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New analysis challenges fluid resuscitation guidelines for patients in shock
Although guideline recommended, according to a detailed analysis of available data, including a randomized trial.
Several sets of guidelines for resuscitation of patients in shock have advocated volume expansion with bolus intravenous fluid, but that recommendation was based on expected physiologic benefits not a randomized trial. The only randomized trial associated this approach showed increased mortality, and a new analysis of these and other data appears to explain why.
According to the findings of a study lead by Michael Levin, MD, of the department of medicine at Imperial College London and colleagues, “volume resuscitation is associated with deterioration of respiratory function and neurological function in some patients.” Their study was published in Lancet Respiratory Medicine. The authors stated that saline-induced hyperchloremic acidosis appears to have been “a major contributor” to the observed increase in adverse outcomes.
The key take home message is that “normal saline and other unbuffered crystalloid solutions should be avoided in resuscitating seriously ill patients,” according to the authors, who believe the findings might be relevant to adults as well as children.
The controversy about the role of volume expansion for management of shock was ignited by a 2011 trial called FEAST (N Engl J Med. 2011;364:2483-95). That trial, which randomized African children with severe febrile illness to a bolus of 20-40 mg of 5% albumin solution, a bolus of 0.9% saline solution, or no bolus, was halted early when 48-hour mortality data showed a lower death rate in the no bolus group (7.3%) than either the albumin (10.6%) or saline (10.5%) bolus groups.
The FEAST result was unexpected and so contrary to accepted thinking that it prompted widespread debate, including whether findings in the resource-poor area of the world where the FEAST trial was conducted could be extrapolated to centers elsewhere in the world. Arguing for benefit, fluid resuscitation is known to increase pulse pressure and urinary output. Arguing against benefit, pulmonary edema is a known complication of bolus fluid replacement.
In an attempt to address and potentially resolve this controversy, data collected in the FEAST trial along with four other sets of data involving volume expansion in critically ill children were evaluated with a focus on changes in cardiovascular, neurological, and respiratory function. Analysis of blood biochemistry and blood oxygen transport were also conducted.
The cardiovascular, respiratory, and neurologic functions were scored on the basis of objective measurements, such as heart rate, respiratory rate, and blood pressure. These measures were evaluated prior to fluid administration and at 1 hour, 4 hours, 8 hours, 24 hours, and 48 hours after fluid administration. Odds ratio (OR) of an adverse outcome were evaluated in the context of each 10-unit change in these scores.
Relative to baseline, there was worsening respiratory and neurological function after fluid administration. Although cardiovascular function improved, hemoglobin concentrations were lower in those who received fluid than in those who did not. Fluid resuscitation was also associated with lower bicarbonate and increased base deficit and chloride at 24 hours.
Regression modeling with physiological variables suggests “that the increased mortality in FEAST can be explained by bolus-induced worsening in respiratory and neurological function, hemodilution, and hyperchloremic acidosis,” according to the authors.
Analyses of the four other sets of data, which included children treated for meningococcal sepsis in the United Kingdom, acutely ill with malaria treated in Malawi, and cohorts of children in South Africa and a London hospital for acute illnesses, provided supportive data.
Although this analysis does not address the value of administering buffered solutions in low volumes, the authors concluded that the data from the FEAST trial are generalizable. They challenge the routine use of bolus infusions of saline or albumin in the initial management of shock, which has been guideline recommended. The risks of fluid resuscitation might be particularly high among children who already have compromised respiratory or neurologic function.
SOURCE: Levin M et al. Lancet Respir Med. 2019;7:581-93.
Although guideline recommended, according to a detailed analysis of available data, including a randomized trial.
Several sets of guidelines for resuscitation of patients in shock have advocated volume expansion with bolus intravenous fluid, but that recommendation was based on expected physiologic benefits not a randomized trial. The only randomized trial associated this approach showed increased mortality, and a new analysis of these and other data appears to explain why.
According to the findings of a study lead by Michael Levin, MD, of the department of medicine at Imperial College London and colleagues, “volume resuscitation is associated with deterioration of respiratory function and neurological function in some patients.” Their study was published in Lancet Respiratory Medicine. The authors stated that saline-induced hyperchloremic acidosis appears to have been “a major contributor” to the observed increase in adverse outcomes.
The key take home message is that “normal saline and other unbuffered crystalloid solutions should be avoided in resuscitating seriously ill patients,” according to the authors, who believe the findings might be relevant to adults as well as children.
The controversy about the role of volume expansion for management of shock was ignited by a 2011 trial called FEAST (N Engl J Med. 2011;364:2483-95). That trial, which randomized African children with severe febrile illness to a bolus of 20-40 mg of 5% albumin solution, a bolus of 0.9% saline solution, or no bolus, was halted early when 48-hour mortality data showed a lower death rate in the no bolus group (7.3%) than either the albumin (10.6%) or saline (10.5%) bolus groups.
The FEAST result was unexpected and so contrary to accepted thinking that it prompted widespread debate, including whether findings in the resource-poor area of the world where the FEAST trial was conducted could be extrapolated to centers elsewhere in the world. Arguing for benefit, fluid resuscitation is known to increase pulse pressure and urinary output. Arguing against benefit, pulmonary edema is a known complication of bolus fluid replacement.
In an attempt to address and potentially resolve this controversy, data collected in the FEAST trial along with four other sets of data involving volume expansion in critically ill children were evaluated with a focus on changes in cardiovascular, neurological, and respiratory function. Analysis of blood biochemistry and blood oxygen transport were also conducted.
The cardiovascular, respiratory, and neurologic functions were scored on the basis of objective measurements, such as heart rate, respiratory rate, and blood pressure. These measures were evaluated prior to fluid administration and at 1 hour, 4 hours, 8 hours, 24 hours, and 48 hours after fluid administration. Odds ratio (OR) of an adverse outcome were evaluated in the context of each 10-unit change in these scores.
Relative to baseline, there was worsening respiratory and neurological function after fluid administration. Although cardiovascular function improved, hemoglobin concentrations were lower in those who received fluid than in those who did not. Fluid resuscitation was also associated with lower bicarbonate and increased base deficit and chloride at 24 hours.
Regression modeling with physiological variables suggests “that the increased mortality in FEAST can be explained by bolus-induced worsening in respiratory and neurological function, hemodilution, and hyperchloremic acidosis,” according to the authors.
Analyses of the four other sets of data, which included children treated for meningococcal sepsis in the United Kingdom, acutely ill with malaria treated in Malawi, and cohorts of children in South Africa and a London hospital for acute illnesses, provided supportive data.
Although this analysis does not address the value of administering buffered solutions in low volumes, the authors concluded that the data from the FEAST trial are generalizable. They challenge the routine use of bolus infusions of saline or albumin in the initial management of shock, which has been guideline recommended. The risks of fluid resuscitation might be particularly high among children who already have compromised respiratory or neurologic function.
SOURCE: Levin M et al. Lancet Respir Med. 2019;7:581-93.
Although guideline recommended, according to a detailed analysis of available data, including a randomized trial.
Several sets of guidelines for resuscitation of patients in shock have advocated volume expansion with bolus intravenous fluid, but that recommendation was based on expected physiologic benefits not a randomized trial. The only randomized trial associated this approach showed increased mortality, and a new analysis of these and other data appears to explain why.
According to the findings of a study lead by Michael Levin, MD, of the department of medicine at Imperial College London and colleagues, “volume resuscitation is associated with deterioration of respiratory function and neurological function in some patients.” Their study was published in Lancet Respiratory Medicine. The authors stated that saline-induced hyperchloremic acidosis appears to have been “a major contributor” to the observed increase in adverse outcomes.
The key take home message is that “normal saline and other unbuffered crystalloid solutions should be avoided in resuscitating seriously ill patients,” according to the authors, who believe the findings might be relevant to adults as well as children.
The controversy about the role of volume expansion for management of shock was ignited by a 2011 trial called FEAST (N Engl J Med. 2011;364:2483-95). That trial, which randomized African children with severe febrile illness to a bolus of 20-40 mg of 5% albumin solution, a bolus of 0.9% saline solution, or no bolus, was halted early when 48-hour mortality data showed a lower death rate in the no bolus group (7.3%) than either the albumin (10.6%) or saline (10.5%) bolus groups.
The FEAST result was unexpected and so contrary to accepted thinking that it prompted widespread debate, including whether findings in the resource-poor area of the world where the FEAST trial was conducted could be extrapolated to centers elsewhere in the world. Arguing for benefit, fluid resuscitation is known to increase pulse pressure and urinary output. Arguing against benefit, pulmonary edema is a known complication of bolus fluid replacement.
In an attempt to address and potentially resolve this controversy, data collected in the FEAST trial along with four other sets of data involving volume expansion in critically ill children were evaluated with a focus on changes in cardiovascular, neurological, and respiratory function. Analysis of blood biochemistry and blood oxygen transport were also conducted.
The cardiovascular, respiratory, and neurologic functions were scored on the basis of objective measurements, such as heart rate, respiratory rate, and blood pressure. These measures were evaluated prior to fluid administration and at 1 hour, 4 hours, 8 hours, 24 hours, and 48 hours after fluid administration. Odds ratio (OR) of an adverse outcome were evaluated in the context of each 10-unit change in these scores.
