Pulmonary Health Hub

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

Although annual influenza vaccinations rates have steadily increased in recent years, more attention must be paid to matching available vaccination strands with the most prevalent disease strains during each season to mitigate the burden of pediatric influenza cases on hospitals and emergency departments, according to a study published in Pediatrics.

“Annual variability in influenza activity, strain virulence, and population immunity to circulating strains makes assessing the impact of [several recent] vaccination policy changes challenging,” wrote lead author Dr. Astride Jules of Vanderbilt University, Nashville, Tenn., and her coauthors (Pediatrics 2014 [doi: 10.1542/peds.2014-1168]). “However, with increasing uptake of influenza vaccines, influenza-related health care visits should decrease over time.”

© Fuse/Thinkstock

In a retrospective, population-based study, Dr. Jules and her associates estimated the proportion of laboratory-confirmed influenza-related hospitalizations and emergency department (ED) visits related to acute respiratory illness (ARI) and fever in children aged 6-59 months by using available data from the Centers for Disease Control and Prevention (CDC) and the Hospital Discharge Data System (HDDS). The investigators then took those proportions and multiplied them by the number of ARI/fever hospitalizations and ED visits for residents of Davidson County, Tenn., looking specifically for trends in vaccination coverage, and influenza-associated hospitalizations and ED visit rates.

For the purposes of this study, flu season was defined as starting in either the first week of November or the first week in which at least two patients were hospitalized with influenza-related illnesses, and covered all consecutive weeks in which influenza virus strains were presented in Davidson County. The only season that did not fit the typical outline was that of the H1N1 outbreak in 2009, when flu season lasted from May 3 to Dec. 5.

The data showed that the rate of fully vaccinated children between the ages of 6 months and 5 years increased from 6% during the 2000-2001 flu season, to 38% in 2010-2011 (P < .05). Over that span of time, influenza-related hospitalizations ranged from 1.9 to 16.0 per 10,000 children annually, with a median of 4.5 (P < .05). ED visits ranged from 89 to 620 per 10,000 children annually, with a median of 143 (P < .05).

However, for the years in which the A(H3N2) strain was prevalent – 2001-2002, 2003-2004, 2004-2005, 2005-2006, and 2007-2008 – median rates of both hospitalizations and ED visits were significantly higher, compared with the other years covered by the study: 8.2 vs. 3.2 for hospitalizations, respectively, and 307 vs. 143 for ED visits, respectively.

Investigators also noted that there were decreases in hospitalizations and increases in ED visits (P < .05 for both) over the course of the study, but these could not be definitively correlated to the increase in vaccination rates. Furthermore, despite more children receiving vaccinations in Davidson County, the rate still fell far below even 50%.

“Overall influenza vaccination coverage remained low (< 50%) in children [under] 5 years, and it is likely that substantially greater vaccination coverage levels and/or new vaccination strategies will be required before broad population level decreases in rates of influenza associated medical visits can be documented,” Dr. Jules and her associates wrote.

The study was funded by the CDC and a National Institutes of Health Clinical and Translational Science Award. Dr. Jules had no relevant financial disclosures, but some of her coauthors had ties to pharmaceutical companies.

[email protected]

The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.

The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.

Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.

This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.

Still, vaccination remains the best line of defense against infection, he said.

The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.

“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.

Dr. Frieden also stressed the importance of antiviral use.

“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.

These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.

“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.

The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.

Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.

“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.

“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.

However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.

“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”

Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.

Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.

The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.

The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.

Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.

This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.

Still, vaccination remains the best line of defense against infection, he said.

The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.

“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.

Dr. Frieden also stressed the importance of antiviral use.

“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.

These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.

“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.

The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.

Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.

“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.

“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.

However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.

“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”

Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.

Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.

The 2014-2015 flu season may be particularly severe, and the 2014-2015 vaccine will provide important, but limited protection, according to a health advisory from the Centers for Disease Control and Prevention that is based on early analyses of reported disease cases.

The advisory also stresses the importance of antiviral treatment in those with confirmed or suspected influenza, particularly those at risk of developing complications, including young children, adults aged 65 years and older, pregnant women, and those with chronic health conditions, such as asthma, diabetes, or heart, lung, or kidney disease.

Influenza A viruses, mainly H3N2, predominate thus far during the 2014-2015 flu season, comprising more than 91% of the specimens collected and analyzed, and only about half of those have been antigenically similar to H3N2 components included in the 2014-2015 vaccine, according to the advisory.

This doesn’t bode well for the effectiveness of the vaccine, which is particularly troubling given that H3N2-predominate seasons historically have been associated with up to twice the rate of overall and age-specific flu-related hospitalizations and deaths, CDC director Dr. Thomas R. Frieden explained during a press briefing.

Still, vaccination remains the best line of defense against infection, he said.

The vaccine will protect against circulating strains that have not undergone significant antigenic drift, including the influenza B viruses, which have comprised about 9% of those collected to date. In addition, the vaccine has been found to provide some protection against the antigenically drifted H3N2 viruses, he said.

“We continue to recommend flu vaccine as the single best way to protect yourself against the flu,” he said.

Dr. Frieden also stressed the importance of antiviral use.

“Antivirals aren’t a substitute for vaccinations … but they are an important second line of defense for treating the flu, and this year, treatment with antiviral drugs is especially important, particularly for people who are at high risk for serious flu complications or for people who are very sick with flu,” he said.

These agents are greatly underprescribed, with fewer than one in six severely ill patients receiving antiviral treatment, he noted.

“It’s very important that we do better for people who are severely ill or who could become severely ill with influenza,” he said, adding that antiviral use is even more important during seasons such as this one when the circulating viruses are different from the vaccine viruses.

The two neuraminidase inhibitor antiviral medications currently approved for treating influenza – oseltamivir and zanamivir – shorten the duration of fever and illness symptoms by about a day and can reduce the risk of severe outcomes, he said.

Treatment should be provided withing 2 days of symptoms onset when possible, but it may also provide benefit to hospitalized patients even if taken later in the course of illness.

“We strongly recommend that if doctors suspect the flu in someone who may be severely ill from the flu, they don’t wait for the results of a flu test before starting antivirals,” he said.

“There is no way to predict with certainly what will happen. We have four different strains of flu circulating. The B strain, the H1 strain, the well-matched H3 strain, and the poorly matched H3 strain. Only time will tell which of them, if any, will predominate for the coming weeks and months of this year’s flu season,” he said.

However, already this season there have been five pediatric deaths from influenza, including three in patients with H3N2 disease, and one in a patient with influenza type B.

“We’ve also heard of outbreaks in schools and in nursing homes,” Dr. Frieden said, adding that “getting a vaccine, even if it doesn’t provide as good protection as we would hope, would be more important than ever, and remains the single most effective way to protect yourself against the flu.”

Physicians should continue to vaccinate patients, he said, noting that nearly 150 million doses have been distributed by manufacturers, and that the supply is expected to meet the demand. The supply of antiviral medications is also expected to be adequate.

