From Reuters Health Information
By Frederik Joelving
NEW YORK (Reuters Health) Mar 21 - Kids should sit in rear-facing car seats as long as they fit into them, or until age two, pediatricians urged Monday.
After that, they should ride in booster seats up to age eight or if they're still too small to fit correctly in seat belts.
"The best possible thing you can do is keep your child rear-facing as long as possible," said Dr. Benjamin Hoffman of the American Academy of Pediatrics, which issued the policy statement.
"We hope we will be able to convince parents to keep their children rear-facing longer."
The new recommendations update a 2002 statement, which had advised parents to follow car seat manufacturer limits, but also mentioned one year and 20 pounds as a minimum.
That led to some confusion among some parents, who would use the one-year cut-off as a milestone for when to make their child ride forward-facing, Dr. Hoffman told Reuters Health.
"The message, while it's been consistent, has not been as clear as it could have been for parents," he added.
According to the new statement, published online in Pediatrics, 1,500 kids under 16 die every year in car crashes in the U.S.
Child safety seats have been shown to cut the risk of death by 28% compared with seatbelts, and they also reduce non-fatal injuries.
That's because they distribute the energy of a collision over a bigger area, instead of concentrating it on the points where the seatbelt touches the body -- the shoulders, the belly and the hips.
Specifically, the AAP recommends:
- Infants should ride in rear-facing car safety seats until age two or until they reach the height and weight limits specified by the manufacturer.
- After that, they should ride in forward-facing car seats with a harness until age four or until they have outgrown the seat.
- Then they should be switched to a belt-positioning booster seat until they can use the seatbelt alone (typically between eight and 12 years, or when they've reached 4 feet 9 inches).
- Kids who are big enough to use the seatbelt alone should sit in the rear of the car until age 13.
The complete guidelines can be downloaded as a pdf file, at the URL given below.
SOURCE: http://bit.ly/hpFWdm
Pediatrics 2011.
Wednesday, March 30, 2011
Acute Otitis Media: Treat or Not?: Viewpoint
http://www.medscape.com/viewarticle/738226_3
Viewpoint
These 2 studies are remarkable in several ways. First, both used large numbers of children who met stringent criteria for entry.
Both sets of investigators feel that the stringent entry criteria accounted for the high rates of failure in the placebo groups – failure rates that were much higher than previously found.
It stands to reason that if previous trials had less rigorous criteria for diagnosis (thereby including more children with nonbacterial middle ear disease) then the failure rate in those who are not treated would be lower in those trials.
The benefits to the patients seem to be consistent between the 2 studies, but one study also demonstrated reduced parental time off from work.
As noted in an accompanying editorial, the failure rates of observation-only groups (33%-51% in these studies) lead to questions about whether observation alone is adequate, especially in children with severe findings.
In fact, Tähtinen and colleagues comment that the failure rate in their placebo group was much higher than in previous meta-analyses and raise the point that many previous studies used less stringent diagnostic criteria at entry.
Therefore, if less stringent criteria for diagnosing AOM were used in past trials, fewer of those children would have experienced clinical failure given that they might not have had AOM in the first place.
No matter how one views the issue of treating or not initially treating AOM, these 2 studies provide some of the best data yet of what to expect with either observation or active treatment of AOM in young children.
Viewpoint
These 2 studies are remarkable in several ways. First, both used large numbers of children who met stringent criteria for entry.
Both sets of investigators feel that the stringent entry criteria accounted for the high rates of failure in the placebo groups – failure rates that were much higher than previously found.
It stands to reason that if previous trials had less rigorous criteria for diagnosis (thereby including more children with nonbacterial middle ear disease) then the failure rate in those who are not treated would be lower in those trials.
The benefits to the patients seem to be consistent between the 2 studies, but one study also demonstrated reduced parental time off from work.
As noted in an accompanying editorial, the failure rates of observation-only groups (33%-51% in these studies) lead to questions about whether observation alone is adequate, especially in children with severe findings.
In fact, Tähtinen and colleagues comment that the failure rate in their placebo group was much higher than in previous meta-analyses and raise the point that many previous studies used less stringent diagnostic criteria at entry.
Therefore, if less stringent criteria for diagnosing AOM were used in past trials, fewer of those children would have experienced clinical failure given that they might not have had AOM in the first place.
No matter how one views the issue of treating or not initially treating AOM, these 2 studies provide some of the best data yet of what to expect with either observation or active treatment of AOM in young children.
Treatment of Acute Otitis Media in Children Under 2 Years of Age
Hoberman A, Paradise JL, Rockette HE, et al
N Engl J Med. 2011;364:105-115
Study Summary
A current clinical practice guideline in the United States suggests watchful waiting as a treatment option for AOM in children 6-23 months with non severe infection.
However, the investigators of the current study comment on the relative lack of high-quality clinical trial data that have included children younger than 2 years. This trial, conducted at 2 centers in the United States, enrolled children aged 6-23 months during 2006-2009.
All children had received at least 2 pneumococcal vaccine doses and had AOM diagnosed on the basis of 3 criteria:
* Onset within previous 48 hours of a symptom score above an established threshold;
* Middle ear effusion; and
* Bulging of the tympanic membrane.
The children were otherwise well, without chronic illnesses that might affect outcomes.
Before randomization, the children were stratified by past AOM history and by exposure to other children for at least 10 hours per week.
The children were then randomly assigned within each stratum.
Treatment-arm children received a 10-day course of amoxicillin-clavulanate at a daily dose of amoxicillin 90 mg/kg.
The placebo preparation was similar to the study drug in taste and color.
Parents and researchers were blinded to group assignment.
Use of acetaminophen was allowed for symptom relief.
Daily symptoms were assessed by phone until day 4 or 5 (first follow-up visit) and then at the end of therapy (days 10-12, second follow-up visit) and at the end of the study (days 21-25, third visit).
The children were examined at each of the follow-up visits at which point tympanic membrane appearance was scored and symptoms were assessed
Clinical failure on or before the visit at day 4-5 was considered to occur if the child's symptoms had worsened, symptoms had not substantially improved, the tympanic membrane had not substantially improved, or tympanic membrane findings had worsened.
Failure at the visit on day 10-12 visit was considered to have occurred if the child had not experienced almost complete resolution of symptoms and otoscopic findings, without regard to the presence or absence of middle ear fluid.
Children who experienced failure were started on a rescue regimen.
Finally, reappearance of AOM at or by the day 21-25 visit was considered a relapse.
The primary outcome of interest was time to resolution of symptoms, measured by both time to reach a minimal symptom score and total symptom burden, determined by calculating the daily score averaged over the first 7 days after initiation of treatment.
Acetaminophen use, adverse events, and use of healthcare resources were also assessed.
More than 1300 children were screened, 498 were eligible, and 291 were enrolled (58% of eligible children).
Of interest, the tympanic membrane findings as assessed by the clinical team did not correlate with parental reports of symptoms at enrollment.
More than half of the children were 6-11 months old; 53% were boys, 45% were white, 41% were black, and 70% were on Medicaid.
Approximately half were exposed to other children, and 52% had bilateral AOM at enrollment. The intervention and placebo groups did not differ in any of the measured or demographic variables at enrollment.
Symptom improvement was not different between the 2 groups.
For example, at day 2, 35% of treated children and 28% of children taking placebo had experienced initial resolution of symptoms. By day 4, the frequencies of symptom resolution were 61% for treated children and 54% for the children on placebo. By day 7, these frequencies were 80% and 74%, respectively.
However, when looking at total symptom burden, the mean symptom scores were lower in the treated children at each timepoint.
The reduction in clinical failure at day 10-12 was as large among children with least severe infection as it was in children whose illnesses were considered severe.
Treatment also produced quicker resolution of middle ear fluid and lower frequencies of persistent infection.
Clinical failure was markedly reduced with treatment.
At day 4-5, treatment failure had occurred in 4% of treated children vs 23% of children who received placebo.
At day 10-12, the failure frequencies were 16% for treated children and 51% for children on placebo.
Being exposed to 3 or more other children, more severe scores at entry, and bilateral AOM were all predictors of worse outcomes.
However, even after controlling for those factors, treatment produced significant improvement over placebo.
Finally, the relapse rates were similar (16% for treated children and 19% for children receiving placebo, a difference that was not statistically significant). One child in the placebo group developed mastoiditis.
The investigators concluded that treatment of AOM with appropriate antibiotics produces short-term symptomatic benefits and improved clinical findings irrespective of the apparent severity of the illness.
N Engl J Med. 2011;364:105-115
Study Summary
A current clinical practice guideline in the United States suggests watchful waiting as a treatment option for AOM in children 6-23 months with non severe infection.
However, the investigators of the current study comment on the relative lack of high-quality clinical trial data that have included children younger than 2 years. This trial, conducted at 2 centers in the United States, enrolled children aged 6-23 months during 2006-2009.
All children had received at least 2 pneumococcal vaccine doses and had AOM diagnosed on the basis of 3 criteria:
* Onset within previous 48 hours of a symptom score above an established threshold;
* Middle ear effusion; and
* Bulging of the tympanic membrane.
The children were otherwise well, without chronic illnesses that might affect outcomes.
Before randomization, the children were stratified by past AOM history and by exposure to other children for at least 10 hours per week.
The children were then randomly assigned within each stratum.
Treatment-arm children received a 10-day course of amoxicillin-clavulanate at a daily dose of amoxicillin 90 mg/kg.
The placebo preparation was similar to the study drug in taste and color.
Parents and researchers were blinded to group assignment.
Use of acetaminophen was allowed for symptom relief.
Daily symptoms were assessed by phone until day 4 or 5 (first follow-up visit) and then at the end of therapy (days 10-12, second follow-up visit) and at the end of the study (days 21-25, third visit).
The children were examined at each of the follow-up visits at which point tympanic membrane appearance was scored and symptoms were assessed
Clinical failure on or before the visit at day 4-5 was considered to occur if the child's symptoms had worsened, symptoms had not substantially improved, the tympanic membrane had not substantially improved, or tympanic membrane findings had worsened.
Failure at the visit on day 10-12 visit was considered to have occurred if the child had not experienced almost complete resolution of symptoms and otoscopic findings, without regard to the presence or absence of middle ear fluid.
Children who experienced failure were started on a rescue regimen.
Finally, reappearance of AOM at or by the day 21-25 visit was considered a relapse.
The primary outcome of interest was time to resolution of symptoms, measured by both time to reach a minimal symptom score and total symptom burden, determined by calculating the daily score averaged over the first 7 days after initiation of treatment.
Acetaminophen use, adverse events, and use of healthcare resources were also assessed.
More than 1300 children were screened, 498 were eligible, and 291 were enrolled (58% of eligible children).
Of interest, the tympanic membrane findings as assessed by the clinical team did not correlate with parental reports of symptoms at enrollment.
More than half of the children were 6-11 months old; 53% were boys, 45% were white, 41% were black, and 70% were on Medicaid.
Approximately half were exposed to other children, and 52% had bilateral AOM at enrollment. The intervention and placebo groups did not differ in any of the measured or demographic variables at enrollment.
Symptom improvement was not different between the 2 groups.
For example, at day 2, 35% of treated children and 28% of children taking placebo had experienced initial resolution of symptoms. By day 4, the frequencies of symptom resolution were 61% for treated children and 54% for the children on placebo. By day 7, these frequencies were 80% and 74%, respectively.
However, when looking at total symptom burden, the mean symptom scores were lower in the treated children at each timepoint.
The reduction in clinical failure at day 10-12 was as large among children with least severe infection as it was in children whose illnesses were considered severe.
Treatment also produced quicker resolution of middle ear fluid and lower frequencies of persistent infection.
Clinical failure was markedly reduced with treatment.
At day 4-5, treatment failure had occurred in 4% of treated children vs 23% of children who received placebo.
At day 10-12, the failure frequencies were 16% for treated children and 51% for children on placebo.
Being exposed to 3 or more other children, more severe scores at entry, and bilateral AOM were all predictors of worse outcomes.
However, even after controlling for those factors, treatment produced significant improvement over placebo.
Finally, the relapse rates were similar (16% for treated children and 19% for children receiving placebo, a difference that was not statistically significant). One child in the placebo group developed mastoiditis.
The investigators concluded that treatment of AOM with appropriate antibiotics produces short-term symptomatic benefits and improved clinical findings irrespective of the apparent severity of the illness.
Alternating Acetaminophen and Ibuprofen in Children: Unsafe?
From Medscape Pharmacists > Ask the Experts
Jessica Stovel, RPh
Adjunct Assistant Professor, Department of Psychiatry, Schulich School of Medicine and Dentistry, University of Western Ontario; Pediatric Clinical Pharmacist, London Health Sciences Center, London, Ontario, Canada
Is the alternating of acetaminophen and ibuprofen appropriate for treatment of pediatric fever?
The alternating of antipyretics to treat fever in children is an old and common practice.