Relative to baseline, there was worsening respiratory and neurological function after fluid administration. Although cardiovascular function improved, hemoglobin concentrations were lower in those who received fluid than in those who did not. Fluid resuscitation was also associated with lower bicarbonate and increased base deficit and chloride at 24 hours.
Regression modeling with physiological variables suggests “that the increased mortality in FEAST can be explained by bolus-induced worsening in respiratory and neurological function, hemodilution, and hyperchloremic acidosis,” according to the authors.
Analyses of the four other sets of data, which included children treated for meningococcal sepsis in the United Kingdom, acutely ill with malaria treated in Malawi, and cohorts of children in South Africa and a London hospital for acute illnesses, provided supportive data.
Although this analysis does not address the value of administering buffered solutions in low volumes, the authors concluded that the data from the FEAST trial are generalizable. They challenge the routine use of bolus infusions of saline or albumin in the initial management of shock, which has been guideline recommended. The risks of fluid resuscitation might be particularly high among children who already have compromised respiratory or neurologic function.
SOURCE: Levin M et al. Lancet Respir Med. 2019;7:581-93.
FROM THE LANCET RESPIRATORY MEDICINE
Little association found between in utero H1N1 vaccine and 5-year health outcomes
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
according to Laura K. Walsh of the University of Ottawa and associates.
The investigators conducted a population-based retrospective cohort study from November 2009 to October 2010 of all live births within the province of Ontario. Of the 104,249 eligible live births reported to the Ontario birth registry, 31,295 were exposed to the H1N1 vaccine in utero. After adjustment, there were no significant differences in the women who did and did not receive vaccines during pregnancy, according to the study, published in the BMJ.
After a median follow-up of 5 years, 14% of children received an asthma diagnosis, with a median age at diagnosis of 1.8 years. Children were more likely to receive an asthma diagnosis if their mothers had a preexisting condition or if they were born preterm. At follow-up, 34% of children had at least one upper respiratory tract infection. Sensory disorder, neoplasm, and pediatric complex chronic condition were rare, each occurring in less than 1% of the study cohort (BMJ. 2019 Jul 10. doi: 10.1136/bmj.l4151).
No significant association was found between prenatal exposure to the H1N1 vaccine and upper or lower respiratory infections, otitis media, all infections, neoplasms, sensory disorders, rates of urgent and inpatient health services use, pediatric complex chronic conditions, or mortality. A weak but significant association was observed for asthma (adjusted hazard ratio, 1.05; 95% confidence interval, 1.02-1.09), and a weak inverse association was found for gastrointestinal infections (adjusted incidence rate ratio, 0.94; 95% CI, 0.91-0.98).
“Although we observed a small, but statistically significant, increase in pediatric asthma and a reduction in gastrointestinal infections, we are not aware of any biologic mechanisms to explain these findings. Future studies in different settings and with different influenza vaccine formulations will be important for developing the evidence base on longer-term pediatric outcomes following influenza vaccination during pregnancy,” the investigators concluded.
The study was funded by grants from the Canadian Institutes of Health Research and the Institute for Clinical Evaluative Sciences.
FROM THE BMJ
Vaping device marketers take aim at youth through social media
with targeted messages and images, a study of e-cigarette promotion has found.
In 2018, the JUUL company declared a commitment to support efforts to raise the age of legal purchase of tobacco to age 21 years in all U.S. states. In addition, JUUL deleted its official Facebook and Instagram accounts in November 2018, but the promotion of these products has continued through affiliated marketing campaigns from other online vendors.
Vaping among teens has shot up in popularity in recent years. The prevalence of vaping among young people aged 16-19 years has been estimated at 16% in 2018, up from 11% in 2017 (BMJ. 2019 Jun 19. doi: 10.1136/bmj.12219. A study published in JAMA Pediatrics (2019;173[7]:690-92) found that an estimated 81% of users following a popular Twitter account (@JUULvapor) were aged 13-20 years, with 45% in the 13-17 year age range.
Elizabeth C. Hair, PhD, senior vice president of the Truth Initiative Schroeder Institute, and a team of investigators conducted a study of the “proliferation of JUUL-related content across four themes over a 3-month period: overt promotional content, nicotine and addiction-related content, lifestyle content, and content related to youth culture.” The study appeared online in Tobacco Control (2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824).
The investigators did a content analysis of social media posts on Instagram related to JUUL and JUUL-like products from March 1 to May 15, 2018. Hash-tag keyword queries of JUUL-related posts on Instagram were collected from the Instagram application programming interface through NUVI, a licensed syndicator of the Instagram firehose. The researchers used 50 hashtags to capture and enumerate individual posts. Examples of the hashtags used are #juul, #juuling, #juulvapor, #juulpod, #switchtojuul, and #juulgang. All posts were included from the official JUUL account and JUUL-related accounts with the highest number of followers at the time of data collection (e.g., @juulcentral, @juulnation, @juul_university, @juul.girls).
The search identified 14,838 posts by 5,201 unique users that featured content relating to product promotion, nicotine and addiction messages, youth culture, and lifestyle themes. Posts were rated promotional incluced branded content, URLs linking to commercial websites, and hashtags indicating affiliations with commercial sites.
Nicotine/addiction posts contained “references to nicotine, including compatible pod-related brand names and nicotine content, as well as any references to addiction or nicotine dependence (e.g., daily use, being an addict, junkie, “nichead,” fiend, maniac), or effects of nicotine use (e.g., “buzz”).
Youth-themed posts included stylistic features such as jargon or slang, acronyms common among youth (e.g., di4j, doit4juul), youth-oriented cartoons, JUUL wrap imagery, youth entertainment, and music. Posts with references to school, the classroom, and other places frequented by youth and youth social networks, family, and peers were included in the youth-themed category.
Lifestyle content referenced "social norms and acceptability-related messages contained any mentions of online or offline communitiesand peer groups (eg, collegelife, juulgirls, juulgang, vapeusa, collegedaily, vapelyfe hashtags) as well as JUUL use during social activities, events, social acceptance of JUULing and any mentions of JUULing as a characteristic of cultural or social identity."
Content analysis of the posts found that 34.3% were promotional, 11% referenced nicotine and addiction themes, and 55.4% featured youth-oriented cultural themes, and 57% featured lifestyle themes. There was overlap among the categories, for example, the 71.9% of the promotional posts had lifestyle messages included and 86.3% of the nicotine/addiction posts contained lifestyle elements. The promotional posts also contained some hashtags referencing cannabis (#420, #710).
An additional feature of the promotional posts is the incentivizing messages. “More than more than a third of JUUL-related posts containing overt promotional content that highlights ways to obtain products at reduced cost, such as giveaways and incentivized friend-tagging. This finding is consistent with previous research which found that Twitter users employed person-tagging (e.g., @username) when purchasing JUUL, suggesting friend-tagging plays an important role in motivating product use,” the researchers wrote.
The study was limited by the short time frame, the analysis of Instagram postings only, and the limitation of only 50 hashtags. These limitations may result in underreporting of the amount of JUUL-related social media messaging that targets youth. In addition, the investigators did not analyze the origin of accounts or the identity of the individuals creating the content.
“The results of this study demonstrate the reach of organic posts that contain JUUL-related content, and posts by third-party vendors of vaping products, who continue to push explicitly youth-targeted advertisements for JUUL and similar e-cigarette products under JUUL-related hashtags,” Dr. Hair wrote. “Our research and studies done by others in the field are one way to build the evidence base to advocate for stricter social media marketing restrictions on tobacco products that are applicable to all players in the field.”
She added that the Food and Drug Administration should use its power to restrict e-cigarette manufacturers from using social media to market to young people. “We also think that social media platforms should do more to adopt and enforce strong and well-enforced policies against the promotion of any tobacco products to young adults,” she concluded.
The study was sponsored by the Truth Initiative. The Truth Initiative was created as a part of the Master Settlement Agreement (MSA) that was negotiated between the tobacco industry and 46 states and the District of Columbia in 1998. The MSA created the American Legacy Foundation (now known as the Truth Initiative), a nonprofit research and educational organization that focuses its efforts on preventing teen smoking and encouraging smokers to quit.
SOURCE: Czaplicki L et al. Tob Control. 2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824.
This article was updated 7/17/2019.
with targeted messages and images, a study of e-cigarette promotion has found.
In 2018, the JUUL company declared a commitment to support efforts to raise the age of legal purchase of tobacco to age 21 years in all U.S. states. In addition, JUUL deleted its official Facebook and Instagram accounts in November 2018, but the promotion of these products has continued through affiliated marketing campaigns from other online vendors.
Vaping among teens has shot up in popularity in recent years. The prevalence of vaping among young people aged 16-19 years has been estimated at 16% in 2018, up from 11% in 2017 (BMJ. 2019 Jun 19. doi: 10.1136/bmj.12219. A study published in JAMA Pediatrics (2019;173[7]:690-92) found that an estimated 81% of users following a popular Twitter account (@JUULvapor) were aged 13-20 years, with 45% in the 13-17 year age range.
Elizabeth C. Hair, PhD, senior vice president of the Truth Initiative Schroeder Institute, and a team of investigators conducted a study of the “proliferation of JUUL-related content across four themes over a 3-month period: overt promotional content, nicotine and addiction-related content, lifestyle content, and content related to youth culture.” The study appeared online in Tobacco Control (2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824).