Patients should also be advised to stay home when they are sick to avoid spreading influenza, and to seek treatment promptly for flu symptoms, including fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and fatigue, he said.

Children who are born prematurely have more than four times the risk of severe flu complications, despite not being considered a high-risk group by U.S., U.K., or World Health Organization guidelines, according to findings from a meta-analysis.

In keeping with existing guidelines, the systematic review and meta-analysis of 27 studies involving 14,086 children also identified children with neurologic disorders (odds ratio, 4.62; 95% confidence interval, 2.82-7.55), sickle cell disease (OR, 3.46; 95% CI, 1.63-7.37), immunosuppression (OR, 2.39; 95% CI, 1.24-4.61), and diabetes (OR, 2.34; 95% CI, 1.20-4.58) at increased risk of flu complications.

The presence of multiple medical conditions significantly increased the risk of hospital admission from 52% (one condition) to 74% (>1 condition), according to Peter J. Gill, D.Phil., of the University of Oxford (England), and associates (Lancet Respir. Med. 2014 Dec. 4 [doi:10.1016/S2213-2600(14)70252-8]).

There was no significant association between hospital admission for influenza and asthma or other respiratory conditions, obesity, heart conditions, or cancer, according to the investigators.

©Fuse/Thinkstockphotos.com

In a linked comment, however, Dr. Harish Nair of the University of Edinburgh (Scotland) and Dr. Marc-Alain Widdowson of the U.S. Centers for Disease Control and Prevention, Atlanta, said that this particular finding should be interpreted with caution, as the authors measured the risk of hospitalization among children already seeking care.

“If respiratory disease or asthma is already associated with seeking ambulatory care for influenza, then these characteristics might not have been identified as risk factors,” they wrote (Lancet Respir. Med 2014 Dec. 4 (doi:10.1016/S2213-2600(14)70285-1).

They also advised caution on the prematurity finding, as five of the seven studies in the analysis did not define prematurity by gestational age. If confirmed, however, it could have “major policy implications” as 11% (15 million) of the world’s babies are born preterm.

“Current WHO guidelines for seasonal influenza vaccination do not include preterm babies in the list of high-risk groups, but perhaps the new findings support their eventual inclusion,” Dr. Nair and Dr. Widdowson wrote.

Protection of these susceptible children, however, comes with challenges. “Children cannot be vaccinated before age 6 months; inactivated vaccines are poorly immunogenic in young children, necessitating two doses, and live, attenuated influenza vaccines are only recommended in children aged 2 years or older,” they noted.

Children who are born prematurely have more than four times the risk of severe flu complications, despite not being considered a high-risk group by U.S., U.K., or World Health Organization guidelines, according to findings from a meta-analysis.

In keeping with existing guidelines, the systematic review and meta-analysis of 27 studies involving 14,086 children also identified children with neurologic disorders (odds ratio, 4.62; 95% confidence interval, 2.82-7.55), sickle cell disease (OR, 3.46; 95% CI, 1.63-7.37), immunosuppression (OR, 2.39; 95% CI, 1.24-4.61), and diabetes (OR, 2.34; 95% CI, 1.20-4.58) at increased risk of flu complications.

The presence of multiple medical conditions significantly increased the risk of hospital admission from 52% (one condition) to 74% (>1 condition), according to Peter J. Gill, D.Phil., of the University of Oxford (England), and associates (Lancet Respir. Med. 2014 Dec. 4 [doi:10.1016/S2213-2600(14)70252-8]).

There was no significant association between hospital admission for influenza and asthma or other respiratory conditions, obesity, heart conditions, or cancer, according to the investigators.

©Fuse/Thinkstockphotos.com

In a linked comment, however, Dr. Harish Nair of the University of Edinburgh (Scotland) and Dr. Marc-Alain Widdowson of the U.S. Centers for Disease Control and Prevention, Atlanta, said that this particular finding should be interpreted with caution, as the authors measured the risk of hospitalization among children already seeking care.

“If respiratory disease or asthma is already associated with seeking ambulatory care for influenza, then these characteristics might not have been identified as risk factors,” they wrote (Lancet Respir. Med 2014 Dec. 4 (doi:10.1016/S2213-2600(14)70285-1).

They also advised caution on the prematurity finding, as five of the seven studies in the analysis did not define prematurity by gestational age. If confirmed, however, it could have “major policy implications” as 11% (15 million) of the world’s babies are born preterm.

“Current WHO guidelines for seasonal influenza vaccination do not include preterm babies in the list of high-risk groups, but perhaps the new findings support their eventual inclusion,” Dr. Nair and Dr. Widdowson wrote.

Protection of these susceptible children, however, comes with challenges. “Children cannot be vaccinated before age 6 months; inactivated vaccines are poorly immunogenic in young children, necessitating two doses, and live, attenuated influenza vaccines are only recommended in children aged 2 years or older,” they noted.

Children who are born prematurely have more than four times the risk of severe flu complications, despite not being considered a high-risk group by U.S., U.K., or World Health Organization guidelines, according to findings from a meta-analysis.

In keeping with existing guidelines, the systematic review and meta-analysis of 27 studies involving 14,086 children also identified children with neurologic disorders (odds ratio, 4.62; 95% confidence interval, 2.82-7.55), sickle cell disease (OR, 3.46; 95% CI, 1.63-7.37), immunosuppression (OR, 2.39; 95% CI, 1.24-4.61), and diabetes (OR, 2.34; 95% CI, 1.20-4.58) at increased risk of flu complications.

The presence of multiple medical conditions significantly increased the risk of hospital admission from 52% (one condition) to 74% (>1 condition), according to Peter J. Gill, D.Phil., of the University of Oxford (England), and associates (Lancet Respir. Med. 2014 Dec. 4 [doi:10.1016/S2213-2600(14)70252-8]).

There was no significant association between hospital admission for influenza and asthma or other respiratory conditions, obesity, heart conditions, or cancer, according to the investigators.

©Fuse/Thinkstockphotos.com

In a linked comment, however, Dr. Harish Nair of the University of Edinburgh (Scotland) and Dr. Marc-Alain Widdowson of the U.S. Centers for Disease Control and Prevention, Atlanta, said that this particular finding should be interpreted with caution, as the authors measured the risk of hospitalization among children already seeking care.

“If respiratory disease or asthma is already associated with seeking ambulatory care for influenza, then these characteristics might not have been identified as risk factors,” they wrote (Lancet Respir. Med 2014 Dec. 4 (doi:10.1016/S2213-2600(14)70285-1).

They also advised caution on the prematurity finding, as five of the seven studies in the analysis did not define prematurity by gestational age. If confirmed, however, it could have “major policy implications” as 11% (15 million) of the world’s babies are born preterm.