One survey found that 50% of pediatricians advised parents to alternate acetaminophen (APAP) and ibuprofen to manage pediatric fever.
However, few clinical data support the effectiveness of this practice and there are significant safety concerns.
Nabulsi performed a systematic review of the literature and identified 5 randomized controlled trials (RCTs) evaluating the efficacy and safety of combined or alternating APAP and ibuprofen therapy compared with monotherapy:
* The coadministration of APAP and ibuprofen compared with either agent alone was as effective as ibuprofen and slightly better than APAP in 2 RCTs;
* The use of APAP and ibuprofen in an alternating fashion was found to be superior to either antipyretic used alone in 2 RCTs; and
* The alternating of APAP and ibuprofen was marginally superior to APAP alone in 1 RCT.
A critical appraisal of these RCTs identified several limitations.
For example, all of the trials used variable drug doses and schedules.
Some used a small sample size, no placebo control group, inadequate double blinding, or insufficient antipyretic doses that could potentially bias the results in favor of the alternating regimen.
Moreover, objective laboratory tests to reveal potential renal and liver toxicity were performed in only 1 of the 5 RCTs, and the other studies monitored for such toxicities from a clinical perspective only.
Consequently, the safety of alternating APAP and ibuprofen remains uncertain.
In addition, a theoretical drug-drug interaction between APAP and ibuprofen may exist.
Ibuprofen inhibits prostaglandin synthesis, reduces glutathione production, and subsequently decreases renal perfusion.
Because oxidative metabolites of APAP are detoxified by conjugation with glutathione, these metabolites may accumulate in the renal medulla resulting in tubular necrosis and renal toxicity.
Therefore, the combination of APAP and ibuprofen may place the child at risk for additional side effects compared with adverse outcomes seen with either drug used alone.
The alternating of ibuprofen and APAP may also represent other safety concerns. Because there are several potential dosing schedules this method may confuse parents with respect to when and how frequently to administer each antipyretic. This method can result in the child receiving more than the recommended daily maximum dose of APAP or ibuprofen or in double-dosing of the same agent.
To complicate matters further both drugs are available in multiple strengths and formulations.
The American Academy of Pediatrics (AAP) recommends that parents use a single antipyretic at a proper dose and frequency to treat a pediatric fever.
Appropriate antipyretic dosing is necessary to prevent subtherapeutic plasma concentrations and ineffective antipyresis.
Parents should not alternate antipyretics without consulting their healthcare providers.
If clinicians recommend alternating APAP and ibuprofen therapy they should do so with extreme caution due to the lack of conclusive clinical evidence in regard to the efficacy and safety of this practice.
The duration of this practice should be limited to minimize the risk for adverse effects.
Parents require thorough and clear education in regard to an alternating dosing schedule and need to understand the importance of keeping children well hydrated while receiving this regimen.
Jessica Stovel, RPh
Adjunct Assistant Professor, Department of Psychiatry, Schulich School of Medicine and Dentistry, University of Western Ontario; Pediatric Clinical Pharmacist, London Health Sciences Center, London, Ontario, Canada
Is the alternating of acetaminophen and ibuprofen appropriate for treatment of pediatric fever?
The alternating of antipyretics to treat fever in children is an old and common practice.
One survey found that 50% of pediatricians advised parents to alternate acetaminophen (APAP) and ibuprofen to manage pediatric fever.
However, few clinical data support the effectiveness of this practice and there are significant safety concerns.
Nabulsi performed a systematic review of the literature and identified 5 randomized controlled trials (RCTs) evaluating the efficacy and safety of combined or alternating APAP and ibuprofen therapy compared with monotherapy:
* The coadministration of APAP and ibuprofen compared with either agent alone was as effective as ibuprofen and slightly better than APAP in 2 RCTs;
* The use of APAP and ibuprofen in an alternating fashion was found to be superior to either antipyretic used alone in 2 RCTs; and
* The alternating of APAP and ibuprofen was marginally superior to APAP alone in 1 RCT.
A critical appraisal of these RCTs identified several limitations.
For example, all of the trials used variable drug doses and schedules.
Some used a small sample size, no placebo control group, inadequate double blinding, or insufficient antipyretic doses that could potentially bias the results in favor of the alternating regimen.
Moreover, objective laboratory tests to reveal potential renal and liver toxicity were performed in only 1 of the 5 RCTs, and the other studies monitored for such toxicities from a clinical perspective only.
Consequently, the safety of alternating APAP and ibuprofen remains uncertain.
In addition, a theoretical drug-drug interaction between APAP and ibuprofen may exist.
Ibuprofen inhibits prostaglandin synthesis, reduces glutathione production, and subsequently decreases renal perfusion.
Because oxidative metabolites of APAP are detoxified by conjugation with glutathione, these metabolites may accumulate in the renal medulla resulting in tubular necrosis and renal toxicity.
Therefore, the combination of APAP and ibuprofen may place the child at risk for additional side effects compared with adverse outcomes seen with either drug used alone.
The alternating of ibuprofen and APAP may also represent other safety concerns. Because there are several potential dosing schedules this method may confuse parents with respect to when and how frequently to administer each antipyretic. This method can result in the child receiving more than the recommended daily maximum dose of APAP or ibuprofen or in double-dosing of the same agent.
To complicate matters further both drugs are available in multiple strengths and formulations.
The American Academy of Pediatrics (AAP) recommends that parents use a single antipyretic at a proper dose and frequency to treat a pediatric fever.
Appropriate antipyretic dosing is necessary to prevent subtherapeutic plasma concentrations and ineffective antipyresis.
Parents should not alternate antipyretics without consulting their healthcare providers.
If clinicians recommend alternating APAP and ibuprofen therapy they should do so with extreme caution due to the lack of conclusive clinical evidence in regard to the efficacy and safety of this practice.
The duration of this practice should be limited to minimize the risk for adverse effects.
Parents require thorough and clear education in regard to an alternating dosing schedule and need to understand the importance of keeping children well hydrated while receiving this regimen.
The Role of Neuroimaging in Children and Adolescents With Recurrent Headaches
From Headache
Young-Il Rho, MD; Hee-Jung Chung, MD; Eun-Sook Suh, MD; Kon-Hee Lee, MD; Baik-Lin Eun, MD; Sang-Ook Nam, MD;Won-Seop Kim, MD; So-Hee Eun, MD; Young-Ok Kim, MD
Posted: 03/24/2011; Headache. 2011;51(3):403-408. © 2011 Blackwell Publishing
Abstract
Objectives.
To evaluate the role of neuroimaging and to estimate the prevalence of significant and treatable intracranial lesions in children and adolescents with recurrent headaches.
Background.
Neuroimaging studies are commonly performed in children and adolescent patients with headache because of increasing demands by parents and physicians, although objective data and studies to support this widespread practice are minimal.
Methods.
We retrospectively reviewed the medical records of all 1562 (male 724, female 838) new patients presenting with recurrent headaches to 9 Pediatric Neurology Clinics of tertiary Hospitals. Data regarding age of onset, duration of symptoms before presentation, frequency, duration of each episode, intensity, location and quality of headache, associated neurologic symptoms and a comprehensive neurological examination were obtained for each patient.
The International Classification of Headache Disorders, second edition, was used to classify headache types.
Results.
Neuroimaging procedures were performed in 77.1% of the patients.Overall, 9.3% (112/1204) of the patients had abnormal findings from neuroimaging.
The highest yield was in patients with an abnormal neurological examination wherein abnormal findings on neuroimaging were seen in 50.0% (9/18) of patients (P < .001). The yield was low when imaging was carried out in view of changes in the type of headache (12.9% [26/201]), neurologic dysfunction (10.8% [9/83]), recent onset of severe headaches (7.0% [12/171]), and demands of parent and physicians (10.1% [21/208]). Eleven patients underwent surgery based on neuroimaging results. There was no significant relation between abnormality on neuroimaging and age, sex, headache type, age of onset of headache, duration of symptoms before presentation, duration, frequency, location and intensity of headache (P > .05).
Conclusions.
Neuroimaging procedures in children and adolescents with headaches, although not always required, are very commonly performed. We suggest that more strict guidelines for rational use of neuroimaging are needed for pediatric headache patients.
Introduction
Although most headaches in children and adolescents are because of benign conditions such as migraine and tension-type headache,parents and physicians are concerned about serious underlying diseases such as brain tumor.
The etiology of headaches can most often be determined by a thorough and precise history and a comprehensive neurologic examination.
Neuroimaging (computed tomography [CT] or magnetic resonance imaging [MRI]) is rarely necessary unless the history or neurologic examination suggests structural etiologies.
Several reports in the literature have assessed the utility of neuroimaging in children and adolescents with headaches.
The results of these studies are varied because most assessed the utility of neuroimaging in various forms of headache in children and in different populations. Therefore, the results of these studies may not reflect the whole group.
The neuroimaging evaluation guidelines for pediatric patients with recurrent headaches were addressed by the American Academy of Neurology based on data available from 6 pediatric studies, and in the report of the US Headache Consortium in 2002.Since then, only a few studies have been reported.
The incidence of brain tumors and sinister intracranial disorders among children with headaches, which are significant concerns to physicians and parents, are very low.
Nevertheless, neuroimaging studies are frequently performed in clinical practice because of the fear of missing serious underlying diseases, increasing parental demands, and the enforcement of clinicians practicing defensive medicine because of the increase in malpractice lawsuits.
This study was performed to evaluate the utility of neuroimaging.
In addition, it was performed to estimate the prevalence of significant and treatable intracranial lesions in children and adolescents with recurrent headaches in the pediatric neurologic clinic of tertiary hospitals.
http://www.medscape.com/viewarticle/738528?src=mp&spon=9
Young-Il Rho, MD; Hee-Jung Chung, MD; Eun-Sook Suh, MD; Kon-Hee Lee, MD; Baik-Lin Eun, MD; Sang-Ook Nam, MD;Won-Seop Kim, MD; So-Hee Eun, MD; Young-Ok Kim, MD
Posted: 03/24/2011; Headache. 2011;51(3):403-408. © 2011 Blackwell Publishing
Abstract
Objectives.
To evaluate the role of neuroimaging and to estimate the prevalence of significant and treatable intracranial lesions in children and adolescents with recurrent headaches.
Background.
Neuroimaging studies are commonly performed in children and adolescent patients with headache because of increasing demands by parents and physicians, although objective data and studies to support this widespread practice are minimal.
Methods.
We retrospectively reviewed the medical records of all 1562 (male 724, female 838) new patients presenting with recurrent headaches to 9 Pediatric Neurology Clinics of tertiary Hospitals. Data regarding age of onset, duration of symptoms before presentation, frequency, duration of each episode, intensity, location and quality of headache, associated neurologic symptoms and a comprehensive neurological examination were obtained for each patient.
The International Classification of Headache Disorders, second edition, was used to classify headache types.
Results.
Neuroimaging procedures were performed in 77.1% of the patients.Overall, 9.3% (112/1204) of the patients had abnormal findings from neuroimaging.
The highest yield was in patients with an abnormal neurological examination wherein abnormal findings on neuroimaging were seen in 50.0% (9/18) of patients (P < .001). The yield was low when imaging was carried out in view of changes in the type of headache (12.9% [26/201]), neurologic dysfunction (10.8% [9/83]), recent onset of severe headaches (7.0% [12/171]), and demands of parent and physicians (10.1% [21/208]). Eleven patients underwent surgery based on neuroimaging results. There was no significant relation between abnormality on neuroimaging and age, sex, headache type, age of onset of headache, duration of symptoms before presentation, duration, frequency, location and intensity of headache (P > .05).
Conclusions.
Neuroimaging procedures in children and adolescents with headaches, although not always required, are very commonly performed. We suggest that more strict guidelines for rational use of neuroimaging are needed for pediatric headache patients.
Introduction
Although most headaches in children and adolescents are because of benign conditions such as migraine and tension-type headache,parents and physicians are concerned about serious underlying diseases such as brain tumor.
The etiology of headaches can most often be determined by a thorough and precise history and a comprehensive neurologic examination.
Neuroimaging (computed tomography [CT] or magnetic resonance imaging [MRI]) is rarely necessary unless the history or neurologic examination suggests structural etiologies.
Several reports in the literature have assessed the utility of neuroimaging in children and adolescents with headaches.
The results of these studies are varied because most assessed the utility of neuroimaging in various forms of headache in children and in different populations. Therefore, the results of these studies may not reflect the whole group.
The neuroimaging evaluation guidelines for pediatric patients with recurrent headaches were addressed by the American Academy of Neurology based on data available from 6 pediatric studies, and in the report of the US Headache Consortium in 2002.Since then, only a few studies have been reported.
The incidence of brain tumors and sinister intracranial disorders among children with headaches, which are significant concerns to physicians and parents, are very low.
Nevertheless, neuroimaging studies are frequently performed in clinical practice because of the fear of missing serious underlying diseases, increasing parental demands, and the enforcement of clinicians practicing defensive medicine because of the increase in malpractice lawsuits.