The investigators did a content analysis of social media posts on Instagram related to JUUL and JUUL-like products from March 1 to May 15, 2018. Hash-tag keyword queries of JUUL-related posts on Instagram were collected from the Instagram application programming interface through NUVI, a licensed syndicator of the Instagram firehose. The researchers used 50 hashtags to capture and enumerate individual posts. Examples of the hashtags used are #juul, #juuling, #juulvapor, #juulpod, #switchtojuul, and #juulgang. All posts were included from the official JUUL account and JUUL-related accounts with the highest number of followers at the time of data collection (e.g., @juulcentral, @juulnation, @juul_university, @juul.girls).
The search identified 14,838 posts by 5,201 unique users that featured content relating to product promotion, nicotine and addiction messages, youth culture, and lifestyle themes. Posts were rated promotional incluced branded content, URLs linking to commercial websites, and hashtags indicating affiliations with commercial sites.
Nicotine/addiction posts contained “references to nicotine, including compatible pod-related brand names and nicotine content, as well as any references to addiction or nicotine dependence (e.g., daily use, being an addict, junkie, “nichead,” fiend, maniac), or effects of nicotine use (e.g., “buzz”).
Youth-themed posts included stylistic features such as jargon or slang, acronyms common among youth (e.g., di4j, doit4juul), youth-oriented cartoons, JUUL wrap imagery, youth entertainment, and music. Posts with references to school, the classroom, and other places frequented by youth and youth social networks, family, and peers were included in the youth-themed category.
Lifestyle content referenced "social norms and acceptability-related messages contained any mentions of online or offline communitiesand peer groups (eg, collegelife, juulgirls, juulgang, vapeusa, collegedaily, vapelyfe hashtags) as well as JUUL use during social activities, events, social acceptance of JUULing and any mentions of JUULing as a characteristic of cultural or social identity."
Content analysis of the posts found that 34.3% were promotional, 11% referenced nicotine and addiction themes, and 55.4% featured youth-oriented cultural themes, and 57% featured lifestyle themes. There was overlap among the categories, for example, the 71.9% of the promotional posts had lifestyle messages included and 86.3% of the nicotine/addiction posts contained lifestyle elements. The promotional posts also contained some hashtags referencing cannabis (#420, #710).
An additional feature of the promotional posts is the incentivizing messages. “More than more than a third of JUUL-related posts containing overt promotional content that highlights ways to obtain products at reduced cost, such as giveaways and incentivized friend-tagging. This finding is consistent with previous research which found that Twitter users employed person-tagging (e.g., @username) when purchasing JUUL, suggesting friend-tagging plays an important role in motivating product use,” the researchers wrote.
The study was limited by the short time frame, the analysis of Instagram postings only, and the limitation of only 50 hashtags. These limitations may result in underreporting of the amount of JUUL-related social media messaging that targets youth. In addition, the investigators did not analyze the origin of accounts or the identity of the individuals creating the content.
“The results of this study demonstrate the reach of organic posts that contain JUUL-related content, and posts by third-party vendors of vaping products, who continue to push explicitly youth-targeted advertisements for JUUL and similar e-cigarette products under JUUL-related hashtags,” Dr. Hair wrote. “Our research and studies done by others in the field are one way to build the evidence base to advocate for stricter social media marketing restrictions on tobacco products that are applicable to all players in the field.”
She added that the Food and Drug Administration should use its power to restrict e-cigarette manufacturers from using social media to market to young people. “We also think that social media platforms should do more to adopt and enforce strong and well-enforced policies against the promotion of any tobacco products to young adults,” she concluded.
The study was sponsored by the Truth Initiative. The Truth Initiative was created as a part of the Master Settlement Agreement (MSA) that was negotiated between the tobacco industry and 46 states and the District of Columbia in 1998. The MSA created the American Legacy Foundation (now known as the Truth Initiative), a nonprofit research and educational organization that focuses its efforts on preventing teen smoking and encouraging smokers to quit.
SOURCE: Czaplicki L et al. Tob Control. 2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824.
This article was updated 7/17/2019.
with targeted messages and images, a study of e-cigarette promotion has found.
In 2018, the JUUL company declared a commitment to support efforts to raise the age of legal purchase of tobacco to age 21 years in all U.S. states. In addition, JUUL deleted its official Facebook and Instagram accounts in November 2018, but the promotion of these products has continued through affiliated marketing campaigns from other online vendors.
Vaping among teens has shot up in popularity in recent years. The prevalence of vaping among young people aged 16-19 years has been estimated at 16% in 2018, up from 11% in 2017 (BMJ. 2019 Jun 19. doi: 10.1136/bmj.12219. A study published in JAMA Pediatrics (2019;173[7]:690-92) found that an estimated 81% of users following a popular Twitter account (@JUULvapor) were aged 13-20 years, with 45% in the 13-17 year age range.
Elizabeth C. Hair, PhD, senior vice president of the Truth Initiative Schroeder Institute, and a team of investigators conducted a study of the “proliferation of JUUL-related content across four themes over a 3-month period: overt promotional content, nicotine and addiction-related content, lifestyle content, and content related to youth culture.” The study appeared online in Tobacco Control (2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824).
The investigators did a content analysis of social media posts on Instagram related to JUUL and JUUL-like products from March 1 to May 15, 2018. Hash-tag keyword queries of JUUL-related posts on Instagram were collected from the Instagram application programming interface through NUVI, a licensed syndicator of the Instagram firehose. The researchers used 50 hashtags to capture and enumerate individual posts. Examples of the hashtags used are #juul, #juuling, #juulvapor, #juulpod, #switchtojuul, and #juulgang. All posts were included from the official JUUL account and JUUL-related accounts with the highest number of followers at the time of data collection (e.g., @juulcentral, @juulnation, @juul_university, @juul.girls).
The search identified 14,838 posts by 5,201 unique users that featured content relating to product promotion, nicotine and addiction messages, youth culture, and lifestyle themes. Posts were rated promotional incluced branded content, URLs linking to commercial websites, and hashtags indicating affiliations with commercial sites.
Nicotine/addiction posts contained “references to nicotine, including compatible pod-related brand names and nicotine content, as well as any references to addiction or nicotine dependence (e.g., daily use, being an addict, junkie, “nichead,” fiend, maniac), or effects of nicotine use (e.g., “buzz”).
Youth-themed posts included stylistic features such as jargon or slang, acronyms common among youth (e.g., di4j, doit4juul), youth-oriented cartoons, JUUL wrap imagery, youth entertainment, and music. Posts with references to school, the classroom, and other places frequented by youth and youth social networks, family, and peers were included in the youth-themed category.
Lifestyle content referenced "social norms and acceptability-related messages contained any mentions of online or offline communitiesand peer groups (eg, collegelife, juulgirls, juulgang, vapeusa, collegedaily, vapelyfe hashtags) as well as JUUL use during social activities, events, social acceptance of JUULing and any mentions of JUULing as a characteristic of cultural or social identity."
Content analysis of the posts found that 34.3% were promotional, 11% referenced nicotine and addiction themes, and 55.4% featured youth-oriented cultural themes, and 57% featured lifestyle themes. There was overlap among the categories, for example, the 71.9% of the promotional posts had lifestyle messages included and 86.3% of the nicotine/addiction posts contained lifestyle elements. The promotional posts also contained some hashtags referencing cannabis (#420, #710).
An additional feature of the promotional posts is the incentivizing messages. “More than more than a third of JUUL-related posts containing overt promotional content that highlights ways to obtain products at reduced cost, such as giveaways and incentivized friend-tagging. This finding is consistent with previous research which found that Twitter users employed person-tagging (e.g., @username) when purchasing JUUL, suggesting friend-tagging plays an important role in motivating product use,” the researchers wrote.
The study was limited by the short time frame, the analysis of Instagram postings only, and the limitation of only 50 hashtags. These limitations may result in underreporting of the amount of JUUL-related social media messaging that targets youth. In addition, the investigators did not analyze the origin of accounts or the identity of the individuals creating the content.
“The results of this study demonstrate the reach of organic posts that contain JUUL-related content, and posts by third-party vendors of vaping products, who continue to push explicitly youth-targeted advertisements for JUUL and similar e-cigarette products under JUUL-related hashtags,” Dr. Hair wrote. “Our research and studies done by others in the field are one way to build the evidence base to advocate for stricter social media marketing restrictions on tobacco products that are applicable to all players in the field.”
She added that the Food and Drug Administration should use its power to restrict e-cigarette manufacturers from using social media to market to young people. “We also think that social media platforms should do more to adopt and enforce strong and well-enforced policies against the promotion of any tobacco products to young adults,” she concluded.
The study was sponsored by the Truth Initiative. The Truth Initiative was created as a part of the Master Settlement Agreement (MSA) that was negotiated between the tobacco industry and 46 states and the District of Columbia in 1998. The MSA created the American Legacy Foundation (now known as the Truth Initiative), a nonprofit research and educational organization that focuses its efforts on preventing teen smoking and encouraging smokers to quit.
SOURCE: Czaplicki L et al. Tob Control. 2019 Jul 2; doi: 10.1136/tobaccocontrol-2018-054824.
This article was updated 7/17/2019.
FROM TOBACCO CONTROL
COPD eosinophil counts predict steroid responders
Triple therapy with an inhaled corticosteroid is particularly helpful for patients with chronic obstructive pulmonary disease (COPD) who have high baseline eosinophil counts, a trial involving more than 10,000 patients found.
