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Hydrocortisone-fludrocortisone cuts deaths in septic shock
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
The results of the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial and the Adjunctive Corticosteroid Treatment in Critically Ill Patients with Septic Shock (ADRENAL), both reported in the latest issue of NEJM, are landmark studies detailing the largest analyses of hydrocortisone use in patients with septic shock.
Both of these trials were massive, with over 5,000 patients combined, which is much larger than all previous studies according to Anthony Suffredini, MD, of the National Institutes of Health. An additional useful feature of these trials was that they had clear criteria for entry into the study. These criteria included: “vasopressor-dependent shock and respiratory failure leading to the use of mechanical ventilation, details of antimicrobial therapy, assessment of survival at 90 days, and well-defined secondary outcomes and analyses of adverse events.”
The ADRENAL and APROCCHSS had vastly different 90-day mortality rates: ADRENAL had mortality rates of 27.9% with hydrocortisone and 28.8% with placebo (P = .50), while APROACCHSS had mortality rates of 43.0% with hydrocortisone plus fludrocortisone and 49.1% with placebo (P = .03). Despite this, they both display the beneficial effect anti-inflammatory therapies, such as hydrocortisone, have on secondary outcomes of shock reversal and the reduction in duration of mechanical ventilation. “It is unlikely that in the near future sufficiently powered trials will provide us with better data” than the ADRENAL and APROCCHSS trials, Dr. Suffredini wrote.
Dr. Suffredini made these comments in an editorial accompanying this study in the New England Journal of Medicine. He is the deputy chief of the critical care medicine department at the National Institutes of Health Clinical Center, and he has served on the executive committee of the Department of Veteran Affairs Cooperative Studies Program. He has no other relevant financial disclosures to report.
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients in a double-blind, randomized, controlled trial.
Prior to this study, two large trials had displayed that corticosteroids were beneficial in improving hemodynamic status and organ function, but little was known about corticosteroids’ ability to increase survival in sepsis patients.
The study, named the Activated Protein C and Corticosteroids for Human Septic Shock (APROCCHSS) trial, was designed to assess the benefit/risk ratio of using activated protein C – drotrecogin alfa (activated) – and corticosteroids together or separately in septic shock patients. The original design of the study included Xigris (drotrecogin alfa) and was composed of four parallel groups, but Xigris was removed from the market in October of 2011, so the study continued with only two parallel groups.
A total of 1,241 patients experiencing chronic septic shock were recruited into the two double-blind, parallel groups, with patients in one group receiving hydrocortisone plus fludrocortisone and the other receiving placebos. The placebos used in this study were similar in appearance to the actual treatment drugs. The placebos for hydrocortisone and fludrocortisone were either parenteral mannitol (133.6 mg), disodium phosphate (8.73 mg), and sodium phosphate (0.92 mg) or tablets of microcrystalline cellulose (59.098 mg), respectively.
Hydrocortisone was given intravenously every 6 hours as a 50-mg intravenous bolus, and fludrocortisone was given once a day as a 50-mcg tablet through a nasogastric tube. Patients in ICUs who had septic shock for less than 24 hours were included in the study. Septic shock was identified by the presence of a clinically or microbiologically documented infection, a Sequential Organ Failure Assessment score of 3 or 4 for at least two organs and for at least 6 hours, and receipt of vasopressor therapy for at least 6 hours.
After 90 days, 264 of 614 of the patients (43%) in the hydrocortisone/fludrocortisone group and almost half (49.1%) of 627 patients in the placebo group had died (P = .03). The relative risk of death was 0.88 (95% confidence interval, 0.78-0.99), which favored the hydrocortisone/fludrocortisone group. The researchers also observed that death was significantly lower in the hydrocortisone/fludrocortisone group, compared with the placebo group, at time of ICU discharge (35.4% vs. 41.0%, respectively; P = .04).
While mortality was reduced, patients still experienced adverse events. 326 of 614 (53.1%) patients in the hydrocortisone/fludrocortisone group and 363 of 626 patients (58.0%) in the placebo group experienced at least one serious adverse event by day 180 (P = 0.08).
“Seven-day treatment with a 50-mg intravenous bolus of hydrocortisone every 6 hours and a daily dose of 50 mcg of oral fludrocortisone resulted in lower mortality at day 90 and at ICU and hospital discharge than placebo among adults with septic shock,” concluded Dr. Annane and his coauthors.
The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
SOURCE: Annana A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
FROM NEJM
Key clinical point: Hydrocortisone in combination with fludrocortisone significantly reduced 90-day mortality in septic shock patients.
Major finding: Mortality rates were lower in patients treated with hydrocortisone plus fludrocortisone, compared with patients treated with placebos (43% vs. 49.1%, respectively; P = .03).
Study details: A randomized, double-blind study of 1,241 patients with septic shock.
Disclosures: The majority of researchers had no relevant financial disclosures to report, while some doctors received grants and personal fees unrelated to this study. This study was funded in part by public grants from the French Ministry of Health.
Source: Annane A et al. NEJM. 2018 Feb 28. doi: 10.1056/NEJMoa1705716.
Firearm home storage practices pose a risk for suicidal teens
according to the findings of a cross-sectional analysis.
“For homes with children and guns, the odds are roughly 2 to 1 that firearms are not stored in accordance with recommendations promulgated by the [American Academy of Pediatrics], regardless of whether children in the home have a history of self-harm risk factors” wrote John Scott of Northeastern University, Boston, and his colleagues. “Given the prevalence of household firearms in the United States, our findings suggest that millions of U.S. children are placed at substantially higher risk of fatal firearm injury, especially suicide, than would be the case were parents to follow guidelines first put forward by the AAP.”
The information from the study was collected from a cross-sectional analysis of a nationally representative, online survey of U.S. adults from March to April of 2015. Of the 7,318 adults invited to participate, 3,949 completed the survey (a 55% response rate). The survey was conducted by the firm Growth for Knowledge to learn about firearm ownership, storage practices, and firearm use in adults. The adults selected for participation were drawn from Growth for Knowledge’s Knowledge Panel.
Survey participants were asked a variety of questions pertaining to gun ownership, such as: “Do you or does anyone else you live with currently own any type of gun?”and “Do you personally own a gun?” After determining gun ownership and style of gun (long rifle vs. handgun), survey respondents were questioned about how they stored their guns: Were they kept locked, unloaded, and away from ammo? Or were they stored unlocked and loaded?
After ascertaining information about firearm possession and storage practices, the researchers asked respondents if they were caregivers for children under the age of 18 and whether or not these children had any of the following medical conditions determined to be self-harm risk factors: depression, mental health conditions other than depression, or ADHD.
The researchers found that firearms were present in 42% of households, regardless of whether a child had a history of self harm risk factors (44%). Only one-third of household firearms were securely locked and unloaded. The proportion of parents who store at least one gun loaded and unlocked is only slightly lower among parents with children who have self-harm risk factors, compared with parents with children who have no history of self-harm risk (12% vs. 20%, respectively). Parents whose children have a history of depression, other mental health issues, and ADHD are also not significantly more likely to store all household firearms locked, compared with those whose children do not have such a history (62% vs. 52%, respectively).
Online surveys such as the one in this study rely on data that are reported by non-health experts, so the potential for a parent to misclassify their child’s mental or behavioral health issues is a distinct possibility. Like most self-reported data, social desirability bias may play a role in determining how parents responded to the survey regarding their children’s health.
While storage practices do not seem to change based on child self harm risk factors, the American Academy of Pediatrics has issued recommendations that may help convince some parents.
“Guidelines intended to reduce firearm injury to children, first issued by the American Academy of Pediatrics (AAP) in 1992, assert that whereas the safest home for a child is one without firearms, risk can be reduced substantially, although not eliminated, by storing all household firearms locked, unloaded, and separate from ammunition” Mr. Scott and his associates wrote. The study was published in Pediatrics.
The authors indicated they had no relevant financial disclosures. The study was supported in part by grants from Fund for a Safer Future, the Joyce Foundation, and the U.S. Department of Veteran Affairs.
SOURCE: Scott J et al. Pediatrics. 2018 February 26. doi: 10.1542/peds.2017-2600.
Adolescent suicide is an issue that weighs heavily on families and society as a whole and is only worsening. From 1999 to 2014, the suicide rate among 10- to 14-year-olds tripled, and doubled among 15- to 25-year-olds. Among these age groups, this is the second leading cause of death.
How guns and mental health interact is a current concern for many people in the United States. The primary focus is how to reduce injuries and deaths through background checks and restricted gun sales to high-risk individuals. While these interventions may reduce some issues associated with gun-related injuries, it may not do as much to protect youth at risk for self-inflicted harm. This responsibility falls to caretakers and parents who must understand the role they play in controlling access to firearms for at-risk youth.