This study was performed to evaluate the utility of neuroimaging.
In addition, it was performed to estimate the prevalence of significant and treatable intracranial lesions in children and adolescents with recurrent headaches in the pediatric neurologic clinic of tertiary hospitals.
http://www.medscape.com/viewarticle/738528?src=mp&spon=9
Tuesday, March 29, 2011
Sucrose Better Than Topical Anesthetic for Venipuncture Pain in Newborns
From Medscape Education Clinical Briefs
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
March 17, 2011 — Sucrose is more effective than liposomal lidocaine for reducing pain during venipuncture in newborns, according to the results of a double-blind, randomized controlled, double-dummy trial study reported online March 14 in Pediatrics.
"Sucrose has been shown to reduce pain responses in infants undergoing venipuncture," write Anna Taddio, PhD, from the University of Toronto in Ontario, Canada, and colleagues. "The relative and combined effectiveness of sucrose and liposomal lidocaine, however, have not been previously evaluated."
The goal of the study was to compare the relative efficacy of liposomal lidocaine, sucrose, and their combination for decreasing pain in term newborns.
Before venipuncture for the newborn screening test, 330 healthy neonates were randomly allocated to pretreatment with 1 g of topical liposomal lidocaine cream, 2 mL of 24% sucrose solution by mouth, or sucrose and liposomal lidocaine.
Pain was evaluated with the facial grimacing score (0 - 100), and safety was determined from adverse events and lidocaine levels.
The groups did not differ in infant characteristics. Compared with the liposomal lidocaine group, the sucrose group had lower facial grimacing scores (mean difference, −27; 95% confidence interval [CI], −36 to −19; P < .001), as did the sucrose plus liposomal lidocaine group (mean difference, −23; 95% CI, −31 to −14; P < .001). There was no significant difference in the sucrose vs sucrose plus liposomal lidocaine groups (mean difference, −5; 95% CI, −13 to 4; P = .3).
There were no apparent local skin reactions. Spitting up occurred in similar proportions of sucrose-exposed and non–sucrose-exposed infants (1.4% vs 2.7%, respectively; P = .22). The mean (SD) plasma lidocaine level was 44.6 (55.3) ng/mL.
"Sucrose was more effective than liposomal lidocaine for reducing pain during venipuncture in newborns," the study authors write. "The addition of liposomal lidocaine to sucrose did not confer any additional benefit to sucrose alone. There was no evidence of harm from liposomal lidocaine or sucrose."
Limitations of this study include lack of a placebo control group, the possibility that all of the pain assessment methods used were insufficiently sensitive to detect the additive benefit of topical liposomal lidocaine, and lack of generalizability to pain relief for other medical procedures.
"Effective pain management is considered a critical aspect of quality neonatal medical care," the study authors conclude. "Notwithstanding the availability of effective agents, procedural pain remains ubiquitous and undertreated. Unanswered questions about the pharmacology of available pain-relieving interventions have been identified as a barrier to optimal pain management."
The Canadian Institutes of Health Research supported this study. Hawaii Medical provided the sucrose and placebo solutions, and Ferndale Laboratories provided the liposomal lidocaine and placebo creams. The study authors have disclosed no relevant financial relationships.
Pediatrics. Published online March 14, 2011. Abstract
Related Link
A guideline on the topic of prevention and management of pain in the neonate has been jointly developed by the American Academy of Pediatrics Committee on Fetus and Newborn, the American Academy of Pediatrics Section on Surgery, and the Canadian Paediatric Society Fetus and Newborn Committee and is available online.
Clinical Context
Venipuncture is a common painful procedure performed in neonates. Analgesic therapies used include topical liposomal lidocaine and oral sucrose solution, but the 2 methods have not been compared or combined.
This is a double-blind, randomized controlled, double-dummy study to examine the efficacy of sucrose with and without topical liposomal lidocaine vs topical lidocaine alone for pain control in infants receiving venipuncture.
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
March 17, 2011 — Sucrose is more effective than liposomal lidocaine for reducing pain during venipuncture in newborns, according to the results of a double-blind, randomized controlled, double-dummy trial study reported online March 14 in Pediatrics.
"Sucrose has been shown to reduce pain responses in infants undergoing venipuncture," write Anna Taddio, PhD, from the University of Toronto in Ontario, Canada, and colleagues. "The relative and combined effectiveness of sucrose and liposomal lidocaine, however, have not been previously evaluated."
The goal of the study was to compare the relative efficacy of liposomal lidocaine, sucrose, and their combination for decreasing pain in term newborns.
Before venipuncture for the newborn screening test, 330 healthy neonates were randomly allocated to pretreatment with 1 g of topical liposomal lidocaine cream, 2 mL of 24% sucrose solution by mouth, or sucrose and liposomal lidocaine.
Pain was evaluated with the facial grimacing score (0 - 100), and safety was determined from adverse events and lidocaine levels.
The groups did not differ in infant characteristics. Compared with the liposomal lidocaine group, the sucrose group had lower facial grimacing scores (mean difference, −27; 95% confidence interval [CI], −36 to −19; P < .001), as did the sucrose plus liposomal lidocaine group (mean difference, −23; 95% CI, −31 to −14; P < .001). There was no significant difference in the sucrose vs sucrose plus liposomal lidocaine groups (mean difference, −5; 95% CI, −13 to 4; P = .3).
There were no apparent local skin reactions. Spitting up occurred in similar proportions of sucrose-exposed and non–sucrose-exposed infants (1.4% vs 2.7%, respectively; P = .22). The mean (SD) plasma lidocaine level was 44.6 (55.3) ng/mL.
"Sucrose was more effective than liposomal lidocaine for reducing pain during venipuncture in newborns," the study authors write. "The addition of liposomal lidocaine to sucrose did not confer any additional benefit to sucrose alone. There was no evidence of harm from liposomal lidocaine or sucrose."
Limitations of this study include lack of a placebo control group, the possibility that all of the pain assessment methods used were insufficiently sensitive to detect the additive benefit of topical liposomal lidocaine, and lack of generalizability to pain relief for other medical procedures.
"Effective pain management is considered a critical aspect of quality neonatal medical care," the study authors conclude. "Notwithstanding the availability of effective agents, procedural pain remains ubiquitous and undertreated. Unanswered questions about the pharmacology of available pain-relieving interventions have been identified as a barrier to optimal pain management."
The Canadian Institutes of Health Research supported this study. Hawaii Medical provided the sucrose and placebo solutions, and Ferndale Laboratories provided the liposomal lidocaine and placebo creams. The study authors have disclosed no relevant financial relationships.
Pediatrics. Published online March 14, 2011. Abstract
Related Link
A guideline on the topic of prevention and management of pain in the neonate has been jointly developed by the American Academy of Pediatrics Committee on Fetus and Newborn, the American Academy of Pediatrics Section on Surgery, and the Canadian Paediatric Society Fetus and Newborn Committee and is available online.
Clinical Context
Venipuncture is a common painful procedure performed in neonates. Analgesic therapies used include topical liposomal lidocaine and oral sucrose solution, but the 2 methods have not been compared or combined.
This is a double-blind, randomized controlled, double-dummy study to examine the efficacy of sucrose with and without topical liposomal lidocaine vs topical lidocaine alone for pain control in infants receiving venipuncture.
Monday, March 14, 2011
AAP Issues Statement on Treating Fever in Pediatric Patients
From Medscape Education Clinical Briefs
News Author: Emma Hitt, PhD
CME Author: Laurie Barclay, MD
March 3, 2011 — Treatment of febrile children should focus on improving the child's comfort rather than bringing the temperature down to normal levels or preventing the onset of fever, according to a new clinical report issued by the American Academy of Pediatrics (AAP).
Janice E. Sullivan, MD, and Henry C. Farrar, MD, and the AAP's Section on Clinical Pharmacology and Therapeutics, and Committee on Drugs authored the report, published in the March issue of Pediatrics.
"Many parents administer antipyretics even when there is minimal or no fever, because they are concerned that the child must maintain a 'normal' temperature," the study authors note. "Fever, however, is not the primary illness but is a physiologic mechanism that has beneficial effects in fighting infection," they write. "There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications."
According to the study authors, there is "no evidence that reducing fever reduces morbidity or mortality from a febrile illness" or that it decreases the recurrence of febrile seizures.
The article outlines strategies to counsel caregivers about treating febrile illness, stating that acetaminophen and ibuprofen, "when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations."
The appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
The appropriate dosing for ibuprofen is 10 mg/kg per dose.
The study also emphasizes the importance of clear labeling, dosing, and proper storage of medications used to treat fever.
It also warns that use of combination therapy with acetaminophen and ibuprofen may place infants and children at increased risk for dosing errors and adverse outcomes.
"To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products," they suggest.
Pediatrics. 2011;127:580-587. Full text
Clinical Context
Fever in a child is one of the most common symptoms for which parents and caregivers seek medical attention from pediatricians, family practitioners, and other healthcare providers. Because of their concern that the child should maintain a "normal" temperature, many parents administer antipyretics to their child even when fever is minimal or absent.
However, fever is a physiologic response that helps the body to fight infection; therefore, it is not the primary illness. Evidence is lacking that fever, in and of itself, worsens the course of an illness or causes long-term neurologic complications.
Study Highlights
* The AAP issued a clinical report, "Fever and Antipyretic Use in Children," to assist pediatricians in educating parents and families about fever and "fever phobia."
* Appropriate counseling on fever management should help parents understand that fever, in and of itself, is not harmful and may actually be of benefit in helping a generally healthy child to ward off infection.
* Clinicians should also emphasize that antipyretic use does not prevent febrile seizures.
* The main objective in treating a child with fever should therefore be to improve the child's overall comfort level, rather than to lower body temperature to the normal range.
* Clinicians should emphasize the child's overall well-being, the need to monitor the child's activity and recognize signs of serious illness, and encouragement of appropriate fluid intake when they advise the parents or caregivers of a febrile child.
* To avoid accidental ingestion by children, clinicians should counsel parents regarding safe storage of antipyretics, in addition to educating them regarding appropriate use and dosing.
* Parents or caregivers should not wake up a sleeping child to administer antipyretic medication.
* When used in appropriate doses, acetaminophen and ibuprofen are generally considered to be safe and effective in most clinical situations, and both have analgesic as well as antipyretic effects.
* Appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
* Appropriate dosing for ibuprofen is 10 mg/kg per dose.
* As with all drugs, however, acetaminophen and ibuprofen should be used judiciously to minimize the risk for adverse drug effects and toxicity.
* For a generally healthy child with fever, acetaminophen and ibuprofen do not differ markedly in safety and effectiveness, based on current evidence.
* Current evidence suggests that combining acetaminophen and ibuprofen is more effective than using either medication alone.
* However, using both drugs in combination may be more complicated, may increase the risk for inaccurate dosing and adverse outcomes, and may promote unsafe use. These potential risks should be carefully considered before combination therapy is prescribed.
* Parents should be informed that they should always use an accurate measuring device for antipyretic medications and that the correct dosage is based on the child's weight.
* To improve patient safety, pediatricians should advocate for a limited number of acetaminophen and ibuprofen formulations, clear labeling of dosing instructions, and a dosing device to be included with antipyretic products.
* The use of alcohol baths is not an appropriate method to reduce fever because of reported adverse events associated with systemic absorption of alcohol.
Clinical Implications
* Appropriate counseling on fever management should help parents understand that fever, in and of itself, is not harmful in a generally healthy child. Therefore, the main goal in treating a child with fever should be to improve the child's overall comfort level, rather than to lower body temperature to the normal range.
* When used in appropriate doses, acetaminophen and ibuprofen are generally considered to be safe and effective in most clinical situations, and both have analgesic as well as antipyretic effects. As with all drugs, however, acetaminophen and ibuprofen should be used judiciously to minimize the risk for adverse drug effects and toxicity.
News Author: Emma Hitt, PhD
CME Author: Laurie Barclay, MD
March 3, 2011 — Treatment of febrile children should focus on improving the child's comfort rather than bringing the temperature down to normal levels or preventing the onset of fever, according to a new clinical report issued by the American Academy of Pediatrics (AAP).
Janice E. Sullivan, MD, and Henry C. Farrar, MD, and the AAP's Section on Clinical Pharmacology and Therapeutics, and Committee on Drugs authored the report, published in the March issue of Pediatrics.
"Many parents administer antipyretics even when there is minimal or no fever, because they are concerned that the child must maintain a 'normal' temperature," the study authors note. "Fever, however, is not the primary illness but is a physiologic mechanism that has beneficial effects in fighting infection," they write. "There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications."
According to the study authors, there is "no evidence that reducing fever reduces morbidity or mortality from a febrile illness" or that it decreases the recurrence of febrile seizures.
The article outlines strategies to counsel caregivers about treating febrile illness, stating that acetaminophen and ibuprofen, "when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations."
The appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
The appropriate dosing for ibuprofen is 10 mg/kg per dose.
The study also emphasizes the importance of clear labeling, dosing, and proper storage of medications used to treat fever.
It also warns that use of combination therapy with acetaminophen and ibuprofen may place infants and children at increased risk for dosing errors and adverse outcomes.
"To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products," they suggest.
Pediatrics. 2011;127:580-587. Full text
Clinical Context
Fever in a child is one of the most common symptoms for which parents and caregivers seek medical attention from pediatricians, family practitioners, and other healthcare providers. Because of their concern that the child should maintain a "normal" temperature, many parents administer antipyretics to their child even when fever is minimal or absent.
However, fever is a physiologic response that helps the body to fight infection; therefore, it is not the primary illness. Evidence is lacking that fever, in and of itself, worsens the course of an illness or causes long-term neurologic complications.
Study Highlights
* The AAP issued a clinical report, "Fever and Antipyretic Use in Children," to assist pediatricians in educating parents and families about fever and "fever phobia."
* Appropriate counseling on fever management should help parents understand that fever, in and of itself, is not harmful and may actually be of benefit in helping a generally healthy child to ward off infection.
* Clinicians should also emphasize that antipyretic use does not prevent febrile seizures.
* The main objective in treating a child with fever should therefore be to improve the child's overall comfort level, rather than to lower body temperature to the normal range.
* Clinicians should emphasize the child's overall well-being, the need to monitor the child's activity and recognize signs of serious illness, and encouragement of appropriate fluid intake when they advise the parents or caregivers of a febrile child.
* To avoid accidental ingestion by children, clinicians should counsel parents regarding safe storage of antipyretics, in addition to educating them regarding appropriate use and dosing.
* Parents or caregivers should not wake up a sleeping child to administer antipyretic medication.
* When used in appropriate doses, acetaminophen and ibuprofen are generally considered to be safe and effective in most clinical situations, and both have analgesic as well as antipyretic effects.
* Appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
* Appropriate dosing for ibuprofen is 10 mg/kg per dose.
* As with all drugs, however, acetaminophen and ibuprofen should be used judiciously to minimize the risk for adverse drug effects and toxicity.
* For a generally healthy child with fever, acetaminophen and ibuprofen do not differ markedly in safety and effectiveness, based on current evidence.
* Current evidence suggests that combining acetaminophen and ibuprofen is more effective than using either medication alone.
* However, using both drugs in combination may be more complicated, may increase the risk for inaccurate dosing and adverse outcomes, and may promote unsafe use. These potential risks should be carefully considered before combination therapy is prescribed.
* Parents should be informed that they should always use an accurate measuring device for antipyretic medications and that the correct dosage is based on the child's weight.
* To improve patient safety, pediatricians should advocate for a limited number of acetaminophen and ibuprofen formulations, clear labeling of dosing instructions, and a dosing device to be included with antipyretic products.
* The use of alcohol baths is not an appropriate method to reduce fever because of reported adverse events associated with systemic absorption of alcohol.
Clinical Implications
* Appropriate counseling on fever management should help parents understand that fever, in and of itself, is not harmful in a generally healthy child. Therefore, the main goal in treating a child with fever should be to improve the child's overall comfort level, rather than to lower body temperature to the normal range.
* When used in appropriate doses, acetaminophen and ibuprofen are generally considered to be safe and effective in most clinical situations, and both have analgesic as well as antipyretic effects. As with all drugs, however, acetaminophen and ibuprofen should be used judiciously to minimize the risk for adverse drug effects and toxicity.
HbA1c May Be Less Effective to Diagnose Adolescent Diabetes
From Medscape Education Clinical Briefs
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
March 4, 2011 — Recommendations for diagnosis of diabetes using hemoglobin A1c (HbA1c) level in adults may not be accurately extrapolated to adolescents, according to the results of a study using data from the National Health and Nutrition Examination Surveys (NHANES 1999-2006), reported online in the February 23 issue of the Journal of Pediatrics.
The American Diabetes Association (ADA) past president of medicine and science, Larry C. Deeb, MD, told Medscape Medical News that this was "an interesting study making a very important point."
"We were all afraid of a massive epidemic of type 2 diabetes in children at the end of the century, but it hasn't happened," said Dr. Deeb, who is also pediatric endocrinologist and medical director at the Diabetes Center at Tallahassee Memorial Hospital and a clinical professor at Florida State University. "This study points out that the actual numbers are much smaller, with few cases uncovered in the screening. This makes predictions using HbA1c really difficult."
The goal of this study was to compare the diagnostic ability of HbA1c to detect diabetes mellitus or prediabetes in 1156 obese and overweight US adolescents aged 12 to 18 years vs adults, using NHANES data from 1999 to 2006.
Criteria for diabetes mellitus were a fasting plasma glucose (FPG) level of at least 126 mg/dL and a 2-hour plasma glucose level (2-hr PG) of at least 200 mg/dL. For prediabetes, diagnostic criteria were an FPG of at least 100 mg/dL and less than 126 mg/dL and 2-hr PG of at least 140 mg/dL and less than 200 mg/dL. Receiver operator characteristic (ROC) analyses allowed assessment of HbA1c test performance.
Only 4 adolescents had undiagnosed diabetes mellitus. For detection of diabetes (based on FPG) in adolescents and adults, respectively, the sensitivity rates of an HbA1c level of 6.5% were 75.0% (95% confidence interval [CI], 30.1% - 95.4%) and 53.8% (95% CI, 47.4% - 60.0%). The specificity rates were 99.9% (95% CI, 99.5% - 100.0%) and 99.5% (95% CI, 99.3% - 99.6%), respectively.
With an HbA1c level of 5.7%, the sensitivity rates were 5.0% (95% CI, 2.6% - 9.2%) and 23.1% (95% CI, 21.3% - 25.0%) for adolescents and adults, respectively, and the specificity rates were 98.3% (95% CI, 97.2% - 98.9%) and 91.1% (95% CI, 90.3% - 91.9%). For adolescents vs adults, HbA1c level was a poorer predictor of diabetes mellitus (area under the ROC curve, 0.88 vs 0.93) and prediabetes (FPG area under the ROC curve, 0.61 vs 0.74). With use of either FPG or 2-hr PG measurements, test performance of HbA1c level was poor in adolescents.
HbA1c Not as Reliable
"Based on the study findings, a fasting blood glucose test should still be used for diagnosing diabetes in children," said lead author Joyce M. Lee, MD, MPH, a pediatric endocrinologist at C.S. Mott Children's Hospital at the University of Michigan, in a news release. "...We found that ...HbA1c is not as reliable a test for identifying children with diabetes and pre-diabetes compared with adults. Using this test in children may lead to missed cases."
Dr. Deeb noted that a major strength of this study was that it was performed in a large, population-based sample, and that a limitation was the low number of individuals with diabetes mellitus in the study sample.
"I wonder if the numbers of cases really doesn't make it harder to use the laboratory and epidemiological data to try to predict sensitivity, specificity, and ROCs," Dr. Deeb said.
The study authors agree that their findings highlight the dilemma of screening for diabetes mellitus in adolescents, because the prevalence of undiagnosed diabetes mellitus in the pediatric population is only 0.02%, resulting in a low positive predictive value for detecting diabetes mellitus using any test, and not just HbA1c level. Other limitations of this study acknowledged by the authors include study sample of only asymptomatic overweight and obese children, and limited ability to diagnose undiagnosed diabetes mellitus and prediabetes because of the absence of subsequent testing of FPG or 2-hr PG.
"My major fear isn't the adolescent getting diabetes, but the young adults in their 20's and 30's," Dr. Deeb said. "While the diabetes epidemic in children isn't happening as we feared, the obesity epidemic is in full swing, and we are having issues with predicting diabetes, but not obesity. Will it turn into diabetes? If the history of the decades past is true....yes."
Current ADA guidelines note that asymptomatic individuals would be classified as having diabetes if HbA1c values are at least 6.5% and having prediabetes if HbA1c values are 6% to 6.4% on 2 separate tests.
"It's important that we not take a cavalier attitude toward someone with an HbA1c of 6.5 and tell them they don't have diabetes — we have to take the whole person into account, including their BMI and family history," Dr. Deeb concluded.
J Pediatrics. Published online February 23, 2011. Abstract
Clinical Context
In 2009, the International Expert Committee assessed the role of HbA1c for the diagnosis of diabetes. The ADA subsequently recommended phasing out the 2-hr PG and the FPG for the diagnosis of diabetes in favor of HbA1c whereby those without diabetes but with an HbA1c level of 6.5% and above would be classified as having diabetes. However, it is unclear if cutoff values for the diagnosis are similar for adults and adolescents.
This is a study of the usefulness of the guidelines for HbA1c in asymptomatic adolescents without prevalent diabetes in the United States to screen for diabetes.
News Author: Laurie Barclay, MD
CME Author: Désirée Lie, MD, MSEd
March 4, 2011 — Recommendations for diagnosis of diabetes using hemoglobin A1c (HbA1c) level in adults may not be accurately extrapolated to adolescents, according to the results of a study using data from the National Health and Nutrition Examination Surveys (NHANES 1999-2006), reported online in the February 23 issue of the Journal of Pediatrics.
The American Diabetes Association (ADA) past president of medicine and science, Larry C. Deeb, MD, told Medscape Medical News that this was "an interesting study making a very important point."
"We were all afraid of a massive epidemic of type 2 diabetes in children at the end of the century, but it hasn't happened," said Dr. Deeb, who is also pediatric endocrinologist and medical director at the Diabetes Center at Tallahassee Memorial Hospital and a clinical professor at Florida State University. "This study points out that the actual numbers are much smaller, with few cases uncovered in the screening. This makes predictions using HbA1c really difficult."
The goal of this study was to compare the diagnostic ability of HbA1c to detect diabetes mellitus or prediabetes in 1156 obese and overweight US adolescents aged 12 to 18 years vs adults, using NHANES data from 1999 to 2006.
Criteria for diabetes mellitus were a fasting plasma glucose (FPG) level of at least 126 mg/dL and a 2-hour plasma glucose level (2-hr PG) of at least 200 mg/dL. For prediabetes, diagnostic criteria were an FPG of at least 100 mg/dL and less than 126 mg/dL and 2-hr PG of at least 140 mg/dL and less than 200 mg/dL. Receiver operator characteristic (ROC) analyses allowed assessment of HbA1c test performance.
Only 4 adolescents had undiagnosed diabetes mellitus. For detection of diabetes (based on FPG) in adolescents and adults, respectively, the sensitivity rates of an HbA1c level of 6.5% were 75.0% (95% confidence interval [CI], 30.1% - 95.4%) and 53.8% (95% CI, 47.4% - 60.0%). The specificity rates were 99.9% (95% CI, 99.5% - 100.0%) and 99.5% (95% CI, 99.3% - 99.6%), respectively.
With an HbA1c level of 5.7%, the sensitivity rates were 5.0% (95% CI, 2.6% - 9.2%) and 23.1% (95% CI, 21.3% - 25.0%) for adolescents and adults, respectively, and the specificity rates were 98.3% (95% CI, 97.2% - 98.9%) and 91.1% (95% CI, 90.3% - 91.9%). For adolescents vs adults, HbA1c level was a poorer predictor of diabetes mellitus (area under the ROC curve, 0.88 vs 0.93) and prediabetes (FPG area under the ROC curve, 0.61 vs 0.74). With use of either FPG or 2-hr PG measurements, test performance of HbA1c level was poor in adolescents.
HbA1c Not as Reliable
"Based on the study findings, a fasting blood glucose test should still be used for diagnosing diabetes in children," said lead author Joyce M. Lee, MD, MPH, a pediatric endocrinologist at C.S. Mott Children's Hospital at the University of Michigan, in a news release. "...We found that ...HbA1c is not as reliable a test for identifying children with diabetes and pre-diabetes compared with adults. Using this test in children may lead to missed cases."
Dr. Deeb noted that a major strength of this study was that it was performed in a large, population-based sample, and that a limitation was the low number of individuals with diabetes mellitus in the study sample.
"I wonder if the numbers of cases really doesn't make it harder to use the laboratory and epidemiological data to try to predict sensitivity, specificity, and ROCs," Dr. Deeb said.
The study authors agree that their findings highlight the dilemma of screening for diabetes mellitus in adolescents, because the prevalence of undiagnosed diabetes mellitus in the pediatric population is only 0.02%, resulting in a low positive predictive value for detecting diabetes mellitus using any test, and not just HbA1c level. Other limitations of this study acknowledged by the authors include study sample of only asymptomatic overweight and obese children, and limited ability to diagnose undiagnosed diabetes mellitus and prediabetes because of the absence of subsequent testing of FPG or 2-hr PG.