Former smokers received greater benefit from inhaled corticosteroids (ICS) than did current smokers, reported lead author Steven Pascoe, MBBS, of GlaxoSmithKline and colleagues. The investigators noted that these findings can help personalize therapy for patients with COPD, which can be challenging to treat because of its heterogeneity. The study was published in Lancet Respiratory Medicine.
The phase 3 IMPACT trial compared single-inhaler fluticasone furoate–umeclidinium–vilanterol with umeclidinium-vilanterol and fluticasone furoate–vilanterol in patients with moderate to very severe COPD at high risk of exacerbation. Of the 10,333 patients involved, approximately one-quarter (26%) had one or more severe exacerbations in the previous year and half (47%) had two or more moderate exacerbations in the same time period. All patients were symptomatic and were aged 40 years or older. A variety of baseline and demographic patient characteristics were recorded, including blood eosinophil count, smoking status, and others. Responses to therapy were measured with trough forced expiratory volume in 1 second (FEV1), symptom scoring, and a quality of life questionnaire.
After 52 weeks, results showed that higher baseline eosinophil counts were associated with progressively greater benefits in favor of triple therapy. For patients with baseline blood eosinophil counts of at least 310 cells per mcL, triple therapy was associated with about half as many moderate and severe exacerbations as treatment with umeclidinium-vilanterol (rate ratio = 0.56; 95% confidence interval, 0.47-0.66). For patients with less than 90 cells per mcL at baseline, the rate ratio for the same two regimens was 0.88, but with a confidence interval crossing 1 (0.74-1.04). For fluticasone furoate–vilanterol vs. umeclidinium-vilanterol, high baseline eosinophil count again demonstrated its predictive power for ICS efficacy, again with an associated rate ratio of 0.56 (0.47-0.66), compared with 1.09 (0.91-1.29) for patients below the lower threshold. Symptom scoring, quality of life, and FEV1 followed a similar trend, although the investigators noted that this was “less marked” for FEV1. Although the trend held regardless of smoking status, benefits were more pronounced among former smokers than current smokers.
“In former smokers, ICS benefits were observed at all blood eosinophil counts when comparing triple therapy with umeclidinium-vilanterol, whereas in current smokers no ICS benefit was observed at lower eosinophil counts, less than approximately 200 eosinophils per [mcL],” the investigators wrote.
“Overall, these results show the potential use of blood eosinophil counts in conjunction with smoking status to predict the magnitude of ICS response within a dual or triple-combination therapy,” the investigators concluded. “Future approaches to the pharmacological management of COPD should move beyond the simple dichotomization of each clinical or biomarker variable, toward more complex algorithms that integrate the interactions between important variables including exacerbation history, smoking status, and blood eosinophil counts.”
The study was funded by GlaxoSmithKline. The investigators disclosed additional relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, CSA Medical, and others.
SOURCE: Pascoe S et al. Lancet Resp Med. 2019 Jul 4. doi: 10.1016/S2213-2600(19)30190-0.
Triple therapy with an inhaled corticosteroid is particularly helpful for patients with chronic obstructive pulmonary disease (COPD) who have high baseline eosinophil counts, a trial involving more than 10,000 patients found.
Former smokers received greater benefit from inhaled corticosteroids (ICS) than did current smokers, reported lead author Steven Pascoe, MBBS, of GlaxoSmithKline and colleagues. The investigators noted that these findings can help personalize therapy for patients with COPD, which can be challenging to treat because of its heterogeneity. The study was published in Lancet Respiratory Medicine.
The phase 3 IMPACT trial compared single-inhaler fluticasone furoate–umeclidinium–vilanterol with umeclidinium-vilanterol and fluticasone furoate–vilanterol in patients with moderate to very severe COPD at high risk of exacerbation. Of the 10,333 patients involved, approximately one-quarter (26%) had one or more severe exacerbations in the previous year and half (47%) had two or more moderate exacerbations in the same time period. All patients were symptomatic and were aged 40 years or older. A variety of baseline and demographic patient characteristics were recorded, including blood eosinophil count, smoking status, and others. Responses to therapy were measured with trough forced expiratory volume in 1 second (FEV1), symptom scoring, and a quality of life questionnaire.
After 52 weeks, results showed that higher baseline eosinophil counts were associated with progressively greater benefits in favor of triple therapy. For patients with baseline blood eosinophil counts of at least 310 cells per mcL, triple therapy was associated with about half as many moderate and severe exacerbations as treatment with umeclidinium-vilanterol (rate ratio = 0.56; 95% confidence interval, 0.47-0.66). For patients with less than 90 cells per mcL at baseline, the rate ratio for the same two regimens was 0.88, but with a confidence interval crossing 1 (0.74-1.04). For fluticasone furoate–vilanterol vs. umeclidinium-vilanterol, high baseline eosinophil count again demonstrated its predictive power for ICS efficacy, again with an associated rate ratio of 0.56 (0.47-0.66), compared with 1.09 (0.91-1.29) for patients below the lower threshold. Symptom scoring, quality of life, and FEV1 followed a similar trend, although the investigators noted that this was “less marked” for FEV1. Although the trend held regardless of smoking status, benefits were more pronounced among former smokers than current smokers.
“In former smokers, ICS benefits were observed at all blood eosinophil counts when comparing triple therapy with umeclidinium-vilanterol, whereas in current smokers no ICS benefit was observed at lower eosinophil counts, less than approximately 200 eosinophils per [mcL],” the investigators wrote.
“Overall, these results show the potential use of blood eosinophil counts in conjunction with smoking status to predict the magnitude of ICS response within a dual or triple-combination therapy,” the investigators concluded. “Future approaches to the pharmacological management of COPD should move beyond the simple dichotomization of each clinical or biomarker variable, toward more complex algorithms that integrate the interactions between important variables including exacerbation history, smoking status, and blood eosinophil counts.”
The study was funded by GlaxoSmithKline. The investigators disclosed additional relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, CSA Medical, and others.
SOURCE: Pascoe S et al. Lancet Resp Med. 2019 Jul 4. doi: 10.1016/S2213-2600(19)30190-0.
Triple therapy with an inhaled corticosteroid is particularly helpful for patients with chronic obstructive pulmonary disease (COPD) who have high baseline eosinophil counts, a trial involving more than 10,000 patients found.
Former smokers received greater benefit from inhaled corticosteroids (ICS) than did current smokers, reported lead author Steven Pascoe, MBBS, of GlaxoSmithKline and colleagues. The investigators noted that these findings can help personalize therapy for patients with COPD, which can be challenging to treat because of its heterogeneity. The study was published in Lancet Respiratory Medicine.
The phase 3 IMPACT trial compared single-inhaler fluticasone furoate–umeclidinium–vilanterol with umeclidinium-vilanterol and fluticasone furoate–vilanterol in patients with moderate to very severe COPD at high risk of exacerbation. Of the 10,333 patients involved, approximately one-quarter (26%) had one or more severe exacerbations in the previous year and half (47%) had two or more moderate exacerbations in the same time period. All patients were symptomatic and were aged 40 years or older. A variety of baseline and demographic patient characteristics were recorded, including blood eosinophil count, smoking status, and others. Responses to therapy were measured with trough forced expiratory volume in 1 second (FEV1), symptom scoring, and a quality of life questionnaire.
After 52 weeks, results showed that higher baseline eosinophil counts were associated with progressively greater benefits in favor of triple therapy. For patients with baseline blood eosinophil counts of at least 310 cells per mcL, triple therapy was associated with about half as many moderate and severe exacerbations as treatment with umeclidinium-vilanterol (rate ratio = 0.56; 95% confidence interval, 0.47-0.66). For patients with less than 90 cells per mcL at baseline, the rate ratio for the same two regimens was 0.88, but with a confidence interval crossing 1 (0.74-1.04). For fluticasone furoate–vilanterol vs. umeclidinium-vilanterol, high baseline eosinophil count again demonstrated its predictive power for ICS efficacy, again with an associated rate ratio of 0.56 (0.47-0.66), compared with 1.09 (0.91-1.29) for patients below the lower threshold. Symptom scoring, quality of life, and FEV1 followed a similar trend, although the investigators noted that this was “less marked” for FEV1. Although the trend held regardless of smoking status, benefits were more pronounced among former smokers than current smokers.
“In former smokers, ICS benefits were observed at all blood eosinophil counts when comparing triple therapy with umeclidinium-vilanterol, whereas in current smokers no ICS benefit was observed at lower eosinophil counts, less than approximately 200 eosinophils per [mcL],” the investigators wrote.
“Overall, these results show the potential use of blood eosinophil counts in conjunction with smoking status to predict the magnitude of ICS response within a dual or triple-combination therapy,” the investigators concluded. “Future approaches to the pharmacological management of COPD should move beyond the simple dichotomization of each clinical or biomarker variable, toward more complex algorithms that integrate the interactions between important variables including exacerbation history, smoking status, and blood eosinophil counts.”
The study was funded by GlaxoSmithKline. The investigators disclosed additional relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, CSA Medical, and others.
SOURCE: Pascoe S et al. Lancet Resp Med. 2019 Jul 4. doi: 10.1016/S2213-2600(19)30190-0.
FROM LANCET RESPIRATORY MEDICINE
Measles cases have slowed but not stopped
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
The United States continues to slowly add new cases of measles to 2019’s postelimination-record total, but California was officially removed from the outbreak list this week, according to the Centers for Disease Control and Prevention.