“Current WHO guidelines for seasonal influenza vaccination do not include preterm babies in the list of high-risk groups, but perhaps the new findings support their eventual inclusion,” Dr. Nair and Dr. Widdowson wrote.

Protection of these susceptible children, however, comes with challenges. “Children cannot be vaccinated before age 6 months; inactivated vaccines are poorly immunogenic in young children, necessitating two doses, and live, attenuated influenza vaccines are only recommended in children aged 2 years or older,” they noted.

SCOTTSDALE, ARIZ. – Patients with migraine often have comorbid psychiatric conditions, but anxiety disorders particularly exacerbate pain, hypervigilance, and the tendency to catastrophize, said Steven Baskin, Ph.D.

“Anxiety is the driver of distress across most emotional disorders,” said Dr. Baskin, a psychologist at the New England Institute for Neurology and Headache in Stamford, Conn. The lifetime prevalence of anxiety disorders among migraineurs is 51%-58%, which is almost twice their lifetime rate of major depression, he added.

Panic disorder is particularly common in migraine patients, with an odds ratio of approximately 10 for migraine with aura and 3 for migraine without aura. However, community studies have also linked migraine to increased odds of generalized anxiety disorder, phobias, and obsessive-compulsive disorder, he said at a symposium sponsored by the American Headache Society.

Anxiety tends to worsen headache symptoms and disability, erodes short-term treatment satisfaction, and decreases therapeutic compliance to a greater extent than depression does, Dr. Baskin said. “Psychological interventions that target anxiety sensitivity may be helpful for headache,” he added.

These therapies include a “top down” approach based on cognitive-behavioral therapy, and a “bottom up” approach based on mindfulness, said Dr. Cynthia Stonnington, chair of the department of psychiatry and psychology at the Mayo Clinic, Phoenix. Cognitive therapy teaches migraineurs to reappraise their situation by focusing on past examples of their resilience and support system instead of catastrophizing their pain, she said. And mindfulness-based therapy trains patients to “make room by breathing, by being aware of what is happening in the body,” she added. “The more you can accept without judgment, and without all that stress and anxiety, the more you will be able to cope with that situation.”

Both therapeutic approaches help to lower the stress response, thereby helping to improve headache symptoms, Dr. Stonnington added. “Patients may be operating outside of their window of tolerance for much of their life without realizing it.”

Taking a longitudinal history also is important to accurately assess psychiatric disorders in migraineurs, Dr. Baskin emphasized. For example, anxiety disorders generally emerge before the onset of episodic migraine, while major depressive disorder typically follows it, he noted.

Genetics, early childhood trauma, and somatic sensitivity all affect the likelihood of anxiety disorders, Dr. Baskin said. Patients can be genetically more likely to develop neurotic personality traits, while severe illness or abuse during childhood can erode perceptions of control in adulthood, he said. Headache in patients who were mistreated as children “is more disabling and more likely to transform from episodic to chronic,” he noted.

In addition, some patients are acutely sensitive to bodily signals of stress or anxiety, such as increased heart rate, Dr. Baskin said. “These patients can feel their bodies, they notice something awry, and they fear it; they think this benign sensation is harmful, is potentially catastrophic,” he said. They are more likely to fear pain, to be affected by headache triggers, to have more frequent and disabling headaches, and to engage in maladaptive thoughts and behaviors, compared with patients with migraine who do not have a comorbid anxiety disorder, he said. Examples of maladaptive thoughts include, “I need to be completely headache free,” “Having migraines is intolerable,” “All these medications have horrible side effects,” and, “If I worry about it, I might prevent it,” he noted.

Patients with comorbid migraine and anxiety disorders also may view themselves as fragile, debilitated, easily unnerved, and helpless in the face of their condition, which tends to further worsen their disability, Dr. Baskin added. Patients also may frequently seek to control situations, see themselves as too special to deserve headaches or, conversely, worry about public humiliation about their migraines, he said.

Dr. Baskin reported serving on advisory boards and speakers bureaus and receiving research support from Allergan, Depomed, and Teva.

SCOTTSDALE, ARIZ. – Patients with migraine often have comorbid psychiatric conditions, but anxiety disorders particularly exacerbate pain, hypervigilance, and the tendency to catastrophize, said Steven Baskin, Ph.D.

“Anxiety is the driver of distress across most emotional disorders,” said Dr. Baskin, a psychologist at the New England Institute for Neurology and Headache in Stamford, Conn. The lifetime prevalence of anxiety disorders among migraineurs is 51%-58%, which is almost twice their lifetime rate of major depression, he added.

Panic disorder is particularly common in migraine patients, with an odds ratio of approximately 10 for migraine with aura and 3 for migraine without aura. However, community studies have also linked migraine to increased odds of generalized anxiety disorder, phobias, and obsessive-compulsive disorder, he said at a symposium sponsored by the American Headache Society.

Anxiety tends to worsen headache symptoms and disability, erodes short-term treatment satisfaction, and decreases therapeutic compliance to a greater extent than depression does, Dr. Baskin said. “Psychological interventions that target anxiety sensitivity may be helpful for headache,” he added.

These therapies include a “top down” approach based on cognitive-behavioral therapy, and a “bottom up” approach based on mindfulness, said Dr. Cynthia Stonnington, chair of the department of psychiatry and psychology at the Mayo Clinic, Phoenix. Cognitive therapy teaches migraineurs to reappraise their situation by focusing on past examples of their resilience and support system instead of catastrophizing their pain, she said. And mindfulness-based therapy trains patients to “make room by breathing, by being aware of what is happening in the body,” she added. “The more you can accept without judgment, and without all that stress and anxiety, the more you will be able to cope with that situation.”

Both therapeutic approaches help to lower the stress response, thereby helping to improve headache symptoms, Dr. Stonnington added. “Patients may be operating outside of their window of tolerance for much of their life without realizing it.”

Taking a longitudinal history also is important to accurately assess psychiatric disorders in migraineurs, Dr. Baskin emphasized. For example, anxiety disorders generally emerge before the onset of episodic migraine, while major depressive disorder typically follows it, he noted.

Genetics, early childhood trauma, and somatic sensitivity all affect the likelihood of anxiety disorders, Dr. Baskin said. Patients can be genetically more likely to develop neurotic personality traits, while severe illness or abuse during childhood can erode perceptions of control in adulthood, he said. Headache in patients who were mistreated as children “is more disabling and more likely to transform from episodic to chronic,” he noted.

In addition, some patients are acutely sensitive to bodily signals of stress or anxiety, such as increased heart rate, Dr. Baskin said. “These patients can feel their bodies, they notice something awry, and they fear it; they think this benign sensation is harmful, is potentially catastrophic,” he said. They are more likely to fear pain, to be affected by headache triggers, to have more frequent and disabling headaches, and to engage in maladaptive thoughts and behaviors, compared with patients with migraine who do not have a comorbid anxiety disorder, he said. Examples of maladaptive thoughts include, “I need to be completely headache free,” “Having migraines is intolerable,” “All these medications have horrible side effects,” and, “If I worry about it, I might prevent it,” he noted.