"My major fear isn't the adolescent getting diabetes, but the young adults in their 20's and 30's," Dr. Deeb said. "While the diabetes epidemic in children isn't happening as we feared, the obesity epidemic is in full swing, and we are having issues with predicting diabetes, but not obesity. Will it turn into diabetes? If the history of the decades past is true....yes."
Current ADA guidelines note that asymptomatic individuals would be classified as having diabetes if HbA1c values are at least 6.5% and having prediabetes if HbA1c values are 6% to 6.4% on 2 separate tests.
"It's important that we not take a cavalier attitude toward someone with an HbA1c of 6.5 and tell them they don't have diabetes — we have to take the whole person into account, including their BMI and family history," Dr. Deeb concluded.
J Pediatrics. Published online February 23, 2011. Abstract
Clinical Context
In 2009, the International Expert Committee assessed the role of HbA1c for the diagnosis of diabetes. The ADA subsequently recommended phasing out the 2-hr PG and the FPG for the diagnosis of diabetes in favor of HbA1c whereby those without diabetes but with an HbA1c level of 6.5% and above would be classified as having diabetes. However, it is unclear if cutoff values for the diagnosis are similar for adults and adolescents.
This is a study of the usefulness of the guidelines for HbA1c in asymptomatic adolescents without prevalent diabetes in the United States to screen for diabetes.
Wednesday, March 9, 2011
Childhood Obesity in the United States
From Morbidity & Mortality Weekly Report
CDC Grand Rounds:
J Bell, MPA; VW Rogers, MD; WH Dietz, MD, PhD; CL Ogden, PhD; C Schuler, PhD; T Popovic, MD, PhD;
Abstract and Introduction
The Magnitude of the Problem
In the United States, childhood obesity affects approximately 12.5 million children and teens (17% of that population).
Changes in obesity prevalence from the 1960s show a rapid increase in the 1980s and 1990s, when obesity prevalence among children and teens tripled, from nearly 5% to approximately 15% (Figure 1).
During the past 10 years, the rapid increase in obesity has slowed and might have leveled. However, among the heaviest boys, a significant increase in obesity has been observed, with the heaviest getting even heavier.
Moreover, substantial racial/ethnic disparities exist, with Hispanic boys and non-Hispanic black girls disproportionately affected by obesity (Figure 2).
Also, older children and teens are more likely to be obese compared with preschoolers.
In the short term, obesity in children can lead to psychosocial problems and to cardiovascular risk factors such as hypertension, high cholesterol, and abnormal glucose tolerance or diabetes.
In one study, 70% of obese children had at least one additional cardiovascular risk factor, and 30% had two or more.
Although the prevalence of type 2 diabetes in teens is very low, a recent report estimated that 15% of new diabetes cases among children and adolescents are type 2 diabetes.
In the 1980s, type 2 diabetes in teens was virtually unheard of.
The prevalence of obesity among U.S. adults (34%) is twice that observed in children and translates into nearly 73 million adult men and women
On average, U.S. adults weigh 24 pounds more than they did in 1960, and they are at increased risk for health conditions such as diabetes, cardiovascular disease, and certain cancers.
Although obesity prevalence has remained mostly flat in the past 10 years, the costs associated with obesity have increased substantially during the same period. One study estimated that approximately 9% of all medical costs in 2008 were obesity-related and amounted to $147 billion, compared with $78.5 billion 10 years before.
Challenges and Strategies to Combat the Problem
Identification of Effective Interventions
Environmental determinants of childhood obesity in the United States include shifts in food consumption, changes in physical activity levels, and higher levels of television viewing, with the consequent inactivity and marketing of food to children. CDC is focusing on best available evidence to implement intervention programs. For maximum population impact, the focus should be on strategies that alter the food and physical activity environments in places where persons live, learn, work, play, and pray. Interventions aimed at single behavioral targets are unlikely to have a substantial impact, and both evidence-based practice and practice-based evidence should be considered.
Breastfeeding has been shown to have substantial health benefits for children, who consequently might be at reduced risk for childhood obesity.[7] The most recent data show that nearly 30% of mothers do not breastfeed, and only approximately 40% of children are still breastfed at age 6 months (the recommended duration of exclusive breast feeding is to age 4–6 months).[8] A study of mothers' experiences during their stay at maternity-care hospitals found that duration of breastfeeding increased when the number of baby-friendly steps the mother experienced increased (e.g., initiating breastfeeding early, exclusive breastfeeding, rooming in, on-demand feedings, no pacifiers, and providing information to new mothers).[9] Interventions that encourage breastfeeding in workplaces also would increase the chances of working mothers continuing to breastfeed longer.
Strategies to reduce energy intake include decreasing consumption of high energy-density foods, increasing consumption of fruits and vegetables, decreasing consumption of sugar-sweetened beverages, and decreasing time spent watching television and exposure to food marketed to children. A substantial proportion of all money spent on food consumed outside the home is spent on fast food.[10] Institutions such as child-care facilities and schools should alter their purchasing strategies to reduce the availability of high-calorie foods. Approaches to reducing energy intake through decreasing consumption of sugar drinks (sodas and 10% juice–containing beverages) include 1) enacting regulations and policies that eliminate availability of such drinks, including sports drinks, in child-care settings and schools and at school events and afterschool programs, 2) increasing availability of fresh water in parks and recreational facilities, and 3) eliminating sugar drinks in school vending machines. Reducing the amount of time children spend watching television, and thus reducing exposure to food marketed to them, can be accomplished by limiting television time at home and in child-care settings and removing televisions from children's bedrooms.
Increasing energy output through increased physical activity plays an important role in preventing and reducing obesity-related illnesses and conditions such as hyperlipidemia, hyperinsulinemia, and elevated blood pressure, even if weight is not reduced.[11] Activity levels can be increased by making it safer to walk or bike to school. Quality school physical education programs that keep children moving the majority of their time in physical education class should be implemented. Providing a safe environment for physical activity and establishing habits (e.g., regular physical activity) that will lead to activity into and throughout adulthood must become priorities.
An example of a comprehensive school-based program was one that was implemented in Philadelphia, Pennsylvania, aimed at 4th, 5th, and 6th graders, which included reducing television time, increasing physical activity, and increasing fruit and vegetable intake.[11] This intervention was based on CDC's School Health Guidelines for Nutrition [12] and included changes in the school food supply to meet the Dietary Guidelines for Americans.[13] The 2-year intervention resulted in a 50% reduction in the incidence of overweight and a 10% reduction in prevalence of overweight. Physical inactivity and television viewing also declined.[14]
Policies and Systems Changes in Action
Changing policy often is the most effective way to implement and sustain these kinds of environmental changes. Policies not traditionally thought of as health policies (e.g., involving transportation, land use, education, agriculture, and economics) can affect health and obesity rates. The following two examples of major policy-driven initiatives requiring system changes focus on access to healthy foods and improving the built environment, respectively.
According to the U.S. Department of Agriculture, approximately 23.5 million persons in urban and rural areas of the United States live in "food deserts" (i.e., low-income areas without access to healthy foods).[15] Improved access to healthy foods might improve eating habits and decrease obesity. The Fresh Food Financing Initiative (FFFI) in Pennsylvania is a public-private partnership that has improved access to healthy foods using one-time loans and grants; as of September 2009, it had committed $59.7 million to projects across the state.[16] As a result of FFFI, approximately 500,000 persons now have access to healthy foods who did not have it before, nearly 5,000 jobs have been created or retained, and approximately 1.5 million square feet of retail space has been created or saved.[16] Eighty-three projects have been implemented, ranging from large supermarkets in urban settings to small stores in small town/rural settings, farmers markets, and community-supported agriculture. Replication of FFFI is under way in California, Colorado, Illinois, Louisiana, New Jersey, and New York. The President's proposed 2011 budget includes support for a Healthy Food Financing Initiative (HFFI), which combines $345 million from the U.S. Department of Agriculture, U.S. Department of Health and Human Services, and U.S. Treasury Department for loans, grants, and tax credits to support a range of projects designed to increase access to healthy foods.*
Supporting HFFI and other policies to increase access to healthy foods through different food and farm policy innovations, and improving the built environment through strategies for walkable, bikeable, and safe neighborhoods, parks, and playgrounds, particularly in underresourced communities, are the focus of the Convergence Partnership, a collaborative of six major funding organizations and CDC.† PolicyLink, a national research and policy institute serves as the Convergence Partnership program lead, providing guidance about policy and strategy.§ Local strategies for enhancing the built environment to support healthy eating and active living include walkable and bikeable neighborhoods, public transit, joint use of school yards, and health impact assessments. Public education and advocacy efforts already have increased awareness of the connection between health and transportation and have altered policy proposals.
Implementation at the State Level: The Maine Experience
In Maine, the pediatric community partnered with community groups, the Maine-Harvard Prevention Research Center, and the state Center for Disease Control and Prevention to develop simple steps clinicians could follow in their practices to reduce childhood obesity. These partnerships led to formation of the Maine Youth Overweight Collaborative (MYOC) in 2004.¶ It started with a simple message: 5-2-1-0: five or more fruits and vegetables per day, 2 hours or less screen time per day, 1 hour or more of physical activity per day, and zero sugar drinks coupled with more water and low fat milk consumption. This message provided clinicians with basic steps to take to combat the childhood obesity epidemic. Before MYOC, clinicians documented body mass index for age and sex approximately 25% of the time; after 24 months of MYOC in action, approximately 90% of encounters resulted in a documented body mass index.
In 2006, a group of local businesses and health-care leaders in Portland, Maine, formed a unique profit/nonprofit partnership called Let's Go! that used lessons learned and tools and resources developed in MYOC to take the 5-2-1-0 message to additional settings: schools, child-care centers, communities, workplaces, after-school programs, and health-care settings.** The core principles of Let's Go! affirm that 1) environmental and policy changes influence behavior change, 2) interconnectivity across sectors is essential, and 3) strategies should be evidence-based and continuously evaluated. Let's Go! has a robust evaluation plan that focuses on qualitative and quantitative data. Because changes in obesity rates take years, progress is tracked through environmental and policy changes as well as behavioral data as precursors to changes in population weight status (Figure 3). Parents already are more likely able to identify all four healthy behaviors correctly, and a 27% increase in perceived behavior change was observed among children in three of four of the 5-2-1-0 targeted behaviors. Let's Go! has begun to expand statewide, and by June 2010, involved nearly 85,000 students in 262 schools, 40 child-care sites caring for thousands of children, approximately 50 physician practices, numerous after-school programs supporting approximately 2,500 youths, six of Portland's largest employers, and eight regions across Maine. Since June 2010, Let's Go! has been disseminated statewide to seven additional regions in Maine.
Other Initiatives
The efforts already under way for obesity prevention and control are further strengthened by Let's Move, the First Lady's initiative to end childhood obesity in a generation, by empowering parents, encouraging healthier foods in schools, increasing physical activity, and increasing access to affordable healthy foods.†† Let's Move includes establishment of the intergovernmental Childhood Obesity Task Force and, in the U.S. Department of Health and Human Services, a Healthy Weight Task Force is developing broad approaches in multiple sectors. Other key programs include those instituted by the Convergence Partnership and programs initiated by CDC with funds from the American Recovery and Reimbursement Act of 2009.
* Additional information available at http://www.letsmove.gov/healthycommunity.php.
† Additional information available at http://www.convergencepartnership.org.
§ Additional information available at http://www.policylink.org.
¶ Additional information available at http://www.letsgo.org/resources/MYOC.php.
** Additional information available at http://www.letsgo.org.
†† Additional information available at http://www.letsmove.gov.
CDC Grand Rounds:
J Bell, MPA; VW Rogers, MD; WH Dietz, MD, PhD; CL Ogden, PhD; C Schuler, PhD; T Popovic, MD, PhD;
Abstract and Introduction
The Magnitude of the Problem
In the United States, childhood obesity affects approximately 12.5 million children and teens (17% of that population).
Changes in obesity prevalence from the 1960s show a rapid increase in the 1980s and 1990s, when obesity prevalence among children and teens tripled, from nearly 5% to approximately 15% (Figure 1).
During the past 10 years, the rapid increase in obesity has slowed and might have leveled. However, among the heaviest boys, a significant increase in obesity has been observed, with the heaviest getting even heavier.
Moreover, substantial racial/ethnic disparities exist, with Hispanic boys and non-Hispanic black girls disproportionately affected by obesity (Figure 2).
Also, older children and teens are more likely to be obese compared with preschoolers.
In the short term, obesity in children can lead to psychosocial problems and to cardiovascular risk factors such as hypertension, high cholesterol, and abnormal glucose tolerance or diabetes.
In one study, 70% of obese children had at least one additional cardiovascular risk factor, and 30% had two or more.
Although the prevalence of type 2 diabetes in teens is very low, a recent report estimated that 15% of new diabetes cases among children and adolescents are type 2 diabetes.
In the 1980s, type 2 diabetes in teens was virtually unheard of.