That is the highest number of cases reported since measles was declared eliminated in 2000 and the most in a single year since 1992.
The end of outbreak-related activity in California leaves three locations still dealing with ongoing cases: Rockland County, N.Y.; New York City; and King, Pierce, and Snohomish Counties in Washington, the CDC said.
Those three jurisdictions currently report the following:
- reported four new cases from July 3 to July 11 and is up to 175 cases for the year.
- had one new case from July 1 to July 8 and is now at 564 for the year.
- reported two cases from July 1 to July 10 and is now at 10 for the year (the other two counties have a total of three cases). Clark County in Washington reported 71 cases in an earlier, unrelated outbreak.
New COPD subtypes help refine risk
Chronic obstructive pulmonary disease (COPD) is often heterogeneous in its presentation and prognosis, and neither pulmonary function tests nor CT alone are always adequate to characterize a patient’s disease. a study has found.
In a paper published in CHEST, Jinkyeong Park, MD, PhD, of Dongguk University Ilsan Hospital in Goyang, South Korea, and colleagues looked at data from 9,080 subjects enrolled in the COPDGene study, an observational cohort of longtime smokers with and without COPD. By assessing visually defined patterns of emphysema with quantitative imaging features and spirometry data, the researchers identified 10 distinct subtypes of COPD (including no disease) and noted significant differences in mortality and progression among them.
Dr. Park and colleagues found that patients in the subgroups with quantitative but no visual emphysema and those with visual but not quantitative emphysema represented unique groups with mild COPD that were both at risk for progression – but with likely different underlying mechanisms. Current smokers, women, and whites were more common among subjects showing visually defined emphysema without quantitative evidence. “Many of the subjects in the visual-only emphysema subtype have areas of low lung density due to emphysema masked by smoking-induced lung inflammation,” the researchers wrote.
Overall 5-year mortality differed significantly among the groups (P less than .01) and was highest in the three groups with moderate to severe centrilobular emphysema. Patients with paraseptal and moderate to severe centrilobular emphysema showed substantial progression of emphysema over 5 years, compared with individuals with no CT abnormality (P less than .05).
“These results suggest that the combination of visual and quantitative CT features, which may reflect different underlying pathobiological processes in COPD, may provide a superior approach to classify individuals with COPD, compared to the use of visual or quantitative CT features alone,” the researchers wrote.
The study received funding from the National Heart, Lung and Blood Institute. Three of the study’s coauthors reported conflicts of interest in the form of patent applications or financial support from pharmaceutical firms. The COPDGene Project receives pharmaceutical industry and U.S. government support.
SOURCE: Park J et al. CHEST. 2019 Jul 5. doi:10:1016/j.chest.2019.06.15.
Chronic obstructive pulmonary disease (COPD) is often heterogeneous in its presentation and prognosis, and neither pulmonary function tests nor CT alone are always adequate to characterize a patient’s disease. a study has found.
In a paper published in CHEST, Jinkyeong Park, MD, PhD, of Dongguk University Ilsan Hospital in Goyang, South Korea, and colleagues looked at data from 9,080 subjects enrolled in the COPDGene study, an observational cohort of longtime smokers with and without COPD. By assessing visually defined patterns of emphysema with quantitative imaging features and spirometry data, the researchers identified 10 distinct subtypes of COPD (including no disease) and noted significant differences in mortality and progression among them.
Dr. Park and colleagues found that patients in the subgroups with quantitative but no visual emphysema and those with visual but not quantitative emphysema represented unique groups with mild COPD that were both at risk for progression – but with likely different underlying mechanisms. Current smokers, women, and whites were more common among subjects showing visually defined emphysema without quantitative evidence. “Many of the subjects in the visual-only emphysema subtype have areas of low lung density due to emphysema masked by smoking-induced lung inflammation,” the researchers wrote.
Overall 5-year mortality differed significantly among the groups (P less than .01) and was highest in the three groups with moderate to severe centrilobular emphysema. Patients with paraseptal and moderate to severe centrilobular emphysema showed substantial progression of emphysema over 5 years, compared with individuals with no CT abnormality (P less than .05).
“These results suggest that the combination of visual and quantitative CT features, which may reflect different underlying pathobiological processes in COPD, may provide a superior approach to classify individuals with COPD, compared to the use of visual or quantitative CT features alone,” the researchers wrote.
The study received funding from the National Heart, Lung and Blood Institute. Three of the study’s coauthors reported conflicts of interest in the form of patent applications or financial support from pharmaceutical firms. The COPDGene Project receives pharmaceutical industry and U.S. government support.
SOURCE: Park J et al. CHEST. 2019 Jul 5. doi:10:1016/j.chest.2019.06.15.
Chronic obstructive pulmonary disease (COPD) is often heterogeneous in its presentation and prognosis, and neither pulmonary function tests nor CT alone are always adequate to characterize a patient’s disease. a study has found.
In a paper published in CHEST, Jinkyeong Park, MD, PhD, of Dongguk University Ilsan Hospital in Goyang, South Korea, and colleagues looked at data from 9,080 subjects enrolled in the COPDGene study, an observational cohort of longtime smokers with and without COPD. By assessing visually defined patterns of emphysema with quantitative imaging features and spirometry data, the researchers identified 10 distinct subtypes of COPD (including no disease) and noted significant differences in mortality and progression among them.
Dr. Park and colleagues found that patients in the subgroups with quantitative but no visual emphysema and those with visual but not quantitative emphysema represented unique groups with mild COPD that were both at risk for progression – but with likely different underlying mechanisms. Current smokers, women, and whites were more common among subjects showing visually defined emphysema without quantitative evidence. “Many of the subjects in the visual-only emphysema subtype have areas of low lung density due to emphysema masked by smoking-induced lung inflammation,” the researchers wrote.
Overall 5-year mortality differed significantly among the groups (P less than .01) and was highest in the three groups with moderate to severe centrilobular emphysema. Patients with paraseptal and moderate to severe centrilobular emphysema showed substantial progression of emphysema over 5 years, compared with individuals with no CT abnormality (P less than .05).
“These results suggest that the combination of visual and quantitative CT features, which may reflect different underlying pathobiological processes in COPD, may provide a superior approach to classify individuals with COPD, compared to the use of visual or quantitative CT features alone,” the researchers wrote.
The study received funding from the National Heart, Lung and Blood Institute. Three of the study’s coauthors reported conflicts of interest in the form of patent applications or financial support from pharmaceutical firms. The COPDGene Project receives pharmaceutical industry and U.S. government support.
SOURCE: Park J et al. CHEST. 2019 Jul 5. doi:10:1016/j.chest.2019.06.15.
FROM CHEST
Patients with COPD at heightened risk for community-acquired pneumonia requiring hospitalization
Patients with chronic obstructive pulmonary disease are at a significantly increased risk for hospitalization for community-acquired pneumonia (CAP), compared with patients without COPD, a large prospective study has found.
Jose Bordon, MD, and colleagues aimed to define incidence and outcomes of COPD patients hospitalized with pneumonia in the city of Louisville, Ky., and to extrapolate the burden of disease in the U.S. population. They conducted a secondary analysis of data from the University of Louisville Pneumonia Study, a prospective population-based cohort study of all hospitalized adults with CAP who were residents in the city of Louisville, Ky., from June 1, 2014, to May 31, 2016.
COPD prevalence in the city of Louisville was derived via data from the 2014 Behavioral Risk Factor Surveillance System (BRFSS) as well as from the 2014 National Health Interview Survey (NHIS). In addition, the researchers analyzed clinical outcomes including time to clinical stability (TCS), length of hospital stay (LOS), and mortality, according to Dr. Bordon, an infectious disease specialist at Providence Health Center, Washington, and colleagues on behalf of the University of Louisville Pneumonia Study Group.
The researchers found an 18-fold greater incidence of community-acquired pneumonia in patients with COPD, compared with non-COPD patients.
A total of 18,246 individuals aged 40 and older with COPD were estimated to live in Louisville, Ky. The researchers found that 3,419 COPD patients were hospitalized due to CAP in Louisville during the 2-year study period. COPD patients, compared with non-COPD patients, were more likely to have a history of heart failure, more ICU admissions, and use of mechanical ventilation, compared with patients without COPD. The two groups had similar pneumonia severity index scores, and 17% received oral steroids prior to admission. COPD patients had more pneumococcal pneumonia, despite receiving pneumococcal vaccine significantly more often than non-COPD patients.
The annual incidence of hospitalized CAP was 9,369 cases per 100,000 COPD patients in the city of Louisville. In the same period, the incidence of CAP in patients without COPD was 509 per 100,000, a more than 18-fold difference.
Although the incidence of CAP in COPD patients was much higher than in those without, the difference didn’t appear to have an impact on clinical outcomes. There were no clinical differences among patients with vs. without COPD in regard to time to reach clinical improvement and time of hospital discharge, and in-hospital mortality was not statistically significantly different between the groups, the authors reported. The mortality of COPD patients during hospitalization, at 30 days, at 6 months, and at 1 year was 5.6% of patients, 11.9%, 24.3%, and 33.0%, respectively vs. 6.6%, 14.2%, 24.2%, and 30.1% in non-COPD patients. However, 1-year all-cause mortality was a significant 25% greater among COPD patients, as might be expected by the progression and effects of the underlying disease.