A hypothetical framework proposes a three-part strategy to restrict gun access to at-risk teenagers. First, parents must be aware of the risk that unlocked guns in the home pose, and how drugs and alcohol can exacerbate the risk for self harm. Second, be ready to discuss access to guns in the house and, if needed, reduce access by utilizing safer storage practices in the home, or by using an outside storage facility. Third, families should seek to provide treatment and care for teenagers suffering from mental health issues with the aim of working toward remission and reducing self-harm risk.
Pediatricians and other health care professionals also play a critical role in preventing youth suicide. Routine screening of all adolescents for depression is recommended by Bright Futures and the U.S. Preventive Services Task Force. This screening process also presents the opportunity to ask about and discuss the presence of firearms and their storage in the home with patients and parents.
The increase in youth firearm suicide over the past 2 decades is indicative of a failure by both health care and public health systems to adequately address prevention of these unfortunate injuries and deaths.
David C. Grossman, MD, MPH, is a senior investigator with Kaiser Permanente Washington Health Research Institute and a Washington pediatrician. He wrote an editorial to accompany the article by Scott et al. (Pediatrics. 2018 Feb 26. doi: 10.1542/peds.2017-3884).
Adolescent suicide is an issue that weighs heavily on families and society as a whole and is only worsening. From 1999 to 2014, the suicide rate among 10- to 14-year-olds tripled, and doubled among 15- to 25-year-olds. Among these age groups, this is the second leading cause of death.
How guns and mental health interact is a current concern for many people in the United States. The primary focus is how to reduce injuries and deaths through background checks and restricted gun sales to high-risk individuals. While these interventions may reduce some issues associated with gun-related injuries, it may not do as much to protect youth at risk for self-inflicted harm. This responsibility falls to caretakers and parents who must understand the role they play in controlling access to firearms for at-risk youth.
A hypothetical framework proposes a three-part strategy to restrict gun access to at-risk teenagers. First, parents must be aware of the risk that unlocked guns in the home pose, and how drugs and alcohol can exacerbate the risk for self harm. Second, be ready to discuss access to guns in the house and, if needed, reduce access by utilizing safer storage practices in the home, or by using an outside storage facility. Third, families should seek to provide treatment and care for teenagers suffering from mental health issues with the aim of working toward remission and reducing self-harm risk.
Pediatricians and other health care professionals also play a critical role in preventing youth suicide. Routine screening of all adolescents for depression is recommended by Bright Futures and the U.S. Preventive Services Task Force. This screening process also presents the opportunity to ask about and discuss the presence of firearms and their storage in the home with patients and parents.
The increase in youth firearm suicide over the past 2 decades is indicative of a failure by both health care and public health systems to adequately address prevention of these unfortunate injuries and deaths.
David C. Grossman, MD, MPH, is a senior investigator with Kaiser Permanente Washington Health Research Institute and a Washington pediatrician. He wrote an editorial to accompany the article by Scott et al. (Pediatrics. 2018 Feb 26. doi: 10.1542/peds.2017-3884).
Adolescent suicide is an issue that weighs heavily on families and society as a whole and is only worsening. From 1999 to 2014, the suicide rate among 10- to 14-year-olds tripled, and doubled among 15- to 25-year-olds. Among these age groups, this is the second leading cause of death.
How guns and mental health interact is a current concern for many people in the United States. The primary focus is how to reduce injuries and deaths through background checks and restricted gun sales to high-risk individuals. While these interventions may reduce some issues associated with gun-related injuries, it may not do as much to protect youth at risk for self-inflicted harm. This responsibility falls to caretakers and parents who must understand the role they play in controlling access to firearms for at-risk youth.
A hypothetical framework proposes a three-part strategy to restrict gun access to at-risk teenagers. First, parents must be aware of the risk that unlocked guns in the home pose, and how drugs and alcohol can exacerbate the risk for self harm. Second, be ready to discuss access to guns in the house and, if needed, reduce access by utilizing safer storage practices in the home, or by using an outside storage facility. Third, families should seek to provide treatment and care for teenagers suffering from mental health issues with the aim of working toward remission and reducing self-harm risk.
Pediatricians and other health care professionals also play a critical role in preventing youth suicide. Routine screening of all adolescents for depression is recommended by Bright Futures and the U.S. Preventive Services Task Force. This screening process also presents the opportunity to ask about and discuss the presence of firearms and their storage in the home with patients and parents.
The increase in youth firearm suicide over the past 2 decades is indicative of a failure by both health care and public health systems to adequately address prevention of these unfortunate injuries and deaths.
David C. Grossman, MD, MPH, is a senior investigator with Kaiser Permanente Washington Health Research Institute and a Washington pediatrician. He wrote an editorial to accompany the article by Scott et al. (Pediatrics. 2018 Feb 26. doi: 10.1542/peds.2017-3884).
according to the findings of a cross-sectional analysis.
“For homes with children and guns, the odds are roughly 2 to 1 that firearms are not stored in accordance with recommendations promulgated by the [American Academy of Pediatrics], regardless of whether children in the home have a history of self-harm risk factors” wrote John Scott of Northeastern University, Boston, and his colleagues. “Given the prevalence of household firearms in the United States, our findings suggest that millions of U.S. children are placed at substantially higher risk of fatal firearm injury, especially suicide, than would be the case were parents to follow guidelines first put forward by the AAP.”
The information from the study was collected from a cross-sectional analysis of a nationally representative, online survey of U.S. adults from March to April of 2015. Of the 7,318 adults invited to participate, 3,949 completed the survey (a 55% response rate). The survey was conducted by the firm Growth for Knowledge to learn about firearm ownership, storage practices, and firearm use in adults. The adults selected for participation were drawn from Growth for Knowledge’s Knowledge Panel.
Survey participants were asked a variety of questions pertaining to gun ownership, such as: “Do you or does anyone else you live with currently own any type of gun?”and “Do you personally own a gun?” After determining gun ownership and style of gun (long rifle vs. handgun), survey respondents were questioned about how they stored their guns: Were they kept locked, unloaded, and away from ammo? Or were they stored unlocked and loaded?
After ascertaining information about firearm possession and storage practices, the researchers asked respondents if they were caregivers for children under the age of 18 and whether or not these children had any of the following medical conditions determined to be self-harm risk factors: depression, mental health conditions other than depression, or ADHD.
The researchers found that firearms were present in 42% of households, regardless of whether a child had a history of self harm risk factors (44%). Only one-third of household firearms were securely locked and unloaded. The proportion of parents who store at least one gun loaded and unlocked is only slightly lower among parents with children who have self-harm risk factors, compared with parents with children who have no history of self-harm risk (12% vs. 20%, respectively). Parents whose children have a history of depression, other mental health issues, and ADHD are also not significantly more likely to store all household firearms locked, compared with those whose children do not have such a history (62% vs. 52%, respectively).
Online surveys such as the one in this study rely on data that are reported by non-health experts, so the potential for a parent to misclassify their child’s mental or behavioral health issues is a distinct possibility. Like most self-reported data, social desirability bias may play a role in determining how parents responded to the survey regarding their children’s health.
While storage practices do not seem to change based on child self harm risk factors, the American Academy of Pediatrics has issued recommendations that may help convince some parents.
“Guidelines intended to reduce firearm injury to children, first issued by the American Academy of Pediatrics (AAP) in 1992, assert that whereas the safest home for a child is one without firearms, risk can be reduced substantially, although not eliminated, by storing all household firearms locked, unloaded, and separate from ammunition” Mr. Scott and his associates wrote. The study was published in Pediatrics.
The authors indicated they had no relevant financial disclosures. The study was supported in part by grants from Fund for a Safer Future, the Joyce Foundation, and the U.S. Department of Veteran Affairs.
SOURCE: Scott J et al. Pediatrics. 2018 February 26. doi: 10.1542/peds.2017-2600.
according to the findings of a cross-sectional analysis.
“For homes with children and guns, the odds are roughly 2 to 1 that firearms are not stored in accordance with recommendations promulgated by the [American Academy of Pediatrics], regardless of whether children in the home have a history of self-harm risk factors” wrote John Scott of Northeastern University, Boston, and his colleagues. “Given the prevalence of household firearms in the United States, our findings suggest that millions of U.S. children are placed at substantially higher risk of fatal firearm injury, especially suicide, than would be the case were parents to follow guidelines first put forward by the AAP.”
