Pulmonary Health Hub

ATLANTA – Vaccination rates increased dramatically and influenza rates decreased dramatically in children aged 6 months to 4 years in Connecticut following institution of a 2011 influenza vaccination requirement for children enrolled in day care, according to surveillance data.

Vaccination rates in this age group during the 2010-2011 influenza season, which was an H3N2-dominant season, were 85%, compared with 54% in 2009-2010, Kimberly Yousey-Hindes reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo © Yarinca/istockphoto.com

Also, the proportion of all emergency department visits for influenza and influenzalike illness was 30% in 2011, compared with 34% in 2008 (the most recent prior H3N2 dominant influenza season), representing a significant decrease, said Ms. Yousey-Hindes, influenza program coordinator for the Connecticut Emerging Infectious Program at Yale University.

"When compared to the 2007-2008 season, among those hospitalized with influenza, the proportion of patients 6 months to 4 years decreased as well (13% vs. 10%)," she wrote, noting that the proportion of laboratory-confirmed influenza cases also decreased ... during the same time period. Both declines were statistically significant.

Vaccination was required effective Jan. 1, 2011, for all children aged 6 months to 59 months who were enrolled in a licensed Connecticut day care. This study used data from the Connecticut Hospital Emergency Department Syndromic Surveillance system, the Connecticut Emerging Infectious Programs’ Influenza-Associated Hospitalization Surveillance system, and influenza reports to the state reportable disease database to measure the impact of the new rule.

An estimated 60% of preschool-age children receive nonparental care each week, mostly in child care centers, suggesting that vaccination of these children could have population-level effects, Ms. Yousey-Hindes noted.

Ms. Yousey-Hindes had no conflicts of interest to report.

ATLANTA – Vaccination rates increased dramatically and influenza rates decreased dramatically in children aged 6 months to 4 years in Connecticut following institution of a 2011 influenza vaccination requirement for children enrolled in day care, according to surveillance data.

Vaccination rates in this age group during the 2010-2011 influenza season, which was an H3N2-dominant season, were 85%, compared with 54% in 2009-2010, Kimberly Yousey-Hindes reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo © Yarinca/istockphoto.com

Also, the proportion of all emergency department visits for influenza and influenzalike illness was 30% in 2011, compared with 34% in 2008 (the most recent prior H3N2 dominant influenza season), representing a significant decrease, said Ms. Yousey-Hindes, influenza program coordinator for the Connecticut Emerging Infectious Program at Yale University.

"When compared to the 2007-2008 season, among those hospitalized with influenza, the proportion of patients 6 months to 4 years decreased as well (13% vs. 10%)," she wrote, noting that the proportion of laboratory-confirmed influenza cases also decreased ... during the same time period. Both declines were statistically significant.

Vaccination was required effective Jan. 1, 2011, for all children aged 6 months to 59 months who were enrolled in a licensed Connecticut day care. This study used data from the Connecticut Hospital Emergency Department Syndromic Surveillance system, the Connecticut Emerging Infectious Programs’ Influenza-Associated Hospitalization Surveillance system, and influenza reports to the state reportable disease database to measure the impact of the new rule.

An estimated 60% of preschool-age children receive nonparental care each week, mostly in child care centers, suggesting that vaccination of these children could have population-level effects, Ms. Yousey-Hindes noted.

Ms. Yousey-Hindes had no conflicts of interest to report.

ATLANTA – Vaccination rates increased dramatically and influenza rates decreased dramatically in children aged 6 months to 4 years in Connecticut following institution of a 2011 influenza vaccination requirement for children enrolled in day care, according to surveillance data.

Vaccination rates in this age group during the 2010-2011 influenza season, which was an H3N2-dominant season, were 85%, compared with 54% in 2009-2010, Kimberly Yousey-Hindes reported in a poster at the International Conference on Emerging Infectious Diseases.

Photo © Yarinca/istockphoto.com

Also, the proportion of all emergency department visits for influenza and influenzalike illness was 30% in 2011, compared with 34% in 2008 (the most recent prior H3N2 dominant influenza season), representing a significant decrease, said Ms. Yousey-Hindes, influenza program coordinator for the Connecticut Emerging Infectious Program at Yale University.

"When compared to the 2007-2008 season, among those hospitalized with influenza, the proportion of patients 6 months to 4 years decreased as well (13% vs. 10%)," she wrote, noting that the proportion of laboratory-confirmed influenza cases also decreased ... during the same time period. Both declines were statistically significant.

Vaccination was required effective Jan. 1, 2011, for all children aged 6 months to 59 months who were enrolled in a licensed Connecticut day care. This study used data from the Connecticut Hospital Emergency Department Syndromic Surveillance system, the Connecticut Emerging Infectious Programs’ Influenza-Associated Hospitalization Surveillance system, and influenza reports to the state reportable disease database to measure the impact of the new rule.

An estimated 60% of preschool-age children receive nonparental care each week, mostly in child care centers, suggesting that vaccination of these children could have population-level effects, Ms. Yousey-Hindes noted.

Ms. Yousey-Hindes had no conflicts of interest to report.

ORLANDO – Children with severe asthma may have their already serious symptoms further worsened by sensitization to common household fungi in the genus Alternaria, suggested investigators at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Among 187 children with asthma enrolled in the National Heart, Lung and Blood Institutes’ Severe Asthma Research Program (SARP), 28% had a positive skin prick test reaction to Alternaria, reported Dr. Jennifer Shih, an allergy and immunology fellow in the department of pediatrics at Emory University in Atlanta.

Photo courtesy CDC/Dr. Lucille K. Georg

Sensitization to Alternaria was significantly more prevalent among children with severe vs. mild to moderate asthma (P less than .01), and children with severe presentation were significantly more likely to exhibit increased airway hyperresponsiveness (P less than .01) and to report a history of acute or chronic sinusitis requiring antibiotics (P less than .05).

"In the future, routine evaluation of Alternaria sensitization may be useful in the clinical management of children with severe asthma. Future studies are needed to evaluate the mechanistic underpinning of Alternaria sensitization in children with severe asthma," she said.

Sensitization to Alternaria has been associated in other studies with asthma persistence into early adulthood, Dr, Shih said. One study showed that Alternaria sensitization was associated with an odds ratio (OR) of 3.6 for chronic asthma at age 22 years (Lancet 2008;372:1058-64).

Increased airway hyperresponsiveness, a hallmark of severe asthma in children, was associated with Alternaria sensitization in the Childhood Asthma Management Research Program, she noted.

To see whether there were differences in Alternaria sensitization between school-age children with mild to moderate or severe asthma, and whether sensitization was associated with clinical features of asthma severity, Dr. Shih and her colleague Dr. Anne Fitzpatrick took a retrospective look at 187 children enrolled in SARP at their institution. The children ranged in age from 6 to 18 years, and all had skin prick test data available. In all, 90 had severe asthma, and 97 mild to moderate asthma.

Asthma severity was determined according to American Thoracic Society 2000 criteria, which require daily use of systemic or high-dose inhaled corticosteroids, plus at least two of the following: additional controller medication, beta-agonist use on at least 5 of 7 days, a baseline forced expiratory volume in 1 second (FEV₁)less than 80% of predicted, 1 or more emergency department visits within the past year, 3 or more oral steroid burst within the past year, prompt deterioration with steroid reduction, and/or a history of intubation(Am. J. Respir. Crit. Care Med. 2000;162:2341-51).

The investigators also reviewed asthma questionnaires, lung function–testing results, allergy evaluations, and biomarker evaluations.

In an analysis adjusted for race and socioeconomic status, they found that 37% of the children with severe asthma tested positive for Alternaria sensitization, compared with 21% of children with mild-to-moderate disease (adjusted OR 2.13, P = .015).

Among children with severe asthma, Alternaria sensitization was not significantly associated with differences in either blood eosinophil or total serum immunoglobulin E (IgE) levels, or in FEV₁, airflow limitation, air trapping, medication requirements, or health care use.

However, exhaled nitric oxide levels were significantly higher among those with severe asthma and sensitivity to Alternaria (P = .029), as was airway hyperresponsiveness to methacholine challenge (P = .012).

Additionally, in an analysis adjusted for socioeconomic status, children with severe asthma and a positive skin prick test to Alternaria had an adjusted OR for sinusitis of 2.43 (P = .046).

"These findings support previous observations from the Childhood Asthma Management Research Program," Dr. Shih said.

In the question and answer portion of her presentation, several clinicians commented that Alternaria might be a general marker for atopy rather than for airway hyperresponsiveness and sinusitis as seen in her study, and that other allergens such as cockroach and mites might account for exacerbations of severe asthma. Dr. Shih agreed that further studies would help to resolve this question.

The study was supported by the NHLBI and Emory University. Dr. Shih reported that she had no relevant disclosures.

ORLANDO – Children with severe asthma may have their already serious symptoms further worsened by sensitization to common household fungi in the genus Alternaria, suggested investigators at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Among 187 children with asthma enrolled in the National Heart, Lung and Blood Institutes’ Severe Asthma Research Program (SARP), 28% had a positive skin prick test reaction to Alternaria, reported Dr. Jennifer Shih, an allergy and immunology fellow in the department of pediatrics at Emory University in Atlanta.

Photo courtesy CDC/Dr. Lucille K. Georg

Sensitization to Alternaria was significantly more prevalent among children with severe vs. mild to moderate asthma (P less than .01), and children with severe presentation were significantly more likely to exhibit increased airway hyperresponsiveness (P less than .01) and to report a history of acute or chronic sinusitis requiring antibiotics (P less than .05).

"In the future, routine evaluation of Alternaria sensitization may be useful in the clinical management of children with severe asthma. Future studies are needed to evaluate the mechanistic underpinning of Alternaria sensitization in children with severe asthma," she said.

Sensitization to Alternaria has been associated in other studies with asthma persistence into early adulthood, Dr, Shih said. One study showed that Alternaria sensitization was associated with an odds ratio (OR) of 3.6 for chronic asthma at age 22 years (Lancet 2008;372:1058-64).

Increased airway hyperresponsiveness, a hallmark of severe asthma in children, was associated with Alternaria sensitization in the Childhood Asthma Management Research Program, she noted.

To see whether there were differences in Alternaria sensitization between school-age children with mild to moderate or severe asthma, and whether sensitization was associated with clinical features of asthma severity, Dr. Shih and her colleague Dr. Anne Fitzpatrick took a retrospective look at 187 children enrolled in SARP at their institution. The children ranged in age from 6 to 18 years, and all had skin prick test data available. In all, 90 had severe asthma, and 97 mild to moderate asthma.

Asthma severity was determined according to American Thoracic Society 2000 criteria, which require daily use of systemic or high-dose inhaled corticosteroids, plus at least two of the following: additional controller medication, beta-agonist use on at least 5 of 7 days, a baseline forced expiratory volume in 1 second (FEV₁)less than 80% of predicted, 1 or more emergency department visits within the past year, 3 or more oral steroid burst within the past year, prompt deterioration with steroid reduction, and/or a history of intubation(Am. J. Respir. Crit. Care Med. 2000;162:2341-51).

The investigators also reviewed asthma questionnaires, lung function–testing results, allergy evaluations, and biomarker evaluations.

In an analysis adjusted for race and socioeconomic status, they found that 37% of the children with severe asthma tested positive for Alternaria sensitization, compared with 21% of children with mild-to-moderate disease (adjusted OR 2.13, P = .015).

Among children with severe asthma, Alternaria sensitization was not significantly associated with differences in either blood eosinophil or total serum immunoglobulin E (IgE) levels, or in FEV₁, airflow limitation, air trapping, medication requirements, or health care use.

However, exhaled nitric oxide levels were significantly higher among those with severe asthma and sensitivity to Alternaria (P = .029), as was airway hyperresponsiveness to methacholine challenge (P = .012).

Additionally, in an analysis adjusted for socioeconomic status, children with severe asthma and a positive skin prick test to Alternaria had an adjusted OR for sinusitis of 2.43 (P = .046).

"These findings support previous observations from the Childhood Asthma Management Research Program," Dr. Shih said.

In the question and answer portion of her presentation, several clinicians commented that Alternaria might be a general marker for atopy rather than for airway hyperresponsiveness and sinusitis as seen in her study, and that other allergens such as cockroach and mites might account for exacerbations of severe asthma. Dr. Shih agreed that further studies would help to resolve this question.

The study was supported by the NHLBI and Emory University. Dr. Shih reported that she had no relevant disclosures.

