetanus and diphtheria toxoids vaccine (Td) booster dose every 10 years thereafter. For children 7 through 18 years old, there is no longer a specified interval between the Td and Tdap vaccines.
* The policy statement contains guidance for use of Haemophilus influenzae type b vaccine in persons at least 5 years old who are at greater risk. Clinicians should consider giving 1 dose of Haemophilus influenzae type b vaccine to persons who are at least 5 years old who have sickle cell disease, leukemia, or HIV infection or in children who have undergone splenectomy.
* To prevent cervical precancerous lesions and cancers in girls, the new guidelines recommend the quadrivalent HPV vaccine (HPV4) and the bivalent vaccine (HPV2). To help prevent genital warts, HPV4 is also recommended for girls, and boys 9 through 18 years old may be given a 3-dose series of HPV4.

"Clinically significant adverse events that follow immunization should be reported to the Vaccine Adverse Event Reporting System (VAERS)," the statement authors conclude. "Guidance about how to obtain and complete a VAERS form can be obtained on the Internet at www.vaers.hhs.gov [new Web address is http://vaers.hhs.gov/index] or by calling 800-822-7967. Additional information can be found in the 2009 RedBook1 and at Red Book Online (www.aapredbook.org)."

Pediatrics. Published online February 1, 2011. Full text

Added Sugar Intake in US Adolescents Linked to Cardiovascular Risk

From Medscape Medical News
Laurie Barclay, MD

January 31, 2011 — Added sugar intake in US adolescents is linked to increased cardiovascular disease risk, according to the results of a cross-sectional study reported online January 10 in Circulation.

"Whereas increased carbohydrate and sugar consumption has been associated with higher cardiovascular disease risk among adults, little is known about the impact of high consumption of added sugars (caloric sweeteners) among US adolescents," write Jean A. Welsh, MPH, RN, from the Nutrition and Health Science Program, Emory University School of Medicine in Atlanta, Georgia, and colleagues.

Dietary data from one 24-hour recall of 2157 US adolescents enrolled in the National Health and Nutrition Examination Survey 1999 to 2004 were merged with added sugar content data from the US Department of Agriculture MyPyramid Equivalents databases. Measures of cardiovascular disease risk were estimated as a function of added sugar intake level (< 10%, 10% to < 15%, 15% to < 20%, 20% to < 25%, 25% to < 30%, and ≥ 30% of total energy).

Multivariable means were weighted to be representative of US adolescents, and variances were adjusted to account for the complex sampling methods.

Average daily intake of added sugars was 21.4% of total energy. Added sugar consumption correlated inversely with mean high-density lipoprotein (HDL) cholesterol levels (mmol/L). The lowest consumers had a mean HDL of 1.40 (95% confidence interval [CI], 1.36 - 1.44), and the highest consumers had a mean HDL of 1.28 (95% CI, 1.23 - 1.33; P for trend = .001).

Added sugar intake correlated positively with geometric mean triglyceride levels (mmol/L), which were 0.81 (95% CI, 0.74 - 0.88) in the lowest consumers and 0.89 (95% CI, 0.83 - 0.96) in the highest consumers (P for trend = .05). Added sugar intake also correlated positively with low-density lipoprotein (LDL) cholesterol levels (mmol/L), which were 2.24 (95% CI, 2.12 - 2.37) in the lowest consumers and 2.44 (95% CI, 2.34 - 2.53) in the highest consumers (P for trend = .01).

For adolescents who were overweight or obese, defined as a body mass index at or above the 85th percentile, added sugars correlated positively with the homeostasis model assessment of insulin resistance (HOMA-IR; P for linear trend = .004).

"Consumption of added sugars among US adolescents is positively associated with multiple measures known to increase cardiovascular disease risk," the study authors write.

Limitations of this study include cross-sectional design with exposures and outcomes measured at the same time, precluding determination of causality; use of a single 24-hour dietary recall; possible residual confounding; and lack of information on the validity of the process used to estimate added sugar content data in the US Department of Agriculture MyPyramid Equivalents databases.

"Though long-term trials to study the effect of reducing the consumption of added sugars are needed, the results of this study suggest that future risk of CVD [cardiovascular disease] may be reduced by minimizing consumption of added sugars among adolescents," the study authors conclude.

Circulation. Published online January 10, 2011. Abstract