“[Our] observations mean that nearly 1 in 10 persons with COPD will be hospitalized annually due to CAP. This translates into approximately 500,000 COPD patients hospitalized with CAP every year in the U.S., resulting in a substantial burden of approximately 5 billion U.S. dollars in hospitalization costs,” the researchers stated.
“Modifiable factors associated with CAP such as tobacco smoking and immunizations should be health interventions to prevent the burden of CAP in COPD patients,” even though “pneumococcal vaccination was used more often in the COPD population than in other CAP patients, but pneumococcal pneumonia still occurred at a numerically higher rate,” they noted.
The study was supported by the University of Louisville, Ky., with partial support from Pfizer. The authors reported having no conflicts.
SOURCE: Bordon JM et al. Clin Microbiol Infect. 2019 Jun 26; doi: 10.1016/j.cmi.2019.06.025.
Patients with chronic obstructive pulmonary disease are at a significantly increased risk for hospitalization for community-acquired pneumonia (CAP), compared with patients without COPD, a large prospective study has found.
Jose Bordon, MD, and colleagues aimed to define incidence and outcomes of COPD patients hospitalized with pneumonia in the city of Louisville, Ky., and to extrapolate the burden of disease in the U.S. population. They conducted a secondary analysis of data from the University of Louisville Pneumonia Study, a prospective population-based cohort study of all hospitalized adults with CAP who were residents in the city of Louisville, Ky., from June 1, 2014, to May 31, 2016.
COPD prevalence in the city of Louisville was derived via data from the 2014 Behavioral Risk Factor Surveillance System (BRFSS) as well as from the 2014 National Health Interview Survey (NHIS). In addition, the researchers analyzed clinical outcomes including time to clinical stability (TCS), length of hospital stay (LOS), and mortality, according to Dr. Bordon, an infectious disease specialist at Providence Health Center, Washington, and colleagues on behalf of the University of Louisville Pneumonia Study Group.
The researchers found an 18-fold greater incidence of community-acquired pneumonia in patients with COPD, compared with non-COPD patients.
A total of 18,246 individuals aged 40 and older with COPD were estimated to live in Louisville, Ky. The researchers found that 3,419 COPD patients were hospitalized due to CAP in Louisville during the 2-year study period. COPD patients, compared with non-COPD patients, were more likely to have a history of heart failure, more ICU admissions, and use of mechanical ventilation, compared with patients without COPD. The two groups had similar pneumonia severity index scores, and 17% received oral steroids prior to admission. COPD patients had more pneumococcal pneumonia, despite receiving pneumococcal vaccine significantly more often than non-COPD patients.
The annual incidence of hospitalized CAP was 9,369 cases per 100,000 COPD patients in the city of Louisville. In the same period, the incidence of CAP in patients without COPD was 509 per 100,000, a more than 18-fold difference.
Although the incidence of CAP in COPD patients was much higher than in those without, the difference didn’t appear to have an impact on clinical outcomes. There were no clinical differences among patients with vs. without COPD in regard to time to reach clinical improvement and time of hospital discharge, and in-hospital mortality was not statistically significantly different between the groups, the authors reported. The mortality of COPD patients during hospitalization, at 30 days, at 6 months, and at 1 year was 5.6% of patients, 11.9%, 24.3%, and 33.0%, respectively vs. 6.6%, 14.2%, 24.2%, and 30.1% in non-COPD patients. However, 1-year all-cause mortality was a significant 25% greater among COPD patients, as might be expected by the progression and effects of the underlying disease.
“[Our] observations mean that nearly 1 in 10 persons with COPD will be hospitalized annually due to CAP. This translates into approximately 500,000 COPD patients hospitalized with CAP every year in the U.S., resulting in a substantial burden of approximately 5 billion U.S. dollars in hospitalization costs,” the researchers stated.
“Modifiable factors associated with CAP such as tobacco smoking and immunizations should be health interventions to prevent the burden of CAP in COPD patients,” even though “pneumococcal vaccination was used more often in the COPD population than in other CAP patients, but pneumococcal pneumonia still occurred at a numerically higher rate,” they noted.
The study was supported by the University of Louisville, Ky., with partial support from Pfizer. The authors reported having no conflicts.
SOURCE: Bordon JM et al. Clin Microbiol Infect. 2019 Jun 26; doi: 10.1016/j.cmi.2019.06.025.
Patients with chronic obstructive pulmonary disease are at a significantly increased risk for hospitalization for community-acquired pneumonia (CAP), compared with patients without COPD, a large prospective study has found.
Jose Bordon, MD, and colleagues aimed to define incidence and outcomes of COPD patients hospitalized with pneumonia in the city of Louisville, Ky., and to extrapolate the burden of disease in the U.S. population. They conducted a secondary analysis of data from the University of Louisville Pneumonia Study, a prospective population-based cohort study of all hospitalized adults with CAP who were residents in the city of Louisville, Ky., from June 1, 2014, to May 31, 2016.
COPD prevalence in the city of Louisville was derived via data from the 2014 Behavioral Risk Factor Surveillance System (BRFSS) as well as from the 2014 National Health Interview Survey (NHIS). In addition, the researchers analyzed clinical outcomes including time to clinical stability (TCS), length of hospital stay (LOS), and mortality, according to Dr. Bordon, an infectious disease specialist at Providence Health Center, Washington, and colleagues on behalf of the University of Louisville Pneumonia Study Group.
The researchers found an 18-fold greater incidence of community-acquired pneumonia in patients with COPD, compared with non-COPD patients.
A total of 18,246 individuals aged 40 and older with COPD were estimated to live in Louisville, Ky. The researchers found that 3,419 COPD patients were hospitalized due to CAP in Louisville during the 2-year study period. COPD patients, compared with non-COPD patients, were more likely to have a history of heart failure, more ICU admissions, and use of mechanical ventilation, compared with patients without COPD. The two groups had similar pneumonia severity index scores, and 17% received oral steroids prior to admission. COPD patients had more pneumococcal pneumonia, despite receiving pneumococcal vaccine significantly more often than non-COPD patients.
The annual incidence of hospitalized CAP was 9,369 cases per 100,000 COPD patients in the city of Louisville. In the same period, the incidence of CAP in patients without COPD was 509 per 100,000, a more than 18-fold difference.
Although the incidence of CAP in COPD patients was much higher than in those without, the difference didn’t appear to have an impact on clinical outcomes. There were no clinical differences among patients with vs. without COPD in regard to time to reach clinical improvement and time of hospital discharge, and in-hospital mortality was not statistically significantly different between the groups, the authors reported. The mortality of COPD patients during hospitalization, at 30 days, at 6 months, and at 1 year was 5.6% of patients, 11.9%, 24.3%, and 33.0%, respectively vs. 6.6%, 14.2%, 24.2%, and 30.1% in non-COPD patients. However, 1-year all-cause mortality was a significant 25% greater among COPD patients, as might be expected by the progression and effects of the underlying disease.
“[Our] observations mean that nearly 1 in 10 persons with COPD will be hospitalized annually due to CAP. This translates into approximately 500,000 COPD patients hospitalized with CAP every year in the U.S., resulting in a substantial burden of approximately 5 billion U.S. dollars in hospitalization costs,” the researchers stated.
“Modifiable factors associated with CAP such as tobacco smoking and immunizations should be health interventions to prevent the burden of CAP in COPD patients,” even though “pneumococcal vaccination was used more often in the COPD population than in other CAP patients, but pneumococcal pneumonia still occurred at a numerically higher rate,” they noted.
The study was supported by the University of Louisville, Ky., with partial support from Pfizer. The authors reported having no conflicts.
SOURCE: Bordon JM et al. Clin Microbiol Infect. 2019 Jun 26; doi: 10.1016/j.cmi.2019.06.025.
FROM CLINICAL MICROBIOLOGY AND INFECTION
C-reactive protein testing reduced antibiotic prescribing in patients with COPD exacerbation
, according to a recent randomized, controlled trial.
Point-of-care C-reactive protein (CRP) testing led to fewer antibiotic prescriptions at the initial consultation, according to investigators participating in the PACE study, a multicenter, open-label trial of more than 600 patients with COPD enrolled at one of 86 general practices in the United Kingdom.
Patient-reported antibiotic use over the next 4 weeks was more than 20 percentage points lower for the group managed with the point-of-care strategy, compared with those who received usual care, according to the investigators, led by Christopher C. Butler, FMedSci, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford (England).
Less antibiotic use and fewer prescriptions did not compromise patient-reported, disease-specific quality of life, added Dr. Butler and colleagues. Their report appears in the New England Journal of Medicine.
In the United States and in Europe, more than 80% of COPD patients with acute exacerbations will receive an antibiotic prescription, according to Dr. Butler and coauthors.
“Although many patients who have acute exacerbations of COPD are helped by these treatments, others are not,” wrote the investigators, noting that in one hospital-based study, about one in five such exacerbations were thought to be due to noninfectious causes.
The present study included patients at least 40 years of age who presented to a primary care practice with an acute exacerbation and at least one of the three Anthonisen criteria (increased dyspnea, sputum production, and sputum purulence) intended to guide antibiotic therapy in COPD. A total of 325 were randomly assigned to the CRP testing group, and 324 to a group that received just usual care.
Antibiotic use was reported by fewer patients in the CRP testing group, compared with the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31, 95% confidence interval, 0.20-0.47), the investigators reported.