ORLANDO – Children with severe asthma may have their already serious symptoms further worsened by sensitization to common household fungi in the genus Alternaria, suggested investigators at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Among 187 children with asthma enrolled in the National Heart, Lung and Blood Institutes’ Severe Asthma Research Program (SARP), 28% had a positive skin prick test reaction to Alternaria, reported Dr. Jennifer Shih, an allergy and immunology fellow in the department of pediatrics at Emory University in Atlanta.

Photo courtesy CDC/Dr. Lucille K. Georg

Sensitization to Alternaria was significantly more prevalent among children with severe vs. mild to moderate asthma (P less than .01), and children with severe presentation were significantly more likely to exhibit increased airway hyperresponsiveness (P less than .01) and to report a history of acute or chronic sinusitis requiring antibiotics (P less than .05).

"In the future, routine evaluation of Alternaria sensitization may be useful in the clinical management of children with severe asthma. Future studies are needed to evaluate the mechanistic underpinning of Alternaria sensitization in children with severe asthma," she said.

Sensitization to Alternaria has been associated in other studies with asthma persistence into early adulthood, Dr, Shih said. One study showed that Alternaria sensitization was associated with an odds ratio (OR) of 3.6 for chronic asthma at age 22 years (Lancet 2008;372:1058-64).

Increased airway hyperresponsiveness, a hallmark of severe asthma in children, was associated with Alternaria sensitization in the Childhood Asthma Management Research Program, she noted.

To see whether there were differences in Alternaria sensitization between school-age children with mild to moderate or severe asthma, and whether sensitization was associated with clinical features of asthma severity, Dr. Shih and her colleague Dr. Anne Fitzpatrick took a retrospective look at 187 children enrolled in SARP at their institution. The children ranged in age from 6 to 18 years, and all had skin prick test data available. In all, 90 had severe asthma, and 97 mild to moderate asthma.

Asthma severity was determined according to American Thoracic Society 2000 criteria, which require daily use of systemic or high-dose inhaled corticosteroids, plus at least two of the following: additional controller medication, beta-agonist use on at least 5 of 7 days, a baseline forced expiratory volume in 1 second (FEV₁)less than 80% of predicted, 1 or more emergency department visits within the past year, 3 or more oral steroid burst within the past year, prompt deterioration with steroid reduction, and/or a history of intubation(Am. J. Respir. Crit. Care Med. 2000;162:2341-51).

The investigators also reviewed asthma questionnaires, lung function–testing results, allergy evaluations, and biomarker evaluations.

In an analysis adjusted for race and socioeconomic status, they found that 37% of the children with severe asthma tested positive for Alternaria sensitization, compared with 21% of children with mild-to-moderate disease (adjusted OR 2.13, P = .015).

Among children with severe asthma, Alternaria sensitization was not significantly associated with differences in either blood eosinophil or total serum immunoglobulin E (IgE) levels, or in FEV₁, airflow limitation, air trapping, medication requirements, or health care use.

However, exhaled nitric oxide levels were significantly higher among those with severe asthma and sensitivity to Alternaria (P = .029), as was airway hyperresponsiveness to methacholine challenge (P = .012).

Additionally, in an analysis adjusted for socioeconomic status, children with severe asthma and a positive skin prick test to Alternaria had an adjusted OR for sinusitis of 2.43 (P = .046).

"These findings support previous observations from the Childhood Asthma Management Research Program," Dr. Shih said.

In the question and answer portion of her presentation, several clinicians commented that Alternaria might be a general marker for atopy rather than for airway hyperresponsiveness and sinusitis as seen in her study, and that other allergens such as cockroach and mites might account for exacerbations of severe asthma. Dr. Shih agreed that further studies would help to resolve this question.

The study was supported by the NHLBI and Emory University. Dr. Shih reported that she had no relevant disclosures.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

A colleague of mine recently made me aware of a resolution in the Kansas House of Representatives "requesting the Kansas Department of Health and Environment to conduct a study regarding tobacco harm reduction." This cacophonous social debate centers on the idea of recommending chewing tobacco (i.e., snuff) to cigarette smokers to reduce societal harm associated with cigarette smoking. Cigarette smoking remains the leading cause of preventable death and disability in the United States, and tobacco harm reduction (THR) has been proposed as a way to mitigate this ongoing public health disaster. One way to more clearly understand this debate is to consider it at two levels: the societal and the individual.

At the societal level, one must envision the population impact of having all smokers switch to smokeless tobacco. Smokeless tobacco is associated with fewer health risks than cigarettes, but it is not "risk free." Statistical modeling has suggested that widespread public health advocacy of this approach could result in net population harm with some smokers becoming "dual users" (i.e., smoking cigarettes and using smokeless tobacco simultaneously). Dual use of tobacco may be associated with more risk than cigarette smoking alone. THR also undermines clear indoor air policies, which are effective in reducing cigarette consumption, because it allows smokers to maintain tobacco dependence by using smokeless tobacco at times when they cannot smoke. Not surprisingly, THR is endorsed by cigarette manufacturers who now also sell smokeless tobacco. THR advocates decree that the reduction in societal adverse health consequences if all smokers switched to smokeless would be significant. The likelihood of this occurring is probably overestimated as smokeless tobacco is already widely available and very few of my smokers are electing to switch.

At the individual level, it is important that primary care providers remain cognizant of the risks associated with our clinical recommendations. Whenever we prescribe or recommend treatment, we assume responsibility for both the clinical benefits and the adverse effects, or risks. Long-term use of smokeless tobacco is associated with an increased risk for adverse cardiovascular events (i.e., stroke and myocardial infarction) and cancer. If we were to recommend that our patients switch from cigarettes to smokeless tobacco, we would necessarily be assuming the responsibility for adverse health effects associated with smokeless tobacco. Regarding the medications currently available for tobacco dependence treatment, we can stand confident with the Food and Drug Administration approval for their use and the thousands of patients who have used these medications safely. If our patients develop cancer or have a heart attack or stroke from the smokeless tobacco that we recommended to treat their smoking addiction, who do we have to blame but ourselves?

Jon O. Ebbert, M.D., is professor of medicine and primary care clinician at the Mayo Clinic in Rochester, Minn. He has received support from Pfizer, maker of varenicline (Chantix), to conduct clinical trials for smoking cessation and has received consulting fees from GlaxoSmithKline, maker of Nicorette. The opinions expressed are solely those of the author. Send him an e-mail at ebbert.jon@mayo.edu.

MIAMI BEACH – With 92 recommendations and 340 references that span 51 pages, clinical practice guidelines for management of infants and children with community-acquired pneumonia might at first seem overwhelming, but they are worth consideration, according to Dr. Mary Anne Jackson.

"Don’t be daunted about getting into it. It actually divides out pneumonia in ways that will be relevant to your particular practice," she said.

The guidelines address management of otherwise healthy children with community-acquired pneumonia (CAP) – not hospital-acquired – in both the outpatient and inpatient settings (Clin. Infect. Disease 2011;53:e25-76). "This is the first time the Pediatric Infectious Diseases Society has been asked to make pediatric-specific recommendations. This is a big step," Dr. Jackson said.

The clinical practice guidelines, developed in conjunction with the Infectious Disease Society of America, address "looking at a child with signs and symptoms and being able to predict pneumonia," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals and Clinics in Kansas City.

Nasal flaring in an infant less than 12 months, for example, had the best positive predictive value. Oxygen saturation less than 94% at sea level "is also clearly predictive," she said. Less surprising predictors include tachypnea and retractions. In contrast, absence of tachypnea or other respiratory signs had the best negative predictive value.

Also addressed within the scope of the evidence-based guidelines are site of care, use of diagnostic testing, appropriate initial anti-infective treatment, adjunctive therapy, management of a child unresponsive to therapy, appropriate discharge criteria, and prevention of community-acquired pneumonia.

"Let’s look at a little of the guidelines and see how these recommendations might influence your practice," Dr. Jackson said at a pediatric update sponsored by Miami Children’s Hospital.

Blood cultures are not necessary for the nontoxic, immunized child who is going to be managed as outpatient, for example. "The guidelines will tell you that less than 1% of the individuals who meet these guidelines will have a positive blood culture if they have been effectively immunized," said Dr. Jackson, who was not one of the 13 authors of the guidelines.

Blood cultures, however, are indicated for the infant or child who requires hospital admission or who has evidence of empyema. An estimated 14%- 27% of children with a complicated pneumonia will have a positive blood culture, she said. "This will help you decide about anti-infective therapy [and] help you provide definitive therapy."

In terms of diagnostic testing, radiography should be obtained for the child sick enough to be admitted to the hospital, for the child who is hypoxic with significant respiratory distress, for the child with an infection that is prolonged or unresponsive, and "certainly if you suspect an empyema."

Think empyema when you suspect CAP, particularly in the setting of prolonged or recurrent fever, Dr. Jackson said. Patients with empyema often report chest and abdominal pain as well. Check their medication history too, she advised. "They may have received azithromycin, which I will tell you is not a good choice for pneumococcal infection or respiratory infection in general (unless you suspect Mycoplasma pneumoniae) in the pediatric population."

The guideline authors outline scenarios where hospitalization is recommended. For example, admission is indicated for suspected bacterial pneumonia in children aged 3-6 months of age or any infant or any child who is not fully immunized, who has oxygen saturation below 90%, or who cannot comply with oral therapy.

Admission is also supported for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. "I have a very high index of suspicion in the sick infant (particularly those under 1 year of age) with bacterial pneumonia [with] MRSA as a pathogen," Dr. Jackson said.

The guidelines also outline antibiotic treatment. Treatment is generally 10 days for CAP or longer with empyema.

The previously healthy and immunized preschool age child treated as an outpatient should receive amoxicillin, the guideline authors stated. They prefer clindamycin for penicillin-allergic patients but offer alternative options. "You should check your antibiogram in your own institution so you know what your clindamycin resistance rates are for pneumococcus," Dr. Jackson said.

In the inpatient setting, an immunized infant or child with CAP can be treated with ampicillin or penicillin G. "Once again, you must know what your local rates of penicillin resistance are in your institution," she said.

Empiric therapy with a third generation parenteral cephalosporin such as ceftriaxone or cefotaxime is recommended for hospitalized infants and children who are not fully immunized in regions with a higher penicillin resistance rate or for children with a life-threatening infection. "I will tell you in those instances you are going to have a higher risk of staphylococcal infection, and ceftriaxone and cefotaxime lack staphylococcal coverage," Dr. Jackson said. "So you’re going to have to broaden your coverage for those patients."

The guideline authors also address prevention of CAP. "Prevention is all about relying on our classic American Academy of Pediatrics policies: who should get palivizumab (Synagis), endorsing immunization of parents and other caregivers, and making sure vaccines are given appropriately to the infant or child," Dr. Jackson said.

The American Academy of Pediatrics endorsed these CAP clinical practice guidelines (Pediatrics 2011;128:e1677).

Dr. Jackson disclosed she is a member of the American Academy of Pediatrics Committee on Infectious Diseases, secretary-treasurer of the Pediatric Infectious Diseases Society, and a member of the Infectious Diseases Society of America Education Committee. She reported that she had no relevant financial disclosures.

MIAMI BEACH – With 92 recommendations and 340 references that span 51 pages, clinical practice guidelines for management of infants and children with community-acquired pneumonia might at first seem overwhelming, but they are worth consideration, according to Dr. Mary Anne Jackson.

"Don’t be daunted about getting into it. It actually divides out pneumonia in ways that will be relevant to your particular practice," she said.

The guidelines address management of otherwise healthy children with community-acquired pneumonia (CAP) – not hospital-acquired – in both the outpatient and inpatient settings (Clin. Infect. Disease 2011;53:e25-76). "This is the first time the Pediatric Infectious Diseases Society has been asked to make pediatric-specific recommendations. This is a big step," Dr. Jackson said.

The clinical practice guidelines, developed in conjunction with the Infectious Disease Society of America, address "looking at a child with signs and symptoms and being able to predict pneumonia," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals and Clinics in Kansas City.

Nasal flaring in an infant less than 12 months, for example, had the best positive predictive value. Oxygen saturation less than 94% at sea level "is also clearly predictive," she said. Less surprising predictors include tachypnea and retractions. In contrast, absence of tachypnea or other respiratory signs had the best negative predictive value.

Also addressed within the scope of the evidence-based guidelines are site of care, use of diagnostic testing, appropriate initial anti-infective treatment, adjunctive therapy, management of a child unresponsive to therapy, appropriate discharge criteria, and prevention of community-acquired pneumonia.

"Let’s look at a little of the guidelines and see how these recommendations might influence your practice," Dr. Jackson said at a pediatric update sponsored by Miami Children’s Hospital.