Patients with comorbid migraine and anxiety disorders also may view themselves as fragile, debilitated, easily unnerved, and helpless in the face of their condition, which tends to further worsen their disability, Dr. Baskin added. Patients also may frequently seek to control situations, see themselves as too special to deserve headaches or, conversely, worry about public humiliation about their migraines, he said.

Dr. Baskin reported serving on advisory boards and speakers bureaus and receiving research support from Allergan, Depomed, and Teva.

SCOTTSDALE, ARIZ. – Patients with migraine often have comorbid psychiatric conditions, but anxiety disorders particularly exacerbate pain, hypervigilance, and the tendency to catastrophize, said Steven Baskin, Ph.D.

“Anxiety is the driver of distress across most emotional disorders,” said Dr. Baskin, a psychologist at the New England Institute for Neurology and Headache in Stamford, Conn. The lifetime prevalence of anxiety disorders among migraineurs is 51%-58%, which is almost twice their lifetime rate of major depression, he added.

Panic disorder is particularly common in migraine patients, with an odds ratio of approximately 10 for migraine with aura and 3 for migraine without aura. However, community studies have also linked migraine to increased odds of generalized anxiety disorder, phobias, and obsessive-compulsive disorder, he said at a symposium sponsored by the American Headache Society.

Anxiety tends to worsen headache symptoms and disability, erodes short-term treatment satisfaction, and decreases therapeutic compliance to a greater extent than depression does, Dr. Baskin said. “Psychological interventions that target anxiety sensitivity may be helpful for headache,” he added.

These therapies include a “top down” approach based on cognitive-behavioral therapy, and a “bottom up” approach based on mindfulness, said Dr. Cynthia Stonnington, chair of the department of psychiatry and psychology at the Mayo Clinic, Phoenix. Cognitive therapy teaches migraineurs to reappraise their situation by focusing on past examples of their resilience and support system instead of catastrophizing their pain, she said. And mindfulness-based therapy trains patients to “make room by breathing, by being aware of what is happening in the body,” she added. “The more you can accept without judgment, and without all that stress and anxiety, the more you will be able to cope with that situation.”

Both therapeutic approaches help to lower the stress response, thereby helping to improve headache symptoms, Dr. Stonnington added. “Patients may be operating outside of their window of tolerance for much of their life without realizing it.”

Taking a longitudinal history also is important to accurately assess psychiatric disorders in migraineurs, Dr. Baskin emphasized. For example, anxiety disorders generally emerge before the onset of episodic migraine, while major depressive disorder typically follows it, he noted.

Genetics, early childhood trauma, and somatic sensitivity all affect the likelihood of anxiety disorders, Dr. Baskin said. Patients can be genetically more likely to develop neurotic personality traits, while severe illness or abuse during childhood can erode perceptions of control in adulthood, he said. Headache in patients who were mistreated as children “is more disabling and more likely to transform from episodic to chronic,” he noted.

In addition, some patients are acutely sensitive to bodily signals of stress or anxiety, such as increased heart rate, Dr. Baskin said. “These patients can feel their bodies, they notice something awry, and they fear it; they think this benign sensation is harmful, is potentially catastrophic,” he said. They are more likely to fear pain, to be affected by headache triggers, to have more frequent and disabling headaches, and to engage in maladaptive thoughts and behaviors, compared with patients with migraine who do not have a comorbid anxiety disorder, he said. Examples of maladaptive thoughts include, “I need to be completely headache free,” “Having migraines is intolerable,” “All these medications have horrible side effects,” and, “If I worry about it, I might prevent it,” he noted.

Patients with comorbid migraine and anxiety disorders also may view themselves as fragile, debilitated, easily unnerved, and helpless in the face of their condition, which tends to further worsen their disability, Dr. Baskin added. Patients also may frequently seek to control situations, see themselves as too special to deserve headaches or, conversely, worry about public humiliation about their migraines, he said.

Dr. Baskin reported serving on advisory boards and speakers bureaus and receiving research support from Allergan, Depomed, and Teva.

AMSTERDAM – A targeted oral medication for the prevention of potentially life-threatening episodes of hereditary angioedema produced a clinically meaningful reduction in attack frequency in a double-blind, placebo-controlled phase II study.

“This is very exciting. Without exaggeration, this is one of the deadliest and most challenging diseases that we deal with as dermatologists. What these patients want is oral prophylaxis, and we’ve got proof of concept with this trial. This is a bright new future for patients with hereditary angioedema, ” Dr. Marcus Maurer said in presenting the results of the OPuS-1 (Oral Prophylaxis for Hereditary Angioedema) trial at the annual congress of the European Academy of Dermatology and Venereology.

The investigational agent BCX4161 is a potent oral inhibitor of plasma kallikrein, which plays a key role in hereditary angioedema (HAE) by inducing vasodilation, edema, and nonvascular smooth muscle contraction.

OPuS-1 was a double-blind, randomized crossover study in which 24 patients with severe HAE were assigned to 4 weeks of BCX4161 at 400 mg or placebo three times daily, then switched to 4 weeks of the other regimen after a washout period. Participants averaged 42 years of age with a mean 32-year duration of HAE. At enrollment, they averaged 1.5 attacks per week, and they had a mean of 1.2 emergency department visits for HAE during the previous year. Twenty of the 24 patients had a history of one or more laryngeal attacks, the most serious manifestation of HAE, which eventually results in death by strangulation in roughly 30% of affected individuals, explained Dr. Maurer, professor of dermatology and allergy at Charité University Hospital in Berlin.

The primary outcome was the adjudicated attack rate, which was 1.27 attacks per week with placebo and a significantly lower 0.82 per week while patients were on BCX4161. Attacks averaged 20-23 hours in duration. Three patients were attack free on BCX4161; none was attack free during the placebo phase.

The novel agent also resulted in significant improvement on the secondary endpoints of quality of life and disease activity. Quality of life, as measured by the Angioedema Quality of Life questionnaire, improved by 8.4 points from baseline during active treatment, compared with 0.5 points with placebo. Disease activity, as assessed by the Angioedema Activity Score, or AA28, decreased while patients were on BCX4161, with a mean score of 21.4 vs. 28.8 with placebo.

The tolerability and side effects of BCX4161 were the same as with placebo. The rate of treatment compliance was 98%.

HAE is a rare and debilitating genetic disease with an estimated prevalence of 1 in 50,000. The most common symptoms include asymmetric swelling of the hands, feet, face, genitals, airway, and GI tract. HAE is caused by a deficiency of the C1 inhibitor, with resultant accumulation of bradykinin. By inhibiting plasma kallikrein, BCX4161 curbs bradykinin production.

“This disease has nothing to do with histamine or mast cells. This is not allergy or urticaria,” Dr. Maurer noted.