The information from the study was collected from a cross-sectional analysis of a nationally representative, online survey of U.S. adults from March to April of 2015. Of the 7,318 adults invited to participate, 3,949 completed the survey (a 55% response rate). The survey was conducted by the firm Growth for Knowledge to learn about firearm ownership, storage practices, and firearm use in adults. The adults selected for participation were drawn from Growth for Knowledge’s Knowledge Panel.
Survey participants were asked a variety of questions pertaining to gun ownership, such as: “Do you or does anyone else you live with currently own any type of gun?”and “Do you personally own a gun?” After determining gun ownership and style of gun (long rifle vs. handgun), survey respondents were questioned about how they stored their guns: Were they kept locked, unloaded, and away from ammo? Or were they stored unlocked and loaded?
After ascertaining information about firearm possession and storage practices, the researchers asked respondents if they were caregivers for children under the age of 18 and whether or not these children had any of the following medical conditions determined to be self-harm risk factors: depression, mental health conditions other than depression, or ADHD.
The researchers found that firearms were present in 42% of households, regardless of whether a child had a history of self harm risk factors (44%). Only one-third of household firearms were securely locked and unloaded. The proportion of parents who store at least one gun loaded and unlocked is only slightly lower among parents with children who have self-harm risk factors, compared with parents with children who have no history of self-harm risk (12% vs. 20%, respectively). Parents whose children have a history of depression, other mental health issues, and ADHD are also not significantly more likely to store all household firearms locked, compared with those whose children do not have such a history (62% vs. 52%, respectively).
Online surveys such as the one in this study rely on data that are reported by non-health experts, so the potential for a parent to misclassify their child’s mental or behavioral health issues is a distinct possibility. Like most self-reported data, social desirability bias may play a role in determining how parents responded to the survey regarding their children’s health.
While storage practices do not seem to change based on child self harm risk factors, the American Academy of Pediatrics has issued recommendations that may help convince some parents.
“Guidelines intended to reduce firearm injury to children, first issued by the American Academy of Pediatrics (AAP) in 1992, assert that whereas the safest home for a child is one without firearms, risk can be reduced substantially, although not eliminated, by storing all household firearms locked, unloaded, and separate from ammunition” Mr. Scott and his associates wrote. The study was published in Pediatrics.
The authors indicated they had no relevant financial disclosures. The study was supported in part by grants from Fund for a Safer Future, the Joyce Foundation, and the U.S. Department of Veteran Affairs.
SOURCE: Scott J et al. Pediatrics. 2018 February 26. doi: 10.1542/peds.2017-2600.
FROM PEDIATRICS
Key clinical point: Millions of children at risk for self harm live in a household with unsecured firearms.
Major finding: One in three parents stored all household firearms locked and unloaded.
Study details: A cross-sectional analysis of a nationally representative, online survey of 3,949 U.S. adults concerning gun ownership and gun storage practices from March to April of 2015.
Disclosures: The authors indicated they have no relevant financial disclosures. The study was supported in part by grants from Fund for a Safer Future, the Joyce Foundation, and the U.S. Department of Veteran Affairs.
Source: Scott J et al. Pediatrics. 2018 February 26. doi: 10.1542/peds.2017-2600.
Fluarix Quadrivalent effective in very young, simplifies flu shots for all ages
Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”
The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.
These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.
A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.
On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.
“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.
For live updates and information concerning influenza, visit the CDC website.
[email protected]
SOURCE: D-QIV-004.
Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”
The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.
These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.
A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.
On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.
“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.
For live updates and information concerning influenza, visit the CDC website.
[email protected]
SOURCE: D-QIV-004.
Fluarix Quadrivalent is highly effective against moderate and severe flu strains in children aged 6-35 months, and has the potential to simplify influenza vaccinations for all ages, according the results of a phase 3 clinical trial presented at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“Fluarix Quadrivalent, at the 0.5-mL dose in young children 6 to 35 months of age, demonstrated efficacy of 63.2% against moderate to severe influenza and 49.8% against any severity influenza disease” stated Leonard Friedland, MD, director of scientific affairs and public health, Vaccines North America, GlaxoSmithKline. Dr. Friedland, a pediatrician in Pennsylvania, said that a standard 0.5-mL dose of Fluarix Quadrivalent has practice-changing implications for physicians. “The use of a 0.5-mL dose (15 mcg per strain) for all persons aged 6 months and older potentially simplifies influenza vaccination by allowing the same vaccine dose to be used for all eligible individuals.”
The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, and in preventing moderate to severe influenza, correlated with a reduction in health care utilization by pediatric influenza patients, he said. Visits to general practitioners and emergency departments decreased by 47% and 79%, respectively, in children aged 6-35 months. Influenza-associated antibiotic use in these pediatric influenza patients also decreased by 50%.
These findings were the result of D-QIV-004, a phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months. These children were split into five cohorts, each in a different influenza season. The study spanned 13 countries and ran from October 2011 to December 2014. To determine the safety of Fluarix, the study utilized noninfluenza vaccine comparator vaccines that were age appropriate, including Prevnar 13, Havrix, and Varivax.
A majority of the children in the study (98%) were vaccine unprimed (had never received two doses of seasonal influenza vaccine) and received two doses of Fluarix. The remaining children received one dose.
On Jan. 11, 2018, the Food and Drug Administration expanded the indication of Fluarix Quadrivalent to include use in persons 6 months and older. Previously, it was approved only for persons 3 years and older.
“These study results support universal vaccination of all individuals from 6 months of age [with Fluarix] to prevent influenza.” Dr. Friedland concluded.
For live updates and information concerning influenza, visit the CDC website.
[email protected]
SOURCE: D-QIV-004.
FROM AN ACIP MEETING
Key clinical point: The high efficacy of Fluarix against almost half of all influenza strains, regardless of severity, as well as preventing moderate to severe influenza, reduced health care utilization by pediatric influenza patients.
Major finding: Fluarix Quadrivalent was effective against moderate to severe influenza in 63.2% and against any severity of influenza in 49.8% of children aged 6-35 months.
Study details: A phase 3, observer-blinded, randomized trial of 12,018 children aged 6-35 months, in which the children were split into five cohorts, each in a different influenza season from October 2011 to December 2014.
Disclosures: No disclosures were reported.
Source: The D-QIV-004 study.
How to lower occupational radiation exposure in the cath lab
Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.
“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”
The report was published in JACC: Cardiovascular Interventions.
SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.
The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.
The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.
Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).
Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).
The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.
Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”
Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.
SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.
While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.
Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.
All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.
Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).
While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.
Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.
All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.
Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).
While concerns about occupational radiation exposure to cardiologists has prompted equipment, shielding, and behavioral modifications to reduce radiation exposure in cardiologists, exposure to staff members such as nurses and technologists has not received this same attention.
Considering that the shield should also absorb approximately 98% of the scatter radiation, the only real issue about its effectiveness is whether technologists and nurses can remain behind the wall while still being able to assist during a procedure.
All cardiology labs should be equipped with these shields to provide adequate radiation protection to those who work there. The work of Madder et al. should provide confidence to nurses and technologists that their occupational radiation exposure can be expected to be low, as well as their cancer risk.
Kenneth A. Fetterly, PhD , a radiologist, and Malcolm R. Bell, MD , a cardiologist and director of the ischemic heart disease program at the Mayo Clinic in Rochester, Minn., made these comments in an editorial ( JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:213-4 ).
Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.
“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”
The report was published in JACC: Cardiovascular Interventions.
SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.
The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.
The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.
Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).
Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).
The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.
Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”
Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.
SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.
Adding some lead shielding in cardiac catheterization labs can cut the amount of radiation that nurse circulators and scrub technologists are exposed to, according to a single-center study of more than 750 patients.
“The simple and relatively inexpensive approach of providing staff members with a dedicated accessory lead shield during cardiac catheterization was associated with a nearly two-thirds reduction in radiation exposure among both nurses and technologists” according to Ryan Madder, MD, and his associates. “The present study is the first, to our knowledge, to observe a similar benefit among nonphysician staff members, an observation that may have important implications for occupational safety in the cardiac catheterization laboratory.”
The report was published in JACC: Cardiovascular Interventions.
SHIELD (Combining Robotic-Stenting and Proactive Shielding Techniques in the Catheterization Laboratory to Achieve Lowest Possible Radiation Exposure to Physicians and Staff) was a single-center, prospective, observational designed study to research radiation exposure levels among physicians and other staff members in cardiac catheterization labs. Dr. Madder, a cardiologist at Spectrum Health in Grand Rapids, Mich., and his colleagues collected radiation exposure information for staff members such as nurse circulators and scrub technologists during August 2015–February 2016 and measured radiation exposure in 764 consecutive cases. Radiation exposure was monitored for these staff members by dosimeters worn on either the left anterior side of the glasses or thyroid collar, and a body dosimeter underneath the lead apparel on the V-neck of their scrub shirt.