Blood cultures are not necessary for the nontoxic, immunized child who is going to be managed as outpatient, for example. "The guidelines will tell you that less than 1% of the individuals who meet these guidelines will have a positive blood culture if they have been effectively immunized," said Dr. Jackson, who was not one of the 13 authors of the guidelines.

Blood cultures, however, are indicated for the infant or child who requires hospital admission or who has evidence of empyema. An estimated 14%- 27% of children with a complicated pneumonia will have a positive blood culture, she said. "This will help you decide about anti-infective therapy [and] help you provide definitive therapy."

In terms of diagnostic testing, radiography should be obtained for the child sick enough to be admitted to the hospital, for the child who is hypoxic with significant respiratory distress, for the child with an infection that is prolonged or unresponsive, and "certainly if you suspect an empyema."

Think empyema when you suspect CAP, particularly in the setting of prolonged or recurrent fever, Dr. Jackson said. Patients with empyema often report chest and abdominal pain as well. Check their medication history too, she advised. "They may have received azithromycin, which I will tell you is not a good choice for pneumococcal infection or respiratory infection in general (unless you suspect Mycoplasma pneumoniae) in the pediatric population."

The guideline authors outline scenarios where hospitalization is recommended. For example, admission is indicated for suspected bacterial pneumonia in children aged 3-6 months of age or any infant or any child who is not fully immunized, who has oxygen saturation below 90%, or who cannot comply with oral therapy.

Admission is also supported for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. "I have a very high index of suspicion in the sick infant (particularly those under 1 year of age) with bacterial pneumonia [with] MRSA as a pathogen," Dr. Jackson said.

The guidelines also outline antibiotic treatment. Treatment is generally 10 days for CAP or longer with empyema.

The previously healthy and immunized preschool age child treated as an outpatient should receive amoxicillin, the guideline authors stated. They prefer clindamycin for penicillin-allergic patients but offer alternative options. "You should check your antibiogram in your own institution so you know what your clindamycin resistance rates are for pneumococcus," Dr. Jackson said.

In the inpatient setting, an immunized infant or child with CAP can be treated with ampicillin or penicillin G. "Once again, you must know what your local rates of penicillin resistance are in your institution," she said.

Empiric therapy with a third generation parenteral cephalosporin such as ceftriaxone or cefotaxime is recommended for hospitalized infants and children who are not fully immunized in regions with a higher penicillin resistance rate or for children with a life-threatening infection. "I will tell you in those instances you are going to have a higher risk of staphylococcal infection, and ceftriaxone and cefotaxime lack staphylococcal coverage," Dr. Jackson said. "So you’re going to have to broaden your coverage for those patients."

The guideline authors also address prevention of CAP. "Prevention is all about relying on our classic American Academy of Pediatrics policies: who should get palivizumab (Synagis), endorsing immunization of parents and other caregivers, and making sure vaccines are given appropriately to the infant or child," Dr. Jackson said.

The American Academy of Pediatrics endorsed these CAP clinical practice guidelines (Pediatrics 2011;128:e1677).

Dr. Jackson disclosed she is a member of the American Academy of Pediatrics Committee on Infectious Diseases, secretary-treasurer of the Pediatric Infectious Diseases Society, and a member of the Infectious Diseases Society of America Education Committee. She reported that she had no relevant financial disclosures.

MIAMI BEACH – With 92 recommendations and 340 references that span 51 pages, clinical practice guidelines for management of infants and children with community-acquired pneumonia might at first seem overwhelming, but they are worth consideration, according to Dr. Mary Anne Jackson.

"Don’t be daunted about getting into it. It actually divides out pneumonia in ways that will be relevant to your particular practice," she said.

The guidelines address management of otherwise healthy children with community-acquired pneumonia (CAP) – not hospital-acquired – in both the outpatient and inpatient settings (Clin. Infect. Disease 2011;53:e25-76). "This is the first time the Pediatric Infectious Diseases Society has been asked to make pediatric-specific recommendations. This is a big step," Dr. Jackson said.

The clinical practice guidelines, developed in conjunction with the Infectious Disease Society of America, address "looking at a child with signs and symptoms and being able to predict pneumonia," said Dr. Jackson, chief of the pediatric infectious diseases section at Children’s Mercy Hospitals and Clinics in Kansas City.

Nasal flaring in an infant less than 12 months, for example, had the best positive predictive value. Oxygen saturation less than 94% at sea level "is also clearly predictive," she said. Less surprising predictors include tachypnea and retractions. In contrast, absence of tachypnea or other respiratory signs had the best negative predictive value.

Also addressed within the scope of the evidence-based guidelines are site of care, use of diagnostic testing, appropriate initial anti-infective treatment, adjunctive therapy, management of a child unresponsive to therapy, appropriate discharge criteria, and prevention of community-acquired pneumonia.

"Let’s look at a little of the guidelines and see how these recommendations might influence your practice," Dr. Jackson said at a pediatric update sponsored by Miami Children’s Hospital.

Blood cultures are not necessary for the nontoxic, immunized child who is going to be managed as outpatient, for example. "The guidelines will tell you that less than 1% of the individuals who meet these guidelines will have a positive blood culture if they have been effectively immunized," said Dr. Jackson, who was not one of the 13 authors of the guidelines.

Blood cultures, however, are indicated for the infant or child who requires hospital admission or who has evidence of empyema. An estimated 14%- 27% of children with a complicated pneumonia will have a positive blood culture, she said. "This will help you decide about anti-infective therapy [and] help you provide definitive therapy."

In terms of diagnostic testing, radiography should be obtained for the child sick enough to be admitted to the hospital, for the child who is hypoxic with significant respiratory distress, for the child with an infection that is prolonged or unresponsive, and "certainly if you suspect an empyema."

Think empyema when you suspect CAP, particularly in the setting of prolonged or recurrent fever, Dr. Jackson said. Patients with empyema often report chest and abdominal pain as well. Check their medication history too, she advised. "They may have received azithromycin, which I will tell you is not a good choice for pneumococcal infection or respiratory infection in general (unless you suspect Mycoplasma pneumoniae) in the pediatric population."

The guideline authors outline scenarios where hospitalization is recommended. For example, admission is indicated for suspected bacterial pneumonia in children aged 3-6 months of age or any infant or any child who is not fully immunized, who has oxygen saturation below 90%, or who cannot comply with oral therapy.

Admission is also supported for suspected methicillin-resistant Staphylococcus aureus (MRSA) infection. "I have a very high index of suspicion in the sick infant (particularly those under 1 year of age) with bacterial pneumonia [with] MRSA as a pathogen," Dr. Jackson said.

The guidelines also outline antibiotic treatment. Treatment is generally 10 days for CAP or longer with empyema.

The previously healthy and immunized preschool age child treated as an outpatient should receive amoxicillin, the guideline authors stated. They prefer clindamycin for penicillin-allergic patients but offer alternative options. "You should check your antibiogram in your own institution so you know what your clindamycin resistance rates are for pneumococcus," Dr. Jackson said.

In the inpatient setting, an immunized infant or child with CAP can be treated with ampicillin or penicillin G. "Once again, you must know what your local rates of penicillin resistance are in your institution," she said.

Empiric therapy with a third generation parenteral cephalosporin such as ceftriaxone or cefotaxime is recommended for hospitalized infants and children who are not fully immunized in regions with a higher penicillin resistance rate or for children with a life-threatening infection. "I will tell you in those instances you are going to have a higher risk of staphylococcal infection, and ceftriaxone and cefotaxime lack staphylococcal coverage," Dr. Jackson said. "So you’re going to have to broaden your coverage for those patients."

The guideline authors also address prevention of CAP. "Prevention is all about relying on our classic American Academy of Pediatrics policies: who should get palivizumab (Synagis), endorsing immunization of parents and other caregivers, and making sure vaccines are given appropriately to the infant or child," Dr. Jackson said.

The American Academy of Pediatrics endorsed these CAP clinical practice guidelines (Pediatrics 2011;128:e1677).

Dr. Jackson disclosed she is a member of the American Academy of Pediatrics Committee on Infectious Diseases, secretary-treasurer of the Pediatric Infectious Diseases Society, and a member of the Infectious Diseases Society of America Education Committee. She reported that she had no relevant financial disclosures.

DENVER – Low-dose adjunctive benzodiazepines are effective in combination with opioids for dyspnea in palliative care patients who don’t respond to opioids alone, according to Dr. Patama Gomutbutra.

When opioids alone aren’t bringing significant improvement, adding a benzodiazepine is worthwhile, she said. The question of whether benzodiazepines alone are effective in the management of dyspnea must await answers from randomized clinical trials.

Dr. Gomutbutra conducted a retrospective chart review of 303 inpatients with dyspnea evaluated by members of the University of California, San Francisco, palliative care program. These were seriously ill patients: Twenty-three percent had primary lung cancer, 32% had cancer outside the lung, 12% had heart failure, and 7% had chronic obstructive pulmonary disease. Of these patients, 47% died in the hospital and 25% were discharged to hospice.

At baseline, physicians rated dyspnea as severe in 19% of patients, moderate in 28%, and mild in 53%. At baseline, 49% of patients were already on opioids at a median dose of 52 mg/day; 87% of these patients remained on opioids at 24 hours, with a bump up in dose to a median of 60 mg/day. Of the patients not initially taking an opioid, 41% were placed on the medication at a median dose of 22 mg/day.

"Our results should not dissuade people from using opioids as the first-line treatment."

At baseline, 17% of patients were on a benzodiazepine at a median dose of 1 mg/day of oral lorazepam or its equivalent. At 24 hours, 24% of patients were on a benzodiazepine, again at a median daily dose of 1 mg.

At follow-up 24 hours after adjustment of dosages or addition of an opioid or a benzodiazepine, the population with severe dyspnea had fallen from 19% to 4%. Dyspnea was rated moderate in 18% and mild in 44%, and was absent in 34%.

Overall, 57% of patients had a clinically meaningful improvement in dyspnea of one severity grade or more, 37% remained the same, and the rest became worse, according to Dr. Gomutbutra of Chiang Mai (Thailand) University.

Taking an opioid and a benzodiazepine at follow-up was independently associated with a 2.1-fold increased likelihood of significant improvement in dyspnea. Having moderate or severe dyspnea at baseline was associated with 4.1- and 4.5-fold increased likelihoods of improvement, respectively.

Surprisingly, being on an opioid at baseline wasn’t associated with significant improvement at follow-up, even though opioids are guideline-recommended therapy for dyspnea.

Dr. Gomutbutra cautioned against overinterpretation of this finding, given that her study was retrospective and thus vulnerable to confounding. For example, she noted, the respiratory rate typically slows near death, so affected patients may not have received continued or increased doses of opioids.

"Our results should not dissuade people from using opioids as the first-line treatment," Dr. Gomutbutra emphasized.

Dr. Gomutbutra carried out this study after observing big differences in how dyspnea is managed in palliative care settings in the United States, compared with Thailand. While the median daily dose of opioids at baseline in the San Francisco study was 52 mg/day, a typical dose in Thailand would be 6 mg/day. And benzodiazepines are far more widely used in treating dyspnea there, she added.

She reported having no financial conflicts.

DENVER – Low-dose adjunctive benzodiazepines are effective in combination with opioids for dyspnea in palliative care patients who don’t respond to opioids alone, according to Dr. Patama Gomutbutra.

When opioids alone aren’t bringing significant improvement, adding a benzodiazepine is worthwhile, she said. The question of whether benzodiazepines alone are effective in the management of dyspnea must await answers from randomized clinical trials.

Dr. Gomutbutra conducted a retrospective chart review of 303 inpatients with dyspnea evaluated by members of the University of California, San Francisco, palliative care program. These were seriously ill patients: Twenty-three percent had primary lung cancer, 32% had cancer outside the lung, 12% had heart failure, and 7% had chronic obstructive pulmonary disease. Of these patients, 47% died in the hospital and 25% were discharged to hospice.

At baseline, physicians rated dyspnea as severe in 19% of patients, moderate in 28%, and mild in 53%. At baseline, 49% of patients were already on opioids at a median dose of 52 mg/day; 87% of these patients remained on opioids at 24 hours, with a bump up in dose to a median of 60 mg/day. Of the patients not initially taking an opioid, 41% were placed on the medication at a median dose of 22 mg/day.

"Our results should not dissuade people from using opioids as the first-line treatment."

At baseline, 17% of patients were on a benzodiazepine at a median dose of 1 mg/day of oral lorazepam or its equivalent. At 24 hours, 24% of patients were on a benzodiazepine, again at a median daily dose of 1 mg.