OPuS-2, a larger 12-week trial, is planned.

[email protected]

AMSTERDAM – A targeted oral medication for the prevention of potentially life-threatening episodes of hereditary angioedema produced a clinically meaningful reduction in attack frequency in a double-blind, placebo-controlled phase II study.

“This is very exciting. Without exaggeration, this is one of the deadliest and most challenging diseases that we deal with as dermatologists. What these patients want is oral prophylaxis, and we’ve got proof of concept with this trial. This is a bright new future for patients with hereditary angioedema, ” Dr. Marcus Maurer said in presenting the results of the OPuS-1 (Oral Prophylaxis for Hereditary Angioedema) trial at the annual congress of the European Academy of Dermatology and Venereology.

The investigational agent BCX4161 is a potent oral inhibitor of plasma kallikrein, which plays a key role in hereditary angioedema (HAE) by inducing vasodilation, edema, and nonvascular smooth muscle contraction.

OPuS-1 was a double-blind, randomized crossover study in which 24 patients with severe HAE were assigned to 4 weeks of BCX4161 at 400 mg or placebo three times daily, then switched to 4 weeks of the other regimen after a washout period. Participants averaged 42 years of age with a mean 32-year duration of HAE. At enrollment, they averaged 1.5 attacks per week, and they had a mean of 1.2 emergency department visits for HAE during the previous year. Twenty of the 24 patients had a history of one or more laryngeal attacks, the most serious manifestation of HAE, which eventually results in death by strangulation in roughly 30% of affected individuals, explained Dr. Maurer, professor of dermatology and allergy at Charité University Hospital in Berlin.

The primary outcome was the adjudicated attack rate, which was 1.27 attacks per week with placebo and a significantly lower 0.82 per week while patients were on BCX4161. Attacks averaged 20-23 hours in duration. Three patients were attack free on BCX4161; none was attack free during the placebo phase.

The novel agent also resulted in significant improvement on the secondary endpoints of quality of life and disease activity. Quality of life, as measured by the Angioedema Quality of Life questionnaire, improved by 8.4 points from baseline during active treatment, compared with 0.5 points with placebo. Disease activity, as assessed by the Angioedema Activity Score, or AA28, decreased while patients were on BCX4161, with a mean score of 21.4 vs. 28.8 with placebo.

The tolerability and side effects of BCX4161 were the same as with placebo. The rate of treatment compliance was 98%.

HAE is a rare and debilitating genetic disease with an estimated prevalence of 1 in 50,000. The most common symptoms include asymmetric swelling of the hands, feet, face, genitals, airway, and GI tract. HAE is caused by a deficiency of the C1 inhibitor, with resultant accumulation of bradykinin. By inhibiting plasma kallikrein, BCX4161 curbs bradykinin production.

“This disease has nothing to do with histamine or mast cells. This is not allergy or urticaria,” Dr. Maurer noted.

OPuS-2, a larger 12-week trial, is planned.

[email protected]

AMSTERDAM – A targeted oral medication for the prevention of potentially life-threatening episodes of hereditary angioedema produced a clinically meaningful reduction in attack frequency in a double-blind, placebo-controlled phase II study.

“This is very exciting. Without exaggeration, this is one of the deadliest and most challenging diseases that we deal with as dermatologists. What these patients want is oral prophylaxis, and we’ve got proof of concept with this trial. This is a bright new future for patients with hereditary angioedema, ” Dr. Marcus Maurer said in presenting the results of the OPuS-1 (Oral Prophylaxis for Hereditary Angioedema) trial at the annual congress of the European Academy of Dermatology and Venereology.

The investigational agent BCX4161 is a potent oral inhibitor of plasma kallikrein, which plays a key role in hereditary angioedema (HAE) by inducing vasodilation, edema, and nonvascular smooth muscle contraction.

OPuS-1 was a double-blind, randomized crossover study in which 24 patients with severe HAE were assigned to 4 weeks of BCX4161 at 400 mg or placebo three times daily, then switched to 4 weeks of the other regimen after a washout period. Participants averaged 42 years of age with a mean 32-year duration of HAE. At enrollment, they averaged 1.5 attacks per week, and they had a mean of 1.2 emergency department visits for HAE during the previous year. Twenty of the 24 patients had a history of one or more laryngeal attacks, the most serious manifestation of HAE, which eventually results in death by strangulation in roughly 30% of affected individuals, explained Dr. Maurer, professor of dermatology and allergy at Charité University Hospital in Berlin.

The primary outcome was the adjudicated attack rate, which was 1.27 attacks per week with placebo and a significantly lower 0.82 per week while patients were on BCX4161. Attacks averaged 20-23 hours in duration. Three patients were attack free on BCX4161; none was attack free during the placebo phase.

The novel agent also resulted in significant improvement on the secondary endpoints of quality of life and disease activity. Quality of life, as measured by the Angioedema Quality of Life questionnaire, improved by 8.4 points from baseline during active treatment, compared with 0.5 points with placebo. Disease activity, as assessed by the Angioedema Activity Score, or AA28, decreased while patients were on BCX4161, with a mean score of 21.4 vs. 28.8 with placebo.

The tolerability and side effects of BCX4161 were the same as with placebo. The rate of treatment compliance was 98%.

HAE is a rare and debilitating genetic disease with an estimated prevalence of 1 in 50,000. The most common symptoms include asymmetric swelling of the hands, feet, face, genitals, airway, and GI tract. HAE is caused by a deficiency of the C1 inhibitor, with resultant accumulation of bradykinin. By inhibiting plasma kallikrein, BCX4161 curbs bradykinin production.

“This disease has nothing to do with histamine or mast cells. This is not allergy or urticaria,” Dr. Maurer noted.

OPuS-2, a larger 12-week trial, is planned.

[email protected]

Criteria recently proposed by the Centers for Medicare & Medicaid Services for the coverage of lung cancer screening using low-dose computed tomography may not be the most efficient way to screen patients.

The criteria adopted, based on recommendations from the U.S. Preventive Services Task Force (USPSTF) and results from the National Lung Screening Trial (NLST) could include some low-risk patients in the screening while at the same time miss certain high-risk patients who might benefit from low-dose CT screening, according to an analysis published online Dec. 2 in PLOS Medicine (2014 [doi:10.1371/journal.pmed.1001764]). A key difference between CMS’s proposed criteria and the USPSTF guidelines is that CMS would only cover high-risk patients up to 74 years of age, while the USPSTF recommends covering up to 80 years of age.

©Sebastian Kaulitzki/thinkstockphotos.com

“However, it has been shown that selecting individuals for screening based on accurate lung cancer risk prediction models is significantly more sensitive in detecting individuals who will be diagnosed with lung cancer and would save more lives than using the NLST criteria,” wrote Martin C. Tammemagi, Ph.D., of Brock University, St. Catharines, Ont., an epidemiologist on the NLST, and colleagues.