The prevalence of obesity among U.S. adults (34%) is twice that observed in children and translates into nearly 73 million adult men and women
On average, U.S. adults weigh 24 pounds more than they did in 1960, and they are at increased risk for health conditions such as diabetes, cardiovascular disease, and certain cancers.
Although obesity prevalence has remained mostly flat in the past 10 years, the costs associated with obesity have increased substantially during the same period. One study estimated that approximately 9% of all medical costs in 2008 were obesity-related and amounted to $147 billion, compared with $78.5 billion 10 years before.
Challenges and Strategies to Combat the Problem
Identification of Effective Interventions
Environmental determinants of childhood obesity in the United States include shifts in food consumption, changes in physical activity levels, and higher levels of television viewing, with the consequent inactivity and marketing of food to children. CDC is focusing on best available evidence to implement intervention programs. For maximum population impact, the focus should be on strategies that alter the food and physical activity environments in places where persons live, learn, work, play, and pray. Interventions aimed at single behavioral targets are unlikely to have a substantial impact, and both evidence-based practice and practice-based evidence should be considered.
Breastfeeding has been shown to have substantial health benefits for children, who consequently might be at reduced risk for childhood obesity.[7] The most recent data show that nearly 30% of mothers do not breastfeed, and only approximately 40% of children are still breastfed at age 6 months (the recommended duration of exclusive breast feeding is to age 4–6 months).[8] A study of mothers' experiences during their stay at maternity-care hospitals found that duration of breastfeeding increased when the number of baby-friendly steps the mother experienced increased (e.g., initiating breastfeeding early, exclusive breastfeeding, rooming in, on-demand feedings, no pacifiers, and providing information to new mothers).[9] Interventions that encourage breastfeeding in workplaces also would increase the chances of working mothers continuing to breastfeed longer.
Strategies to reduce energy intake include decreasing consumption of high energy-density foods, increasing consumption of fruits and vegetables, decreasing consumption of sugar-sweetened beverages, and decreasing time spent watching television and exposure to food marketed to children. A substantial proportion of all money spent on food consumed outside the home is spent on fast food.[10] Institutions such as child-care facilities and schools should alter their purchasing strategies to reduce the availability of high-calorie foods. Approaches to reducing energy intake through decreasing consumption of sugar drinks (sodas and 10% juice–containing beverages) include 1) enacting regulations and policies that eliminate availability of such drinks, including sports drinks, in child-care settings and schools and at school events and afterschool programs, 2) increasing availability of fresh water in parks and recreational facilities, and 3) eliminating sugar drinks in school vending machines. Reducing the amount of time children spend watching television, and thus reducing exposure to food marketed to them, can be accomplished by limiting television time at home and in child-care settings and removing televisions from children's bedrooms.
Increasing energy output through increased physical activity plays an important role in preventing and reducing obesity-related illnesses and conditions such as hyperlipidemia, hyperinsulinemia, and elevated blood pressure, even if weight is not reduced.[11] Activity levels can be increased by making it safer to walk or bike to school. Quality school physical education programs that keep children moving the majority of their time in physical education class should be implemented. Providing a safe environment for physical activity and establishing habits (e.g., regular physical activity) that will lead to activity into and throughout adulthood must become priorities.
An example of a comprehensive school-based program was one that was implemented in Philadelphia, Pennsylvania, aimed at 4th, 5th, and 6th graders, which included reducing television time, increasing physical activity, and increasing fruit and vegetable intake.[11] This intervention was based on CDC's School Health Guidelines for Nutrition [12] and included changes in the school food supply to meet the Dietary Guidelines for Americans.[13] The 2-year intervention resulted in a 50% reduction in the incidence of overweight and a 10% reduction in prevalence of overweight. Physical inactivity and television viewing also declined.[14]
Policies and Systems Changes in Action
Changing policy often is the most effective way to implement and sustain these kinds of environmental changes. Policies not traditionally thought of as health policies (e.g., involving transportation, land use, education, agriculture, and economics) can affect health and obesity rates. The following two examples of major policy-driven initiatives requiring system changes focus on access to healthy foods and improving the built environment, respectively.
According to the U.S. Department of Agriculture, approximately 23.5 million persons in urban and rural areas of the United States live in "food deserts" (i.e., low-income areas without access to healthy foods).[15] Improved access to healthy foods might improve eating habits and decrease obesity. The Fresh Food Financing Initiative (FFFI) in Pennsylvania is a public-private partnership that has improved access to healthy foods using one-time loans and grants; as of September 2009, it had committed $59.7 million to projects across the state.[16] As a result of FFFI, approximately 500,000 persons now have access to healthy foods who did not have it before, nearly 5,000 jobs have been created or retained, and approximately 1.5 million square feet of retail space has been created or saved.[16] Eighty-three projects have been implemented, ranging from large supermarkets in urban settings to small stores in small town/rural settings, farmers markets, and community-supported agriculture. Replication of FFFI is under way in California, Colorado, Illinois, Louisiana, New Jersey, and New York. The President's proposed 2011 budget includes support for a Healthy Food Financing Initiative (HFFI), which combines $345 million from the U.S. Department of Agriculture, U.S. Department of Health and Human Services, and U.S. Treasury Department for loans, grants, and tax credits to support a range of projects designed to increase access to healthy foods.*
Supporting HFFI and other policies to increase access to healthy foods through different food and farm policy innovations, and improving the built environment through strategies for walkable, bikeable, and safe neighborhoods, parks, and playgrounds, particularly in underresourced communities, are the focus of the Convergence Partnership, a collaborative of six major funding organizations and CDC.† PolicyLink, a national research and policy institute serves as the Convergence Partnership program lead, providing guidance about policy and strategy.§ Local strategies for enhancing the built environment to support healthy eating and active living include walkable and bikeable neighborhoods, public transit, joint use of school yards, and health impact assessments. Public education and advocacy efforts already have increased awareness of the connection between health and transportation and have altered policy proposals.
Implementation at the State Level: The Maine Experience
In Maine, the pediatric community partnered with community groups, the Maine-Harvard Prevention Research Center, and the state Center for Disease Control and Prevention to develop simple steps clinicians could follow in their practices to reduce childhood obesity. These partnerships led to formation of the Maine Youth Overweight Collaborative (MYOC) in 2004.¶ It started with a simple message: 5-2-1-0: five or more fruits and vegetables per day, 2 hours or less screen time per day, 1 hour or more of physical activity per day, and zero sugar drinks coupled with more water and low fat milk consumption. This message provided clinicians with basic steps to take to combat the childhood obesity epidemic. Before MYOC, clinicians documented body mass index for age and sex approximately 25% of the time; after 24 months of MYOC in action, approximately 90% of encounters resulted in a documented body mass index.
In 2006, a group of local businesses and health-care leaders in Portland, Maine, formed a unique profit/nonprofit partnership called Let's Go! that used lessons learned and tools and resources developed in MYOC to take the 5-2-1-0 message to additional settings: schools, child-care centers, communities, workplaces, after-school programs, and health-care settings.** The core principles of Let's Go! affirm that 1) environmental and policy changes influence behavior change, 2) interconnectivity across sectors is essential, and 3) strategies should be evidence-based and continuously evaluated. Let's Go! has a robust evaluation plan that focuses on qualitative and quantitative data. Because changes in obesity rates take years, progress is tracked through environmental and policy changes as well as behavioral data as precursors to changes in population weight status (Figure 3). Parents already are more likely able to identify all four healthy behaviors correctly, and a 27% increase in perceived behavior change was observed among children in three of four of the 5-2-1-0 targeted behaviors. Let's Go! has begun to expand statewide, and by June 2010, involved nearly 85,000 students in 262 schools, 40 child-care sites caring for thousands of children, approximately 50 physician practices, numerous after-school programs supporting approximately 2,500 youths, six of Portland's largest employers, and eight regions across Maine. Since June 2010, Let's Go! has been disseminated statewide to seven additional regions in Maine.
Other Initiatives
The efforts already under way for obesity prevention and control are further strengthened by Let's Move, the First Lady's initiative to end childhood obesity in a generation, by empowering parents, encouraging healthier foods in schools, increasing physical activity, and increasing access to affordable healthy foods.†† Let's Move includes establishment of the intergovernmental Childhood Obesity Task Force and, in the U.S. Department of Health and Human Services, a Healthy Weight Task Force is developing broad approaches in multiple sectors. Other key programs include those instituted by the Convergence Partnership and programs initiated by CDC with funds from the American Recovery and Reimbursement Act of 2009.
* Additional information available at http://www.letsmove.gov/healthycommunity.php.
† Additional information available at http://www.convergencepartnership.org.
§ Additional information available at http://www.policylink.org.
¶ Additional information available at http://www.letsgo.org/resources/MYOC.php.
** Additional information available at http://www.letsgo.org.
†† Additional information available at http://www.letsmove.gov.
Pediatric Mumps
eMedicine Specialties > Pediatrics: General Medicine > Infectious Disease
Cem S Demirci, MD, Fellow in Endocrinology, Children's Hospital of Pittsburgh
Walid Abuhammour, MD, FAAP, Professor of Pediatrics, Michigan State University, Director of Pediatric Infectious Disease, Department of Pediatrics, Hurley Medical Center
Background
Mumps is a single-stranded RNA virus and a member of the family Paramyxoviridae, genus Paramyxovirus. It has 2 major surface glycoproteins: the hemagglutinin-neuraminidase and the fusion protein. Mumps virus is sensitive to heat and ultraviolet light.
Mumps vaccine was licensed in the United States in December 1967, and the Advisory Committee on Immunization Practices (ACIP) recommended that its use be considered for children approaching puberty, for adolescents, and for adults.
At that time, the public health community considered mumps control a low priority, and the ACIP stated that mumps immunization should not compromise the effectiveness of established public health programs.
However, in 1972, the ACIP recommendations were strengthened to indicate that mumps vaccination was particularly important for the initially targeted age groups;
in 1977, the ACIP recommended the routine vaccination of all children aged 12 months or older.
The use of mumps vaccine in young children was facilitated by the introduction (in 1977) and extensive use of the measles-mumps-rubella (MMR) vaccine.
In 1980, stronger recommendations called for the vaccination of susceptible children, adolescents, and adults, unless such vaccination was contraindicated. Following these increasingly comprehensive recommendations and the enactment of state laws requiring mumps vaccination for school entry and attendance, the reported incidence of mumps steadily declined.
However, during 1986 and 1987, large outbreaks occurred among underimmunized cohorts of persons born during 1967-1977, resulting in a shift in peak incidence from persons aged 5-9 years to persons aged 10-19 years.1
In 1989, the ACIP recommended that a second dose of measles-containing vaccine be administered to children aged 4-6 years (at time of entry to kindergarten or first grade) and designated MMR as the vaccine of choice.1,2
The incidence of mumps during 1988-1998 decreased among all age groups.
The greatest decrease occurred among persons aged 10-19 years, which was the same age group in which the greatest increases had occurred during 1986 and 1987, when a resurgence of outbreaks occurred among susceptible adolescents and young adults. Subsequent outbreaks have occurred among highly vaccinated populations.
During 1989-1990, a large outbreak occurred among students in a primary and a secondary school; most of the students in these schools had been vaccinated, suggesting that vaccination failure, in addition to failure to vaccinate, might have contributed to the outbreak.
In 1991, another outbreak occurred in a secondary school where most of the students had been vaccinated; this outbreak was also mostly attributed to primary vaccination failure.
The shift in higher risk for mumps to these other age groups (ie, from younger children of school ages to older children, adolescents, and young adults), which occurred after the routine use of the mumps vaccine was initiated, has persisted despite minimal fluctuations in disease incidence that occurred in recent years among the various age groups.
Pathophysiology
Mumps virus produces a generalized infection. After entry into the oropharynx, viral replication occurs, causing subsequent viremia and involving glands or nervous tissue.
The virus may be isolated from saliva, blood, urine, and cerebrospinal fluid (CSF). Affected glands show edema and lymphocyte infiltration.
for rest of article refer:
http://emedicine.medscape.com/article/966678-overview
Cem S Demirci, MD, Fellow in Endocrinology, Children's Hospital of Pittsburgh
Walid Abuhammour, MD, FAAP, Professor of Pediatrics, Michigan State University, Director of Pediatric Infectious Disease, Department of Pediatrics, Hurley Medical Center
Background
Mumps is a single-stranded RNA virus and a member of the family Paramyxoviridae, genus Paramyxovirus. It has 2 major surface glycoproteins: the hemagglutinin-neuraminidase and the fusion protein. Mumps virus is sensitive to heat and ultraviolet light.
Mumps vaccine was licensed in the United States in December 1967, and the Advisory Committee on Immunization Practices (ACIP) recommended that its use be considered for children approaching puberty, for adolescents, and for adults.
At that time, the public health community considered mumps control a low priority, and the ACIP stated that mumps immunization should not compromise the effectiveness of established public health programs.