The radiation protection used in the study followed standard institutional operating procedures, which includes two shields between the patient and physician, a ceiling mounted upper body shield with a patient contour cutout, and a lower body shield attached to the side of the operating table, extending from the table to the floor. Staff members wore traditional lead garments, consisting of a lead skirt, apron, and thyroid collar. Additional radiation absorbing disposable pads were used as desired by the staff members.
The study was split into two phases to evaluate the effectiveness of accessory shields with phase 1 (401 cases) utilizing traditional protective measures. Phase 2 (363 cases) used the same material as phase I, but a dedicated accessory lead shield was used. For nurse circulators, this shield was placed between the patient and the intravenous medication pole. For scrub technologists, the shield was placed at the foot of the patient’s bed.
Radiation exposure was higher in phase 1 than phase 2 for all workers. In phase I, technologists faced an effective dose normalized to the dose-area product (EDAP) of 2.4 mcSv/(mGy x cm2) x 10-5 per case. This dropped significantly in phase 2 to an EDAP of 0.9per case, a 62.5% lower dose per case (P less than .0001).
Nurses experienced a similar decrease in exposure per case from phase 1 (EDAP 1.1) and phase 2 (EDAP 0.4). This accounted for a 63.6% lower dose per case (P less than .0001).
The contrast delivery system used at the lab did not allow technologists to maximize their distance from radiation sources, so it is unclear whether the results of this study can be extrapolated to centers where technologists do not perform contrast injections.
Dr. Madder and his colleagues pointed out that this research only begins to scratch the surface of the occupational hazards that catheterization laboratory personnel face.“The use of accessory lead shields, which might be effective to reduce staff radiation exposure, will not likely reduce other occupational hazards of working in the catheterization laboratory related to wearing heavy lead garments, including the risks for orthopedic injuries and experiencing chronic work-related pain.”
Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.
SOURCE: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.
FROM JACC: CARDIOVASCULAR INTERVENTIONS
Key clinical point: Accessory lead shielding reduces radiation exposure for nurses and technologists.
Major finding: Accessory lead shielding reduced radiation exposure by over two-thirds.
Study details: A single-center, prospective, observational study of 764 cases.
Disclosures: Corindus Vascular Robotics partially funded this study and has provided research support to Dr. Madder. All other researchers have no financial conflicts to report.
Source: Madder R. JACC: Cardiovasc Interven. 2018 Jan 22;11[2]:206-12.
FDA warns against clarithromycin use in patients with heart disease
The Food and Drug Administration has added a new warning for an increased risk of death in patients with heart disease who have used clarithromycin (Biaxin), on the basis of results of a 10-year follow-up from the CLARICOR trial.
The CLARICOR trial followed 4,372 randomized patients for at least 2 years after undergoing 14 days of treatment with daily doses of 500 mg clarithromycin. Among these patients, researchers observed an unexpected increase in deaths in patients with coronary heart disease. (The Feb. 22 FDA statement announcing the alert did not provide data from CLARICOR.) As of yet, there is no clear explanation of how clarithromycin would lead to more deaths, compared with a placebo, the agency said.
Regardless, two of the six observational studies published found a link between clarithromycin use and long-term risks; four did not. The CLARICOR trial provides the strongest evidence of increased health risks, the statement said.
The FDA is recommending that health care professionals be aware of the risks associated with clarithromycin use and consider the benefits and risks of use in patients with heart disease. If at all possible, the use of other antibiotics may be a better option. Doctors should advise patients to be aware of signs and symptoms associated with cardiovascular issues.
Patients are also an important piece of the puzzle and should communicate with their health care providers about heart disease, particularly when taking antibiotics to treat for an infection.
The FDA has added the results of the CLARICOR trial to the clarithromycin drug labels. The agency will continue to monitor the safety reports in patients using clarithromycin.
Serious adverse events associated with clarithromycin should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
The Food and Drug Administration has added a new warning for an increased risk of death in patients with heart disease who have used clarithromycin (Biaxin), on the basis of results of a 10-year follow-up from the CLARICOR trial.
The CLARICOR trial followed 4,372 randomized patients for at least 2 years after undergoing 14 days of treatment with daily doses of 500 mg clarithromycin. Among these patients, researchers observed an unexpected increase in deaths in patients with coronary heart disease. (The Feb. 22 FDA statement announcing the alert did not provide data from CLARICOR.) As of yet, there is no clear explanation of how clarithromycin would lead to more deaths, compared with a placebo, the agency said.
Regardless, two of the six observational studies published found a link between clarithromycin use and long-term risks; four did not. The CLARICOR trial provides the strongest evidence of increased health risks, the statement said.
The FDA is recommending that health care professionals be aware of the risks associated with clarithromycin use and consider the benefits and risks of use in patients with heart disease. If at all possible, the use of other antibiotics may be a better option. Doctors should advise patients to be aware of signs and symptoms associated with cardiovascular issues.
Patients are also an important piece of the puzzle and should communicate with their health care providers about heart disease, particularly when taking antibiotics to treat for an infection.
The FDA has added the results of the CLARICOR trial to the clarithromycin drug labels. The agency will continue to monitor the safety reports in patients using clarithromycin.
Serious adverse events associated with clarithromycin should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
The Food and Drug Administration has added a new warning for an increased risk of death in patients with heart disease who have used clarithromycin (Biaxin), on the basis of results of a 10-year follow-up from the CLARICOR trial.
The CLARICOR trial followed 4,372 randomized patients for at least 2 years after undergoing 14 days of treatment with daily doses of 500 mg clarithromycin. Among these patients, researchers observed an unexpected increase in deaths in patients with coronary heart disease. (The Feb. 22 FDA statement announcing the alert did not provide data from CLARICOR.) As of yet, there is no clear explanation of how clarithromycin would lead to more deaths, compared with a placebo, the agency said.
Regardless, two of the six observational studies published found a link between clarithromycin use and long-term risks; four did not. The CLARICOR trial provides the strongest evidence of increased health risks, the statement said.
The FDA is recommending that health care professionals be aware of the risks associated with clarithromycin use and consider the benefits and risks of use in patients with heart disease. If at all possible, the use of other antibiotics may be a better option. Doctors should advise patients to be aware of signs and symptoms associated with cardiovascular issues.
Patients are also an important piece of the puzzle and should communicate with their health care providers about heart disease, particularly when taking antibiotics to treat for an infection.
The FDA has added the results of the CLARICOR trial to the clarithromycin drug labels. The agency will continue to monitor the safety reports in patients using clarithromycin.
Serious adverse events associated with clarithromycin should be reported to the FDA’s MedWatch program at 800-332-1088 or www.fda.gov/medwatch/.
ACIP unanimously recommends HEPLISAV-B
At a meeting of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices, members unanimously voted to include HEPLISAV-B on the ACIP list of recommended products to vaccinate adults against hepatitis B.
“I think this is a huge advance, and a step forward “ said David S. Stephens, MD, of Emory University, Atlanta, who is a voting member of ACIP.
According to Sarah Schillie, MD, of ACIP’s Hepatitis Work Group, the reduction from three doses to two also will improve vaccine series completion rates, providing more effective protection. This could be very important for health care professionals, with only about 60% of treated individuals fulfilling the three doses necessary for complete HBV protection.
Although fewer doses are needed with HEPLISAV-B, it displays similar immunogenicity to similar vaccines (90.0%-100% vs. 70.5%-90.2%). It is also more effective, compared with similar vaccines in those with type II diabetes (90.0% vs. 65.1%) and chronic kidney disease (89.9% vs. 81.1%).
HEPLISAV-B uses an adjuvant, but it appears to be safe and well tolerated. The rate of mild (45.6% vs. 45.7%) and serious (5.4% vs. 6.3%) reactions were similar among HEPLISAV-B and comparable vaccines, although cardiovascular events were more common with this vaccine than with others (0.27% vs. 0.14%).
Dr. Stephens, who supported the recommendation of HEPLISAV-B, voiced reservations about these findings. “I am concerned about the myocardial infarction signal and the use of this new adjuvant and certainly urge us to look at the postmarketing data carefully.”
While the reported incidence rate of acute HBV cases consistently fell during 2000-2015, it began to rise again at the end of 2015. This is linked with concomitant rise in injection drug use, which also is a risk factor in transmitting HBV. Over the same period, the incidence of HBV was highest in people aged 30-49 years. With these factors to consider, the vote by ACIP for HEPLISAV-B as a recommended vaccine is timely and may help reduce HBV infections in adults.