The authors recommend using the PLCO_m2012 model, a “logistic regression lung cancer risk prediction model based on the 6-y incidence of lung cancer occurring in smokers in the control arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).” The model uses four smoking variables (smoking intensity, smoking duration, quit time in former smokers, and current smoking status) and seven nonsmoking variables (age, race/ethnicity, socioeconomic circumstance estimated by education level, body mass index, personal history of cancer, chronic obstructive pulmonary disease, and family history of lung cancer).

“The PLCO_m2012 model demonstrated high predictive performance, both discrimination and calibration, in external validation in PLCO intervention arm smokers,” the authors note.

Researchers found that applying the “PLCO_m2012 model with a risk greater than or equal to 0.0151 threshold for selecting individuals for screening is statistically and clinically more efficient than the USPSTF criteria, because it leads to a smaller number of individuals being screened, identifies significantly more lung cancers, and has higher PPV [positive predictive value].”

This risk prediction model would have selected 8.8% fewer candidates for screening but detected 12.4% more lung cancers using the results from the PLCO and NLST trial to test the risk prediction model, “and because specificity is significantly improved, fewer false positive screens are expected,” the authors note.

And while no formal cost-effective analysis was done, the authors expect applying the model will do better than the current criteria, which already have been determined to be cost effective, because they select less people for screening and capture more positive results.

Researchers suggest that these criteria be implemented on an investigative basis in parallel with the USPSTF and if a patient meets the screening criteria in one or the other, the patient would get the screening.

“This approach is justifiable because it should be more cost-effective than using the USPSTF criteria alone,” they conclude.

[email protected]

Criteria recently proposed by the Centers for Medicare & Medicaid Services for the coverage of lung cancer screening using low-dose computed tomography may not be the most efficient way to screen patients.

The criteria adopted, based on recommendations from the U.S. Preventive Services Task Force (USPSTF) and results from the National Lung Screening Trial (NLST) could include some low-risk patients in the screening while at the same time miss certain high-risk patients who might benefit from low-dose CT screening, according to an analysis published online Dec. 2 in PLOS Medicine (2014 [doi:10.1371/journal.pmed.1001764]). A key difference between CMS’s proposed criteria and the USPSTF guidelines is that CMS would only cover high-risk patients up to 74 years of age, while the USPSTF recommends covering up to 80 years of age.

©Sebastian Kaulitzki/thinkstockphotos.com

“However, it has been shown that selecting individuals for screening based on accurate lung cancer risk prediction models is significantly more sensitive in detecting individuals who will be diagnosed with lung cancer and would save more lives than using the NLST criteria,” wrote Martin C. Tammemagi, Ph.D., of Brock University, St. Catharines, Ont., an epidemiologist on the NLST, and colleagues.

The authors recommend using the PLCO_m2012 model, a “logistic regression lung cancer risk prediction model based on the 6-y incidence of lung cancer occurring in smokers in the control arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).” The model uses four smoking variables (smoking intensity, smoking duration, quit time in former smokers, and current smoking status) and seven nonsmoking variables (age, race/ethnicity, socioeconomic circumstance estimated by education level, body mass index, personal history of cancer, chronic obstructive pulmonary disease, and family history of lung cancer).

“The PLCO_m2012 model demonstrated high predictive performance, both discrimination and calibration, in external validation in PLCO intervention arm smokers,” the authors note.

Researchers found that applying the “PLCO_m2012 model with a risk greater than or equal to 0.0151 threshold for selecting individuals for screening is statistically and clinically more efficient than the USPSTF criteria, because it leads to a smaller number of individuals being screened, identifies significantly more lung cancers, and has higher PPV [positive predictive value].”

This risk prediction model would have selected 8.8% fewer candidates for screening but detected 12.4% more lung cancers using the results from the PLCO and NLST trial to test the risk prediction model, “and because specificity is significantly improved, fewer false positive screens are expected,” the authors note.

And while no formal cost-effective analysis was done, the authors expect applying the model will do better than the current criteria, which already have been determined to be cost effective, because they select less people for screening and capture more positive results.

Researchers suggest that these criteria be implemented on an investigative basis in parallel with the USPSTF and if a patient meets the screening criteria in one or the other, the patient would get the screening.

“This approach is justifiable because it should be more cost-effective than using the USPSTF criteria alone,” they conclude.

[email protected]

Criteria recently proposed by the Centers for Medicare & Medicaid Services for the coverage of lung cancer screening using low-dose computed tomography may not be the most efficient way to screen patients.

The criteria adopted, based on recommendations from the U.S. Preventive Services Task Force (USPSTF) and results from the National Lung Screening Trial (NLST) could include some low-risk patients in the screening while at the same time miss certain high-risk patients who might benefit from low-dose CT screening, according to an analysis published online Dec. 2 in PLOS Medicine (2014 [doi:10.1371/journal.pmed.1001764]). A key difference between CMS’s proposed criteria and the USPSTF guidelines is that CMS would only cover high-risk patients up to 74 years of age, while the USPSTF recommends covering up to 80 years of age.

©Sebastian Kaulitzki/thinkstockphotos.com

“However, it has been shown that selecting individuals for screening based on accurate lung cancer risk prediction models is significantly more sensitive in detecting individuals who will be diagnosed with lung cancer and would save more lives than using the NLST criteria,” wrote Martin C. Tammemagi, Ph.D., of Brock University, St. Catharines, Ont., an epidemiologist on the NLST, and colleagues.

The authors recommend using the PLCO_m2012 model, a “logistic regression lung cancer risk prediction model based on the 6-y incidence of lung cancer occurring in smokers in the control arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).” The model uses four smoking variables (smoking intensity, smoking duration, quit time in former smokers, and current smoking status) and seven nonsmoking variables (age, race/ethnicity, socioeconomic circumstance estimated by education level, body mass index, personal history of cancer, chronic obstructive pulmonary disease, and family history of lung cancer).

“The PLCO_m2012 model demonstrated high predictive performance, both discrimination and calibration, in external validation in PLCO intervention arm smokers,” the authors note.

Researchers found that applying the “PLCO_m2012 model with a risk greater than or equal to 0.0151 threshold for selecting individuals for screening is statistically and clinically more efficient than the USPSTF criteria, because it leads to a smaller number of individuals being screened, identifies significantly more lung cancers, and has higher PPV [positive predictive value].”

This risk prediction model would have selected 8.8% fewer candidates for screening but detected 12.4% more lung cancers using the results from the PLCO and NLST trial to test the risk prediction model, “and because specificity is significantly improved, fewer false positive screens are expected,” the authors note.

And while no formal cost-effective analysis was done, the authors expect applying the model will do better than the current criteria, which already have been determined to be cost effective, because they select less people for screening and capture more positive results.

Researchers suggest that these criteria be implemented on an investigative basis in parallel with the USPSTF and if a patient meets the screening criteria in one or the other, the patient would get the screening.