At follow-up 24 hours after adjustment of dosages or addition of an opioid or a benzodiazepine, the population with severe dyspnea had fallen from 19% to 4%. Dyspnea was rated moderate in 18% and mild in 44%, and was absent in 34%.

Overall, 57% of patients had a clinically meaningful improvement in dyspnea of one severity grade or more, 37% remained the same, and the rest became worse, according to Dr. Gomutbutra of Chiang Mai (Thailand) University.

Taking an opioid and a benzodiazepine at follow-up was independently associated with a 2.1-fold increased likelihood of significant improvement in dyspnea. Having moderate or severe dyspnea at baseline was associated with 4.1- and 4.5-fold increased likelihoods of improvement, respectively.

Surprisingly, being on an opioid at baseline wasn’t associated with significant improvement at follow-up, even though opioids are guideline-recommended therapy for dyspnea.

Dr. Gomutbutra cautioned against overinterpretation of this finding, given that her study was retrospective and thus vulnerable to confounding. For example, she noted, the respiratory rate typically slows near death, so affected patients may not have received continued or increased doses of opioids.

"Our results should not dissuade people from using opioids as the first-line treatment," Dr. Gomutbutra emphasized.

Dr. Gomutbutra carried out this study after observing big differences in how dyspnea is managed in palliative care settings in the United States, compared with Thailand. While the median daily dose of opioids at baseline in the San Francisco study was 52 mg/day, a typical dose in Thailand would be 6 mg/day. And benzodiazepines are far more widely used in treating dyspnea there, she added.

She reported having no financial conflicts.

DENVER – Low-dose adjunctive benzodiazepines are effective in combination with opioids for dyspnea in palliative care patients who don’t respond to opioids alone, according to Dr. Patama Gomutbutra.

When opioids alone aren’t bringing significant improvement, adding a benzodiazepine is worthwhile, she said. The question of whether benzodiazepines alone are effective in the management of dyspnea must await answers from randomized clinical trials.

Dr. Gomutbutra conducted a retrospective chart review of 303 inpatients with dyspnea evaluated by members of the University of California, San Francisco, palliative care program. These were seriously ill patients: Twenty-three percent had primary lung cancer, 32% had cancer outside the lung, 12% had heart failure, and 7% had chronic obstructive pulmonary disease. Of these patients, 47% died in the hospital and 25% were discharged to hospice.

At baseline, physicians rated dyspnea as severe in 19% of patients, moderate in 28%, and mild in 53%. At baseline, 49% of patients were already on opioids at a median dose of 52 mg/day; 87% of these patients remained on opioids at 24 hours, with a bump up in dose to a median of 60 mg/day. Of the patients not initially taking an opioid, 41% were placed on the medication at a median dose of 22 mg/day.

"Our results should not dissuade people from using opioids as the first-line treatment."

At baseline, 17% of patients were on a benzodiazepine at a median dose of 1 mg/day of oral lorazepam or its equivalent. At 24 hours, 24% of patients were on a benzodiazepine, again at a median daily dose of 1 mg.

At follow-up 24 hours after adjustment of dosages or addition of an opioid or a benzodiazepine, the population with severe dyspnea had fallen from 19% to 4%. Dyspnea was rated moderate in 18% and mild in 44%, and was absent in 34%.

Overall, 57% of patients had a clinically meaningful improvement in dyspnea of one severity grade or more, 37% remained the same, and the rest became worse, according to Dr. Gomutbutra of Chiang Mai (Thailand) University.

Taking an opioid and a benzodiazepine at follow-up was independently associated with a 2.1-fold increased likelihood of significant improvement in dyspnea. Having moderate or severe dyspnea at baseline was associated with 4.1- and 4.5-fold increased likelihoods of improvement, respectively.

Surprisingly, being on an opioid at baseline wasn’t associated with significant improvement at follow-up, even though opioids are guideline-recommended therapy for dyspnea.

Dr. Gomutbutra cautioned against overinterpretation of this finding, given that her study was retrospective and thus vulnerable to confounding. For example, she noted, the respiratory rate typically slows near death, so affected patients may not have received continued or increased doses of opioids.

"Our results should not dissuade people from using opioids as the first-line treatment," Dr. Gomutbutra emphasized.

Dr. Gomutbutra carried out this study after observing big differences in how dyspnea is managed in palliative care settings in the United States, compared with Thailand. While the median daily dose of opioids at baseline in the San Francisco study was 52 mg/day, a typical dose in Thailand would be 6 mg/day. And benzodiazepines are far more widely used in treating dyspnea there, she added.

She reported having no financial conflicts.

MIAMI BEACH – An internist and an orthopedic surgery recently squared off on the best strategy to prevent deep vein thrombosis following major joint-replacement surgery.

Anticoagulant agents effectively prevent deep vein thrombosis (DVT) after total hip replacement or total knee replacement, according to a large body of scientific studies, the internist argued. In contrast to the well studied, relatively small number of anticoagulants, the myriad of mechanical devices are supported by more limited, less rigorous research in the medical literature, Dr. James D. Douketis said at a meeting on perioperative medicine sponsored by the University of Miami.

The risk of major or clinically relevant bleeding associated with anticoagulant use can be minimized with appropriate administration, such as waiting at least 12 hours after surgery to start therapy, said Dr. Douketis, director of the vascular medicine program at St. Joseph’s Healthcare in Hamilton, Ont.

"I agree that the bleeding risk is relatively low if these drugs are used properly, but why do you have to take any risk?" orthopedic surgeon Dr. Clifford W. Colwell Jr. asked at the meeting.

Most bleeding episodes, when they do occur, are easy to mitigate, Dr. Douketis said. Unlike DVTs, most of these events do not have long-term consequences, he said. In addition, mechanical methods are not always benign. There are reports of trauma associated with use of intermittent compression devices, for example.

Dr. Colwell countered that a zero risk of an adverse bleeding event is one of the main benefits of mechanical devices to prevent DVT. For this reason, these devices are ideal for patients at a high risk for bleeding who cannot take anticoagulants, he said. Enhancement of the effectiveness of drug-based thromboprophylaxis and reduced leg swelling are other potential benefits of these devices.

The effectiveness of mechanical compression devices is directly correlated with how much time they are worn and these devices are nearly complication free, said Dr. Colwell, medical director at the Shiley Center for Orthopaedic Research and Education at Scripps Clinic in La Jolla, Calif.

But why can’t these devices be more portable? The ActiveCare+S.F.T. Portable Intermittent Compression Device, or PICD (Medical Compression Systems Ltd.), is a miniature, battery-powered device that overcomes a major limitation of some mechanical devices: Their design and size can impede ambulation after surgery. The PICD can be worn out of bed and out of the hospital, Dr. Colwell said. It synchronizes compression with the patient’s respiratory phase so it provides a naturalistic phasic venous flow.

An initial study of its efficacy in 121 patients "was small ... I was not convinced," Dr. Colwell said (J. Arthroplasty 2006;21;206-14). A more recent multicenter, prospective study that Dr. Colwell performed with his associates compared effectiveness of the portable device to low-molecular-weight heparin for 10 days for total hip arthroplasties and was more compelling (J. Bone Joint Surg. Am. 2010:92:527-35).

At 3 months, the DVT rate was "essentially the same" at 4.1% in the device group compared with 4.2% in the anticoagulant cohort. There was no fatal PE or any deaths among the 410 randomized participants. In addition, major bleeding occurred for 0% of the device wearers and 5.6% of the pharmacologically treated patients.

"I acknowledge that mechanical prophylaxis has a role after major orthopedic surgery major, but it’s a second-line strategy," said Dr. Douketis, who also is on the medicine faculty at McMaster University. Pharmacologic prophylaxis should be first-line therapy because it has been shown to prevent DVT, and pulmonary embolism (PE), including fatal PE, he said.

A meta-analysis Dr. Douketis performed with his colleagues showed extended duration prophylaxis with heparin or warfarin significantly decreased the frequency of symptomatic venous thromboembolism, compared with placebo after total hip or knee replacement (Lancet 2001;358:9-15).

There is less confidence about prevention of proximal DVTs with mechanical devices, Dr. Douketis said.

The risks should be weighed against this efficacy, Dr. Douketis said. In a study, researchers determined the risk of major or clinically-relevant bleeding was 4% of 1,501 patients treated with apixaban and 5% of 1,508 patients treated with enoxaparin (Lancet 2010;375:807-15).

American College of Chest Physician (ACCP) guidelines recommend use of low-molecular weight heparin to prevent DVT in these surgical populations but list a number of other pharmacologic prophylaxis options (supported by grade 2C/2B evidence). They also recommend addition of an intermittent pneumatic compressive device during the hospital stay of patients taking anticoagulants, but supported by grade 2C evidence. The authors also recommend one of these devices or no prophylaxis for patients at increased bleeding risk (again, grade 2C evidence). The full recommendations were published in February (Chest 2012;141:e278S-325S).

Dr. Colwell said patient compliance is monitored by and clearly reported on the screen of the PICD. Compliance with wearing the device was 86% in an unpublished study that included 3,060 total hip and total knee surgery patients. These patients wore the device a mean of 20 hr/day.

Dr. Douketis remained unconvinced about the PICD and said he preferred to withhold judgment until more studies are completed. "We are much more confident with anticoagulants than mechanical strategies."

Dr. Colwell said the new PICD is akin to an iPhone. "You don’t need 30 years of experience to know it’s a good product."

Dr. Douketis disclosed that he is a consultant for AGEN, Ortho-Janssen, Boehringer Ingelheim, Pfizer, and Bristol-Myers Squibb. He also receives indirect payment as part of the event adjudication and advisory board for Sanofi Aventis, Bayer, Bristol-Myers Squibb, Astra Zeneca, and Boehringer Ingelheim. Dr. Colwell disclosed that he is a consultant for and receives research grants from Medical Compression Systems Inc.

MIAMI BEACH – An internist and an orthopedic surgery recently squared off on the best strategy to prevent deep vein thrombosis following major joint-replacement surgery.

Anticoagulant agents effectively prevent deep vein thrombosis (DVT) after total hip replacement or total knee replacement, according to a large body of scientific studies, the internist argued. In contrast to the well studied, relatively small number of anticoagulants, the myriad of mechanical devices are supported by more limited, less rigorous research in the medical literature, Dr. James D. Douketis said at a meeting on perioperative medicine sponsored by the University of Miami.

The risk of major or clinically relevant bleeding associated with anticoagulant use can be minimized with appropriate administration, such as waiting at least 12 hours after surgery to start therapy, said Dr. Douketis, director of the vascular medicine program at St. Joseph’s Healthcare in Hamilton, Ont.

"I agree that the bleeding risk is relatively low if these drugs are used properly, but why do you have to take any risk?" orthopedic surgeon Dr. Clifford W. Colwell Jr. asked at the meeting.

Most bleeding episodes, when they do occur, are easy to mitigate, Dr. Douketis said. Unlike DVTs, most of these events do not have long-term consequences, he said. In addition, mechanical methods are not always benign. There are reports of trauma associated with use of intermittent compression devices, for example.

Dr. Colwell countered that a zero risk of an adverse bleeding event is one of the main benefits of mechanical devices to prevent DVT. For this reason, these devices are ideal for patients at a high risk for bleeding who cannot take anticoagulants, he said. Enhancement of the effectiveness of drug-based thromboprophylaxis and reduced leg swelling are other potential benefits of these devices.

The effectiveness of mechanical compression devices is directly correlated with how much time they are worn and these devices are nearly complication free, said Dr. Colwell, medical director at the Shiley Center for Orthopaedic Research and Education at Scripps Clinic in La Jolla, Calif.

But why can’t these devices be more portable? The ActiveCare+S.F.T. Portable Intermittent Compression Device, or PICD (Medical Compression Systems Ltd.), is a miniature, battery-powered device that overcomes a major limitation of some mechanical devices: Their design and size can impede ambulation after surgery. The PICD can be worn out of bed and out of the hospital, Dr. Colwell said. It synchronizes compression with the patient’s respiratory phase so it provides a naturalistic phasic venous flow.

An initial study of its efficacy in 121 patients "was small ... I was not convinced," Dr. Colwell said (J. Arthroplasty 2006;21;206-14). A more recent multicenter, prospective study that Dr. Colwell performed with his associates compared effectiveness of the portable device to low-molecular-weight heparin for 10 days for total hip arthroplasties and was more compelling (J. Bone Joint Surg. Am. 2010:92:527-35).