At a meeting of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices, members unanimously voted to include HEPLISAV-B on the ACIP list of recommended products to vaccinate adults against hepatitis B.
“I think this is a huge advance, and a step forward “ said David S. Stephens, MD, of Emory University, Atlanta, who is a voting member of ACIP.
According to Sarah Schillie, MD, of ACIP’s Hepatitis Work Group, the reduction from three doses to two also will improve vaccine series completion rates, providing more effective protection. This could be very important for health care professionals, with only about 60% of treated individuals fulfilling the three doses necessary for complete HBV protection.
Although fewer doses are needed with HEPLISAV-B, it displays similar immunogenicity to similar vaccines (90.0%-100% vs. 70.5%-90.2%). It is also more effective, compared with similar vaccines in those with type II diabetes (90.0% vs. 65.1%) and chronic kidney disease (89.9% vs. 81.1%).
HEPLISAV-B uses an adjuvant, but it appears to be safe and well tolerated. The rate of mild (45.6% vs. 45.7%) and serious (5.4% vs. 6.3%) reactions were similar among HEPLISAV-B and comparable vaccines, although cardiovascular events were more common with this vaccine than with others (0.27% vs. 0.14%).
Dr. Stephens, who supported the recommendation of HEPLISAV-B, voiced reservations about these findings. “I am concerned about the myocardial infarction signal and the use of this new adjuvant and certainly urge us to look at the postmarketing data carefully.”
While the reported incidence rate of acute HBV cases consistently fell during 2000-2015, it began to rise again at the end of 2015. This is linked with concomitant rise in injection drug use, which also is a risk factor in transmitting HBV. Over the same period, the incidence of HBV was highest in people aged 30-49 years. With these factors to consider, the vote by ACIP for HEPLISAV-B as a recommended vaccine is timely and may help reduce HBV infections in adults.
At a meeting of the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices, members unanimously voted to include HEPLISAV-B on the ACIP list of recommended products to vaccinate adults against hepatitis B.
“I think this is a huge advance, and a step forward “ said David S. Stephens, MD, of Emory University, Atlanta, who is a voting member of ACIP.
According to Sarah Schillie, MD, of ACIP’s Hepatitis Work Group, the reduction from three doses to two also will improve vaccine series completion rates, providing more effective protection. This could be very important for health care professionals, with only about 60% of treated individuals fulfilling the three doses necessary for complete HBV protection.
Although fewer doses are needed with HEPLISAV-B, it displays similar immunogenicity to similar vaccines (90.0%-100% vs. 70.5%-90.2%). It is also more effective, compared with similar vaccines in those with type II diabetes (90.0% vs. 65.1%) and chronic kidney disease (89.9% vs. 81.1%).
HEPLISAV-B uses an adjuvant, but it appears to be safe and well tolerated. The rate of mild (45.6% vs. 45.7%) and serious (5.4% vs. 6.3%) reactions were similar among HEPLISAV-B and comparable vaccines, although cardiovascular events were more common with this vaccine than with others (0.27% vs. 0.14%).
Dr. Stephens, who supported the recommendation of HEPLISAV-B, voiced reservations about these findings. “I am concerned about the myocardial infarction signal and the use of this new adjuvant and certainly urge us to look at the postmarketing data carefully.”
While the reported incidence rate of acute HBV cases consistently fell during 2000-2015, it began to rise again at the end of 2015. This is linked with concomitant rise in injection drug use, which also is a risk factor in transmitting HBV. Over the same period, the incidence of HBV was highest in people aged 30-49 years. With these factors to consider, the vote by ACIP for HEPLISAV-B as a recommended vaccine is timely and may help reduce HBV infections in adults.
REPORTING FROM AN ACIP MEETING
Topical imiquimod helps clear blurred lines in lentigo maligna excision
according to a study from the University of Utah.
Lentigo maligna is a subtype of melanoma in situ, usually occurring in the head and neck regions, the researchers said.
“Neoadjuvant topical imiquimod 5% cream applied 5 times weekly for 8 weeks was associated with decreased MDCs in LM treatment sites compared with the MDCs of negative control sites,” wrote Shadai Flores of the University of Utah, Salt Lake City, and her colleagues.
Previously, the ability to distinguish between the surgical border and surrounding background melanocytic hyperplasia was uncertain. Because of this uncertainty, LM removal required an average margin of 7.2 mm. Another study showed that topical imiquimod 5% cream enabled the removal of most LM tumors with 2-mm margins. This study “sought to evaluate MDCs in imiquimod-treated LM and negative control biopsy specimens to determine if there was a measurable difference in melanocyte density,” the researchers wrote in a research letter published in JAMA Dermatology.
The study prospectively followed 52 cases of LM treated with imiquimod 5% topical cream 5 days per week for 8 weeks followed by conservative staged excisions with 2-mm margins. Treatment with imiquimod 5% of LM was followed by a 2- to 4-month recuperation period before surgery could be performed. All patients in the study were treated by one Mohs surgeon at the Huntsman Cancer Institute at the university.
To establish an MDC baseline, a 10-mm long fusiform biopsy was taken as a negative control. The negative control sample site and the LM site were separated by approximately 6 cm, found on the same side of the body, and showed similar color changes. After a negative control was taken, an LM lesion was resected and subsequently quadrisected. The MDCs then were concurrently counted by the researchers and compared with the negative controls.
Of the 52 LM specimens, 44 (85%) exhibited decreases in MDCs, compared with the negative controls. The median MDC from post–imiquimod-treated sites was 14.4, with a range of 0.5-26.6. This showed marked improvement over the negative controls, which had a median MDC of 20.0 (range of 9.0-36.7). A 2-tailed paired t test revealed that the results displayed statistical significance (P less than .001). Residual LM was seen in the central areas of 9 (17%) specimens, but 43 (83%) had no indication of residual LM.
“The decreased melanocytic hyperplasia in imiquimod-treated sites reduced ambiguity in making a distinction between the border of the excised LM and background melanocytic hyperplasia,” noted Ms. Flores and her colleagues.
The authors had no conflicts of interest.
SOURCE: Flores S et al. JAMA Dermatol. 2018 Feb 16. doi: 10.1001/jamadermatol.2017.5632.
according to a study from the University of Utah.
Lentigo maligna is a subtype of melanoma in situ, usually occurring in the head and neck regions, the researchers said.
“Neoadjuvant topical imiquimod 5% cream applied 5 times weekly for 8 weeks was associated with decreased MDCs in LM treatment sites compared with the MDCs of negative control sites,” wrote Shadai Flores of the University of Utah, Salt Lake City, and her colleagues.
Previously, the ability to distinguish between the surgical border and surrounding background melanocytic hyperplasia was uncertain. Because of this uncertainty, LM removal required an average margin of 7.2 mm. Another study showed that topical imiquimod 5% cream enabled the removal of most LM tumors with 2-mm margins. This study “sought to evaluate MDCs in imiquimod-treated LM and negative control biopsy specimens to determine if there was a measurable difference in melanocyte density,” the researchers wrote in a research letter published in JAMA Dermatology.
The study prospectively followed 52 cases of LM treated with imiquimod 5% topical cream 5 days per week for 8 weeks followed by conservative staged excisions with 2-mm margins. Treatment with imiquimod 5% of LM was followed by a 2- to 4-month recuperation period before surgery could be performed. All patients in the study were treated by one Mohs surgeon at the Huntsman Cancer Institute at the university.
To establish an MDC baseline, a 10-mm long fusiform biopsy was taken as a negative control. The negative control sample site and the LM site were separated by approximately 6 cm, found on the same side of the body, and showed similar color changes. After a negative control was taken, an LM lesion was resected and subsequently quadrisected. The MDCs then were concurrently counted by the researchers and compared with the negative controls.
Of the 52 LM specimens, 44 (85%) exhibited decreases in MDCs, compared with the negative controls. The median MDC from post–imiquimod-treated sites was 14.4, with a range of 0.5-26.6. This showed marked improvement over the negative controls, which had a median MDC of 20.0 (range of 9.0-36.7). A 2-tailed paired t test revealed that the results displayed statistical significance (P less than .001). Residual LM was seen in the central areas of 9 (17%) specimens, but 43 (83%) had no indication of residual LM.
“The decreased melanocytic hyperplasia in imiquimod-treated sites reduced ambiguity in making a distinction between the border of the excised LM and background melanocytic hyperplasia,” noted Ms. Flores and her colleagues.
The authors had no conflicts of interest.
SOURCE: Flores S et al. JAMA Dermatol. 2018 Feb 16. doi: 10.1001/jamadermatol.2017.5632.
according to a study from the University of Utah.