“This approach is justifiable because it should be more cost-effective than using the USPSTF criteria alone,” they conclude.

[email protected]

Despite a decline in use of soft bedding in infant sleep environments since 1993, more than half of parents continue the practice, putting their children at risk, according to a recent study.

“The use of certain types of bedding in the infant sleep environment is a modifiable risk factor for SIDS [sudden infant death syndrome] and unintentional sleep-related suffocation,” reported Carrie Shapiro-Mendoza, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and her colleagues.

The American Academy of Pediatrics recommends that soft objects – such as blankets, pillows, soft toys, quilts, comforters, and sheepskin – not be placed in infants’ sleeping areas.

©Travis Manley/Thinkstock

“However, despite such recommendations, the use of bedding over and under the infant for sleep seems to have remained a common practice,” the authors wrote (Pediatrics 2014 [doi:10.1542/peds.2014-1793]).

The authors analyzed data from the annual, cross-sectional National Infant Sleep Position telephone survey data from 1993 to 2010. Among the 18,952 respondents – all of whom were parents of children under 8 months old – 83% were white, 45% had a college education, and 52% had a previous child.

Use of soft bedding dropped from an average 86% in 1993-1995 to 55% in 2008-2010. Thick blankets and quilts/comforters were the most common covers used, and blankets and cushions were the most common items used under infants.

Although use of thick blanket coverings declined from 56% to 27% during that time and quilt/comforter cover use declined from 39% to 8%, the use of blankets and cushions under sleeping infants actually increased, from 26% to 32% and 3% to 5%, respectively.

Risk factors for soft bedding use included lack of college education, nonwhite race, and younger maternal age, with 84% of teenage mothers reporting soft bedding use. In 1993-2010, an average 64% of white parents, 76% of Hispanic parents, and 75% of black parents used bedding.

The study was funded by the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no disclosures.

Despite a decline in use of soft bedding in infant sleep environments since 1993, more than half of parents continue the practice, putting their children at risk, according to a recent study.

“The use of certain types of bedding in the infant sleep environment is a modifiable risk factor for SIDS [sudden infant death syndrome] and unintentional sleep-related suffocation,” reported Carrie Shapiro-Mendoza, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and her colleagues.

The American Academy of Pediatrics recommends that soft objects – such as blankets, pillows, soft toys, quilts, comforters, and sheepskin – not be placed in infants’ sleeping areas.

©Travis Manley/Thinkstock

“However, despite such recommendations, the use of bedding over and under the infant for sleep seems to have remained a common practice,” the authors wrote (Pediatrics 2014 [doi:10.1542/peds.2014-1793]).

The authors analyzed data from the annual, cross-sectional National Infant Sleep Position telephone survey data from 1993 to 2010. Among the 18,952 respondents – all of whom were parents of children under 8 months old – 83% were white, 45% had a college education, and 52% had a previous child.

Use of soft bedding dropped from an average 86% in 1993-1995 to 55% in 2008-2010. Thick blankets and quilts/comforters were the most common covers used, and blankets and cushions were the most common items used under infants.

Although use of thick blanket coverings declined from 56% to 27% during that time and quilt/comforter cover use declined from 39% to 8%, the use of blankets and cushions under sleeping infants actually increased, from 26% to 32% and 3% to 5%, respectively.

Risk factors for soft bedding use included lack of college education, nonwhite race, and younger maternal age, with 84% of teenage mothers reporting soft bedding use. In 1993-2010, an average 64% of white parents, 76% of Hispanic parents, and 75% of black parents used bedding.

The study was funded by the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no disclosures.

Despite a decline in use of soft bedding in infant sleep environments since 1993, more than half of parents continue the practice, putting their children at risk, according to a recent study.

“The use of certain types of bedding in the infant sleep environment is a modifiable risk factor for SIDS [sudden infant death syndrome] and unintentional sleep-related suffocation,” reported Carrie Shapiro-Mendoza, Ph.D., of the Centers for Disease Control and Prevention, Atlanta, and her colleagues.

The American Academy of Pediatrics recommends that soft objects – such as blankets, pillows, soft toys, quilts, comforters, and sheepskin – not be placed in infants’ sleeping areas.

©Travis Manley/Thinkstock

“However, despite such recommendations, the use of bedding over and under the infant for sleep seems to have remained a common practice,” the authors wrote (Pediatrics 2014 [doi:10.1542/peds.2014-1793]).

The authors analyzed data from the annual, cross-sectional National Infant Sleep Position telephone survey data from 1993 to 2010. Among the 18,952 respondents – all of whom were parents of children under 8 months old – 83% were white, 45% had a college education, and 52% had a previous child.

Use of soft bedding dropped from an average 86% in 1993-1995 to 55% in 2008-2010. Thick blankets and quilts/comforters were the most common covers used, and blankets and cushions were the most common items used under infants.

Although use of thick blanket coverings declined from 56% to 27% during that time and quilt/comforter cover use declined from 39% to 8%, the use of blankets and cushions under sleeping infants actually increased, from 26% to 32% and 3% to 5%, respectively.

Risk factors for soft bedding use included lack of college education, nonwhite race, and younger maternal age, with 84% of teenage mothers reporting soft bedding use. In 1993-2010, an average 64% of white parents, 76% of Hispanic parents, and 75% of black parents used bedding.

The study was funded by the National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors reported no disclosures.

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

Creatas Images

Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

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Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

The reported link between early life exposure to acetaminophen and the development of asthma in children is “weak” and “overstated” based on currently available evidence, according to a report published by the Archives of Disease in Childhood.

In a review of currently available data culled from Embase and PubMed databases, 1,192 relevant studies conducted between 1967 and 2013 were analyzed, of which 11 were included for analysis. Of these 11 studies, 5 found “increased odds” that exposure to acetaminophen during the first trimester of pregnancy could lead to development of asthma (pooled odds ratio, 1.39); however, there was a high degree of between-study heterogeneity among the trials (I² = 64.2%, P = .03), reported Dr. M. Cheelo of the University of Melbourne, and associates.

Creatas Images

Of those five, only two studies examined the effects of acetaminophen exposure during the second trimester, but attained widely disparate results: Study one reported an OR of 1.06, while the other reported an OR of 2.15, with I² = 80%. Two studies also tested acetaminophen exposure during the third trimester and found a “weak association,” with a pooled OR of 1.17. Three studies look at acetaminophen exposure through an entire pregnancy, but all had “significant heterogeneity” in their findings (OR = 1.65, 1.22, and 0.74; I² = 89%). Only one study that was examined adjusted for respiratory tract infections during pregnancy, but according to the authors, “all studies that adjusted for early life respiratory tract infections found a reduction in the association between [acetaminophen] exposure and subsequent childhood asthma” (Arch. Dis. Child. 2014 [doi:10.1136/archdischild-2012-303043]).