Only 47.7% of patients in the CRP-guided group received antibiotic prescriptions at the initial consultation, vs. 69.7% of patients in the usual care group.
Hospitalizations over 6 months of follow-up were reported for 8.6% and 9.3% of patients in the CRP-guided and usual-care groups, respectively, while diagnoses of pneumonia were recorded for 3.0% and 4.0%. There was no clinically important difference between groups in the rate of antibiotic-related adverse effects.
“The evidence from our trial suggests that CRP-guided antibiotic prescribing for COPD exacerbations in primary care clinics may reduce patient-reported use of antibiotics and the prescribing of antibiotics by clinicians,” Dr. Butler and colleagues said in a discussion of these results.
Findings from the study by Dr. Butler and colleagues are “compelling enough” to support C-reactive protein (CRP) testing to guide antibiotic use in patient who have acute exacerbations of COPD, wrote the authors of an accompanying editorial.
“The trial achieved its objective, which was to show that CRP testing safely reduces antibiotic use,” stated Allan S. Brett, MD, and Majdi N. Al-Hasan, MB,BS, of the department of medicine at the University of South Carolina, Columbia.
Point-of-care testing of CRP could be applied even more broadly in clinical practice, Dr. Brett and Dr. Al-Hasan wrote, since testing has been shown to reduce prescribing of antibiotics for suspected lower respiratory tract infections and other common presentations in patients with no COPD.
“Whether primary care practices in the United States would embrace point-of-care CRP testing is another matter, given the regulatory requirements for in-office laboratory testing and uncertainty about reimbursement,” they noted.
Reduced antibiotic prescribing in patients with COPD likely has certain benefits, including reducing risk of Clostridioides difficile colitis, according to the authors.
By contrast, the current study did not determine which COPD patients might benefit from antibiotics, if any, nor which antibiotic might be warranted for those patients.
The study was supported by the Health Technology Assessment Program of the UK National Institute for Health Research. Dr. Butler reported disclosures related to Roche Molecular Systems and Roche Molecular Diagnostics, among others.
SOURCE: Butler CC et al. N Engl J Med. 2019 Jul 10;381:111-20. doi: 10.1056/NEJMoa1803185.
, according to a recent randomized, controlled trial.
Point-of-care C-reactive protein (CRP) testing led to fewer antibiotic prescriptions at the initial consultation, according to investigators participating in the PACE study, a multicenter, open-label trial of more than 600 patients with COPD enrolled at one of 86 general practices in the United Kingdom.
Patient-reported antibiotic use over the next 4 weeks was more than 20 percentage points lower for the group managed with the point-of-care strategy, compared with those who received usual care, according to the investigators, led by Christopher C. Butler, FMedSci, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford (England).
Less antibiotic use and fewer prescriptions did not compromise patient-reported, disease-specific quality of life, added Dr. Butler and colleagues. Their report appears in the New England Journal of Medicine.
In the United States and in Europe, more than 80% of COPD patients with acute exacerbations will receive an antibiotic prescription, according to Dr. Butler and coauthors.
“Although many patients who have acute exacerbations of COPD are helped by these treatments, others are not,” wrote the investigators, noting that in one hospital-based study, about one in five such exacerbations were thought to be due to noninfectious causes.
The present study included patients at least 40 years of age who presented to a primary care practice with an acute exacerbation and at least one of the three Anthonisen criteria (increased dyspnea, sputum production, and sputum purulence) intended to guide antibiotic therapy in COPD. A total of 325 were randomly assigned to the CRP testing group, and 324 to a group that received just usual care.
Antibiotic use was reported by fewer patients in the CRP testing group, compared with the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31, 95% confidence interval, 0.20-0.47), the investigators reported.
Only 47.7% of patients in the CRP-guided group received antibiotic prescriptions at the initial consultation, vs. 69.7% of patients in the usual care group.
Hospitalizations over 6 months of follow-up were reported for 8.6% and 9.3% of patients in the CRP-guided and usual-care groups, respectively, while diagnoses of pneumonia were recorded for 3.0% and 4.0%. There was no clinically important difference between groups in the rate of antibiotic-related adverse effects.
“The evidence from our trial suggests that CRP-guided antibiotic prescribing for COPD exacerbations in primary care clinics may reduce patient-reported use of antibiotics and the prescribing of antibiotics by clinicians,” Dr. Butler and colleagues said in a discussion of these results.
Findings from the study by Dr. Butler and colleagues are “compelling enough” to support C-reactive protein (CRP) testing to guide antibiotic use in patient who have acute exacerbations of COPD, wrote the authors of an accompanying editorial.
“The trial achieved its objective, which was to show that CRP testing safely reduces antibiotic use,” stated Allan S. Brett, MD, and Majdi N. Al-Hasan, MB,BS, of the department of medicine at the University of South Carolina, Columbia.
Point-of-care testing of CRP could be applied even more broadly in clinical practice, Dr. Brett and Dr. Al-Hasan wrote, since testing has been shown to reduce prescribing of antibiotics for suspected lower respiratory tract infections and other common presentations in patients with no COPD.
“Whether primary care practices in the United States would embrace point-of-care CRP testing is another matter, given the regulatory requirements for in-office laboratory testing and uncertainty about reimbursement,” they noted.
Reduced antibiotic prescribing in patients with COPD likely has certain benefits, including reducing risk of Clostridioides difficile colitis, according to the authors.
By contrast, the current study did not determine which COPD patients might benefit from antibiotics, if any, nor which antibiotic might be warranted for those patients.
The study was supported by the Health Technology Assessment Program of the UK National Institute for Health Research. Dr. Butler reported disclosures related to Roche Molecular Systems and Roche Molecular Diagnostics, among others.
SOURCE: Butler CC et al. N Engl J Med. 2019 Jul 10;381:111-20. doi: 10.1056/NEJMoa1803185.
, according to a recent randomized, controlled trial.
Point-of-care C-reactive protein (CRP) testing led to fewer antibiotic prescriptions at the initial consultation, according to investigators participating in the PACE study, a multicenter, open-label trial of more than 600 patients with COPD enrolled at one of 86 general practices in the United Kingdom.
Patient-reported antibiotic use over the next 4 weeks was more than 20 percentage points lower for the group managed with the point-of-care strategy, compared with those who received usual care, according to the investigators, led by Christopher C. Butler, FMedSci, of the Nuffield Department of Primary Care Health Sciences at the University of Oxford (England).
Less antibiotic use and fewer prescriptions did not compromise patient-reported, disease-specific quality of life, added Dr. Butler and colleagues. Their report appears in the New England Journal of Medicine.
In the United States and in Europe, more than 80% of COPD patients with acute exacerbations will receive an antibiotic prescription, according to Dr. Butler and coauthors.
“Although many patients who have acute exacerbations of COPD are helped by these treatments, others are not,” wrote the investigators, noting that in one hospital-based study, about one in five such exacerbations were thought to be due to noninfectious causes.
The present study included patients at least 40 years of age who presented to a primary care practice with an acute exacerbation and at least one of the three Anthonisen criteria (increased dyspnea, sputum production, and sputum purulence) intended to guide antibiotic therapy in COPD. A total of 325 were randomly assigned to the CRP testing group, and 324 to a group that received just usual care.
Antibiotic use was reported by fewer patients in the CRP testing group, compared with the usual-care group (57.0% vs. 77.4%; adjusted odds ratio, 0.31, 95% confidence interval, 0.20-0.47), the investigators reported.
Only 47.7% of patients in the CRP-guided group received antibiotic prescriptions at the initial consultation, vs. 69.7% of patients in the usual care group.
Hospitalizations over 6 months of follow-up were reported for 8.6% and 9.3% of patients in the CRP-guided and usual-care groups, respectively, while diagnoses of pneumonia were recorded for 3.0% and 4.0%. There was no clinically important difference between groups in the rate of antibiotic-related adverse effects.
“The evidence from our trial suggests that CRP-guided antibiotic prescribing for COPD exacerbations in primary care clinics may reduce patient-reported use of antibiotics and the prescribing of antibiotics by clinicians,” Dr. Butler and colleagues said in a discussion of these results.
Findings from the study by Dr. Butler and colleagues are “compelling enough” to support C-reactive protein (CRP) testing to guide antibiotic use in patient who have acute exacerbations of COPD, wrote the authors of an accompanying editorial.
“The trial achieved its objective, which was to show that CRP testing safely reduces antibiotic use,” stated Allan S. Brett, MD, and Majdi N. Al-Hasan, MB,BS, of the department of medicine at the University of South Carolina, Columbia.
Point-of-care testing of CRP could be applied even more broadly in clinical practice, Dr. Brett and Dr. Al-Hasan wrote, since testing has been shown to reduce prescribing of antibiotics for suspected lower respiratory tract infections and other common presentations in patients with no COPD.
“Whether primary care practices in the United States would embrace point-of-care CRP testing is another matter, given the regulatory requirements for in-office laboratory testing and uncertainty about reimbursement,” they noted.
Reduced antibiotic prescribing in patients with COPD likely has certain benefits, including reducing risk of Clostridioides difficile colitis, according to the authors.
By contrast, the current study did not determine which COPD patients might benefit from antibiotics, if any, nor which antibiotic might be warranted for those patients.
The study was supported by the Health Technology Assessment Program of the UK National Institute for Health Research. Dr. Butler reported disclosures related to Roche Molecular Systems and Roche Molecular Diagnostics, among others.