Lentigo maligna is a subtype of melanoma in situ, usually occurring in the head and neck regions, the researchers said.
“Neoadjuvant topical imiquimod 5% cream applied 5 times weekly for 8 weeks was associated with decreased MDCs in LM treatment sites compared with the MDCs of negative control sites,” wrote Shadai Flores of the University of Utah, Salt Lake City, and her colleagues.
Previously, the ability to distinguish between the surgical border and surrounding background melanocytic hyperplasia was uncertain. Because of this uncertainty, LM removal required an average margin of 7.2 mm. Another study showed that topical imiquimod 5% cream enabled the removal of most LM tumors with 2-mm margins. This study “sought to evaluate MDCs in imiquimod-treated LM and negative control biopsy specimens to determine if there was a measurable difference in melanocyte density,” the researchers wrote in a research letter published in JAMA Dermatology.
The study prospectively followed 52 cases of LM treated with imiquimod 5% topical cream 5 days per week for 8 weeks followed by conservative staged excisions with 2-mm margins. Treatment with imiquimod 5% of LM was followed by a 2- to 4-month recuperation period before surgery could be performed. All patients in the study were treated by one Mohs surgeon at the Huntsman Cancer Institute at the university.
To establish an MDC baseline, a 10-mm long fusiform biopsy was taken as a negative control. The negative control sample site and the LM site were separated by approximately 6 cm, found on the same side of the body, and showed similar color changes. After a negative control was taken, an LM lesion was resected and subsequently quadrisected. The MDCs then were concurrently counted by the researchers and compared with the negative controls.
Of the 52 LM specimens, 44 (85%) exhibited decreases in MDCs, compared with the negative controls. The median MDC from post–imiquimod-treated sites was 14.4, with a range of 0.5-26.6. This showed marked improvement over the negative controls, which had a median MDC of 20.0 (range of 9.0-36.7). A 2-tailed paired t test revealed that the results displayed statistical significance (P less than .001). Residual LM was seen in the central areas of 9 (17%) specimens, but 43 (83%) had no indication of residual LM.
“The decreased melanocytic hyperplasia in imiquimod-treated sites reduced ambiguity in making a distinction between the border of the excised LM and background melanocytic hyperplasia,” noted Ms. Flores and her colleagues.
The authors had no conflicts of interest.
SOURCE: Flores S et al. JAMA Dermatol. 2018 Feb 16. doi: 10.1001/jamadermatol.2017.5632.
FROM JAMA DERMATOLOGY
Key clinical point: Neoadjuvant, topical imiquimod 5% cream is associated with a decrease in melanocyte density counts (MDC).
Major finding: Of 52 patient specimens, 44 (85%) exhibited decreases in MDCs, compared with the negative controls.
Study details: A prospective study of 52 cases of lentigo maligna treated with imiquimod 5% topical cream 5 days per week for 8 weeks, followed by conservative staged excisions with 2-mm margins.
Disclosures: The authors had no conflicts of interest.
Source: Flores S et al. JAMA Dermatol. 2018 Feb 16. doi: 10.1001/jamadermatol.2017.5632.
Nd:YAG laser treatment improves the appearance of facial wrinkles
wrote Eric F. Bernstein, MD, a laser surgeon in private practice in Ardmore, Pa., and his associates.
In the study, two fractionated lasers were each combined with a specially designed “holographic beam-splitting optic” to treat mild to moderate facial wrinkles in 24 patients aged 18-75 years with Fitzpatrick skin types I-VI; 14 patients received five monthly treatments with the 1,064 nm laser, while the other 10 patients received four monthly treatments with the 532 nm laser.
Blinded evaluators assessed images taken at baseline and at 12 weeks after treatment. The evaluators found improvements of greater than 20% in 56.9% of the evaluated images, with no statistically significant difference between the two wavelengths. Of those treated with the 1,064 nm laser, 12 of 14 patients were “satisfied” or “very satisfied”; of those treated with the 532 nm laser, 8 of the 10 were “satisfied” or “very satisfied,” Dr. Bernstein and his colleagues wrote in the Journal of Drugs in Dermatology.
Patients experienced only mild to moderate discomfort during the laser treatment. Side effects were mild and were limited to erythema and edema in almost all patients; fewer than half the patients developed petechiae. Side effects generally resolved within a few days of treatment.
Dr. Bernstein and some of the other authors reported relationships with Syneron Candela, which provided funding for and loaned equipment used in the study.
Source: Bernstein EF et al. J Drugs Dermatol. 2017 Nov 1;16(11):1077-82.
wrote Eric F. Bernstein, MD, a laser surgeon in private practice in Ardmore, Pa., and his associates.
In the study, two fractionated lasers were each combined with a specially designed “holographic beam-splitting optic” to treat mild to moderate facial wrinkles in 24 patients aged 18-75 years with Fitzpatrick skin types I-VI; 14 patients received five monthly treatments with the 1,064 nm laser, while the other 10 patients received four monthly treatments with the 532 nm laser.
Blinded evaluators assessed images taken at baseline and at 12 weeks after treatment. The evaluators found improvements of greater than 20% in 56.9% of the evaluated images, with no statistically significant difference between the two wavelengths. Of those treated with the 1,064 nm laser, 12 of 14 patients were “satisfied” or “very satisfied”; of those treated with the 532 nm laser, 8 of the 10 were “satisfied” or “very satisfied,” Dr. Bernstein and his colleagues wrote in the Journal of Drugs in Dermatology.
Patients experienced only mild to moderate discomfort during the laser treatment. Side effects were mild and were limited to erythema and edema in almost all patients; fewer than half the patients developed petechiae. Side effects generally resolved within a few days of treatment.
Dr. Bernstein and some of the other authors reported relationships with Syneron Candela, which provided funding for and loaned equipment used in the study.
Source: Bernstein EF et al. J Drugs Dermatol. 2017 Nov 1;16(11):1077-82.
wrote Eric F. Bernstein, MD, a laser surgeon in private practice in Ardmore, Pa., and his associates.
In the study, two fractionated lasers were each combined with a specially designed “holographic beam-splitting optic” to treat mild to moderate facial wrinkles in 24 patients aged 18-75 years with Fitzpatrick skin types I-VI; 14 patients received five monthly treatments with the 1,064 nm laser, while the other 10 patients received four monthly treatments with the 532 nm laser.
Blinded evaluators assessed images taken at baseline and at 12 weeks after treatment. The evaluators found improvements of greater than 20% in 56.9% of the evaluated images, with no statistically significant difference between the two wavelengths. Of those treated with the 1,064 nm laser, 12 of 14 patients were “satisfied” or “very satisfied”; of those treated with the 532 nm laser, 8 of the 10 were “satisfied” or “very satisfied,” Dr. Bernstein and his colleagues wrote in the Journal of Drugs in Dermatology.
Patients experienced only mild to moderate discomfort during the laser treatment. Side effects were mild and were limited to erythema and edema in almost all patients; fewer than half the patients developed petechiae. Side effects generally resolved within a few days of treatment.
Dr. Bernstein and some of the other authors reported relationships with Syneron Candela, which provided funding for and loaned equipment used in the study.
Source: Bernstein EF et al. J Drugs Dermatol. 2017 Nov 1;16(11):1077-82.
FROM THE JOURNAL OF DRUGS IN DERMATOLOGY
Acne is linked to higher chances of major depression
according to a retrospective cohort analysis published as a research letter.
“The onset of acne, when patients present for treatment because of active disease, is associated with a greater risk of developing depression” wrote Isabelle A. Vallerand, an MD/PhD student at the University of Calgary (Alta.), and her associates. “Although the severity of acne was not assessed directly in the current study, this finding suggests a potential dose/response relationship such that more active disease may lead to a greater risk of depression.”
In total, 134,437 acne patients and 1,731,608 patients without acne were identified from THIN. Over a 15-year follow-up, the probability of developing MDD was 18.5% among patients with acne, and 12% for those without acne. This risk was much higher within the first year after diagnosis (adjusted hazard ratio, 1.63; 95% confidence interval, 1.33-2), which subsequently decreased.
The researchers found that patients with acne tended to be younger (67.6% vs. 22.8%), female (58.6% vs. 48.6%), and of a higher socioeconomic status (24.4% vs. 22.1%) compared with patients without acne. Those with acne tended to smoke (58.4% vs. 48.6%) and to have comorbidities (17.2% vs. 13.8%). Conversely, acne patients were less likely to use alcohol (17% vs. 39%) and less likely to be obese (2.3% vs. 6.6%) (all P less than .001).