At 3 months, the DVT rate was "essentially the same" at 4.1% in the device group compared with 4.2% in the anticoagulant cohort. There was no fatal PE or any deaths among the 410 randomized participants. In addition, major bleeding occurred for 0% of the device wearers and 5.6% of the pharmacologically treated patients.

"I acknowledge that mechanical prophylaxis has a role after major orthopedic surgery major, but it’s a second-line strategy," said Dr. Douketis, who also is on the medicine faculty at McMaster University. Pharmacologic prophylaxis should be first-line therapy because it has been shown to prevent DVT, and pulmonary embolism (PE), including fatal PE, he said.

A meta-analysis Dr. Douketis performed with his colleagues showed extended duration prophylaxis with heparin or warfarin significantly decreased the frequency of symptomatic venous thromboembolism, compared with placebo after total hip or knee replacement (Lancet 2001;358:9-15).

There is less confidence about prevention of proximal DVTs with mechanical devices, Dr. Douketis said.

The risks should be weighed against this efficacy, Dr. Douketis said. In a study, researchers determined the risk of major or clinically-relevant bleeding was 4% of 1,501 patients treated with apixaban and 5% of 1,508 patients treated with enoxaparin (Lancet 2010;375:807-15).

American College of Chest Physician (ACCP) guidelines recommend use of low-molecular weight heparin to prevent DVT in these surgical populations but list a number of other pharmacologic prophylaxis options (supported by grade 2C/2B evidence). They also recommend addition of an intermittent pneumatic compressive device during the hospital stay of patients taking anticoagulants, but supported by grade 2C evidence. The authors also recommend one of these devices or no prophylaxis for patients at increased bleeding risk (again, grade 2C evidence). The full recommendations were published in February (Chest 2012;141:e278S-325S).

Dr. Colwell said patient compliance is monitored by and clearly reported on the screen of the PICD. Compliance with wearing the device was 86% in an unpublished study that included 3,060 total hip and total knee surgery patients. These patients wore the device a mean of 20 hr/day.

Dr. Douketis remained unconvinced about the PICD and said he preferred to withhold judgment until more studies are completed. "We are much more confident with anticoagulants than mechanical strategies."

Dr. Colwell said the new PICD is akin to an iPhone. "You don’t need 30 years of experience to know it’s a good product."

Dr. Douketis disclosed that he is a consultant for AGEN, Ortho-Janssen, Boehringer Ingelheim, Pfizer, and Bristol-Myers Squibb. He also receives indirect payment as part of the event adjudication and advisory board for Sanofi Aventis, Bayer, Bristol-Myers Squibb, Astra Zeneca, and Boehringer Ingelheim. Dr. Colwell disclosed that he is a consultant for and receives research grants from Medical Compression Systems Inc.

MIAMI BEACH – An internist and an orthopedic surgery recently squared off on the best strategy to prevent deep vein thrombosis following major joint-replacement surgery.

Anticoagulant agents effectively prevent deep vein thrombosis (DVT) after total hip replacement or total knee replacement, according to a large body of scientific studies, the internist argued. In contrast to the well studied, relatively small number of anticoagulants, the myriad of mechanical devices are supported by more limited, less rigorous research in the medical literature, Dr. James D. Douketis said at a meeting on perioperative medicine sponsored by the University of Miami.

The risk of major or clinically relevant bleeding associated with anticoagulant use can be minimized with appropriate administration, such as waiting at least 12 hours after surgery to start therapy, said Dr. Douketis, director of the vascular medicine program at St. Joseph’s Healthcare in Hamilton, Ont.

"I agree that the bleeding risk is relatively low if these drugs are used properly, but why do you have to take any risk?" orthopedic surgeon Dr. Clifford W. Colwell Jr. asked at the meeting.

Most bleeding episodes, when they do occur, are easy to mitigate, Dr. Douketis said. Unlike DVTs, most of these events do not have long-term consequences, he said. In addition, mechanical methods are not always benign. There are reports of trauma associated with use of intermittent compression devices, for example.

Dr. Colwell countered that a zero risk of an adverse bleeding event is one of the main benefits of mechanical devices to prevent DVT. For this reason, these devices are ideal for patients at a high risk for bleeding who cannot take anticoagulants, he said. Enhancement of the effectiveness of drug-based thromboprophylaxis and reduced leg swelling are other potential benefits of these devices.

The effectiveness of mechanical compression devices is directly correlated with how much time they are worn and these devices are nearly complication free, said Dr. Colwell, medical director at the Shiley Center for Orthopaedic Research and Education at Scripps Clinic in La Jolla, Calif.

But why can’t these devices be more portable? The ActiveCare+S.F.T. Portable Intermittent Compression Device, or PICD (Medical Compression Systems Ltd.), is a miniature, battery-powered device that overcomes a major limitation of some mechanical devices: Their design and size can impede ambulation after surgery. The PICD can be worn out of bed and out of the hospital, Dr. Colwell said. It synchronizes compression with the patient’s respiratory phase so it provides a naturalistic phasic venous flow.

An initial study of its efficacy in 121 patients "was small ... I was not convinced," Dr. Colwell said (J. Arthroplasty 2006;21;206-14). A more recent multicenter, prospective study that Dr. Colwell performed with his associates compared effectiveness of the portable device to low-molecular-weight heparin for 10 days for total hip arthroplasties and was more compelling (J. Bone Joint Surg. Am. 2010:92:527-35).

At 3 months, the DVT rate was "essentially the same" at 4.1% in the device group compared with 4.2% in the anticoagulant cohort. There was no fatal PE or any deaths among the 410 randomized participants. In addition, major bleeding occurred for 0% of the device wearers and 5.6% of the pharmacologically treated patients.

"I acknowledge that mechanical prophylaxis has a role after major orthopedic surgery major, but it’s a second-line strategy," said Dr. Douketis, who also is on the medicine faculty at McMaster University. Pharmacologic prophylaxis should be first-line therapy because it has been shown to prevent DVT, and pulmonary embolism (PE), including fatal PE, he said.

A meta-analysis Dr. Douketis performed with his colleagues showed extended duration prophylaxis with heparin or warfarin significantly decreased the frequency of symptomatic venous thromboembolism, compared with placebo after total hip or knee replacement (Lancet 2001;358:9-15).

There is less confidence about prevention of proximal DVTs with mechanical devices, Dr. Douketis said.

The risks should be weighed against this efficacy, Dr. Douketis said. In a study, researchers determined the risk of major or clinically-relevant bleeding was 4% of 1,501 patients treated with apixaban and 5% of 1,508 patients treated with enoxaparin (Lancet 2010;375:807-15).

American College of Chest Physician (ACCP) guidelines recommend use of low-molecular weight heparin to prevent DVT in these surgical populations but list a number of other pharmacologic prophylaxis options (supported by grade 2C/2B evidence). They also recommend addition of an intermittent pneumatic compressive device during the hospital stay of patients taking anticoagulants, but supported by grade 2C evidence. The authors also recommend one of these devices or no prophylaxis for patients at increased bleeding risk (again, grade 2C evidence). The full recommendations were published in February (Chest 2012;141:e278S-325S).

Dr. Colwell said patient compliance is monitored by and clearly reported on the screen of the PICD. Compliance with wearing the device was 86% in an unpublished study that included 3,060 total hip and total knee surgery patients. These patients wore the device a mean of 20 hr/day.

Dr. Douketis remained unconvinced about the PICD and said he preferred to withhold judgment until more studies are completed. "We are much more confident with anticoagulants than mechanical strategies."

Dr. Colwell said the new PICD is akin to an iPhone. "You don’t need 30 years of experience to know it’s a good product."

Dr. Douketis disclosed that he is a consultant for AGEN, Ortho-Janssen, Boehringer Ingelheim, Pfizer, and Bristol-Myers Squibb. He also receives indirect payment as part of the event adjudication and advisory board for Sanofi Aventis, Bayer, Bristol-Myers Squibb, Astra Zeneca, and Boehringer Ingelheim. Dr. Colwell disclosed that he is a consultant for and receives research grants from Medical Compression Systems Inc.

ATLANTA – A large proportion of children apparently are not receiving the 13-valent pneumococcal conjugate vaccine as recommended by the Advisory Committee on Immunization Practices, surveillance data from the Centers for Disease Control and Prevention suggest.

According to the data from an ongoing evaluation of PCV13 vaccine effectiveness, 86 (78%) vaccine-eligible children out of 110 diagnosed with invasive pneumococcal disease secondary to serotypes unique to PCV13 in the year after the vaccine was introduced had not received the dosing recommended by the Advisory Committee on Immunization Practices (ACIP), Dr. Chad M. Cox reported at the International Conference on Emerging Infectious Diseases.

The ACIP recommendations, published March 12, 2010, call for the same dosing schedule used for PCV7 (immunizations at ages 2, 4, and 6 months, with a booster dose at age 12-15 months). ACIP also called for a single supplemental dose of PCV13 in all children aged 14-59 months who previously received an age-appropriate series of PCV7, and for use of PCV13 for the fourth dose in those who had received only three of the four previously recommended doses of PCV7.

PCV13 includes six additional serotypes not included in PCV7, which was introduced in 2000 using the seven most commonly circulating serotypes.

After the introduction of PCV7, a sharp decrease occurred in disease caused by these seven serotypes, but in more recent years an increase was seen in disease caused by serotypes not covered by PC7. Because of the emergence of this "replacement disease," PCV13 was introduced, Dr. Cox explained.

"The [PCV13] vaccine was readily available soon after [the March 2010 ACIP recommendations], and quickly replaced PCV7 in most provider’s offices," said Dr. Cox of the CDC in Atlanta.

Nonetheless, in June 2011 the California Department of Health reported a fatal case of invasive pneumococcal disease in a 2-year-old, which was caused by a serotype in the PCV13 vaccine; 30 additional cases were identified in counties not included in the CDC surveillance area.

This led to a health advisory issued in August 2011 – reminding providers of the ACIP recommendations – and to this study of outcomes in 10 participating surveillance areas representing 3.8 million children under age 5 years.

The hospitalized children in this study included those from the surveillance areas for whom complete vaccination information was available. About two-thirds were aged 2-4 years, Dr. Cox said.

About two-thirds of patients in the study were noncompliant because they had not received a supplemental PCV13 dose after completion of the PCV7 series, and about one-fifth had not received the fourth dose in the series, which should have been a PCV13 dose, he noted.

The majority of the children (93%) had no underlying medical conditions, and 79% were hospitalized. No deaths occurred.

These findings demonstrate that invasive pneumococcal disease resulting from pneumococcal serotyopes unique to PCV13 continued to occur in those who did not receive the recommended dose of PCV13 in the year after it became available, Dr. Cox said.

Prevention of invasive pneumococcal disease requires that a single supplemental dose of PCV13 be given to all children aged 14-59 months who have received an age-appropriate series of PCV7, he said. Efforts have been made, using these and other CDC data, to better educate health care professionals about the ACIP recommendations.

"This is something we continue to watch," he said, noting that the vaccine effectiveness evaluation will continue for 2 more years.

Dr. Cox said that he had no relevant financial disclosures to report.

ATLANTA – A large proportion of children apparently are not receiving the 13-valent pneumococcal conjugate vaccine as recommended by the Advisory Committee on Immunization Practices, surveillance data from the Centers for Disease Control and Prevention suggest.

According to the data from an ongoing evaluation of PCV13 vaccine effectiveness, 86 (78%) vaccine-eligible children out of 110 diagnosed with invasive pneumococcal disease secondary to serotypes unique to PCV13 in the year after the vaccine was introduced had not received the dosing recommended by the Advisory Committee on Immunization Practices (ACIP), Dr. Chad M. Cox reported at the International Conference on Emerging Infectious Diseases.

The ACIP recommendations, published March 12, 2010, call for the same dosing schedule used for PCV7 (immunizations at ages 2, 4, and 6 months, with a booster dose at age 12-15 months). ACIP also called for a single supplemental dose of PCV13 in all children aged 14-59 months who previously received an age-appropriate series of PCV7, and for use of PCV13 for the fourth dose in those who had received only three of the four previously recommended doses of PCV7.

PCV13 includes six additional serotypes not included in PCV7, which was introduced in 2000 using the seven most commonly circulating serotypes.

After the introduction of PCV7, a sharp decrease occurred in disease caused by these seven serotypes, but in more recent years an increase was seen in disease caused by serotypes not covered by PC7. Because of the emergence of this "replacement disease," PCV13 was introduced, Dr. Cox explained.