However, in 1972, the ACIP recommendations were strengthened to indicate that mumps vaccination was particularly important for the initially targeted age groups;
in 1977, the ACIP recommended the routine vaccination of all children aged 12 months or older.
The use of mumps vaccine in young children was facilitated by the introduction (in 1977) and extensive use of the measles-mumps-rubella (MMR) vaccine.
In 1980, stronger recommendations called for the vaccination of susceptible children, adolescents, and adults, unless such vaccination was contraindicated. Following these increasingly comprehensive recommendations and the enactment of state laws requiring mumps vaccination for school entry and attendance, the reported incidence of mumps steadily declined.
However, during 1986 and 1987, large outbreaks occurred among underimmunized cohorts of persons born during 1967-1977, resulting in a shift in peak incidence from persons aged 5-9 years to persons aged 10-19 years.1
In 1989, the ACIP recommended that a second dose of measles-containing vaccine be administered to children aged 4-6 years (at time of entry to kindergarten or first grade) and designated MMR as the vaccine of choice.1,2
The incidence of mumps during 1988-1998 decreased among all age groups.
The greatest decrease occurred among persons aged 10-19 years, which was the same age group in which the greatest increases had occurred during 1986 and 1987, when a resurgence of outbreaks occurred among susceptible adolescents and young adults. Subsequent outbreaks have occurred among highly vaccinated populations.
During 1989-1990, a large outbreak occurred among students in a primary and a secondary school; most of the students in these schools had been vaccinated, suggesting that vaccination failure, in addition to failure to vaccinate, might have contributed to the outbreak.
In 1991, another outbreak occurred in a secondary school where most of the students had been vaccinated; this outbreak was also mostly attributed to primary vaccination failure.
The shift in higher risk for mumps to these other age groups (ie, from younger children of school ages to older children, adolescents, and young adults), which occurred after the routine use of the mumps vaccine was initiated, has persisted despite minimal fluctuations in disease incidence that occurred in recent years among the various age groups.
Pathophysiology
Mumps virus produces a generalized infection. After entry into the oropharynx, viral replication occurs, causing subsequent viremia and involving glands or nervous tissue.
The virus may be isolated from saliva, blood, urine, and cerebrospinal fluid (CSF). Affected glands show edema and lymphocyte infiltration.
for rest of article refer:
http://emedicine.medscape.com/article/966678-overview
Japan Halts Prevenar, ActHIB Vaccines After Four Children Die
From Reuters Health Information > Alerts, Approvals and Safety Changes > Alerts
By James Topham
TOKYO (Reuters) Mar 07 - Japan's health ministry has halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA to prevent meningitis and pneumonia following the deaths of four children.
The infants died shortly after receiving the vaccines. While it was unclear if there was link between the deaths and vaccines, use of Pfizer's Prevenar (called Prevnar in some countries) and Sanofi's ActHIB (an Haemophilus b conjugate vaccine) will be suspended while the deaths are investigated, the ministry said in a statement.
A ministry safety panel is scheduled to discuss findings in the investigations on Tuesday.
In February last year health authorities in the Netherlands said no relation was found between Prevenar and the deaths of three infants who had received the vaccine.
Three of the children who died in Japan received Prevenar together with ActHIB. In addition, three of the children also received a mixed vaccine against diphtheria, whooping cough and tetanus on the same day they received the other vaccines.
Three of the four children died a day after being immunized. The deaths happened between March 2 and March 4.
Representatives for Pfizer and Sanofi in Tokyo said the companies were cooperating with the investigation.
A spokesman for Sanofi said that the company has shipped more than 3 million doses of ActHIB in Japan since 2008. A spokesman for Pfizer said the firm has distributed more than 2 million doses of Prevenar in Japan since last year.
Prevenar is active against 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
By James Topham
TOKYO (Reuters) Mar 07 - Japan's health ministry has halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA to prevent meningitis and pneumonia following the deaths of four children.
The infants died shortly after receiving the vaccines. While it was unclear if there was link between the deaths and vaccines, use of Pfizer's Prevenar (called Prevnar in some countries) and Sanofi's ActHIB (an Haemophilus b conjugate vaccine) will be suspended while the deaths are investigated, the ministry said in a statement.
A ministry safety panel is scheduled to discuss findings in the investigations on Tuesday.
In February last year health authorities in the Netherlands said no relation was found between Prevenar and the deaths of three infants who had received the vaccine.
Three of the children who died in Japan received Prevenar together with ActHIB. In addition, three of the children also received a mixed vaccine against diphtheria, whooping cough and tetanus on the same day they received the other vaccines.
Three of the four children died a day after being immunized. The deaths happened between March 2 and March 4.
Representatives for Pfizer and Sanofi in Tokyo said the companies were cooperating with the investigation.
A spokesman for Sanofi said that the company has shipped more than 3 million doses of ActHIB in Japan since 2008. A spokesman for Pfizer said the firm has distributed more than 2 million doses of Prevenar in Japan since last year.
Prevenar is active against 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Friday, March 4, 2011
Low Vitamin D Linked to Allergy Risk in Kids
From WebMD Health News
Bill Hendrick
March 3, 2011 — Children who don’t get enough vitamin D may be at increased risk of developing allergies, new research indicates.
Researchers in New York examined serum vitamin D levels in the blood of more than 3,100 children and adolescents and 3,400 adults.
No association was found between low vitamin D levels and allergies in adults, but the link was significant in children and adolescents.
Children and adolescents aged 1 to 21 with low vitamin D levels were at increased risk of having sensitivities to 11 of 17 allergens tested, including environmental and food allergies.
For example, children who had vitamin D deficiency, which was defined as less than 15 nanograms of vitamin D per milliliter of blood, were 2.4 times more likely to have a peanut allergy than kids with sufficient levels, or 30 nanograms of vitamin D per milliliter of blood.
Children with low vitamin D levels also had increased risk of allergic sensitization to shrimp, dogs, cockroaches, ragweed, oak, ryegrass, Bermuda grass, and thistle.
Avoiding Vitamin D Deficiency
The data came from the National Health and Nutrition Examination Survey 2005-2006 (NHANES), which is a program of studies aimed at assessing the health and nutritional status of adults and children in the U.S.
The study participants underwent blood tests measuring levels of Immunoglobulin E(IgE), a protein that is produced when the immune system responds to allergens.
Researchers say their findings don’t prove that insufficient vitamin D causes allergies in children and adolescents, but strongly suggests that young people should get adequate amounts of the vitamin.
“The latest dietary recommendations calling for children to take in 600 IU of vitamin D daily should keep them from becoming vitamin D deficient,” researcher Michal Melamed, MD, MHS, of the Albert Einstein College Medicine of Yeshiva University, says in a news release.
The study says vitamin D is thought to have anti-inflammatory effects in the body.
The researchers note that the prevalence of vitamin D deficiency is increasing in the U.S., and so is the prevalence of food allergies.
The study is published in the Feb. 17 online edition of the Journal of Allergy and Clinical Immunology.
Bill Hendrick
March 3, 2011 — Children who don’t get enough vitamin D may be at increased risk of developing allergies, new research indicates.
Researchers in New York examined serum vitamin D levels in the blood of more than 3,100 children and adolescents and 3,400 adults.
No association was found between low vitamin D levels and allergies in adults, but the link was significant in children and adolescents.
Children and adolescents aged 1 to 21 with low vitamin D levels were at increased risk of having sensitivities to 11 of 17 allergens tested, including environmental and food allergies.
For example, children who had vitamin D deficiency, which was defined as less than 15 nanograms of vitamin D per milliliter of blood, were 2.4 times more likely to have a peanut allergy than kids with sufficient levels, or 30 nanograms of vitamin D per milliliter of blood.
Children with low vitamin D levels also had increased risk of allergic sensitization to shrimp, dogs, cockroaches, ragweed, oak, ryegrass, Bermuda grass, and thistle.
Avoiding Vitamin D Deficiency
The data came from the National Health and Nutrition Examination Survey 2005-2006 (NHANES), which is a program of studies aimed at assessing the health and nutritional status of adults and children in the U.S.
The study participants underwent blood tests measuring levels of Immunoglobulin E(IgE), a protein that is produced when the immune system responds to allergens.
Researchers say their findings don’t prove that insufficient vitamin D causes allergies in children and adolescents, but strongly suggests that young people should get adequate amounts of the vitamin.
“The latest dietary recommendations calling for children to take in 600 IU of vitamin D daily should keep them from becoming vitamin D deficient,” researcher Michal Melamed, MD, MHS, of the Albert Einstein College Medicine of Yeshiva University, says in a news release.
The study says vitamin D is thought to have anti-inflammatory effects in the body.
The researchers note that the prevalence of vitamin D deficiency is increasing in the U.S., and so is the prevalence of food allergies.
The study is published in the Feb. 17 online edition of the Journal of Allergy and Clinical Immunology.
Thursday, March 3, 2011
Egg Allergy and the Influenza Vaccine -- A New Perspective
From Medscape Allergy & Clinical Immunology
An expert interview with Matthew J. Greenhawt, MD, MBA
Laurie Scudder, DNP, NP
Editor's Note
The American Academy of Asthma, Allergy, & Immunology (AAAAI) issued a paper titled Administering Influenza Vaccine to Egg Allergic Recipients in October 2010.
The report offered guidance in the administration of influenza vaccine to egg-allergic (EA) individuals, concluding that most of these patients can safely be vaccinated. A follow-up practice parameter published in January 2011 provided more information about the quality of the evidence underpinning recommendations for vaccine administration.
Matthew J. Greenhawt, MD, MBA, Assistant Professor, University of Michigan Medical School, Division of Allergy and Clinical Immunology, and co-author of both reports discussed issues around implementation of these recommendations for both the primary care and allergy/immunology settings with Medscape editor Laurie Scudder DNP, NP.
The Evidence for Administration of Vaccine
Medscape: The report describes 3 recent studies that have examined the use of trivalent inactivated influenza vaccine (TIV) in egg-allergic individuals. Can you describe these studies?
Matthew J. Greenhawt, MD, MBA: During the 2009-2010 influenza season and H1N1 pandemic, 3 studies emerged examining this issue. The first was a retrospective study conducted by researchers at Boston Children's Hospital that examined their institution's experience in vaccinating their population of children with non-anaphylactic egg allergy.
A total of 171 patients met eligibility criteria and were vaccinated with trivalent influenza vaccine using a 2-step protocol without skin testing prior to vaccination. The 2-step protocol involved administering approximately 10% of the volume of the vaccine, then monitoring the child for 30 minutes to make sure that no symptoms developed, and then administering the residual 90% of the vaccine.
This is a common dosing protocol many allergists use to safely provide the vaccine to egg-allergic children.
In this study, there were 29 localized reactions, mostly redness or induration at the injection site.
There were 7 reactions considered to be systemic, 6 of which occurred within the initial 30-minute observation period after the 10% dose and one that occurred outside of that 30-minute observation period for the 90% dose.
The researchers' overall conclusion was that for egg-allergic children without a history of anaphylaxis, use of a 2-step graded dose approach is a valid and safe method of providing vaccination, and this can be done without any pretesting to the influenza vaccine.
This study did not report the ovalbumin content of the vaccines used. Ovalbumin is the egg protein that is a contaminant in influenza vaccine.
Additionally, it was a retrospective study and had fairly restrictive selection criteria, both factors that introduce some bias.
The design excluded kids who had a prior positive influenza vaccine skin test and/or a history of severe symptoms attributable to eggs.
So, although the patient population in this study was not entirely representative of the general egg-allergic population, this study importantly introduced the concept that vaccination can be safely performed without skin testing using a 2-step protocol.
The second study was a prospective multicenter trial conducted in Canada during the 2009-2010 pandemic.
This study used H1N1 influenza A vaccine that had been specifically formulated to contain approximately 0.3 μg/mL ovalbumin. This was a special vaccine not available in the United States. Patients were not skin tested to the vaccine prior to administration.
Two dosing strategies were used: 72 patients with a history of severe cardiovascular/respiratory symptoms attributable to egg or with uncontrolled asthma were vaccinated with a 2-step graded challenge; the remaining 758 egg-allergic individuals without such a history were vaccinated with a single dose.
A very low rate of reactions was found, with approximately 3% experiencing mild symptoms within a 1-hour observation period.
At 24 hours after vaccination, 13% had reported some mild symptoms, mainly gastrointestinal or runny nose.
Thus, the vaccine was well tolerated in this egg-allergic population.
Based on those results, a separate group of 3640 patients with self-reported egg allergy were vaccinated according to the same protocol. Among this additional group, symptoms consistent with an allergic reaction developed in approximately 2% of patients, with 2 patients requiring epinephrine. This study offered proof that a single-dose approach is acceptable and prospectively demonstrated that vaccine skin testing was not necessary to safely administer the vaccine. A
lthough this study was prospective and involved multiple centers, it did use a very specific vaccine type that was not available in the United States, which may hinder the ability to generalize these findings.