The other 6 of the 11 total studies examined acetaminophen exposure over the first 2 years of life. Three of these studies found a “weak positive association,” as did four studies directly comparing children with and without acetaminophen exposure. All but one study adjusted results for respiratory tract infections during pregnancy, which caused a “moderate attenuation of the association between frequency of [acetaminophen] intake and childhood asthma.” Consequently, investigators concluded that “evidence of an association between early life [acetaminophen] and asthma is often overstated, and there is currently insufficient evidence to support changing guidelines in the use of this medicine.”

The authors reported no relevant financial conflicts of interest.

[email protected]

One of the biggest lessons so far from the West African Ebola outbreak is the importance of early identification of infectious disease outbreaks. That’s the best way to get a quick response, and a quick response can mean the difference between an outbreak’s control or spread.

As reported from the International Meeting on Emerging Diseases and Surveillance (IMED) in early November, the Ebola experience in Africa this past year has been marked by slow responses in Liberia and Sierra Leone, followed by unprecedented Ebola spread – and quick responses in Nigeria and the Democratic Republic of the Congo, followed by declarations by the World Health Organization that Nigeria and then DRC had become Ebola-free.

Wikimedia Commons

Many factors play into early identification of infection outbreaks, but a new approach may be one of the best, especially once it fully catches on. It’s called participatory surveillance, and it means that everyone – or at least as many as can be persuaded – commits to regularly updating (usually weekly) a public health database on their health status.

While participatory surveillance is not being used in Africa, it’s being used elsewhere, including in the United States as the Flu Near You program. As also reported out of the same IMED meeting, Flu Near You is the best U.S. example of participatory surveillance, with a current database of about 100,000 U.S. enrollees. Ideally, the participants reply each week to a short survey that asks if they had any of 10 symptoms that can flag influenza, such as fever, headache, cough, sore throat, or fatigue.

When we first reported on Flu Near You nearly 2 years ago, it was an interesting concept just starting to roll out. Returning to Flu Near You for a second look a few weeks ago revealed that it had become a useful if still immature tool that had caught the notice of the Centers for Disease Control and Prevention (CDC).

Now it’s poised for the next step, which is where you come in: Sign up, and be active by responding to the weekly survey.

A CDC staffer in Atlanta told us that the agency already sees Flu Near You as a valuable adjunct to the flu surveillance it traditionally conducts. If the database is helpful for tracking national influenza trends with 100,000 Americans registered, imagine how much more informative it would be with 1 million, 10 million, or even more participants. The only way participatory surveillance succeeds is if people buy in and become part of the process. If enough people did that, the public health insights would soar.

Numbers are what’s holding Flu Near You back right now. Each of us has the ability to change that a little.

[email protected]

On Twitter @mitchelzoler

One of the biggest lessons so far from the West African Ebola outbreak is the importance of early identification of infectious disease outbreaks. That’s the best way to get a quick response, and a quick response can mean the difference between an outbreak’s control or spread.

As reported from the International Meeting on Emerging Diseases and Surveillance (IMED) in early November, the Ebola experience in Africa this past year has been marked by slow responses in Liberia and Sierra Leone, followed by unprecedented Ebola spread – and quick responses in Nigeria and the Democratic Republic of the Congo, followed by declarations by the World Health Organization that Nigeria and then DRC had become Ebola-free.

Wikimedia Commons

Many factors play into early identification of infection outbreaks, but a new approach may be one of the best, especially once it fully catches on. It’s called participatory surveillance, and it means that everyone – or at least as many as can be persuaded – commits to regularly updating (usually weekly) a public health database on their health status.

While participatory surveillance is not being used in Africa, it’s being used elsewhere, including in the United States as the Flu Near You program. As also reported out of the same IMED meeting, Flu Near You is the best U.S. example of participatory surveillance, with a current database of about 100,000 U.S. enrollees. Ideally, the participants reply each week to a short survey that asks if they had any of 10 symptoms that can flag influenza, such as fever, headache, cough, sore throat, or fatigue.

When we first reported on Flu Near You nearly 2 years ago, it was an interesting concept just starting to roll out. Returning to Flu Near You for a second look a few weeks ago revealed that it had become a useful if still immature tool that had caught the notice of the Centers for Disease Control and Prevention (CDC).

Now it’s poised for the next step, which is where you come in: Sign up, and be active by responding to the weekly survey.

A CDC staffer in Atlanta told us that the agency already sees Flu Near You as a valuable adjunct to the flu surveillance it traditionally conducts. If the database is helpful for tracking national influenza trends with 100,000 Americans registered, imagine how much more informative it would be with 1 million, 10 million, or even more participants. The only way participatory surveillance succeeds is if people buy in and become part of the process. If enough people did that, the public health insights would soar.

Numbers are what’s holding Flu Near You back right now. Each of us has the ability to change that a little.

[email protected]

On Twitter @mitchelzoler

One of the biggest lessons so far from the West African Ebola outbreak is the importance of early identification of infectious disease outbreaks. That’s the best way to get a quick response, and a quick response can mean the difference between an outbreak’s control or spread.

As reported from the International Meeting on Emerging Diseases and Surveillance (IMED) in early November, the Ebola experience in Africa this past year has been marked by slow responses in Liberia and Sierra Leone, followed by unprecedented Ebola spread – and quick responses in Nigeria and the Democratic Republic of the Congo, followed by declarations by the World Health Organization that Nigeria and then DRC had become Ebola-free.

Wikimedia Commons

Many factors play into early identification of infection outbreaks, but a new approach may be one of the best, especially once it fully catches on. It’s called participatory surveillance, and it means that everyone – or at least as many as can be persuaded – commits to regularly updating (usually weekly) a public health database on their health status.

While participatory surveillance is not being used in Africa, it’s being used elsewhere, including in the United States as the Flu Near You program. As also reported out of the same IMED meeting, Flu Near You is the best U.S. example of participatory surveillance, with a current database of about 100,000 U.S. enrollees. Ideally, the participants reply each week to a short survey that asks if they had any of 10 symptoms that can flag influenza, such as fever, headache, cough, sore throat, or fatigue.

When we first reported on Flu Near You nearly 2 years ago, it was an interesting concept just starting to roll out. Returning to Flu Near You for a second look a few weeks ago revealed that it had become a useful if still immature tool that had caught the notice of the Centers for Disease Control and Prevention (CDC).

Now it’s poised for the next step, which is where you come in: Sign up, and be active by responding to the weekly survey.

A CDC staffer in Atlanta told us that the agency already sees Flu Near You as a valuable adjunct to the flu surveillance it traditionally conducts. If the database is helpful for tracking national influenza trends with 100,000 Americans registered, imagine how much more informative it would be with 1 million, 10 million, or even more participants. The only way participatory surveillance succeeds is if people buy in and become part of the process. If enough people did that, the public health insights would soar.

Numbers are what’s holding Flu Near You back right now. Each of us has the ability to change that a little.

[email protected]

On Twitter @mitchelzoler