Although these results are promising, there are several limitations that could have influenced the study findings. The misclassification of patients with acne and MDD could have occurred if patients did not present themselves to a physician for treatment. Another limitation was that isotretinoin was the only acne treatment that was considered by the researchers. Considering that treatment has been shown to reduce depressive symptoms, the researchers believe that their estimates are conservative.
“Given the tremendous burden of MDD and its temporal association with active acne, it is critical that physicians monitor mood symptoms in patients with acne and initiate prompt MDD management or seek consultation from a psychiatrist when needed” wrote Ms. Vallerand and her colleagues.
Ms. Vallerand received funding for this study from the Alberta Innovates Health Solutions MD-PhD Studentship and from the Mach-Gaensslen Foundation of Canada. None of the other authors had disclosures to report.
SOURCE: Vallerand I et al. Br J Dermatol. 2018 Feb 7. doi: 10.1111/bjd.16099.
according to a retrospective cohort analysis published as a research letter.
“The onset of acne, when patients present for treatment because of active disease, is associated with a greater risk of developing depression” wrote Isabelle A. Vallerand, an MD/PhD student at the University of Calgary (Alta.), and her associates. “Although the severity of acne was not assessed directly in the current study, this finding suggests a potential dose/response relationship such that more active disease may lead to a greater risk of depression.”
In total, 134,437 acne patients and 1,731,608 patients without acne were identified from THIN. Over a 15-year follow-up, the probability of developing MDD was 18.5% among patients with acne, and 12% for those without acne. This risk was much higher within the first year after diagnosis (adjusted hazard ratio, 1.63; 95% confidence interval, 1.33-2), which subsequently decreased.
The researchers found that patients with acne tended to be younger (67.6% vs. 22.8%), female (58.6% vs. 48.6%), and of a higher socioeconomic status (24.4% vs. 22.1%) compared with patients without acne. Those with acne tended to smoke (58.4% vs. 48.6%) and to have comorbidities (17.2% vs. 13.8%). Conversely, acne patients were less likely to use alcohol (17% vs. 39%) and less likely to be obese (2.3% vs. 6.6%) (all P less than .001).
Although these results are promising, there are several limitations that could have influenced the study findings. The misclassification of patients with acne and MDD could have occurred if patients did not present themselves to a physician for treatment. Another limitation was that isotretinoin was the only acne treatment that was considered by the researchers. Considering that treatment has been shown to reduce depressive symptoms, the researchers believe that their estimates are conservative.
“Given the tremendous burden of MDD and its temporal association with active acne, it is critical that physicians monitor mood symptoms in patients with acne and initiate prompt MDD management or seek consultation from a psychiatrist when needed” wrote Ms. Vallerand and her colleagues.
Ms. Vallerand received funding for this study from the Alberta Innovates Health Solutions MD-PhD Studentship and from the Mach-Gaensslen Foundation of Canada. None of the other authors had disclosures to report.
SOURCE: Vallerand I et al. Br J Dermatol. 2018 Feb 7. doi: 10.1111/bjd.16099.
according to a retrospective cohort analysis published as a research letter.
“The onset of acne, when patients present for treatment because of active disease, is associated with a greater risk of developing depression” wrote Isabelle A. Vallerand, an MD/PhD student at the University of Calgary (Alta.), and her associates. “Although the severity of acne was not assessed directly in the current study, this finding suggests a potential dose/response relationship such that more active disease may lead to a greater risk of depression.”
In total, 134,437 acne patients and 1,731,608 patients without acne were identified from THIN. Over a 15-year follow-up, the probability of developing MDD was 18.5% among patients with acne, and 12% for those without acne. This risk was much higher within the first year after diagnosis (adjusted hazard ratio, 1.63; 95% confidence interval, 1.33-2), which subsequently decreased.
The researchers found that patients with acne tended to be younger (67.6% vs. 22.8%), female (58.6% vs. 48.6%), and of a higher socioeconomic status (24.4% vs. 22.1%) compared with patients without acne. Those with acne tended to smoke (58.4% vs. 48.6%) and to have comorbidities (17.2% vs. 13.8%). Conversely, acne patients were less likely to use alcohol (17% vs. 39%) and less likely to be obese (2.3% vs. 6.6%) (all P less than .001).
Although these results are promising, there are several limitations that could have influenced the study findings. The misclassification of patients with acne and MDD could have occurred if patients did not present themselves to a physician for treatment. Another limitation was that isotretinoin was the only acne treatment that was considered by the researchers. Considering that treatment has been shown to reduce depressive symptoms, the researchers believe that their estimates are conservative.
“Given the tremendous burden of MDD and its temporal association with active acne, it is critical that physicians monitor mood symptoms in patients with acne and initiate prompt MDD management or seek consultation from a psychiatrist when needed” wrote Ms. Vallerand and her colleagues.
Ms. Vallerand received funding for this study from the Alberta Innovates Health Solutions MD-PhD Studentship and from the Mach-Gaensslen Foundation of Canada. None of the other authors had disclosures to report.
SOURCE: Vallerand I et al. Br J Dermatol. 2018 Feb 7. doi: 10.1111/bjd.16099.
FROM BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Patients with acne have a much higher chance of developing major depressive disorder (MDD).
Major finding: The chance of developing MDD was 18.5% in patients with acne.
Study details: Analysis of retrospective cohort data obtained from the Health Improvement Network (THIN) between 1986 and 2012.
Disclosures: Ms. Vallerand received funding for this study from the Alberta Innovates Health Solutions MD-PhD Studentship and from the Mach-Gaensslen Foundation of Canada. None of the other authors had disclosures to report.
Source: Vallerand I et al. Br J Dermatol. 2018 Feb 7. doi: 10.1111/bjd.16099.
Pediatrician blogs generally provide accurate vaccine information
Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.
“ However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”
Ultimately, the researchers examined 31 blogs with 324 posts related to vaccine content. Most of the information addressed “specific vaccines,” which accounted for 36% of all vaccine-related blog posts. The two most discussed vaccines were MMR (41% of vaccine-specific posts) and influenza (35%). Pediatrician bloggers also commonly addressed “activism against antivaccination,” which was the second most popular topic category.
The analysis revealed that many of the blog posts (91%) on 29 pediatrician blogs provided CDCC information. Only two blogs contained inaccurate vaccine information. Vaccine safety was the most commonly refuted CDCC information, with inaccurate information such as, “We are literally poisoning unborn children with the Tdap now being given to pregnant women with no testing ever done to inject that much aluminum into pregnant animals even!”
Vaccine-scheduling CDCC information was another topic that was addressed inaccurately, with statements such as, “Routine administration of hepatitis B vaccine to 1-day-old infants, which began in 1991, is an unwarranted practice that needs to stopped as soon as possible.” Delayed vaccinations also were inaccurately discussed in 5% of blog posts from two bloggers, who recommended that hepatitis B and MMR vaccines be delayed.
The study had several limitations, including how the blogs were selected for analysis; all were identified using common search engines, which may have caused researchers to miss an unknown number of blogs. In addition, information may have been augmented by “hyperbloggers,” who account for a large proportion of blog posts about vaccines, the researchers reported in Vaccine.
“While uncommon, the presentation of inaccurate, antivaccine information on pediatrician blogs may be persuasive to parents reading vaccine information online. Parents who delay immunizations due to safety concerns are more likely to use the Internet to learn more about vaccines,” wrote Dr. Bryan and her colleagues. “While these negative pediatrician bloggers are the exception, their impact may be disproportionate as people exposed to negative vaccine information in blog format have a more negative view of vaccinations than those exposed to positive vaccine information. Half of parents do not cross-check the information they read online with their doctor.”
The authors had no relevant financial disclosures.
SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.
Facebook and Twitter are useful tools for spreading vaccine information to families, but refuting “antivaccine” information can cause pushback.
“I use social media to disseminate information to families in my practice via a practice Facebook page, as well as to a larger audience via Twitter. I also share information with personal comments on my personal Facebook page,” Deborah Greenhouse, MD, said in an interview. “I have definitely run into questions over concerns with specific vaccines, particularly HPV [human papillomavirus] vaccine and MMR vaccine. Most of these originate with anecdotal posts about vaccine adverse effects.”
When addressing vaccine fears, Dr. Greenhouse presents current, fact-based information from credible sources, stressing the fact that correlation does not equal causation. To keep the lines of communication open, she encourages her patients to call with vaccine safety related questions.
While she has had some positive experiences with refuting “antivaccine” information, it also has been unpleasant. “Sometimes my posts and tweets have led to good interactive discussion. But sometimes they have led to extremely hostile and sometimes obscenity-laden responses by antivaccine activists.”
Despite “antivaccine” concern and pushback via social media, “alternative scheduling” is not viewed as “better than nothing,” she said. The vaccine schedule is based on solid science and should be adhered to. Deviating from a recommended vaccine schedule can put a child at unnecessary, and unacceptable, risk.