"The [PCV13] vaccine was readily available soon after [the March 2010 ACIP recommendations], and quickly replaced PCV7 in most provider’s offices," said Dr. Cox of the CDC in Atlanta.

Nonetheless, in June 2011 the California Department of Health reported a fatal case of invasive pneumococcal disease in a 2-year-old, which was caused by a serotype in the PCV13 vaccine; 30 additional cases were identified in counties not included in the CDC surveillance area.

This led to a health advisory issued in August 2011 – reminding providers of the ACIP recommendations – and to this study of outcomes in 10 participating surveillance areas representing 3.8 million children under age 5 years.

The hospitalized children in this study included those from the surveillance areas for whom complete vaccination information was available. About two-thirds were aged 2-4 years, Dr. Cox said.

About two-thirds of patients in the study were noncompliant because they had not received a supplemental PCV13 dose after completion of the PCV7 series, and about one-fifth had not received the fourth dose in the series, which should have been a PCV13 dose, he noted.

The majority of the children (93%) had no underlying medical conditions, and 79% were hospitalized. No deaths occurred.

These findings demonstrate that invasive pneumococcal disease resulting from pneumococcal serotyopes unique to PCV13 continued to occur in those who did not receive the recommended dose of PCV13 in the year after it became available, Dr. Cox said.

Prevention of invasive pneumococcal disease requires that a single supplemental dose of PCV13 be given to all children aged 14-59 months who have received an age-appropriate series of PCV7, he said. Efforts have been made, using these and other CDC data, to better educate health care professionals about the ACIP recommendations.

"This is something we continue to watch," he said, noting that the vaccine effectiveness evaluation will continue for 2 more years.

Dr. Cox said that he had no relevant financial disclosures to report.

ATLANTA – A large proportion of children apparently are not receiving the 13-valent pneumococcal conjugate vaccine as recommended by the Advisory Committee on Immunization Practices, surveillance data from the Centers for Disease Control and Prevention suggest.

According to the data from an ongoing evaluation of PCV13 vaccine effectiveness, 86 (78%) vaccine-eligible children out of 110 diagnosed with invasive pneumococcal disease secondary to serotypes unique to PCV13 in the year after the vaccine was introduced had not received the dosing recommended by the Advisory Committee on Immunization Practices (ACIP), Dr. Chad M. Cox reported at the International Conference on Emerging Infectious Diseases.

The ACIP recommendations, published March 12, 2010, call for the same dosing schedule used for PCV7 (immunizations at ages 2, 4, and 6 months, with a booster dose at age 12-15 months). ACIP also called for a single supplemental dose of PCV13 in all children aged 14-59 months who previously received an age-appropriate series of PCV7, and for use of PCV13 for the fourth dose in those who had received only three of the four previously recommended doses of PCV7.

PCV13 includes six additional serotypes not included in PCV7, which was introduced in 2000 using the seven most commonly circulating serotypes.

After the introduction of PCV7, a sharp decrease occurred in disease caused by these seven serotypes, but in more recent years an increase was seen in disease caused by serotypes not covered by PC7. Because of the emergence of this "replacement disease," PCV13 was introduced, Dr. Cox explained.

"The [PCV13] vaccine was readily available soon after [the March 2010 ACIP recommendations], and quickly replaced PCV7 in most provider’s offices," said Dr. Cox of the CDC in Atlanta.

Nonetheless, in June 2011 the California Department of Health reported a fatal case of invasive pneumococcal disease in a 2-year-old, which was caused by a serotype in the PCV13 vaccine; 30 additional cases were identified in counties not included in the CDC surveillance area.

This led to a health advisory issued in August 2011 – reminding providers of the ACIP recommendations – and to this study of outcomes in 10 participating surveillance areas representing 3.8 million children under age 5 years.

The hospitalized children in this study included those from the surveillance areas for whom complete vaccination information was available. About two-thirds were aged 2-4 years, Dr. Cox said.

About two-thirds of patients in the study were noncompliant because they had not received a supplemental PCV13 dose after completion of the PCV7 series, and about one-fifth had not received the fourth dose in the series, which should have been a PCV13 dose, he noted.

The majority of the children (93%) had no underlying medical conditions, and 79% were hospitalized. No deaths occurred.

These findings demonstrate that invasive pneumococcal disease resulting from pneumococcal serotyopes unique to PCV13 continued to occur in those who did not receive the recommended dose of PCV13 in the year after it became available, Dr. Cox said.

Prevention of invasive pneumococcal disease requires that a single supplemental dose of PCV13 be given to all children aged 14-59 months who have received an age-appropriate series of PCV7, he said. Efforts have been made, using these and other CDC data, to better educate health care professionals about the ACIP recommendations.

"This is something we continue to watch," he said, noting that the vaccine effectiveness evaluation will continue for 2 more years.

Dr. Cox said that he had no relevant financial disclosures to report.

ORLANDO – Reports of U.S. children with a food allergy jumped by a third between 2003-2004 and 2007-2008.

The finding is based on survey responses collected by the Centers for Disease Control and Prevention from more than 90,000 patients during each of the two time periods. An analysis of other data collected by the surveys implicated younger age, lack of health insurance, and eczema as three factors associated with the increased prevalence of food allergies in children, Dr. Karen A. DeMuth said during a poster presentation at the meeting (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.147]).

Other possible factors not accounted for in the survey results might also have played a role in the sharp rise, such as an increased level of awareness about food allergies among parents, and an increased rate of testing children for food allergies, she acknowledged in an interview. The telephone surveys conducted by the CDC relied exclusively on parents’ reports of allergies in their children, and so the rates do not reflect allergy rates documented by physician examinations or food-challenge tests. But the fact that these limitations applied in both survey periods – 2003-2004 and 2007-2008 – makes it less likely that they played a major role in explaining the increased food allergy prevalence.

"These data show us how many parents think their kids have a food allergy," Dr. DeMuth said.

She and her associate used data collected in the first two National Surveys of Children’s Health. During 2003-2004, the CDC completed telephone surveys with 102,353 U.S. households, and during 2007-2008, the agency obtained responses from 91,642 families. During each survey, the CDC collected data for a single child aged 0-17 years from each responding family.

During the first survey, parents reported a food allergy in their child at a rate of 3,566 cases/100,000 children, a prevalence rate of 3.6%. By the second survey, the prevalence rose to 4,848 cases/100,000 children, a rate of 4.8%, a 33% relative increase that was statistically significant, reported Dr. DeMuth, an allergist and immunologist at Emory University in Atlanta.

The prevalence rates increased by an absolute rate of more than 2% in eight states: Arkansas, Delaware, Georgia, Hawaii, Maryland, Ohio, Oklahoma, and New Hampshire. The greatest absolute rise in percent terms was in Oklahoma, where the prevalence rate jumped by 3.2 percentage points. During 2007-2008, the highest overall reported prevalence rate for pediatric food allergies was in New Hampshire, where 6.7% of families reported having a child with a food allergy. The lowest prevalence rate during 2007-2008 was in Wisconsin, with a 3.3% rate. Between 2003-2004 and 2007-2008, a statistically significant increase in the prevalence of pediatric food allergies occurred in 17 states.

Three factors were linked on a statistically significant level with the increased rate of food allergies: Age of 0-5 years boosted the food allergies rate by 33%, compared with older children; having no health insurance was linked with a 48% higher rate of food allergy increase; and having eczema or atopic dermatitis was linked with a 4.7-fold higher rate of food-allergy increase, compared with children without skin atopy.

Results from two other studies reported in posters at the meeting further documented recent prevalence rates of pediatric food allergies in U.S. populations.

A survey of randomly-selected U.S. families was conducted during June 2009-February 2010 and collected information on 38,480 children aged 0-17. The results found that 3,218 parents (8%) said they had a child with a food allergy, reported Dr. Ruchi S. Gupta and her associates from Northwestern University in Chicago (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.145]).

The parents said that 70% of these children had been identified as having a food allergy by a physician, and that 20% of the children had their food allergy documented by an oral food-challenge test. The allergens that the responding parents reported were peanut, milk, tree nut, shellfish, egg, fin fish, wheat, soy, and sesame. The most common presenting symptom was urticaria, reported for roughly half of the children with a food allergy.

The second report included data from a retrospective chart review done at a single, hospital-based Medicaid clinic in the East Harlem section of New York City. During July 1, 2008-July 1, 2010, the clinic saw 9,314 children, of whom 331 (3.6%) had a physician-diagnosed food allergy, reported Dr. Sarah A. Taylor-Black and her associate from Mount Sinai Medical Center in New York (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.148]). The patients’ average age at diagnosis was 1.7 years, with a range of 4 months to 10 years old. The most common allergy was to peanut, followed by shellfish, egg, tree nut, milk, fruit, fish, soy, vegetable, seed, and wheat. Allergy prevalence was 5.6% among black children, compared with 3.0% among Hispanic children, a statistically significant difference. Skin symptoms were the most common presentation in children with allergies to peanut, shellfish, egg, milk, and fish.

Dr. DeMuth, Dr. Gupta, and Dr. Taylor-Black all said that they had no disclosures.

Mitchel L. Zoler/IMNG Medical Media

ORLANDO – Reports of U.S. children with a food allergy jumped by a third between 2003-2004 and 2007-2008.

The finding is based on survey responses collected by the Centers for Disease Control and Prevention from more than 90,000 patients during each of the two time periods. An analysis of other data collected by the surveys implicated younger age, lack of health insurance, and eczema as three factors associated with the increased prevalence of food allergies in children, Dr. Karen A. DeMuth said during a poster presentation at the meeting (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.147]).

Other possible factors not accounted for in the survey results might also have played a role in the sharp rise, such as an increased level of awareness about food allergies among parents, and an increased rate of testing children for food allergies, she acknowledged in an interview. The telephone surveys conducted by the CDC relied exclusively on parents’ reports of allergies in their children, and so the rates do not reflect allergy rates documented by physician examinations or food-challenge tests. But the fact that these limitations applied in both survey periods – 2003-2004 and 2007-2008 – makes it less likely that they played a major role in explaining the increased food allergy prevalence.

"These data show us how many parents think their kids have a food allergy," Dr. DeMuth said.

She and her associate used data collected in the first two National Surveys of Children’s Health. During 2003-2004, the CDC completed telephone surveys with 102,353 U.S. households, and during 2007-2008, the agency obtained responses from 91,642 families. During each survey, the CDC collected data for a single child aged 0-17 years from each responding family.

During the first survey, parents reported a food allergy in their child at a rate of 3,566 cases/100,000 children, a prevalence rate of 3.6%. By the second survey, the prevalence rose to 4,848 cases/100,000 children, a rate of 4.8%, a 33% relative increase that was statistically significant, reported Dr. DeMuth, an allergist and immunologist at Emory University in Atlanta.

The prevalence rates increased by an absolute rate of more than 2% in eight states: Arkansas, Delaware, Georgia, Hawaii, Maryland, Ohio, Oklahoma, and New Hampshire. The greatest absolute rise in percent terms was in Oklahoma, where the prevalence rate jumped by 3.2 percentage points. During 2007-2008, the highest overall reported prevalence rate for pediatric food allergies was in New Hampshire, where 6.7% of families reported having a child with a food allergy. The lowest prevalence rate during 2007-2008 was in Wisconsin, with a 3.3% rate. Between 2003-2004 and 2007-2008, a statistically significant increase in the prevalence of pediatric food allergies occurred in 17 states.

Three factors were linked on a statistically significant level with the increased rate of food allergies: Age of 0-5 years boosted the food allergies rate by 33%, compared with older children; having no health insurance was linked with a 48% higher rate of food allergy increase; and having eczema or atopic dermatitis was linked with a 4.7-fold higher rate of food-allergy increase, compared with children without skin atopy.

Results from two other studies reported in posters at the meeting further documented recent prevalence rates of pediatric food allergies in U.S. populations.

A survey of randomly-selected U.S. families was conducted during June 2009-February 2010 and collected information on 38,480 children aged 0-17. The results found that 3,218 parents (8%) said they had a child with a food allergy, reported Dr. Ruchi S. Gupta and her associates from Northwestern University in Chicago (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.145]).

The parents said that 70% of these children had been identified as having a food allergy by a physician, and that 20% of the children had their food allergy documented by an oral food-challenge test. The allergens that the responding parents reported were peanut, milk, tree nut, shellfish, egg, fin fish, wheat, soy, and sesame. The most common presenting symptom was urticaria, reported for roughly half of the children with a food allergy.