However, and most importantly, this study showed that egg-allergic patients without a history of a severe reaction could receive a low-ovalbumin containing vaccine safely without vaccine skin testing, and as a single dose.
The third study was done by our group at Michigan using H1N1 vaccine.
We conducted a controlled prospective study of 105 egg-allergic children and 19 non-egg-allergic controls. All patients, including controls, received skin testing. All control patients received a single-dose injection.
In the egg-allergic group, only those with negative vaccine skin testing received a single dose.
If the skin testing was positive, these patients were given a 2-step graded challenge.
The specific questions we were interested in were as follows:
* Is skin testing predictive of vaccine tolerance?
* Is a 2-step graded challenge rather than a single dose necessary?
* Does a patient's past egg allergy severity affect vaccine tolerance (given that influenza vaccine is technically contraindicated in children with anaphylaxis or with a severe reaction to egg)?
* Is vaccine ovalbumin content a factor in vaccine tolerance?
We found that 44 of our total group of both egg-allergic and non-egg-allergic patients had positive vaccine skin tests, but all received the vaccine without an allergic reaction developing.
Therefore, we concluded that the skin testing was not predictive of vaccine tolerance.
Interestingly, we found that as the vaccine ovalbumin content increased, all patients were more likely to have a positive skin test to the vaccine, which suggested that the vaccine may act as a skin irritant during testing.
We enrolled 25 egg-allergic patients with a history of anaphylaxis attributable to egg. Thirteen had a positive skin test and were vaccinated using a 2-step graded challenge. The remaining 12 had a negative skin test and received a single dose. All 25 received the vaccine safely without any symptom development.
Additionally, past recommendations suggested that booster doses of vaccine should be given using the same manufacturer lot because of concerns that different lots may contain different levels of ovalbumin.
In our study, 94 patients received a booster from a different lot, and none of the patients had any symptoms of allergic reaction, demonstrating that concerns about lot-to-lot variability may not be valid.
A limitation of our study was that the highest ovalbumin level in any of the vaccine lots used was 50 ng/mL. However, in a published study of vaccine ovalbumin levels, all 2009-2010 H1N1 ovalbumin levels analyzed were found to contain under 100 ng/mL, which was several-fold less than the trivalent influenza vaccine lots.
The findings from these studies, each using a different approach and methodology, all point to the same conclusions: that the vaccine is well tolerated in most egg-allergic patients, that vaccine skin testing is not necessary, and that there is evidence to support the use of either a single dose or a 2-step approach to safely administer the vaccine.
Medscape: The report also notes that a larger multicenter trial examining administration strategies for EA patients is currently underway. Are you able to tell us any more about that trial and the questions you hope it will answer?
Dr. Greenhawt: There is a study currently underway exploring the safety of this season's combined trivalent influenza vaccine (which contains H1N1) among a population of patients with severe egg allergy and/or anaphylaxis to egg, to evaluate the safety of providing the vaccine to this population.
An expert interview with Matthew J. Greenhawt, MD, MBA
Laurie Scudder, DNP, NP
Editor's Note
The American Academy of Asthma, Allergy, & Immunology (AAAAI) issued a paper titled Administering Influenza Vaccine to Egg Allergic Recipients in October 2010.
The report offered guidance in the administration of influenza vaccine to egg-allergic (EA) individuals, concluding that most of these patients can safely be vaccinated. A follow-up practice parameter published in January 2011 provided more information about the quality of the evidence underpinning recommendations for vaccine administration.
Matthew J. Greenhawt, MD, MBA, Assistant Professor, University of Michigan Medical School, Division of Allergy and Clinical Immunology, and co-author of both reports discussed issues around implementation of these recommendations for both the primary care and allergy/immunology settings with Medscape editor Laurie Scudder DNP, NP.
The Evidence for Administration of Vaccine
Medscape: The report describes 3 recent studies that have examined the use of trivalent inactivated influenza vaccine (TIV) in egg-allergic individuals. Can you describe these studies?
Matthew J. Greenhawt, MD, MBA: During the 2009-2010 influenza season and H1N1 pandemic, 3 studies emerged examining this issue. The first was a retrospective study conducted by researchers at Boston Children's Hospital that examined their institution's experience in vaccinating their population of children with non-anaphylactic egg allergy.
A total of 171 patients met eligibility criteria and were vaccinated with trivalent influenza vaccine using a 2-step protocol without skin testing prior to vaccination. The 2-step protocol involved administering approximately 10% of the volume of the vaccine, then monitoring the child for 30 minutes to make sure that no symptoms developed, and then administering the residual 90% of the vaccine.
This is a common dosing protocol many allergists use to safely provide the vaccine to egg-allergic children.
In this study, there were 29 localized reactions, mostly redness or induration at the injection site.
There were 7 reactions considered to be systemic, 6 of which occurred within the initial 30-minute observation period after the 10% dose and one that occurred outside of that 30-minute observation period for the 90% dose.
The researchers' overall conclusion was that for egg-allergic children without a history of anaphylaxis, use of a 2-step graded dose approach is a valid and safe method of providing vaccination, and this can be done without any pretesting to the influenza vaccine.
This study did not report the ovalbumin content of the vaccines used. Ovalbumin is the egg protein that is a contaminant in influenza vaccine.
Additionally, it was a retrospective study and had fairly restrictive selection criteria, both factors that introduce some bias.
The design excluded kids who had a prior positive influenza vaccine skin test and/or a history of severe symptoms attributable to eggs.
So, although the patient population in this study was not entirely representative of the general egg-allergic population, this study importantly introduced the concept that vaccination can be safely performed without skin testing using a 2-step protocol.
The second study was a prospective multicenter trial conducted in Canada during the 2009-2010 pandemic.
This study used H1N1 influenza A vaccine that had been specifically formulated to contain approximately 0.3 μg/mL ovalbumin. This was a special vaccine not available in the United States. Patients were not skin tested to the vaccine prior to administration.
Two dosing strategies were used: 72 patients with a history of severe cardiovascular/respiratory symptoms attributable to egg or with uncontrolled asthma were vaccinated with a 2-step graded challenge; the remaining 758 egg-allergic individuals without such a history were vaccinated with a single dose.
A very low rate of reactions was found, with approximately 3% experiencing mild symptoms within a 1-hour observation period.
At 24 hours after vaccination, 13% had reported some mild symptoms, mainly gastrointestinal or runny nose.
Thus, the vaccine was well tolerated in this egg-allergic population.
Based on those results, a separate group of 3640 patients with self-reported egg allergy were vaccinated according to the same protocol. Among this additional group, symptoms consistent with an allergic reaction developed in approximately 2% of patients, with 2 patients requiring epinephrine. This study offered proof that a single-dose approach is acceptable and prospectively demonstrated that vaccine skin testing was not necessary to safely administer the vaccine. A
lthough this study was prospective and involved multiple centers, it did use a very specific vaccine type that was not available in the United States, which may hinder the ability to generalize these findings.
However, and most importantly, this study showed that egg-allergic patients without a history of a severe reaction could receive a low-ovalbumin containing vaccine safely without vaccine skin testing, and as a single dose.
The third study was done by our group at Michigan using H1N1 vaccine.
We conducted a controlled prospective study of 105 egg-allergic children and 19 non-egg-allergic controls. All patients, including controls, received skin testing. All control patients received a single-dose injection.
In the egg-allergic group, only those with negative vaccine skin testing received a single dose.
If the skin testing was positive, these patients were given a 2-step graded challenge.
The specific questions we were interested in were as follows:
* Is skin testing predictive of vaccine tolerance?
* Is a 2-step graded challenge rather than a single dose necessary?
* Does a patient's past egg allergy severity affect vaccine tolerance (given that influenza vaccine is technically contraindicated in children with anaphylaxis or with a severe reaction to egg)?
* Is vaccine ovalbumin content a factor in vaccine tolerance?
We found that 44 of our total group of both egg-allergic and non-egg-allergic patients had positive vaccine skin tests, but all received the vaccine without an allergic reaction developing.
Therefore, we concluded that the skin testing was not predictive of vaccine tolerance.
Interestingly, we found that as the vaccine ovalbumin content increased, all patients were more likely to have a positive skin test to the vaccine, which suggested that the vaccine may act as a skin irritant during testing.
We enrolled 25 egg-allergic patients with a history of anaphylaxis attributable to egg. Thirteen had a positive skin test and were vaccinated using a 2-step graded challenge. The remaining 12 had a negative skin test and received a single dose. All 25 received the vaccine safely without any symptom development.
Additionally, past recommendations suggested that booster doses of vaccine should be given using the same manufacturer lot because of concerns that different lots may contain different levels of ovalbumin.
In our study, 94 patients received a booster from a different lot, and none of the patients had any symptoms of allergic reaction, demonstrating that concerns about lot-to-lot variability may not be valid.
A limitation of our study was that the highest ovalbumin level in any of the vaccine lots used was 50 ng/mL. However, in a published study of vaccine ovalbumin levels, all 2009-2010 H1N1 ovalbumin levels analyzed were found to contain under 100 ng/mL, which was several-fold less than the trivalent influenza vaccine lots.
The findings from these studies, each using a different approach and methodology, all point to the same conclusions: that the vaccine is well tolerated in most egg-allergic patients, that vaccine skin testing is not necessary, and that there is evidence to support the use of either a single dose or a 2-step approach to safely administer the vaccine.
Medscape: The report also notes that a larger multicenter trial examining administration strategies for EA patients is currently underway. Are you able to tell us any more about that trial and the questions you hope it will answer?
Dr. Greenhawt: There is a study currently underway exploring the safety of this season's combined trivalent influenza vaccine (which contains H1N1) among a population of patients with severe egg allergy and/or anaphylaxis to egg, to evaluate the safety of providing the vaccine to this population.
AAP Issues Statement on Treating Fever in Pediatric Patients
From Medscape Medical News
Emma Hitt, PhD
March 3, 2011 — Treatment of febrile children should focus on improving the child's comfort rather than bringing the temperature down to normal levels or preventing the onset of fever, according to a new clinical report issued by the American Academy of Pediatrics (AAP).
Janice E. Sullivan, MD, and Henry C. Farrar, MD, and the AAP's Section on Clinical Pharmacology and Therapeutics, and Committee on Drugs authored the report, published in the March issue of Pediatrics.
"Many parents administer antipyretics even when there is minimal or no fever, because they are concerned that the child must maintain a 'normal' temperature," the study authors note. "Fever, however, is not the primary illness but is a physiologic mechanism that has beneficial effects in fighting infection," they write. "There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications."
According to the study authors, there is "no evidence that reducing fever reduces morbidity or mortality from a febrile illness" or that it decreases the recurrence of febrile seizures.
The article outlines strategies to counsel caregivers about treating febrile illness, stating that acetaminophen and ibuprofen, "when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations."
The appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
The appropriate dosing for ibuprofen is 10 mg/kg per dose.
The study also emphasizes the importance of clear labeling, dosing, and proper storage of medications used to treat fever. It also warns against the use of combination therapy with acetaminophen and ibuprofen because this approach may place infants and children at increased risk for dosing errors and adverse outcomes.
"To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products," they suggest.
This study was not commercially funded. The study authors have disclosed no relevant financial relationships.
Pediatrics. 2011;127:580-587. Full text
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Emma Hitt, PhD
March 3, 2011 — Treatment of febrile children should focus on improving the child's comfort rather than bringing the temperature down to normal levels or preventing the onset of fever, according to a new clinical report issued by the American Academy of Pediatrics (AAP).
Janice E. Sullivan, MD, and Henry C. Farrar, MD, and the AAP's Section on Clinical Pharmacology and Therapeutics, and Committee on Drugs authored the report, published in the March issue of Pediatrics.
"Many parents administer antipyretics even when there is minimal or no fever, because they are concerned that the child must maintain a 'normal' temperature," the study authors note. "Fever, however, is not the primary illness but is a physiologic mechanism that has beneficial effects in fighting infection," they write. "There is no evidence that fever itself worsens the course of an illness or that it causes long-term neurologic complications."
According to the study authors, there is "no evidence that reducing fever reduces morbidity or mortality from a febrile illness" or that it decreases the recurrence of febrile seizures.
The article outlines strategies to counsel caregivers about treating febrile illness, stating that acetaminophen and ibuprofen, "when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations."
The appropriate dosing for acetaminophen is 10 to 15 mg/kg per dose given every 4 to 6 hours orally, which produces an antipyretic effect within 30 to 60 minutes in approximately 80% of children.
The appropriate dosing for ibuprofen is 10 mg/kg per dose.
The study also emphasizes the importance of clear labeling, dosing, and proper storage of medications used to treat fever. It also warns against the use of combination therapy with acetaminophen and ibuprofen because this approach may place infants and children at increased risk for dosing errors and adverse outcomes.
"To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products," they suggest.
This study was not commercially funded. The study authors have disclosed no relevant financial relationships.
Pediatrics. 2011;127:580-587. Full text
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