SOURCE: Butler CC et al. N Engl J Med. 2019 Jul 10;381:111-20. doi: 10.1056/NEJMoa1803185.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Parent education improves pediatric influenza vaccination rates
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
according to a randomized clinical trial published in Pediatrics.
Vanessa P. Scott, MD, MS, of Columbia University, New York, and colleagues randomized 400 parent-child dyads into any of three arms: receiving a handout based on national data, receiving a handout based on local data, or receiving usual care. This convenience sample was drawn from two pediatric clinics in New York between August 2016 and March 2017.
After adjustment for parents’ education level, the trial found that parents who received either handout were significantly more likely than were those receiving usual care to vaccinate their children by the end of season (75% and 65%, respectively; adjusted odds ratio, 1.68; 95% confidence interval, 1.06-2.67), but the effects of any intervention versus those of usual care on vaccination on day of visit were not statistically significant (59% vs. 53%; aOR, 1.36; 95% CI, 0.89-2.09).The researchers had hoped that using a targeted approach based on local data would increase vaccine receipt, but that was not seen in the results.
They did find that, across all three arms in the trial, baseline parental intent to vaccinate (likely versus unlikely) was associated with vaccination rates: Both vaccination on clinic visit day (70% vs. 22%; aOR, 8.38; 95% CI, 4.85-14.34) and vaccination by end of season (87% vs. 29%; aOR, 18.26; 95% CI, 9.94-33.52) were affected.
Strengths of the study included the randomized, controlled design and assessment of baseline factors, such as intention to vaccinate, to reduce confounding effects. Limitations included use of a convenience sample, which could have introduced selection bias.
One author was an unremunerated coinvestigator of an unrelated trial that received an investigator-initiated grant from the Pfizer Medical Education Group. Two authors were funded by other grants, but no potential conflicts of interests to disclose were indicated by any of the authors in this study.
SOURCE: Scott VP et al. Pediatrics. 2019. doi: 10.1542/peds.2018-2580.
FROM PEDIATRICS
No reduction in PE risk with vena cava filters after severe injury
MELBOURNE – Use of a prophylactic vena cava filter to trap blood clots in severely injured patients does not appear to reduce the risk of pulmonary embolism or death, according to data presented at the International Society on Thrombosis and Haemostasis congress.
The researchers reported the outcomes of a multicenter, controlled trial in which 240 severely injured patients with a contraindication to anticoagulants were randomized to receive a vena cava filter within 72 hours of admission, or no filter. The findings were published simultaneously in the New England Journal of Medicine.
The study showed no significant differences between the filter and no-filter groups in the primary outcome of a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment (13.9% vs. 14.4% respectively, P = .98).
In a prespecified subgroup analysis, researchers examined patients who survived 7 days after injury and did not receive prophylactic anticoagulation in those 7 days. Among this group of patients, none of those who received the vena cava filter experienced a symptomatic pulmonary embolism between day 8 and day 90, but five patients (14.7%) in the no-filter group did.
Filters were left in place for a median duration of 27 days (11-90 days). Among the 122 patients who received a filter – which included two patients in the control group – researchers found trapped thrombi in the filter in six patients.
Transfusion requirements, and the incidence of major and nonmajor bleeding and leg deep vein thrombosis, were similar between the filter and no-filter groups. Seven patients in the filter group (5.7%) required more than one attempt to remove the filter, and in one patient the filter had to be removed surgically.
Kwok M. Ho, PhD, of the department of intensive care medicine at Royal Perth Hospital, Australia, and coauthors wrote that while vena cava filters are widely used in trauma centers to prevent pulmonary embolism in patients at high risk of bleeding, there are conflicting recommendations regarding their use, and most studies so far have been observational.
“Given the cost and risks associated with a vena cava filter, our data suggest that there is no urgency to insert the filter in patients who can be treated with prophylactic anticoagulation within 7 days after injury,” they wrote. “Unnecessary insertion of a vena cava filter has the potential to cause harm.”
However, they noted that patients with multiple, large intracranial hematomas were particularly at risk from bleeding with anticoagulant therapy, and therefore may benefit from the use of a vena cava filter.
The Medical Research Foundation of Royal Perth Hospital and the Western Australian Department of Health funded the study. Dr. Ho reported funding from the Western Australian Department of Health and the Raine Medical Research Foundation to conduct the study, as well as serving as an adviser to Medtronic and Cardinal Health.
SOURCE: Ho KM et al. N Engl J Med. 2019 Jul 7. doi: 10.156/NEJMoa1806515.
MELBOURNE – Use of a prophylactic vena cava filter to trap blood clots in severely injured patients does not appear to reduce the risk of pulmonary embolism or death, according to data presented at the International Society on Thrombosis and Haemostasis congress.
The researchers reported the outcomes of a multicenter, controlled trial in which 240 severely injured patients with a contraindication to anticoagulants were randomized to receive a vena cava filter within 72 hours of admission, or no filter. The findings were published simultaneously in the New England Journal of Medicine.
The study showed no significant differences between the filter and no-filter groups in the primary outcome of a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment (13.9% vs. 14.4% respectively, P = .98).
In a prespecified subgroup analysis, researchers examined patients who survived 7 days after injury and did not receive prophylactic anticoagulation in those 7 days. Among this group of patients, none of those who received the vena cava filter experienced a symptomatic pulmonary embolism between day 8 and day 90, but five patients (14.7%) in the no-filter group did.
Filters were left in place for a median duration of 27 days (11-90 days). Among the 122 patients who received a filter – which included two patients in the control group – researchers found trapped thrombi in the filter in six patients.
Transfusion requirements, and the incidence of major and nonmajor bleeding and leg deep vein thrombosis, were similar between the filter and no-filter groups. Seven patients in the filter group (5.7%) required more than one attempt to remove the filter, and in one patient the filter had to be removed surgically.
Kwok M. Ho, PhD, of the department of intensive care medicine at Royal Perth Hospital, Australia, and coauthors wrote that while vena cava filters are widely used in trauma centers to prevent pulmonary embolism in patients at high risk of bleeding, there are conflicting recommendations regarding their use, and most studies so far have been observational.
“Given the cost and risks associated with a vena cava filter, our data suggest that there is no urgency to insert the filter in patients who can be treated with prophylactic anticoagulation within 7 days after injury,” they wrote. “Unnecessary insertion of a vena cava filter has the potential to cause harm.”
However, they noted that patients with multiple, large intracranial hematomas were particularly at risk from bleeding with anticoagulant therapy, and therefore may benefit from the use of a vena cava filter.
The Medical Research Foundation of Royal Perth Hospital and the Western Australian Department of Health funded the study. Dr. Ho reported funding from the Western Australian Department of Health and the Raine Medical Research Foundation to conduct the study, as well as serving as an adviser to Medtronic and Cardinal Health.
SOURCE: Ho KM et al. N Engl J Med. 2019 Jul 7. doi: 10.156/NEJMoa1806515.
MELBOURNE – Use of a prophylactic vena cava filter to trap blood clots in severely injured patients does not appear to reduce the risk of pulmonary embolism or death, according to data presented at the International Society on Thrombosis and Haemostasis congress.
The researchers reported the outcomes of a multicenter, controlled trial in which 240 severely injured patients with a contraindication to anticoagulants were randomized to receive a vena cava filter within 72 hours of admission, or no filter. The findings were published simultaneously in the New England Journal of Medicine.
The study showed no significant differences between the filter and no-filter groups in the primary outcome of a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment (13.9% vs. 14.4% respectively, P = .98).
In a prespecified subgroup analysis, researchers examined patients who survived 7 days after injury and did not receive prophylactic anticoagulation in those 7 days. Among this group of patients, none of those who received the vena cava filter experienced a symptomatic pulmonary embolism between day 8 and day 90, but five patients (14.7%) in the no-filter group did.
Filters were left in place for a median duration of 27 days (11-90 days). Among the 122 patients who received a filter – which included two patients in the control group – researchers found trapped thrombi in the filter in six patients.
Transfusion requirements, and the incidence of major and nonmajor bleeding and leg deep vein thrombosis, were similar between the filter and no-filter groups. Seven patients in the filter group (5.7%) required more than one attempt to remove the filter, and in one patient the filter had to be removed surgically.
Kwok M. Ho, PhD, of the department of intensive care medicine at Royal Perth Hospital, Australia, and coauthors wrote that while vena cava filters are widely used in trauma centers to prevent pulmonary embolism in patients at high risk of bleeding, there are conflicting recommendations regarding their use, and most studies so far have been observational.
“Given the cost and risks associated with a vena cava filter, our data suggest that there is no urgency to insert the filter in patients who can be treated with prophylactic anticoagulation within 7 days after injury,” they wrote. “Unnecessary insertion of a vena cava filter has the potential to cause harm.”
However, they noted that patients with multiple, large intracranial hematomas were particularly at risk from bleeding with anticoagulant therapy, and therefore may benefit from the use of a vena cava filter.
The Medical Research Foundation of Royal Perth Hospital and the Western Australian Department of Health funded the study. Dr. Ho reported funding from the Western Australian Department of Health and the Raine Medical Research Foundation to conduct the study, as well as serving as an adviser to Medtronic and Cardinal Health.
SOURCE: Ho KM et al. N Engl J Med. 2019 Jul 7. doi: 10.156/NEJMoa1806515.
REPORTING FROM 2019 ISTH CONGRESS