The second report included data from a retrospective chart review done at a single, hospital-based Medicaid clinic in the East Harlem section of New York City. During July 1, 2008-July 1, 2010, the clinic saw 9,314 children, of whom 331 (3.6%) had a physician-diagnosed food allergy, reported Dr. Sarah A. Taylor-Black and her associate from Mount Sinai Medical Center in New York (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.148]). The patients’ average age at diagnosis was 1.7 years, with a range of 4 months to 10 years old. The most common allergy was to peanut, followed by shellfish, egg, tree nut, milk, fruit, fish, soy, vegetable, seed, and wheat. Allergy prevalence was 5.6% among black children, compared with 3.0% among Hispanic children, a statistically significant difference. Skin symptoms were the most common presentation in children with allergies to peanut, shellfish, egg, milk, and fish.

Dr. DeMuth, Dr. Gupta, and Dr. Taylor-Black all said that they had no disclosures.

Mitchel L. Zoler/IMNG Medical Media

ORLANDO – Reports of U.S. children with a food allergy jumped by a third between 2003-2004 and 2007-2008.

The finding is based on survey responses collected by the Centers for Disease Control and Prevention from more than 90,000 patients during each of the two time periods. An analysis of other data collected by the surveys implicated younger age, lack of health insurance, and eczema as three factors associated with the increased prevalence of food allergies in children, Dr. Karen A. DeMuth said during a poster presentation at the meeting (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.147]).

Other possible factors not accounted for in the survey results might also have played a role in the sharp rise, such as an increased level of awareness about food allergies among parents, and an increased rate of testing children for food allergies, she acknowledged in an interview. The telephone surveys conducted by the CDC relied exclusively on parents’ reports of allergies in their children, and so the rates do not reflect allergy rates documented by physician examinations or food-challenge tests. But the fact that these limitations applied in both survey periods – 2003-2004 and 2007-2008 – makes it less likely that they played a major role in explaining the increased food allergy prevalence.

"These data show us how many parents think their kids have a food allergy," Dr. DeMuth said.

She and her associate used data collected in the first two National Surveys of Children’s Health. During 2003-2004, the CDC completed telephone surveys with 102,353 U.S. households, and during 2007-2008, the agency obtained responses from 91,642 families. During each survey, the CDC collected data for a single child aged 0-17 years from each responding family.

During the first survey, parents reported a food allergy in their child at a rate of 3,566 cases/100,000 children, a prevalence rate of 3.6%. By the second survey, the prevalence rose to 4,848 cases/100,000 children, a rate of 4.8%, a 33% relative increase that was statistically significant, reported Dr. DeMuth, an allergist and immunologist at Emory University in Atlanta.

The prevalence rates increased by an absolute rate of more than 2% in eight states: Arkansas, Delaware, Georgia, Hawaii, Maryland, Ohio, Oklahoma, and New Hampshire. The greatest absolute rise in percent terms was in Oklahoma, where the prevalence rate jumped by 3.2 percentage points. During 2007-2008, the highest overall reported prevalence rate for pediatric food allergies was in New Hampshire, where 6.7% of families reported having a child with a food allergy. The lowest prevalence rate during 2007-2008 was in Wisconsin, with a 3.3% rate. Between 2003-2004 and 2007-2008, a statistically significant increase in the prevalence of pediatric food allergies occurred in 17 states.

Three factors were linked on a statistically significant level with the increased rate of food allergies: Age of 0-5 years boosted the food allergies rate by 33%, compared with older children; having no health insurance was linked with a 48% higher rate of food allergy increase; and having eczema or atopic dermatitis was linked with a 4.7-fold higher rate of food-allergy increase, compared with children without skin atopy.

Results from two other studies reported in posters at the meeting further documented recent prevalence rates of pediatric food allergies in U.S. populations.

A survey of randomly-selected U.S. families was conducted during June 2009-February 2010 and collected information on 38,480 children aged 0-17. The results found that 3,218 parents (8%) said they had a child with a food allergy, reported Dr. Ruchi S. Gupta and her associates from Northwestern University in Chicago (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.145]).

The parents said that 70% of these children had been identified as having a food allergy by a physician, and that 20% of the children had their food allergy documented by an oral food-challenge test. The allergens that the responding parents reported were peanut, milk, tree nut, shellfish, egg, fin fish, wheat, soy, and sesame. The most common presenting symptom was urticaria, reported for roughly half of the children with a food allergy.

The second report included data from a retrospective chart review done at a single, hospital-based Medicaid clinic in the East Harlem section of New York City. During July 1, 2008-July 1, 2010, the clinic saw 9,314 children, of whom 331 (3.6%) had a physician-diagnosed food allergy, reported Dr. Sarah A. Taylor-Black and her associate from Mount Sinai Medical Center in New York (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.148]). The patients’ average age at diagnosis was 1.7 years, with a range of 4 months to 10 years old. The most common allergy was to peanut, followed by shellfish, egg, tree nut, milk, fruit, fish, soy, vegetable, seed, and wheat. Allergy prevalence was 5.6% among black children, compared with 3.0% among Hispanic children, a statistically significant difference. Skin symptoms were the most common presentation in children with allergies to peanut, shellfish, egg, milk, and fish.

Dr. DeMuth, Dr. Gupta, and Dr. Taylor-Black all said that they had no disclosures.

Mitchel L. Zoler/IMNG Medical Media

ORLANDO – Immunotherapy with a pill formulated from ragweed pollen safely and effectively reduced symptoms and the need for therapy to manage symptoms in patients with ragweed allergy.

The findings were noted in two pivotal, placebo-controlled trials that together enrolled 1,349 patients in North America and Europe. The company that is developing the oral formulation, Merck, plans to use the results as the basis for a licensing application to the Food and Drug Administration next year, Dr. Hendrick Nolte, the company’s senior director for research in Kenilworth, N.J., said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

But the studies only assessed the pill’s efficacy for ragweed desensitization while patients were on treatment, and only during the first year of treatment. Thus, both studies failed to address the ability of the new formulation to modify disease, a hallmark effect of standard pollen desensitization by serial injections.

"Immunotherapy based on injections is disease modifying when used for 3-5 years. You can stop [the injections] and see continued benefit," said Dr. Peter S. Creticos, lead investigator for one of the two Merck studies (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.481]). Both ragweed pollen trials "were only single-season studies, so they can’t answer" whether disease was modified, he said in an interview during a poster presentation at the meeting.

However, a European study that used the same formulation examined the impact of 3 consecutive years of oral desensitization to ragweed followed by 2 years when patients received no immunotherapy. The results showed long-lasting tolerance that persisted during both follow-up years, said Dr. Creticos, an allergy and immunology physician at Johns Hopkins Hospital in Baltimore.

Reductions in symptoms and the need for symptom-controlling medications during ragweed-pollen season ranged from 21%-27%, compared with placebo, depending on the dosage. These differences were "clinically meaningful" and similar in efficacy to conventional, injection-based desensitization against ragweed, added Dr. Creticos. Unlike injections, the oral formulation did not cause any systemic reactions.

If the oral ragweed pill eventually receives U.S. marketing approval, it is likely to appeal to some patients, but may also have some downsides.

"A small percentage of patients won’t get injections because they are afraid of injections, they are afraid of systemic reactions, or they don’t want to have to regularly go to a doctor’s office," he said. "A daily pill is more convenient and easier, and it may be safer and just as effective." The main drawback is less reliable compliance. "A patient must be willing to take the pill daily, starting 16 weeks before the (allergy) season starts."

The study he presented randomized 565 North American adults with allergic rhinoconjunctivitis to ragweed to treatment with a pill containing 6 Amb a 1-U ragweed pollen, 12 Amb a 1-U, or placebo. Treatment began approximately 16 weeks before the start of each patient’s local ragweed pollen season, and continued for 52 weeks. Patients in all three arms could freely use symptom-controlling medications as needed: an oral antihistamine, antihistamine eyedrops, a nasal steroid, and an oral steroid.

The study’s primary efficacy end point was the patient’s total combined score – their rhinoconjunctivitis daily symptom score and daily medication-use score – during the peak of the ragweed season. For this measure, patients receiving the higher-dose ragweed pill had an average 27% reduction in their combined score, compared with the average among the placebo patients, and patients who received the lower-dose pill had an average 21% reduction, compared with placebo, both statistically significant differences. Both treatment groups showed similar improvements, compared with placebo, for secondary end points of total score throughout the entire ragweed season, symptom score during both the season’s peak and the entire season, and medication-use score during the season’s peak and the entire season.

The daily, oral pill was well tolerated at both dosages, with no deaths, systemic allergic reactions, or life-threatening events. The most common, treatment-related adverse events occurred early, and were transient and self-limited. Throat irritation occurred in 26%-29% of the active pill recipients, depending on the dosage. Other side effects included oral pruritus, in 19%; a swollen tongue, in 12%-19%; ear pruritus; tongue pruritus; oral paresthesia; and several other effects that occurred in less than 10% of treated patients. The majority of the adverse effects were mild or moderate, and none were serious. Two patients received epinephrine during the study. One patient had to a concomitant food-allergy reaction and the second was treated for local swelling and nervousness, so epinephrine treatment was not really needed.

"In routine practice, desensitization injections produce systemic reactions in 2%-6% of patients. I think we didn’t see that with the pill because the uptake is slower," Dr. Creticos said.

Results from the second trial, reported in a poster by Dr. Nolte, came from a study with a similar design that randomized 784 patients at sites in both North America and Europe (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.482]). This 52-week treatment study added a third active-treatment arm in which patients receive a daily pill containing 1.5 Amb a 1-U ragweed pollen. This low-dose pill did not produce a statistically-significant improvement in efficacy, compared with placebo. The 6 Amb a 1-U and 12 Amb a 1-U dosages resulted in a 19% and 24% average reduction in the total combined score during the peak ragweed season, statistically significant benefits for the study’s primary end point. The safety profile of the two highest doses also mimicked the first study, with no serious adverse effects and no systemic allergic reactions, anaphylaxis, or life-threatening effects. The type and severity of the treatment-related adverse effects were very similar to the first study. One patient in the second study received epinephrine, for a concomitant food-allergy reaction.

Both trials were sponsored by Merck, which is developing the oral ragweed-pollen desensitization pill. Dr. Creticos said that he has received research support from and has been a consultant to Merck as well as to several other drug companies. Dr. Nolte is an employee of Merck.

ORLANDO – Immunotherapy with a pill formulated from ragweed pollen safely and effectively reduced symptoms and the need for therapy to manage symptoms in patients with ragweed allergy.

The findings were noted in two pivotal, placebo-controlled trials that together enrolled 1,349 patients in North America and Europe. The company that is developing the oral formulation, Merck, plans to use the results as the basis for a licensing application to the Food and Drug Administration next year, Dr. Hendrick Nolte, the company’s senior director for research in Kenilworth, N.J., said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

But the studies only assessed the pill’s efficacy for ragweed desensitization while patients were on treatment, and only during the first year of treatment. Thus, both studies failed to address the ability of the new formulation to modify disease, a hallmark effect of standard pollen desensitization by serial injections.

"Immunotherapy based on injections is disease modifying when used for 3-5 years. You can stop [the injections] and see continued benefit," said Dr. Peter S. Creticos, lead investigator for one of the two Merck studies (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.481]). Both ragweed pollen trials "were only single-season studies, so they can’t answer" whether disease was modified, he said in an interview during a poster presentation at the meeting.

However, a European study that used the same formulation examined the impact of 3 consecutive years of oral desensitization to ragweed followed by 2 years when patients received no immunotherapy. The results showed long-lasting tolerance that persisted during both follow-up years, said Dr. Creticos, an allergy and immunology physician at Johns Hopkins Hospital in Baltimore.

Reductions in symptoms and the need for symptom-controlling medications during ragweed-pollen season ranged from 21%-27%, compared with placebo, depending on the dosage. These differences were "clinically meaningful" and similar in efficacy to conventional, injection-based desensitization against ragweed, added Dr. Creticos. Unlike injections, the oral formulation did not cause any systemic reactions.

If the oral ragweed pill eventually receives U.S. marketing approval, it is likely to appeal to some patients, but may also have some downsides.

"A small percentage of patients won’t get injections because they are afraid of injections, they are afraid of systemic reactions, or they don’t want to have to regularly go to a doctor’s office," he said. "A daily pill is more convenient and easier, and it may be safer and just as effective." The main drawback is less reliable compliance. "A patient must be willing to take the pill daily, starting 16 weeks before the (allergy) season starts."