Dr. Greenhouse has used social media outreach to effectively provide information to her patients, but also has noted that some pediatricians provide inaccurate information online. “They are tougher to refute than the typical layperson because their credentials make them seem credible.”
Dr. Deborah Greenhouse is a board-certified pediatrician at the Palmetto Pediatric and Adolescent Clinic in Columbia, S.C. She is also a fellow of the American Academy of Pediatrics.
Facebook and Twitter are useful tools for spreading vaccine information to families, but refuting “antivaccine” information can cause pushback.
“I use social media to disseminate information to families in my practice via a practice Facebook page, as well as to a larger audience via Twitter. I also share information with personal comments on my personal Facebook page,” Deborah Greenhouse, MD, said in an interview. “I have definitely run into questions over concerns with specific vaccines, particularly HPV [human papillomavirus] vaccine and MMR vaccine. Most of these originate with anecdotal posts about vaccine adverse effects.”
When addressing vaccine fears, Dr. Greenhouse presents current, fact-based information from credible sources, stressing the fact that correlation does not equal causation. To keep the lines of communication open, she encourages her patients to call with vaccine safety related questions.
While she has had some positive experiences with refuting “antivaccine” information, it also has been unpleasant. “Sometimes my posts and tweets have led to good interactive discussion. But sometimes they have led to extremely hostile and sometimes obscenity-laden responses by antivaccine activists.”
Despite “antivaccine” concern and pushback via social media, “alternative scheduling” is not viewed as “better than nothing,” she said. The vaccine schedule is based on solid science and should be adhered to. Deviating from a recommended vaccine schedule can put a child at unnecessary, and unacceptable, risk.
Dr. Greenhouse has used social media outreach to effectively provide information to her patients, but also has noted that some pediatricians provide inaccurate information online. “They are tougher to refute than the typical layperson because their credentials make them seem credible.”
Dr. Deborah Greenhouse is a board-certified pediatrician at the Palmetto Pediatric and Adolescent Clinic in Columbia, S.C. She is also a fellow of the American Academy of Pediatrics.
Facebook and Twitter are useful tools for spreading vaccine information to families, but refuting “antivaccine” information can cause pushback.
“I use social media to disseminate information to families in my practice via a practice Facebook page, as well as to a larger audience via Twitter. I also share information with personal comments on my personal Facebook page,” Deborah Greenhouse, MD, said in an interview. “I have definitely run into questions over concerns with specific vaccines, particularly HPV [human papillomavirus] vaccine and MMR vaccine. Most of these originate with anecdotal posts about vaccine adverse effects.”
When addressing vaccine fears, Dr. Greenhouse presents current, fact-based information from credible sources, stressing the fact that correlation does not equal causation. To keep the lines of communication open, she encourages her patients to call with vaccine safety related questions.
While she has had some positive experiences with refuting “antivaccine” information, it also has been unpleasant. “Sometimes my posts and tweets have led to good interactive discussion. But sometimes they have led to extremely hostile and sometimes obscenity-laden responses by antivaccine activists.”
Despite “antivaccine” concern and pushback via social media, “alternative scheduling” is not viewed as “better than nothing,” she said. The vaccine schedule is based on solid science and should be adhered to. Deviating from a recommended vaccine schedule can put a child at unnecessary, and unacceptable, risk.
Dr. Greenhouse has used social media outreach to effectively provide information to her patients, but also has noted that some pediatricians provide inaccurate information online. “They are tougher to refute than the typical layperson because their credentials make them seem credible.”
Dr. Deborah Greenhouse is a board-certified pediatrician at the Palmetto Pediatric and Adolescent Clinic in Columbia, S.C. She is also a fellow of the American Academy of Pediatrics.
Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.
“ However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”
Ultimately, the researchers examined 31 blogs with 324 posts related to vaccine content. Most of the information addressed “specific vaccines,” which accounted for 36% of all vaccine-related blog posts. The two most discussed vaccines were MMR (41% of vaccine-specific posts) and influenza (35%). Pediatrician bloggers also commonly addressed “activism against antivaccination,” which was the second most popular topic category.
The analysis revealed that many of the blog posts (91%) on 29 pediatrician blogs provided CDCC information. Only two blogs contained inaccurate vaccine information. Vaccine safety was the most commonly refuted CDCC information, with inaccurate information such as, “We are literally poisoning unborn children with the Tdap now being given to pregnant women with no testing ever done to inject that much aluminum into pregnant animals even!”
Vaccine-scheduling CDCC information was another topic that was addressed inaccurately, with statements such as, “Routine administration of hepatitis B vaccine to 1-day-old infants, which began in 1991, is an unwarranted practice that needs to stopped as soon as possible.” Delayed vaccinations also were inaccurately discussed in 5% of blog posts from two bloggers, who recommended that hepatitis B and MMR vaccines be delayed.
The study had several limitations, including how the blogs were selected for analysis; all were identified using common search engines, which may have caused researchers to miss an unknown number of blogs. In addition, information may have been augmented by “hyperbloggers,” who account for a large proportion of blog posts about vaccines, the researchers reported in Vaccine.
“While uncommon, the presentation of inaccurate, antivaccine information on pediatrician blogs may be persuasive to parents reading vaccine information online. Parents who delay immunizations due to safety concerns are more likely to use the Internet to learn more about vaccines,” wrote Dr. Bryan and her colleagues. “While these negative pediatrician bloggers are the exception, their impact may be disproportionate as people exposed to negative vaccine information in blog format have a more negative view of vaccinations than those exposed to positive vaccine information. Half of parents do not cross-check the information they read online with their doctor.”
The authors had no relevant financial disclosures.
SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.
Pediatrician blogs frequently provide accurate information to parents concerning vaccines, although some blogs do provide information inconsistent with Centers for Disease Control and Prevention guidelines, a study found.
“ However, we identified two exceptions in which pediatrician blogs conveyed extremely inaccurate, antivaccine information,” wrote Mersine A. Bryan, MD, of the University of Washington, Seattle, and her colleagues. “These two extreme blogs were the only blogs that contained any information that was not consistent with CDC information. This finding is important because pediatricians are viewed by parents as a trusted source of information about vaccines.”
Ultimately, the researchers examined 31 blogs with 324 posts related to vaccine content. Most of the information addressed “specific vaccines,” which accounted for 36% of all vaccine-related blog posts. The two most discussed vaccines were MMR (41% of vaccine-specific posts) and influenza (35%). Pediatrician bloggers also commonly addressed “activism against antivaccination,” which was the second most popular topic category.
The analysis revealed that many of the blog posts (91%) on 29 pediatrician blogs provided CDCC information. Only two blogs contained inaccurate vaccine information. Vaccine safety was the most commonly refuted CDCC information, with inaccurate information such as, “We are literally poisoning unborn children with the Tdap now being given to pregnant women with no testing ever done to inject that much aluminum into pregnant animals even!”
Vaccine-scheduling CDCC information was another topic that was addressed inaccurately, with statements such as, “Routine administration of hepatitis B vaccine to 1-day-old infants, which began in 1991, is an unwarranted practice that needs to stopped as soon as possible.” Delayed vaccinations also were inaccurately discussed in 5% of blog posts from two bloggers, who recommended that hepatitis B and MMR vaccines be delayed.
The study had several limitations, including how the blogs were selected for analysis; all were identified using common search engines, which may have caused researchers to miss an unknown number of blogs. In addition, information may have been augmented by “hyperbloggers,” who account for a large proportion of blog posts about vaccines, the researchers reported in Vaccine.
“While uncommon, the presentation of inaccurate, antivaccine information on pediatrician blogs may be persuasive to parents reading vaccine information online. Parents who delay immunizations due to safety concerns are more likely to use the Internet to learn more about vaccines,” wrote Dr. Bryan and her colleagues. “While these negative pediatrician bloggers are the exception, their impact may be disproportionate as people exposed to negative vaccine information in blog format have a more negative view of vaccinations than those exposed to positive vaccine information. Half of parents do not cross-check the information they read online with their doctor.”
The authors had no relevant financial disclosures.
SOURCE: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.
FROM VACCINE
Key clinical point: Pediatricians usually provide accurate information via blogs.
Major finding: 91% of blog posts on 29 pediatrician blogs contained only CDC-consistent information.
Study details: A content analysis of 31 pediatrician blogs from Jan. 1, 2014, to Feb. 28, 2015.
Disclosures: The authors had no relevant financial disclosures.
Source: Bryan MA et al. Vaccine. 2018 Jan 29;36(5):765-70.