The study he presented randomized 565 North American adults with allergic rhinoconjunctivitis to ragweed to treatment with a pill containing 6 Amb a 1-U ragweed pollen, 12 Amb a 1-U, or placebo. Treatment began approximately 16 weeks before the start of each patient’s local ragweed pollen season, and continued for 52 weeks. Patients in all three arms could freely use symptom-controlling medications as needed: an oral antihistamine, antihistamine eyedrops, a nasal steroid, and an oral steroid.

The study’s primary efficacy end point was the patient’s total combined score – their rhinoconjunctivitis daily symptom score and daily medication-use score – during the peak of the ragweed season. For this measure, patients receiving the higher-dose ragweed pill had an average 27% reduction in their combined score, compared with the average among the placebo patients, and patients who received the lower-dose pill had an average 21% reduction, compared with placebo, both statistically significant differences. Both treatment groups showed similar improvements, compared with placebo, for secondary end points of total score throughout the entire ragweed season, symptom score during both the season’s peak and the entire season, and medication-use score during the season’s peak and the entire season.

The daily, oral pill was well tolerated at both dosages, with no deaths, systemic allergic reactions, or life-threatening events. The most common, treatment-related adverse events occurred early, and were transient and self-limited. Throat irritation occurred in 26%-29% of the active pill recipients, depending on the dosage. Other side effects included oral pruritus, in 19%; a swollen tongue, in 12%-19%; ear pruritus; tongue pruritus; oral paresthesia; and several other effects that occurred in less than 10% of treated patients. The majority of the adverse effects were mild or moderate, and none were serious. Two patients received epinephrine during the study. One patient had to a concomitant food-allergy reaction and the second was treated for local swelling and nervousness, so epinephrine treatment was not really needed.

"In routine practice, desensitization injections produce systemic reactions in 2%-6% of patients. I think we didn’t see that with the pill because the uptake is slower," Dr. Creticos said.

Results from the second trial, reported in a poster by Dr. Nolte, came from a study with a similar design that randomized 784 patients at sites in both North America and Europe (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.482]). This 52-week treatment study added a third active-treatment arm in which patients receive a daily pill containing 1.5 Amb a 1-U ragweed pollen. This low-dose pill did not produce a statistically-significant improvement in efficacy, compared with placebo. The 6 Amb a 1-U and 12 Amb a 1-U dosages resulted in a 19% and 24% average reduction in the total combined score during the peak ragweed season, statistically significant benefits for the study’s primary end point. The safety profile of the two highest doses also mimicked the first study, with no serious adverse effects and no systemic allergic reactions, anaphylaxis, or life-threatening effects. The type and severity of the treatment-related adverse effects were very similar to the first study. One patient in the second study received epinephrine, for a concomitant food-allergy reaction.

Both trials were sponsored by Merck, which is developing the oral ragweed-pollen desensitization pill. Dr. Creticos said that he has received research support from and has been a consultant to Merck as well as to several other drug companies. Dr. Nolte is an employee of Merck.

ORLANDO – Immunotherapy with a pill formulated from ragweed pollen safely and effectively reduced symptoms and the need for therapy to manage symptoms in patients with ragweed allergy.

The findings were noted in two pivotal, placebo-controlled trials that together enrolled 1,349 patients in North America and Europe. The company that is developing the oral formulation, Merck, plans to use the results as the basis for a licensing application to the Food and Drug Administration next year, Dr. Hendrick Nolte, the company’s senior director for research in Kenilworth, N.J., said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

But the studies only assessed the pill’s efficacy for ragweed desensitization while patients were on treatment, and only during the first year of treatment. Thus, both studies failed to address the ability of the new formulation to modify disease, a hallmark effect of standard pollen desensitization by serial injections.

"Immunotherapy based on injections is disease modifying when used for 3-5 years. You can stop [the injections] and see continued benefit," said Dr. Peter S. Creticos, lead investigator for one of the two Merck studies (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.481]). Both ragweed pollen trials "were only single-season studies, so they can’t answer" whether disease was modified, he said in an interview during a poster presentation at the meeting.

However, a European study that used the same formulation examined the impact of 3 consecutive years of oral desensitization to ragweed followed by 2 years when patients received no immunotherapy. The results showed long-lasting tolerance that persisted during both follow-up years, said Dr. Creticos, an allergy and immunology physician at Johns Hopkins Hospital in Baltimore.

Reductions in symptoms and the need for symptom-controlling medications during ragweed-pollen season ranged from 21%-27%, compared with placebo, depending on the dosage. These differences were "clinically meaningful" and similar in efficacy to conventional, injection-based desensitization against ragweed, added Dr. Creticos. Unlike injections, the oral formulation did not cause any systemic reactions.

If the oral ragweed pill eventually receives U.S. marketing approval, it is likely to appeal to some patients, but may also have some downsides.

"A small percentage of patients won’t get injections because they are afraid of injections, they are afraid of systemic reactions, or they don’t want to have to regularly go to a doctor’s office," he said. "A daily pill is more convenient and easier, and it may be safer and just as effective." The main drawback is less reliable compliance. "A patient must be willing to take the pill daily, starting 16 weeks before the (allergy) season starts."

The study he presented randomized 565 North American adults with allergic rhinoconjunctivitis to ragweed to treatment with a pill containing 6 Amb a 1-U ragweed pollen, 12 Amb a 1-U, or placebo. Treatment began approximately 16 weeks before the start of each patient’s local ragweed pollen season, and continued for 52 weeks. Patients in all three arms could freely use symptom-controlling medications as needed: an oral antihistamine, antihistamine eyedrops, a nasal steroid, and an oral steroid.

The study’s primary efficacy end point was the patient’s total combined score – their rhinoconjunctivitis daily symptom score and daily medication-use score – during the peak of the ragweed season. For this measure, patients receiving the higher-dose ragweed pill had an average 27% reduction in their combined score, compared with the average among the placebo patients, and patients who received the lower-dose pill had an average 21% reduction, compared with placebo, both statistically significant differences. Both treatment groups showed similar improvements, compared with placebo, for secondary end points of total score throughout the entire ragweed season, symptom score during both the season’s peak and the entire season, and medication-use score during the season’s peak and the entire season.

The daily, oral pill was well tolerated at both dosages, with no deaths, systemic allergic reactions, or life-threatening events. The most common, treatment-related adverse events occurred early, and were transient and self-limited. Throat irritation occurred in 26%-29% of the active pill recipients, depending on the dosage. Other side effects included oral pruritus, in 19%; a swollen tongue, in 12%-19%; ear pruritus; tongue pruritus; oral paresthesia; and several other effects that occurred in less than 10% of treated patients. The majority of the adverse effects were mild or moderate, and none were serious. Two patients received epinephrine during the study. One patient had to a concomitant food-allergy reaction and the second was treated for local swelling and nervousness, so epinephrine treatment was not really needed.

"In routine practice, desensitization injections produce systemic reactions in 2%-6% of patients. I think we didn’t see that with the pill because the uptake is slower," Dr. Creticos said.

Results from the second trial, reported in a poster by Dr. Nolte, came from a study with a similar design that randomized 784 patients at sites in both North America and Europe (J. Allergy Clin. Immunol. 2012 [doi:10.1016/j.jaci.2011.12.482]). This 52-week treatment study added a third active-treatment arm in which patients receive a daily pill containing 1.5 Amb a 1-U ragweed pollen. This low-dose pill did not produce a statistically-significant improvement in efficacy, compared with placebo. The 6 Amb a 1-U and 12 Amb a 1-U dosages resulted in a 19% and 24% average reduction in the total combined score during the peak ragweed season, statistically significant benefits for the study’s primary end point. The safety profile of the two highest doses also mimicked the first study, with no serious adverse effects and no systemic allergic reactions, anaphylaxis, or life-threatening effects. The type and severity of the treatment-related adverse effects were very similar to the first study. One patient in the second study received epinephrine, for a concomitant food-allergy reaction.

Both trials were sponsored by Merck, which is developing the oral ragweed-pollen desensitization pill. Dr. Creticos said that he has received research support from and has been a consultant to Merck as well as to several other drug companies. Dr. Nolte is an employee of Merck.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.

Notable declines in both pneumonia hospitalizations and inpatient mortality attributed to pneumonia actually appear to be statistical artifacts related to changes in diagnostic coding rather than to bonafide improvements in health care, according to a report in the April 4 issue of JAMA.

A nationwide 27% reduction in pneumonia hospitalizations and an accompanying 28% reduction in pneumonia mortality were offset by concomitant rises in the rates of hospitalization and death due to sepsis (with a secondary diagnosis of pneumonia) and to respiratory failure (with a secondary diagnosis of pneumonia), said Dr. Peter K. Lindenauer of the Center for Quality of Care Research, Baystate Medical Center, Springfield, Mass., and his associates.

"These results suggest that secular trends in documentation and coding, rather than improvements in actual outcomes, may explain much of the observed change in this and other studies," they noted.

The findings also suggest that ratings of hospital performance based on pneumonia statistics may be inaccurate because of variation across hospitals in the use of diagnostic codes for pneumonia, sepsis, and respiratory failure, they added.

Noting that several epidemiologic studies have reported improvements in pneumonia statistics but that there haven’t been any "care-transforming technologies" to account for this improvement, Dr. Lindenauer and his colleagues analyzed trends in pneumonia hospital admissions and outcomes over time. They used data from the 2003 through the 2009 Nationwide Inpatient Sample (NIS), the largest all-payer hospital database in the country, which covers between 5 million and 8 million discharges each year. The NIS is sponsored by the U.S. Agency for Healthcare Research and Quality.

The researchers assessed hospitalizations for a principal diagnosis of pneumonia, as well as for a principal diagnosis of sepsis or respiratory failure together with a secondary diagnosis of pneumonia. For control conditions, they assessed hospitalizations for a principal diagnosis of ischemic stroke, ST-segment-elevation myocardial infarction (STEMI), and ruptured thoracic or abdominal aortic aneurysms.

"We also considered change over time in discharge disposition, including discharge to hospice, as a secondary outcome because increasing referral to inpatient nursing and rehabilitation facilities and hospice might allow sicker patients to be discharged rather than retained in the hospital," they noted.

From 2003 to 2009, the hospitalization rate of patients with a principal diagnosis of pneumonia decreased by 27.4%, from 5.5 per 1,000 to 4.0 per 1,000. This reversed "a well-documented decades-long trend toward increasing hospitalization" for the disorder, the investigators said (JAMA 2012;307:1405-13).

During the same period, however, the hospitalization rate for patients with a principal diagnosis of sepsis and a secondary diagnosis of pneumonia rose 177.6%, from 0.4 per 1,000 to 1.1 per 1,000. And the hospitalization rate for patients with a principal diagnosis of respiratory failure and a secondary diagnosis of pneumonia rose 9.3%, from 0.44 per 1,000 to 0.48 per 1,000.

These trends were consistent across all age groups and for both men and women.

During the same period, inpatient pneumonia mortality declined from 5.8% to 4.2%, a relative risk reduction (RRR) of 28.2%. There was a concomitant decline in inpatient sepsis mortality (RRR, 12%) and in inpatient respiratory failure mortality (RRR, 23.7%).

However, "when the three groups were combined ... there was little change in the inpatient mortality rate, varying from a small increase to a small decline, depending on the approach to risk adjustment," Dr. Lindenauer and his associates said.

As expected, the reductions in inpatient hospitalizations for the three control conditions were significantly smaller than those for pneumonia hospitalizations. Ischemic stroke, STEMI, and ruptured aortic aneurysms were indeed "less susceptible to secular changes in the choice of an alternative principal diagnosis," they pointed out.

Also as expected, the proportion of pneumonia patients discharged to nursing facilities and hospices did not account for the large decline in pneumonia inpatients.

The results of the primary analysis in this study were supported by those of a secondary analysis of bacteriologic types. Hospitalization rates for pneumococcal, pseudomonas, and staphylococcal pneumonias all declined to a similar extent as overall pneumonia and were offset by matching rises in the rates of sepsis due to these organisms.

The study findings have important implications well beyond the scope of pneumonia. "Several recent studies have reported very rapid growth in the rate of hospitalizations of patients with sepsis and severe sepsis, suggesting that the phenomenon in this study" may extend to many other infectious diseases, the investigators said.

Turning to the question of why clinicians might be switching from a principal diagnosis of pneumonia to a principal diagnosis of sepsis/secondary diagnosis of pneumonia, Dr. Lindenauer and his colleagues offered two possible explanations.

First, there was a well-publicized national campaign advocating the early recognition and treatment of sepsis in 2002. Second, hospital reimbursement rates for sepsis and respiratory failure are higher than those for pneumonia, they noted.

No conflicts of interest were reported.